Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations
| Published date | 14 August 2019 |
| Citation | 84 FR 40482 |
| Record Number | 2019-16041 |
| Section | Proposed rules |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 84 Issue 157 (Wednesday, August 14, 2019)
[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Proposed Rules]
[Pages 40482-41289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16041]
[[Page 40481]]
Vol. 84
Wednesday,
No. 157
August 14, 2019
Part II
Book 2 of 3 Books
Pages 40481-41289
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 403, 410, 415, 416, et al.
Medicare Program; CY 2020 Revisions to Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment Policies;
Medicare Shared Savings Program Requirements; Medicaid Promoting
Interoperability Program Requirements for Eligible Professionals;
Establishment of an Ambulance Data Collection System; Updates to the
Quality Payment Program; Medicare Enrollment of Opioid Treatment
Programs and Enhancements to Provider Enrollment Regulations Concerning
Improper Prescribing and Patient Harm; and Amendments to Physician
Self-Referral Law Advisory Opinion Regulations; Proposed Rules
Federal Register / Vol. 84 , No. 157 / Wednesday, August 14, 2019 /
Proposed Rules
[[Page 40482]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 410, 414, 415, 416, 418, 424, 425, 489, and 498
[CMS-1715-P]
RIN 0938-AT72
Medicare Program; CY 2020 Revisions to Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment Policies;
Medicare Shared Savings Program Requirements; Medicaid Promoting
Interoperability Program Requirements for Eligible Professionals;
Establishment of an Ambulance Data Collection System; Updates to the
Quality Payment Program; Medicare Enrollment of Opioid Treatment
Programs and Enhancements to Provider Enrollment Regulations Concerning
Improper Prescribing and Patient Harm; and Amendments to Physician
Self-Referral Law Advisory Opinion Regulations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This major proposed rule addresses: Changes to the physician
fee schedule (PFS); other changes to Medicare Part B payment policies
to ensure that payment systems are updated to reflect changes in
medical practice, relative value of services, and changes in the
statute; Medicare Shared Savings Program quality reporting
requirements; Medicaid Promoting Interoperability Program requirements
for eligible professionals; the establishment of an ambulance data
collection system; updates to the Quality Payment Program; Medicare
enrollment of Opioid Treatment Programs and enhancements to provider
enrollment regulations concerning improper prescribing and patient
harm; and amendments to Physician Self-Referral Law advisory opinion
regulations.
DATES: Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on September 27, 2019.
ADDRESSES: In commenting, please refer to file code CMS-1715-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1715-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1715-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
FURTHER INFORMATION CONTACT:
Jamie Hermansen, (410) 786-2064, for any issues not identified
below.
Michael Soracoe, (410) 786-6312, for issues related to practice
expense, work RVUs, conversion factor, and impacts.
Geri Mondowney, (410) 786-1172, or Tourette Jackson, (410) 786-
4735, for issues related to malpractice RVUs and geographic practice
cost indicies (GPCIs).
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Lindsey Baldwin, (410) 786-1694, or Emily Yoder, (410) 786-1804,
for issues related to telehealth services.
Pierre Yong, (410) 786-8896, or Lindsey Baldwin, (410) 786-1694,
for issues related to Medicare coverage of opioid use disorder
treatment services furnished by opioid treatment programs (OTPs).
Lindsey Baldwin, (410) 786-1694, for issues related to bundled
payments under the PFS for substance use disorders.
Emily Yoder, (410) 786-1804, or Christiane LaBonte, (410) 786-7237,
for issues related to the comment solicitation on opportunities for
bundled payments under the PFS.
Regina Walker-Wren, (410) 786-9160, for issues related to physician
supervision for physician assistant (PA) services and review and
verification of medical record documentation.
Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, Liane
Grayson, (410) 786-6583, or Christiane LaBonte, (410) 786-7237, for
issues related to care management services.
Kathy Bryant, (410) 786-3448, for issues related to coinsurance for
colorectal cancer screening tests.
Pamela West, (410) 786-2302, for issues related to therapy
services.
Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, or
Christiane LaBonte, (410) 786-7237, for issues related to payment for
evaluation and management services.
Kathy Bryant, (410) 786-3448, for issues related to global surgery
data collection.
Thomas Kessler, (410) 786-1991, for issues related to ambulance
physician certification statement.
Felicia Eggleston, (410) 786-9287, or Amy Gruber, (410) 786-1542,
for issues related to the ambulance fee schedule-BBA of 2018
requirements for Medicare ground ambulance services data collection
system.
Linda Gousis, (410) 786-8616, for issues related to intensive
cardiac rehabilitation.
David Koppel, (303) 844-2883, or Elizabeth LeBreton, (202) 615-
3816, for issues related to the Medicaid Promoting Interoperability
Program.
Fiona Larbi, (410) 786-7224, for issues related to the Medicare
Shared Savings Program (Shared Savings Program) Quality Measures.
Katie Mucklow, (410) 786-0537, or Diana Behrendt, (410) 786-6192,
for issues related to open payments.
Cheryl Gilbreath, (410) 786-5919, for issues related to home
infusion therapy benefit.
Joseph Schultz, (410) 786-2656, for issues related to Medicare
enrollment of opioid treatment programs, and enhancements to provider
enrollment regulations concerning improper prescribing and patient
harm.
Jacqueline Leach, (410) 786-4282, for issues related to Deferring
to State Scope of Practice Requirements: Ambulatory Surgical Centers
(ASC).
Mary Rossi-Coajou, (410) 786-6051, for issues related to Deferring
to State Scope of Practice Requirements: Hospice.
[email protected], for issues related to Advisory
Opinions on Application of the Physician Self-referral law.
Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
Megan Hyde, (410) 786-3247, for inquiries related to Alternative
Payment Models (APMs).
SUPPLEMENTARY INFORMATION:
Addenda Available Only Through the Internet on the CMS Website
The PFS Addenda along with other supporting documents and tables
referenced in this proposed rule are available on the CMS website at
http://www.cms.gov/Medicare/Medicare-Fee-
[[Page 40483]]
for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-
Notices.html. Click on the link on the left side of the screen titled,
``PFS Federal Regulations Notices'' for a chronological list of PFS
Federal Register and other related documents. For the CY 2020 PFS
proposed rule, refer to item CMS-1715-P. Readers with questions related
to accessing any of the Addenda or other supporting documents
referenced in this proposed rule and posted on the CMS website
identified above should contact Jamie Hermansen at (410) 786-2064.
CPT (Current Procedural Terminology) Copyright Notice
Throughout this proposed rule, we use CPT codes and descriptions to
refer to a variety of services. We note that CPT codes and descriptions
are copyright 2019 American Medical Association. All Rights Reserved.
CPT is a registered trademark of the American Medical Association
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense
Federal Acquisition Regulations (DFAR) apply.
I. Executive Summary
A. Purpose
This major proposed rule proposes to revise payment polices under
the Medicare PFS and make other policy changes, including proposals to
implement certain provisions of the Bipartisan Budget Act of 2018 (BBA
of 2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment
(SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub. L.
115-271, October 24, 2018), related to Medicare Part B payment,
applicable to services furnished in CY 2020 and thereafter. In
addition, this proposed rule includes proposals related to payment
policy changes that are addressed in section III. of this proposed
rule. We are requesting public comments on all of the proposals being
made in this proposed rule.
1. Summary of the Major Provisions
The statute requires us to establish payments under the PFS based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: Work;
practice expense (PE); and malpractice (MP) expense. In addition, the
statute requires that we establish by regulation each year's payment
amounts for all physicians' services paid under the PFS, incorporating
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major proposed rule, we are proposing to establish RVUs for
CY 2020 for the PFS to ensure that our payment systems are updated to
reflect changes in medical practice and the relative value of services,
as well as changes in the statute. This proposed rule also includes
discussions and proposals regarding several other Medicare Part B
payment policies, Medicare Shared Savings Program quality reporting
requirements, Medicaid Promoting Interoperability Program requirements
for eligible professionals, the establishment of an ambulance data
collection system, updates to the Quality Payment Program, Medicare
enrollment of Opioid Treatment Programs and enhancements to provider
enrollment regulations concerning improper prescribing and patient
harm; and amendments to Physician Self-Referral Law advisory opinion
regulations. This proposed rule addresses:
Practice Expense RVUs (section II.B.)
Malpractice RVUs (section II.C.)
Geographic Practice Cost Indices (GPCIs) (section II.D.)
Potentially Misvalued Services Under the PFS (section II.E.)
Telehealth Services (section II.F.)
Medicare Coverage for Opioid Use Disorder Treatment Services
Furnished by Opioid Treatment Programs (section II.G.)
Bundled Payments Under the PFS for Substance Use Disorders
(section II.H.)
Physician Supervision for Physician Assistant (PA) Services
(section II.I.)
Review and Verification of Medical Record Documentation
(section II.J.)
Care Management Services (section II.K.)
Coinsurance for Colorectal Cancer Screening Tests (section
II.L.)
Therapy Services (section II.M.)
Valuation of Specific Codes (section II.N.)
Comment Solicitation on Opportunities for Bundled Payments
Under the PFS (section II.O.)
Payment for Evaluation and Management (E/M) Services (section
II.P.)
Ambulance Coverage Services--Physician Certification Statement
(section III.A.)
Ambulance Fee Schedule--Medicare Ground Ambulance Services
Data Collection System (section III.B.)
Intensive Cardiac Rehabilitation (section III.C.)
Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals (EPs) (section III.D.)
Medicare Shared Savings Program Quality Measures (section
III.E.)
Open Payments (section III.F.)
Home Infusion Therapy Benefit (section III.G.)
Medicare Enrollment of Opioid Treatment Programs and
Enhancements to Existing General Enrollment Policies Related to
Improper Prescribing and Patient Harm (section III.H.)
Deferring to State Scope of Practice Requirements (section
III.I.)
Advisory Opinions on the Application of the Physician Self-
Referral Law (section III.J.)
Updates to the Quality Payment Program (section III.K.)
2. Summary of Costs and Benefits
We have determined that this major proposed rule is economically
significant. For a detailed discussion of the economic impacts, see
section VI. of this proposed rule.
II. Provisions of the Proposed Rule for the PFS
A. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Act, ``Payment for Physicians' Services.''
The PFS relies on national relative values that are established for
work, practice expense (PE), and malpractice (MP), which are adjusted
for geographic cost variations. These values are multiplied by a
conversion factor (CF) to convert the relative value units (RVUs) into
payment rates. The concepts and methodology underlying the PFS were
enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub.
L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus
Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November
5, 1990) (OBRA '90). The final rule published in the November 25, 1991
Federal Register (56 FR 59502) set forth the first fee schedule used
for payment for physicians' services.
We note that throughout this major proposed rule, unless otherwise
noted, the term ``practitioner'' is used to describe both physicians
and nonphysician practitioners (NPPs) who are permitted to bill
Medicare under the PFS for the services they furnish to Medicare
beneficiaries.
1. Development of the RVUs
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
[[Page 40484]]
implemented on January 1, 1992, were developed with extensive input
from the physician community. A research team at the Harvard School of
Public Health developed the original work RVUs for most codes under a
cooperative agreement with the Department of Health and Human Services
(HHS). In constructing the code-specific vignettes used in determining
the original physician work RVUs, Harvard worked with panels of
experts, both inside and outside the federal government, and obtained
input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work
component of physicians' services means the portion of the resources
used in furnishing the service that reflects physician time and
intensity. We establish work RVUs for new, revised and potentially
misvalued codes based on our review of information that generally
includes, but is not limited to, recommendations received from the
American Medical Association/Specialty Society Relative Value Scale
Update Committee (RUC), the Health Care Professionals Advisory
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC),
and other public commenters; medical literature and comparative
databases; as well as a comparison of the work for other codes within
the Medicare PFS, and consultation with other physicians and health
care professionals within CMS and the federal government. We also
assess the methodology and data used to develop the recommendations
submitted to us by the RUC and other public commenters, and the
rationale for their recommendations. In the CY 2011 PFS final rule with
comment period (75 FR 73328 through 73329), we discussed a variety of
methodologies and approaches used to develop work RVUs, including
survey data, building blocks, crosswalk to key reference or similar
codes, and magnitude estimation. More information on these issues is
available in that rule.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and
required us to develop resource-based PE RVUs for each physicians'
service beginning in 1998. We were required to consider general
categories of expenses (such as office rent and wages of personnel, but
excluding MP expenses) comprising PEs. The PE RVUs continue to
represent the portion of these resources involved in furnishing PFS
services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L.
105-33, enacted on August 5, 1997) (BBA of 1997) delayed implementation
of the resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA of 1997 provided for a 4-year transition
period from the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in the November 2, 1998 final rule (63 FR 58814), effective for
services furnished in CY 1999. Based on the requirement to transition
to a resource-based system for PE over a 4-year period, payment rates
were not fully based upon resource-based PE RVUs until CY 2002. This
resource-based system was based on two significant sources of actual PE
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's
Socioeconomic Monitoring System (SMS) data. These data sources are
described in greater detail in the CY 2012 PFS final rule with comment
period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some resource costs are borne by the
facility. Medicare's payment to the facility (such as the outpatient
prospective payment system (OPPS) payment to the HOPD) would reflect
costs typically incurred by the facility. Thus, payment associated with
those specific facility resource costs is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
Health and Human Services (the Secretary) to establish a process under
which we accept and use, to the maximum extent practicable and
consistent with sound data practices, data collected or developed by
entities and organizations to supplement the data we normally collect
in determining the PE component. On May 3, 2000, we published the
interim final rule (65 FR 25664) that set forth the criteria for the
submission of these supplemental PE survey data. The criteria were
modified in response to comments received, and published in the Federal
Register (65 FR 65376) as part of a November 1, 2000 final rule. The
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246
and 68 FR 63196) extended the period during which we would accept these
supplemental data through March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA of 1997 amended section 1848(c) of the
Act to require that we implement resource-based MP RVUs for services
furnished on or after CY 2000. The resource-based MP RVUs were
implemented in the PFS final rule with comment period published
November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and
physician-owned insurers' MP insurance premium data from all the
states, the District of Columbia, and Puerto Rico. For more information
on MP RVUs, see section II.C. of this proposed rule, Determination of
Malpractice Relative Value Units.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently. We completed 5-year
reviews of work RVUs that were effective for calendar years 1997, 2002,
2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
[[Page 40485]]
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the 5-year reviews, beginning for CY 2009, CMS and
the RUC identified and reviewed a number of potentially misvalued codes
on an annual basis based on various identification screens. This annual
review of work and PE RVUs for potentially misvalued codes was
supplemented by the amendments to section 1848 of the Act, as enacted
by section 3134 of the Affordable Care Act, that require the agency to
periodically identify, review and adjust values for potentially
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
As described in section VI. of this proposed rule, the Regulatory
Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of
the Act, if revisions to the RVUs cause expenditures for the year to
change by more than $20 million, we make adjustments to ensure that
expenditures do not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
To calculate the payment for each service, the components of the
fee schedule (work, PE, and MP RVUs) are adjusted by geographic
practice cost indices (GPCIs) to reflect the variations in the costs of
furnishing the services. The GPCIs reflect the relative costs of work,
PE, and MP in an area compared to the national average costs for each
component. Please refer to the CY 2017 PFS final rule with comment
period for a discussion of the last GPCI update (81 FR 80261 through
80270).
RVUs are converted to dollar amounts through the application of a
CF, which is calculated based on a statutory formula by CMS's Office of
the Actuary (OACT). The formula for calculating the Medicare PFS
payment amount for a given service and fee schedule area can be
expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
MP)] x CF
3. Separate Fee Schedule Methodology for Anesthesia Services
Section 1848(b)(2)(B) of the Act specifies that the fee schedule
amounts for anesthesia services are to be based on a uniform relative
value guide, with appropriate adjustment of an anesthesia CF, in a
manner to ensure that fee schedule amounts for anesthesia services are
consistent with those for other services of comparable value.
Therefore, there is a separate fee schedule methodology for anesthesia
services. Specifically, we establish a separate CF for anesthesia
services and we utilize the uniform relative value guide, or base
units, as well as time units, to calculate the fee schedule amounts for
anesthesia services. Since anesthesia services are not valued using
RVUs, a separate methodology for locality adjustments is also
necessary. This involves an adjustment to the national anesthesia CF
for each payment locality.
B. Determination of PE RVUs
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding MP expenses, as specified in section 1848(c)(1)(B) of the
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a
resource-based system for determining PE RVUs for each physicians'
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the 5-year review of work relative value
units under the PFS and proposed changes to the practice expense
methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007
PFS final rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and NPPs paid under the PFS using a survey instrument and methods
highly consistent with those used for the SMS and the supplemental
surveys. The PPIS gathered information from 3,656 respondents across 51
physician specialty and health care professional groups. We believe the
PPIS is the most comprehensive source of PE survey information
available. We used the PPIS data to update the PE/HR data for the CY
2010 PFS for almost all of the Medicare-recognized specialties that
participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
[[Page 40486]]
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file called ``CY 2020 PFS Proposed Rule PE/HR'' on the
CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2020, we have incorporated the available utilization data
for two new specialties, each of which became a recognized Medicare
specialty during 2018. These specialties are Medical Toxicology and
Hematopoietic Cell Transplantation and Cellular Therapy. We are
proposing to use proxy PE/HR values for these new specialties, as there
are no PPIS data for these specialties, by crosswalking the PE/HR as
follows from specialties that furnish similar services in the Medicare
claims data:
Medical Toxicology from Emergency Medicine; and
Hematopoietic Cell Transplantation and Cellular Therapy
from Hematology/Oncology.
These updates are reflected in the ``CY 2020 PFS Proposed Rule PE/
HR'' file available on the CMS website under the supporting data files
for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level on the basis of
the direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion. The general
approach to developing the indirect portion of the PE RVUs is as
follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Next, we incorporate the specialty-specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: Facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: A
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be
[[Page 40487]]
furnished together as a global service. When services have separately
billable PC and TC components, the payment for the global service
equals the sum of the payment for the TC and PC. To achieve this, we
use a weighted average of the ratio of indirect to direct costs across
all the specialties that furnish the global service, TCs, and PCs; that
is, we apply the same weighted average indirect percentage factor to
allocate indirect expenses to the global service, PCs, and TCs for a
service. (The direct PE RVUs for the TC and PC sum to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct readers to the file called ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this proposed rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to a RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Codes with low Medicare service volume require special attention
since billing or enrollment irregularities for a given year can result
in significant changes in specialty mix assignment. We finalized a
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning specialty mix based on the specialties
of the practitioners reporting the services in the claims data, we
instead use the expected specialty that we identify on a list developed
based on medical review and input from expert stakeholders. We display
this list of expected specialty assignments as part of the annual set
of data files we make available as part of notice and comment
rulemaking and consider recommendations from the RUC and other
stakeholders on changes to this list on an annual basis. Services for
which the specialty is automatically assigned based on previously
finalized policies under our established methodology (for example,
``always therapy'' services) are unaffected by the list of expected
specialty assignments. We also finalized in the CY 2018 PFS final rule
(82 FR 52982 through 59283) a policy to apply these service-level
overrides for both PE and MP, rather than one or the other category.
For CY 2020, we are proposing to clarify the expected specialty
assignment for a series of cardiothoracic services. Prior to the
creation of the expected specialty list for low volume services in CY
2018, we previously finalized through rulemaking a crosswalk to the
thoracic surgery specialty for a series of cardiothoracic services that
typically had fewer than 100 services reported each year (see, for
example, the CY 2012 PFS final rule (76 FR 73188-73189)). However, we
noted that for many of the affected codes, the expected specialty list
for low volume services incorrectly listed a crosswalk to the cardiac
surgery specialty instead of the thoracic surgery specialty. We are
proposing to update the expected specialty list to accurately reflect
the previously finalized crosswalk to thoracic surgery for these
services. The affected codes are shown in Table 1.
Table 1--Proposed Updates to Expected Specialty
------------------------------------------------------------------------
CY 2019 expected Updated CY 2020 expected
CPT code specialty specialty
------------------------------------------------------------------------
33414............. Cardiac Surgery.......... Thoracic Surgery.
33468............. Cardiac Surgery.......... Thoracic Surgery.
33470............. Cardiac Surgery.......... Thoracic Surgery.
33471............. Cardiac Surgery.......... Thoracic Surgery.
33476............. Cardiac Surgery.......... Thoracic Surgery.
33478............. Cardiac Surgery.......... Thoracic Surgery.
33502............. Cardiac Surgery.......... Thoracic Surgery.
33503............. Cardiac Surgery.......... Thoracic Surgery.
33504............. Cardiac Surgery.......... Thoracic Surgery.
33505............. Cardiac Surgery.......... Thoracic Surgery.
33506............. Cardiac Surgery.......... Thoracic Surgery.
33507............. Cardiac Surgery.......... Thoracic Surgery.
33600............. Cardiac Surgery.......... Thoracic Surgery.
33602............. Cardiac Surgery.......... Thoracic Surgery.
33606............. Cardiac Surgery.......... Thoracic Surgery.
33608............. Cardiac Surgery.......... Thoracic Surgery.
33610............. Cardiac Surgery.......... Thoracic Surgery.
33611............. Cardiac Surgery.......... Thoracic Surgery.
33612............. Cardiac Surgery.......... Thoracic Surgery.
33615............. Cardiac Surgery.......... Thoracic Surgery.
33617............. Cardiac Surgery.......... Thoracic Surgery.
33619............. Cardiac Surgery.......... Thoracic Surgery.
33620............. Cardiac Surgery.......... Thoracic Surgery.
33621............. Cardiac Surgery.......... Thoracic Surgery.
33622............. Cardiac Surgery.......... Thoracic Surgery.
33645............. Cardiac Surgery.......... Thoracic Surgery.
33647............. Cardiac Surgery.......... Thoracic Surgery.
33660............. Cardiac Surgery.......... Thoracic Surgery.
33665............. Cardiac Surgery.......... Thoracic Surgery.
33670............. Cardiac Surgery.......... Thoracic Surgery.
33675............. Cardiac Surgery.......... Thoracic Surgery.
33676............. Cardiac Surgery.......... Thoracic Surgery.
33677............. Cardiac Surgery.......... Thoracic Surgery.
33684............. Cardiac Surgery.......... Thoracic Surgery.
33688............. Cardiac Surgery.......... Thoracic Surgery.
33690............. Cardiac Surgery.......... Thoracic Surgery.
33692............. Cardiac Surgery.......... Thoracic Surgery.
33694............. Cardiac Surgery.......... Thoracic Surgery.
33697............. Cardiac Surgery.......... Thoracic Surgery.
33702............. Cardiac Surgery.......... Thoracic Surgery.
33710............. Cardiac Surgery.......... Thoracic Surgery.
33720............. Cardiac Surgery.......... Thoracic Surgery.
33722............. Cardiac Surgery.......... Thoracic Surgery.
33724............. Cardiac Surgery.......... Thoracic Surgery.
33726............. Cardiac Surgery.......... Thoracic Surgery.
33730............. Cardiac Surgery.......... Thoracic Surgery.
33732............. Cardiac Surgery.......... Thoracic Surgery.
33735............. Cardiac Surgery.......... Thoracic Surgery.
33736............. Cardiac Surgery.......... Thoracic Surgery.
[[Page 40488]]
33737............. Cardiac Surgery.......... Thoracic Surgery.
33750............. Cardiac Surgery.......... Thoracic Surgery.
33755............. Cardiac Surgery.......... Thoracic Surgery.
33762............. Cardiac Surgery.......... Thoracic Surgery.
33764............. Cardiac Surgery.......... Thoracic Surgery.
33766............. Cardiac Surgery.......... Thoracic Surgery.
33767............. Cardiac Surgery.......... Thoracic Surgery.
33768............. Cardiac Surgery.......... Thoracic Surgery.
33770............. Cardiac Surgery.......... Thoracic Surgery.
33771............. Cardiac Surgery.......... Thoracic Surgery.
33774............. Cardiac Surgery.......... Thoracic Surgery.
33775............. Cardiac Surgery.......... Thoracic Surgery.
33776............. Cardiac Surgery.......... Thoracic Surgery.
33777............. Cardiac Surgery.......... Thoracic Surgery.
33778............. Cardiac Surgery.......... Thoracic Surgery.
33779............. Cardiac Surgery.......... Thoracic Surgery.
33780............. Cardiac Surgery.......... Thoracic Surgery.
33781............. Cardiac Surgery.......... Thoracic Surgery.
33782............. Cardiac Surgery.......... Thoracic Surgery.
33783............. Cardiac Surgery.......... Thoracic Surgery.
33786............. Cardiac Surgery.......... Thoracic Surgery.
33788............. Cardiac Surgery.......... Thoracic Surgery.
33800............. Cardiac Surgery.......... Thoracic Surgery.
33802............. Cardiac Surgery.......... Thoracic Surgery.
33803............. Cardiac Surgery.......... Thoracic Surgery.
33813............. Cardiac Surgery.......... Thoracic Surgery.
33814............. Cardiac Surgery.......... Thoracic Surgery.
33820............. Cardiac Surgery.......... Thoracic Surgery.
33822............. Cardiac Surgery.......... Thoracic Surgery.
33824............. Cardiac Surgery.......... Thoracic Surgery.
33840............. Cardiac Surgery.......... Thoracic Surgery.
33845............. Cardiac Surgery.......... Thoracic Surgery.
33851............. Cardiac Surgery.......... Thoracic Surgery.
33852............. Cardiac Surgery.......... Thoracic Surgery.
33853............. Cardiac Surgery.......... Thoracic Surgery.
33917............. Cardiac Surgery.......... Thoracic Surgery.
33920............. Cardiac Surgery.......... Thoracic Surgery.
33922............. Cardiac Surgery.......... Thoracic Surgery.
33924............. Cardiac Surgery.......... Thoracic Surgery.
33925............. Cardiac Surgery.......... Thoracic Surgery.
33926............. Cardiac Surgery.......... Thoracic Surgery.
35182............. Cardiac Surgery.......... Thoracic Surgery.
------------------------------------------------------------------------
We note that the cardiac surgery and thoracic surgery specialties
are similar to one another, sharing the same PE/HR data for PE
valuation and nearly identical MP risk factors for MP valuation. As a
result, we do not anticipate this proposal having a discernible effect
on the valuation of the codes listed above. For additional discussion
on this issue, we refer readers to section II.C of this proposed rule,
Malpractice. The complete list of expected specialty assignments for
individual low volume services, including the assignments for the codes
identified in Table 1, is available on our website under downloads for
the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs would be allocated
using the work RVUs, and for the TC service, indirect PEs would be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
called ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of
current aggregate PE and work RVUs. This adjustment ensures that all PE
RVUs in the PFS account for the fact that certain specialties are
excluded from the calculation of PE RVUs but included in maintaining
overall PFS budget neutrality. (See ``Specialties excluded from
ratesetting calculation'' later in this proposed rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable
[[Page 40489]]
adjustments in work, PE, and MP RVUs shall be phased in over a 2-year
period. In implementing the phase-in, we consider a 19 percent
reduction as the maximum 1-year reduction for any service not described
by a new or revised code. This approach limits the year one reduction
for the service to the maximum allowed amount (that is, 19 percent),
and then phases in the remainder of the reduction. To comply with
section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure that the
total RVUs for all services that are not new or revised codes decrease
by no more than 19 percent, and then apply a relativity adjustment to
ensure that the total pool of aggregate PE RVUs remains relative to the
pool of work and MP RVUs. For a more detailed description of the
methodology for the phase-in of significant RVU changes, we refer
readers to the CY 2016 PFS final rule with comment period (80 FR 70927
through 70931).
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE and MP RVUs, we exclude certain
specialties, such as certain NPPs paid at a percentage of the PFS and
low-volume specialties, from the calculation. These specialties are
included for the purposes of calculating the BN adjustment. They are
displayed in Table 2.
Table 2--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
Specialty code Specialty description
------------------------------------------------------------------------
49...................... Ambulatory surgical center.
50...................... Nurse practitioner.
51...................... Medical supply company with certified
orthotist.
52...................... Medical supply company with certified
prosthetist.
53...................... Medical supply company with certified
prosthetist[dash]orthotist.
54...................... Medical supply company not included in 51, 52,
or 53.
55...................... Individual certified orthotist.
56...................... Individual certified prosthetist.
57...................... Individual certified
prosthetist[dash]orthotist.
58...................... Medical supply company with registered
pharmacist.
59...................... Ambulance service supplier, e.g., private
ambulance companies, funeral homes, etc.
60...................... Public health or welfare agencies.
61...................... Voluntary health or charitable agencies.
73...................... Mass immunization roster biller.
74...................... Radiation therapy centers.
87...................... All other suppliers (e.g., drug and department
stores).
88...................... Unknown supplier/provider specialty.
89...................... Certified clinical nurse specialist.
96...................... Optician.
97...................... Physician assistant.
A0...................... Hospital.
A1...................... SNF.
A2...................... Intermediate care nursing facility.
A3...................... Nursing facility, other.
A4...................... HHA.
A5...................... Pharmacy.
A6...................... Medical supply company with respiratory
therapist.
A7...................... Department store.
A8...................... Grocery store.
B1...................... Supplier of oxygen and/or oxygen related
equipment (eff. 10/2/2007).
B2...................... Pedorthic personnel.
B3...................... Medical supply company with pedorthic
personnel.
B4...................... Rehabilitation Agency.
B5...................... Ocularist.
C1...................... Centralized Flu.
C2...................... Indirect Payment Procedure.
C5...................... Dentistry.
------------------------------------------------------------------------
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
[[Page 40490]]
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 3 details the manner in which the
modifiers are applied.
Table 3--Application of Payment Modifiers to Utilization Files
------------------------------------------------------------------------
Volume
Modifier Description adjustment Time adjustment
------------------------------------------------------------------------
80,81,82............ Assistant at 16%............ Intraoperative
Surgery. portion.
AS.................. Assistant at 14% (85% * 16%) Intraoperative
Surgery--Physic portion.
ian Assistant.
50 or LT and RT..... Bilateral 150%........... 150% of work
Surgery. time.
51.................. Multiple 50%............ Intraoperative
Procedure. portion.
52.................. Reduced Services 50%............ 50%.
53.................. Discontinued 50%............ 50%.
Procedure.
54.................. Intraoperative Preoperative + Preoperative +
Care only. Intraoperative Intraoperative
Percentages on portion.
the payment
files used by
Medicare
contractors to
process
Medicare
claims.
55.................. Postoperative Postoperative Postoperative
Care only. Percentage on portion.
the payment
files used by
Medicare
contractors to
process
Medicare
claims.
62.................. Co-surgeons..... 62.5%.......... 50%.
66.................. Team Surgeons... 33%............ 33%.
------------------------------------------------------------------------
We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (MPPRs). We note that
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
for multiple imaging procedures and multiple therapy services from the
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
proposed rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate)-life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage=1); generally 150,000 minutes.
usage = variable, see discussion below in this proposed rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this proposed
rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Stakeholders have often suggested that particular equipment items
are used less frequently than 50 percent of the time in the typical
setting and that CMS should reduce the equipment utilization rate based
on these recommendations. We appreciate and share stakeholders'
interest in using the most accurate assumption regarding the equipment
utilization rate for particular equipment items. However, we believe
that absent robust, objective, auditable data regarding the use of
particular items, the 50 percent assumption is the most appropriate
within the relative value system. We welcome the submission of data
that would support an alternative rate.
[[Page 40491]]
Maintenance: This factor for maintenance was finalized in the CY
1998 PFS final rule with comment period (62 FR 33164). As we previously
stated in the CY 2016 PFS final rule with comment period (80 FR 70897),
we do not believe the annual maintenance factor for all equipment is
precisely 5 percent, and we concur that the current rate likely
understates the true cost of maintaining some equipment. We also
believe it likely overstates the maintenance costs for other equipment.
When we solicited comments regarding sources of data containing
equipment maintenance rates, commenters were unable to identify an
auditable, robust data source that could be used by CMS on a wide
scale. We do not believe that voluntary submissions regarding the
maintenance costs of individual equipment items would be an appropriate
methodology for determining costs. As a result, in the absence of
publicly available datasets regarding equipment maintenance costs or
another systematic data collection methodology for determining a
different maintenance factor, we do not believe that we have sufficient
information at present to propose a variable maintenance factor for
equipment cost per minute pricing. We continue to investigate potential
avenues for determining equipment maintenance costs across a broad
range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment period
(77 FR 68902), we updated the interest rates used in developing an
equipment cost per minute calculation (see 77 FR 68902 for a thorough
discussion of this issue). The interest rate was based on the Small
Business Administration (SBA) maximum interest rates for different
categories of loan size (equipment cost) and maturity (useful life). We
are not proposing any changes to these interest rates for CY 2020. The
Interest rates are listed in Table 4.
Table 4--SBA Maximum Interest Rates
------------------------------------------------------------------------
Interest
Price Useful life years rate (%)
------------------------------------------------------------------------
$50K.............................. $50K.............................. 7+.................... 6.00
------------------------------------------------------------------------
3. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2020 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2020 PFS
proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640-67641), we continue to make improvements to the direct PE
input database to provide the number of clinical labor minutes assigned
for each task for every code in the database instead of only including
the number of clinical labor minutes for the preservice, service, and
postservice periods for each code. In addition to increasing the
transparency of the information used to set PE RVUs, this level of
detail would allow us to compare clinical labor times for activities
associated with services across the PFS, which we believe is important
to maintaining the relativity of the direct PE inputs. This information
would facilitate the identification of the usual numbers of minutes for
clinical labor tasks and the identification of exceptions to the usual
values. It would also allow for greater transparency and consistency in
the assignment of equipment minutes based on clinical labor times.
Finally, we believe that the detailed information can be useful in
maintaining standard times for particular clinical labor tasks that can
be applied consistently to many codes as they are valued over several
years, similar in principle to the use of physician preservice time
packages. We believe that setting and maintaining such standards would
provide greater consistency among codes that share the same clinical
labor tasks and could improve relativity of values among codes. For
example, as medical practice and technologies change over time, changes
in the standards could be updated simultaneously for all codes with the
applicable clinical labor tasks, instead of waiting for individual
codes to be reviewed.
In the CY 2016 PFS final rule with comment period (80 FR 70901), we
solicited comments on the appropriate standard minutes for the clinical
labor tasks associated with services that use digital technology. After
consideration of comments received, we finalized standard times for
clinical labor tasks associated with digital imaging at 2 minutes for
``Availability of prior images confirmed'', 2 minutes for ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'', 2
minutes for ``Review examination with interpreting MD'', and 1 minute
for ``Exam documents scanned into PACS.'' Exam completed in RIS system
to generate billing process and to populate images into Radiologist
work queue.'' In the CY 2017 PFS final rule (81 FR 80184 through
80186), we finalized a policy to establish a range of appropriate
standard minutes for the clinical labor activity, ``Technologist QCs
images in PACS, checking for all images, reformats, and dose page.''
These standard minutes will be applied to new and revised codes that
make use of this clinical labor activity when they are reviewed by us
for valuation. We finalized a policy to establish 2 minutes as the
standard for the simple case, 3 minutes as the standard for the
intermediate case, 4 minutes as the standard for the complex case, and
5 minutes as the standard for the highly complex case. These values
were based upon a review of the existing minutes assigned for this
clinical labor activity; we determined that 2 minutes is the duration
for most services and a small number of codes with more complex forms
of digital imaging have higher values.
[[Page 40492]]
We also finalized standard times for clinical labor tasks
associated with pathology services in the CY 2016 PFS final rule with
comment period (80 FR 70902) at 4 minutes for ``Accession specimen/
prepare for examination'', 0.5 minutes for ``Assemble and deliver
slides with paperwork to pathologists'', 0.5 minutes for ``Assemble
other light microscopy slides, open nerve biopsy slides, and clinical
history, and present to pathologist to prepare clinical pathologic
interpretation'', 1 minute for ``Clean room/equipment following
procedure'', 1 minute for ``Dispose of remaining specimens, spent
chemicals/other consumables, and hazardous waste'', and 1 minute for
``Prepare, pack and transport specimens and records for in-house
storage and external storage (where applicable).'' We do not believe
these activities would be dependent on number of blocks or batch size,
and we believe that these values accurately reflect the typical time it
takes to perform these clinical labor tasks.
In reviewing the RUC-recommended direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical labor time traditionally
assigned to the ``Prepare room, equipment and supplies'' (CA013)
clinical labor activity were split into 2 minutes for the ``Prepare
room, equipment and supplies'' activity and 1 minute for the ``Confirm
order, protocol exam'' (CA014) activity. We proposed to maintain the 3
minutes of clinical labor time for the ``Prepare room, equipment and
supplies'' activity and remove the clinical labor time for the
``Confirm order, protocol exam'' activity wherever we observed this
pattern in the RUC-recommended direct PE inputs. Commenters explained
in response that when the new version of the PE worksheet introduced
the activity codes for clinical labor, there was a need to translate
old clinical labor tasks into the new activity codes, and that a prior
clinical labor task was split into two of the new clinical labor
activity codes: CA007 (``Review patient clinical extant information and
questionnaire'') in the preservice period, and CA014 (``Confirm order,
protocol exam'') in the service period. Commenters stated that the same
clinical labor from the old PE worksheet was now divided into the CA007
and CA014 activity codes, with a standard of 1 minute for each
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity
code and 1 minute for the CA014 activity code in situations where this
was the case. However, when reviewing the clinical labor for the
reviewed codes affected by this issue, we found that several of the
codes did not include this old clinical labor task, and we also noted
that several of the reviewed codes that contained the CA014 clinical
labor activity code did not contain any clinical labor for the CA007
activity. In these situations, we continue to believe that in these
cases the 3 total minutes of clinical staff time would be more
accurately described by the CA013 ``Prepare room, equipment and
supplies'' activity code, and we finalized these clinical labor
refinements. For additional details, we direct readers to the
discussion in the CY 2019 PFS final rule (83 FR 59463-59464).
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in developing and
submitting recommendations will help us to simplify and standardize the
hundreds of different clinical labor tasks currently listed in our
direct PE database. As we did in previous calendar years, to facilitate
rulemaking for CY 2020, we are continuing to display two versions of
the Labor Task Detail public use file: One version with the old listing
of clinical labor tasks, and one with the same tasks crosswalked to the
new listing of clinical labor activity codes. These lists are available
on the CMS website under downloads for the CY 2020 PFS proposed rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Equipment Recommendations for Scope Systems
During our routine reviews of direct PE input recommendations, we
have regularly found unexplained inconsistencies involving the use of
scopes and the video systems associated with them. Some of the scopes
include video systems bundled into the equipment item, some of them
include scope accessories as part of their price, and some of them are
standalone scopes with no other equipment included. It is not always
clear which equipment items related to scopes fall into which of these
categories. We have also frequently found anomalies in the equipment
recommendations, with equipment items that consist of a scope and video
system bundle recommended, along with a separate scope video system.
Based on our review, the variations do not appear to be consistent with
the different code descriptions.
To promote appropriate relativity among the services and facilitate
the transparency of our review process, during the review of the
recommended direct PE inputs for the CY 2017 PFS proposed rule, we
developed a structure that separates the scope, the associated video
system, and any scope accessories that might be typical as distinct
equipment items for each code. Under this approach, we proposed
standalone prices for each scope, and separate prices for the video
systems and accessories that are used with scopes.
(1) Scope Equipment
Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through
46177), we proposed standardizing refinements to the way scopes have
[[Page 40493]]
been defined in the direct PE input database. We believe that there are
four general types of scopes: Non-video scopes; flexible scopes; semi-
rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and
rigid scopes would typically be paired with one of the scope video
systems, while the non-video scopes would not. The flexible scopes can
be further divided into diagnostic (or non-channeled) and therapeutic
(or channeled) scopes. We proposed to identify for each anatomical
application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video
flexible scope; (4) a non-channeled flexible video scope; and (5) a
channeled flexible video scope. We proposed to classify the existing
scopes in our direct PE database under this classification system, to
improve the transparency of our review process and improve appropriate
relativity among the services. We planned to propose input prices for
these equipment items through future rulemaking.
We proposed these changes only for the reviewed codes for CY 2017
that made use of scopes, along with updated prices for the equipment
items related to scopes utilized by these services. We did not propose
to apply these policies to codes with inputs reviewed prior to CY 2017.
We also solicited comment on this separate pricing structure for
scopes, scope video systems, and scope accessories, which we could
consider proposing to apply to other codes in future rulemaking. We did
not finalize price increases for a series of other scopes and scope
accessories, as the invoices submitted for these components indicated
that they are different forms of equipment with different product IDs
and different prices. We did not receive any data to indicate that the
equipment on the newly submitted invoices was more typical in its use
than the equipment that we were currently using for pricing.
We did not make further changes to existing scope equipment in CY
2017 to allow the RUC's PE Subcommittee the opportunity to provide
feedback. However, we believed there was some miscommunication on this
point, as the RUC's PE Subcommittee workgroup that was created to
address scope systems stated that no further action was required
following the finalization of our proposal. Therefore, we made further
proposals in the CY 2018 PFS proposed rule (82 FR 33961 through 33962)
to continue clarifying scope equipment inputs, and sought comments
regarding the new set of scope proposals. We considered creating a
single scope equipment code for each of the five categories detailed in
this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video
flexible scope; (4) a non-channeled flexible video scope; and (5) a
channeled flexible video scope. Under the current classification
system, there are many different scopes in each category depending on
the medical specialty furnishing the service and the part of the body
affected. We stated our belief that the variation between these scopes
was not significant enough to warrant maintaining these distinctions,
and we believed that creating and pricing a single scope equipment code
for each category would help provide additional clarity. We sought
public comment on the merits of this potential scope organization, as
well as any pricing information regarding these five new scope
categories.
After considering the comments on the CY 2018 PFS proposed rule, we
did not finalize our proposal to create and price a single scope
equipment code for each of the five categories previously identified.
Instead, we supported the recommendation from the commenters to create
scope equipment codes on a per-specialty basis for six categories of
scopes as applicable, including the addition of a new sixth category of
multi-channeled flexible video scopes. Our goal was to create an
administratively simple scheme that would be easier to maintain and
help to reduce administrative burden. In 2018, the RUC convened a Scope
Equipment Reorganization Workgroup to incorporate feedback from expert
stakeholders with the intention of making recommendations to us on
scope organization and scope pricing. Since the workgroup was not
convened in time to submit recommendations for the CY 2019 PFS
rulemaking cycle, we delayed proposals for any further changes to scope
equipment until CY 2020 in order to incorporate the feedback from the
aforementioned workgroup.
(2) Scope Video System
We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through
46177) to define the scope video system as including: (1) A monitor;
(2) a processor; (3) a form of digital capture; (4) a cart; and (5) a
printer. We believe that these equipment components represent the
typical case for a scope video system. Our model for this system was
the ``video system, endoscopy (processor, digital capture, monitor,
printer, cart)'' equipment item (ES031), which we proposed to re-price
as part of this separate pricing approach. We obtained current pricing
invoices for the endoscopy video system as part of our investigation of
these issues involving scopes, which we proposed to use for this re-
pricing. In response to comments, we finalized the addition of a
digital capture device to the endoscopy video system (ES031) in the CY
2017 PFS final rule (81 FR 80188). We finalized our proposal to price
the system at $33,391, based on component prices of $9,000 for the
processor, $18,346 for the digital capture device, $2,000 for the
monitor, $2,295 for the printer, and $1,750 for the cart. In the CY
2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did
not finalize, a proposal to add an LED light source into the cost of
the scope video system (ES031), which would remove the need for a
separate light source in these procedures. We also described a proposal
to increase the price of the scope video system by $1,000 to cover the
expense of miscellaneous small equipment associated with the system
that falls below the threshold of individual equipment pricing as scope
accessories (such as cables, microphones, foot pedals, etc.). With the
addition of the LED light (equipment code EQ382 at a price of $1,915),
the updated total price of the scope video system would be set at
$36,306.
We did not finalize this updated pricing to the scope video system
in CY 2018, but we did propose and finalize the updated pricing for CY
2019 to $36,306 along with changing the name of the ES031 equipment
item to ``scope video system (monitor, processor, digital capture,
cart, printer, LED light)'' to reflect the fact that the use of the
ES031 scope video system is not limited to endoscopy procedures.
(3) Scope Accessories
We understand that there may be other accessories associated with
the use of scopes. We finalized a proposal in the CY 2017 PFS final
rule (81 FR 80188) to separately price any scope accessories outside
the use of the scope video system, and individually evaluate their
inclusion or exclusion as direct PE inputs for particular codes as
usual under our current policy based on whether they are typically used
in furnishing the services described by the particular codes.
(4) Scope Proposals for CY 2020
The Scope Equipment Reorganization Workgroup organized by the RUC
submitted detailed recommendations to CMS for consideration in the CY
2020 rule cycle, describing 23 different types of scope equipment, the
HCPCS codes associated with each scope type, and a series of invoices
for scope pricing. We
[[Page 40494]]
appreciate the information provided by the workgroup and continue to
welcome additional comments and feedback from stakeholders. Based on
the recommendations from the workgroup, we are proposing to establish
23 new scope equipment codes (see Table 5).
Table 5--CY 2020 Proposed New Scope Equipment Codes
------------------------------------------------------------------------
Proposed scope
CMS code equipment Proposed price Number of
description invoices
------------------------------------------------------------------------
ES070................ rigid scope, .............. 0
cystoscopy.
ES071................ rigid scope, .............. 0
hysteroscopy.
ES072................ rigid scope, .............. 0
otoscopy.
ES073................ rigid scope, .............. 0
nasal/sinus
endoscopy.
ES074................ rigid scope, .............. 0
proctosigmoidosc
opy.
ES075................ rigid scope, $3,966.08 5
laryngoscopy.
ES076................ rigid scope, 14,500.00 1
colposcopy.
ES077................ non-channeled .............. 0
flexible digital
scope,
hysteroscopy.
ES078................ non-channeled .............. 0
flexible digital
scope,
nasopharyngoscop
y.
ES079................ non-channeled .............. 0
flexible digital
scope,
bronchoscopy.
ES080................ non-channeled 21,485.51 7
flexible digital
scope,
laryngoscopy.
ES081................ channeled .............. 0
flexible digital
scope,
cystoscopy.
ES082................ channeled .............. 0
flexible digital
scope,
hysteroscopy.
ES083................ channeled .............. 0
flexible digital
scope,
bronchoscopy.
ES084................ channeled 18,694.39 5
flexible digital
scope,
laryngoscopy.
ES085................ multi-channeled 17,360.00 1
flexible digital
scope, flexible
sigmoidoscopy.
ES086................ multi-channeled 38,058.81 6
flexible digital
scope,
colonoscopy.
ES087................ multi-channeled .............. 0
flexible digital
scope,
esophagoscopy
gastroscopy
duodenoscopy
(EGD).
ES088................ multi-channeled 34,585.35 5
flexible digital
scope,
esophagoscopy.
ES089................ multi-channeled .............. 0
flexible digital
scope, ileoscopy.
ES090................ multi-channeled .............. 0
flexible digital
scope,
pouchoscopy.
ES091................ ultrasound .............. 0
digital scope,
endoscopic
ultrasound.
ES092................ non-video 5,078.04 4
flexible scope,
laryngoscopy.
------------------------------------------------------------------------
We note that we did not receive invoices for many of the new scope
equipment items. There also was some inconsistency in the workgroup
recommendations regarding the non-channeled flexible digital scope,
laryngoscopy (ES080) equipment item and the non-video flexible scope,
laryngoscopy (ES092) equipment item. These scopes were listed as a
single equipment item in some of the workgroup materials and listed as
separate equipment items in other materials. We are proposing to
establish them as separate equipment items based on the submitted
invoices, which demonstrated that these were two different types of
scopes with distinct price points of approximately $17,000 and $5,000
respectively.
We noted a similar issue with the submitted invoices for the rigid
scope, laryngoscopy (ES075) equipment item. Among the eight total
invoices, five of them were clustered around a price point of
approximately $4,000 while the other three invoices had prices of
roughly $15,000 apiece. The invoices indicated that these prices came
from two distinct types of equipment, and as a result we are proposing
to consider these items separately. We are proposing to use the initial
five invoices to establish a proposed price of $3,966.08 for the rigid
scope, laryngoscopy (ES075) equipment item. We note that this is a
close match for the current price of $3,178.08 used by the endoscope,
rigid, laryngoscopy (ES010) equipment, which is the closest equivalent
scope equipment. The other three invoices appear to describe a type of
stroboscopy system rather than a scope, and they have an average price
of $14,737. This is a reasonably close match for the price of our
current stroboscoby system (ES065) equipment, which has a CY 2020 price
of $17,950.28 as it transitions to a final CY 2022 destination price of
$16,843.87 (see the 4-year pricing transition of the market-based
supply and equipment pricing update discussed later in this section for
more information). We believe that these invoices reinforce the value
established by the market-based pricing update for the stroboscoby
system carried out last year, and we are not proposing to update the
price of the ES065 equipment at this time. However, we are open to
feedback from stakeholders if they believe it would be more accurate to
assign a price of $14,737 to the stroboscoby system based on these
invoice submissions, as opposed to maintaining the current pricing
transition to a CY 2022 price of $16,843.87.
For the eight new scope equipment items where we have submitted
invoices for pricing, we are proposing to replace the existing scopes
with the new scope equipment. We received recommendations from the
RUC's scope workgroup regarding which HCPCS codes make use of the new
scope equipment items, and we are proposing to make this scope
replacement for approximately 100 HCPCS codes in total (see Table 6).
BILLING CODE 4120-01-P
[[Page 40495]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.000
[[Page 40496]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.001
[[Page 40497]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.002
[[Page 40498]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.003
BILLING CODE 4120-01-C
In all but three cases, we are proposing for the new scope
equipment item to replace the existing scope with the identical amount
of equipment time. For CPT codes 92612 (Flexible endoscopic evaluation
of swallowing by cine or video recording), 92614 (Flexible endoscopic
evaluation, laryngeal sensory testing by cine or video recording), and
92616 (Flexible endoscopic evaluation of swallowing and laryngeal
sensory testing by cine or video recording), the current scopes in use
are the FEES video system (ES027) and the FEESST video system (ES028).
Since we are proposing the use of a non-channeled flexible digital
scope that requires a corresponding scope video system, we are adding
the ES080 equipment at the same equipment time
[[Page 40499]]
to these three procedures rather than replacing the ES027 and ES028
equipment. In all other cases, we are proposing to replace the current
scope equipment listed in Table 6 with the new scope equipment, while
maintaining the same amount of equipment time.
We identified inconsistencies with the workgroup recommendations
for a small number of HCPCS codes. CPT code 45350 (Sigmoidoscopy,
flexible; with band ligation(s) (e.g., hemorrhoids)) was recommended to
include a multi-channeled flexible digital scope, flexible
sigmoidoscopy (ES085), however, we noted that this CPT code does not
include any scopes among its current direct PE inputs. CPT code 31595
was recommended to include a non-channeled flexible digital scope,
laryngoscopy (ES080) but it no longer exists as a CPT code after having
been deleted for CY 2019. CPT code 43232 (Esophagoscopy, flexible,
transoral; with transendoscopic ultrasound-guided intramural or
transmural fine needle aspiration/biopsy(s)) was recommended to include
a multi-channeled flexible digital scope, esophagoscopy (ES088), but it
does not include a scope amongst its direct PE inputs any longer
following clarification from the same workgroup recommendations that
CPT code 43232 is never performed in the nonfacility setting. In all
three of these cases, we are not proposing to add one of the new scope
equipment items to these procedures.
We did not receive pricing information along with the workgroup
recommendations for the other 15 new scope equipment items. For CY
2020, we are proposing to establish new equipment codes for these
scopes as detailed in Table 5. However, due to a lack of pricing
information, we are not proposing to replace existing scope equipment
with the new equipment items as we did for the other eight new scope
equipment items for CY 2020. We welcome additional feedback from
stakeholders regarding the pricing of these scope equipment items,
especially the submission of detailed invoices with pricing data. We
are proposing to transition the scopes for which we do have pricing
information over to the new equipment items for CY 2020, and we look
forward to engaging with stakeholders to assist in pricing and then
transitioning the remaining scopes in future rulemaking.
c. Technical Corrections to Direct PE Input Database and Supporting
Files
Subsequent to the publication of the CY 2019 PFS final rule,
stakeholders alerted us to several clerical inconsistencies in the
direct PE database. We are proposing to correct these inconsistencies
as described below and reflected in the CY 2020 proposed direct PE
input database displayed on the CMS website under downloads for the CY
2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2020, we are proposing to address the following
inconsistencies:
The RUC's Scope Equipment Reorganization Workgroup
recommended deletion of the non-facility inputs for CPT codes 43231
(Esophagoscopy, flexible, transoral; with endoscopic ultrasound
examination) and 43232 (Esophagoscopy, flexible, transoral; with
transendoscopic ultrasound-guided intramural or transmural fine needle
aspiration/biopsy(s)). The gastroenterology specialty societies stated
that these services are never performed in the non-facility setting.
After our own review of these services, we agree with the workgroup's
recommendation, and we are proposing to remove the non-facility direct
PE inputs for these two CPT codes.
In rulemaking for CY 2018, we reviewed a series of CPT
codes describing nasal sinus endoscopy surgeries. At that time, we
sought comments on whether the broader family of nasal sinus endoscopy
surgery services should be subject to the special rules for multiple
endoscopic procedures instead of the standard multiple procedure
payment reduction. We received very few comments in response to our
solicitation. In the CY 2018 PFS final rule (82 FR 53043), we indicated
that we would continue to explore this option for future rulemaking. We
are proposing to apply the special rule for multiple endoscopic
procedures to this family of codes beginning in CY 2020. This proposal
would treat this group of CPT codes consistently with other similar
endoscopic procedures when codes within the CPT code family are billed
together with another endoscopy service in the same family. Similar to
other similar endoscopic procedure code families, we are proposing that
CPT code 31231 (Nasal endoscopy, diagnostic, unilateral or bilateral
(separate procedure)) would be the base procedure for the remainder of
nasal sinus endoscopies. The codes affected by this proposal are as
follows (see Table 7).
Table 7--Proposed Nasal Sinus Endoscopy Codes Subject to Special Rules
for Multiple Endoscopic Procedures
------------------------------------------------------------------------
CPT code Short descriptor
------------------------------------------------------------------------
31231................................ Nasal endoscopy dx.
31233................................ Nasal/sinus endoscopy dx.
31235................................ Nasal/sinus endoscopy dx.
31237................................ Nasal/sinus endoscopy surg.
31238................................ Nasal/sinus endoscopy surg.
31239................................ Nasal/sinus endoscopy surg.
31240................................ Nasal/sinus endoscopy surg.
31241................................ Nsl/sins ndsc w/artery lig.
31253................................ Nsl/sins ndsc total.
31254................................ Nsl/sins ndsc w/prtl ethmdct.
31255................................ Nsl/sins ndsc w/tot ethmdct.
31256................................ Exploration maxillary sinus.
31257................................ Nsl/sins ndsc tot w/sphendt.
31259................................ Nsl/sins ndsc sphn tiss rmvl.
31267................................ Endoscopy maxillary sinus.
31276................................ Nsl/sins ndsc frnt tiss rmvl.
31287................................ Nasal/sinus endoscopy surg.
31288................................ Nasal/sinus endoscopy surg.
31290................................ Nasal/sinus endoscopy surg.
31291................................ Nasal/sinus endoscopy surg.
31292................................ Nasal/sinus endoscopy surg.
31293................................ Nasal/sinus endoscopy surg.
31294................................ Nasal/sinus endoscopy surg.
31295................................ Sinus endo w/balloon dil.
31296................................ Sinus endo w/balloon dil.
31297................................ Sinus endo w/balloon dil.
31298................................ Nsl/sins ndsc w/sins dilat.
------------------------------------------------------------------------
Special rules for multiple endoscopic procedures would apply if any
of the procedures listed in Table 7 are billed together for the same
patient on the same day. We apply the multiple endoscopy payment rules
to a code family before ranking the family with other procedures
performed on the same day (for example, if multiple endoscopies in the
same family are reported on the same day as endoscopies in another
family, or on the same day as a non-endoscopic procedure). If an
endoscopic procedure is reported together with its base procedure, we
do not pay separately for the base procedure. Payment for the base
procedure is included in the payment for the other endoscopy. For
additional information about the payment adjustment under the special
rule for multiple endoscopic services, we refer readers to the CY 1992
PFS final rule where this policy was established (56 FR 59515) and to
Pub. 100-04, Medicare Claims Processing Manual, Chapter 23 (available
on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf).
d. Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public
[[Page 40500]]
requests to update equipment and supply price and equipment useful life
inputs through annual rulemaking, beginning with the CY 2012 PFS
proposed rule. For CY 2020, we are proposing the following price
updates for existing direct PE inputs.
We are proposing to update the price of one supply and one
equipment item in response to the public submission of invoices. As
these pricing updates were each part of the formal review for a code
family, we are proposing that the new pricing take effect for CY 2020
for these items instead of being phased in over 4 years. For the
details of these proposed price updates, please refer to Table 22,
Proposed CY 2020 Invoices Received for Existing Direct PE Inputs in
section II.N., Proposed Valuation of Specific Codes, of this proposed
rule.
We are also proposing to update the name of the EP001 equipment
item from ``DNA/digital image analyzer (ACIS)'' to ``DNA/Digital Image
Analyzer'' due to clarification from stakeholders regarding the typical
use of this equipment.
(1) Market-Based Supply and Equipment Pricing Update
Section 220(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) provides that the Secretary may collect or
obtain information from any eligible professional or any other source
on the resources directly or indirectly related to furnishing services
for which payment is made under the PFS, and that such information may
be used in the determination of relative values for services under the
PFS. Such information may include the time involved in furnishing
services; the amounts, types and prices of PE inputs; overhead and
accounting information for practices of physicians and other suppliers,
and any other elements that would improve the valuation of services
under the PFS.
As part of our authority under section 1848(c)(2)(M) of the Act, we
initiated a market research contract with StrategyGen to conduct an in-
depth and robust market research study to update the PFS direct PE
inputs (DPEI) for supply and equipment pricing for CY 2019. These
supply and equipment prices were last systematically developed in 2004-
2005. StrategyGen submitted a report with updated pricing
recommendations for approximately 1300 supplies and 750 equipment items
currently used as direct PE inputs. This report is available as a
public use file displayed on the CMS website under downloads for the CY
2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The StrategyGen team of researchers, attorneys, physicians, and
health policy experts conducted a market research study of the supply
and equipment items currently used in the PFS direct PE input database.
Resources and methodologies included field surveys, aggregate
databases, vendor resources, market scans, market analysis, physician
substantiation, and statistical analysis to estimate and validate
current prices for medical equipment and medical supplies. StrategyGen
conducted secondary market research on each of the 2,072 DPEI medical
equipment and supply items that CMS identified from the current DPEI.
The primary and secondary resources StrategyGen used to gather price
data and other information were:
Telephone surveys with vendors for top priority items
(Vendor Survey).
Physician panel validation of market research results,
prioritized by total spending (Physician Panel).
The General Services Administration system (GSA).
An aggregate health system buyers database with discounted
prices (Buyers).
Publicly available vendor resources, that is, Amazon
Business, Cardinal Health (Vendors).
Federal Register, current DPEI data, historical proposed
and final rules prior to CY 2018, and other resources; that is, AMA RUC
reports (References).
StrategyGen prioritized the equipment and supply research based on
current share of PE RVUs attributable by item provided by CMS.
StrategyGen developed the preliminary Recommended Price (RP)
methodology based on the following rules in hierarchical order
considering both data representativeness and reliability.
(1) If the market share, as well as the sample size, for the top
three commercial products were available, the weighted average price
(weighted by percent market share) was the reported RP. Commercial
price, as a weighted average of market share, represents a more robust
estimate for each piece of equipment and a more precise reference for
the RP.
(2) If no data were available for commercial products, the current
CMS prices were used as the RP.
GSA prices were not used to calculate the StrategyGen recommended
prices, due to our concern that the GSA system curtails the number and
type of suppliers whose products may be accessed on the GSA Advantage
website, and that the GSA prices may often be lower than prices that
are available to non-governmental purchasers. After reviewing the
StrategyGen report, we proposed to adopt the updated direct PE input
prices for supplies and equipment as recommended by StrategyGen.
StrategyGen found that despite technological advancements, the
average commercial price for medical equipment and supplies has
remained relatively consistent with the current CMS price.
Specifically, preliminary data indicated that there was no
statistically significant difference between the estimated commercial
prices and the current CMS prices for both equipment and supplies. This
cumulative stable pricing for medical equipment and supplies appears
similar to the pricing impacts of non-medical technology advancements
where some historically high-priced equipment (that is, desktop PCs)
has been increasingly substituted with current technology (that is,
laptops and tablets) at similar or lower price points. However, while
there were no statistically significant differences in pricing at the
aggregate level, medical specialties would experience increases or
decreases in their Medicare payments if CMS were to adopt the pricing
updates recommended by StrategyGen. At the service level, there may be
large shifts in PE RVUs for individual codes that happened to contain
supplies and/or equipment with major changes in pricing, although we
note that codes with a sizable PE RVU decrease would be limited by the
requirement to phase in significant reductions in RVUs, as required by
section 1848(c)(7) of the Act. The phase-in requirement limits the
maximum RVU reduction for codes that are not new or revised to 19
percent in any individual calendar year.
We believe that it is important to make use of the most current
information available for supply and equipment pricing instead of
continuing to rely on pricing information that is more than a decade
old. Given the potentially significant changes in payment that would
occur, both for specific services and more broadly at the specialty
level, in the CY 2019 PFS proposed rule we proposed to phase in our use
of the new direct PE input pricing over a 4-year period using a 25/75
percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021),
and 100/0 percent (CY 2022) split between new and old pricing. This
approach is consistent with how we have previously incorporated
significant new data into the calculation of PE RVUs, such as the 4-
year transition period finalized in CY 2007 PFS final rule with comment
period when changing to the ``bottom-
[[Page 40501]]
up'' PE methodology (71 FR 69641). This transition period will not only
ease the shift to the updated supply and equipment pricing, but will
also allow interested parties an opportunity to review and respond to
the new pricing information associated with their services.
We proposed to implement this phase-in over 4 years so that supply
and equipment values transition smoothly from the prices we currently
include to the final updated prices in CY 2022. We proposed to
implement this pricing transition such that one quarter of the
difference between the current price and the fully phased-in price is
implemented for CY 2019, one third of the difference between the CY
2019 price and the final price is implemented for CY 2020, and one half
of the difference between the CY 2020 price and the final price is
implemented for CY 2021, with the new direct PE prices fully
implemented for CY 2022. An example of the transition from the current
to the fully-implemented new pricing is provided in Table 8.
Table 8--Example of Direct PE Pricing Transition
------------------------------------------------------------------------
------------------------------------------------------------------------
Current Price............... $100
Final Price................. 200 ....................
Year 1 (CY 2019) Price.. 125 \1/4\ difference
between $100 and
$200.
Year 2 (CY 2020) Price.. 150 \1/3\ difference
between $125 and
$200.
Year 3 (CY 2021) Price.. 175 \1/2\ difference
between $150 and
$200.
Final (CY 2022) Price... 200 ....................
------------------------------------------------------------------------
For new supply and equipment codes for which we establish prices
during the transition years (CYs 2019, 2020 and 2021) based on the
public submission of invoices, we proposed to fully implement those
prices with no transition since there are no current prices for these
supply and equipment items. These new supply and equipment codes would
immediately be priced at their newly established values. We also
proposed that, for existing supply and equipment codes, when we
establish prices based on invoices that are submitted as part of a
revaluation or comprehensive review of a code or code family, they will
be fully implemented for the year they are adopted without being phased
in over the 4-year pricing transition. The formal review process for a
HCPCS code includes a review of pricing of the supplies and equipment
included in the code. When we find that the price on the submitted
invoice is typical for the item in question, we believe it would be
appropriate to finalize the new pricing immediately along with any
other revisions we adopt for the code valuation.
For existing supply and equipment codes that are not part of a
comprehensive review and valuation of a code family and for which we
establish prices based on invoices submitted by the public, we proposed
to implement the established invoice price as the updated price and to
phase in the new price over the remaining years of the proposed 4-year
pricing transition. During the proposed transition period, where price
changes for supplies and equipment are adopted without a formal review
of the HCPCS codes that include them (as is the case for the many
updated prices we proposed to phase in over the 4-year transition
period), we believe it is important to include them in the remaining
transition toward the updated price. We also proposed to phase in any
updated pricing we establish during the 4-year transition period for
very commonly used supplies and equipment that are included in 100 or
more codes, such as sterile gloves (SB024) or exam tables (EF023), even
if invoices are provided as part of the formal review of a code family.
We would implement the new prices for any such supplies and equipment
over the remaining years of the proposed 4-year transition period. Our
proposal was intended to minimize any potential disruptive effects
during the proposed transition period that could be caused by other
sudden shifts in RVUs due to the high number of services that make use
of these very common supply and equipment items (meaning that these
items are included in 100 or more codes).
We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining
stability and allowing stakeholders the opportunity to address
potential concerns about changes in payment for particular items.
Updating the pricing of direct PE inputs for supplies and equipment
over a longer time frame will allow more opportunities for public
comment and submission of additional, applicable data. We welcomed
feedback from stakeholders on the proposed updated supply and equipment
pricing, including the submission of additional invoices for
consideration.
We received many comments regarding the market-based supply and
equipment pricing proposal following the publication of the CY 2019 PFS
proposed rule. For a full discussion of these comments, we direct
readers to the CY 2019 PFS final rule (83 FR 59475-59480). In each
instance in which a commenter raised questions about the accuracy of a
supply or equipment code's recommended price, the StrategyGen
contractor conducted further research on the item and its price with
special attention to ensuring that the recommended price was based on
the correct item in question and the clarified unit of measure. Based
on the commenters' requests, the StrategyGen contractor conducted an
extensive examination of the pricing of any supply or equipment items
that any commenter identified as requiring additional review. Invoices
submitted by multiple commenters were greatly appreciated and ensured
that medical equipment and supplies were re-examined and clarified.
Multiple researchers reviewed these specified supply and equipment
codes for accuracy and proper pricing. In most cases, the contractor
also reached out to a team of nurses and their physician panel to
further validate the accuracy of the data and pricing information. In
some cases, the pricing for individual items needed further
clarification due to a lack of information or due to significant
variation in packaged items. After consideration of the comments and
this additional price research, we updated the recommended prices for
approximately 70 supply and equipment codes identified by the
commenters. Table 9 in the CY 2019 PFS final rule lists the supply and
equipment codes with price changes based on feedback from the
commenters and the resulting additional research into pricing (83 FR
59479-59480).
After consideration of the public comments, we finalized our
proposals associated with the market research study to update the PFS
direct PE inputs for supply and equipment pricing. We continue to
believe that implementing the proposed updated prices with a 4-year
phase-in will improve payment
[[Page 40502]]
accuracy, while maintaining stability and allowing stakeholders the
opportunity to address potential concerns about changes in payment for
particular items. We continue to welcome feedback from stakeholders on
the proposed updated supply and equipment pricing, including the
submission of additional invoices for consideration.
For CY 2020, we received invoice submissions for approximately 30
supply and equipment codes from stakeholders as part of the second year
of the market-based supply and equipment pricing update. These invoices
were reviewed by the StrategyGen contractor and the submitted invoices
were used in many cases to supplement the pricing originally proposed
for the CY 2019 PFS rule cycle. The contractor reviewed the invoices,
as well as prior data for the relevant supply/equipment codes to make
sure the item in the invoice was representative of the supply/equipment
item in question and aligned with past research. Based on this
research, we are proposing to update the prices of the following supply
and equipment items:
BILLING CODE 4120-01-P
[[Page 40503]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.004
BILLING CODE 4120-01-C
For most supply and equipment items, there was an alignment between
the research carried out by the StrategyGen contractor and the
submitted invoice. The updated CY 2020 pricing was calculated using an
average between the previous market research and the newly submitted
invoices in these cases. In some cases the submitted invoices were not
representative of market prices, such as for the centrifuge with rotor
(EP007) equipment item where the invoice price of $8,563 appeared to be
an outlier. We did not use the invoices to calculate our pricing
recommendation in these situations and instead continued to rely on our
prior pricing data. In other instances, such as for the kit, probe,
cryoablation, prostate (Galil-Endocare)
[[Page 40504]]
(SA099) supply item, our research indicated that the submitted invoice
price was more representative of the commercial price than our CY 2019
research and pricing. We are proposing the new invoice prices for these
supply and equipment items due to our belief in their greater accuracy.
For some of the remaining supply and equipment items, such as the
five-gallon paraffin (EP031) equipment and the Olympus DP21 camera
(EP089) equipment, we maintained the extant pricing for CY 2019 due to
a lack of sufficient data to update the pricing. In these situations
where we did not have an updated price for CY 2019, we believe that the
newly submitted invoices are more representative of the current
commercial prices that are being paid on the market. We are again
proposing the new invoice prices for these supply and equipment items
due to our belief in their greater accuracy.
In addition, we were alerted by stakeholders that the price of the
EM visit pack (SA047) supply did not match the sum of the component
prices of the supplies included in the pack. After reviewing the prices
of the individual component supplies, we agree with the stakeholders
that there was a discrepancy in the previous pricing of this supply
pack. We are proposing to update the price of the EM visit pack to
$5.47 to match the sum of the prices of the component supplies, and
proposing to continue to transition towards this price over the
remaining years of the phase-in period.
We finalized a policy last year to phase in the new supply and
equipment pricing over 4 years so that supply and equipment values
transition smoothly from their current prices to the final updated
prices in CY 2022. We finalized our proposal to implement this pricing
transition such that one quarter of the difference between the current
price and the fully phased in price was implemented for CY 2019, one
third of the difference between the CY 2019 price and the final price
is implemented for CY 2020, and one half of the difference between the
CY 2020 price and the final price is implemented for CY 2021, with the
new direct PE prices fully implemented for CY 2022. An example of the
transition from the current to the fully-implemented new pricing is
provided in Table 8. For CY 2020, one third of the difference between
the CY 2019 price and the final price will be implemented as per the
previously finalized policy.
The full list of updated supply and equipment pricing as it will be
implemented over the 4-year transition period will be made available as
a public use file displayed on the CMS website under downloads for the
CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(2) Invoice Submission
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC-recommended values for the codes. For CY 2020, we noted that
some stakeholders have submitted invoices for new, revised, or
potentially misvalued codes after the February 10th deadline
established for code valuation recommendations. To be included in a
given year's proposed rule, we generally need to receive invoices by
the same February 10th deadline we noted for consideration of RUC
recommendations. However, we would consider invoices submitted as
public comments during the comment period following the publication of
the PFS proposed rule, and would consider any invoices received after
February 10th or outside of the public comment process as part of our
established annual process for requests to update supply and equipment
prices.
(3) Adjustment to Allocation of Indirect PE for Some Office-Based
Services
In the CY 2018 PFS final rule (82 FR 52999 through 53000), we
established criteria for identifying the services most affected by the
indirect PE allocation anomaly that does not allow for a site of
service differential that accurately reflects the relative indirect
costs involved in furnishing services in nonfacility settings. We also
finalized a modification in the PE methodology for allocating indirect
PE RVUs to better reflect the relative indirect PE resources involved
in furnishing these services. The methodology, as described, is based
on the difference between the ratio of indirect PE to work RVUs for
each of the codes meeting eligibility criteria and the ratio of
indirect PE to work RVU for the most commonly reported visit code. We
refer readers to the CY 2018 PFS final rule (82 FR 52999 through 53000)
for a discussion of our process for selecting services subject to the
revised methodology, as well as a description of the methodology, which
we began implementing for CY 2018 as the first year of a 4-year
transition. For CY 2020, we are proposing to continue with the third
year of the transition of this adjustment to the standard process for
allocating indirect PE.
C. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that each service paid under
the PFS be composed of three components: Work, PE, and malpractice (MP)
expense. As required by section 1848(c)(2)(C)(iii) of the Act,
beginning in CY 2000, MP RVUs are resource based. Section
1848(c)(2)(B)(i) of the Act also requires that we review, and if
necessary adjust, RVUs no less often than every 5 years. In the CY 2015
PFS final rule with comment period, we implemented the third review and
update of MP RVUs. For a comprehensive discussion of the third review
and update of MP RVUs, see the CY 2015 proposed rule (79 FR 40349
through 40355) and final rule with comment period (79 FR 67591 through
67596). In the CY 2018 proposed rule (82 FR 33965 through 33970), we
proposed to update the specialty-level risk factors used in the
calculation of MP RVUs, prior to the next required 5 year update (CY
2020), using the updated MP premium data that were used in the eighth
Geographic Practice Cost Index (GPCI) update for CY 2017; however the
proposal was ultimately not finalized for CY 2018.
We consider the following factors when we determine MP RVUs for
individual PFS services: (1) Specialty-level risk factors derived from
data on specialty-specific MP premiums incurred by practitioners; (2)
service-level risk factors derived from Medicare claims data of the
weighted average risk factors of the specialties that furnish each
service; and (3) an intensity/complexity of service adjustment to the
service-level risk factor based on either the higher of the work RVU or
clinical labor portion of the direct PE RVU. Prior to CY 2016, MP RVUs
were only updated once every 5 years, except in the case of new and
revised codes.
As explained in the CY 2011 PFS final rule with comment period (75
FR 73208), MP RVUs for new and revised codes effective before the next
5-year review of MP RVUs were determined either by a direct crosswalk
from a similar source code or by a modified crosswalk to account for
differences in work RVUs between the new/revised code and the source
code. For the modified crosswalk approach, we adjusted (or scaled) the
MP RVU for the new/revised code to reflect the difference in work RVU
between the source code and the new/revised work RVU (or, if greater,
the difference in the
[[Page 40505]]
clinical labor portion of the fully implemented PE RVU) for the new
code. For example, if the proposed work RVU for a revised code was 10
percent higher than the work RVU for its source code, the MP RVU for
the revised code would be increased by 10 percent over the source code
MP RVU. Under this approach, the same risk factor was applied for the
new/revised code and source code, but the work RVU for the new/revised
code was used to adjust the MP RVUs for risk.
In the CY 2016 PFS final rule with comment period (80 FR 70906
through 70910), we finalized a policy to begin conducting annual MP RVU
updates to reflect changes in the mix of practitioners providing
services (using Medicare claims data), and to adjust MP RVUs for risk
for intensity and complexity (using the work RVU or clinical labor
RVU). We also finalized a policy to modify the specialty mix assignment
methodology (for both MP and PE RVU calculations) to use an average of
the three most recent years of data instead of a single year of data.
Under this approach, for new and revised codes, we generally assign a
specialty-level risk factor to individual codes based on the same
utilization assumptions we make regarding specialty mix we use for
calculating PE RVUs and for PFS budget neutrality. We continue to use
the work RVU or clinical labor RVU to adjust the MP RVU for each code
for intensity and complexity. In finalizing this policy, we stated that
the specialty-level risk factors would continue to be updated through
notice and comment rulemaking every 5 years using updated premium data,
but would remain unchanged between the 5-year reviews.
Section 1848(e)(1)(C) of the Act requires us to review, and if
necessary, adjust the GPCIs at least every 3 years. For CY 2020, we are
conducting the statutorily required 3-year review of the GPCIs, which
coincides with the statutorily required 5-year review of the MP RVUs.
We note that the MP premium data used to update the MP GPCIs are the
same data used to determine the specialty-level risk factors, which are
used in the calculation of MP RVUs. Going forward, we believe it would
be logical and efficient to align the update of MP premium data used to
determine the MP RVUs with the update of the MP GPCI. Therefore, we are
proposing to align the update of MP premium data with the update to the
MP GPCIs, that is, we are proposing to review, and if necessary update
the MP RVUs at least every 3 years, similar to our review and update of
the GPCIs. If we align the two updates, we would conduct the next
statutorily-mandated review and update of both the GPCI and MP RVU for
implementation in CY 2023. We are proposing to implement the fourth
comprehensive review and update of MP RVUs for CY 2020 and are seeking
comment on these proposals.
2. Methodology for the Proposed Revision of Resource-Based Malpractice
RVUs
a. General Discussion
We calculated the proposed MP RVUs using updated malpractice
premium data obtained from state insurance rate filings. The
methodology used in calculating the proposed CY 2020 review and update
of resource-based MP RVUs largely parallels the process used in the CY
2015 update; however, we are proposing to incorporate several
methodological refinements, which are described below in this proposed
rule. The MP RVU calculation requires us to obtain information on
specialty-specific MP premiums that are linked to specific services,
and using this information, we derive relative risk factors for the
various specialties that furnish a particular service. Because MP
premiums vary by state and specialty, the MP premium information must
be weighted geographically and by specialty. We calculated the proposed
MP RVUs using four data sources: Malpractice premium data presumed to
be in effect as of December 31, 2017; CY 2018 Medicare payment and
utilization data; higher of the CY 2020 proposed work RVUs or the
clinical labor portion of the direct PE RVUs; and CY 2019 GPCIs. We
will use the higher of the CY 2020 final work RVUs or clinical labor
portion of the direct PE RVUs in our calculation to develop the CY 2020
final MP RVUs while maintaining overall PFS budget neutrality.
Similar to the CY 2015 update, the proposed MP RVUs were calculated
using specialty-specific malpractice premium data because they
represent the expense incurred by practitioners to obtain malpractice
insurance as reported by insurers. For CY 2020, the most current
malpractice premium data available, with a presumed effective date of
no later than December 31, 2017, were obtained from insurers with the
largest market share in each state. We identified insurers with the
largest market share using the National Association of Insurance
Commissioners (NAIC) market share report. This annual report provides
state-level market share for entities that provide premium liability
insurance (PLI) in a state. Premium data were downloaded from the
System for Electronic Rates & Forms Filing Access Interface (SERFF)
(accessed from the NAIC website) for participating states. For non-
SERFF states, data were downloaded from the state-specific website (if
available online) or obtained directly from the state's alternate
access to filings. For SERFF states and non-SERFF states with online
access to filings, the 2017 market share report was used to select
companies. For non-SERFF states without online access to filings, the
2016 market share report was used to identify companies. These were the
most current data available during the data collection and acquisition
process.
Malpractice insurance premium data were collected from all 50
States, and the District of Columbia. Efforts were made to collect
filings from Puerto Rico; however, no recent filings were submitted at
the time of data collection and therefore filings from the previous
update were used. Consistent with the CY 2015 update, no filings were
collected for the other U.S. territories: American Samoa, Guam, Virgin
Islands, or Northern Mariana Islands. Malpractice premiums were
collected for coverage limits of $1 million/$3 million, mature, claims-
made policies (policies covering claims made, rather than those
covering losses occurring, during the policy term). A $1 million/$3
million liability limit policy means that the most that would be paid
on any claim is $1 million and the most that the policy would pay for
claims over the timeframe of the policy is $3 million. Adjustments were
made to the premium data to reflect mandatory surcharges for patient
compensation funds (PCF, funds used to pay for any claim beyond the
state's statutory amount, thereby limiting an individual physician's
liability in cases of a large suit) in states where participation in
such funds is mandatory.
Premium data were included for all physician and NPP specialties,
and all risk classifications available in the collected rate filings.
Although premium data were collected from all states, the District of
Columbia, and previous filings for Puerto Rico were utilized, not all
specialties had distinct premium data in the rate filings from all
states. In previous updates, specialties for which premium data were
not available for at least 35 states, and specialties for which there
were not distinct risk groups (surgical, non-surgical, and surgical
with obstetrics) among premium data in the rate filings, were
crosswalked to a similar specialty, either conceptually or based on
available premium data. This resulted in not using those premium data
because
[[Page 40506]]
the 35 state threshold was not met. In this proposed CY 2020 update, we
note that the proposed methodological improvement discussed below in
this proposed rule expands the specialties and amount of filings data
used to develop the proposed risk factors, which are used to develop
the proposed MP RVUs.
b. Proposed Methodological Refinements
For the CY 2020 update, we are proposing the following
methodological improvements to the development of MP premium data:
(1) Downloading and using a broader set of filings from the largest
market share insurers in each state, beyond those listed as
``physician'' and ``surgeon'' to obtain a more comprehensive data set.
(2) Combining minor surgery and major surgery premiums to create
the surgery service risk group, which yields a more representative
surgical risk factor. In the previous update, only premiums for major
surgery were used in developing the surgical risk factor.
(3) Utilizing partial and total imputation to develop a more
comprehensive data set when CMS specialty names are not distinctly
identified in the insurer filings, which sometimes use unique specialty
names.
In instances where insurers report data for some (but not all)
specialties that explicitly corresponded to a CMS specialty, where
those data were missing, we propose to use partial imputation based on
available data to establish what the premiums would likely have been
had that specialty been delineated in the filing. In instances where
there are no data corresponding to a CMS specialty in the filing, we
propose to use total imputation to establish premiums.
For example, if a specialty of Sleep Medicine is listed on the
insurer's rate filing, this rate will be matched to the CMS specialty
Sleep Medicine (C0). However, if the Sleep Medicine specialty is not
listed on the insurer's rate filing, under our proposed methodology,
the insurer's rate filing for General Practice would be matched to the
CMS specialty of Sleep Medicine (C0). In this example, we believe
General Practice is likely to be consistent with the rate that a Sleep
Medicine provider would be charged by that insurer. This proposed
methodological improvement means that instead of discarding specialty-
specific information from some insurers' filings because other insurers
lacked that same level of detail, we would instead impute the missing
rates at the insurer/specialty level in an effort to utilize as much of
the information from the filings as possible.
We are seeking comment on these proposed methodological
improvements. Additional technical details are available in our interim
report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs
for the Medicare Physician Fee Schedule,'' on our website. It is
located under the supporting documents section for the CY 2020 PFS
proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
c. Steps for Calculating Malpractice RVUs
Calculation of the proposed MP RVUs conceptually follows the
specialty-weighted approach used in the CY 2015 final rule with comment
period (79 FR 67591), along with the above proposed methodological
improvements. The specialty-weighted approach bases the MP RVUs for a
given service on a weighted average of the risk factors of all
specialties furnishing the service. This approach ensures that all
specialties furnishing a given service are reflected in the calculation
of the MP RVUs. The steps for calculating the proposed MP RVUs are
described below.
Step (1): Compute a preliminary national average premium for each
specialty.
Insurance rating area malpractice premiums for each specialty are
mapped to the county level. The specialty premium for each county is
then multiplied by its share of the total U.S. population (from the
U.S. Census Bureau's 2013-2017 American Community Survey (ACS) 5-year
estimates). This is in contrast to the method used for creating
national average premiums for each specialty in the 2015 update; in
that update, specialty premiums were weighted by the total RVU per
county, rather than by the county share of the total U.S. population.
We refer readers to the CY 2016 PFS final rule with comment period (80
FR 70909) for a discussion of why we have adopted a weighting method
based on share of total U.S. population. This calculation is then
divided by the average MP GPCI across all counties for each specialty
to yield a normalized national average premium for each specialty. The
specialty premiums are normalized for geographic variation so that the
locality cost differences (as reflected by the 2019 GPCIs) would not be
counted twice. Without the geographic variation adjustment, the cost
differences among fee schedule areas would be reflected once under the
methodology used to calculate the MP RVUs and again when computing the
service specific payment amount for a given fee schedule area.
Step (2): Determine which premium service risk groups to use within
each specialty.
Some specialties had premium rates that differed for surgery,
surgery with obstetrics, and non-surgery. These premium classes are
designed to reflect differences in risk of professional liability and
the cost of malpractice claims if they occur. To account for the
presence of different classes in the malpractice premium data and the
task of mapping these premiums to procedures, we calculated distinct
risk factors for surgical, surgical with obstetrics, and nonsurgical
procedures where applicable. However, the availability of data by
surgery and non-surgery varied across specialties. Historically, no
single approach accurately addressed the variability in premium class
among specialties, and we previously employed several methods for
calculating average premiums by specialty. These methods are discussed
below.
Developing Distinct Service Risk Groups: We determined that there
were sufficient data for surgery and non-surgery premiums, as well as
sufficient differences in rates between classes for 15 specialties
(there were 10 such specialties in the CY 2015 update). These
specialties are listed in Table 10. Additionally, as described in the
proposed methodological refinements, in some instances, we combined
minor surgery and major surgery premiums to create a premium to develop
the surgery service risk group, rather than discard minor surgery
premium data as was done in the previous update. Therefore, we
calculated a national average surgical premium and non-surgical premium
for those specialties. For all other specialties (those that are not
listed in Table 10) that typically do not distinguish premiums as
described above, a single risk factor was calculated, and that
specialty risk factor was applied to all services performed by those
specialties.
This is consistent with prior practice; however, we have refined
the nomenclature to more precisely describe that some specialties are
delineated into service risk groups, as is the case for surgical, non-
surgical, and surgical with obstetrics, and some specialties are not
further delineated into service risk subgroups and are instead referred
to as ``All''--meaning that all services performed by that specialty
receive the same risk factor.
[[Page 40507]]
Table 10--Proposed Specialties Subdivided Into Service Risk Groups
------------------------------------------------------------------------
Service risk groups Specialties
------------------------------------------------------------------------
Surgery/No Surgery............. Otolaryngology (04), Cardiology (06),
Dermatology (07), Gastroenterology
(10), Neurology (13), Ophthalmology
(18), Urology (34), Geriatric Medicine
(38), Nephrology (39), Endocrinology
(46), Podiatry (48), Emergency
Medicine (93).
Surgery/No Surgery/OB.......... General Practice (01), Family Practice
(08), OB/GYN (16).
------------------------------------------------------------------------
Step (3): Calculate a risk factor for each specialty.
The relative differences in national average premiums between
specialties are expressed in our methodology as a specialty-level risk
factor. These risk factors are calculated by dividing the national
average premium for each specialty by the national average premium for
the specialty with the lowest premiums for which we had sufficient and
reliable data, which remains allergy and immunology (03). For
specialties with rate filings that are indicative of sufficient
surgical and non-surgical premium data, we recognized those service-
risk groups (that is, surgical, and non-surgical) as risk groups of the
specialty and we calculated both a surgical and non-surgical risk
factor. Similarly, for specialties with rate filings that distinguished
surgical premiums with obstetrics, we recognized that service-risk
subgroup of the specialty and calculated a separate surgical with
obstetrics risk factor.
(a) Technical Component (TC) Only Services
We note that for determining the risk factor for suppliers of TC-
only services in the CY 2015 update, we updated the premium data for
independent diagnostic testing facilities (IDTFs) that we used in the
CY 2010 update. Those data were obtained from a survey conducted by the
Radiology Business Management Association (RBMA) in 2009; we ultimately
used those data to calculate an updated TC specialty risk factor. We
applied the updated TC specialty risk factor to suppliers of TC-only
services. In the CY 2015 final rule with comment period (79 FR 67595),
RBMA voluntarily submitted updated MP premium information collected
from IDTFs in 2014, and requested that we use the data for calculating
the CY 2015 MP RVUs for TC-only services. We declined to utilize the
data and stated that we believe further study is necessary and we would
consider this matter and propose any changes through future rulemaking.
We continue to believe that data for a broader set of TC-only services
are needed, and are working to acquire a broader set of data.
For CY 2020, we propose to assign a risk factor of 1.00 for TC-only
services, which corresponds to the lowest physician specialty-level
risk factor. We assigned the risk factor of 1.00 to the TC-only
services because we do not have sufficient comparable professional
liability premium data for the full range of clinicians that furnish
TC-only services. In lieu of comprehensive, comparable data, we propose
to assign 1.00, the lowest physician specialty-level risk factor
calculated using the updated premium data, as the default minimum risk
factor. However, we seek information on the most comparable and
appropriate proxy for the broader set of TC-only services for future
use, as well as any empirical information that would support assignment
of an alternative risk factor for these services.
Table 11 shows the proposed risk factors by specialty type and
service risk group.
BILLING CODE 4120-01-P
[[Page 40508]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.005
[[Page 40509]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.006
BILLING CODE 4120-01-C
Step (4): Calculate malpractice RVUs for each CPT/HCPCS code.
Resource-based MP RVUs were calculated for each CPT/HCPCS code that
has work or PE RVUs. The first step was to identify the percentage of
services furnished by each specialty for each respective CPT/HCPCS
code. This
[[Page 40510]]
percentage was then multiplied by each respective specialty's risk
factor as calculated in Step 3. The products for all specialties for
the CPT/HCPCS code were then added together, yielding a specialty-
weighted service specific risk factor reflecting the weighted
malpractice costs across all specialties furnishing that procedure. The
service specific risk factor was multiplied by the greater of the work
RVU or clinical labor portion of the direct PE RVU for that service, to
reflect differences in the complexity and risk-of-service between
services.
Low volume service codes: As we discussed above in this proposed
rule, for low volume services code, we finalized the proposal in the CY
2018 PFS final rule (82 FR 53000 through 53006) to apply the list of
expected specialties instead of the claims-based specialty mix for low
volume services to address stakeholder concerns about the year to year
variability in PE and MP RVUs for low volume services (which also
includes no volume services); these are defined as codes that have 100
allowed services or fewer. These service-level overrides are used to
determine the specialty for low volume procedures for both PE and MP.
In the CY 2018 PFS final rule (82 FR 53000 through 53006), we also
finalized our proposal to eliminate general use of an MP-specific
specialty-mix crosswalk for new and revised codes. However, we
indicated that we would continue to consider, in conjunction with
annual recommendations, specific recommendations regarding specialty
mix assignments for new and revised codes, particularly in cases where
coding changes are expected to result in differential reporting of
services by specialty, or where the new or revised code is expected to
be low-volume. Absent such information, the specialty mix assumption
for a new or revised code would derive from the analytic crosswalk in
the first year, followed by the introduction of actual claims data,
which is consistent with our approach for developing PE RVUs.
For CY 2020, we are soliciting public comment on the list of
expected specialties. We also note that the list has been updated to
include a column indicating if a service is identified as a low volume
service for CY 2020, and therefore, whether or not the service-level
override is being applied for CY 2020. The proposed list of codes and
expected specialties is available on our website under downloads for
the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Step (5): Rescale for budget neutrality.
The statute requires that changes to fee schedule RVUs must be
budget neutral. Thus, the last step is to adjust for relativity by
rescaling the proposed MP RVUs so that the total proposed resource
based MP RVUs are equal to the total current resource based MP RVUs
scaled by the ratio of the pools of the proposed and current MP and
work RVUs. This scaling is necessary to maintain the work RVUs for
individual services from year to year while also maintaining the
overall relationship among work, PE, and MP RVUs.
Specialties Excluded from Ratesetting Calculation: In section II.B.
of this proposed rule, Determination of Practice Expense Relative Value
Units, we discuss specialties that are excluded from ratesetting for
the purposes of calculating PE RVUs. We are proposing to treat those
excluded specialties in a consistent manner for the purposes of
calculating MP RVUs. We note that all specialties are included for
purposes of calculating the final BN adjustment. The list of
specialties excluded from the ratesetting calculation for the purpose
of calculating the PE RVUs that we are proposing to also exclude for
the purpose of calculating MP RVUs is available in section II.B. of
this proposed rule, Determination of Practice Expense Relative Value
Units. The proposed resource based MP RVUs are shown in Addendum B,
which is available on the CMS website under the downloads section of
the CY 2020 PFS rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Because a different share of the resources involved in furnishing
PFS services is reflected in each of the three fee schedule components,
implementation of the resource-based MP RVU update will have much
smaller payment effects than implementing updates of resource-based
work RVUs and resource-based PE RVUs. On average, work represents about
50.9 percent of payment for a service under the fee schedule, PE about
44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change
in PE RVUs or work RVUs for a service would result in a change in
payment of about 11 to 13 percent. In contrast, a corresponding 25
percent change in MP values for a service would yield a change in
payment of only about 1 percent. Estimates of the effects on payment by
specialty type can be found in section VI. of this proposed rule,
Regulatory Impact Analysis.
Additional information on our proposed methodology for updating the
MP RVUs is available in the ``Interim Report for the CY 2020 Update of
GPCIs and MP RVUs for the Medicare Physician Fee Schedule,'' which is
available on the CMS website under the downloads section of the CY 2020
PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
D. Geographic Practice Cost Indices (GPCIs)
1. Background
Section 1848(e)(1)(A) of the Act requires us to develop separate
Geographic Practice Cost Indices (GPCIs) to measure relative cost
differences among localities compared to the national average for each
of the three fee schedule components (that is, work, practice expense
(PE), and malpractice (MP)). We discuss the localities established
under the PFS below in this section. Although the statute requires that
the PE and MP GPCIs reflect full relative cost differences, section
1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only
one-quarter of the relative cost differences compared to the national
average. In addition, section 1848(e)(1)(G) of the Act sets a permanent
1.5 work GPCI floor for services furnished in Alaska beginning January
1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE
GPCI floor for services furnished in frontier states (as defined in
section 1848(e)(1)(I) of the Act) beginning January 1, 2011.
Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor
for the work GPCIs, which was set to expire at the end of 2017. Section
50201 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-
123, enacted February 9, 2018) amended the statute to extend the 1.0
floor for the work GPCIs through CY 2019 (that is, for services
furnished no later than December 31, 2019).
Section 1848(e)(1)(C) of the Act requires us to review and, if
necessary, adjust the GPCIs at least every 3 years. Section
1848(e)(1)(C) of the Act requires that, if more than 1 year has elapsed
since the date of the last previous GPCI adjustment, the adjustment to
be applied in the first year of the next adjustment shall be \1/2\ of
the adjustment that otherwise would be made. Therefore, since the
previous GPCI update was implemented in CYs 2017 and 2018, we are
proposing to phase in \1/2\ of the latest GPCI adjustment in CY 2020.
[[Page 40511]]
We have completed a review of the GPCIs and are proposing new GPCIs
in this proposed rule. We also calculate a geographic adjustment factor
(GAF) for each PFS locality. The GAFs are a weighted composite of each
PFS localities work, PE and MP expense GPCIs using the national GPCI
cost share weights. While we do not actually use GAFs in computing the
fee schedule payment for a specific service, they are useful in
comparing overall areas costs and payments. The actual effect on
payment for any actual service would deviate from the GAF to the extent
that the proportions of work, PE and MP RVUs for the service differ
from those of the GAF.
As noted above, section 50201 of the BBA of 2018 extended the 1.0
work GPCI floor for services furnished only through December 31, 2019.
Therefore, the proposed CY 2020 work GPCIs and summarized GAFs do not
reflect the 1.0 work floor. However, as required by sections
1848(e)(1)(G) and (I) of the Act, the 1.5 work GPCI floor for Alaska
and the 1.0 PE GPCI floor for frontier states are permanent, and
therefore, applicable in CY 2020. See Addenda D and E to this proposed
rule for the CY 2020 proposed GPCIs and summarized proposed GAFs
available on the CMS website under the supporting documents section of
the CY 2020 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
2. Payment Locality Background
Prior to 1992, Medicare payments for physicians' services were made
under the reasonable charge system. Payments under this system largely
reflected the charging patterns of physicians, which resulted in large
differences in payment for physicians' services among types of
services, physician specialties and geographic payment areas.
Local Medicare carriers initially established 210 payment
localities, to reflect local physician charging patterns and economic
conditions. These localities changed little between the inception of
Medicare in 1967 and the beginning of the PFS in 1992. In 1994, we
undertook a study that culminated in a comprehensive locality revision
(based on locality resource cost differences as reflected by the GPCIs)
that we implemented in 1997. The development of the current locality
structure is described in detail in the CY 1997 PFS final rule (61 FR
34615) and the subsequent final rule with comment period (61 FR 59494).
The revised locality structure reduced the number of localities from
210 to 89, and increased the number of statewide localities from 22 to
34.
Section 220(h) of the Protecting Access to Medicare Act (PAMA)
(Pub. L. 113-93, enacted April 1, 2014) required modifications to the
payment localities in California for payment purposes beginning with
2017. As a result, in the CY 2017 PFS final rule (81 FR 80265 through
80268) we established 23 additional localities, increasing the total
number of PFS localities from 89 to 112. The 112 payment localities
include 34 statewide areas (that is, only one locality for the entire
state) and 75 localities in the other 16 states, with 10 states having
two localities, two states having three localities, one state having
four localities, and three states having five or more localities. The
remainder of the 112 PFS payment localities are comprised as follows:
The combined District of Columbia, Maryland, and Virginia suburbs;
Puerto Rico; and the Virgin Islands. We note that the localities
generally represent a grouping of one or more constituent counties.
The current 112 fee schedule areas are defined alternatively by
state boundaries (for example, Wisconsin), metropolitan areas (for
example, Metropolitan St. Louis, MO), portions of a metropolitan area
(for example, Manhattan), or rest-of-state areas that exclude
metropolitan areas (for example, Rest of Missouri). This locality
configuration is used to calculate the GPCIs that are in turn used to
calculate locality adjusted payments for physicians' services under the
PFS.
As stated in the CY 2011 PFS final rule with comment period (75 FR
73261), changes to the PFS locality structure would generally result in
changes that are budget neutral within a state. For many years, before
making any locality changes, we have sought consensus from among the
professionals whose payments would be affected. We refer readers to the
CY 2014 PFS final rule with comment period (78 FR 74384 through 74386)
for further discussion regarding additional information about locality
configuration considerations.
3. GPCI Update
As required by the statute, we developed GPCIs to measure relative
cost differences among payment localities compared to the national
average for each of the three fee schedule components (that is, work,
PE, and MP). We describe the data sources and methodologies we use to
calculate each of the three GPCIs below in this section. Additional
information on the CY 2020 GPCI update is available in an interim
report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs
for the Medicare Physician Fee Schedule,'' on our website located under
the supporting documents section for the CY 2020 PFS proposed rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
a. Work GPCIs
The work GPCIs are designed to reflect the relative cost of
physician labor by Medicare PFS locality. As required by statute, the
work GPCI reflects one quarter of the relative wage differences for
each locality compared to the national average.
To calculate the work GPCIs, we use wage data for seven
professional specialty occupation categories, adjusted to reflect one-
quarter of the relative cost differences for each locality compared to
the national average, as a proxy for physicians' wages. Physicians'
wages are not included in the occupation categories used in calculating
the work GPCI because Medicare payments are a key determinant of
physicians' earnings. Including physician wage data in calculating the
work GPCIs would potentially introduce some circularity to the
adjustment since Medicare payments typically contribute to or influence
physician wages. That is, including physicians' wages in the physician
work GPCIs would, in effect, make the indices, to some extent,
dependent upon Medicare payments.
The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based
on professional earnings data from the 2000 Census. However, for the CY
2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage
and earnings data were not available from the more recent Census
because the ``long form'' was discontinued. Therefore, we used the
median hourly earnings from the 2006 through 2008 Bureau of Labor
Statistics (BLS) Occupational Employment Statistics (OES) wage data as
a replacement for the 2000 Census data. The BLS OES data meet several
criteria that we consider to be important for selecting a data source
for purposes of calculating the GPCIs. For example, the BLS OES wage
and employment data are derived from a large sample size of
approximately 200,000 establishments of varying sizes nationwide from
every metropolitan area and can be easily accessible to the public at
no cost. Additionally, the BLS OES is updated regularly, and includes a
comprehensive set of occupations and industries (for example, 800
occupations in 450 industries). For the CY 2014 GPCI update, we used
updated BLS OES data (2009 through 2011) as a
[[Page 40512]]
replacement for the 2006 through 2008 data to compute the work GPCIs;
and for the CY 2017 GPCI update, we used updated BLS OES data (2011
through 2014) as a replacement for the 2009 through 2011 data to
compute the work GPCIs.
Because of its reliability, public availability, level of detail,
and national scope, we believe the BLS OES data continue to be the most
appropriate source of wage and employment data for use in calculating
the work GPCIs (and as discussed below, the employee wage component and
purchased services component of the PE GPCI). Therefore, for the
proposed CY 2020 GPCI update, we used updated BLS OES data (2014
through 2017) as a replacement for the 2011 through 2014 data to
compute the work GPCIs.
b. Practice Expense (PE) GPCIs
The PE GPCIs are designed to measure the relative cost difference
in the mix of goods and services comprising PEs (not including MP
expenses) among the PFS localities as compared to the national average
of these costs. Whereas the physician work GPCIs (and as discussed
later in this section, the MP GPCIs) are comprised of a single index,
the PE GPCIs are comprised of four component indices (employee wages;
purchased services; office rent; and equipment, supplies and other
miscellaneous expenses). The employee wage index component measures
geographic variation in the cost of the kinds of skilled and unskilled
labor that would be directly employed by a physician practice. Although
the employee wage index adjusts for geographic variation in the cost of
labor employed directly by physician practices, it does not account for
geographic variation in the cost of services that typically would be
purchased from other entities, such as law firms, accounting firms,
information technology consultants, building service managers, or any
other third-party vendor. The purchased services index component of the
PE GPCI (which is a separate index from employee wages) measures
geographic variation in the cost of contracted services that physician
practices would typically buy. For more information on the development
of the purchased service index, we refer readers to the CY 2012 PFS
final rule with comment period (76 FR 73084 through 73085). The office
rent index component of the PE GPCI measures relative geographic
variation in the cost of typical physician office rents. For the
medical equipment, supplies, and miscellaneous expenses component, we
believe there is a national market for these items such that there is
not significant geographic variation in costs. Therefore, the
equipment, supplies and other miscellaneous expense cost index
component of the PE GPCI is given a value of 1.000 for each PFS
locality.
For the previous update to the GPCIs (implemented in CY 2017), we
used 2011 through 2014 BLS OES data to calculate the employee wage and
purchased services indices for the PE GPCI. As discussed previously in
this section, because of its reliability, public availability, level of
detail, and national scope, we continue to believe the BLS OES is the
most appropriate data source for collecting wage and employment data.
Therefore, in calculating the proposed CY 2020 GPCI update, we used
updated BLS OES data (2014 through 2017) as a replacement for the 2011
through 2014 data for purposes of calculating the employee wage
component and purchased service index component of the PE GPCI. In
calculating the proposed CY 2020 GPCI update, for the office rent index
component of the PE GPCI we used the most recently available, 2013
through 2017, American Community Survey (ACS) 5-year estimates as a
replacement for the 2009 through 2013 ACS data.
c. Malpractice Expense (MP) GPCIs
The MP GPCIs measure the relative cost differences among PFS
localities for the purchase of professional liability insurance (PLI).
The MP GPCIs are calculated based on insurer rate filings of premium
data for $1 million to $3 million mature claims-made policies (policies
for claims made rather than losses occurring during the policy term).
For the CY 2017 GPCI update, we used 2014 and 2015 malpractice premium
data. The proposed CY 2020 MP GPCI update reflects premium data
presumed in effect as of December 30, 2017. We note that we finalized a
few technical refinements to the MP GPCI methodology in CY 2017, and
refer readers to the CY 2017 PFS final rule (81 FR 80270) for
additional discussion.
d. GPCI Cost Share Weights
For CY 2020 GPCIs, we are proposing to continue to use the current
cost share weights for determining the PE GPCI values and locality
GAFs. We refer readers to the CY 2014 PFS final rule with comment
period (78 FR 74382 through 74383), for further discussion regarding
the 2006-based MEI cost share weights revised in CY 2014 that we also
finalized for use in the CY 2017 GPCI update.
The proposed GPCI cost share weights for CY 2020 are displayed in
Table 12.
Table 12--Proposed Cost Share Weights for CY 2020 GPCI Update
------------------------------------------------------------------------
Proposed CY 2020
Expense category Current cost cost share weight
share weight (%) (%)
------------------------------------------------------------------------
Work.............................. 50.866 50.866
Practice Expense.................. 44.839 44.839
--Employee Compensation....... 16.553 16.553
--Office Rent................. 10.223 10.223
--Purchased Services.......... 8.095 8.095
--Equipment, Supplies, Other.. 9.968 9.968
Malpractice Insurance............. 4.295 4.295
-------------------------------------
Total......................... 100.000 100.000
------------------------------------------------------------------------
e. PE GPCI Floor for Frontier States
Section 10324(c) of the Affordable Care Act added a new
subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0
PE GPCI floor for physicians' services furnished in frontier states
effective January 1, 2011. In accordance with section 1848(e)(1)(I) of
the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for
physicians' services furnished in states determined to be frontier
states. In general, a frontier state is one in which at least 50
percent of the counties are ``frontier counties,'' which are those that
[[Page 40513]]
have a population per square mile of less than 6. For more information
on the criteria used to define a frontier state, we refer readers to
the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75
FR 50160 through 50161). There are no changes in the states identified
as Frontier States for the CY 2020 PFS proposed rule. The qualifying
states are: Montana; Wyoming; North Dakota; South Dakota; and Nevada.
In accordance with statute, we would apply a 1.0 PE GPCI floor for
these states in CY 2020.
f. Methodology for Calculating GPCIs in the U.S. Territories
Prior to CY 2017, for all the island territories other than Puerto
Rico, the lack of comprehensive data about unique costs for island
territories had minimal impact on GPCIs because we used either the
Hawaii GPCIs (for the Pacific territories: Guam; American Samoa; and
Northern Mariana Islands) or used the unadjusted national averages (for
the Virgin Islands). In an effort to provide greater consistency in the
calculation of GPCIs given the lack of comprehensive data regarding the
validity of applying the proxy data used in the States in accurately
accounting for variability of costs for these island territories, in
the CY 2017 PFS final rule (81 FR 80268 through 80270), we finalized a
policy to treat the Caribbean Island territories (the Virgin Islands
and Puerto Rico) in a consistent manner. We do so by assigning the
national average of 1.0 to each GPCI index for both Puerto Rico and the
Virgin Islands. We refer readers to the CY 2017 PFS final rule for a
comprehensive discussion of this policy.
g. California Locality Update to the Fee Schedule Areas Used for
Payment Under Section 220(h) of the Protecting Access to Medicare Act
Section 220(h) of the PAMA added a new section 1848(e)(6) to the
Act that modified the fee schedule areas used for payment purposes in
California beginning in CY 2017. Prior to CY 2017, the fee schedule
areas used for payment in California were based on the revised locality
structure that was implemented in 1997 as previously discussed.
Beginning in CY 2017, section 1848(e)(6)(A)(i) of the Act required that
the fee schedule areas used for payment in California must be
Metropolitan Statistical Areas (MSAs) as defined by the Office of
Management and Budget (OMB) as of December 31 of the previous year; and
section 1848(e)(6)(A)(ii) of the Act required that all areas not
located in an MSA must be treated as a single rest-of-state fee
schedule area. The resulting modifications to California's locality
structure increased its number of localities from 9 under the current
locality structure to 27 under the MSA-based locality structure;
although for the purposes of payment the actual number of localities
under the MSA-based locality structure is 32. We refer readers to the
CY 2017 PFS final rule (81 FR 80267) for a detailed discussion of this
operational consideration.
Section 1848(e)(6)(D) of the Act defined transition areas as the
fee schedule areas for 2013 that were the rest-of-state locality, and
locality 3, which was comprised of Marin County, Napa County, and
Solano County. Section 1848(e)(6)(B) of the Act specified that the GPCI
values used for payment in a transition area are to be phased in over 6
years, from 2017 through 2022, using a weighted sum of the GPCIs
calculated under the new MSA-based locality structure and the GPCIs
calculated under the current PFS locality structure. That is, the GPCI
values applicable for these areas during this transition period are a
blend of what the GPCI values would have been for California under the
current locality structure, and what the GPCI values would be for
California under the MSA-based locality structure. For example, in CY
2020, which represents the fourth year, the applicable GPCI values for
counties that were previously in rest-of-state or locality 3 and are
now in MSAs are a blend of \2/3\ of the GPCI value calculated for the
year under the MSA-based locality structure, and \1/3\ of the GPCI
value calculated for the year under the current locality structure. The
proportions continue to shift by \1/6\ in each subsequent year so that,
by CY 2021, the applicable GPCI values for counties within transition
areas are a blend of \5/6\ of the GPCI value for the year under the
MSA-based locality structure, and \1/6\ of the GPCI value for the year
under the current locality structure. Beginning in CY 2022, the
applicable GPCI values for counties in transition areas are the values
calculated solely under the new MSA-based locality structure. For
clarity, we reiterate that this incremental phase-in is only applicable
to those counties that are in transition areas that are now in MSAs,
which are only some of the counties in the 2013 California rest-of
state locality and locality 3.
Additionally, section 1848(e)(6)(C) of the Act establishes a hold
harmless for transition areas beginning with CY 2017 whereby the
applicable GPCI values for a year under the new MSA-based locality
structure may not be less than what they would have been for the year
under the current locality structure. There are a total of 58 counties
in California, 50 of which are in transition areas as defined in
section 1848(e)(6)(D) of the Act. The eight counties that are not
within transition areas are: Orange; Los Angeles; Alameda; Contra
Costa; San Francisco; San Mateo; Santa Clara; and Ventura counties.
For the purposes of calculating budget neutrality and consistent
with the PFS budget neutrality requirements as specified under section
1848(c)(2)(B)(ii)(II) of the Act, we finalized the policy to start by
calculating the national GPCIs as if the current localities are still
applicable nationwide; then, for the purposes of payment in California,
we override the GPCI values with the values that are applicable for
California consistent with the requirements of section 1848(e)(6) of
the Act. This approach is consistent with the implementation of the
GPCI floor provisions that have previously been implemented--that is,
as an after-the-fact adjustment that is implemented for purposes of
payment after both the GPCIs and PFS budget neutrality have already
been calculated.
Additionally, section 1848(e)(1)(C) of the Act requires that, if
more than 1 year has elapsed since the date of the last previous GPCI
adjustment, the adjustment to be applied in the first year of the next
adjustment shall be \1/2\ of the adjustment that otherwise would be
made. However, since section 1848(e)(6)(B) of the Act provides for a
gradual phase in of the GPCI values under the new MSA-based locality
structure for California, specifically in one-sixth increments over 6
years, if we were to also apply the requirement to phase in \1/2\ of
the adjustment in year 1 of the GPCI update then the first year
increment would effectively be \1/12\. Therefore, in CY 2017, we
finalized a policy that the requirement at section 1848(e)(1)(C) of the
Act to phase in \1/2\ of the adjustment in year 1 of the GPCI update
would not apply to counties that were previously in the rest-of-state
or locality 3 and are now in MSAs that are subject to the blended
phase-in as described above in this section. We reiterate that this is
only applicable through CY 2021 since, beginning in CY 2022, the GPCI
values for such areas in an MSA would be fully based on the values
calculated under the new MSA-based locality structure for California.
For a comprehensive discussion of this provision, transition areas, and
operational considerations, we refer readers to the CY 2017 PFS final
rule (81 FR 80265 through 80268).
[[Page 40514]]
h. Refinements to the GPCI Methodology
In the process of calculating GPCIs for the purposes of this
proposed rule, we identified two technical refinements to the
methodology that yield improvements over the current method; these
refinements are applicable to the work GPCI and the employee wage index
and purchased services index components of the PE GPCI. We are
proposing to weight by total employment when computing county median
wages for each occupation code which addresses the fact that the
occupation wage can vary by industry within a county. Additionally, we
are also proposing to use a weighted average when calculating the final
county-level wage index; this removes the possibility that a county
index would imply a wage of 0 for any occupation group not present in
the county's data. These proposed methodological refinements yield
improved mathematical precision. Additional information on the GPCI
methodology and the proposed refinements are available in the interim
report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs
for the Medicare Physician Fee Schedule'' on our website located under
the supporting documents section of the CY 2020 PFS proposed rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
i. Proposed GPCI Update Summary
As explained above in the Background section above, the periodic
review and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of
the Act. At each update, the proposed GPCIs are published in the PFS
proposed rule to provide an opportunity for public comment and further
revisions in response to comments prior to implementation. The proposed
CY 2020 updated GPCIs for the first and second year of the 2-year
transition, along with the GAFs, are displayed in Addenda D and E to
this proposed rule available on our website under the supporting
documents section of the CY 2020 PFS proposed rule web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
E. Potentially Misvalued Services Under the PFS
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the RVUs
established under the PFS. Section 1848(c)(2)(K) of the Act requires
the Secretary to periodically identify potentially misvalued services
using certain criteria and to review and make appropriate adjustments
to the relative values for those services. Section 1848(c)(2)(L) of the
Act also requires the Secretary to develop a process to validate the
RVUs of certain potentially misvalued codes under the PFS, using the
same criteria used to identify potentially misvalued codes, and to make
appropriate adjustments.
As discussed in section II.N. of this proposed rule, Valuation of
Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the RUC, MedPAC,
and other stakeholders. For many years, the RUC has provided us with
recommendations on the appropriate relative values for new, revised,
and potentially misvalued PFS services. We review these recommendations
on a code-by-code basis and consider these recommendations in
conjunction with analyses of other data, such as claims data, to inform
the decision-making process as authorized by law. We may also consider
analyses of work time, work RVUs, or direct PE inputs using other data
sources, such as Department of Veteran Affairs (VA), National Surgical
Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons
(STS), and the Merit-based Incentive Payment System (MIPS) data. In
addition to considering the most recently available data, we assess the
results of physician surveys and specialty recommendations submitted to
us by the RUC for our review. We also consider information provided by
other stakeholders. We conduct a review to assess the appropriate RVUs
in the context of contemporary medical practice. We note that section
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
other techniques to determine the RVUs for physicians' services for
which specific data are not available and requires us to take into
account the results of consultations with organizations representing
physicians who provide the services. In accordance with section 1848(c)
of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed
the importance of appropriately valuing physicians' services, noting
that misvalued services can distort the market for physicians'
services, as well as for other health care services that physicians
order, such as hospital services. In that same report, MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work required
for certain services would be expected to decline as physicians become
more familiar with the service and more efficient in furnishing it.''
We believe services can also become overvalued when PE declines. This
can happen when the costs of equipment and supplies fall, or when
equipment is used more frequently than is estimated in the PE
methodology, reducing its cost per use. Likewise, services can become
undervalued when physician work increases or PE rises.
As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in PE.
Codes that describe new technologies or services within an
appropriate time period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are multiple codes that are frequently billed
in conjunction with furnishing a single service.
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
Codes that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the
PFS.
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site
of service since the code was last valued.
Codes for which there is a significant difference in
payment for the
[[Page 40515]]
same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
Codes with high intraservice work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well. Individuals and stakeholder groups may submit codes for review
under the potentially misvalued codes initiative to CMS in one of two
ways. Nominations may be submitted to CMS via email or through postal
mail. Email submissions should be sent to the CMS emailbox
[email protected], with the phrase ``Potentially
Misvalued Codes'' in the subject line. Physical letters for nominations
should be sent via the U.S. Postal Service to the Centers for Medicare
and Medicaid Service, Mail Stop: C4-01-26, 7500 Security Blvd.,
Baltimore, Maryland 21244. Envelopes containing the nomination letters
must be labeled ``Attention: Division of Practitioner Services,
Potentially Misvalued Codes''. Nominations for consideration in our
next annual rule cycle should be received by our February 10th
deadline. Since CY 2009, as a part of the annual potentially misvalued
code review and Five-Year Review process, we have reviewed
approximately 1,700 potentially misvalued codes to refine work RVUs and
direct PE inputs. We have assigned appropriate work RVUs and direct PE
inputs for these services as a result of these reviews. A more detailed
discussion of the extensive prior reviews of potentially misvalued
codes is included in the Medicare Program; Payment Policies Under the
Physician Fee Schedule, Five-Year Review of Work Relative Value Units,
Clinical Laboratory Fee Schedule: Signature on Requisition, and Other
Revisions to Part B for CY 2012; Final Rule (76 FR 73052 through 73055)
(hereinafter referred to as the CY 2012 PFS final rule with comment
period). In the CY 2012 PFS final rule with comment period (76 FR 73055
through 73958), we finalized our policy to consolidate the review of
physician work and PE at the same time, and established a process for
the annual public nomination of potentially misvalued services.
In the Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the
Requirement for Termination of Non-Random Prepayment Complex Medical
Review and Other Revisions to Part B for CY 2013 (77 FR 68892)
(hereinafter referred to as the CY 2013 PFS final rule with comment
period), we built upon the work we began in CY 2009 to review
potentially misvalued codes that have not been reviewed since the
implementation of the PFS (so-called ``Harvard-valued codes''). In the
Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2009; and Revisions to
the Amendment of the E-Prescribing Exemption for Computer Generated
Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter
referred to the CY 2009 PFS proposed rule), we requested
recommendations from the RUC to aid in our review of Harvard-valued
codes that had not yet been reviewed, focusing first on high-volume,
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services.
In the CY 2013 PFS final rule with comment period, we identified
specific Harvard-valued services with annual allowed charges that total
at least $10,000,000 as potentially misvalued. In addition to the
Harvard-valued codes, in the CY 2013 PFS final rule with comment period
we finalized for review a list of potentially misvalued codes that have
stand-alone PE (codes with physician work and no listed work time and
codes with no physician work that have listed work time).
In the Medicare Program; Revisions to Payment Policies under the
Physician Fee Schedule and Other Revisions to Part B for CY 2016 final
rule with comment period (80 FR 70886) (hereinafter referred to as the
CY 2016 PFS final rule with comment period), we finalized for review a
list of potentially misvalued services, which included eight codes in
the neurostimulators analysis-programming family (CPT codes 95970-
95982). We also finalized as potentially misvalued 103 codes identified
through our screen of high expenditure services across specialties.
In the Medicare Program; Revisions to Payment Policies under the
Physician Fee Schedule and Other Revisions to Part B for CY 2017;
Medicare Advantage Bid Pricing Data Release; Medicare Advantage and
Part D Medical Loss Ratio Data Release; Medicare Advantage Provider
Network Requirements; Expansion of Medicare Diabetes Prevention Program
Model; Medicare Shared Savings Program Requirements final rule (81 FR
80170) (hereinafter referred to as the CY 2017 PFS final rule), we
finalized for review a list of potentially misvalued services, which
included eight codes in the end-stage renal disease home dialysis
family (CPT codes 90963-90970). We also finalized as potentially
misvalued 19 codes
[[Page 40516]]
identified through our screen for 0-day global services that are
typically billed with an evaluation and management (E/M) service with
modifier 25.
In the CY 2018 PFS final rule, we finalized arthrodesis of
sacroiliac joint (CPT code 27279) as potentially misvalued. Through the
use of comment solicitations with regard to specific codes, we also
examined the valuations of other services, in addition to, new
potentially misvalued code screens (82 FR 53017 through 53018).
3. CY 2020 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606
through 67608), we modified this process whereby the public and
stakeholders may nominate potentially misvalued codes for review by
submitting the code with supporting documentation by February 10th of
each year. Supporting documentation for codes nominated for the annual
review of potentially misvalued codes may include the following:
Documentation in peer reviewed medical literature or other
reliable data that demonstrate changes in physician work due to one or
more of the following: Technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate for each nominated code whether we
agree with its inclusion as a potentially misvalued code. The public
has the opportunity to comment on these and all other proposed
potentially misvalued codes. In that year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
We received three submissions that nominated codes for review under
the potentially misvalued code initiative, prior to our February 10,
2019 deadline. In addition to three public nominations, CMS also
nominated one additional code for review.
One commenter requested that CMS consider CPT code 10005 (Fine
needle aspiration biopsy, including ultrasound guidance; first lesion)
and CPT code 10021 (Fine needle aspiration biopsy, without imaging
guidance; first lesion) for nomination as potentially misvalued. We
note that these two CPT codes were recently reviewed within a family of
13 similar codes. Our review of these codes and our rationale for
finalizing the current values are discussed extensively in the CY 2019
PFS final rule (83 FR 59517). For CPT code 10021, the RUC recommended a
32 percent reduction from its previous physician time and a 5 percent
reduction in the work RVU. The commenter disagreed with this change and
stated that there was a change in intensity of the procedure now as
compared to what it was in 1995 when this code was last evaluated. The
commenter also stated that there was a change in intensity of the work
performed due to use of more complicated equipment, more stringent
specimen sampling that allow for extensive examination of smaller and
deeper lesions within the body. The commenter disagreed with the CMS'
crosswalked CPT code 36440 (Push blood transfusion, patient 2 years or
younger) and presented CPT codes 40490 (Biopsy of lip) and 95865
(Needle measurement and recording of electrical activity of muscles of
voice box) as more appropriate crosswalks.
Another commenter requested that CMS consider HCPCS code G0166
(External counterpulsation, per treatment session) as potentially
misvalued. This code was reviewed for the CY 2019 PFS final rule (83 FR
59578), and the work RVU and direct PE inputs as recommended by the AMA
RUC were finalized by CMS. We finalized the valuation of this code with
no refinements. However, the commenter noted that the PE inputs that
were considered for this code did not fully reflect the total resources
required to deliver the service. We will review the commenter's
submission of additional new data and public comments received in
combination with what was previously presented in the CY 2019 PFS final
rule.
CMS nominated CPT code 76377 (3D rendering with interpretation and
reporting of computed tomography, magnetic resonance imaging,
ultrasound, or other tomographic modality with image postprocessing
under concurrent supervision; requiring image postprocessing on an
independent workstation) as potentially misvalued. CPT code 76376 (3D
rendering with interpretation and reporting of computed tomography,
magnetic resonance imaging, ultrasound, or other tomographic modality
with image postprocessing under concurrent supervision; not requiring
image postprocessing on an independent workstation) was reviewed by the
AMA RUC at the April 2018 RUC meeting. However, CPT code 76377, which
is very similar to CPT code 76376, was not reviewed, and is likely now
misvalued, in light of the similarities between the two codes. The
specialty societies noted that the two codes are different because they
are utilized by different patient populations (as evidenced by the ICD-
10 diagnoses); however, we view both codes to be similar enough that
CPT code 76377 should be reviewed to maintain relativity in the code
family.
We are proposing the aforementioned public and CMS nominated codes
as potentially misvalued and welcome public comment on these codes.
Another commenter provided information to CMS in which they stated
that the work involved in furnishing services represented by the
office/outpatient evaluation and management (E/M) code set (CPT codes
99201-99215) has changed sufficiently to warrant revaluation.
Specifically, the commenter stated that these codes have not been
reviewed in over 12 years and in that time have suffered passive
devaluation as more and more procedures and other services have been
added to the CPT code set, which are subsequently valued in a budget
neutral manner, through notice and comment rulemaking, on the Medicare
PFS. The commenter also stated that re-evaluation of these codes is
critical to the success
[[Page 40517]]
of CMS' objective of advancing value-based care through the
introduction of advanced alternative payment models (APMs) as these
APMs rely on the underlying E/M codes as the basis for payment or
reference price for bundled payments.
We acknowledge the points made by the commenter, and continue to
consider the best ways to recognize the significant changes in
healthcare practice as discussed by the commenter. We agree, in
principle, that the existing set of office/outpatient E/M CPT codes may
not be correctly valued. In recent years, we have specifically
considered how best to update and revalue the E/M codes, which
represent a significant proportion of PFS expenditures, and have also
engaged in ongoing dialogue with the practitioner community. In the CY
2019 PFS proposed and final rules, in part due to these ongoing
stakeholder discussions, we proposed and finalized changes to E/M
payment and documentation requirements to implement policy objectives
focused on reducing provider documentation burden (83 FR 59625).
Concurrently, the CPT Editorial Panel, under similar burden reduction
guiding principles, convened a workgroup and proposed to refine and
revalue the existing E/M office/outpatient code set. We thank the
commenter for the views represented in their comment. As stated earlier
in this section, we agree in principle that the existing set of office/
outpatient E/M CPT codes may not be correctly valued, and therefore, we
will continue to consider opportunities to revalue these codes, in
light of their significance to payment for services billed under
Medicare.
Table 13 lists the HCPCS and CPT codes that we are proposing as
potentially misvalued.
Table 13--HCPCS and CPT Codes Proposed as Potentially Misvalued
------------------------------------------------------------------------
CPT/HCPCS code Short description
------------------------------------------------------------------------
10005................................ Fna bx w/us gdn 1st les.
10021................................ Fna bx w/o img gdn 1st les.
76377................................ 3d render w/intrp postproces.
G0166................................ Extrnl counterpulse, per tx.
------------------------------------------------------------------------
F. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
As discussed in this rule and in prior rulemaking, several
conditions must be met for Medicare to make payment for telehealth
services under the PFS. For further details, see the full discussion of
the scope of Medicare telehealth services in the CY 2018 PFS final rule
(82 FR 53006) and in 42 CFR 410.78 and 414.65.
1. Adding Services to the List of Medicare Telehealth Services
In the CY 2003 PFS final rule with comment period (67 FR 79988), we
established a process for adding services to or deleting services from
the list of Medicare telehealth services in accordance with section
1834(m)(4)(F)(ii) of the Act. This process provides the public with an
ongoing opportunity to submit requests for adding services, which are
then reviewed by us. Under this process, we assign any submitted
request to add to the list of telehealth services to one of the
following two categories:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the list of telehealth services. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
service; for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to those on the
current list of telehealth services. Our review of these requests
includes an assessment of whether the service is accurately described
by the corresponding code when furnished via telehealth and whether the
use of a telecommunications system to furnish the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits.
Some examples of clinical benefit include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
The list of telehealth services, including the proposed additions
described later in this section, can be located on the CMS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Historically, requests to add services to the list of Medicare
telehealth services had to be submitted and received no later than
December 31 of each calendar year to be considered for the next
rulemaking cycle. However, beginning in CY 2019 we stated that for CY
2019 and onward, we intend to accept requests through February 10,
consistent with the deadline for our receipt of code valuation
recommendations from the RUC. For example, to be considered during PFS
rulemaking for CY 2021, requests to add services to the list of
Medicare telehealth services must be submitted and received by February
10, 2020. Each request to add a service to the list of Medicare
telehealth services must include any supporting documentation the
requester wishes us to consider as we review the request. Because we
use the annual PFS rulemaking process as the vehicle to make changes to
the list of Medicare telehealth services, requesters should be advised
that any information submitted as part of a request is subject to
public disclosure for this purpose. For more information on submitting
a request to add services to the list of Medicare telehealth services,
including where to mail these requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
2. Requests To Add Services to the List of Telehealth Services for CY
2020
Under our current policy, we add services to the telehealth list on
a Category 1 basis when we determine that they are similar to services
on the existing telehealth list for the roles of,
[[Page 40518]]
and interactions among, the beneficiary, physician (or other
practitioner) at the distant site and, if necessary, the telepresenter.
As we stated in the CY 2012 PFS final rule with comment period (76 FR
73098), we believe that the Category 1 criteria not only streamline our
review process for publicly requested services that fall into this
category, but also expedite our ability to identify codes for the
telehealth list that resemble those services already on this list.
We did not receive any requests from the public for additions to
the Medicare Telehealth list for CY 2020. We believe that the vast
majority of services under the PFS that can be appropriately furnished
as Medicare telehealth services have already been added to the list.
However, there are three HCPCS G-codes describing new services
being proposed in section II.H. of this rule for CY 2020 which we
believe are sufficiently similar to services currently on the
telehealth list to be added on a Category 1 basis. Therefore, we are
proposing to add the face-to-face portions of the following services to
the telehealth list on a Category 1 basis for CY 2020:
HCPCS code GYYY1: Office-based treatment for opioid use
disorder, including development of the treatment plan, care
coordination, individual therapy and group therapy and counseling; at
least 70 minutes in the first calendar month.
HCPCS code GYYY2: Office-based treatment for opioid use
disorder, including care coordination, individual therapy and group
therapy and counseling; at least 60 minutes in a subsequent calendar
month.
HCPCS code GYYY3: Office-based treatment for opioid use
disorder, including care coordination, individual therapy and group
therapy and counseling; each additional 30 minutes beyond the first 120
minutes (List separately in addition to code for primary procedure).
Similar to our addition of the required face-to-face visit
component of TCM services to the Medicare Telehealth list in the CY
2014 PFS final rule with comment period (78 FR 74403), since HCPCS
codes GYYY1, GYYY2, and GYYY3 include face-to-face psychotherapy
services, we believe that the face-to-face portions of these services
are sufficiently similar to services currently on the list of Medicare
telehealth services for these services to be added under Category 1.
Specifically, we believe that the psychotherapy portions of the bundled
codes are similar to the psychotherapy codes described by CPT codes
90832 and 90853, which are currently on the Medicare telehealth
services list. We note that like certain other non-face-to-face PFS
services, the other components of HCPCS codes GYYY1-3 describing care
coordination are commonly furnished remotely using telecommunications
technology, and do not require the patient to be present in-person with
the practitioner when they are furnished. As such, we do not need to
consider whether the non-face-to-face aspects of HCPCS codes GYYY1-3
are similar to other telehealth services. Were these components of
HCPCS codes GYYY1-3 separately billable, they would not need to be on
the Medicare telehealth list to be covered and paid in the same way as
services delivered without the use of telecommunications technology.
As discussed in the CY 2019 PFS final rule (83 FR 59496), we note
that section 2001(a) of the SUPPORT Act (Pub. L. 115-271, October 24,
2018) amended section 1834(m) of the Act, adding a new paragraph (7)
that removes the geographic limitations for telehealth services
furnished on or after July 1, 2019, for individuals diagnosed with a
substance use disorder (SUD) for the purpose of treating the SUD or a
co-occurring mental health disorder. Section 1834(m)(7) of the Act also
allows telehealth services for treatment of a diagnosed SUD or co-
occurring mental health disorder to be furnished to individuals at any
telehealth originating site (other than a renal dialysis facility),
including in a patient's home. Section 2001(a) of the SUPPORT Act
additionally amended section 1834(m) of the Act to require that no
originating site facility fee will be paid in instances when the
individual's home is the originating site. We believe that adding HCPCS
codes GYYY1, GYYY2, and GYYY3 will complement the existing policies
related to flexibilities in treating SUDs under Medicare Telehealth.
We note that we welcome public nominations for additions to the
Medicare telehealth list. More information on the nomination process is
posted under the Telehealth section of the CMS website, which can be
accessed at the following web address https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
G. Medicare Coverage for Opioid Use Disorder Treatment Services
Furnished by Opioid Treatment Programs (OTPs)
1. Overview
Opioid use disorder (OUD) and deaths from prescription and illegal
opioid overdoses have reached alarming levels. The Centers for Disease
Control and Prevention (CDC) estimated 47,000 overdose deaths were from
opioids in 2017 and 36 percent of those deaths were from prescription
opioids.\1\ OUD has become a public health crisis. On October 26, 2017,
Acting Health and Human Services Secretary, Eric D. Hargan declared a
nationwide public health emergency on the opioid crisis as requested by
President Donald Trump.\2\ This public health emergency was renewed by
Secretary Alex M. Azar II on January 24, 2018, April 24, 2018, July 23,
2018, and October 21, 2018, January 17, 2019 and most recently, on
April 19, 2019.\3\
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\1\ https://www.cdc.gov/drugoverdose/data/index.html.
\2\ https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html.
\3\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/opioid-19apr2019.aspx.
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The Medicare population, including individuals who are eligible for
both Medicare and Medicaid, has the fastest growing prevalence of OUD
compared to the general adult population, with more than 300,000
beneficiaries diagnosed with OUD in 2014.\4\ An effective treatment for
OUD is known as medication-assisted treatment (MAT). The Substance
Abuse and Mental Health Services Administration (SAMHSA) defines MAT as
the use of medication in combination with behavioral health services to
provide an individualized approach to the treatment of substance use
disorder, including opioid use disorder (42 CFR 8.2). Currently,
Medicare covers medications for MAT, including buprenorphine,
buprenorphine-naloxone combination products, and extended-release
injectable naltrexone under Part B or Part D, but does not cover
methadone. Medicare also covers counseling and behavioral therapy
services that are reasonable and necessary and furnished by
practitioners that can bill and receive payment under Medicare.
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\4\ https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2535238.
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Historically, Medicare has not covered methadone for MAT because of
the unique manner in which this drug is dispensed and administered.
Medicare Part B covers physician-administered drugs, drugs used in
[[Page 40519]]
conjunction with durable medical equipment, and certain other
statutorily specified drugs. Medicare Part D covers drugs that are
dispensed upon a prescription by a pharmacy. Methadone for MAT is not a
drug administered by a physician under the incident to benefit like
other MAT drugs (that is, implanted buprenorphine or injectable
extended-release naltrexone) and therefore has not previously been
covered by Medicare Part B. Methadone for MAT is also not a drug
dispensed by a pharmacy like certain other MAT drugs (that is
buprenorphine or buprenorphine-naloxone combination products) and
therefore is not covered under Medicare Part D. Methadone for MAT is a
schedule II controlled substance that is highly regulated because it
has a high potential for abuse which may lead to severe psychological
or physical dependence. As a result, methadone for MAT can only be
dispensed and administered by an opioid treatment program (OTP) as
provided under section 303(g)(1) of the Controlled Substances Act (21
U.S.C. 823(g)(1)) and 42 CFR part 8. Additionally, OTPs, which are
healthcare entities that focus on providing MAT for people diagnosed
with OUD, were not previously entities that could bill and receive
payment from Medicare for the services they furnish. Therefore, there
has historically been a gap in Medicare coverage of MAT for OUD since
methadone (one of the three FDA-approved drugs for MAT) has not been
covered.
Section 2005 of the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities Act (the
SUPPORT Act) (Pub. L. 115-271, enacted October 24, 2018) added a new
section 1861(jjj) to the Act, establishing a new Part B benefit
category for OUD treatment services furnished by an OTP beginning on or
after January 1, 2020. Section 1861(jjj)(1) of the Act defines OUD
treatment services as items and services furnished by an OTP (as
defined in section 1861(jjj)(2)) for treatment of OUD. Section 2005 of
the SUPPORT Act also amended the definition of ``medical and other
health services'' in section 1861(s) of the Act to provide for coverage
of OUD treatment services and added a new section 1834(w) to the Act
and amended section 1833(a)(1) of the Act to establish a bundled
payment to OTPs for OUD treatment services furnished during an episode
of care beginning on or after January 1, 2020.
OTPs must have a current, valid certification from SAMHSA to
satisfy the Controlled Substances Act registration requirement under 21
U.S.C. 823(g)(1). To obtain SAMHSA certification, OTPs must have a
valid accreditation by an accrediting body approved by SAMHSA, and must
be certified by SAMHSA as meeting federal opioid treatment standards in
42 CFR 8.12. There are currently about 1,700 OTPs nationwide.\5\ All
states except Wyoming have OTPs. Approximately 74 percent of patients
receiving services from OTPs receive methadone for MAT, with the vast
majority of the remaining patients receiving buprenorphine.\6\
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\5\ https://dpt2.samhsa.gov/treatment/directory.aspx.
\6\ https://wwwdasis.samhsa.gov/dasis2/nssats.htm.
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Many payers currently cover MAT services for treatment of OUD.
Medicaid \7\ is one of the largest payers of medications for substance
use disorder (SUD), including methadone for MAT provided in OTPs.\8\
OUD treatment services and MAT are also covered by other payers such as
TRICARE and private insurers. TRICARE established coverage and payment
for MAT and OUD treatment services furnished by OTPs in late 2016 (81
FR 61068). In addition, as discussed in the ``Patient Protection and
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for
2020'' proposed rule, many qualified health plans covered MAT
medications for plan year 2018 (84 FR 285).
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\7\ Medicaid provides health care coverage to 65.9 million
Americans, including low-income adults, children, pregnant women,
elderly adults and people with disabilities. Medicaid is
administered by states, according to federal requirements, and is
funded jointly by states and the federal government. States have the
flexibility to administer the Medicaid program to meet their own
state needs within the Medicaid program parameters set forth in
federal statute and regulations. As a result, there is variation in
how each state implements its programs.
\8\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
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In the CY 2019 PFS final rule (83 FR 59497), we included a Request
for Information (RFI) to solicit public comments on the implementation
of the new Medicare benefit category for OUD treatment services
furnished by OTPs established by section 2005 of the SUPPORT Act. We
received 9 public comments. Commenters were generally supportive of the
new benefit and expanding access to OUD treatment for Medicare
beneficiaries. We received feedback that the bundled payments to OTPs
should recognize the intensity of services furnished in the initiation
stages, durations of care, the needs of patients with more complex
needs, costs of emerging technologies, and use of peer support groups.
We also received feedback that costs associated with care coordination
among the beneficiary's practitioners should be included in the bundled
payment given the myriad of health issues beneficiaries with OUD face.
We considered this feedback as we developed our proposals for
implementing the new benefit category for OUD treatment services
furnished by OTPs and the proposed bundled payments for these services.
To implement section 2005 of the SUPPORT Act, we are proposing to
establish rules to govern Medicare coverage of and payment for OUD
treatment services furnished in OTPs. In the following discussion, we
propose to establish definitions of OUD treatment services and OTP for
purposes of the Medicare Program. We also propose a methodology for
determining Medicare payment for such services provided by OTPs. We are
proposing to codify these policies in a new section of the regulations
at Sec. 410.67. For a discussion about Medicare enrollment
requirements and the proposed program integrity approach for OTPs, we
refer readers to section III.H. Medicare Enrollment of Opioid Treatment
Programs, in this proposed rule.
2. Proposed Definitions
a. Opioid Use Disorder Treatment Services
The SUPPORT Act amended section 1861 of the Act by adding a new
subsection (jjj)(1) that defines ``opioid use disorder treatment
services'' as the items and services that are furnished by an OTP for
the treatment of OUD, as set forth in subparagraphs (A) through (F) of
section 1861(jjj)(1) of the Act which include:
Opioid agonist and antagonist treatment medications
(including oral, injected, or implanted versions) that are approved by
the Food and Drug Administration (FDA) under section 505 of the Federal
Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 355) for use in the
treatment of OUD;
Dispensing and administration of such medications, if
applicable;
Substance use counseling by a professional to the extent
authorized under state law to furnish such services;
Individual and group therapy with a physician or
psychologist (or other mental health professional to the extent
authorized under state law);
Toxicology testing; and
Other items and services that the Secretary determines are
appropriate (but in no event to include meals or transportation).
As described previously, section 1861(jjj)(1)(A) of the Act defines
covered OUD treatment services to include oral,
[[Page 40520]]
injected, and implanted opioid agonist and antagonist medications
approved by FDA under section 505 of the FFDCA for use in the treatment
of OUD. There are three drugs currently approved by the FDA for the
treatment of opioid dependence: Buprenorphine, methadone, and
naltrexone.\9\ FDA notes that all three of these medications have been
demonstrated to be safe and effective in combination with counseling
and psychosocial support and that those seeking treatment for an OUD
should be offered access to all three options as this allows providers
to work with patients to select the medication best suited to an
individual's needs.\10\ Each of these medications is discussed below in
more detail.
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\9\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
\10\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
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Buprenorphine is FDA-approved for acute and chronic pain in
addition to opioid dependence. It is listed by the Drug Enforcement
Administration (DEA) as a Schedule III controlled substance because of
its moderate to low potential for physical and psychological
dependence.\11\ \12\ The medication's partial agonist properties allow
for its use in opioid replacement therapy, which is a process of
treating OUD by using a substance, for example, buprenorphine or
methadone, to substitute for a stronger full agonist opioid.\13\
Buprenorphine drug products that are currently FDA-approved and
marketed for the treatment of opioid dependence include oral
buprenorphine and naloxone \14\ films and tablets, an extended-release
buprenorphine injection for subcutaneous use, and a buprenorphine
implant for subdermal administration.\15\ In most patients with opioid
dependence, the initial oral dose is 2 to 4 mg per day with a
maintenance dose of 8-12 mg per day.\16\ Dosing for the extended-
release injection is 300 mg monthly for the first 2 months followed by
a maintenance dose of 100 mg monthly.\17\ The extended-release
injection is indicated for patients who have initiated treatment with
an oral buprenorphine product for a minimum of 7 days.\18\ The
buprenorphine implant consists of four rods containing 74.2 mg of
buprenorphine each, and provides up to 6 months of treatment for
patients who are clinically stable on low-to-moderate doses of an oral
buprenorphine-containing product.\19\ Currently, federal regulations
permit buprenorphine to be prescribed or dispensed by qualifying
physicians and qualifying other practitioners at office-based practices
and dispensed in OTPs.\20\ \21\
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\11\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
\12\ https://www.dea.gov/drug-scheduling.
\13\ https://www.ncbi.nlm.nih.gov/books/NBK459126/.
\14\ Naloxone is added to buprenorphine in order to reduce its
abuse potential and limit diversion.
\15\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
\16\ https://www.ncbi.nlm.nih.gov/books/NBK459126/.
\17\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf.
\18\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf.
\19\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf.
\20\ https://www.fda.gov/Drugs/NewsEvents/ucm611659.htm.
\21\ 21 U.S.C. 823(g)(2).
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Methadone is FDA-approved for management of severe pain in addition
to opioid dependence. It is listed by the DEA as a Schedule II
controlled substance because of its high potential for abuse, with use
potentially leading to severe psychological or physical dependence.\22\
\23\ Methadone drug products that are FDA-approved for the treatment of
opioid dependence include oral methadone concentrate and tablets.\24\
In patients with opioid dependence, the total daily dose of methadone
on the first day of treatment should not ordinarily exceed 40 mg,
unless the program physician documents in the patient's record that 40
milligrams did not suppress opioid abstinence, with clinical stability
generally achieved at doses between 80 to 120 mg/day.\25\ By law,
methadone can only be dispensed through an OTP certified by SAMHSA.\26\
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\22\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
\23\ https://www.dea.gov/drug-scheduling.
\24\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
\25\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017116s032lbl.pdf.
\26\ https://www.samhsa.gov/medication-assisted-treatment/treatment/methadone.
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Naltrexone is FDA-approved to treat alcohol dependence in addition
to opioid use disorder.\27\ Unlike buprenorphine and methadone, which
activate opioid receptors, naltrexone binds and blocks opioid receptors
and reduces opioid cravings.\28\ Therefore, naltrexone is not a
scheduled substance; there is no abuse and diversion potential with
naltrexone.29 30 The naltrexone drug product that is FDA-
approved for the treatment of opioid dependence is an extended-release,
intramuscular injection.\31\ The recommended dose is 380 mg delivered
intramuscularly every 4 weeks or once a month after the patient has
achieved an opioid-free duration of a minimum of 7-10 days.\32\
Naltrexone can be prescribed by any health care provider who is
licensed to prescribe medications.\33\
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\27\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf.
\28\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
\29\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
\30\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
\31\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
\32\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf.
\33\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
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We propose that the OUD treatment services that may be furnished by
OTPs include the first five items and services listed in the statutory
definition described above, specifically the medications approved by
the FDA under section 505 of the FFDCA for use in the treatment of OUD;
the dispensing and administration of such medication, if applicable;
substance use counseling; individual and group therapy; and toxicology
testing. We also propose to use our discretion under section
1861(jjj)(1)(F) of the Act to include other items and services that the
Secretary determines are appropriate to include the use of
telecommunications for certain services, as discussed later in this
section. We propose to codify this definition of OUD treatment services
furnished by OTPs at Sec. 410.67(b). As part of this definition, we
also propose to specify that an OUD treatment service is an item or
service that is furnished by an OTP that meets the applicable
requirements to participate in the Medicare Program and receive
payment.
We seek comment on any other items and services (not including
meals or transportation as they are statutorily prohibited) currently
covered and paid for under Medicare Part B when furnished by Medicare-
enrolled providers/suppliers that the Secretary should consider adding
to this definition, including any evidence supporting the impact of the
use of such items and services in the treatment of OUD and enumeration
of their costs. We are particularly interested in public feedback on
whether intake activities, which may include services such as an
initial physical examination, initial assessments and preparation of a
treatment plan, as well as periodic assessments, should be included in
the definition of OUD treatment services. Additionally, we understand
that while the current FDA-approved medications under section 505 of
the FFDCA for the treatment of OUD are opioid agonists and antagonist
medications, other
[[Page 40521]]
medications that are not opioid agonist and antagonist medications,
including drugs and biologicals, could be developed for the treatment
of OUD in the future. We would like public feedback on whether there
are any drug development efforts in the pipeline that could result in
medications intended for use in the treatment of OUD with a novel
mechanism of action that does not involve opioid agonist and antagonist
mechanisms (that is, outside of activating and/or blocking opioid
receptors). We also welcome comment on how medications that may be
approved by the FDA in the future for use in the treatment of OUD with
a novel mechanism of action, such as medications approved under section
505 of the FFDCA to treat OUD and biological products licensed under
section 351 of the Public Health Service Act to treat OUD, should be
considered in the context of OUD treatment services provided by OTPs,
and whether CMS should use the discretion afforded under section
1861(jjj)(1)(F) of the Act to include such medications in the
definition of OUD treatment services given the possibility that such
medications could be approved in the future.
b. Opioid Treatment Program
Section 2005 of the SUPPORT Act also amended section 1861 of the
Act by adding a new subsection (jjj)(2) to define an OTP as an entity
meeting the definition of OTP in 42 CFR 8.2 or any successor regulation
(that is, a program or practitioner engaged in opioid treatment of
individuals with an opioid agonist treatment medication registered
under 21 U.S.C. 823(g)(1)), that meets the additional requirements set
forth in subparagraphs (A) through (D) of section 1861(jjj)(2) of the
Act. Specifically that the OTP:
Is enrolled under section 1866(j) of the Act;
Has in effect a certification by SAMHSA for such a
program;
Is accredited by an accrediting body approved by SAMHSA;
and
Meets such additional conditions as the Secretary may find
necessary to ensure the health and safety of individuals being
furnished services under such program and the effective and efficient
furnishing of such services.
These requirements are discussed in more detail in this section.
(1) Enrollment
As discussed previously, under section 1861(jjj)(2)(A) of the Act,
an OTP must be enrolled in Medicare to receive Medicare payment for
covered OUD treatment services under section 1861(jjj)(1) of the Act.
We refer the reader to section III.H. of this proposed rule, Medicare
Enrollment of Opioid Treatment Programs, for further details on our
proposed policies related to enrollment of OTPs.
(2) Certification by SAMHSA
As provided in section 1861(jjj)(2)(B) of the Act, OTPs must be
certified by SAMHSA to furnish Medicare-covered OUD treatment services.
SAMHSA has created a system to certify and accredit OTPs, which is
governed by 42 CFR part 8, subparts B and C. This regulatory framework
allows SAMHSA to focus its oversight efforts on improving treatment
rather than solely ensuring that OTPs are meeting regulatory criteria,
and preserves states' authority to regulate OTPs. To be certified by
SAMHSA, OTPs must comply with the federal opioid treatment standards as
outlined in Sec. 8.12, be accredited by a SAMHSA-approved
accreditation body, and comply with any other conditions for
certification established by SAMHSA. Specifically, SAMHSA requires OTPs
to provide the following services:
General--OTPs shall provide adequate medical, counseling,
vocational, educational, and other assessment and treatment services.
Initial medical examination services--OTPs shall require
each patient to undergo a complete, fully documented physical
evaluation by a program physician or a primary care physician, or an
authorized healthcare professional under the supervision of a program
physician, before admission to the OTP.
Special services for pregnant patients--OTPs must maintain
current policies and procedures that reflect the special needs of
patients who are pregnant. Prenatal care and other gender specific
services for pregnant patients must be provided either by the OTP or by
referral to appropriate healthcare providers.
Initial and periodic assessment services--Each patient
accepted for treatment at an OTP shall be assessed initially and
periodically by qualified personnel to determine the most appropriate
combination of services and treatment.
Counseling services--OTPs must provide adequate substance
abuse counseling to each patient as clinically necessary by a program
counselor, qualified by education, training, or experience to assess
the patient's psychological and sociological background.
Drug abuse testing services--OTPs must provide adequate
testing or analysis for drugs of abuse, including at least eight random
drug abuse tests per year, per patient in maintenance treatment, in
accordance with generally accepted clinical practice. For patients in
short-term detoxification treatment, defined in 42 CFR 8.2 as
detoxification treatment not in excess of 30 days, the OTP shall
perform at least one initial drug abuse test. For patients receiving
long-term detoxification treatment, the program shall perform initial
and monthly random tests on each patient.
The provisions governing recordkeeping and patient confidentiality
at Sec. 8.12(g)(1) require that OTPs shall establish and maintain a
recordkeeping system that is adequate to document and monitor patient
care. All records are required to be kept confidential in accordance
with all applicable federal and state requirements. The requirements at
Sec. 8.12(g)(2) state that OTPs shall document in each patient's
record that the OTP made a good faith effort to review whether or not
the patient is enrolled in any other OTP. A patient enrolled in an OTP
shall not be permitted to obtain treatment in any other OTP except in
exceptional circumstances, which is determined by the medical director
or program physician of the OTP in which the patient is enrolled (42
CFR 8.12(g)(2)). Additionally, the requirements at Sec. 8.12(h)
address medication administration, dispensing, and use.
SAMHSA requires that OTPs shall ensure that opioid agonist
treatment medications are administered or dispensed only by a
practitioner licensed under the appropriate state law and registered
under the appropriate state and federal laws to administer or dispense
opioid drugs, or by an agent of such a practitioner, supervised by and
under the order of the licensed practitioner. OTPs shall use only those
opioid agonist treatment medications that are approved by the FDA for
use in the treatment of OUD. They must maintain current procedures that
are adequate to ensure that the dosing requirements are met, and each
opioid agonist treatment medication used by the program is administered
and dispensed in accordance with its approved product labeling.
At Sec. 8.12(i), regarding unsupervised or ``take-home'' use of
opioid agonist treatment medications, SAMHSA has specified that OTPs
must follow requirements specified by SAMHSA to limit the potential for
diversion of opioid agonist treatment medications to the illicit market
when dispensed to patients as take-homes, including maintaining current
procedures to identify the theft or diversion of take-
[[Page 40522]]
home medications. The requirements at Sec. 8.12(j) for interim
maintenance treatment, state that the program sponsor of a public or
nonprofit private OTP subject to the approval of SAMHSA and the state,
may place an individual, who is eligible for admission to comprehensive
maintenance treatment, in interim maintenance treatment if the
individual cannot be placed in a public or nonprofit private
comprehensive program within a reasonable geographic area and within 14
days of the individual's application for admission to comprehensive
maintenance treatment. Patients in interim maintenance treatment are
permitted to receive daily dosing, but take-homes are not permitted.
During interim maintenance treatment, initial treatment plans and
periodic treatment plan evaluations are not required and a primary
counselor is not required to be assigned to the patient. The OTP must
be able to transfer these patients from interim maintenance into
comprehensive maintenance treatment within 120 days. Interim
maintenance treatment must be provided in a manner consistent with all
applicable federal and state laws.
The SAMHSA requirements at Sec. 8.12(b) address administrative and
organizational structure, requiring that an OTP's organizational
structure and facilities shall be adequate to ensure quality patient
care and meet the requirements of all pertinent federal, state, and
local laws and regulations. At a minimum, each OTP shall formally
designate a program sponsor and medical director who is a physician who
is licensed to practice medicine in the jurisdiction in which the OTP
is located. The program sponsor shall agree on behalf of the OTP to
adhere to all requirements set forth in 42 CFR part 8, subpart C and
any regulations regarding the use of opioid agonist treatment
medications in the treatment of OUD, which may be promulgated in the
future. The medical director shall assume responsibility for
administering all medical services performed by the OTP. In addition,
the medical director shall be responsible for ensuring that the OTP is
in compliance with all applicable federal, state, and local laws and
regulations.
The provision governing patient admission criteria at Sec. 8.12(e)
requires that an OTP shall maintain current procedures designed to
ensure that patients are admitted to maintenance treatment by qualified
personnel who have determined, using accepted medical criteria such as
those listed in the Diagnostic and Statistical Manual of Mental
Disorders, including that the person has an OUD, and that the person
has had an OUD at least 1 year before admission for treatment. If under
18 years of age, the patient is required to have had two documented
unsuccessful attempts at short-term detoxification or drug-free
treatment within a 12-month period and have the written consent of a
parent, legal guardian or responsible adult designated by the relevant
state authority to be eligible for maintenance treatment.
To ensure continuous quality improvement, the requirements at Sec.
8.12(c) state that an OTP must maintain current quality assurance and
quality control plans that include, among other things, annual reviews
of program policies and procedures and ongoing assessment of patient
outcomes and a current Diversion Control Plan as part of its quality
assurance program.
The requirements at Sec. 8.12(d) with respect to staff
credentials, state that each person engaged in the treatment of OUD
must have sufficient education, training, and experience, or any
combination thereof, to enable that person to perform the assigned
functions.
In addition to meeting the criteria described above, OTPs must
apply to SAMHSA for certification. As part of the conditions for
certification, SAMHSA specifies that OTPs shall:
Comply with all pertinent state laws and regulations.
Allow inspections and surveys by duly authorized employees
of SAMHSA, by accreditation bodies, by the DEA, and by authorized
employees of any relevant State or federal governmental authority.
Comply with the provisions of 42 CFR part 2 (regarding
confidentiality of substance use disorder patient records).
Notify SAMHSA within 3 weeks of any replacement or other
change in the status of the program sponsor or medical director.
Comply with all regulations enforced by the DEA under 21
CFR chapter II, and be registered by the DEA before administering or
dispensing opioid agonist treatment medications.
Operate in accordance with federal opioid treatment
standards and approved accreditation elements.
Furthermore, SAMHSA has issued additional guidance for OTPs that
describes how programs can achieve and maintain compliance with federal
regulations.\34\
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\34\ https://store.samhsa.gov/system/files/pep15-fedguideotp.pdf.
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(3) Accreditation of OTPs by a SAMHSA-Approved Accrediting Body
As provided in section 1861(jjj)(2)(C) of the Act, OTPs must be
accredited by a SAMHSA-approved accrediting body in order to furnish
Medicare-covered OUD treatment services. In 2001, the Department of
Health and Human Services (HHS) and SAMHSA issued final regulations to
establish a new oversight system for the treatment of substance use
disorders with MAT (42 CFR part 8). SAMHSA-approved accrediting bodies
evaluate OTPs and perform site visits to ensure SAMHSA's opioid
dependency treatment standards are met. SAMHSA also requires OTPs to be
accredited by a SAMHSA-approved accrediting body (42 CFR 8.11).
The SAMHSA regulations establish procedures for an entity to apply
to become a SAMHSA-approved accrediting body (42 CFR 8.3). When
determining whether to approve an applicant as an accreditation body,
SAMHSA examines the following:
Evidence of the nonprofit status of the applicant (that
is, of fulfilling Internal Revenue Service requirements as a nonprofit
organization) if the applicant is not a state governmental entity or
political subdivision;
The applicant's accreditation elements or standards and a
detailed discussion showing how the proposed accreditation elements or
standards will ensure that each OTP surveyed by the applicant is
qualified to meet or is meeting each of the federal opioid treatment
standards set forth in Sec. 8.12;
A detailed description of the applicant's decision-making
process, including:
++ Procedures for initiating and performing onsite accreditation
surveys of OTPs;
++ Procedures for assessing OTP personnel qualifications;
++ Copies of an application for accreditation, guidelines,
instructions, and other materials the applicant will send to OTPs
during the accreditation process;
++ Policies and procedures for notifying OTPs and SAMHSA of
deficiencies and for monitoring corrections of deficiencies by OTPs;
for suspending or revoking an OTP's accreditation; and to ensure
processing of applications for accreditation and for renewal of
accreditation within a timeframe approved by SAMHSA; and;
++ A description of the applicant's appeals process to allow OTPs
to contest adverse accreditation decisions.
Policies and procedures established by the accreditation
body to avoid conflicts of interest, or the appearance of conflicts of
interest;
[[Page 40523]]
A description of the education, experience, and training
requirements for the applicant's professional staff, accreditation
survey team membership, and the identification of at least one licensed
physician on the applicant's staff;
A description of the applicant's training policies;
Fee schedules, with supporting cost data;
Satisfactory assurances that the applicant will comply
with the requirements of Sec. 8.4, including a contingency plan for
investigating complaints under Sec. 8.4(e);
Policies and procedures established to protect
confidential information the applicant will collect or receive in its
role as an accreditation body; and
Any other information SAMHSA may require.
SAMHSA periodically evaluates the performance of accreditation
bodies primarily by inspecting a selected sample of the OTPs accredited
by the accrediting body and by evaluating the accreditation body's
reports of surveys conducted, to determine whether the OTPs surveyed
and accredited by the accreditation body are in compliance with the
federal opioid treatment standards. There are currently six SAMHSA-
approved accreditation bodies.\35\
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\35\ https://www.samhsa.gov/medication-assisted-treatment/opioid-treatment-accrediting-bodies/approved.
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(4) Provider Agreement
Section 2005(d) of the SUPPORT Act amends section 1866(e) of the
Act by adding a new paragraph (3) which includes opioid treatment
programs (but only with respect to the furnishing of opioid use
disorder treatment services) as a ``provider of services'' for purposes
of section 1866 of the Act. All providers of services under section
1866 of the Act must enter into a provider agreement with the Secretary
and comply with other requirements specified in that section. These
requirements are implemented at 42 CFR part 489. Therefore, we are
proposing to amend part 489 to include OTPs (but only with respect to
the furnishing of opioid use disorder treatment services) as a
provider. Specifically, we are proposing to add OTPs (but only with
respect to the furnishing of opioid use disorder treatment services) to
the list of providers in Sec. 489.2. This addition makes clear that
the other requirements specified in Section 1866, and implemented in
part 489, which include the limits on charges to beneficiaries, would
apply to OTPs (with respect to the furnishing of opioid use disorder
treatment services). We are also proposing additional changes to make
clear that certain parts of part 489, which implement statutory
requirements other than section 1866 of the Act, do not apply to OTPs.
For example, since we are not proposing any conditions of participation
for OTPs, we are proposing to amend Sec. 489.10(a), which states that
providers specified in Sec. 489.2 must meet conditions of
participation, to add that OTPs must meet the requirements set forth in
part 489 and elsewhere in that chapter. In addition, we are proposing
to specify that the effective date of the provider agreement is the
date on which CMS accepts a signed agreement (proposed amendment to
Sec. 489.13(a)(2)), and is not dependent on surveys or an accrediting
organization's determination related to conditions of participation.
Finally, as noted earlier in the preamble, OTPs are required to be
certified by SAMHSA and accredited by an accrediting body approved by
SAMHSA. In Sec. 489.53, we are proposing to create a basis for
termination of the provider agreement if the OTP no longer meets the
requirements set forth in part 489 or elsewhere in that chapter
(including if it no longer has a SAMHSA certification or accreditation
by a SAMHSA-approved accrediting body). Finally, we are also proposing
to revise 42 CFR part 498 to ensure that OTPs have access to the appeal
process in case of an adverse determination concerning continued
participation in the Medicare program. Specifically, we are amending
the definition of provider in Sec. 498.2 to include OTPs. We are
continuing to review the application of the provider agreement
requirements to OTPs and may make further amendments to parts 489 and
498 as necessary to ensure that the existing provider agreement
regulations are applied to OTPs consistent with our proposals and
Section 2005 of the SUPPORT Act.
(5) Additional Conditions
As provided in section 1861(jjj)(2)(D) of the Act, to furnish
Medicare-covered OUD treatment services, OTPs must meet any additional
conditions as the Secretary may find necessary to ensure the health and
safety of individuals being furnished services under such program and
the effective and efficient furnishing of such services. The
comprehensive OTP standards for certification of OTPs address the same
topics as would be addressed by CMS supplier standards, such as client
assessment and the services required to be provided. Furthermore, the
detailed process established by SAMHSA for selecting and overseeing its
accreditation organizations is similar to the accrediting organization
oversight process that would typically be established by CMS. Thus, we
believe the existing SAMHSA certification and accreditation
requirements are both appropriate and sufficient to ensure the health
and safety of individuals being furnished services by OTPs, as well as
the effective and efficient furnishing of such services. We also
believe that creating additional conditions at this time for
participation in Medicare by OTPs could create unnecessary regulatory
duplication and could be potentially burdensome for OTPs. Therefore,
CMS is not proposing any additional conditions for participation in
Medicare by OTPs at this time. We welcome public comments on this
proposed approach, including input on whether there are any additional
conditions that should be required for OTPs furnishing Medicare-covered
OUD treatment services.
(6) Proposed Definition of Opioid Treatment Program
We propose to define ``opioid treatment program'' at Sec.
410.67(b) as an entity that is an opioid treatment program as defined
in 42 CFR 8.2 (or any successor regulation) and meets the applicable
requirements for an OTP. We propose to codify this definition at Sec.
410.67(b). In addition, we propose that for an OTP to participate and
receive payment under the Medicare program, the OTP must be enrolled
under section 1866(j) of the Act, have in effect a certification by
SAMHSA for such a program, and be accredited by an accrediting body
approved by SAMHSA. We are also proposing that an OTP must have a
provider agreement as required by section 1866(a) of the Act. We
propose to codify these requirements at Sec. 410.67(c). We welcome
public comments on the proposed definition of OTP and the proposed
Medicare requirements for OTPs.
3. Proposed Bundled Payments for OUD Treatment Services
Section 1834(w) of the Act, added by section 2005 of the SUPPORT
Act, directs the Secretary to pay to the OTP an amount that is equal to
100 percent of a bundled payment for OUD treatment services that are
furnished by the OTP to an individual during an episode of care. We are
proposing to establish bundled payments for OUD treatment services
which, as discussed above, would include the medications approved by
the FDA under section 505
[[Page 40524]]
of the FFDCA for use in the treatment of OUD; the dispensing and
administration of such medication, if applicable; substance use
counseling; individual and group therapy; and toxicology testing. In
calculating the proposed bundled payments, we propose to apply separate
payment methodologies for the drug component (which includes the
medications approved by the FDA under section 505 of the FFDCA for use
in the treatment of OUD) and the non-drug component (which includes the
dispensing and administration of such medications, if applicable;
substance use counseling; individual and group therapy; and toxicology
testing) of the bundled payments. We propose to calculate the full
bundled payment rate by combining the drug component and the non-drug
components. Below, we discuss our proposals for determining the bundled
payments for OUD treatment services. As part of this discussion, we
address payment rates for these services under the Medicaid and TRICARE
programs, duration of the episode of care for which the bundled payment
is made (including partial episodes), methodology for determining
bundled payment rates for the drug and non-drug components, site of
service, coding and beneficiary cost sharing. We propose to codify the
methodology for determining the bundled payment rates for OUD treatment
services at Sec. 410.67(d).
a. Review of Medicaid and TRICARE Programs
Section 1834(w)(2) of the Act, added by section 2005(c) of the
SUPPORT Act, provides that in developing the bundled payment rates for
OUD treatment services furnished by OTPs, the Secretary may consider
payment rates paid to the OTPs for comparable services under the state
plans under title XIX of the Act (Medicaid) or under the TRICARE
program under chapter 55 of title 10 of the United States Code
(U.S.C.). The payments for comparable services under TRICARE and
Medicaid programs are discussed below. We understand that many private
payers cover services furnished by OTPs, and welcome comment on the
scope of private payer OTP coverage and the payment rates private
payers have established for OTPs furnishing comparable OUD treatment
services. We may consider this information as part of the development
of the final bundled payment rates for OUD treatment services furnished
by OTPs in the final rule.
(1) TRICARE
In the ``TRICARE: Mental Health and Substance Use Disorder
Treatment'' final rule, which appeared in the September 2, 2016 Federal
Register (81 FR 61068) (hereinafter referred to as the 2016 TRICARE
final rule), the Department of Defense (DOD) finalized its methodology
for determining payments for services furnished to TRICARE
beneficiaries by an OTP in the regulations at 32 CFR 199.14(a)(2)(ix).
The payments are also described in Chapter 7, Section 5 and Chapter 1,
Section 15 of the TRICARE Reimbursement Manual 6010.61-M, April 1,
2015. As discussed in the 2016 TRICARE final rule, a number of
commenters indicated that they believed the rates established by DOD
are near market rates and acceptable (81 FR 61079).
In the 2016 TRICARE final rule, DOD established separate payment
methodologies for treatment in OTPs based on the particular medication
being administered. DOD finalized a weekly all-inclusive per diem rate
for OTPs when furnishing methadone for MAT. Under 32 CFR
199.14(a)(2)(ix)(A)(3)(i), this weekly rate includes the cost of the
drug and the cost of related non-drug services (that is, the costs
related to the intake/assessment, drug dispensing and screening and
integrated psychosocial and medical treatment and supportive services),
hereafter referred as the non-drug services. We note that the services
included in the TRICARE weekly bundle are generally comparable to the
definition of OUD treatment services in Section 2005 of the SUPPORT
Act. The weekly all-inclusive per diem rate for these services was
determined based on preliminary review of industry billing practices
(which included Medicaid and other third-party payers) for the
dispensing of methadone, including an estimated daily drug cost of $3
and a daily estimated cost of $15 for the non-drug services. These
daily costs were converted to an estimated weekly per diem rate of $126
($18 per day x 7 days) in the 2016 TRICARE final rule. Under 32 CFR
199.14(a)(2)(iv)(C)(S), this rate is updated annually by the Medicare
hospital inpatient prospective payment system (IPPS) update factor. The
2019 TRICARE weekly per diem rate for methadone treatment in an OTP is
$133.15.\36\ Beneficiary cost-sharing consists of a flat copayment that
may be applied to this weekly rate.
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\36\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
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DOD also established payment rates for other medications used for
MAT (buprenorphine and extended-release injectable naltrexone) to allow
OTPs to bill for the full range of medications available. Under 32 CFR
199.14(a)(2)(ix)(A)(3)(ii), DOD established a fee-for-service payment
methodology for buprenorphine and extended-release injectable
naltrexone because they are more likely to be prescribed and
administered in an office-based treatment setting but are still
available for treatment furnished in an OTP. DOD stated in the 2016
TRICARE final rule (81 FR 61080) that treatment with buprenorphine and
naltrexone is more variable in dosage and frequency than with
methadone. Therefore, TRICARE pays for these medications and the
accompanying non-drug services separately on a fee-for-service basis.
Buprenorphine is paid based on 95 percent of average wholesale price
(AWP) and the non-drug component is paid on a per visit basis at an
estimated cost of $22.50 per visit. Extended-release injectable
naltrexone is paid at the average sales price (ASP) plus a drug
administration fee while the non-drug services are also paid at an
estimated per visit cost of $22.50. DOD also reserved discretion to
establish the payment methodology for new drugs and biologicals that
may become available for the treatment of SUDs in OTPs.
DOD instructed that OTPs use the ``Alcohol and/or other drug use
services, not otherwise specified'' H-code for billing the non-drug
services when buprenorphine or naltrexone is used, and required OTPs to
also include both the J-code and the National Drug Code (NDC) for the
drug used, as well as the dosage and acquisition cost on the claim
form.\37\ Drugs listed on Medicare's Part B ASP files are paid using
the ASP.\38\ Drugs not appearing on the Medicare ASP file are paid at
the lesser of billed charges or 95 percent of the AWP.\39\ Using this
methodology, TRICARE estimated a daily drug cost of $10 for
buprenorphine and a monthly drug cost of $1,129 for extended-release
injectable naltrexone.\40\
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\37\ 81 FR 61080.
\38\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
\39\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
\40\ 81 FR 61080.
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[[Page 40525]]
(2) Medicaid (Title XIX)
States have the flexibility to administer the Medicaid program to
meet their own needs within the Medicaid program parameters set forth
in federal statute and regulations. All states cover and pay for some
form of medications for medication-assisted treatment of OUD under
their Medicaid programs. However, as of 2018, only 42 states covered
methadone for MAT for OUD under their Medicaid programs.\41\ We note
that section 1006(b) of the SUPPORT Act amends sections 1902 and 1905
of the Social Security Act to require that Medicaid State plans cover
all drugs approved under section 505 of the FFDCA to treat OUD,
including methadone, and all biological products licensed under section
351 of the Public Health Service Act to treat OUD, beginning October 1,
2020. This requirement sunsets on September 30, 2025.
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\41\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
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In reviewing Medicaid payments for OUD treatment services furnished
by OTPs in a few states, we found significant variation in the MAT
coverage, OUD treatment services, and payment structure among the
states. Thus, it is difficult to identify a standardized Medicaid
payment amount for OTP services. A number of factors such as the unit
of payment, types of services bundled within a payment code, and how
MAT services are paid varied among the states. For example, for
treatment of OUD using methadone for MAT, most OTPs bill under HCPCS
code H0020 (Alcohol and/or drug services; methadone administration and/
or service (provision of the drug by a licensed program)) under the
Medicaid program; however, the unit of payment varies by state from
daily, weekly, or monthly. For example, the unit of payment in
California is daily for methadone treatment,\42\ while the unit of
payment in Maryland for methadone maintenance is weekly,\43\ and
Vermont uses a monthly unit \44\ of payment of these OUD treatment
items and services.
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\42\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
\43\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
\44\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
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For the other MAT drugs, all states cover buprenorphine and the
buprenorphine-naloxone medications; \45\ however, fewer than 70 percent
cover the implanted or extended-release injectable versions of
buprenorphine.\46\ In addition, all states cover the extended-release
injectable naltrexone.\47\ We also found that many states pay different
rates based on the specific type of drug used for MAT.
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\45\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
\46\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
\47\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
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Non-drug items and services may be included in a bundled payment
with the drug or paid separately, depending on the state, and can
include dosing, dispensing and administration of the drug, individual
and group counseling, and toxicology testing. In some states, certain
services such as assessments, individual and group counseling, and
toxicology testing can be billed separately. For example, some states
(such as Maryland,\48\ Texas,\49\ and California) \50\ separately
reimburse for individual and group counseling services, while other
states (such as Vermont \51\ and New Mexico) \52\ included these
services in the OUD bundled payment.
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\48\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
\49\ http://www.tmhp.com/News_Items/2018/11-Nov/11-16-18%20Substance%20Use%20Disorder%20Benefits%20to%20Change%20for%20Texas%20Medicaid%20January%201,%202019.pdf.
\50\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
\51\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
\52\ http://www.hsd.state.nm.us/uploads/FileLinks/e7cfb008157f422597cccdc11d2034f0/MAT_Proposed_reimb_MAD_website_pdf.pdf.
https://stre.samhsa.gov/system/files/medicaidfinancingmatreport.pdfnm.us/uploads/FileLinks/c78b68d063e04ce5adffe29376ff402e/12_10_MAT_OTC_Clinics_Supp_09062012__2_.pdf.
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b. Aspects of the Bundle
(1) Duration of Bundle
Section 1834(w)(1) of the Act requires the Secretary to pay an OTP
an amount that is equal to 100 percent of the bundled payment for OUD
treatment services that are furnished by the OTP to an individual
during an episode of care (as defined by the Secretary) beginning on or
after January 1, 2020. We are proposing that the duration of an episode
of care for OUD treatment services would be a week (that is, a
contiguous 7-day period that may start on any day of the week). This is
similar to the structure of the TRICARE bundled payment to OTPs for
methadone, which is based on a weekly bundled rate (81 FR 61079), as
well as the payments by some state Medicaid programs. Given this
similarity to existing coding structures, we believe a weekly duration
for an episode of care would be most familiar to OTPs and therefore the
least disruptive to adopt. We welcome comments on whether we should
consider a daily or monthly bundled payment. We are proposing to define
an episode of care at Sec. 410.67(b) as a 1 week (contiguous 7-day)
period.
We recognize that patients receiving MAT are often on this
treatment regimen for an indefinite amount of time and therefore, we
are not proposing any maximum number of weeks during an overall course
of treatment for OUD.
(a) Requirements for an Episode
We note that SAMHSA requires OTPs to have a treatment plan for each
patient that identifies the frequency with which items and services are
to be provided (Sec. 8.12(f)(4)). We recognize that there is a range
of service intensity depending on the severity of a patient's OUD and
stage of treatment and therefore, a ``full weekly bundle'' may consist
of a very different frequency of services for a patient in the initial
phase of treatment compared to a patient in the maintenance phase of
treatment, but that we would still consider the requirements to bill
for the full weekly bundle to be met if the patient is receiving the
majority of the services identified in their treatment plan at that
time. However, for the purposes of valuation, we assumed one substance
use counseling session, one individual therapy session, and one group
therapy session per week and one toxicology test per month. Given the
anticipated changes in service intensity over time based on the
individual patient's needs, we expect that treatment plans would be
updated to reflect these changes or noted in the patient's medical
record, for example, in a progress note. In cases where the OTP has
furnished the majority (51 percent or more) of the services identified
in the patient's current treatment plan (including any changes noted in
the patient's medical record) over the course of a week, we propose
that it could bill for a full weekly bundle. We are proposing to codify
the payment methodology for full episodes of care (as well as partial
episodes of care and non-drug episodes of care, as discussed below) in
Sec. 410.67(d)(2).
(b) Partial Episode of Care
We understand that there may be instances in which a beneficiary
does not receive all of the services expected in a given week due to
any number of issues, including, for example, an inpatient
hospitalization during which a
[[Page 40526]]
beneficiary would not be able to go to the OTP or inclement weather
that impedes access to transportation. To provide more accurate payment
to OTPs in cases where a beneficiary is not able to or chooses not to
receive all items and services described in their treatment plan or the
OTP is unable to furnish services, for example, in the case of a
natural disaster, we are proposing to establish separate payment rates
for partial episodes that correspond with each of the full weekly
bundles. In cases where the OTP has furnished at least one of the items
or services (for example, dispensing one day of an oral MAT medication
or one counseling session or one toxicology test) but less than 51
percent of the items and services included in OUD treatment services
identified in the patient's current treatment plan (including any
changes noted in the patient's medical record) over the course of a
week, we propose that it could bill for a partial weekly bundle. In
cases in which the beneficiary does not receive a drug during the
partial episode, we propose that the code describing a non-drug partial
weekly bundle must be used. For example, the OTP could bill for a
partial episode in instances where the OTP is transitioning the
beneficiary from one OUD medication to another and therefore the
beneficiary is receiving less than a week of one type of medication. In
those cases, two partial episodes could be billed, one for each of the
medications, or one partial episode and one full episode, if all
requirements for billing are met. We intend to monitor this issue and
will consider whether we would need to make changes to this policy in
future rulemaking to ensure that the billing for partial episodes is
not being abused. We are proposing to define a partial episode of care
in Sec. 410.67(b) and to codify the payment methodology for partial
episodes in Sec. 410.67(d). We seek comments on our proposed approach
to full and partial episodes, including the threshold that should be
applied to determine when an OTP may bill for the full weekly bundle
versus a partial episode. We also seek comment on the minimum threshold
that should be applied to determine when a partial episode could be
billed (for example, at least one item or service, or an alternative
threshold such as 10 or 25 percent of the items and services included
in OUD treatment services identified in the patient's current treatment
plan (including any changes noted in the patient's medical record) over
the course of a week). We also welcome feedback regarding whether any
other payers of OTP services allow for billing partial bundles and what
thresholds they use.
(c) Non-Drug Episode of Care
In addition to the bundled payments for full and partial episodes
of care that are based on the medication administered for treatment
(and include both a drug and non-drug component described in detail
below), we are proposing to establish a non-drug episode of care to
provide a mechanism for OTPs to bill for non-drug services, including
substance use counseling, individual and group therapy, and toxicology
testing that are rendered during weeks when a medication is not
administered, for example, in cases where a patient is being treated
with injectable buprenorphine or naltrexone on a monthly basis or has a
buprenorphine implant. We are proposing to codify this non-drug episode
of care at Sec. 410.67(d).
(2) Drug and Non-Drug Components
As discussed above, in establishing the bundled payment rates, we
propose to develop separate payment methodologies for the drug
component and the non-drug (which includes the dispensing and
administration of such medication, if applicable; substance use
counseling; individual and group therapy; and toxicology testing)
components of the bundled payment. Each of these components is
discussed in this section.
(a) Drug Component
As discussed previously, the cost of medications used by OTPs to
treat OUD varies widely. Creating a single bundled payment rate that
does not reflect the type of drug used could result in access issues
for beneficiaries who might be best served by treatment using a more
expensive medication. As a result, we believe that the significant
variation in the cost of these drugs needs to be reflected adequately
in the bundled payment rates for OTP services to avoid impairing access
to appropriate care.
Section 1834(w)(2) of the Act states that the Secretary may
implement the bundled payment to OTPs though one or more bundles based
on a number of factors, including the type of medication provided (such
as buprenorphine, methadone, extended-release injectable naltrexone, or
a new innovative drug). Accordingly, consistent with the discretion
afforded under section 1834(w)(2) of the Act, and after consideration
of payment rates paid to OTPs for comparable services by other payers
as discussed above, we propose to base the OTP bundled payment rates,
in part, on the type of medication used for treatment. Specifically, we
propose the following categories of bundled payments to reflect those
drugs currently approved by the FDA under section 505 of the FFDCA for
use in treatment of OUD:
Methadone (oral).
Buprenorphine (oral).
Buprenorphine (injection).
Buprenorphine (implant).
Naltrexone (injection).
In addition, we propose to create a category of bundled payment
describing a drug not otherwise specified to be used for new drugs (as
discussed further below). We are also proposing a non-drug bundled
payment to be used when medication is not administered (as discussed
further below). We believe creating these categories of bundled
payments based on the drug used for treatment would strike a reasonable
balance between recognizing the variable costs of these medications and
the statutory requirement to make a bundled payment for OTP services.
We propose to codify this policy of establishing the categories of
bundled payments based on the type of opioid agonist and antagonist
treatment medication in Sec. 410.67(d)(1).
i. New Drugs
We anticipate that there may be new FDA-approved opioid agonist and
antagonist treatment medications to treat OUD in the future. In the
scenario where an OTP furnishes MAT using a new FDA-approved opioid
agonist or antagonist medication for OUD treatment that is not
specified in one of our existing codes, we propose that OTPs would bill
for the episode of care using the medication not otherwise specified
(NOS) code, HCPCS code GXXX9 (or GXXX19 for a partial episode). In such
cases, we propose to use the typical or average maintenance dose to
determine the drug cost for the new bundle. Then, we propose that
pricing would be determined based on the relevant pricing methodology
as described later in this section (section II.G.) of the proposed rule
or invoice pricing in the event the information necessary to apply the
relevant pricing methodology is not available. For example, in the case
of injectable and implantable drugs, which are generally covered and
paid for under Medicare Part B, we propose to use the methodology in
section 1847A of the Act (which bases most payments on ASP). For oral
medications, which are generally covered and paid for under Medicare
Part D, we propose to use ASP-based payment when we receive
manufacturer-submitted ASP data for
[[Page 40527]]
these drugs. In the event that we do not receive manufacturer-submitted
ASP pricing data, we are considering several potential pricing
mechanisms (as discussed further below) to estimate the payment amounts
for oral drugs typically paid for under Medicare Part D but that would
become OTP drugs paid under Part B when used as part of MAT furnished
in an OTP. We are not proposing a specific pricing mechanism at this
time for the situation in which we do not receive manufacturer-
submitted ASP pricing data, but are requesting public comment on
several potential approaches for estimating the acquisition cost and
payment amounts for these drugs. We will consider the comments received
in developing our final policy for determining these drug prices. If
the information necessary to apply the alternative pricing methodology
chosen for the oral drugs is also not available to price the new
medication, we propose to use invoice pricing until either ASP pricing
data or the information necessary to apply the chosen pricing
methodology becomes available to price the medication. We are proposing
to codify this approach for determining the amount of the bundled
payment for new medications in Sec. 410.67(d)(2).The medication NOS
code would be used until CMS has the opportunity to consider through
rulemaking establishing a unique bundled payment for episodes of care
during which the new drug is furnished. We welcome comments on this
proposed approach to the treatment of new drugs used for MAT in OTPs.
As discussed above, we also welcome comments on how new medications
that may be approved by the FDA in the future for use in the treatment
of OUD with a novel mechanism of action (for example, not an opioid
agonist and/or antagonist), such as medications approved under section
505 of the FFDCA to treat OUD and biological products licensed under
section 351 of the Public Health Service Act to treat OUD, should be
considered in the context of OUD treatment services provided by OTPs.
We additionally welcome comments on how such new drugs with a novel
mechanism of action should be priced, and specifically whether pricing
for these new non-opioid agonist and/or antagonist medications should
be determined using the same pricing methodology proposed for new
opioid agonist and antagonist treatment medications, described above or
whether an alternative pricing methodology should be used.
(b) Non-Drug Component
i. Counseling, Therapy, Toxicology Testing, and Drug Administration
As discussed above, the bundled payment is for OUD treatment
services furnished during the episode of care, which we are proposing
to define as the FDA-approved opioid agonist and antagonist treatment
medications, the dispensing and administration of such medications (if
applicable), substance use disorder counseling by a professional to the
extent authorized under state law to furnish such services, individual
and group therapy with a physician or psychologist (or other mental
health professional to the extent authorized under state law), and
toxicology testing. The non-drug component of the OUD treatment
services includes all items and services furnished during an episode of
care except for the medication.
Under the SAMSHA certification standards at Sec. 8.12(f)(5), OTPs
must provide adequate substance abuse counseling to each patient as
clinically necessary. We note that section 1861(jjj)(1)(C) of the Act,
as added by section 2005(b) of the SUPPORT Act defines OUD treatment
services as including ``substance use counseling by a professional to
the extent authorized under state law to furnish such services.''
Therefore, professionals furnishing therapy or counseling services for
OUD treatment must be operating within state law and scope of practice.
These professionals could include licensed professional counselors,
licensed clinical alcohol and drug counselors, and certified peer
specialists that are permitted to furnish this type of therapy or
counseling by state law and scope of practice. To the extent that the
individuals furnishing therapy or counseling services are not
authorized under state law to furnish such services, the therapy or
counseling services would not be covered as OUD treatment services.
Additionally, under SAMSHA certification standards at Sec.
8.12(f)(6), OTPs are required to provide adequate testing or analysis
for drugs of abuse, including at least eight random drug abuse tests
per year, per patient in maintenance treatment, in accordance with
generally accepted clinical practice. These drug abuse tests (which are
identified as toxicology tests in the definition of OUD treatment
services in section 1861(jjj)(1)(E) of the Act) are used for
diagnosing, monitoring and evaluating progress in treatment. The
testing typically includes tests for opioids and other controlled
substances. Urinalysis is primarily used for this testing; however,
there are other types of testing such as hair or fluid analysis that
could be used. We note that any of these types of toxicology tests
would be considered to be OUD treatment services and would be included
in the bundled payment for services furnished by an OTP.
The non-drug component of the bundle also includes the cost of drug
dispensing and/or administration, as applicable. Additional details
regarding our proposed approach for pricing this aspect of the non-drug
component of the bundle are included in our discussion of payment rates
later in this section.
ii. Other Services
As discussed earlier, we are proposing to define OUD treatment
services as those items and services that are specifically enumerated
in section 1861(jjj)(1) of the Act, including services that are
furnished via telecommunications technology, and are seeking comment on
any other items and services we might consider including as OUD
treatment services under the discretion given to the Secretary in
subparagraph (F) of that section to determine other appropriate items
and services. If we were to finalize a definition of OUD treatment
services that includes any other items or services, such as intake
activities or periodic assessments as discussed above, we would
consider whether any changes to the payment rates for the bundled
payments are necessary. See below for additional discussion related to
how we could price these services.
(3) Adjustment to Bundled Payment Rate for Additional Counseling or
Therapy Services
In addition to the items and services already included in the
proposed bundles, we recognize that counseling and therapy are
important components of MAT and that patients may need to receive
counseling and/or therapy more frequently at certain points in their
treatment. We seek to ensure that patients have access to these needed
services. Accordingly, we are proposing to adjust the bundled payment
rates through the use of an add-on code in order to account for
instances in which effective treatment requires additional counseling
or group or individual therapy to be furnished for a particular patient
that substantially exceeds the amount specified in the patient's
individualized treatment plan. As noted previously, we understand that
there is variability in the frequency of services a patient might
receive in a given week depending on the patient's severity and stage
of treatment; however, we assume
[[Page 40528]]
that a typical case might include one substance use counseling session,
one individual therapy session, and one group therapy session per week.
We further understand that the frequency of services will vary among
patients and will change over time based on the individual patient's
needs. We expect that the patient's treatment plan or the medical
record will be updated to reflect when there are changes in the
expected frequency of medically necessary services based on the
patient's condition and following such an update, the add-on code
should no longer be billed if the frequency of the patient's counseling
and/or therapy services is consistent with the treatment plan or
medical record. In the case of unexpected or unforeseen circumstances
that are time-limited, resolve quickly, and do not lead to updates to
the treatment plan, we expect that the medical necessity for billing
the add-on code would be documented in the medical record. This add-on
code (HCPCS code GXX19) would describe each additional 30 minutes of
counseling or group or individual therapy furnished in a week of MAT,
which could be billed in conjunction with the codes describing the full
episode of care or the partial episodes. For example, there may be some
weeks when a patient has a relapse or unexpected psychosocial stressors
arise that warrant additional reasonable and necessary counseling
services that were not foreseen at the time that the treatment plan was
developed. Additionally, we note that there may be situations in which
the add-on code could be billed in conjunction with the code for a
partial episode; for example, if a patient requires prolonged
counseling services on the initial day of treatment, but does not
return for any of the other services specified in their treatment plan,
such as daily medication dispensing, for the remainder of that week. We
acknowledge that an unintended consequence of using the treatment plan
is a potential incentive for OTPs to document minimal counseling and/or
therapy needs for a beneficiary, thereby resulting in increased
opportunity for billing the add-on code. We expect that OTPs will
ensure that treatment plans reflect the full scope of services expected
to be furnished during an episode of care and that they will update
treatment plans regularly to reflect changes. We intend to monitor this
issue and will consider whether we need to make changes to this policy
through future rulemaking to ensure that this adjustment is not being
abused. We welcome comments on the proposed add-on code and the
threshold for billing. We propose to codify this adjustment to the
bundled payment rate for additional counseling or therapy services in
Sec. 410.67(d)(3)(i).
(4) Site of Service (Telecommunications)
In recent years, we have sought to decrease barriers to access to
care by furthering policies that expand the use of communication
technologies. In the CY 2019 PFS final rule (83 FR 59482), we finalized
new separate payments for communication technology-based services,
including a virtual check-in and a remote evaluation of pre-recorded
patient information. SAMHSA's federal guidelines (https://store.samhsa.gov/system/files/pep15-fedguideotp.pdf) for OTPs refer to
the CMS guidance on telemedicine and also state that OTPs are advised
to proceed with full understanding of requirements established by state
or health professional licensing boards. SAMHSA's federal guidelines
for OTPs state that exceptional attention needs to be paid to data
security and privacy in this evolving field. Telemedicine services
should, under no circumstances, expand the scope of practice of a
healthcare professional or permit practice in a jurisdiction (the
location of the patient) where the provider is not licensed.
We are proposing to allow OTPs to furnish the substance use
counseling, individual therapy, and group therapy included in the
bundle via two-way interactive audio-video communication technology, as
clinically appropriate, in order to increase access to care for
beneficiaries. We believe this is an appropriate approach because, as
discussed previously, we expect the telehealth services that will be
furnished by OTPs will be similar to the Medicare telehealth services
furnished under section 1834(m) of the Act, and the use of two-way
interactive audio-video communication technology is required for these
Medicare telehealth services under Sec. 410.78(a)(3). By allowing use
of communication technology in furnishing these services, OTPs in rural
communities or other health professional shortage areas could
facilitate treatment through virtual care coming from an urban or other
external site; however, we note that the physicians and other
practitioners furnishing these services would be required to comply
with all applicable requirements related to professional licensing and
scope of practice.
We note that section 1834(m) of the Act applies only to Medicare
telehealth services furnished by a physician or other practitioner.
Because OUD treatment services furnished by an OTP are not considered
to be services furnished by a physician or other practitioner, the
restrictions of section 1834(m) of the Act would not apply.
Additionally, we note that counseling or therapy furnished via
communication technology as part of OUD treatment services furnished by
an OTP must not be separately billed by the practitioner furnishing the
counseling or therapy because these services would already be paid
through the bundled payment made to the OTP.
We are proposing to include language in Sec. 410.67(b) in the
definition of opioid use disorder treatment services to allow OTPs to
use two-way interactive audio-video communication technology, as
clinically appropriate, in furnishing substance use counseling and
individual and group therapy services, respectively. We invite comment
as to whether this proposal, including whether furnishing these
services through communication technology is clinically appropriate. We
also invite public comment on other components of the bundle that may
be clinically appropriate to be furnished via communication technology,
while also considering SAMHSA's guidance that OTPs should pay
exceptional attention to data security and privacy.
(5) Coding
We are proposing to adopt a coding structure for OUD treatment
services that varies by the medication administered. To operationalize
this approach, we are proposing to establish G codes for weekly bundles
describing treatment with methadone, buprenorphine oral, buprenorphine
injectable, buprenorphine implants (insertion, removal, and insertion/
removal), extended-release injectable naltrexone, a non-drug bundle,
and one for a medication not otherwise specified. We also propose to
establish partial episode G codes to correspond with each of those
bundles, respectively. Additionally, we propose to create an add-on
code to describe additional counseling that is furnished beyond the
amount specified in the patient's treatment plan. As discussed above,
we are seeking comment on whether to include intake activities and
periodic assessments in the definition of OUD treatment services. Were
we to finalize including these activities in the definition of OUD
treatment services, we welcome feedback on whether we should consider
modifying the payment associated with the bundle or creating add-on
codes for services such as the
[[Page 40529]]
initial physical examination, initial assessments and preparation of a
treatment plan, periodic assessments or additional toxicology testing,
and if so, what inputs we might consider in pricing such services, such
as payment amounts for similar services under the PFS or Clinical Lab
Fee Schedule (CLFS). For example, to price the initial assessment,
medical examination, and development of a treatment plan, we could
crosswalk to the Medicare payment rate for a level 3 Evaluation and
Management (E/M) visit for a new patient and to price the periodic
assessments, we could crosswalk to the Medicare payment rate for a
level 3 E/M visit for an established patient. To price additional
toxicology testing, we could crosswalk to the Medicare payment for
presumptive drug testing, such as that described by CPT code 80305.
Additionally, we welcome feedback on whether we should consider
creating codes to describe bundled payments that include only the cost
of the drug and drug administration as applicable in order to account
for beneficiaries who are receiving interim maintenance treatment (as
described previously in this section) or other situations in which the
beneficiary is not receiving all of the services described in the full
bundles.
Regarding the non-drug bundle, we note that this code would be
billed for services furnished during an episode of care or partial
episode of care when a medication is not administered. For example,
when a patient receives a buprenorphine injection on a monthly basis,
the OTP will only require payment for the medication during the first
week of the month when the injection is given, and therefore, would
bill the code describing the bundle that includes injectable
buprenorphine during the first week of the month and would bill the
code describing the non-drug bundle for the remaining weeks in that
month for services such as substance use counseling, individual and
group therapy, and toxicology testing.
As discussed previously, we propose that the codes describing the
bundled payment for an episode of care with a medication not otherwise
specified, HCPCS codes GXXX9 and GXX18, should be used when the OTP
furnishes MAT with a new opioid agonist or antagonist treatment
medication approved by the FDA under section 505 of the FFDCA for the
treatment of OUD. OTPs would use these codes until we have the
opportunity to propose and finalize a new G code to describe the
bundled payment for treatment using that drug and price it accordingly
in the next rulemaking cycle. We note that the code describing the
weekly bundle for a medication not otherwise specified should not be
used when the drug being administered is not a new opioid agonist or
antagonist treatment medication approved by the FDA under section 505
of the FFDCA for the treatment of OUD, and therefore, for which
Medicare would not have the authority to make payment since section
1861(jjj)(1)(A) of the Act requires that the medication must be an
opioid agonist or antagonist treatment medication approved by the FDA
under section 505 of the FFDCA for the treatment of OUD. Given the
program integrity concerns regarding the potential for misuse of such a
code, we also welcome comments as to whether this code is needed.
The codes and long descriptors for the proposed OTP bundled
services are:
HCPCS code GXXX1: Medication assisted treatment,
methadone; weekly bundle including dispensing and/or administration,
substance use counseling, individual and group therapy, and toxicology
testing, if performed (provision of the services by a Medicare-enrolled
Opioid Treatment Program).
HCPCS code GXXX2: Medication assisted treatment,
buprenorphine (oral); weekly bundle including dispensing and/or
administration, substance use counseling, individual and group therapy,
and toxicology testing if performed (provision of the services by a
Medicare-enrolled Opioid Treatment Program).
HCPCS code GXXX3: Medication assisted treatment,
buprenorphine (injectable); weekly bundle including dispensing and/or
administration, substance use counseling, individual and group therapy,
and toxicology testing if performed (provision of the services by a
Medicare-enrolled Opioid Treatment Program).
HCPCS code GXXX4: Medication assisted treatment,
buprenorphine (implant insertion); weekly bundle including dispensing
and/or administration, substance use counseling, individual and group
therapy, and toxicology testing if performed (provision of the services
by a Medicare-enrolled Opioid Treatment Program).
HCPCS code GXXX5: Medication assisted treatment,
buprenorphine (implant removal); weekly bundle including dispensing
and/or administration, substance use counseling, individual and group
therapy, and toxicology testing if performed (provision of the services
by a Medicare-enrolled Opioid Treatment Program).
HCPCS code GXXX6: Medication assisted treatment,
buprenorphine (implant insertion and removal); weekly bundle including
dispensing and/or administration, substance use counseling, individual
and group therapy, and toxicology testing if performed (provision of
the services by a Medicare-enrolled Opioid Treatment Program).
HCPCS code GXXX7: Medication assisted treatment,
naltrexone; weekly bundle including dispensing and/or administration,
substance use counseling, individual and group therapy, and toxicology
testing if performed (provision of the services by a Medicare-enrolled
Opioid Treatment Program).
HCPCS code GXXX8: Medication assisted treatment, weekly
bundle not including the drug, including substance use counseling,
individual and group therapy, and toxicology testing if performed
(provision of the services by a Medicare-enrolled Opioid Treatment
Program).
HCPCS code GXXX9: Medication assisted treatment,
medication not otherwise specified; weekly bundle including dispensing
and/or administration, substance use counseling, individual and group
therapy, and toxicology testing, if performed (provision of the
services by a Medicare-enrolled Opioid Treatment Program).
HCPCS code GXX10: Medication assisted treatment,
methadone; weekly bundle including dispensing and/or administration,
substance use counseling, individual and group therapy, and toxicology
testing if performed (provision of the services by a Medicare-enrolled
Opioid Treatment Program); partial episode. Do not report with GXXX1.
HCPCS code GXX11: Medication assisted treatment,
buprenorphine (oral); weekly bundle including dispensing and/or
administration, substance use counseling, individual and group therapy,
and toxicology testing if performed (provision of the services by a
Medicare-enrolled Opioid Treatment Program); partial episode. Do not
report with GXXX2.
HCPCS code GXX12: Medication assisted treatment,
buprenorphine (injectable); weekly bundle including dispensing and/or
administration, substance use counseling, individual and group therapy,
and toxicology testing if performed (provision of the services by a
Medicare-enrolled Opioid Treatment Program); partial episode. Do not
report with GXXX3.
[[Page 40530]]
HCPCS code GXX13: Medication assisted treatment,
buprenorphine (implant insertion); weekly bundle including dispensing
and/or administration, substance use counseling, individual and group
therapy, and toxicology testing if performed (provision of the services
by a Medicare-enrolled Opioid Treatment Program); partial episode (only
to be billed once every 6 months). Do not report with GXXX4.
HCPCS code GXX14: Medication assisted treatment,
buprenorphine (implant removal); weekly bundle including dispensing
and/or administration, substance use counseling, individual and group
therapy, and toxicology testing if performed (provision of the services
by a Medicare-enrolled Opioid Treatment Program); partial episode. Do
not report with GXXX5.
HCPCS code GXX15: Medication assisted treatment,
buprenorphine (implant insertion and removal); weekly bundle including
dispensing and/or administration, substance use counseling, individual
and group therapy, and toxicology testing if performed (provision of
the services by a Medicare-enrolled Opioid Treatment Program); partial
episode. Do not report with GXXX6.
HCPCS code GXX16: Medication assisted treatment,
naltrexone; weekly bundle including dispensing and/or administration,
substance use counseling, individual and group therapy, and toxicology
testing if performed (provision of the services by a Medicare-enrolled
Opioid Treatment Program); partial episode. Do not report with GXXX7.
HCPCS code GXX17: Medication assisted treatment, weekly
bundle not including the drug, including substance use counseling,
individual and group therapy, and toxicology testing if performed
(provision of the services by a Medicare-enrolled Opioid Treatment
Program); partial episode. Do not report with GXXX8.
HCPCS code GXX18: Medication assisted treatment,
medication not otherwise specified; weekly bundle including dispensing
and/or administration, substance use counseling, individual and group
therapy, and toxicology testing, if performed (provision of the
services by a Medicare-enrolled Opioid Treatment Program); partial
episode. Do not report with GXXX9.
HCPCS code GXX19: Each additional 30 minutes of counseling
or group or individual therapy in a week of medication assisted
treatment, (provision of the services by a Medicare-enrolled Opioid
Treatment Program); List separately in addition to code for primary
procedure.
See Table 15 for proposed valuations for HCPCS codes GXXX1-GXX19.
We propose that only an entity enrolled with Medicare as an OTP could
bill these codes. Additionally, we propose that OTPs would be limited
to billing only these codes describing bundled payments, and may not
bill for other codes, such as those paid under the PFS.
(6) Payment Rates
The codes describing the proposed OTP bundled services (HCPCS codes
GXXX1-GXX19) would be assigned flat dollar payment amounts, which are
listed in Table 15. As discussed previously, section 2005 of the
SUPPORT Act amended the definition of ``medical and other health
services'' in section 1861(s) of the Act to provide for coverage of OUD
treatment services furnished by an OTP and also added a new section
1834(w) to the Act and amended section 1833(a)(1) of the Act to
establish a bundled payment to OTPs for OUD treatment services
furnished during an episode of care beginning on or after January 1,
2020. Therefore, OUD treatment services and the payments for such
services are wholly separate from physicians' services, as defined
under section 1848(j)(3) of the Act, and for which payment is made
under the section 1848 of the Act. Because OUD treatment services are
not considered physicians' services and are paid outside the PFS, they
would not be priced using relative value units (RVUs).
Consistent with section 1834(w) of the Act, which requires the
Secretary to make a bundled payment for OUD treatment services
furnished by OTPs, we are proposing to build the payment rates for OUD
treatment services by combining the cost of the drug and the non-drug
components (as applicable) into a single bundled payment as described
in more detail below.
(a) Drug Component
As part of determining a payment rate for these proposed bundles
for OUD treatment services, a dosage of the applicable medication must
be selected in order to calculate the costs of the drug component of
the bundle. We propose to use the typical or average maintenance dose,
as discussed earlier in this section, to determine the drug costs for
each of the proposed bundles. As dosing for some, but not all, of these
drugs varies considerably, this approach attempts to strike an
appropriate balance between high- and low-dose drug regimens in the
context of a bundled payment. Specifically, we propose to calculate
payment rates using a 100 mg daily dose for methadone, a 10 mg daily
dose for oral buprenorphine, a 100 mg monthly dose for the extended-
release buprenorphine injection, four rods each containing 74.2 mg of
buprenorphine for the 6-month buprenorphine implant, and a 380 mg
monthly dose for extended-release injectable naltrexone. We invite
public comments on our proposal to use the typical maintenance dose in
order to calculate the drug component of the bundled payment rate for
each of the proposed codes. We also seek comment on the specific
typical maintenance dosage level that we have identified for each drug,
and a process for identifying the typical maintenance dose for new
opioid agonist or antagonist treatment medication approved by the FDA
under section 505 of the FFDCA when such medications are billed using
the medication NOS code, such as using the FDA-approved prescribing
information or a review of the published, preferably peer-reviewed,
literature. We note that the bundled payment rates are intended to be
comprehensive with respect to the drugs provided; therefore, we do not
intend to include any other amounts related to drugs, other than for
administration, as discussed below. This means, for example, that we
would not pay for drug wastage, which we do not anticipate to be
significant in the OTP setting.
i. Potential Drug Pricing Data Sources
Payment structures that are closely tailored to the provider's
actual acquisition cost reduce the likelihood that a drug will be
chosen primarily for a reason that is unrelated to the clinical care of
the patient, such as the drug's profit margin for a provider. We are
proposing to estimate an OTP's costs for the drug component of the
bundles based on available data regarding drug costs rather than a
provider-specific cost-to-charge ratio or another more direct
assessment of facility or industry-specific drug costs. OTPs do not
currently report costs associated with their services to the Medicare
program, and we do not believe that a cost-to-charge ratio based on
such reported information could be available for a significant period
of time. Furthermore, we are unaware of any industry-specific data that
may be used to more accurately assess the prices at which OTPs acquire
the medications used for OUD treatment. Therefore, at this time, we are
proposing to estimate an OTP's costs for the drugs used in MAT based on
other available data sources, rather than applying a cost-to-charge
ratio or
[[Page 40531]]
another more direct assessment of drug acquisition cost, though we
intend to continue to explore alternate ways to gather this
information. As described in greater detail below, we propose that the
payment amounts for the drug component of the bundles be based on CMS
pricing mechanisms currently in place. We request comment on other
potential data sources for pricing OUD treatment medications either
generally or specifically with respect to acquisition by OTPs. In the
case of oral drugs that we are proposing to include in the OTP bundled
payments and for which we do not receive manufacturer-submitted ASP
data, we are considering several potential approaches for determining
the payment amounts for the drug component of the bundles. Although we
are not proposing a specific pricing mechanism at this time, we are
soliciting comments on several different approaches, and we intend to
develop a final policy for determining the payment amount for the drug
component of the relevant bundles after considering the comments
received.
In considering the payment amount for the drug component of each of
the bundled payments that include a drug, we will begin by breaking the
drugs into two categories based on their current coverage and payment
by Medicare. First, we discuss the injectable and implantable drugs,
which are generally covered and paid for under Medicare Part B, and
then discuss the oral medications, which are generally covered and paid
for under Medicare Part D.\53\ Buprenorphine (injection), buprenorphine
(implant), and naltrexone (injection) would fall into the former
category and methadone and buprenorphine (oral) would fall into the
latter category.
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\53\ Because, by law, methadone used in MAT cannot be dispensed
by a pharmacy, it is not currently considered a Part D drug when
used for MAT. Methadone used for this purpose can be dispensed only
through an OTP certified by SAMHSA. However, methadone dispensed for
pain may be considered a Part D drug and can be dispensed by a
pharmacy.
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ii. Part B Drugs
Part B includes a limited drug benefit that encompasses drugs and
biologicals described in section 1861(t) of the Act. Currently, covered
Part B drugs fall into three general categories: Drugs furnished
incident to a physician's services, drugs administered via a covered
item of durable medical equipment, and other drugs specified by statute
(generally in section 1861(s)(2) of the Act). Types of providers and
suppliers that are paid for all or some of the Medicare-covered Part B
drugs that they furnish include physicians, pharmacies, durable medical
equipment suppliers, hospital outpatient departments, and end-stage
renal disease (ESRD) facilities.
The majority of Part B drug expenditures are for drugs furnished
incident to a physician's service. Drugs furnished incident to a
physician's service are typically injectable drugs that are
administered in a non-facility setting (covered under section
1861(s)(2)(A) of the Act) or in a hospital outpatient setting (covered
under section 1861(s)(2)(B) of the Act). The statute (sections
1861(s)(2)(A) and 1861(s)(2)(B) of the Act) limits ``incident to''
services to drugs that are not usually self-administered; self-
administered drugs, such as orally administered tablets and capsules
are not paid for under the ``incident to'' provision. Payment for drugs
furnished incident to a physician's service falls under section 1842(o)
of the Act. In accordance with section 1842(o)(1)(C) of the Act,
``incident to'' drugs furnished in a non-facility setting are paid
under the methodology in section 1847A of the Act. ``Incident to''
drugs furnished in a facility setting also are paid using the
methodology in section 1847A of the Act when it has been incorporated
under the relevant payment system (for example, the Hospital Outpatient
Prospective Payment System (OPPS) \54\).
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\54\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
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In most cases, determining payment using the methodology in section
1847A of the Act means payment is based on the ASP plus a statutorily
mandated 6 percent add-on. The payment for these drugs does not include
costs for administering the drug to the patient (for example, by
injection or infusion); payments for these physician and hospital
services are made separately, and the payment amounts are determined
under the PFS \55\ and the OPPS, respectively. The ASP payment amount
determined under section 1847A of the Act reflects a volume-weighted
ASP for all NDCs that are assigned to a HCPCS code. The ASP is
calculated quarterly using manufacturer-submitted data on sales to all
purchasers (with limited exceptions as articulated in section
1847A(c)(2) of the Act such as sales at nominal charge and sales exempt
from best price) with manufacturers' rebates, discounts, and price
concessions reflected in the manufacturer's determination of ASP.
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\55\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
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Although the Part B drug benefit is generally considered to be
limited in scope, it includes many categories of drugs and encompasses
a variety of care settings and payment methodologies. In addition to
the ``incident to'' drugs described above, Part B also covers and pays
for certain oral drugs with specific benefit categories defined under
section 1861(s) of the Act including certain oral anti-cancer drugs and
certain oral antiemetic drugs. In accordance with section 1842(o)(1) of
the Act or through incorporation under the relevant payment system as
discussed above, most of these oral Part B drugs are also paid based on
the ASP methodology described in section 1847A of the Act.
However, at times Part B drugs are paid based on wholesale
acquisition cost (WAC) as authorized under section 1847A(c)(4) of the
Act \56\ or average manufacturer price (AMP)-based price substitutions
as authorized under section 1847A(d) of the Act.\57\ Also, in
accordance with section 1842(o) of the Act, other payment methodologies
may be applied to determine the payment amount for certain Part B
drugs, for example, AWP-based payments (using current AWP) are made for
influenza, pneumococcal pneumonia, and hepatitis B vaccines.\58\ We
also use current AWP to make payment under the OPPS for very new drugs
without an ASP.\59\ Contractors may also make independent payment
amount determinations in situations where a national price is not
available for physician and other supplier claims and for drugs that
are specifically excluded from payment based on section 1847A of the
Act (for example, radiopharmaceuticals as noted in section 303(h) of
the Medicare Prescription Drug, Improvement and Modernization Act of
2003 (MMA) (Pub. L. 108-173, enacted December 8, 2003). In such cases,
pricing may be determined based on compendia or invoices.\60\
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\56\ See 75 FR 73465-73466, the section titled Partial Quarter
ASP data.
\57\ See 77 FR 69140.
\58\ Section 1842(o)(1)(A)(iv) of the Act.
\59\ 80 FR 70426 and 80 FR 70442-3; Medicare Claims Processing
Manual 100-04, Chapter 17, Section 20.1.3.
\60\ Medicare Claims Processing Manual 100-04, Chapter 17,
Section 20.1.3.
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While most Part B drugs are paid based on the ASP methodology,
MedPAC has noted that the ASP methodology may encourage the use of more
expensive drugs because the 6 percent add-on generates more revenue
[[Page 40532]]
for more expensive drugs.\61\ The ASP payment amount also does not vary
based on the price an individual provider or supplier pays to acquire
the drug. The statute does not identify a reason for the additional 6
percent add-on above ASP; however, as noted in the MedPAC report (and
by sources cited in the report), the add-on is needed to account for
handling and overhead costs and/or for additional mark-up in the
distribution channels that are not captured in the manufacturer-
reported ASP.\62\
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\61\ See MedPAC Report to the Congress: Medicare and the Health
Care Delivery System June 2015, pages 65-72.
\62\ Ibid.
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We propose to use the methodology in section 1847A of the Act
(which bases most payments on ASP) to set the payment rates for the
``incident to'' drugs. However, we propose to limit the payment amounts
for ``incident to'' drugs to 100 percent of the volume-weighted ASP for
a HCPCS code instead of 106 percent of the volume-weighted ASP for a
HCPCS code. We believe limiting the add-on will incentivize the use of
the most clinically appropriate drug for a given patient. In addition,
we understand that many OTPs purchase directly from drug manufacturers,
thereby limiting the markup from distribution channels. We also propose
to use the same version of the quarterly manufacturer-submitted data
used for calculating the most recently posted ASP data files in
preparing the CY 2020 payment rates for OTPs. Please note that the
quarterly ASP Drug Pricing Files include ASP plus 6 percent payment
amounts.\63\ Accordingly, we would adjust these amounts consistent with
our proposal to limit the payment amounts for these drugs to 100
percent of the volume-weighted ASP for a HCPCS code. Proposed payment
rates are provided below in this section of this proposed rule. A
discussion of the proposed annual payment update methodology is also
provided below. We propose to codify the ASP payment methodology for
the drug component at Sec. 410.67(d)(2). We solicit public comment on
these proposals, as well as on using alternative ASP-based payments to
price these drugs, such as a rolling average of the past year's ASP
payment rates.
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\63\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
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iii. Oral Drugs
We propose to use ASP-based payment, which would be determined
based on ASP data that have been calculated consistent with the
provisions in 42 CFR part 414, subpart 800, to set the payment rates
for the oral product categories when we receive manufacturer-submitted
ASP data for these drugs. We believe that using the ASP pricing data
for oral OTP drugs currently covered under Part D \64\ would facilitate
the computation of the estimated costs of these drugs. However, we do
not collect ASP pricing information under section 1927(b) of the Act
for these drugs. We request public comment on whether manufacturers
would be willing to submit ASP pricing data for OTP drugs currently
covered under Part D on a voluntary basis.
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\64\ Please note that methadone is not currently considered a
Part D drug when used for MAT. Methadone used for this purpose can
be dispensed only through an OTP certified by SAMHSA. However,
methadone dispensed for pain may be considered a Part D drug.
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We also propose to limit the payment amounts for oral drugs to 100
percent of the volume-weighted ASP for a HCPCS code instead of 106
percent of the volume-weighted ASP for a HCPCS code. We believe
limiting the add-on will incentivize the use of the most clinically
appropriate drug for a given patient. In addition, we understand that
many OTPs purchase directly from drug manufacturers, thereby limiting
the markup from distribution channels. We propose to use the same
version of the quarterly manufacturer-submitted data used for
calculating the most recently posted ASP data files in preparing the CY
2020 payment rates for OTPs. Please note that the quarterly ASP Drug
Pricing Files include ASP plus 6 percent payment amounts.\65\
Accordingly, we would adjust these amounts consistent with our proposal
to limit the payment amounts for these drugs to 100 percent of the
volume-weighted ASP for a HCPCS code. Proposed payment rates are
provided below in this section of this proposed rule. A discussion of
the proposed annual payment update methodology is also provided below.
We propose to codify the ASP payment methodology for the drug component
at Sec. 410.67(d)(2). We solicit public comment on these proposals, as
well as on using alternative ASP-based payments to price these drugs,
such as a rolling average of the past year's ASP payment rates.
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\65\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
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In the event that we do not receive manufacturer-submitted ASP
pricing data, we are considering several potential pricing mechanisms
to estimate the payment amounts for oral drugs typically paid for under
Medicare Part D but that would become OTP drugs paid under Part B when
used as part of MAT in an OTP. We are not proposing a specific pricing
mechanism for these drugs at this time, but are requesting public
comment on the following potential approaches for estimating the
acquisition cost and payment amounts for these drugs and on alternative
approaches. We will consider the comments received in developing our
final policy for determining these drug prices.
Approach 1: The Methodology in Section 1847A of the Act
One approach for estimating the cost of the drugs that are
currently covered under Part D and for which ASP data are not available
would be to use the methodology in section 1847A of the Act. Please see
above for a discussion of the methodology in section 1847A of the Act.
Under the methodology in section 1847A of the Act, when ASP data are
not available, this option would price drugs using, for example, WAC or
invoice pricing.
Approach 2: Medicare's Part D Prescription Drug Plan Finder Data
On January 28, 2005, we issued the ``Medicare Program; Medicare
Prescription Drug Benefit'' final rule (70 FR 4194) which implemented
the Medicare voluntary prescription drug benefit, as enacted by section
101 of the MMA. Beginning on January 1, 2006, a prescription drug
benefit program was available to beneficiaries with much broader drug
coverage than was previously provided under Part B to include: Brand-
name prescription drugs and biologicals, generic drugs, biosimilars,
vaccines, and medical supplies associated with the injection of
insulin.\66\ This prescription drug benefit is offered to Medicare
beneficiaries through Medicare Advantage Drug Plans (MA-PDs) and stand-
alone Prescription Drug Plans (PDPs). The prescription drug benefit
under Medicare Part D is administered based on the ``negotiated
prices'' of covered Part D drugs. Under Sec. 423.100 of the Part D
regulations, the negotiated price of a Part D drug equals the amount
paid by the Part D sponsor (or its pharmacy benefit manager) to the
pharmacy at the point-of-sale for that drug. Typically, these Part D
``negotiated prices'' are based on AWP minus a percentage for brand
drugs or either the maximum allowable cost, which is based on
proprietary methodologies used to establish the same payment for
therapeutically equivalent products marketed by multiple labelers with
different AWPs,
[[Page 40533]]
or the Generic Effective Rate, which guarantees aggregate minimum
reimbursement (for example, AWP-85 percent). The negotiated price under
Part D also includes a dispensing fee (for example, $1-$2), which is
added to the cost of the drug.
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\66\ See section 1860D-2(e) of the Act.
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Many of the beneficiaries who choose to enroll in Part D drug plans
must pay premiums, deductibles, and copayments/co-insurance. The
Medicare Prescription Drug Plan Finder is an online tool available at
http://www.medicare.gov. This web tool allows beneficiaries to make
informed choices about enrolling in Part D plans by comparing the
plans' benefit packages, premiums, formularies, pharmacies, and pricing
data. PDPs and MA-PDs are required to submit this information to CMS
for posting on the Medicare Drug Plan Finder. The database structure
provides the drug pricing and pharmacy network information necessary to
accurately communicate plan information in a comparative format. The
Medicare Prescription Drug Plan Finder displays information on
pharmacies that are contracted to participate in the sponsors' network
as either retail or mail order pharmacies.
Another approach for estimating the cost of the drugs that are
currently covered under Part D and for which ASP data are not available
would be to use data retrieved from the online Medicare Prescription
Drug Plan Finder. For example, the Part D drug prices for each drug
used by an OTP as part of MAT could be estimated based on a national
average price charged by all Part D plans and their network pharmacies.
However, the prices listed in the Medicare Prescription Drug Plan
Finder generally reflect the prices that are negotiated by larger
buying groups, as larger pharmacies often have significant buying power
and smaller pharmacies generally contract with a pharmacy services
administrative organization (PSAO). As a result, our primary concern
with this pricing approach is that such prices may fail to reflect the
drug prices that smaller OTP facilities may pay in acquiring these
drugs and could therefore disadvantage these facilities. If we were to
select this pricing approach for oral drugs for which ASP data are not
available, we would anticipate setting the pricing for these drugs
using the most recent Medicare Drug Plan Finder data available at the
drafting of the CY 2020 PFS final rule. We note that, for the Part B
ESRD prospective payment system (PPS) outlier calculation, which
provides ESRD facilities with additional payment in situations where
the costs for treating patients exceed an established threshold under
the ESRD PPS, we chose to adopt the ASP methodology in section 1847A of
the Act, and the other pricing methodologies under section 1847A of the
Act, as appropriate, when ASP data are not available, to price the
renal dialysis drugs and biological products that were or would have
been separately billable under Part B prior to implementation of the
ESRD PPS,\67\ and the national average drug prices based on the
Medicare Prescription Drug Plan Finder as the data source for pricing
the renal dialysis drugs or biological products that were or would have
been separately covered under Part D prior to implementation of the
ESRD PPS.\68\
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\67\ 82 FR 50742 through 50745.
\68\ 75 FR 49142.
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We believe that all of the MAT drugs proposed for inclusion in the
OTP benefit that are currently covered under Part D have clinical
treatment indications beyond MAT such as for the treatment of pain.\69\
These drugs will continue to be covered under Part D for these other
indications. Buprenorphine will continue to be covered under Part D for
MAT as well. Consequently, Part D pricing information should continue
to be available for these drugs and could be used in the computation of
payment under the approach discussed above.
---------------------------------------------------------------------------
\69\ For example, while methadone is not covered by Medicare
Part D for MAT, methadone dispensed for pain may be considered a
Part D drug.
---------------------------------------------------------------------------
Because, by law, methadone used in MAT cannot be dispensed by a
pharmacy, it is not currently considered a Part D drug when used for
MAT. Methadone used for this purpose can be dispensed only through an
OTP certified by SAMHSA. However, methadone dispensed for pain may be
considered a Part D drug and can be dispensed by a pharmacy.
Accordingly, we also seek comment on the applicability of Part D
payment rates for methadone dispensed by a pharmacy to methadone
dispensed by an OTP for MAT.
Approach 3: Wholesale Acquisition Cost (WAC)
Another approach for estimating the cost of the oral drugs that we
propose to include as part of the bundled payments but for which ASP
data are not available would be to use WAC. Section 1847A(c)(6)(B) of
the Act defines WAC as the manufacturer's list price for the drug to
wholesalers or direct purchasers in the U.S., not including prompt pay
or other discounts, rebates, or reductions in price, for the most
recent month for which the information is available, as reported in
wholesale price guides or other publications of drug pricing data. As
noted above in the discussion of Part B drugs, WAC is used as the basis
for pricing some Part B drugs; for example, it is used when it is less
than ASP in the case of single source drugs (section 1847A(b)(4) of the
Act) and in cases where ASP is unavailable during the first quarter of
sales (section 1847A(c)(4) of the Act).
Because WAC is the manufacturer's list price to wholesalers, we
believe that it is more reflective of the price paid by the end user
than the AWP. As a result, we believe that this pricing mechanism would
be consistent with pricing that currently occurs for drugs that are
separately billable under Part B. However, we have concerns about the
fact that WAC does not include prompt pay or other discounts, rebates,
or reductions in price. If we select this option to estimate the cost
of certain drugs, we would develop pricing using the most recent data
files available at the drafting of the CY 2020 PFS final rule.
Approach 4: National Average Drug Acquisition Cost (NADAC)
Another approach for estimating the cost of the oral drugs that we
propose to include as part of the bundled payments but for which ASP
data are not available would be to use Medicaid's NADAC survey. This
survey provides another national drug pricing benchmark. CMS conducts
surveys of retail community pharmacy prices, including drug ingredient
costs, to develop the NADAC pricing benchmark. The NADAC was designed
to create a national benchmark that is reflective of the prices paid by
retail community pharmacies to acquire prescription and over-the-
counter covered outpatient drugs and is available for consideration by
states to assist with their individual pharmacy payment policies.
State Medicaid agencies reimburse pharmacy providers for prescribed
covered outpatient drugs dispensed to Medicaid beneficiaries. The
reimbursement formula consists of two parts: (1) Drug ingredient costs;
and (2) a professional dispensing fee. In a final rule with comment
period titled ``Medicaid Program; Covered Outpatient Drugs,'' which
appeared in the February 1, 2016 Federal Register (81 FR 5169), we
revised the methodology that state Medicaid programs use to determine
drug ingredient costs, establishing an Actual Acquisition Cost (AAC)
based determination, as opposed to a determination based on estimated
acquisition costs (EAC). AAC is defined
[[Page 40534]]
at 42 CFR 447.502 as the agency's determination of the pharmacy
providers' actual prices paid to acquire drugs marketed or sold by
specific manufacturers. As explained in the Covered Outpatient Drugs
final rule with comment period (81 FR 5175), CMS believes shifting from
an EAC to an AAC based determination of ingredient costs is more
consistent with the dictates of section 1902(a)(30)(A) of the Act. In
2010, a working group within the National Association of State Medicaid
Directors (NASMD) recommended the establishment of a single national
pricing benchmark based on average drug acquisition costs. Pricing
metrics based on actual drug purchase prices provide greater accuracy
and transparency in how drug prices are established and are more
resistant to manipulation. The NASMD requested that CMS coordinate,
develop, and support this benchmark.
Section 1927(f) of the Act provides, in part, that CMS may contract
with a vendor to conduct monthly surveys with respect to prices for
covered outpatient drugs dispensed by retail community pharmacies. We
entered into a contract with Myers & Stauffer, LLC to perform a monthly
nationwide retail price survey of retail community pharmacy covered
outpatient drug prices (CMS-10241, OMB 0938-1041) and to provide states
with weekly updates on pricing files, that is, the NADAC files. The
NADAC survey process focuses on drug ingredient costs for retail
community pharmacies. The survey collects acquisition costs for covered
outpatient drugs purchased by retail pharmacies, which include invoice
prices from independent and chain retail community pharmacies. The
survey data provide information that CMS uses to assure compliance with
federal requirements. We believe NADAC data could be used to set the
prices for the oral drugs furnished by OTPs for which ASP data are not
available. Survey data on invoice prices provide the closest pricing
metric to ASP that we are aware of. However, similar to the other
available pricing metrics, we have concerns about the applicability of
retail pharmacy prices to the acquisition costs available to OTPs since
we have no evidence to suggest that these entities would be able to
acquire drugs at a similar price point. If we select this option, we
would develop pricing using the most recent data files available at the
drafting of the CY 2020 PFS final rule.
Alternative Methadone Pricing: TRICARE
We are also considering an approach for estimating the cost of
methadone using the amount calculated by TRICARE. As discussed above in
this section of this proposed rule, the TRICARE rates for medications
used in OTPs to treat opioid use disorder are spelled out in the 2016
TRICARE final rule (81 FR 61068); in the regulations at Sec.
199.14(a)(2)(ix); and in Chapter 7, Section 5 and Chapter 1, Section 15
of the TRICARE Reimbursement Manual 6010.61-M, April 1, 2015.
In the 2016 TRICARE final rule, DOD established separate payment
methodologies for OTPs based on the particular medication being
administered for treatment.\70\ Based on TRICARE's review of industry
billing practices, the initial weekly bundled rate for administration
of methadone included a daily drug cost of $3, which is subject to an
update factor.\71\
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\70\ 81 FR 61079.
\71\ 81 FR 61079.
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This option would only be applicable for methadone because TRICARE
has developed a fee-for-service payment methodology for buprenorphine
and naltrexone.\72\ In the 2016 TRICARE final rule, the DOD stated that
the payments for buprenorphine and naltrexone are more variable in
dosage and frequency for both the drug and non-drug services.\73\
Accordingly, TRICARE pays for drugs listed on Medicare's Part B ASP
files, such as the injectable and implantable versions of buprenorphine
using the ASP; drugs not appearing on the Medicare ASP file, such as
oral buprenorphine, are priced at the lesser of billed charges or 95
percent of the AWP.\74\
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\72\ 81 FR 61080.
\73\ 81 FR 61080.
\74\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
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We believe that pricing methadone consistent with the TRICARE
payment rate may provide a reasonable payment amount for methadone when
ASP data are not available. As DOD noted in the 2016 TRICARE final
rule, ``a number of commenters indicated that they believed the rates
DOD proposed for OTPs' services are near market rates and are
acceptable.'' \75\
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\75\ 81 FR 61080.
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We are proposing to codify this proposal to apply an alternative
approach for determining the payment rate for oral drugs only if ASP
data are not available in Sec. 410.67(d)(2). We request public comment
on the potential alternative approaches set forth above for estimating
the cost of oral drugs that we propose to include as part of the
bundled payments but for which ASP data are not available, including
any other alternate sources of data to estimate the cost of these oral
MAT drugs. Payment rates based on these different options are set forth
in Table 14. We will consider the comments received on these different
potential approaches when deciding on the approach that we will use to
determine the payment rates for these drugs in the CY 2020 PFS final
rule. We also invite public comment on any other potential data sources
for estimating the provider acquisition costs of OTP drugs currently
paid under either Part B or Part D. As noted previously, we welcome
comments on how new drugs with a novel mechanism of action should be
priced, and specifically whether pricing for non-opioid agonist and/or
antagonist medications should be determined using the same pricing
methodology, including the alternatives discussed above, as would be
used for medications included in the proposed definition of OUD
treatment services.
TABLE 14--Estimated * Initial Drug Payment Rates for Each Pricing
Approach
------------------------------------------------------------------------
Estimated initial
Pricing approach (or Estimated initial weekly drug payment
alternative) weekly drug payment for oral
for methadone buprenorphine
------------------------------------------------------------------------
Proposal: ASP-Based Payment. ASPs currently not ASPs currently not
reported. reported.
Approach 1: The Methodology $29.61.............. $117.68.
in Section 1847A of the Act.
Approach 2: Medicare's Part 22.47............... 97.65.
D Prescription Drug Plan
Finder Data.
Approach 3: WAC............. 27.93............... 111.02.
Approach 4: NADAC........... 11.76............... 97.02.
[[Page 40535]]
Alternative Methadone 22.19............... N/A.
Pricing: TRICARE.
------------------------------------------------------------------------
* The estimated payment amounts in this table are based on data files
posted at the time of the drafting of this proposed rule. We would
develop the final pricing for CY 2020 using the most recent data files
available at the drafting of the CY 2020 PFS final rule.
(b) Non-Drug Component
To price the non-drug component of the bundled payments, we are
proposing to use a crosswalk to the non-drug component of the TRICARE
weekly bundled rate for services furnished when a patient is prescribed
methadone. As described above, in 2016, TRICARE finalized a weekly
bundled rate for administration of methadone that included a daily drug
cost of $3, along with a $15 per day cost for non-drug services (that
is, the costs related to the intake/assessment, drug dispensing and
screening and integrated psychosocial and medical treatment and
supportive services). The daily projected per diem cost ($18/day) was
converted to a weekly rate of $126 ($18/day x 7 days) (81 FR 61079).
TRICARE updates the weekly bundled methadone rate for OTPs annually
using the Medicare update factor used for other mental health care
services rendered (that is, the Inpatient Prospective Payment System
update factor) under TRICARE (81 FR 61079). The updated amount for CY
2019 to $133.15 (of which $22.19 is the methadone cost and the
remainder, $110.96, is for the non-drug services).\76\ We believe using
the TRICARE weekly bundled rate is a reasonable approach to setting the
payment rate for the non-drug component of the bundled payments to
OTPs, particularly given the time constraints in developing a payment
methodology prior to the January 1, 2020 effective date of this new
Medicare benefit category. The TRICARE rate is an established national
payment rate that was established through notice and comment
rulemaking. As a result, OTPs and other interested parties had an
opportunity to present information regarding the costs of these
services. Furthermore the TRICARE rate describes a generally similar
bundle of services to those services that are included in the
definition of OUD treatment services in section 1861(jjj)(1) of the
Act. We recognize that there are differences in the patient population
for TRICARE compared with the Medicare beneficiary population. However,
as OTP services have not previously been covered by Medicare, it is not
clear what impact, if any, these differences would have on the cost of
the services included in the non-drug component of the proposed bundled
payments. We are proposing to codify the methodology for determining
the payment rate for the non-drug component of the bundled payments
using the TRICARE weekly rate for non-drug services at Sec.
410.67(d)(2). As part of this proposal, we would plan to monitor
utilization of non-drug services by Medicare beneficiaries and, if
needed, would consider in future rulemaking ways we could tailor the
TRICARE payment rate for these non-drug services to the Medicare
population, including dually eligible beneficiaries.
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\76\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
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Because the TRICARE payment rate for the non-drug services included
in its weekly bundled rate for methadone includes daily administration
of methadone, as part of our proposed approach we would adjust the
TRICARE payment rate for non-drug services for most of the other
bundled payments to more accurately reflect the cost of administering
the other drugs used in MAT. For the oral buprenorphine bundled
payment, we propose to retain the same amount as the rate for the
methadone bundled payment based on an assumption that this drug is also
being dispensed daily. We understand that patients who have stabilized
may be given 7-14 day supplies of oral buprenorphine at a time, but for
the purposes of developing the proposed rates, we valued this service
to include daily drug dispensing to account for cases where daily drug
dispensing is occurring. For the injectable drugs (buprenorphine and
naltrexone), we propose to subtract from the non-drug component, an
amount that is comparable to the dispensing fees paid by several state
Medicaid programs ($10.50) for a week of daily dispensing of methadone.
This adjustment accounts for the fact that these injectable drugs are
not oral drugs that are dispensed daily; we would then instead add the
fee that Medicare pays for the administration of an injection (which is
currently $16.94 under the CY 2019 non-facility Medicare payment rate
for CPT code 96372). We propose to update the amount of this adjustment
annually using the same methodology that we are proposing to use to
update the non-drug component of the bundled payments.
Similarly, the payment rates for the non-drug component of the
codes for the weekly bundled payments for buprenorphine implants would
be adjusted to add an amount for insertion and/or removal based on a
direct crosswalk to the non-facility payment rates under the Medicare
PFS for the insertion, removal, or insertion and removal of these
implants, which describe the physician work, practice expense (PE), and
malpractice costs associated with these procedures, and to remove the
costs of daily drug dispensing (determined based on the dispensing fees
paid by several state Medicaid programs for a week of daily dispensing
of methadone, currently $10.50). For HCPCS code GXXX5, we would use a
crosswalk to the rate for HCPCS code G0516 (Insertion of non-
biodegradable drug delivery implants, 4 or more (services for subdermal
rod implant)); for HCPCS code GXXX6, we would use a crosswalk to the
rate for HCPCS code G0517 (Removal of non-biodegradable drug delivery
implants, 4 or more (services for subdermal implants)); and for HCPCS
code GXXX7, we would use a crosswalk to the rate for HCPCS code G0518
(Removal with reinsertion, non-biodegradable drug delivery implants, 4
or more (services for subdermal implants)). The amounts for HCPCS codes
G0516, G0517 and G0518 under the CY 2019 non-facility Medicare payment
rate are $111.00, $126.86, and $204.70, respectively.
In order to determine the payment rates for the code describing a
non-drug bundled payment, HCPCS code GXXX8, we propose to use a
crosswalk to the reimbursement rate for the non-drug services included
in the TRICARE weekly bundled rate for administration of methadone,
adjusted to subtract the cost of methadone dispensing (using an amount
that is comparable to the dispensing fees paid by several state
Medicaid programs for a week of daily dispensing of methadone, which is
currently $10.50).
We propose that the payment rate for the add-on code, HCPCS code
GXX19, would be based on 30 minutes of
[[Page 40536]]
substance use counseling and valued based on a crosswalk to the rates
set by state Medicaid programs for similar services.
i. Medication Not Otherwise Specified
We would expect the non-drug component for medication not otherwise
specified bundled payments (HCPCS code GXXX9) to be consistent with the
pricing methodology for the other bundled payments and therefore, be
based on a crosswalk to the TRICARE rate, adjusted for any applicable
administration and dispensing fees. For example, for oral medications,
we would use the rate for the non-drug services included in the TRICARE
methadone bundle, based on an assumption that the drug is also being
dispensed daily. For the injectable medications, we would adjust the
TRICARE payment rate for non-drug services using the same methodology
we are proposing for injectable medications above (to subtract an
amount for daily dispensing and add the non-facility Medicare payment
rate for administration of the injection). For implantable medications,
we would also use the same methodology we propose above, with the same
crosswalked non-facility Medicare payment rates (for insertion,
removal, and insertion and removal). We welcome comments on all of the
proposed pricing methodologies described in this section. As noted
above, we also welcome comments on how new drugs with a novel mechanism
of action (that is, drugs that are not opioid agonists and/or
antagonists) should be priced. We additionally welcome comments on how
the price of the non-drug component of such bundled payments should be
determined, in particular the dispensing and/or administration fees,
including whether the methodology we propose above for determining the
payment rate for the non-drug component of an episodes of are that
includes a new opioid agonist and antagonist medication (which is based
on whether the drug is oral, injectable, or implantable) would be
appropriate to use for these new drugs.
(c) Partial Episode of Care
For HCPCS codes GXX10 and GXX11 (codes describing partial episodes
for methadone and oral buprenorphine), we propose that the payment
rates for the non-drug component would be calculated by taking one half
of the payment rate for the non-drug component for the corresponding
weekly bundles. We chose one half as the best approximation of the
median cost of the services furnished during a partial episode
consistent with our proposal above to make a partial episode bundled
payment when the majority of services described in a beneficiary's
treatment plan are not furnished during a specific episode of care.
However, we welcome comment on other methods that could be used to
calculate these payment rates. We propose that the payment rates for
the drug component of these partial episode bundles would be calculated
by taking one half of the payment rate for the drug component of the
corresponding weekly bundles.
For HCPCS codes GXX12 and GXX16 (codes describing partial episodes
for injectable buprenorphine and naltrexone), we propose that the
payment rates for the drug component would be the same as the payment
rate for the drug component of the full weekly bundle so that the OTP
would be reimbursed for the cost of the drug that is given at the start
of the episode. For the non-drug component, we propose that the payment
rate would be calculated as follows: The TRICARE non-drug component
payment rate ($110.96), adjusted to remove the cost of daily
administration of an oral drug ($10.50), then divided by two; that
amount would be added to the fee that Medicare pays for the
administration of an injection (which is currently $16.94 under the CY
2019 non-facility Medicare payment rate for CPT code 96372).
For HCPCS codes GXX13, GXX14, GXX15 (codes describing partial
episodes for the buprenorphine implant insertion, removal, and
insertion and removal, respectively) we propose that the payment rates
for drug component would be the same as the payment rate for the
corresponding weekly bundle. For the non-drug component, we propose
that the payment rate would be calculated as follows: The TRICARE non-
drug component payment rate ($110.96), adjusted to remove the cost of
daily administration of an oral drug ($10.50), then divided by two;
that amount would be added to the Medicare non-facility payment rate
for the insertion, removal, or insertion and removal of the implants,
respectively (based on the non-facility rates for HCPCS codes G0516,
G0517, and G0518, which are currently $111.00, $126.86, and $204.70,
respectively).
For HCPCS code GXX17 (code describing a non-drug partial episode of
care), we propose that the payment rate would be calculated by taking
one half of the payment rate for the corresponding weekly bundle.
We propose that the payment rate for the code describing partial
episodes for a medication not otherwise specified (HCPCS code GXX18)
would be calculated based on whether the medication is oral, injectable
or implantable, following the methodology described above. For oral
drugs, we would follow the methodology described for HCPCS codes GXX10
and GXX11. For injectable drugs, we would follow the methodology
described for HCPCS codes GXX12 and GXX16. For implantable drugs, we
would follow the methodology described for HCPCS codes GXX13, GXX14,
and GXX15. We welcome comments on how partial episodes of care using
new drugs with a novel mechanism of action (that is, non-opioid agonist
and/or antagonist treatment medications) should be priced. For example,
we could use the same approach described previously for pricing new
opioid agonist and antagonist medications not otherwise specified,
which is to follow the methodology based on whether the drug is oral,
injectable or implantable.
BILLING CODE 4120-01-P
[[Page 40537]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.007
[[Page 40538]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.008
[[Page 40539]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.009
BILLING CODE 4120-01-C
(8) Place of Service (POS) Code for Services Furnished at OTPs
We are creating a new POS code specific to OTPs since there are no
existing POS codes that specifically describe OTPs. Claims for OTP
services would include this place of service code. We note that POS
codes are available for use by all payers. We are not proposing to make
any differential payment based on the use of this new POS code. Further
guidance will be issued regarding the POS code that should be used by
OTPs.
c. Duplicative Payments Under Parts B or D
Section 1834(w)(1) of the Act, added by section 2005(c) of the
SUPPORT Act, requires the Secretary to ensure, as determined
appropriate by the Secretary, that no duplicative payments are made
under Part B or Part D for items and services furnished by an OTP. We
note that many of the individual items or services provided by OTPs
that would be included in the bundled payment rates under our proposal
may also be appropriately available to beneficiaries through other
Medicare benefits. Although we recognize the potential for significant
program integrity concerns when similar items or services are payable
under separate Medicare benefits, we also believe that it is important
that any efforts to prevent duplicative payments not inadvertently
restrict Medicare beneficiaries' access to other Medicare benefits even
for the time period they are being treated by an OTP. For example, we
believe that a beneficiary receiving counseling or therapy as part of
an OTP bundle of services may also be receiving medically reasonable
and necessary counseling or therapy as part of a physician's service
during the same time period. Similarly, we believe there could be
circumstances where Medicare beneficiaries with OUD could receive
treatment and/or medication from non-OTP entities that would not result
in duplicative payments, presuming that both the OTP and the other
entity appropriately furnished separate medically necessary services or
items. Consequently, we do not believe that provision of the same kinds
of services by both an OTP and a separate provider or supplier would
itself constitute a duplicative payment.
We believe that duplicative payments would result from the
submission of claims to Medicare leading to payment for drugs furnished
to a Medicare beneficiary and the associated dispensing fees on a
certain date of service to both an OTP and another provider or supplier
under a different benefit. In these circumstances, we would consider
only one of the claims to be paid for appropriately. Accordingly, for
purposes of implementing section 1834(w)(1) of the Act, we propose to
consider payment for medications delivered, administered or dispensed
to the beneficiary as part of the OTP bundled payment to be a
duplicative payment if delivery, administration or dispensing of the
same medications was also separately paid under Medicare Parts B or D.
We propose to codify this policy at Sec. 410.67(d)(4). We understand
that some OTPs negotiate arrangements whereby community pharmacies
supply MAT-related medications to OTPs. If the OTP provides medically
necessary MAT-related medications as part of an episode of care, we
would expect the OTP to take measures to ensure that there is no claim
for payment for these drugs other than as part of the OTP bundled
payment. (For example, the MAT drugs billed by an OTP as part of a
bundled payment should not be reported to or paid under a Part D plan.)
We expect that OTPs will take reasonable steps to ensure that the items
and services furnished under their care are not reported or billed
under a different Medicare benefit. CMS intends to monitor for
duplicative payments, and would take appropriate action as needed when
such duplicative payments are identified. Therefore, we are proposing
that in cases where a payment for drugs used as part of an OTP's
treatment plan is identified as being a duplicative payment because the
same costs were paid under a different Medicare benefit, CMS will
generally recoup the duplicative payment made to the OTP as the OTP
would be in the best position to know whether or not the drug that is
included as part of the beneficiary's treatment plan is furnished by
the OTP or by another provider or supplier given that the OTP is
responsible for managing the beneficiary's overall OUD treatment. We
propose to codify this policy at Sec. 410.67(d)(4). CMS notes that
this general approach would not preclude CMS or other auditors from
conducting appropriate oversight of duplicative payments made to the
other provider or suppliers, particularly in cases of fraud and/or
abuse.
[[Page 40540]]
d. Cost Sharing
Section 2005(c) of the SUPPORT Act amends section 1833(a)(1) of the
Act, relating to payment of Part B services, by adding a new
subparagraph (CC), which specifies with respect to OUD treatment
services furnished by an OTP during an episode of care that the amount
paid shall be equal to the amount payable under section 1834(w) of the
Act less any copayment required as specified by the Secretary. Section
1834(w) of the Act, which was also added by section 2005(c) of the
SUPPORT Act, requires that the Secretary pay an amount that is equal to
100 percent of a bundled payment under this part for OUD treatment
services. Given these two provisions, we believe that there is
flexibility for CMS to set the copayment amount for OTP services either
at zero or at an amount above zero. Therefore, we are proposing to set
the copayment at zero for a time-limited duration (for example, for the
duration of the national opioid crisis), as we believe this would
minimize barriers to patient access to OUD treatment services. Setting
the copayment at zero also ensures OTP providers receive the full
Medicare payment amount for Medicare beneficiaries if secondary payers
are not available or do not pay the copayment, especially for those
dually eligible for Medicare and Medicaid.\77\ We intend to continue to
monitor the opioid crisis in order to determine at what point in the
future a copayment may be imposed. At such a time we deem appropriate,
we would institute cost sharing through future notice and comment
rulemaking. We welcome feedback from the public on our proposal to set
the copayment at zero for a time-limited duration, such as for the
duration of the national opioid crisis, and any other metrics CMS might
consider using to determine when to start requiring a copayment. In
developing our proposed approach, we also considered other
alternatives, such as setting the copayment at a fixed fee calculated
based on 20 percent of the payment rate for the bundle, consistent with
the standard copayment requirement for other Part B services, or
applying a flat dollar copayment amount similar to TRICARE's copayment;
however, we recognize that setting the copayment for OUD services at a
non-zero amount could create a barrier to access to treatment for many
beneficiaries. We propose to codify the proposed copayment amount of
zero at Sec. 410.67(e). We welcome feedback on our proposal to set the
copayment amount for OTP services at zero, and on the alternatives
considered, including whether we should consider any of these
alternatives for CY 2020 or future years.
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\77\ For those dually eligible individuals in the Qualified
Medicare Beneficiary program (7.7 million of the 12 million dually
eligible individuals in 2017), state Medicaid programs cover the
Medicare Part A and B deductible and coinsurance. However, section
4714 of the Balanced Budget Act of 1997 (Pub. L. 105-33) provides
discretion for states to pay Medicare cost-sharing only if the
Medicaid payment rate for the service is above the Medicare paid
amount for the service. Since most states opt for this discretion,
and most Medicaid rates are lower than Medicare's, states often do
not pay the provider for the Medicare cost-sharing amount. Providers
are further prohibited from collecting the Medicare cost-sharing
amount from the beneficiary, effectively having to take a discount
compared to the amount received for other Medicare beneficiaries.
---------------------------------------------------------------------------
Separately, we note that the Part B deductible would apply for OUD
treatment services, as mandated for all Part B services by section
1833(b) of the Act.
4. Adjustments to Bundled Payment Rates for OUD Treatment Services
The costs of providing OUD treatment services will likely vary over
time and depending on the geographic location where the services are
furnished. Below we discuss our proposed adjustments to the bundled
payment rates to account for these factors.
a. Locality Adjustment
Section 1834(w)(2) of the Act, as added by section 2005(c) of the
SUPPORT Act provides that the Secretary may implement the bundled
payment for OUD treatment services furnished by OTPs through one or
more bundles based on the type of medications, the frequency of
services, the scope of services furnished, characteristics of the
individuals furnished such services, or other factors as the Secretary
determines appropriate. The cost for the provision of OTP treatment
services, like many other healthcare services covered by Medicare, will
likely vary across the country based upon the differing cost in a given
geographic locality. To account for such geographic cost differences in
the provision of services, in a number of payment systems, Medicare
routinely applies geographic locality adjustments to the payment rates
for particular services. As we believe OTP treatment services will also
be subject to varying cost based upon the geographic locality where the
services are furnished, we propose to apply a geographic locality
adjustment to the bundled payment rate for OTP treatment services.
Below, we discuss our proposed approach with respect to the drug
component (which reflects payment for the drug) and the non-drug
component (which reflects payment for all other services furnished to
the beneficiary by the OTP, such as drug administration, counseling,
toxicology testing, etc.) of the bundled payment.
(1) Drug Component
Because our proposed approaches for pricing the MAT drugs included
in the bundles all reflect national pricing, and because there is no
geographic adjustment factor applied to the payment of Part B drugs
under the ASP methodology, we do not believe that it is necessary to
adjust the drug component of the bundled payment rates for OTP services
based upon geographic locality. Therefore, we are proposing not to
apply a geographic locality adjustment to the drug component of the
bundled payment rate for OTP services.
(2) Non-Drug Component
Unlike the national pricing of drugs, the costs for the services
included in the non-drug component of the OTP bundled payment for OUD
treatments are not constant across all geographic localities. For
example, OTPs' costs for rent or employee wages could vary
significantly across different localities and could potentially result
in disparate costs for the services included in the non-drug component
of OUD treatment services. Because the costs of furnishing the services
included in the non-drug component of the OTP bundled payment for OUD
treatment services will vary based upon the geographic locality in
which the services are provided, we believe it would be appropriate to
apply a geographic locality adjustment to the non-drug component of the
bundled payments. We believe that the geographic variation in cost of
the non-drug services provided by OTPs will be similar to the
geographic variation in the cost of services furnished in physician
offices. Therefore, to account for the differential costs of OUD
treatment services across the country, we are proposing to adjust the
non-drug component of the bundled payment rates for OUD treatment
services using an approach similar to the established methodology used
to geographically adjust payments under the PFS based upon the location
where the service is furnished. The PFS currently provides for an
adjustment to the payment for PFS services based upon the fee schedule
area in which the service is provided through the use of Geographic
Practice Cost Indices (GPCIs), which measure the relative cost
differences among localities compared to the national average for each
of the
[[Page 40541]]
three fee schedule components (work, PE, and malpractice).
Although we are proposing to adjust the non-drug component of the
OUD treatment services using an approach similar to the established
methodology used to adjust PFS payment for geographic locality, because
GPCIs provide for the application of geographic locality adjustments to
the three distinct components of PFS services, and the OTP bundled
payment is a flat rate payment for all OUD treatment services furnished
during an episode of care, a single factor would be required to apply
the geographic locality adjustment to the non-drug component of the OTP
bundled payment rate. Therefore, to apply a geographic locality
adjustment to the non-drug component of the OTP bundled payment for OUD
treatment services through a single factor, we are proposing to use the
Geographic Adjustment Factor (GAF) at Sec. 414.26. Specifically, we
are proposing to use the GAF to adjust the payment for the non-drug
component of the OTP bundled payment to reflect the costs of furnishing
the non-drug component of OUD treatment services in each of the PFS fee
schedule areas. The GAF is calculated using the GPCIs under the PFS,
and is used to account for cost differences in furnishing physicians'
services in differing geographic localities. The GAF is calculated for
each fee schedule area as the weighted composite of all three GPCIs
(work, PE, and malpractice) for that given locality using the national
GPCI cost share weights. In developing this proposal, we also
considered geographically adjusting the payment for the non-drug
component of the OTP bundled payment using only the PE GPCI value for
each fee schedule area. However, because the the non-drug component of
OUD treatment services is comprised of work, PE, and malpractice
expenses, we ultimately decided to propose using the GAF as we believe
the weighted composite of all three GPCIs reflected in the GAF would be
the more appropriate geographic adjustment factor to reflect geographic
variations in the cost of furnishing these services.
The GAF, which is determined under Sec. 414.26, is further
discussed earlier in section II.D.1. of this proposed rule and the
specific GAF values for each payment locality are posted in Addendum D
to this proposed rule. In developing the proposed geographic locality
adjustment for the non-drug component of the OUD treatment services
payment rate, we also considered other potential locality adjustments,
such as the Inpatient Prospective Payment System (IPPS) hospital wage
index. However, we have opted to propose using the GAF as we believe
the services provided in an OTP more closely resemble the services
provided at a physician office than the services provided in other
settings, such as inpatient hospitals. We propose to codify using the
GAF to adjust the non-drug component of the OTP bundled payments to
reflect the cost differences in furnishing these services in differing
geographic localities at Sec. 410.67(d)(3)(ii). We invite public
comment on our proposal to adjust the non-drug component of the OTP
bundled payments for geographic variations in the costs of furnishing
OUD treatment services using the GAF. We also welcome comments on any
factors, other than the GAF, that could be used to make this payment
adjustment.
Additionally, we note that the majority of OTPs operate in urban
localities. In light of this fact, we are interested in receiving
information on whether rural areas have appropriate access to treatment
for OUD. We are particularly interested in any potential limitations on
access to care for OUD in rural areas and whether there are additional
adjustments to the proposed bundled payments that should be made to
account for the costs incurred by OTPs in furnishing OUD treatment
services in rural areas. We invite public comment on this issue and
potential solutions we could consider adopting to address this
potential issue through future rulemaking.
b. Annual Update
Section 1834(w)(3) of the Act, as added by section 2005(c) of the
SUPPORT Act, requires that the Secretary provide an update each year to
the OTP bundled payment rates. To fulfill this statutory requirement,
we are proposing to apply a blended annual update, comprised of
distinct updates for the drug and non-drug components of the bundled
payment rates, to account for the differing rate of growth in the
prices of drugs relative to other services. We propose that this
blended annual update for the OTP bundled payment rates would first
apply for determining the CY 2021 OTP bundled payment rates. The
specific details of the proposed updates for the drug and non-drug
components respectively are discussed in this section.
(1) Drug Component
As stated above, we are proposing to establish the pricing of the
drug component of the OTP bundled payment rates for OUD treatment
services based on CMS pricing mechanisms currently in place. To
recognize the potential change in costs of the drugs used in MAT from
year to year and to fulfill the requirement to provide an annual update
to the OTP bundled payment rates, we are proposing to update the
payment for the drug component based upon the changes in drug costs
reported under the pricing mechanism used to establish the pricing of
the drug component of the applicable bundled payment rate, as discussed
earlier. As an example, if we were to finalize our proposal to price
the drug component of the bundled payment rate for episodes of care
that include injectable and implantable drugs generally covered and
paid under Medicare Part B using ASP data, the pricing of the drug
component for these OTP bundled payments, would be updated using the
most recently available ASP data at the time of ratesetting for the
applicable calendar year. Similarly, if we finalize our proposal to
price the drug component of the bundled payment rate for episodes of
care that include oral drugs using ASP data, if such data are
available, we would also update the pricing of the drug component using
the most recently available ASP data at the time of ratesetting for the
applicable calendar year. Previously, we also discussed a number of
alternative data sources that could be used to price oral drugs in the
drug component of OTP bundled payments in cases when we do not receive
manufacturer-submitted ASP pricing data. As an example, if we were to
use NADAC data as discussed as one of the alternatives, to determine
the payment for the drug component of the bundled payment for oral
drugs in cases when we do not have manufacturer-submitted ASP pricing
data, this payment rate would also be updated using the most recently
available NADAC data at the time of ratesetting for the applicable
calendar year. We propose to codify this methodology for determining
the annual update to the payment rate for the drug component at Sec.
410.67(d)(3)(i).
In developing the proposal to annually update the pricing of the
drug component of the OUD treatment services payment rate, we also
considered other methodologies, including applying a single uniform
update factor to the drug and non-drug components of the proposed
payment rates. We ultimately determined not to propose the use of a
single uniform update factor, because we believe that it is important
to apply an annual update to the payment rates that recognizes the
differing rate of growth of drug costs
[[Page 40542]]
compared to the rate of growth in the cost of the other services. In
addition, we also considered annually updating the pricing of the drug
component of the OUD treatment services payment rate via an established
update factor such as the Producer Price Index (PPI) for chemicals and
allied products, analgesics (WPU06380202). The PPI for chemicals and
allied products, analgesics is a subset of the PPI produced by the
Bureau of Labor Statistics, which measures the average change over time
in the selling prices received by domestic producers for their output.
Ultimately we decided against updating the pricing of the drug
component of the OUD treatment services payment rate via an established
update factor such as the PPI in favor of our proposed approach because
we believe the proposed approach updated the pricing of the drug
component of the OUD treatment services payment rate in the manner most
familiar to stakeholders. We invite public comment on our proposed
approach to updating the drug component of the bundled payment rates.
We also seek comment on possible alternate methodologies for updating
the drug component of the payment rate for OUD treatment services, such
as use of the PPI for chemicals and allied products, analgesics.
(2) Non-Drug Component
To account for the potential changing costs of the services
included in the non-drug component of the bundled payment rates for OUD
treatment services, we are proposing to update the non-drug component
of the bundled payment for OUD treatment services based upon the
Medicare Economic Index (MEI). The MEI is defined in section 1842(i)(3)
of the Act and the methodology for computing the MEI is described in
Sec. 405.504(d). The MEI is used to update the payment rates for
physician services under section 1842(b)(3) of the Act, which states
that prevailing charge levels beginning after June 30, 1973, may not
exceed the level from the previous year except to the extent that the
Secretary finds, on the basis of appropriate economic index data, that
such a higher level is justified by year-to-year economic changes. The
MEI is a fixed-weight input price index that reflects the physicians'
own time and the physicians' practice expenses, with an adjustment for
the change in economy-wide, private nonfarm business multifactor
productivity. The MEI was last revised in the CY 2014 PFS final rule
with comment period (78 FR 74264). In developing the proposed update
factor for the non-drug component of the OUD treatment services payment
rate, we considered other potential update factors, such as the Bureau
of Labor Statistics Consumer Price Index for All Items for Urban
Consumers (Bureau of Labor Statistics #CUUR0000SA0 (https://www.bls.gov/cpi/data.htm) and the IPPS hospital market basket reduced
by the multifactor productivity adjustment. The Consumer Price Index
for All Items (CPI-U) is a measure of the average change over time in
the prices paid by urban consumers for a market basket of consumer
goods and services. However, we concluded that a healthcare-specific
update factor, such as the MEI, would be more appropriate for OTPs than
the CPI-U, which measures general inflation, as the MEI would more
accurately reflect the change in the prices of goods and services
included in the non-drug component of the OTP bundled payments.
Similarly, we believe the MEI would be more appropriate than the
IPPS market basket to update the non-drug component of the bundled
payment rates as the services provided by an OTP more closely resemble
the services provided at a physician office than the services provided
by an inpatient hospital. Accordingly, we propose to update the payment
amount for the non-drug component of each of the bundled payment rates
for OUD treatment services furnished by OTPs based upon the most
recently available historical annual growth in the MEI available at the
time of rulemaking. We propose to codify this proposal at Sec.
410.67(d)(3)(iii). We invite public comment on this proposal.
H. Bundled Payments Under the PFS for Substance Use Disorders
1. Background and Proposal
In the CY 2019 PFS proposed rule (83 FR 35730), we solicited
comment on creating a bundled episode of care payment for management
and counseling treatment for substance use disorders. We received
approximately 50 comments on this topic, most of which were supportive
of creating a separate bundled payment for these services. Some
commenters recommended focusing the bundle on services related to
medication assisted treatment (MAT) used in treatment for opioid use
disorder (OUD). Several commenters also recommended that we establish
higher payment amounts for patients with more complex needs who require
more intensive services and management, and also expressed concern that
an episode of care that limited the duration of treatment would not be
conducive to treating OUD, given the chronic nature of this disorder.
Other commenters recommended that we establish separate bundled
payments for treatment of substance use disorders that does, and does
not, involve MAT.
In response to the public comments, we are proposing to establish
bundled payments for the overall treatment of OUD, including
management, care coordination, psychotherapy, and counseling
activities. We note that, if a patient's treatment involves MAT, this
proposed bundled payment would not include payment for the medication
itself. Billing and payment for medications under Medicare Part B or
Part D would remain unchanged. Additionally, payment for medically
necessary toxicology testing would not be included in the proposed OUD
bundle, and would continue to be billed separately under the Clinical
Lab Fee Schedule. We are also proposing in this proposed rule to
implement the new Medicare Part B benefit added by section 2005 of the
SUPPORT Act for coverage of certain services furnished by Opioid
Treatment Programs (OTPs) beginning in CY 2020. We believe the proposed
bundled payment under the PFS for OUD treatment described below will
create an avenue for physicians and other health professionals to bill
for a bundle of services that is similar to the new bundled OUD
treatment services benefit, but not furnished by an OTP. By creating a
separate bundled payment for these services under the PFS, we hope to
incentivize increased provision of counseling and care coordination for
patients with OUD in the office setting, thereby expanding access to
OUD care.
To implement this new bundled payment, we are proposing to create
two HCPCS G-codes to describe monthly bundles of services that include
overall management, care coordination, individual and group
psychotherapy and counseling for office-based OUD treatment. Although
we considered proposing weekly-reported codes to describe a bundle of
services that would align with the proposed OTP bundle, we believe that
monthly-reported codes will better align with the practice and billing
of other types of care management services furnished in office settings
and billed under the PFS (for example, behavioral health integration
(BHI) services). We believe monthly-reported codes would be less
administratively burdensome for practitioners, and more likely to be
consistent with care management and prescribing patterns in the office
setting (as compared with an OTP) given the increased use of long-
acting MAT drugs (such as injectable naltrexone or
[[Page 40543]]
implanted buprenorphine) in the office setting compared to the OTP
setting. Based on feedback we received through the comment
solicitation, we are proposing to create a code to describe the initial
month of treatment, which would include intake activities and
development of a treatment plan, as well as assessments to aid in
development of the treatment plan in addition to care coordination,
individual therapy, group therapy, and counseling; a code to describe
subsequent months of treatment including care coordination, individual
therapy, group therapy, and counseling; and an add-on code that could
be billed in circumstances when effective treatment requires additional
resources for a particular patient that substantially exceed the
resources included in the base codes. In other words, the add-on code
would address extraordinary circumstances that are not contemplated by
the bundled code. We acknowledge that the course of treatment for OUD
is variable, and in some instances, the first several months of
treatment may be more resource intensive. We welcome comments on
whether we should consider creating a separately billable code or codes
to describe additional resources involved in furnishing OUD treatment-
related services after the first month, for example, when substantial
revisions to the treatment plan are needed, and what resource inputs we
might consider in setting values for such codes.
We believe that, in general, bundled payments create incentives to
provide efficient care by mitigating incentives tied to volume of
services furnished, and that these incentives can be undermined by
creating separate billing mechanisms to account for higher resource
costs for particular patients. However, we share some of the concerns
raised by commenters that an OUD bundle should not inadvertently limit
the appropriate amount of OUD care furnished to patients with varying
medical needs. In consideration of this concern, we are proposing to
create an add-on code to make appropriate payment for additional
resource costs in order to mitigate the risks that the bundled OUD
payment might limit clinically-indicated patient care for patients that
require significantly more care than is in the range of what is typical
for the kinds of care described by the base codes. However, we are also
interested in comments regarding ways we might better stratify the
coding for OUD treatment to reflect the varying needs of patients
(based on complexity or frequency of services, for example) while
maintaining the full advantage of the bundled payment, including
increased efficiency and flexibility in furnishing care.
We anticipate that these services would often be billed by
addiction specialty practitioners, but note that these codes are not
limited to any particular physician or non-physician practitioner
specialty. Additionally, unlike the codes that describe care furnished
using the psychiatric collaborative care model (CPT codes 99492, 99493,
and 99494), which require consultation with a psychiatric consultant,
we are not proposing to require consultation with a specialist as a
condition of payment for these codes.
The codes and descriptors for the proposed services are:
HCPCS code GYYY1: Office-based treatment for opioid use
disorder, including development of the treatment plan, care
coordination, individual therapy and group therapy and counseling; at
least 70 minutes in the first calendar month.
HCPCS code GYYY2: Office-based treatment for opioid use
disorder, including care coordination, individual therapy and group
therapy and counseling; at least 60 minutes in a subsequent calendar
month.
HCPCS code GYYY3: Office-based treatment for opioid use
disorder, including care coordination, individual therapy and group
therapy and counseling; each additional 30 minutes beyond the first 120
minutes (List separately in addition to code for primary procedure).
For the purposes of valuation for HCPCS codes GYYY1 and GYYY2, we
are assuming two individual psychotherapy sessions per month and four
group psychotherapy sessions per month; however, we understand that the
number of therapy and counseling sessions furnished per month will vary
among patients and also fluctuate over time based on the individual
patient's needs. Consistent with the methodology for pricing other
services under the PFS, HCPCS codes GYYY1, GYYY2, and GYYY3 are valued
based on what we believe to be a typical case, and we understand that
based on variability in patient needs, some patients will require more
resources, and some fewer. In order to maintain the advantages inherent
in developing a payment bundle, we are proposing that the add-on code
(HCPCS code GYYY3) can only be billed when the total time spent by the
billing professional and the clinical staff furnishing the OUD
treatment services described by the base code exceeds double the
minimum amount of service time required to bill the base code for the
month. We believe it is appropriate to limit billing of the add-on code
to situations where medically necessary OUD treatment services for a
particular patient exceed twice the minimum service time for the base
code because, as noted above, the add-on code is intended to address
extraordinary situations where effective treatment requires additional
resources that substantially exceed the resources included in the base
codes. For example, the needs of a particular patient in a month may be
unusually acute, well beyond the needs of the typical patient; or there
may be some months when psychosocial stressors arise that were
unforeseen at the time the treatment plan was developed, but warrant
additional or more intensive therapy services for the patient. We are
proposing that when the time requirement is met, HCPCS code GYYY3 could
be billed as an add-on code during the initial month or subsequent
months of OUD treatment. Practitioners should document the medical
necessity for the use of the add-on code in the patient's medical
record. We welcome comments on this proposal.
We are proposing to value HCPCS codes GYYY1, GYYY2, and GYYY3 using
a building block methodology that sums the work RVUs and direct PE
inputs from codes that describe the component services we believe would
be typical, consistent with the approach we have previously used in
valuing monthly care management services that include face-to-face
services within the payment. For HCPCS code GYYY1, we developed
proposed inputs using a crosswalk to CPT code 99492 (Initial
psychiatric collaborative care management, first 70 minutes in the
first calendar month of behavioral health care manager activities, in
consultation with a psychiatric consultant, and directed by the
treating physician or other qualified health care professional, with
the following required elements: Outreach to and engagement in
treatment of a patient directed by the treating physician or other
qualified health care professional; initial assessment of the patient,
including administration of validated rating scales, with the
development of an individualized treatment plan; review by the
psychiatric consultant with modifications of the plan if recommended;
entering patient in a registry and tracking patient follow-up and
progress using the registry, with appropriate documentation, and
participation in weekly caseload consultation with the psychiatric
[[Page 40544]]
consultant; and provision of brief interventions using evidence-based
techniques such as behavioral activation, motivational interviewing,
and other focused treatment strategies.), which is assigned a work RVU
of 1.70, plus CPT code 90832 (Psychotherapy, 30 minutes with patient),
which is assigned a work RVU of 1.50 (assuming two over the course of
the month), and CPT code 90853 (Group psychotherapy (other than of a
multiple-family group)), which is assigned a work RVU of 0.59 (assuming
four over the course of a month), for a work RVU of 7.06. The required
minimum number of minutes described in HCPCS code GYYY1 is also based
on a crosswalk to CPT codes 99492. Additionally, for HCPCS code GYYY1,
we are proposing to use a crosswalk to the direct PE inputs associated
with CPT code 99492, CPT code 90832 (times two), and CPT code 90853
(times four). We believe that the work and practice expense described
by these crosswalk codes is analogous to the services described in
HCPCS code GYYY1 because HCPCS code GYYY1 includes similar care
coordination activities as described in CPT code 99492 and bundles in
the psychotherapy services described in CPT codes 90832 and 90853.
We are proposing to value HCPCS code GYYY2 using a crosswalk to CPT
code 99493 (Subsequent psychiatric collaborative care management, first
60 minutes in a subsequent month of behavioral health care manager
activities, in consultation with a psychiatric consultant, and directed
by the treating physician or other qualified health care professional,
with the following required elements: Tracking patient follow-up and
progress using the registry, with appropriate documentation;
participation in weekly caseload consultation with the psychiatric
consultant; ongoing collaboration with and coordination of the
patient's mental health care with the treating physician or other
qualified health care professional and any other treating mental health
providers; additional review of progress and recommendations for
changes in treatment, as indicated, including medications, based on
recommendations provided by the psychiatric consultant; provision of
brief interventions using evidence-based techniques such as behavioral
activation, motivational interviewing, and other focused treatment
strategies; monitoring of patient outcomes using validated rating
scales; and relapse prevention planning with patients as they achieve
remission of symptoms and/or other treatment goals and are prepared for
discharge from active treatment), which is assigned a work RVU of 1.53,
plus CPT code 90832, which is assigned a work RVU of 1.50 (assuming two
over the course of the month), and CPT code 90853, which is assigned a
work RVU of 0.59 (assuming four over the course of a month), for a work
RVU of 6.89. The required minimum number of minutes described in HCPCS
code GYYY2 is also based on a crosswalk to CPT codes 99493. For HCPCS
code GYYY2, we are proposing to use a crosswalk to the direct PE inputs
associated with CPT code 99493, CPT code 90832 (times two), and CPT
code 90853 (times four). We believe that the work and practice expense
described by these crosswalk codes is analogous to the services
described in HCPCS code GYYY2 because HCPCS code GYYY2 includes similar
care coordination activities as described in CPT code 99493 and bundles
in the psychotherapy services described in CPT codes 90832 and 90853.
We are proposing to value HCPCS code GYYY3 using a crosswalk to CPT
code 99494 (Initial or subsequent psychiatric collaborative care
management, each additional 30 minutes in a calendar month of
behavioral health care manager activities, in consultation with a
psychiatric consultant, and directed by the treating physician or other
qualified health care professional (List separately in addition to code
for primary procedure)), which is assigned a work RVU of 0.82. The
required minimum number of minutes described in HCPCS code GYYY2 is
also based on a crosswalk to CPT codes 99493. For HCPCS code GYYY3, we
are proposing to use a crosswalk to the direct PE inputs associated
with CPT code 99494. We believe that the work and practice expense
described by this crosswalk code is analogous to the services described
in HCPCS code GYYY3 because HCPCS code GYYY3 includes similar care
coordination activities as described in CPT code 99494.
For additional details on the proposed direct PE inputs for HCPCS
codes GYYY1-GYYY3, see Table 22.
We understand that many beneficiaries with OUD have comorbidities
and may require medically-necessary psychotherapy services for other
behavioral health conditions. In order to avoid duplicative billing, we
are proposing that, when furnished to treat OUD, CPT codes 90832,
90834, 90837, and 90853 may not be reported by the same practitioner
for the same beneficiary in the same month as HCPCS codes GYYY1, GYYY2,
and GYYY3. We welcome comments on this proposal.
We are proposing that practitioners reporting the OUD bundle must
furnish a separately reportable initiating visit in association with
the onset of OUD treatment, since the bundle requires a level of care
coordination that cannot be effective without appropriate evaluation of
the patient's needs. This is similar to the requirements for chronic
care management (CCM) services (CPT codes 99487, 99489, 99490, and
99491) and BHI services (CPT codes 99484, 99492, 99493, and 99494)
finalized in the CY 2017 PFS final rule (81 FR 80239) The initiating
visit would establish the beneficiary's relationship with the billing
practitioner, ensure the billing practitioner assesses the beneficiary
to determine clinical appropriateness of MAT in cases where MAT is
being furnished, and provide an opportunity to obtain beneficiary
consent to receive care management services (as discussed further
below). We propose that the same services that can serve as the
initiating visit for CCM services and BHI services can serve as the
initiating visit for the proposed services described by HCPCS codes
GYYY1-GYYY3. For new patients or patients not seen by the practitioner
within a year prior to the commencement of CCM services and BHI
services, the billing practitioner must initiate the service during a
``comprehensive'' E/M visit (levels 2 through 5 E/M visits), annual
wellness visit (AWV) or initial preventive physical exam (IPPE). The
face-to-face visit included in transitional care management (TCM)
services (CPT codes 99495 and 99496) also qualifies as a
``comprehensive'' visit for CCM and BHI initiation. We propose that
these visits could similarly serve as the initiating visit for OUD
services.
We are proposing that the counseling, therapy, and care
coordination described in the proposed OUD treatment codes could be
provided by professionals who are qualified to provide the services
under state law and within their scope of practice ``incident to'' the
services of the billing physician or other practitioner. We are also
proposing that the billing clinician would manage the patient's overall
care, as well as supervise any other individuals participating in the
treatment, similar to the structure of the BHI codes describing the
psychiatric collaborative care model finalized in the CY 2017 PFS final
rule (81 FR 80229), in which services are reported by a treating
physician or other qualified health care professional and include the
services of the treating physician or other qualified health care
professional,
[[Page 40545]]
as well as the services of other professionals who furnish services
incident to the services of the treating physician or other qualified
health care professional. Additionally, we are proposing to add these
codes to the list of designated care management services for which we
allow general supervision of the non-face-to-face portion of the
required services. Consistent with policies for other separately
billable care management services under the PFS, because these proposed
OUD treatment bundles include non-face-to-face care management
components, we are proposing that the billing practitioner or clinical
staff must document in the beneficiary's medical record that they
obtained the beneficiary's consent to receive the services, and that,
as part of the consent, they informed the beneficiary that there is
cost sharing associated with these services, including potential
deductible and coinsurance amounts, for both in-person and non-face-to-
face services that are provided.
We are also proposing to allow any of the individual therapy, group
therapy and counseling services included in HCPCS codes GYYY1, GYYY2,
and GYYY3 to be furnished via telehealth, as clinically appropriate, in
order to increase access to care for beneficiaries. As discussed in
section II.F. of this proposed rule regarding Telehealth Services, like
certain other non-face-to-face PFS services, the components of HCPCS
codes GYYY1 through GYYY3 describing care coordination are commonly
furnished remotely using telecommunications technology, and do not
require the patient to be present in-person with the practitioner when
they are furnished. As such, these services are not considered
telehealth services for purposes of Medicare, and we do not need to
consider whether the non-face-to-face aspects of HCPCS codes GYYY1
through GYYY3 are similar to other telehealth services. If the non-
face-to-face components of HCPCS codes GYYY1 through GYYY3 were
separately billable, they would not need to be on the Medicare
telehealth list to be covered and paid in the same way as services
delivered without the use of telecommunications technology.
Section 2001(a) of the SUPPORT Act amended section 1834(m) of the
Act, adding a new paragraph (7) that removes the geographic limitations
for telehealth services furnished on or after July 1, 2019, to an
individual with a substance use disorder (SUD) diagnosis for purposes
of treatment of such disorder or co-occurring mental health disorder.
The new paragraph at section 1834(m)(7) of the Act also allows
telehealth services for treatment of a diagnosed SUD or co-occurring
mental health disorder to be furnished to individuals at any telehealth
originating site (other than a renal dialysis facility), including in a
patient's home. As discussed in section II.F. of this proposed rule,
Telehealth Services, we are proposing to add HCPCS codes GYYY1, GYYY2,
and GYYY3 to the list of Medicare Telehealth services. Because certain
required services (such as individual psychotherapy or group
psychotherapy services) that are included in the proposed OUD bundled
payment codes would be furnished to treat a diagnosed SUD, and would
ordinarily require a face-to-face encounter, they could be furnished
more broadly as telehealth services as permitted under section
1834(m)(7) of the Act.
For these proposed services described above (HCPCS codes GYYY1,
GYYY2, and GYYY3), we seek comment on how these potential codes,
descriptors, and payment rates align with state Medicaid coding and
payment rates for the purposes of state payment of cost sharing for
Medicare-Medicaid dually eligible individuals. Additionally, we
understand that treatment for OUD can vary, and that MAT alone has
demonstrated efficacy. In cases where a medication such as
buprenorphine or naltrexone is used to treat OUD alone, without therapy
or counseling, we note that existing applicable codes can be used to
furnishing and bill for that care (for example, using E/M visits, in
lieu of billing the bundled OUD codes proposed here).
As discussed in section II.G. of this proposed rule, Medicare
Coverage for Certain Services Furnished by Opioid Treatment Programs,
we are proposing to set the copayment at zero for OUD services
furnished by an OTP, given the flexibility in section 1834(w)(1) of the
Act for us to set the copayment amount for OTP services either at zero
or at an amount above zero. We note that we do not have the statutory
authority to eliminate the deductible and coinsurance requirements for
the bundled OUD treatment services under the PFS. We acknowledge the
potential impact of coinsurance on patient health care decisions and
intend to monitor its impact if these proposals were to be finalized.
Finally, we recognize that historically, the CPT Editorial Panel
has frequently created CPT codes describing services that we originally
established using G-codes and adopted them through the CPT Editorial
Panel process. We note that we would consider new using any available
CPT coding to describe services similar to those described here in
future rulemaking, as early as CY 2021. We would consider and adopt any
such CPT codes through subsequent rulemaking.
Additionally, we understand that in some cases, OUD can first
become apparent to practitioners in the emergency department setting.
We recognize that there is not specific coding that describes diagnosis
of OUD or the initiation of, or referral for, MAT in the emergency
department setting. We are seeking comment on the use of MAT in the
emergency department setting, including initiation of MAT and the
potential for either referral or follow-up care, as well as the
potential for administration of long-acting MAT agents in this setting,
in order to better understand typical practice patterns to help inform
whether we should consider making separate payment for such services in
future rulemaking. We welcome feedback from stakeholders and the public
on other potential bundles describing services for other substance use
disorders for our consideration in future rulemaking.
2. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers
(FQHCs)
In the CY 2018 PFS final rule (82 FR 53169 through 53180), we
established payment for General Care Management (CCM) services using
HCPCS G0511 which is an RHC and FQHC-specific G code for at least 20
minutes of CCM, complex CCM, or general behavioral health services.
Payment for this code is currently set at the average of the non-
facility, non-geographically adjusted payment rates for CPT codes
99490, 99487, 99491, and 99484. The types of chronic conditions that
are eligible for care management services include mental health or
behavioral health conditions, including substance use disorders.
In the CY 2018 PFS final rule with comment period (82 FR 53169
through 53180), we also established payment for psychiatric
Collaborative Care Services (CoCM) using HCPCS code G0512, which is an
RHC and FQHC specific G-code for at least 70 minutes in the first
calendar month, and at least 60 minutes in subsequent calendar months
of psychiatric CoCM services. Payment for this code is set at the
average of the non-facility, non-geographically adjusted rates for CPT
codes 99492 and 99493. The psychiatric CoCM model of care may be used
to treat patients with any behavioral health condition that is being
treated by the billing practitioner, including substance use disorders.
[[Page 40546]]
RHCs and FQHCs can also bill for individual psychotherapy services
using CPT codes 90791, 90792, 90832, 90834, 90837, 90839, or 90845,
which are billable visits under the RHC all-inclusive rate (AIR) and
FQHC Prospective Payment System (PPS) when furnished by an RHC or FQHC
practitioner. If a qualified mental health service is furnished on the
same day as a qualified primary care service, the RHC or FQHC can bill
for 2 visits.
RHCs and FQHCs are engaged primarily in providing services that are
furnished typically in a physician's office or an outpatient clinic. As
a result of the proposed bundled payment under the PFS for OUD
treatment furnished by physicians, we reviewed the applicability of
RHCs and FQHCs furnishing and billing for similar services.
Specifically, we considered establishing a new RHC and FQHC specific G
code for OUD treatment with the payment rate set at the average of the
non-facility, non-geographically adjusted payment rates for GYYY1 and
GYYY2, beginning on January 1, 2020. The requirements to bill the
services would be similar to the requirements under the PFS for GYYY1
and GYYY2, including that an initiating visit with a primary care
practitioner must occur within one year before OUD services begin, and
that consent be obtained before services are furnished.
However, because RHCs and FQHCs that choose to furnish OUD services
can continue to report these individual codes when treating OUD, and
can also offer their patients comprehensive care coordination services
using HCPCS codes G0511 and G0512, we do not believe that adding a new
and separate code to report a bundle of OUD services is necessary.
Therefore, we are not proposing to add a new G code for a bundle of OUD
service.
I. Physician Supervision for Physician Assistant (PA) Services
1. Background
Section 4072(e) of the Omnibus Budget Reconciliation Act of 1986
(Pub. L. 99-509, October 21, 1986), added section 1861(s)(2)(K)(i) of
the Act to establish a benefit for services furnished by a physician
assistant (PA) under the supervision of a physician. We have
interpreted this physician supervision requirement in the regulation at
Sec. 410.74(a)(2)(iv) to require PA services to be furnished under the
general supervision of a physician. This general supervision
requirement was based upon another longstanding regulation at Sec.
410.32(b)(3)(i) that defines three levels of supervision for diagnostic
tests, which are general, direct and personal supervision. Of these
three supervision levels, general supervision is the most lenient.
Specifically, the general supervision requirement means that PA
services must be furnished under a physician's overall direction and
control, but the physician's presence is not required during the
performance of PA services.
In the CY 2018 PFS proposed rule (82 FR 34172 through 34173), we
published a request for information (RFI) on CMS flexibilities and
efficiencies. In response to this RFI, commenters including PA
stakeholders informed us about recent changes in the practice of
medicine for PAs, particularly regarding physician supervision. These
commenters also reached out separately to CMS with their concerns. They
stated that PAs are now practicing more autonomously, like nurse
practitioners (NPs) and clinical nurse specialists (CNSs), as members
of medical teams that often consist of physicians, nonphysician
practitioners and other allied health professionals. This changed
approach to the delivery of health care services involving PAs has
resulted in changes to scope of practice laws for PAs regarding
physician supervision across some states. According to these
commenters, some states have already relaxed their requirements for PAs
related to physician supervision, some states have made changes and are
now silent about their physician supervision requirements, while other
states have not yet changed their PA scope of practice in terms of
their physician supervision requirements. Overall, these commenters
believe that as states continue to make changes to their physician
supervision requirements for PAs, the Medicare requirement for general
supervision of PA services may become increasingly out of step with
current medical practice, imposing a more stringent standard than state
laws governing physician supervision of PA services. Furthermore, as
currently defined, stakeholders have suggested that the supervision
requirement is often misinterpreted or misunderstood in a manner that
restricts PAs' ability to practice to the full extent of their
education and expertise. The stakeholders have suggested that the
current regulatory definition of physician supervision as it applies to
PAs could inappropriately restrict the practice of PAs in delivering
their professional services to the Medicare population.
We note that we have understood our current policy to require
general physician supervision for PA services to fulfill the statutory
physician supervision requirement; and we believe that general
physician supervision gives PAs flexibility to furnish their
professional services without the need for a physician's physical
presence or availability. Nonetheless, we appreciate the concerns
articulated by stakeholders. To more fully understand the current
landscape for medical practice involving PA services and how the
current regulatory definition may be problematic, we invite public
comments on specific examples of changes in state law and state scope
of practice rules that enable PAs to practice more broadly such that
those rules are in tension with the Medicare requirement for general
physician supervision of PA services that has been in place since the
inception of the PA benefit category under Medicare law.
Given the commenters' understanding of ongoing changes underway to
the state scope of practice laws regarding physician supervision of PA
services, commenters on our CY 2018 RFI have requested that CMS
reconsider its interpretation of the statutory requirement that PA
services must be furnished under the supervision of a physician to
allow PAs to operate similarly to NPs and CNSs, who are required by
section 1861(s)(2)(K)(ii) of the Act to furnish their services ``in
collaboration'' with a physician. In general, we have interpreted
collaboration for this purpose at Sec. Sec. 410.75(c)(3) and
410.76(c)(3) of our regulations to mean a process in which an NP or CNS
(respectively) works with one or more physicians to deliver health care
services within the scope of the practitioner's expertise, with medical
direction and appropriate supervision as provided by state law in which
the services are performed. The commenters stated that allowing PA
services to be furnished using such a collaborative process would offer
PAs the flexibility necessary to deliver services more effectively
under today's health care system in accordance with the scope of
practice in the state(s) where they practice, rather than being limited
by the system that was in place when PA services were first covered
under Medicare Part B over 30 years ago.
2. Proposal
After considering the comments we received on the RFI, as well as
information we received regarding the scope of practice laws in some
states regarding supervision requirements for PAs, we are proposing to
revise the regulation at Sec. 410.74 that establishes physician
supervision requirements for PAs. Specifically, we are proposing to
[[Page 40547]]
revise Sec. 410.74(a)(2) to provide that the statutory physician
supervision requirement for PA services at section 1861(s)(2)(K)(i) of
the Act would be met when a PA furnishes their services in accordance
with state law and state scope of practice rules for PAs in the state
in which the services are furnished, with medical direction and
appropriate supervision as provided by state law in which the services
are performed. In the absence of state law governing physician
supervision of PA services, the physician supervision required by
Medicare for PA services would be evidenced by documentation in the
medical record of the PA's approach to working with physicians in
furnishing their services. Consistent with current rules, such
documentation would need to be available to CMS, upon request. This
proposed change would substantially align the regulation on physician
supervision for PA services at Sec. 410.74(a)(2) with our current
regulations on physician collaboration for NP and CNS services at
Sec. Sec. 410.75(c)(3) and 410.76(c)(3). We continue to engage with
key stakeholders on this issue and receive information on the expanded
role of nonphysician practitioners as members of the medical team. As
we are informed about transitions in state law and state scope of
practice governing physician supervision, as well as changes in the way
that PAs practice, we acknowledge the state's role and autonomy to
establish, uphold, and enforce their state laws and PA scope of
practice requirements to ensure that an appropriate level of physician
oversight occurs when PAs furnish their professional services to
Medicare Part B patients. Our policy proposal on this issue largely
defers to state law and state scope of practice and enables states the
flexibility to develop requirements for PA services that are unique and
appropriate for their respective state, allowing the states to be
accountable for the safety and quality of health care services that PAs
furnish.
J. Review and Verification of Medical Record Documentation
1. Background
In an effort to reduce mandatory and duplicative medical record
evaluation and management (E/M) documentation requirements, we
finalized an amended regulatory provision at 42 CFR part 415, subpart
D, in the CY 2019 PFS final rule (83 FR 59653 through 59654).
Specifically, Sec. 415.172(a) requires as a condition of payment under
the PFS that the teaching physician (as defined in Sec. 415.152) must
be present during certain portions of services that are furnished with
the involvement of residents (individuals who are training in a
graduate medical education program). Section 415.174(a) provides for an
exception to the teaching physician presence requirements in the case
of certain E/M services under certain conditions, but requires that the
teaching physician must direct and review the care provided by no more
than four residents at a time. Sections 415.172(b) and 415.174(a)(6),
respectively require that the teaching physician's presence and
participation in services involving residents must be documented in the
medical record. We amended these regulations to provide that a
physician, resident, or nurse may document in the patient's medical
record that the teaching physician presence and participation
requirements were met. As a result, for E/M visits furnished beginning
January 1, 2019, the extent of the teaching physician's participation
in services involving residents may be demonstrated by notes in the
medical records made by a physician, resident, or nurse.
For the same burden reduction purposes, we issued CR 10412,
Transmittal 3971 https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3971CP.pdf on February 2, 2018, which
revised a paragraph in our manual instructions on ``Teaching Physician
Services'' at Pub. 100-04, Medicare Claims Processing Manual, Chapter
12, Section 100.1.1B., to reduce duplicative documentation requirements
by allowing a teaching physician to review and verify (sign/date) notes
made by a student in a patient's medical record for E/M services,
rather than having to re-document the information, largely duplicating
the student's notes. We issued corrections to CR 10412 through
Transmittal 4068 https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4068CP.pdf and re-issued the CR on May 31,
2018. Pub. 100-04, Medicare Claims Processing Manual, Chapter 12,
Section 100 contains a list of definitions pertinent to teaching
physician services. Following these amendments to our regulations and
manual, certain stakeholders raised concerns about the definitions in
this section, particularly those for teaching physician, student, and
documentation; and when considered in conjunction with the
interpretation of the manual provision at Pub. 100-04, Medicare Claims
Processing Manual, Chapter 12, Section 100.1.1B., which addresses
documentation of E/M services involving students. While there is no
regulatory definition of student, the manual instruction defines a
student as an individual who participates in an accredited educational
program (for example, a medical school) that is not an approved
graduate medical education (GME) program. The manual instructions also
specify that a student is never considered to be an intern or a
resident, and that Medicare does not pay for services furnished by a
student (see Section 100.1.1B. for a discussion concerning E/M service
documentation performed by students).
We are aware that nonphysician practitioners who are authorized
under Medicare Part B to furnish and be paid for all levels of E/M
services are seeking similar relief from burdensome E/M documentation
requirements that would allow them to review and verify medical record
notes made by their students, rather than having to re-document the
information. These nonphysician practitioners include nurse
practitioners (NPs), clinical nurse specialists (CNSs), and certified
nurse-midwives (CNMs), collectively referred to hereafter for purposes
of this discussion as advanced practice registered nurses (APRNs), as
well as physician assistants (PAs). Subsequent to the publication of
the CY 2019 PFS final rule (83 FR 59653 through 59654), through
feedback from listening sessions hosted by CMS' Documentation
Requirements Simplification workgroup, we began to hear concerns from a
variety of stakeholders about the requirements for teaching physician
review and verification of documentation added to the medical record by
other individuals. Physician and nonphysician practitioner stakeholders
expressed concern about the scope of the changes to Sec. Sec.
415.172(b) and 415.174(a)(6) which authorize only a physician,
resident, or nurse to include notes in the medical record to document
E/M services furnished by teaching physicians, because they believed
that students and other members of the medical team should be similarly
permitted to provide E/M medical record documentation. In addition to
students, these stakeholders indicated that ``other members of the
medical team'' could include individuals who the teaching physician,
other physicians, PA and APRN preceptors designate as being appropriate
to document services in the medical record, which the billing
practitioner would then review and verify, and rely upon for billing
purposes.
Subsequent to the publication of the student documentation manual
[[Page 40548]]
instruction change at section 100.1.1B of the Medicare Claims
Processing Manual, representatives of PAs and APRNs requested
clarification about whether PA and APRN preceptors and their students
were subject to the same E/M documentation requirements as teaching
physicians and their medical students. These stakeholders suggested
that the reference to ``student'' in the manual instruction on E/M
documentation provided by students is ambiguous because it does not
specify ``medical student''. These stakeholders also suggested that the
definition of ``student'' in section 100 of this manual instruction is
ambiguous because PA and APRN preceptors also educate students who are
individuals who participate in an accredited educational program that
is not an approved GME program. Accordingly, these stakeholders
expressed concern that the uncertainty throughout the health care
industry, including among our contractors, concerning the student E/M
documentation review and verification policy under these manual
guidelines results in unequal treatment as compared to teaching
physicians. The stakeholders stated that depending on how the manual
instruction is interpreted, PA and APRN preceptors may be required to
re-document E/M services in full when their students include notes in
the medical records, without having the same option that teaching
physicians do to simply review and verify medical student
documentation.
2. Proposal
After considering the concerns expressed by these stakeholders, we
believe it would be appropriate to provide broad flexibility to the
physicians, PAs and APRNs (regardless of whether they are acting in a
teaching capacity) who document and who are paid under the PFS for
their professional services. Therefore, we propose to establish a
general principle to allow the physician, the PA, or the APRN who
furnishes and bills for their professional services to review and
verify, rather than re-document, information included in the medical
record by physicians, residents, nurses, students or other members of
the medical team. This principle would apply across the spectrum of all
Medicare-covered services paid under the PFS. Because this proposal is
intended to apply broadly, we propose to amend regulations for teaching
physicians, physicians, PAs, and APRNs to add this new flexibility for
medical record documentation requirements for professional services
furnished by physicians, PAs and APRNs in all settings. We invite
comments on this proposal.
Specifically, to reflect our simplified and standardized approach
to medical record documentation for all professional services furnished
by physicians, PAs and APRNs paid under the PFS, we are proposing to
amend Sec. Sec. 410.20 (Physicians' services), 410.74 (PA services),
410.75 (NP services), 410.76 (CNS services) and 410.77 (CNM services)
to add a new paragraph entitled, ``Medical record documentation.'' This
paragraph would specify that, when furnishing their professional
services, the clinician may review and verify (sign/date) notes in a
patient's medical record made by other physicians, residents, nurses,
students, or other members of the medical team, including notes
documenting the practitioner's presence and participation in the
services, rather than fully re-documenting the information. We note
that, while the proposed change addresses who may document services in
the medical record, subject to review and verification by the
furnishing and billing clinician, it does not modify the scope of, or
standards for, the documentation that is needed in the medical record
to demonstrate medical necessity of services, or otherwise for purposes
of appropriate medical recordkeeping.
We are also proposing to make conforming amendments to Sec. Sec.
415.172(b) and 415.174(a)(6) to also allow physicians, residents,
nurses, students, or other members of the medical team to enter
information in the medical record that can then be reviewed and
verified by a teaching physician without the need for re-documentation.
We invite comments on these proposed amendments to our regulations.
K. Care Management Services
1. Background
In recent years, we have updated PFS payment policies to improve
payment for care management and care coordination. Working with the CPT
Editorial Panel and other clinicians, we have expanded the suite of
codes describing these services. New CPT codes were created that
distinguish between services that are face-to-face; represent a single
encounter, monthly service or both; are timed services; represent
primary care versus specialty care; address specific conditions; and
represent the work of the billing practitioner, their clinical staff,
or both (see Table 16). Additional information regarding recent new
codes and associated PFS payment rules is available on our website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
Table 16--Summary of Special Care Management Codes
------------------------------------------------------------------------
Service Summary
------------------------------------------------------------------------
Care Plan Oversight (CPO) (also Supervision of home health,
referred to as Home Health hospice, per month.
Supervision, Hospice Supervision)
(HCPCS Codes G0181, G0182).
ESRD Monthly Services (CPT Codes 90951- ESRD management, with and
70). without face-to-face visits,
by age, per month.
Transitional Care Management (TCM) Management of transition from
(adopted in 2013) (CPT Codes 99495, acute care or certain
99496). outpatient stays to a
community setting, with face-
to-face visit, once per
patient within 30 days post-
discharge.
Chronic Care Management (CCM) (adopted Management of all care for
in 2015, 2017, 2019) (CPT Codes 99487, patients with two or more
99489, 99490, 99491). serious chronic conditions,
timed, per month.
Advance Care Planning (ACP) (adopted in Counseling/discussing advance
2016) (CPT Codes 99497, 99498). directives, face-to-face,
timed.
Behavioral Health Integration (BHI) Management of behavioral health
(adopted in 2017) (CPT Codes 99484, conditions(s), timed, per
99492, 99493, 99494). month.
Assessment/Care Planning for Cognitive Assessment and care planning of
Impairment (adopted in 2017) (CPT Code cognitive impairment, face-to-
99483). face visit.
Prolonged Evaluation & Management (E/M) Non-face-to-face E&M work
Without Direct Patient Contact related to a face-to-face
(adopted in 2017) (CPT Codes 99358, visit, timed.
99359).
[[Page 40549]]
Remote Patient Monitoring (adopted in Review and analysis of patient-
2019) (CPT Code 99091). generated health data, timed,
per 30 days.
Interprofessional Consultation (adopted Inter-practitioner
in 2019) (CPT Codes 99446, 99447, consultation.
99448, 99449, 99451, 99452).
------------------------------------------------------------------------
Based on our review of the Medicare claims data we estimate that
approximately 3 million unique beneficiaries (9 percent of the Medicare
fee-for-service (FFS) population) receive these services annually, with
higher use of chronic care management (CCM), transitional care
management (TCM), and advance care planning (ACP) services. We believe
gaps remain in coding and payment, such as for care management of
patients having a single, serious, or complex chronic condition. In
this proposed rule, we continue our ongoing work in this area through
code set refinement related to TCM services and CCM services, in
addition to proposing new coding for principal care management (PCM)
services, and addressing chronic care remote physiologic monitoring
(RPM) services.
2. Transitional Care Management (TCM) Services
Utilization of TCM services has increased each year since CMS
established coding and began paying separately for TCM services.
Specifically, there were almost 300,000 TCM professional claims during
2013, the first year of TCM services, and almost 1.3 million
professional claims during 2018, the most recent year of complete
claims data. However, based upon an analysis of claims data by Bindman
and Cox,\78\ utilization of TCM services is low when compared to the
number of Medicare beneficiaries with eligible discharges.
Additionally, Bindman and Cox noted that the beneficiaries who received
TCM services demonstrated reduced readmission rates, lower mortality,
and decreased health care costs. Based upon these findings, we believe
that increasing utilization of TCM services could positively affect
patient outcomes.
---------------------------------------------------------------------------
\78\ Bindman, AB, Cox DF. Changes in health care costs and
mortality associated with transitional care management services
after a discharge among Medicare beneficiaries [published online
July 30, 2018]. JAMA Intern Med, doi:10.1001/
jamainternmed.2018.2572.
---------------------------------------------------------------------------
In developing a proposal designed to increase utilization of TCM
services, we considered possible factors contributing to low
utilization. Bindman and Cox identified two likely contributing
factors: The administrative burdens associated with billing TCM
services and the payment amount to physicians for services.
We focused initially on the requirements for billing TCM services.
In reviewing the TCM billing requirements, we noted that we had
established in the CY 2013 PFS final rule with comment period a list of
57 HCPCS codes that cannot be billed during the 30-day period covered
by TCM services by the same practitioner reporting TCM (77 FR 68990).
This list mirrored reporting restrictions put in place by the CPT
Editorial Panel for the TCM codes upon their creation. At the time we
established separate payment for the TCM CPT codes, we agreed with the
CPT Editorial Panel that the services described by the 57 codes could
be overlapping and duplicative with TCM in their definition and scope;
although, many of these codes were not separately payable or covered
under the PFS so even if they were reported for PFS payment, they would
not be have been separately paid (see, for example, 77 FR 68985). In
response to those concerns, we adopted billing restrictions to avoid
duplicative billing and payment for covered services. In our recent
analysis of the services associated with the 57 codes, we found that
the majority of codes on the list remain either bundled, noncovered by
Medicare, or invalid for Medicare payment purposes. Table 17 provides
detailed information regarding the subset of these codes that would be
separately payable under the PFS (Status Indicator ``A'') and, as such,
are the focus of this year's CY 2020 proposed policy for TCM. Fourteen
(14) codes on the list represent active codes that are paid separately
under the PFS and that upon reconsideration, we believe may not
substantially overlap with TCM services and should be separately
payable alongside TCM. For example, CPT code 99358 (Prolonged E/M
service before and/or after direct patient care; first hour; non-face-
to-face time spent by a physician or other qualified health care
professional on a given date providing prolonged service) would allow
the physician or other qualified healthcare professional extra time to
review records and manage patient support services after the face-to-
face visit required as part of TCM services. CPT code 99091 (Collection
& interpretation of physiologic data, requiring a minimum of 30 minutes
each 30 days) would permit the physician or other qualified healthcare
professional to collect and analyze physiologic parameters associated
with the patient's chronic disease.
Thus, after review of the services described by these 14 HCPCS
codes, we believe these codes, when medically necessary, may complement
TCM services rather than substantially overlap or duplicate services.
We also believe removing the billing restrictions associated with these
codes may increase utilization of TCM services.
Table 17--14 HCPCS Codes That Currently Cannot Be Billed Concurrently
With TCM by the Same Practitioner and Are Active Codes Payable by
Medicare PFS
------------------------------------------------------------------------
Code family HCPCS code Descriptor
------------------------------------------------------------------------
Prolonged Services without Direct 99358 Prolonged E/M service
Patient Contact. before and/or after
direct patient care;
first hour; non-face-to-
face time spent by a
physician or other
qualified health care
professional on a given
date providing
prolonged service.
99359 Prolonged E/M service
before and/or after
direct patient care;
each additional 30
minutes beyond the
first hour of prolonged
services.
[[Page 40550]]
Home and Outpatient International 93792 Patient/caregiver
Normalized Ratio (INR) 93793 training for initiation
Monitoring Services. of home INR monitoring.
Anticoagulant management
for a patient taking
warfarin; includes
review and
interpretation of a new
home, office, or lab
INR test result,
patient instructions,
dosage adjustment and
scheduling of
additional test(s).
End Stage Renal Disease Services 90960 ESRD related services
(patients who are 20+ years). monthly with 4 or more
face-to-face visits per
month; for patients 20
years and older.
90961 ESRD related services
monthly with 2-3 face-
to-face visits per
month; for patients 20
years and older.
90962 ESRD related services
with 1 face-to-face
visit per month; for
patients 20 years and
older.
90966 ESRD related services
for home dialysis per
full month; for
patients 20 years and
older.
90970 ESRD related services
for dialysis less than
a full month of
service; per day; for
patient 20 years and
older.
Interpretation of Physiological 99091 Collection &
Data. interpretation of
physiologic data,
requiring a minimum of
30 minutes each 30
days.
Complex Chronic Care Management 99487 Complex Chronic Care
Services. 99489 with 60 minutes of
clinical staff time per
calendar month.
Complex Chronic Care;
additional 30 minutes
of clinical staff time
per month.
Care Plan Oversight Services..... G0181 Physician supervision of
a patient receiving
Medicare-covered
services provided by a
participating home
health agency (patient
not present) requiring
complex and
multidisciplinary care
modalities within a
calendar month; 30+
minutes.
G0182 Physician supervision of
a patient receiving
Medicare-covered
hospice services (Pt
not present) requiring
complex and
multidisciplinary care
modalities; within a
calendar month; 30+
minutes.
------------------------------------------------------------------------
Thus, with the goal of increasing medically appropriate use of TCM
services, we are proposing to revise our billing requirements for TCM
by allowing TCM codes to be billed concurrently with any of these
codes. Before we finalize such a rule, however, we seek comment on
whether overlap of services exists, and if so, which services should be
restricted from being billed concurrently with TCM. We also seek
comment on whether any overlap would depend upon whether the same or a
different practitioner reports the services. We note that CPT reporting
rules generally apply at the practitioner level, and we are seeking
input from stakeholders as to whether our policy should differ based on
whether it is the same or a different practitioner reporting the
services. We are seeking comment on whether the newest CPT code in the
chronic care management services family (CPT code 99491 for CCM by a
physician or other qualified health professional, established in 2019)
overlaps with TCM or should be reportable and separately payable in the
same service period.
As part of our analysis of the utilization data for TCM services,
we also examined how current payment rates for TCM might negatively
affect the appropriate utilization of TCM services, an idea proposed by
Bindman and Cox. CPT code 99495 (Transitional Care Management services
with the following required elements: Communication (direct contact,
telephone, electronic) with the patient and/or caregiver within two
business days of discharge; medical decision making of at least
moderate complexity during the service period; face-to-face visit
within 14 calendar days of discharge) and CPT code 99496 (Transitional
Care Management services with the following required elements:
Communication (direct contact, telephone, electronic) with the patient
and/or caregiver within two business days of discharge; medical
decision making of at least high complexity during the service period;
face-to-face visit within 7 calendar days of discharge) were resurveyed
during 2018 as part of a regular RUC review of new technologies or
services. For this RUC resurvey, several years of claims data were
available and clinicians had more experience to inform their views
about the work required to furnish TCM services. Based upon the results
of the 2018 RUC survey of the two TCM codes, the RUC recommended a
slight increase in work RVUs for both codes. We believe the results
from the new survey will better reflect the work involved in furnishing
TCM services as care management services. Thus, also for CY 2020, we
are proposing the RUC-recommended work RVU of 2.36 for CPT code 99495
and the RUC-recommended work RVU of 3.10 for CPT code 99496. We are not
proposing any direct PE refinements to the RUC's recommendations for
this code family.
3. Chronic Care Management (CCM) Services
CCM services are comprehensive care coordination services per
calendar month, furnished by a physician or non-physician practitioner
(NPP) managing overall care and their clinical staff, for patients with
two or more serious chronic conditions. There are currently two subsets
of codes: One for non-complex chronic care management (starting in
2015, with a new code for 2019) and a set of codes for complex chronic
care management (starting in 2017). Table 17 provides a high-level
summary of the CCM service elements.
Early data show that, in general, CCM services are increasing
patient and practitioner satisfaction, saving costs and enabling solo
practitioners to remain in independent practice.\79\ Utilization has
reached approximately 75 percent of the level we initially assumed
under the PFS when we began paying for CCM services separately under
the PFS. While these are positive results, we believe that CCM services
(especially complex CCM services) continue to be underutilized. In
addition, we note that, at the February 2019 CPT Editorial Panel
meeting, certain specialty associations requested refinements to the
existing CCM codes, and consideration of their proposal was postponed.
Also, we have heard from some stakeholders suggesting that the
[[Page 40551]]
time increments for non-complex CCM performed by clinical staff should
be changed to recognize finer increments of time, and that certain
requirements related to care planning are unclear. Based on our
consideration of this ongoing feedback, we believe some of the
refinements requested by specialty associations and other stakeholders
may be necessary to improve payment accuracy, reduce unnecessary burden
and help ensure that beneficiaries who need CCM services have access to
them. Accordingly, we are proposing the following changes to the CCM
code set for CY 2020.
---------------------------------------------------------------------------
\79\ https://innovation.cms.gov/Files/reports/chronic-care-mngmt-finalevalrpt.pdf.
---------------------------------------------------------------------------
a. Non-Complex CCM Services by Clinical Staff (CPT Code 99490, HCPCS
Codes GCCC1 and GCCC2)
Currently, the clinical staff CPT code for non-complex CCM, CPT
code 99490 (Chronic care management services, at least 20 minutes of
clinical staff time directed by a physician or other qualified health
care professional, per calendar month, with the following required
elements: Multiple (two or more) chronic conditions expected to last at
least 12 months, or until the death of the patient; chronic conditions
place the patient at significant risk of death, acute exacerbation/
decompensation, or functional decline; comprehensive care plan
established, implemented, revised, or monitored.) describes 20 or more
minutes of clinical staff time spent performing chronic care management
activities under the direction of a physician/qualified health care
professional. When we initially adopted this code for payment and, in
feedback we have since received, a number of stakeholders suggested
that CMS undervalued the PE RVU because we assumed that the minimum
time for the code (20 minutes of clinical staff time) would be typical
(see, for example, 79 FR 67717 through 67718). In the CY 2017 PFS final
rule with comment period, we continued to consider whether the payment
amount for CPT code 99490 is appropriate, given the amount of time
typically spent furnishing CCM services (81 FR 80243 through 80244). We
adopted the complex CCM codes for payment beginning in CY 2017, in
part, to pay more appropriately for services furnished to beneficiaries
requiring longer service times.
There are two CPT codes for complex CCM:
CPT code 99487 (Complex chronic care management services,
with the following required elements: Multiple (two or more) chronic
conditions expected to last at least 12 months, or until the death of
the patient; chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional decline;
establishment or substantial revision of a comprehensive care plan;
moderate or high complexity medical decision making; 60 minutes of
clinical staff time directed by physician or other qualified health
care professional, per calendar month. (Complex chronic care management
services of less than 60 minutes duration, in a calendar month, are not
reported separately); and
CPT code 99489 (each additional 30 minutes of clinical
staff time directed by a physician or other qualified health care
professional, per calendar month (List separately in addition to code
for primary procedure).
Complex CCM describes care management for patients who require not
only more clinical staff time, but also complex medical decision-
making. Some stakeholders continue to recommend that, in addition to
separate payment for the complex CCM codes, we should create an add-on
code for non-complex CCM, such that non-complex CCM would be defined
and valued in 20-minute increments of time with additional payment for
each additional 20 minutes, or extra payment for 20 to 40 minutes of
clinical staff time spent performing care management activities.
We agree that coding changes that identify additional time
increments would improve payment accuracy for non-complex CCM.
Accordingly, we propose to adopt two new G codes with new increments of
clinical staff time instead of the existing single CPT code (CPT code
99490). The first G code would describe the initial 20 minutes of
clinical staff time, and the second G code would describe each
additional 20 minutes thereafter. We intend these would be temporary G
codes, to be used for PFS payment instead of CPT code 99490 until the
CPT Editorial Panel can consider revisions to the current CPT code set.
We would consider adopting any CPT code(s) once the CPT Editorial Panel
completes its work. We acknowledge that imposing a transitional period
during which G codes would be used under the PFS in lieu of the CPT
codes is potentially disruptive, and are seeking comment on whether the
benefit of proceeding with the proposed G codes outweighs the burden of
transitioning to their use in the intervening year(s) before a decision
by the CPT Editorial Panel.
We are proposing that the base code would be HCPCS code GCCC1
(Chronic care management services, initial 20 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month, with the following required elements:
Multiple (two or more) chronic conditions expected to last at least 12
months, or until the death of the patient; chronic conditions place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline; and comprehensive care plan
established, implemented, revised, or monitored. (Chronic care
management services of less than 20 minutes duration, in a calendar
month, are not reported separately)). We propose a work RVU of 0.61 for
HCPCS code GCCC1, which we crosswalked from CPT code 99490. We believe
these codes have a similar amount of work since they would have the
same intra-service time of 15 minutes.
We propose an add-on HCPCS code GCCC2 (Chronic care management
services, each additional 20 minutes of clinical staff time directed by
a physician or other qualified health care professional, per calendar
month (List separately in addition to code for primary procedure). (Use
GCCC2 in conjunction with GCCC1). (Do not report GCCC1, GCCC2 in the
same calendar month as GCCC3, GCCC4, 99491)). We are proposing a work
RVU of 0.54 for HCPCS code GCCC2 based on a crosswalk to CPT code 11107
(Incisional biopsy of skin (eg, wedge) (including simple closure, when
performed); each separate/additional lesion (List separately in
addition to code for primary procedure)), which has a work RVU of 0.54,
which we believe accurately reflects the work associated with each
additional 20 minutes of CCM services. Both codes have the same
intraservice time of 15 minutes. We note that the nature of the PFS
relative value system is such that all services are appropriately
subject to comparisons to one another. Although codes that describe
clinically similar services are sometimes stronger comparator codes,
codes need not share the same site of service, patient population, or
utilization level to serve as an appropriate crosswalk. In this case,
CPT code 11107 shares a similar work intensity to proposed HCPCS code
GCCC2. Furthermore, although HCPCS codes GCCC1 and GCCC2 share the same
intraservice time, add-on codes often have lower intensity than the
base codes because they describe the continuation of an already
initiated service.
We are soliciting public comment on whether we should limit the
number of times this add-on code (HCPCS code GCCC2) can be reported in
a given service period for a given beneficiary. It
[[Page 40552]]
is not clear how often more than 40 minutes of clinical staff time is
currently spent or is medically necessary. In addition, once 60 minutes
of clinical staff time is spent, many or most patients might also
require complex medical decision-making, and such patients would be
already described under existing coding for complex CCM. A limit (such
as allowing the add-on code to be reported only once per service period
per beneficiary) may be appropriate in order to maintain distinctions
between complex and non-complex CCM, as well as appropriately limit
beneficiary cost sharing and program spending to medically necessary
services. We note that complex CCM already describes (in part) 60 or
more minutes of clinical staff time in a service period. We are seeking
comment on whether and how often beneficiaries who do not require
complex CCM (for example, do not require the complex medical decision
making that is part of complex CCM) would need 60 or more minutes of
non-complex CCM clinical staff time and thereby warrant more than one
use of HCPCS code GCCC2 within a service period.
b. Complex CCM Services (CPT Codes 99487 and 99489, and HCPCS Codes
GCCC3 and GCCC4)
Currently, the CPT codes for complex CCM include in the code
descriptors a requirement for establishment or substantial revision of
the comprehensive care plan (see above). The code descriptors for
complex CCM also include moderate to high complexity medical decision-
making (moderate to high complexity medical decision-making is an
explicit part of the services). We propose to adopt two new G codes
that would be used for billing under the PFS instead of CPT codes 99487
and 99489, and that would not include the service component of
substantial care plan revision. We believe it is not necessary to
explicitly include substantial care plan revision because patients
requiring moderate to high complexity medical decision making
implicitly need and receive substantial care plan revision. The service
component of substantial care plan revision is potentially duplicative
with the medical decision making service component and, therefore, we
believe it is unnecessary as a means of distinguishing eligible
patients. Instead of CPT code 99487, we propose to adopt HCPCS code
GCCC3 (Complex chronic care management services, with the following
required elements: Multiple (two or more) chronic conditions expected
to last at least 12 months, or until the death of the patient; chronic
conditions place the patient at significant risk of death, acute
exacerbation/decompensation, or functional decline; comprehensive care
plan established, implemented, revised, or monitored; moderate or high
complexity medical decision making; 60 minutes of clinical staff time
directed by physician or other qualified health care professional, per
calendar month. (Complex chronic care management services of less than
60 minutes duration, in a calendar month, are not reported
separately)). We are proposing a work RVU of 1.00 for HCPCS code GCCC3,
which is a crosswalk to CPT code 99487.
Instead of CPT code 99489, we propose to adopt HCPCS code GCCC4
(each additional 30 minutes of clinical staff time directed by a
physician or other qualified health care professional, per calendar
month (List separately in addition to code for primary procedure).
(Report GCCC4 in conjunction with GCCC3). (Do not report GCCC4 for care
management services of less than 30 minutes additional to the first 60
minutes of complex chronic care management services during a calendar
month)). We are proposing a work RVU of 0.50 for HCPCS code GCCC4,
which is a crosswalk to CPT code 99489.
We intend these would be temporary G codes to remain in place until
the CPT Editorial Panel can consider revising the current code
descriptors for complex CCM services. We would consider adopting any
new or revised complex CCM CPT code(s) once the CPT Editorial Panel
completes its work. We acknowledge that imposing a transitional period
during which G codes would be used under the PFS in lieu of the CPT
codes is potentially disruptive. We are seeking comment on whether the
benefit of proceeding with the proposed G codes outweighs the burden of
transitioning to their use in the intervening year(s) before a decision
by the CPT Editorial Panel.
c. Typical Care Plan
In 2013, in working with the physician community to develop and
propose the CCM codes for PFS payment, the medical community
recommended and CMS agreed that adequate care planning is integral to
managing patients with multiple chronic conditions. We stated our
belief that furnishing care management to beneficiaries with multiple
chronic conditions requires complex and multidisciplinary care
modalities that involve, among other things, regular physician
development and/or revision of care plans and integration of new
information into the care plan (78 FR 43337). In the CY 2014 PFS final
rule with comment period (78 FR 74416 through 74418), consistent with
recommendations CMS received in 2013 from the AMA's Complex Chronic
Care Coordination Workgroup, we finalized a CCM scope of service
element for a patient-centered plan of care with the following
characteristics: It is a comprehensive plan of care for all health
problems and typically includes, but is not limited to, the following
elements: Problem list; expected outcome and prognosis; measurable
treatment goals; cognitive and functional assessment; symptom
management; planned interventions; medical management; environmental
evaluation; caregiver assessment; community/social services ordered;
how the services of agencies and specialists unconnected to the
practice will be directed/coordinated; identify the individuals
responsible for each intervention, requirements for periodic review;
and when applicable, revisions of the care plan.
The CPT Editorial Panel also incorporated and adopted this language
in the prefatory language for Care Management Services codes (page 49
of the 2019 CPT Codebook) including CCM services.
As we continue to consider the need for potential refinements to
the CCM code set, we have heard that there is still some confusion in
the medical community regarding what a care plan typically includes. We
have re-reviewed this language for CCM, and we believe there may be
aspects of the typical care plan language we adopted for CCM that are
redundant or potentially unduly burdensome. We note that because these
are ``typical'' care plan elements, these elements do not comprise a
set of strict requirements that must be included in a care plan for
purposes of billing for CCM services; the elements are intended to
reflect those that are typically, but perhaps not always, included in a
care plan as medically appropriate for a particular beneficiary.
Nevertheless, we are proposing to eliminate the phrase ``community/
social services ordered, how the services of agencies and specialists
unconnected to the practice will be directed/coordinated, identify the
individuals responsible for each intervention'' and insert the phrase
``interaction and coordination with outside resources and practitioners
and providers.'' We believe simpler language would describe the
important work of interacting and coordinating with resources external
to the practice. While it is preferable, when feasible, to identify who
is responsible for
[[Page 40553]]
interventions, it may be difficult to maintain an up-to-date listing of
responsible individuals especially when they are outside of the
practice, for example, when there is staff turnover or assignment
changes.
Our proposed new language would read: The comprehensive care plan
for all health issues typically includes, but is not limited to, the
following elements:
Problem list.
Expected outcome and prognosis.
Measurable treatment goals.
Cognitive and functional assessment.
Symptom management.
Planned interventions.
Medical management.
Environmental evaluation.
Caregiver assessment.
Interaction and coordination with outside resources and
practitioners and providers.
Requirements for periodic review.
When applicable, revision of the care plan.
We welcome feedback on our proposal, including language that would
best guide practitioners as they decide what to include in their
comprehensive care plan for CCM recipients.
Additional information regarding the existing requirements for
billing CCM, including links to prior rules, is available on our
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
4. Principal Care Management (PCM) Services
A gap we identified in coding and payment for care management
services is care management for patients with only one chronic
condition. The current CCM codes require patients to have two or more
chronic conditions. These codes are primarily billed by practitioners
who are managing a patient's total care over a month, including primary
care practitioners and some specialists such as cardiologists or
nephrologists. We have heard from a number of stakeholders, especially
those in specialties that use the office/outpatient E/M code set to
report the majority of their services, that there can be significant
resources involved in care management for a single high risk disease or
complex chronic condition that is not well accounted for in existing
coding (FR 78 74415). This issue has also been raised by the
stakeholder community in proposal submissions to the Physician-Focused
Payment Model Technical Advisory Committee (PTAC), which are available
at https://aspe.hhs.gov/ptac-physician-focused-payment-model-technical-advisory-committee. Therefore, we are proposing separate coding and
payment for Principal Care Management (PCM) services, which describe
care management services for one serious chronic condition. A
qualifying condition would typically be expected to last between three
months and a year, or until the death of the patient, may have led to a
recent hospitalization, and/or place the patient at significant risk of
death, acute exacerbation/decompensation, or functional decline.
While we are not proposing any restrictions on the specialties that
could bill for PCM, we expect that most of these services would be
billed by specialists who are focused on managing patients with a
single complex chronic condition requiring substantial care management.
We expect that, in most instances, initiation of PCM would be triggered
by an exacerbation of the patient's complex chronic condition or recent
hospitalization such that disease-specific care management is
warranted. We anticipate that in the majority of instances, PCM
services would be billed when a single condition is of such complexity
that it could not be managed as effectively in the primary care
setting, and instead requires management by another, more specialized,
practitioner. For example, a typical patient may present to their
primary care practitioner with an exacerbation of an existing chronic
condition. While the primary care practitioner may be able to provide
care management services for this one complex chronic condition, it is
also possible that the primary care practitioner and/or the patient
could instead decide that another clinician should provide relevant
care management services. In this case, the primary care practitioner
would still oversee the overall care for the patient while the
practitioner billing for PCM services would provide care management
services for the specific complex chronic condition. The treating
clinician may need to provide a disease-specific care plan or may need
to make frequent adjustments to the patient's medication regimen. The
expected outcome of PCM is for the patient's condition to be stabilized
by the treating clinician so that overall care management for the
patient's condition can be returned to the patient's primary care
practitioner. If the beneficiary only has one complex chronic condition
that is overseen by the primary care practitioner, then the primary
care practitioner would also be able to bill for PCM services. We are
proposing that PCM services include coordination of medical and/or
psychosocial care related to the single complex chronic condition,
provided by a physician or clinical staff under the direction of a
physician or other qualified health care professional.
We anticipate that many patients will have more than one complex
chronic condition. If a clinician is providing PCM services for one
complex chronic condition, management of the patient's other conditions
would continue to be managed by the primary care practitioner while the
patient is receiving PCM services for a single complex condition. It is
also possible that the patient could receive PCM services from more
than one clinician if the patient experiences an exacerbation of more
than one complex chronic condition simultaneously.
For CY 2020, we are proposing to make separate payment for PCM
services via two new G codes: HCPCS code GPPP1 (Comprehensive care
management services for a single high-risk disease, e.g., Principal
Care Management, at least 30 minutes of physician or other qualified
health care professional time per calendar month with the following
elements: One complex chronic condition lasting at least 3 months,
which is the focus of the care plan, the condition is of sufficient
severity to place patient at risk of hospitalization or have been the
cause of a recent hospitalization, the condition requires development
or revision of disease-specific care plan, the condition requires
frequent adjustments in the medication regimen, and/or the management
of the condition is unusually complex due to comorbidities) and HCPCS
code GPPP2 (Comprehensive care management for a single high-risk
disease services, e.g., Principal Care Management, at least 30 minutes
of clinical staff time directed by a physician or other qualified
health care professional, per calendar month with the following
elements: One complex chronic condition lasting at least 3 months,
which is the focus of the care plan, the condition is of sufficient
severity to place patient at risk of hospitalization or have been cause
of a recent hospitalization, the condition requires development or
revision of disease-specific care plan, the condition requires frequent
adjustments in the medication regimen, and/or the management of the
condition is unusually complex due to comorbidities). HCPCS code GPPP1
would be reported when, during the calendar month, at least 30 minutes
of physician or other qualified health care provider time is spent on
comprehensive care management for a
[[Page 40554]]
single high risk disease or complex chronic condition. HCPCS code GPPP2
would be reported when, during the calendar month, at least 30 minutes
of clinical staff time is spent on comprehensive management for a
single high risk disease or complex chronic condition.
For HCPCS code GPPP1, we are proposing a crosswalk to the work
value associated with CPT code 99217 (Observation care discharge day
management (This code is to be utilized to report all services provided
to a patient on discharge from outpatient hospital ``observation
status'' if the discharge is on other than the initial date of
``observation status.'' To report services to a patient designated as
``observation status'' or ``inpatient status'' and discharged on the
same date, use the codes for Observation or Inpatient Care Services
[including Admission and Discharge Services, 99234-99236 as
appropriate])) as we believe these values most accurately reflect the
resource costs associated when the billing practitioner performs PCM
services. CPT code 99217 has the same intraservice time as HCPCS code
GPPP1 and the physician work is of similar intensity. Therefore, we are
proposing a work RVU of 1.28 for HCPCS code GPPP1.
For HCPCS code GPPP2 we are proposing a crosswalk to the work and
PE inputs associated with CPT code 99490 (clinical staff non-complex
CCM) as we believe these values reflect the resource costs associated
with the clinician's direction of clinical staff who are performing the
PCM services, and the intraservice times and intensity of the work for
the two codes would be the same. Therefore, we are proposing a work RVU
of 0.61 for HCPCS code GPPP2.
While we are proposing separate coding and payment for PCM services
performed by clinical staff with the oversight of the billing
professional and services furnished directly by the billing
professional, we are seeking comment on whether both codes are
necessary to appropriately describe and bill for PCM services. We note
that we are basing this coding structure on the codes for CCM services
with CPT code 99491 reflecting care management by the billing
professional and CPT code 99490 reflecting care management by clinical
staff directed by a physician or other qualified health care
professional.
We acknowledge that we are concurrently proposing revisions for
both complex and non-complex CCM services. Were we not to finalize the
proposed changes for both complex and non-complex CCM services, we
believe that the overall structure and description of the CCM services
remain close enough to serve as a model for the coding structure and
description of services for the proposed PCM services. We are seeking
public comment on whether it would be appropriate to create an add-on
code for additional time spent each month (similar to HCPCS code GCCC2
discussed above) when PCM services are furnished by clinical staff
under the direction of the billing practitioner.
While we believe that PCM services describe a situation where a
patient's condition is severe enough to require care management for a
single complex chronic condition beyond what is described by CCM or
performed in the primary care setting, we are concerned that a possible
unintended consequence of making separate payment for care management
for a single chronic condition is that a patient with multiple chronic
conditions could have their care managed by multiple practitioners,
each only billing for PCM, which could potentially result in fragmented
patient care, overlaps in services, and duplicative services. While we
are not proposing additional requirements for the proposed PCM
services, we did consider alternatives such as requiring that the
practitioner billing PCM must document ongoing communication with the
patient's primary care practitioner to demonstrate that there is
continuity of care between the specialist and primary care settings, or
requiring that the patient have had a face-to-face visit with the
practitioner billing PCM within the prior 30 days to demonstrate that
they have an ongoing relationship. We are seeking comment on whether
requirements such as these are necessary or appropriate, and whether
there should be additional requirements to prevent potential care
fragmentation or service duplication.
Due to the similarity between the description of the PCM and CCM
services, both of which involve non-face-to-face care management
services, we are proposing that the full CCM scope of service
requirements apply to PCM, including documenting the patient's verbal
consent in the medical record. We are seeking comment on whether there
are required elements of CCM services that the public and stakeholders
believe should not be applicable to PCM, and should be removed or
altered. A high level summary of these requirements is available in
Table 18 and available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ChronicCareManagement.pdf. Both the initiating visit and the patient's
verbal consent are necessary as not all patients who meet the criteria
to receive separately billable PCM services may want to receive these
services. The beneficiary should be educated as to what PCM services
are and any cost sharing that may apply. Additionally, as practitioners
have informed us that beneficiary cost sharing is a significant barrier
to provision of other care management services, we are seeking comment
on how best to educate practitioners and beneficiaries on the benefits
of PCM services.
Additionally, we are proposing to add GPPP2 to the list of
designated care management services for which we allow general
supervision as described in our regulation at Sec. 410.26(b)(5). Due
to the potential for duplicative payment, we are proposing that PCM
could not be billed by the same practitioner for the same patient
concurrent with certain other care management services, such as CCM,
behavioral health integration services, and monthly capitated ESRD
payments. We are also proposing that PCM would not be billable by the
same practitioner for the same patient during a surgical global period,
as we believe those resource costs would already be included in the
valuation of the global surgical code.
Table 18--Chronic Care Management Services Summary
------------------------------------------------------------------------
CCM Service Summary *
-------------------------------------------------------------------------
Verbal Consent:
Inform regarding availability of the service; that only one
practitioner can bill per month; the right to stop services
effective at the end of any service period; and that cost sharing
applies (if no supplemental insurance).
Document that consent was obtained.
Initiating Visit for New Patients (separately paid).
Certified Electronic Health Record (EHR) Use:
Structured Recording of Core Patient Information Using
Certified EHR (demographics, problem list, medications, allergies).
[[Page 40555]]
24/7 Access (``On Call'' Service).
Designated Care Team Member.
Comprehensive Care Management:
Systematic needs assessment (medical and psychosocial).
Ensure receipt of preventive services.
Medication reconciliation, management and oversight of self-
management.
Comprehensive Electronic Care Plan:
Plan is available timely within and outside the practice
(can include fax).
Copy of care plan to patient/caregiver (format not
prescribed).
Establish, implement, revise or monitor the plan.
Management of Care Transitions/Referrals (e.g., discharges, ED visit
follow up, referrals):
Create/exchange continuity of care document(s) timely
(format not prescribed).
Home- and Community-Based Care Coordination:
Coordinate with any home- and community-based clinical
service providers, and document communication with them regarding
psychosocial needs and functional deficits.
Enhanced Communication Opportunities:
Offer asynchronous non-face-to-face methods other than
telephone, such as secure email.
------------------------------------------------------------------------
* All elements that are medically reasonable and necessary must be
furnished during the month, but all elements do not necessarily apply
every month. Consent need only be obtained once, and initiating visits
are only for new patients or patients not seen within a year prior to
initiation of CCM.
We are also seeking comment on any potential for duplicative
payment between the proposed PCM services and other services, such as
interprofessional consultation services (CPT codes 99446-99449
(Interprofessional telephone/internet/electronic health record
assessment and management service provided by a consultative physician,
including a verbal and written report to the patient's treating/
requesting physician or other qualified health care professional), CPT
code 99451 (Interprofessional telephone/internet/electronic health
record assessment and management service provided by a consultative
physician, including a written report to the patient's treating/
requesting physician or other qualified health care professional, 5
minutes or more of medical consultative time), and CPT code 99452
(Interprofessional telephone/internet/electronic health record referral
service(s) provided by a treating/requesting physician or other
qualified health care professional, 30 minutes)) or remote patient
monitoring (CPT code 99091 (Collection and interpretation of
physiologic data (e.g., ECG, blood pressure, glucose monitoring)
digitally stored and/or transmitted by the patient and/or caregiver to
the physician or other qualified health care professional, qualified by
education, training, licensure/regulation (when applicable) requiring a
minimum of 30 minutes of time, each 30 days), CPT code 99453 (Remote
monitoring of physiologic parameter(s) (e.g., weight, blood pressure,
pulse oximetry, respiratory flow rate), initial; set-up and patient
education on use of equipment), and CPT code 99457 (Remote physiologic
monitoring treatment management services, 20 minutes or more of
clinical staff/physician/other qualified health care professional time
in a calendar month requiring interactive communication with the
patient/caregiver during the month)).
5. Chronic Care Remote Physiologic Monitoring Services
Chronic Care remote physiologic monitoring (RPM) services involve
the collection, analysis, and interpretation of digitally collected
physiologic data, followed by the development of a treatment plan, and
the managing of a patient under the treatment plan. The current CPT
code 99457 is a treatment management code, billable after 20 minutes or
more of clinical staff/physician/other qualified professional time with
a patient in a calendar month.
In September 2018, the CPT Editorial Panel revised the CPT code
structure for CPT code 99457 effective beginning in CY 2020. The new
code structure retains CPT code 99457 as a base code that describes the
first 20 minutes of the treatment management services, and uses a new
add-on code to describe subsequent 20 minute intervals of the service.
The new code descriptors for CY 2020 are: CPT code 99457 (Remote
physiologic monitoring treatment management services, clinical staff/
physician/other qualified health care professional time in a calendar
month requiring interactive communication with the patient/caregiver
during the month; initial 20 minutes) and CPT code 994X0 (Remote
physiologic monitoring treatment management services, clinical staff/
physician/other qualified health care professional time in a calendar
month requiring interactive communication with the patient/caregiver
during the month; additional 20 minutes).
In considering the work RVUs for the new add-on CPT code 994X0, we
first considered the value of its base code. We previously valued the
base code at 0.61 work RVUs. Given the value of the base code, we do
not agree with the RUC-recommended work RVU of 0.61 for the add-on
code. Instead, we are proposing a work RVU of 0.50 for the add-on code.
This value is supported by CPT code 88381 (Microdissection (i.e.,
sample preparation of microscopically identified target); manual),
which has the same intraservice and total times of 20 minutes with an
XXX global period and work RVU of 0.53, as well as the survey value at
the 25th percentile. We are proposing the RUC-recommended direct PE
inputs for CPT code 994X0.
Finally, we are proposing that RPM services reported with CPT codes
99457 and 994X0 may be furnished under general supervision rather than
the currently required direct supervision. Because care management
services include establishing, implementing, revising, or monitoring
treatment plans, as well as providing support services, and because RPM
services (that is, CPT codes 99457 and 994X0) include establishing,
implementing, revising, and monitoring a specific treatment plan for a
patient related to one or more chronic conditions that are monitored
remotely, we believe that CPT codes 99457 and 994X0 should be included
as designated care management services. Designated care management
services can be furnished under general
[[Page 40556]]
supervision. Section 410.26(b)(5) of our regulations states that
designated care management services can be furnished under the general
supervision of the ``physician or other qualified health care
professional (who is qualified by education, training, licensure/
regulation and facility privileging)'' (see also 2019 CPT Codebook,
page xii) when these services or supplies are provided incident to the
services of a physician or other qualified healthcare professional. The
physician or other qualified healthcare professional supervising the
auxiliary personnel need not be the same individual treating the
patient more broadly. However, only the supervising physician or other
qualified healthcare professional may bill Medicare for incident to
services.
6. Comment Solicitation on Consent for Communication Technology-Based
Services
In the CY 2019 PFS Final Rule, CMS finalized separate payment for a
number of services that could be furnished via telecommunications
technology. Specifically, CMS finalized HCPCS code G2010 (Remote
evaluation of recorded video and/or images submitted by an established
patient (e.g., store and forward), including interpretation with
follow-up with the patient within 24 business hours, not originating
from a related E/M service provided within the previous 7 days nor
leading to an E/M service or procedure within the next 24 hours or
soonest available appointment)), HCPCS code G2012 (Brief communication
technology-based service, e.g. virtual check-in, by a physician or
other qualified health care professional who can report evaluation and
management services, provided to an established patient, not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion)), CPT codes 99446-99449 (Interprofessional telephone/
internet/electronic health record assessment and management service
provided by a consultative physician, including a verbal and written
report to the patient's treating/requesting physician or other
qualified health care professional), CPT code 99451 (Interprofessional
telephone/internet/electronic health record assessment and management
service provided by a consultative physician, including a written
report to the patient's treating/requesting physician or other
qualified health care professional, 5 minutes or more of medical
consultative time), and CPT code 99452 (Interprofessional telephone/
internet/electronic health record referral service(s) provided by a
treating/requesting physician or other qualified health care
professional, 30 minutes).
As discussed in that rule, (83 FR 59490-59491), while a few
commenters suggested that it would be less burdensome to obtain a
general consent for multiple services at once, we stipulated that
verbal consent must be documented in the medical record for each
service furnished so that the beneficiary is aware of any applicable
cost sharing. This is similar to the requirements for other non-face-
to-face care management services under the PFS.
We have continued to hear from stakeholders that requiring advance
beneficiary consent for each of these services is burdensome. For HCPCS
codes G2010 and G2012, stakeholders have stated that it is difficult
and burdensome to obtain consent at the outset of each of what are
meant to be brief check-in services. For CPT codes 99446-99449, 99451
and 99452, practitioners have informed us that it is particularly
difficult for the consulting practitioner to obtain consent from a
patient they have never seen. Given our longstanding goals to reduce
burden and promote the use of communication technology-based services,
we are seeking comment on whether a single advance beneficiary consent
could be obtained for a number of communication technology-based
services. During the consent process, the practitioner would make sure
the beneficiary is aware that utilization of these services will result
in a cost sharing obligation. We are seeking comment on the appropriate
interval of time or number of services for which consent could be
obtained, for example, for all these services furnished within a 6
month or one year period, or for a set number of services, after which
a new consent would need to be obtained. We are also seeking comment on
the potential program integrity concerns associated with allowing
advance consent and how best to minimize those concerns.
7. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers
(FQHCs)
RHCs and FQHCs are paid for general care management services using
HCPCS code G0511, which is an RHC and FQHC-specific G-code for 20
minutes or more of CCM services, complex CCM services, or general
behavioral health services. Payment for this service is set at the
average of the national, non-facility payment rates for CPT codes
99490, 99487, and 99484. We are proposing to use the non-facility
payment rates for HCPCS codes GCCC1 and GCCC3 instead of the non-
facility payment rates for CPT codes 99490 and 99487, respectively, if
these changes are finalized for practitioners billing under the PFS. We
note that we are not proposing any changes in the valuation of these
codes. Upon finalization, the payment for HCPCS code G0511 would be set
at the average of the national, non-facility payment rates for HCPCS
codes GCCC1 and GCCC3 and CPT code 99484.
L. Coinsurance for Colorectal Cancer Screening Tests
Section 1861(pp) of the Act defines ``colorectal cancer screening
tests'' and, under sections 1861(pp)(1)(B) and (C) of the Act,
``screening flexible sigmoidoscopy'' and ``screening colonoscopy'' are
two of the recognized procedures. Among other things, section
1861(pp)(1)(D) of the Act authorizes the Secretary to include other
tests or procedures in the definition, and modifications to the tests
and procedures described under this subsection, ``with such frequency
and payment limits, as the Secretary determines appropriate, in
consultation with appropriate organizations.'' Section 1861(s)(2)(R) of
the Act includes these colorectal cancer screening tests in the
definition of the medical and other health services that fall within
the scope of Medicare Part B benefits described in section 1832(a)(1)
of the Act. Section 1861(ddd)(3) of the Act includes these colorectal
cancer screening services within the definition of ``preventive
services.'' In addition, section 1833(a)(1)(Y) of the Act provides for
payment for preventive services recommended by the United States
Preventive Services Task Force (USPSTF) with a grade of A or B under
the PFS at 100 percent of the lesser of the actual charge or the fee
schedule amount for these colorectal cancer screening tests, and under
the OPPS at 100 percent of the OPPS payment amount. As such, there is
no beneficiary responsibility for coinsurance for recommended
colorectal cancer screening tests as defined in section 1861(pp)(1) of
the Act.
Under these statutory provisions, we have issued regulations
governing payment for colorectal cancer screening tests at 42 CFR
410.152(l)(5). We pay 100 percent of the Medicare payment amount
established under the applicable payment methodology for the setting
for providers and suppliers, and beneficiaries are not required to pay
Part B coinsurance.
[[Page 40557]]
In addition to screening tests, which typically are furnished to
patients in the absence of signs or symptoms of illness or injury,
Medicare also covers various diagnostic tests (Sec. 410.32). In
general, diagnostic tests must be ordered by the physician or
practitioner who is treating the beneficiary, and who uses the results
of the diagnostic test in the management of the patient's specific
medical problem. Under Part B, Medicare may cover flexible
sigmoidoscopies and colonoscopies as diagnostic tests when those tests
are reasonable and necessary as specified in section 1862(a)(1)(A) of
the Act. When these services are furnished as diagnostic tests rather
than as screening tests, patients are responsible for the Part B
coinsurance (normally 20 percent) associated with these services.
We define ``colorectal cancer screening tests'' in our regulation
at Sec. 410.37(a)(1) to include ``flexible screening sigmoidoscopies''
and ``screening colonoscopies, including anesthesia furnished in
conjunction with the service.'' Under our current policies, we exclude
from the definition of colorectal screening services colonoscopies and
sigmoidoscopies that begin as a screening service, but where a polyp or
other growth is found and removed as part of the procedure. The
exclusion of these services from the definition of colorectal cancer
screening services is based upon separate provisions of the statute
dealing with the detection of lesions or growths during procedures (62
FR 59048, 59082, October 31, 1997). Section 1834(d)(2)(D) of the Act
provides that if, during the course of a screening flexible
sigmoidoscopy, a lesion or growth is detected which results in a biopsy
or removal of the lesion or growth, payment under Medicare Part B shall
not be made for the screening flexible sigmoidoscopy but shall be made
for the procedure classified as a flexible sigmoidoscopy with such
biopsy or removal. Similarly, section 1834(d)(3)(D) of the Act that
provides if, during the course of a screening colonoscopy, a lesion or
growth is detected which results in a biopsy or removal of the lesion
or growth, payment under Medicare Part B shall not be made for the
screening colonoscopy but shall be made for the procedure classified as
a colonoscopy with such biopsy or removal.
Because we interpret sections 1834(d)(2)(C)(ii) and
1834(d)(3)(C)(ii) of the Act to require us to pay for these tests as
diagnostic tests, rather than as screening tests, the 100 percent
payment rate for recommended preventive services under section
1833(a)(1)(Y) of the Act, as codified in our regulation at Sec.
410.152(l)(5), would not apply to those diagnostic procedures. As such,
beneficiaries are responsible for the usual coinsurance that applies to
the services (20 or 25 percent of the cost of the services depending on
the setting).
Under section 1833(b) of the Act, before making payment under
Medicare Part B for expenses incurred by a beneficiary for covered Part
B services, beneficiaries must first meet the applicable deductible for
the year. Section 4104 of the Affordable Care Act (that is, the Patient
Protection and Affordable Care Act (Pub. L. 111-148, enacted March 23,
2010), and the Health Care and Education Reconciliation Act of 2010
(Pub. L. 111-152, enacted March 30, 2010), collectively referred to as
the ``Affordable Care Act'') amended section 1833(b)(1) of the Act to
make the deductible inapplicable to expenses incurred for certain
preventive services that are recommended with a grade of A or B by the
USPSTF, including colorectal cancer screening tests as defined in
section 1861(pp) of the Act. Section 4104 of the Affordable Care Act
also added a sentence at the end of section 1833(b)(1) of the Act
specifying that the exception to the deductible shall apply with
respect to a colorectal cancer screening test regardless of the code
that is billed for the establishment of a diagnosis as a result of the
test, or for the removal of tissue or other matter or other procedure
that is furnished in connection with, as a result of, and in the same
clinical encounter as the screening test. Although the Affordable Care
Act addressed the applicability of the deductible in the case of a
colorectal cancer screening test that involves biopsy or tissue
removal, it did not alter the coinsurance provision in section 1833(a)
of the Act for such procedures. Although public commenters encouraged
the agency to also eliminate the coinsurance in these circumstances,
the agency found that the statute did not provide for elimination of
the coinsurance (75 FR 73170, 73431, November 29, 2010).
Beneficiaries have continued to contact us noting their
``surprise'' that a coinsurance (20 or 25 percent depending on the
setting) applies when they expected to receive a colorectal screening
procedure to which coinsurance does not apply, but instead received
what Medicare considers to be a diagnostic procedure because polyps
were discovered and removed. Similarly, physicians have also expressed
concerns about the reactions of beneficiaries when they are informed
that they will be responsible for coinsurance if polyps are discovered
and removed during what they expected to be a screening procedure to
which coinsurance does not apply. Other stakeholders and some members
of Congress have regularly expressed to us that they consider the
agency's policy on coinsurance for colorectal screening procedures
during which tissue is removed to be a misinterpretation of the law.
Over the years, we have released a wide variety of publicly
available educational materials that explain the Medicare preventive
services benefits as part of our overall outreach activities to
Medicare beneficiaries. These materials contain a complete description
of the Medicare preventive services benefits, including information on
colorectal cancer screening, and also provide relevant details on the
applicability of cost sharing. These materials can be found at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/MLN-Publications-Items/CMS1243319.html. We believe that the
information in these materials can be instrumental in continuing to
educate physicians and beneficiaries about cost sharing obligations in
order to mitigate instances of ``surprise'' billing. We invite comment
on whether we should consider establishing a requirement that the
physician who plans to furnish a colorectal cancer screening notify the
patient in advance that a screening procedure could result in a
diagnostic procedure if polyps are discovered and removed, and that
coinsurance may apply. We specifically invite comment on whether we
should require the physician, or their staff, to provide a verbal
notice with a notation in the medical record, or whether we should
consider a different approach to informing patients of the copay
implications, such as a written notice with standard language that we
would require the physician, or their staff, to provide to patients
prior to a colorectal cancer screening. We note that we would consider
adopting such a requirement in the final rule in accordance with public
comments. We also invite comment on what mechanism, if any, we should
consider using to monitor compliance with a notification requirement if
we decide to finalize one for CY 2020 or through future rulemaking.
[[Page 40558]]
M. Therapy Services
1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate
Therapy
a. Background
In the CY 2019 PFS proposed and final rules (83 FR 34850; 83 FR
59654 and 59661), we discussed the statutory requirements of section
50202 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-
123, February 9, 2018). Beginning January 1, 2018, section 50202 of the
BBA of 2018 repealed the Medicare outpatient therapy caps and the
therapy cap exceptions process, while retaining the cap amounts as
limitations and requiring medical review to ensure that therapy
services are furnished when appropriate. Section 50202 of the BBA of
2018 amended section 1833(g) of the Act by adding a new paragraph
(7)(A) requiring that after expenses incurred for the beneficiary's
outpatient therapy services for the year have exceeded one or both of
the previous therapy cap amounts, all therapy suppliers and providers
must continue to use an appropriate modifier on claims. We implemented
this provision by continuing to require use of the existing KX
modifier. By using the KX modifier on the claim, the therapy supplier
or provider is attesting that the services are medically necessary and
that supportive justification is documented in the medical record. As
with the incurred expenses for the prior therapy cap amounts, there is
one amount for physical therapy (PT) and speech language pathology
(SLP) services combined, and a separate amount for occupational therapy
(OT) services. These KX modifier threshold amounts are indexed annually
by the Medicare Economic Index (MEI). After the beneficiary's incurred
expenditures for outpatient therapy services exceed the KX modifier
threshold amount for the year, claims for outpatient therapy services
without the KX modifier are denied.
Section 50202 of the BBA of 2018 also added a new paragraph 7(B) to
section 1833(g) of the Act which retained the targeted medical review
(MR) process for 2018 and subsequent years, but established a lower
threshold amount of $3,000 rather than the $3,700 threshold amount that
had applied for the original manual MR process established by section
3005(g) of the Middle Class Tax Relief and Jobs Creation Act of 2012
(MCTRJCA) (Pub. L. 112-96, February 22, 2012). The manual MR process
with a threshold amount of $3,700 was replaced by the targeted MR
process with the same threshold amount through amendments made by
section 202 of the Medicare Access and CHIP Reauthorization Act of 2015
(MACRA) (Pub. L. 114-10, April 16, 2015).
With the latest amendments made by the BBA of 2018, for CY 2018
(and each successive calendar year until 2028, at which time it is
indexed annually by the MEI), the MR threshold is $3,000 for PT and SLP
services and $3,000 for OT services. For purposes of applying the
targeted MR process, we use a criteria-based process for selecting
providers and suppliers that includes factors such as a high percentage
of patients receiving therapy beyond the medical review threshold as
compared to peers. For information on the targeted medical review
process, please visit https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/TherapyCap.html.
In the CY 2019 PFS final rule (83 FR 59661), when discussing our
tracking and accrual process for outpatient therapy services in the
section on the KX Threshold Amounts, we noted that we track each
beneficiary's incurred expenses for therapy services annually by
applying the PFS-based payment amount for each service less any
applicable multiple procedure reduction for CMS-designated ``always
therapy'' services. We also stated that we use the PFS rates to accrue
expenses for therapy services provided in critical access hospitals
(CAHs) as required by section 1833(g)(6)(B) of the Act, added by
section 603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub.
L. 112-240, January 2, 2013). As discussed below, we mistakenly
indicated that this statutory requirement was extended by subsequent
legislation, including section 50202 of the BBA of 2018.
b. Proposed Regulatory Revisions
While we explained and implemented the changes required by section
50202 of the BBA of 2018 in CY 2019 PFS rulemaking (83 FR 34850; 83 FR
59654 and 59661), we did not codify those changes in regulation text.
We are now proposing to revise the regulations at Sec. Sec. 410.59
(outpatient occupational therapy) and 410.60 (physical therapy and
speech-language pathology) to incorporate the changes made by section
50202 of the BBA of 2018. We propose to add a new paragraph (e)(1)(v)
to Sec. Sec. 410.59 and 410.60 to clarify that the specified amounts
of annual per-beneficiary incurred expenses are no longer applied as
limitations but as threshold amounts above which services require, as a
condition of payment, inclusion of the KX modifier; and that use of the
KX modifier confirms that the services are medically necessary as
justified by appropriate documentation in the patient's medical record.
We propose to amend paragraph (e)(2) in Sec. Sec. 410.59 and 410.60 to
specify the therapy services and amounts that are accrued for purposes
of applying the KX modifier threshold, including the continued accrual
of therapy services furnished by CAHs directly or under arrangements at
the PFS-based payment rates. We are also proposing to amend paragraph
(e)(3) in Sec. Sec. 410.59 and 410.60 for the purpose of applying the
medical review threshold to clarify the threshold amounts and the
applicable years for both the manual MR process originally established
through section 3005(g) of MCTRJCA and the targeted MR process
established by the MACRA, and including the changes made through
section 50202 of the BBA of 2018 as discussed previously.
In the CY 2019 PFS final rule (83 FR 59661), we incorrectly stated
that section 1833(g)(6)(B) of the Act continues to require that we
accrue expenses for therapy services furnished by CAHs at the PFS rate
because the provision, originally added by section 603(b) of the ATRA,
was extended by subsequent legislation, including section 50202 of the
BBA of 2018. The requirement in section 1833(g)(6)(B) of the Act was
actually time-limited to services furnished in CY 2013. To apply the
therapy caps (and now the KX modifier thresholds) after the expiration
of the requirement in 1833(g)(6)(B) of the Act, we needed a process to
accrue the annual expenses for therapy services furnished by CAHs and,
in the CY 2014 PFS final rule with comment period, we elected to
continue the process prescribed in section 1833(g)(6)(B) of the Act (78
FR 74405 through 74410).
2. Proposed Payment for Outpatient PT and OT Services Furnished by
Therapy Assistants
a. Background
Section 53107 of the BBA of 2018 added a new subsection 1834(v) to
the Act to require in paragraph (1) that, for services furnished on or
after January 1, 2022, payment for outpatient physical and occupational
therapy services for which payment is made under sections 1848 or
1834(k) of the Act which are furnished in whole or in part by a therapy
assistant must be paid at 85 percent of the amount that is otherwise
applicable. Section 1834(v)(2) of the Act further required that we
establish a modifier to identify these services by January 1, 2019, and
that claims for outpatient therapy services furnished in
[[Page 40559]]
whole or in part by a therapy assistant must include the modifier
effective for dates of service beginning on January 1, 2020. Section
1834(v)(3) of the Act required that we implement the subsection through
notice and comment rulemaking.
In the CY 2019 PFS proposed and final rules (83 FR 35850 through
35852 and 83 FR 59654 through 50660, respectively), we established two
modifiers--one to identify services furnished in whole or in part by a
physical therapist assistant (PTA) and the other to identify services
furnished in whole or in part by an occupational therapy assistant
(OTA). The modifiers are defined as follows:
CQ Modifier: Outpatient physical therapy services
furnished in whole or in part by a physical therapist assistant.
CO Modifier: Outpatient occupational therapy services
furnished in whole or in part by an occupational therapy assistant.
In the CY 2019 PFS final rule, we clarified that the CQ and CO
modifiers are required to be used when applicable for services
furnished on or after January 1, 2020, on the claim line of the service
alongside the respective GP or GO therapy modifier to identify services
furnished under a PT or OT plan of care. The GP and GO therapy
modifiers, along with the GN modifier for speech-language pathology
(SLP) services, have been used since 1998 to track and accrue the per-
beneficiary incurred expenses amounts to different therapy caps, now KX
modifier thresholds, one amount for PT and SLP services combined and a
separate amount for OT services. We also clarified in the CY 2019 PFS
final rule that the CQ and CO modifiers will trigger application of the
reduced payment rate for outpatient therapy services furnished in whole
or in part by a PTA or OTA, beginning for services furnished in CY
2022.
In response to public comments on the CY 2019 PFS proposed rule, we
did not finalize our proposed definition of ``furnished in whole or in
part by a PTA or OTA'' as a service for which any minute of a
therapeutic service is furnished by a PTA or OTA. Instead, we finalized
a de minimis standard under which a service is considered to be
furnished in whole or in part by a PTA or OTA when more than 10 percent
of the service is furnished by the PTA or OTA.
We also explained in the CY 2019 PFS proposed and final rules (83
FR 35850 through 35852 and 83 FR 59654 through 59660, respectively)
that the CQ and CO modifiers would not apply to claims for outpatient
therapy services that are furnished by, or incident to the services of,
physicians or nonphysician practitioners (NPPs) including nurse
practitioners, physician assistants, and clinical nurse specialists.
This is because our regulations for outpatient physical and
occupational therapy services require that an individual furnishing
outpatient therapy services incident to the services of a physician or
NPP must meet the qualifications and standards for a therapist. As
such, only therapists and not therapy assistants can furnish outpatient
therapy services incident to the services of a physician or NPP (83 FR
59655 through 59656); and, the new PTA and OTA modifiers cannot be used
on the line of service of the professional claim when the rendering NPI
identified on the claim is a physician or an NPP. We also intend to
revise our manual provisions at Pub. 100-02, Medicare Benefit Policy
Manual (MBPM), Chapter 15, section 230, as appropriate, to reflect
requirements for the new CQ and CO modifiers that will be used to
identify services furnished in whole or in part by a PTA or OTA
starting in CY 2020. We anticipate amending these manual provisions for
CY 2020 to reflect the policies we adopt through the CY 2020 PFS notice
and comment rulemaking process.
In PFS rulemaking for CY 2019, we identified certain situations
when the therapy assistant modifiers do apply. The modifiers are
applicable to:
Therapeutic portions of outpatient therapy services
furnished by PTAs/OTAs, as opposed to administrative or other non-
therapeutic services that can be performed by others without the
education and training of OTAs and PTAs.
Services wholly furnished by PTAs or OTAs without physical
or occupational therapists.
Evaluative services that are furnished in part by PTAs/
OTAs (keeping in mind that PTAs/OTAs are not recognized to wholly
furnish PT and OT evaluation or re-evaluations).
We also identified some situations when the therapy assistant
modifiers do not apply. They do not apply when:
PTAs/OTAs furnish services that can be done by a
technician or aide who does not have the training and education of a
PTA/OTA.
Therapists exclusively furnish services without the
involvement of PTAs/OTAs.
Finally, we noted that we would be further addressing application
of the modifiers for therapy assistant services and the 10 percent de
minimis standard more specifically in PFS rulemaking for CY 2020,
including how the modifiers are applied in different scenarios for
different types of services.
b. Applying the CQ and CO Modifiers
CMS interprets the references in section 1834(v)(1) and (2) of the
Act to outpatient physical therapy ``service'' and outpatient
occupational therapy ``service'' to mean a specific procedure code that
describes a PT or OT service. This interpretation makes sense because
section 1834(v)(2) of the Act requires the use of a modifier to
identify on each request for payment, or bill submitted for an
outpatient therapy service furnished in whole or in part by a PTA/OTA.
For purposes of billing, each outpatient therapy service is identified
by a procedure code.
To apply the de minimis standard under which a service is
considered to be furnished in whole or in part by a PTA or OTA when
more than 10 percent of the service is furnished by the PTA or OTA, we
propose to make the 10 percent calculation based on the respective
therapeutic minutes of time spent by the therapist and the PTA/OTA,
rounded to the nearest whole minute. The minutes of time spent by a
PTA/OTA furnishing a therapeutic service can overlap partially or
completely with the time spent by a physical or occupational therapist
furnishing the service. We propose that the total time for a service
would be the total time spent by the therapist (whether independent of,
or concurrent with, a PTA/OTA) plus any additional time spent by the
PTA/OTA independently furnishing the therapeutic service. When deciding
whether the therapy assistant modifiers apply, we propose that if the
PTA/OTA participates in the service concurrently with the therapist for
only a portion of the total time that the therapist delivers a service,
the CQ/CO modifiers apply when the minutes furnished by the therapy
assistant are greater than 10 percent of the total minutes spent by the
therapist furnishing the service. If the PTA/OTA and the therapist each
separately furnish portions of the same service, we propose that the
CQ/CO modifiers would apply when the minutes furnished by the therapy
assistant are greater than 10 percent of the total minutes--the sum of
the minutes spent by the therapist and therapy assistant--for that
service. We propose to apply the CQ/CO modifier policies to all
services that would be billed with the respective GP or GO therapy
modifier. We believe this is appropriate because it is the same way
that CMS currently identifies physical therapy or occupational therapy
services for purposes of accruing incurred expenses for the thresholds
and targeted review process.
[[Page 40560]]
For purposes of deciding whether the 10 percent de minimis standard
is exceeded, we offer two different ways to compute this. The first is
to divide the PTA/OTA minutes by the total minutes for the service--
which is (a) the therapist's total time when PTA/OTA minutes are
furnished concurrently with the therapist, or (b) the sum of the PTA/
OTA and therapist minutes when the PTA/OTA's services are furnished
separately from the therapist; and then to multiply this number by 100
to calculate the percentage of the service that involves the PTA/OTA.
We propose to round to the nearest whole number so that when this
percentage is 11 percent or greater, the 10 percent de minimis standard
is exceeded and the CQ/CO modifier is applied. The other method is
simply to divide the total time for the service (as described above) by
10 to identify the 10 percent de minimis standard, and then to add one
minute to identify the number of minutes of service by the PTA/OTA that
would be needed to exceed the 10 percent standard. For example, where
the total time of a service is 60 minutes, the 10 percent standard is
six (6) minutes, and adding one minute yields seven (7) minutes. Once
the PTA/OTA furnishes at least 7 minutes of the service, the CQ/CO
modifier is required to be added to the claim for that service. As
noted above, we propose to round the minutes and percentages of the
service to the nearest whole integer. For example, when the total time
for the service is 45 minutes, the 10 percent calculation would be 4.5
which would be rounded up to 5, and the PTA/OTA's contribution would
need to meet or exceed 6 minutes before the CQ/CO modifier is required
to be reported on the claim. See Table 19 for minutes needed to meet or
exceed using the ``simple'' method with typical times for the total
time of a therapy service.
Table 19--Simple Method for Determining When CQ/CO Modifiers Apply
----------------------------------------------------------------------------------------------------------------
Method Two: simple method to apply 10 percent de minimis standard
-----------------------------------------------------------------------------------------------------------------
Determine the 10 percent
Total Time * examples using standard by dividing Round 10 percent standard PTA/OTA Minutes needed to
typical service total times service Total Time by 10 to next whole integer exceed--apply CQ/CO
----------------------------------------------------------------------------------------------------------------
10 1.0 1.0 2.0
15 1.5 2.0 3.0
20 2.0 2.0 3.0
30 3.0 3.0 4.0
45 4.5 5.0 6.0
60 6.0 6.0 7.0
75 7.5 8.0 9.0
----------------------------------------------------------------------------------------------------------------
Total Time equals total therapist minutes plus any PTA/OTA independent minutes. Concurrent minutes: When PTA/
OTA's minutes are furnished concurrently with the therapist, total time equals the total minutes of the
therapist's service. Separate minutes: When PTA/OTA's minutes are furnished separately from the minutes
furnished by the therapist, total time equals the sum of the minutes of the service furnished by the PT/OT
plus the minutes of the service furnished separately by the PTA/OTA.
We want to clarify that the 10 percent de minimis standard, and
therefore the CQ/CO modifiers, are not applicable to services in which
the PTA/OTA did not participate. To the extent that the PTA/OTA and the
physical therapist/occupational therapist (PT/OT) separately furnish
different services that are described by procedure codes defined in 15-
minute increments, billing examples and proposed policies are included
below in Scenario Two.
As we indicated in the CY 2019 PFS final rule, we are addressing
more specifically in this proposed rule the application of the 10
percent de minimis standard in various clinical scenarios to decide
when the CQ/CO modifiers apply. We acknowledge that application of the
10 percent de minimis standard can work differently depending on the
types of services and scenarios involving both the PTA/OTA and the PT/
OT. Therapy services are typically furnished in multiple units of the
same or different services on a given treatment day, which can include
untimed services (not billable in multiple units) and timed services
that are defined by codes described in 15-minute intervals. The
majority of the untimed services that therapists bill for fall into
three categories: (1) Evaluative procedures, (2) group therapy, and (3)
supervised modalities. We discuss each of these in greater detail
below. Only one (1) unit can be reported in the claim field labeled
``units'' for each procedure code representing an untimed service. The
preponderance of therapy services, though, are billed using codes that
are described in 15-minute increments. These services are typically
furnished to a patient on a single day in multiple units of the same
and/or different services. Under our current policy, the total number
of units of one or more timed services that can be added to a claim
depends on the total time for all the 15-minute timed codes that were
delivered to a patient on a single date of service. We address our
proposals for applying the CQ/CO modifiers using the 10 percent de
minimis standard, along with applicable billing scenarios, by category
below. In each of these scenarios, we assume that the PTA/OTA minutes
are for therapeutic services.
Evaluations and re-evaluations: CPT codes 97161 through
97163 for physical therapy evaluations for low, moderate, and high
complexity level, and CPT code 97164 for physical therapy re-
evaluation; and CPT codes 97165 through 97167 for occupational therapy
evaluations for low, moderate, and high complexity level, and CPT 97168
for occupational therapy re-evaluation. These PT and OT evaluative
procedures are untimed codes and cannot be billed in multiple units--
one unit is billed on the claim. As discussed in CY 2019 PFS rulemaking
(83 FR 35852 and 83 FR 59656) and noted above, PTAs/OTAs are not
recognized to furnish evaluative or assessment services, but to the
extent that they furnish a portion of an evaluation or re-evaluation
(such as completing clinical labor tasks for each code) that exceeds
the 10 percent de minimis standard, the appropriate therapy assistant
modifier (CQ or CO) must be used on the claim. We note that it is
possible for the PTA/OTA to furnish these minutes either concurrently
or separately from the therapist. For example, when the PTA/OTA assists
the PT/OT concurrently for a 5-minute portion of the 30 minutes that a
PT or OT spent furnishing an evaluation (for example, CPT code 97162
for moderate complexity PT evaluation or CPT code 97165 for a low
complexity OT evaluation--each have a typical therapist face-to-face
time of 30
[[Page 40561]]
minutes), the respective CQ or CO modifier is applied to the service
because the 5 minutes surpasses the 10 percent de minimis standard. In
other words, 10 percent of 30 minutes is 3 minutes, and the CQ or CO
modifier applies if the PTA/OTA furnishes more than 3 minutes, meaning
at least 4 minutes, of the service. If the PTA/OTA separately furnishes
a portion of the service that takes 5 minutes (for example, performing
clinical labor tasks such as obtaining vital signs, providing self-
assessment tool to the patient and verifying its completion), and then
the PT/OT separately (without the PTA/OTA) furnishes a 30 minute face-
to-face evaluative procedure--bringing the total time of the service to
35 minutes (the sum of the separate PTA/OTA minutes, that is, 5
minutes, plus the 30-minute therapist service), the CQ or CO modifier
would be applied to the service because the 5 minutes of OTA/PTA time
exceeds 10 percent of the 35 total minutes for the service. In other
words, 10 percent of 35 minutes is 3.5 minutes which is rounded up to 4
minutes. The CQ or CO modifier would apply when the PTA/OTA furnishes 5
or more minutes of the service, as discussed above and referenced in
Table 19.
Group Therapy: CPT code 97150 (requires constant
attendance of therapist or assistant, or both). CPT code 97150
describes a service furnished to a group of 2 or more patients. Like
evaluative services, this code is an untimed service and cannot be
billed in multiple units on the claim, so one unit of the service is
billed for each patient in the group. For the group service, the CQ/CO
modifier would apply when the PTA/OTA wholly furnishes the service
without the therapist. The CQ/CO modifier would also apply when the
total minutes of the service furnished by the PTA/OTA (whether
concurrently with, or separately from, the therapist), exceed 10
percent of the total time, in minutes, of the group therapy service
(that is, the total minutes of service spent by the therapist (with or
without the PTA/OTA) plus any minutes spent by the PTA/OTA separately
from the therapist). For example, the modifiers would apply when the
PTA/OTA participates concurrently with the therapist for 5 minutes of a
total group therapy service time of 40-minutes (based on the time of
the therapist); or when the PTA/OTA separately furnishes 5 minutes of a
total group time of 40 minutes (based on the sum of minutes of the PTA/
OTA (5) and therapist (35)).
Supervised Modalities: CPT codes 97010 through 97028, and
HCPCS codes G0281, G0183, and G0329. Modalities, in general, are
physical agents that are applied to body tissue in order to produce a
therapeutic change through various forms of energy, including but not
limited to thermal, acoustic, light, mechanical or electric. Supervised
modalities, for example vasopneumatic devices, paraffin bath, and
electrical stimulation (unattended), do not require the constant
attendance of the therapist or supervised therapy assistant, unlike the
modalities defined in 15-minute increments that are discussed in the
below category. When a supervised modality, such as whirlpool (CPT code
97022), is provided without the direct contact of a PT/OT and/or PTA/
OTA, that is, it is furnished entirely by a technician or aide, the
service is not covered and cannot be billed to Medicare. Supervised
modality services are untimed, so only one unit of the service can be
billed regardless of the number of body areas that are treated. For
example, when paraffin bath treatment is provided to both of the
patient's hands, one unit of CPT code 97018 can be billed, not two. For
supervised modalities, the CQ or CO modifier would apply to the service
when the PTA/OTA fully furnishes all the minutes of the service, or
when the minutes provided by the PTA or OTA exceed 10 percent of total
minutes of the service. For example, the CQ/CO modifiers would apply
when either (1) the PTA/OTA concurrently furnishes 2 minutes of a total
8-minute service by the therapist furnishing paraffin bath treatment
(HCPCS code 97018) because 2 minutes is greater than 10 percent of 8
minutes (0.8 minute, or 1 minute after rounding); or (2) the PTA/OTA
furnishes 3 minutes of the service separately from the therapist who
furnishes 5 minutes of treatment for a total time of 8 minutes (total
time equals the sum of the PT/OT minutes plus the separate PTA/OTA
minutes) because 3 minutes is greater than 10 percent of 8 total
minutes (0.8 minute rounded to 1 minute).
Services defined by 15-minute increments/units: These
timed codes are included in the following current CPT code ranges: CPT
codes 97032 through 97542--including the subset of codes for modalities
in the series CPT codes 97032 through 97036; and, codes for procedures
in the series CPT codes 97110-97542; CPT codes 97750-97755 for tests
and measurements; and CPT codes: 97760-97763 for orthotic management
and training and prosthetic training. Based on CPT instructions for
these codes, the therapist (or their supervised therapy assistant, as
appropriate) is required to furnish the service directly in a one-on-
one encounter with the patient, meaning they are treating only one
patient during that time. Examples of modalities requiring one-on-one
patient contact include electrical stimulation (attended), CPT code
97032, and ultrasound, CPT code 97035. Examples of procedures include
therapeutic exercise, CPT code 97110, neuromuscular reeducation, CPT
97112, and gait training, CPT code 97116.
Our policy for reporting of service units with HCPCS codes for both
untimed services and timed services (that is, only those therapy
services defined in 15-minute increments) is explained in section 20.2
of Chapter 5 of the Medicare Claims Processing Manual (MCPM). To bill
for services described by the timed codes (hereafter, those codes
described per each 15-minutes) furnished to a patient on a date of
service, the therapist or therapy assistant needs to first identify all
timed services furnished to a patient on that day, and then total all
the minutes of all those timed codes. Next, the therapist or therapy
assistant needs to identify the total number of units of timed codes
that can be reported on the claim for the physical or occupational
therapy services for a patient in one treatment day. Once the number of
billable units is identified, the therapist or therapy assistant
assigns the appropriate number of unit(s) to each timed service code
according to the total time spent furnishing each service. For example,
to bill for one 15-minute unit of a timed code, the qualified
professional (the therapist or therapy assistant) must furnish at least
8 minutes and up to 22 minutes of the service; to bill for 2 units, at
least 23 minutes and up to 37 minutes, and to bill for 3 units, at
least 38 minutes and up to 52 minutes. We note that these minute ranges
are applicable when one service, or multiple services, defined by timed
codes are furnished by the qualified professional on a treatment day.
We understand that the therapy industry often refers to these billing
conventions as the ``eight-minute rule.'' The idea is that when a
therapist or therapy provider bills for one or more units of services
that are described by timed codes, the therapist's direct, one-on-one
patient contact time would average 15 minutes per unit. This idea is
also the basis for the work values we have established for these timed
codes. Our current policies for billing of timed codes and related
documentation do not take into consideration whether a service is
furnished ``in whole or in
[[Page 40562]]
part'' by a PTA/OTA, or otherwise address the application of the CQ/CO
modifier when the 10 percent de minimis standard is exceeded, for those
services in which both the PTA/OTA and the PT/OT work together to
furnish a service or services.
To support the number of 15-minute timed units billed on a claim
for each treatment day, we require that the total timed-code treatment
time be documented in the medical record, and that the treatment note
must document each timed service, whether or not it is billed, because
the unbilled timed service(s) can impact billing. The minutes that each
service is furnished can be, but are not required to be, documented. We
also require that each untimed service be documented in the treatment
note in order to support these services billed on the claim; and, that
the total treatment time for each treatment day be documented--
including minutes spent providing services represented by the timed
codes (the total timed-code treatment time) and the untimed codes. To
minimize burden, we are not proposing changes to these documentation
requirements in this proposed rule.
Beginning January 1, 2020, in order to provide support for
application of the CQ/CO modifier(s) to the claim as required by
section 1834(v)(2)(B) of the Act and our proposed regulations at
Sec. Sec. 410.59(a)(4) and 410.60(a)(4), we propose to add a
requirement that the treatment notes explain, via a short phrase or
statement, the application or non-application of the CQ/CO modifier for
each service furnished that day. We would include this documentation
requirement in subsection in Chapter 15, MBPM, section 220.3.E on
treatment notes. Because the CQ/CO modifiers also apply to untimed
services, our proposal to revise our documentation requirement for the
daily treatment note extends to those codes and services as well. For
example, when PTAs/OTAs assist PTs/OTs to furnish services, the
treatment note could state one of the following, as applicable: (a)
``Code 97110: CQ/CO modifier applied--PTA/OTA wholly furnished''; or,
(b) ``Code 97150: CQ/CO modifier applied--PTA/OTA minutes = 15%''; or
``Code 97530: CQ/CP modifier not applied--PTA/OTA minutes less than 10%
standard.'' For those therapy services furnished exclusively by
therapists without the use of PTAs/OTA, the PT/OT could note one of the
following: ``CQ/CO modifier NA'', or ``CQ/CO modifier NA--PT/OT fully
furnished all services.'' Given that the minutes of service furnished
by or with the PTA/OTA and the total time in minutes for each service
(timed and untimed) are used to decide whether the CQ/CO modifier is
applied to a service, we seek comment on whether it would be
appropriate to require documentation of the minutes as part of the CQ/
CO modifier explanation as a means to avoid possible additional burden
associated with a contractor's medical review process conducted for
these services. We are also interested in hearing from therapists and
therapy providers about current burden associated with the medical
review process based on our current policy that does not require the
times for individual services to be documented. Based on comments
received, if we were to adopt a policy to include documentation of the
PTA/OTA minutes and total time (TT) minutes, the CQ/CO modifier
explanation could read similar to the following: ``Code 97162 (TT = 30
minutes): CQ/CO modifier not applied--PTA/OTA minutes (3) did not
exceed the 10 percent standard.''
To recap, under our proposed policy, therapists or therapy
assistants would apply the therapy assistant modifiers to the timed
codes by first following the usual process to identify all procedure
codes for the 15-minute timed services furnished to a beneficiary on
the date of service, add up all the minutes of the timed codes
furnished to the beneficiary on the date of service, decide how many
total units of timed services are billable for the beneficiary on the
date of service (based on time ranges in the chart in the manual), and
assign billable units to each billable procedure code. The therapist or
therapy assistant would then need to decide for each billed procedure
code whether or not the therapy assistant modifiers apply.
As previously explained, the CQ/CO modifier does not apply if all
units of a procedure code were furnished entirely by the therapist;
and, where all units of the procedure code were furnished entirely by
the PTA/OTA, the appropriate CQ/CO modifier would apply. When some
portion of the billed procedure code is furnished by the PTA/OTA, the
therapist or therapy assistant would need to look at the total minutes
for all the billed units of the service, and compare it to the minutes
of the service furnished by the PTA/OTA as described above in order to
decide whether the 10 percent de minimis standard is exceeded. If the
minutes of the service furnished by the PTA/OTA are more than 10
percent of the total minutes of the service, the therapist or therapy
assistant would assign the appropriate CQ or CO modifier. We would make
clarifying technical changes to chapter 5, section 20.2 of the MCPM to
reflect the policies adopted through in this rulemaking related to the
application or non-application of the therapy assistant modifiers. We
anticipate that we will add examples to illustrate when the applicable
therapy assistant modifiers must be applied, similar to the examples
provided below.
We are providing the following examples of clinical scenarios to
illustrate how the 10 percent de minimis standard would be applied
under our proposals when therapists and their assistants work together
concurrently or separately to treat the same patient on the same day.
These examples reflect how the therapist or therapy provider would
decide whether the CQ or CO therapy assistant modifier should be
included when billing for one or more service units of the 15-minute
timed codes. In the following scenarios, ``PT'' is used to represent
physical therapist and ``OT'' is used to refer to an occupational
therapist for ease of reference; and, the services of the PTA/OTA are
assumed to be therapeutic in nature, and not services that a technician
or aide without the education and training of a PTA/OTA could provide.
Scenario One: Where only one service, described by a
single HCPCS code defined in 15-minute increments, is furnished in a
treatment day:
(1) The PT/OT and PTA/OTA each separately, that is individually and
exclusively, furnish minutes of the same therapeutic exercise service
(HCPCS code 97110) in different time frames: The PT/OT furnishes 7
minutes and the PTA furnishes 7 minutes for a total of 14 minutes, one
unit can be billed using the total time minute range of at least 8
minutes and up to 22 minutes.
Billing Example: One 15-minute unit of HCPCS code 97110 is reported
on the claim with the CQ/CO modifier to signal that the time of the
service furnished by the PTA/OTA (7 minutes) exceeded 10 percent of the
14-minute total service time (1.4 minutes rounded to 1 minute, so the
modifier would apply if the PTA/OTA had furnished 2 or more minutes of
the service).
(2) The PT/OT and PTA/OTA each separately, exclusive of the other,
furnish minutes of the same therapeutic exercise service (HCPCS code
97110) in different time frames: The PT/OT furnishes 20 minutes and the
PTA/OTA furnishes 25 minutes for a total of 45 minutes, three units can
be billed using the total time minute range of at least 38 minutes and
up to 52 minutes.
Billing Example: All three units of CPT code 97110 are reported on
the claim with the corresponding CQ/CO modifier because the 25 minutes
[[Page 40563]]
furnished by the PTA/OTA exceeds 10 percent of the 45-minute total
service time (4.5 minutes rounded to 5 minutes, so the modifier would
apply if the PTA/OTA had furnished 6 or more minutes of the service).
(3) The PTA/OTA works concurrently with the respective PT/OT as a
team to furnish the same neuromuscular reeducation service (HCPCS code
97112) for a 30-minute session, resulting in 2 billable units of the
service (at least 23 minutes and up to 37 minutes).
Billing Example: Both units of HCPCS code 97112 are reported with
the appropriate CQ or CO modifier because the service time furnished by
the PTA/OTA (30 minutes) exceeded 10 percent of the 30-minute total
service time (3 minutes, so the modifier would apply if the PTA/OTA had
furnished 4 or more minutes of the service).
Scenario Two: When services that are represented by
different procedure codes are furnished. Follow our current policy to
identify the procedure codes to bill and the units to bill for the
service(s) provided for the most time. We propose that when the PT/OT
and the PTA/OTA each independently furnish a service defined by a
different procedure code for the same number of minutes, for example 10
minutes, for a total time of 20 minutes, qualifying for 1 unit to be
billed (at least 8 minutes up to 23 minutes), the code for the service
furnished by the PT/OT is selected to break the tie--one unit of that
service would be billed without the CQ/CO modifier.
(1) When only one unit of a service can be billed (requires a
minimum of 8 minutes but less than 23 minutes):
(a) The PT/OT independently furnishes 15 minutes of manual therapy
(HCPCS code 97140) and the PTA/OTA independently furnishes 7 minutes of
therapeutic exercise (HCPCS code 97110). One unit of HCPCS code 97140
can be billed (at least 8 minutes and up to 22 minutes).
Billing Example: One unit of HCPCS code 97140 is billed without the
CQ/CO modifier because the PT/OT exclusively (without the PTA/OTA)
furnished a full unit of a service defined by 15-minute time interval
(current instructions require ``1'' unit to be reported). The 7 minutes
of a different service delivered solely by the PTA/OTA do not result in
a billable service. Both services, though, are documented in the
medical record, noting which services were furnished by the PT/OT or
PTA/OTA; and, the 7 minutes of HCPCS code 97110 would be included in
the total minutes of timed codes that are considered when identifying
the procedure codes and units of each that can be billed on the claim.
(b) If instead, the PT/OT independently furnished 7 minutes of CPT
code 97140 and the PTA/OTA independently furnished a full 15-minutes of
CPT code 97110, one unit of CPT code 97110 is billed and the CQ/CO
modifier is applied; the 7 minutes of the PT/OT service (CPT code
97140) do not result in billable service, but all the minutes are
documented and included in the total minutes of the timed codes that
are considered when identifying the procedure codes and units of each
that can be billed on the claim.
(c) If the PT/OT and PTA/OTA each independently furnish an equal
number of minutes of CPT codes 97140 and 97110, respectively, that is
less than the full 15-minute mark, and the total minutes of the timed
codes qualify for billing one unit of a service, the code furnished by
the PT/OT would be selected to break the tie and billed without a CQ/CO
modifier because the PT/OT furnished that service independently of the
PTA/OTA.
If instead the PT/OT furnishes an 8-minute service (CPT code 97140)
and the PTA/OTA delivers a 13-minute service (CPT code 97110), one unit
of the 13-minute PTA/OTA-delivered service (CPT code 97110) would be
billed consistent with our current policy to bill the service with the
greater time; and the service would be billed with a CQ/CO modifier
because the PTA/OTA furnished the service independently.
(2) When two or more units can be billed (requires a minimum of 23
minutes), follow current instructions for billing procedure codes and
units for each timed code.
(a) The PT/OT furnishes 20 minutes of neuromuscular reeducation
(CPT code 97112) and the PTA/OTA furnishes 8 minutes of therapeutic
exercise (CPT code 97110) for a total of 28 minutes, which permits two
units of the timed codes to be billed (at least 23 minutes and up to 37
minutes).
Billing Example: Following our usual process for billing for the
procedure codes and units based on services furnished with the most
minutes, one unit of each procedure code would be billed--one unit of
CPT code 97112 is billed without a CQ/CO modifier and one unit of CPT
code 97110 is billed with a CQ/CO modifier. This is because, under our
current policy, the two billable units of timed codes are allocated
among procedure codes by assigning the first 15 minutes of service to
code 97112 (the code with the highest number of minutes), which leaves
another 13 minutes of timed services: 5 minutes of code 97112 (20 minus
15) and 8 minutes of code 97110. Since the 8 minutes of code 97110 is
greater than the remaining 5 minutes of code 97112, the second billable
unit of service would be assigned to 97110. The CQ/CO modifier would
not apply to CPT code 97112 because the therapist furnished all minutes
of that service independently. The CQ/CO modifier would apply to CPT
code 97110 because the PTA/OTA furnished all minutes of that service
independently.
(b) The PT/OT furnishes 32 minutes of neuromuscular reeducation
(CPT code 97112), the PT/OT and the PTA/OTA each separately furnish 12
minutes and 14 minutes, respectively, of therapeutic exercise (CPT code
97110) for a total of 26 minutes, and the PTA/OTA independently
furnishes 12 minutes of self-care (CPT code 97535) for a total of 70
minutes of timed code services, permitting five units to be billed (68-
82 minutes). Under our current policy, the five billable units would be
assigned as follows: Two units to CPT code 97112, two units to CPT code
97110, and one unit to CPT code 97535.
Billing Example: The two units of CPT code 97112 would be billed
without a CQ/CO modifier because all 32 minutes of that service were
furnished independently by the PT/OT. The two units of CPT code 97110
would be billed with the CQ/CO modifier because the PTA/OTA's 14
minutes of the service are greater than 10 percent of the 26 total
minutes of the service (2.6 minutes which is rounded to 3 minutes, so
the modifiers would apply if the PTA/OTA furnished 4 or more minutes of
the service), and the one unit of CPT code 97535 would be billed with a
CQ/CO modifier because the PTA/OTA independently furnished all minutes
of that service.
(c) The PT/OT independently furnishes 12 minutes of neuromuscular
reeducation activities (CPT code 97112) and the PTA/OTA independently
furnishes 8 minutes of self-care activities (CPT code 97535) and 7
minutes of therapeutic exercise (CPT code 97110)--the total treatment
time of 27 minutes allows for two units of service to be billed (at
least 23 minutes and up to 37 minutes). Under our current policy, the
two billable units would be assigned as follows: One unit of CPT code
97112 and one unit of CPT code 97535.
Billing Example: The one unit of HCPCS code 97112 would be billed
without the CQ/CO modifier because it was furnished independently by
the PT/OT; and, the one unit of CPT code 97535 is billed with the CQ/CO
modifier because it was independently furnished
[[Page 40564]]
by the PTA/OTA. In this example, CPT code 97110 is not billable;
however, the minutes for all three codes are documented and counted
toward the total time of the timed code services furnished to the
patient on the date of service.
(d) The PT/OT furnishes 15 minutes of each of two services
described by CPT codes 97112 and 97535, and is assisted by the PTA/OTA
who furnishes 3 minutes of each service concurrently with the PT/OT.
The total time of 30 minutes allows two 15-minute units to be billed--
one unit each of CPT code 97112 and CPT code 97535.
Billing Example: Both CPT codes 97112 and 97535 are billed with the
applicable CQ/CO modifier because the time the PTA/OTA spent assisting
the PT/OT for each service exceeds 10 percent of the 15-minute total
time for each service (1.5 minutes which is rounded to 2 minutes, so
that the modifiers apply if the PTA/OTA furnishes 3 or more minutes of
the service).
c. Proposed Regulatory Provisions
In accordance with section 1834(v)(2)(B) of the Act, we are
proposing to amend Sec. Sec. 410.59(a)(4) and 410.60(a)(4) for
outpatient physical and occupational therapy services, respectively,
and Sec. 410.105(d) for physical and occupational therapy services
furnished by comprehensive outpatient rehabilitation facilities (CORFs)
as authorized under section 1861(cc) of the Act, to establish as a
condition of payment that claims for services furnished in whole or in
part by an OTA or PTA must include a prescribed modifier; and that
services will not be considered furnished in part by an OTA or PTA
unless they exceed 10 percent of the total minutes for that service,
beginning for services furnished on and after January 1, 2020. To
implement section 1834(v)(1) of the Act, we are proposing to amend
Sec. Sec. 410.59(a)(4) and 410.60(a)(4) for outpatient physical and
occupational therapy services, respectively, and at Sec. 410.105(d)
for physical and occupational therapy services furnished by CORFs to
specify that claims from physical and occupational therapists in
private practice paid under section 1848 of the Act and from providers
paid under section 1834(k) of the Act for physical therapy and
occupational therapy services that contain a therapy assistant
modifier, are paid at 85 percent of the otherwise applicable payment
amount for the service for dates of service on and after January 1,
2022. As specified in the CY 2019 PFS final rule, we also note that the
CQ or CO modifier is to be applied alongside the corresponding GP or GO
therapy modifier that is required on each claim line of service for
physical therapy or occupational therapy services. Beginning for dates
of service and after January 1, 2020, claims missing the corresponding
GP or GO therapy modifier will be rejected/returned to the therapist or
therapy provider so they can be corrected and resubmitted for
processing.
As discussed in the CY 2019 PFS proposed and final rules (see 83 FR
35850 and 83 FR 59654), we established that the reduced payment rate
under section 1834(v)(1) of the Act for the outpatient therapy services
furnished in whole or in part by therapy assistants is not applicable
to outpatient therapy services furnished by CAHs, for which payment is
made under section 1834(g) of the Act. We would like to take this
opportunity to clarify that we do not interpret section 1834(v) of the
Act to apply to outpatient physical therapy or occupational therapy
services furnished by CAHs, or by other providers for which payment for
outpatient therapy services is not made under section 1834(k) of the
Act based on the PFS rates.
N. Valuation of Specific Codes
1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since the inception of the PFS,
it has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year
review process, revisions in RVUs were proposed and finalized via
rulemaking. In addition to the 5-year reviews, beginning with CY 2009,
CMS and the RUC identified a number of potentially misvalued codes each
year using various identification screens, as discussed in section
II.E. of this proposed rule, Potentially Misvalued Services under the
PFS. Historically, when we received RUC recommendations, our process
had been to establish interim final RVUs for the potentially misvalued
codes, new codes, and any other codes for which there were coding
changes in the final rule with comment period for a year. Then, during
the 60-day period following the publication of the final rule with
comment period, we accepted public comment about those valuations. For
services furnished during the calendar year following the publication
of interim final rates, we paid for services based upon the interim
final values established in the final rule. In the final rule with
comment period for the subsequent year, we considered and responded to
public comments received on the interim final values, and typically
made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period (79 FR 67547), we
finalized a new process for establishing values for new, revised and
potentially misvalued codes. Under the new process, we include proposed
values for these services in the proposed rule, rather than
establishing them as interim final in the final rule with comment
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
new process was applicable to all codes, except for new codes that
describe truly new services. For CY 2017, we proposed new values in the
CY 2017 PFS proposed rule for the vast majority of new, revised, and
potentially misvalued codes for which we received complete RUC
recommendations by February 10, 2016. To complete the transition to
this new process, for codes for which we established interim final
values in the CY 2016 PFS final rule with comment period (81 FR 80170),
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period (80 FR 70886), and reproposed values for those codes in the CY
2017 PFS proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process, we
will adopt interim final values only in the case of wholly new services
for which there are no predecessor codes or values and for which we do
not receive recommendations in time to propose values.
As part of our obligation to establish RVUs for the PFS, we
thoroughly review and consider available information including
recommendations and supporting information from the RUC, the Health
Care Professionals Advisory Committee (HCPAC), public commenters,
medical literature, Medicare claims data, comparative databases,
comparison with other codes
[[Page 40565]]
within the PFS, as well as consultation with other physicians and
healthcare professionals within CMS and the federal government as part
of our process for establishing valuations. Where we concur that the
RUC's recommendations, or recommendations from other commenters, are
reasonable and appropriate and are consistent with the time and
intensity paradigm of physician work, we propose those values as
recommended. Additionally, we continually engage with stakeholders,
including the RUC, with regard to our approach for accurately valuing
codes, and as we prioritize our obligation to value new, revised, and
potentially misvalued codes. We continue to welcome feedback from all
interested parties regarding valuation of services for consideration
through our rulemaking process.
2. Methodology for Establishing Work RVUs
For each code identified in this section, we conduct a review that
included the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our reviews of recommended work RVUs and time
inputs generally include, but have not been limited to, a review of
information provided by the RUC, the HCPAC, and other public
commenters, medical literature, and comparative databases, as well as a
comparison with other codes within the PFS, consultation with other
physicians and health care professionals within CMS and the federal
government, as well as Medicare claims data. We also assess the
methodology and data used to develop the recommendations submitted to
us by the RUC and other public commenters and the rationale for the
recommendations. In the CY 2011 PFS final rule with comment period (75
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation (see the CY 2011 PFS final rule with comment period (75 FR
73328 through 73329) for more information). When referring to a survey,
unless otherwise noted, we mean the surveys conducted by specialty
societies as part of the formal RUC process.
Components that we use in the building block approach may include
preservice, intraservice, or postservice time and post-procedure
visits. When referring to a bundled CPT code, the building block
components could include the CPT codes that make up the bundled code
and the inputs associated with those codes. We use the building block
methodology to construct, or deconstruct, the work RVU for a CPT code
based on component pieces of the code. Magnitude estimation refers to a
methodology for valuing work that determines the appropriate work RVU
for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we frequently utilize an incremental methodology in
which we value a code based upon its incremental difference between
another code and another family of codes. The statute specifically
defines the work component as the resources in time and intensity
required in furnishing the service. Also, the published literature on
valuing work has recognized the key role of time in overall work. For
particular codes, we refine the work RVUs in direct proportion to the
changes in the best information regarding the time resources involved
in furnishing particular services, either considering the total time or
the intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently, there are preservice time packages for
services typically furnished in the facility setting (for example,
preservice time packages reflecting the different combinations of
straightforward or difficult procedure, and straightforward or
difficult patient). Currently, there are three preservice time packages
for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value
services appropriately when they have common billing patterns. In cases
where a service is typically furnished to a beneficiary on the same day
as an evaluation and management (E/M) service, we believe that there is
overlap between the two services in some of the activities furnished
during the preservice evaluation and postservice time. Our longstanding
adjustments have reflected a broad assumption that at least one-third
of the work time in both the preservice evaluation and postservice
period is duplicative of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we adjust the work RVU and/or times to account
for the overlap. The work RVU for a service is the product of the time
involved in furnishing the service multiplied by the intensity of the
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which
means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU.
Therefore, in many cases when we remove 2 minutes of preservice
time and 2 minutes of postservice time from a procedure to account for
the overlap with the same day E/M service, we also remove a work RVU of
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
time had already been accounted for in the work RVU. The RUC has
recognized this valuation policy and, in many cases, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
The following paragraphs contain a general discussion of our
approach to reviewing RUC recommendations and developing proposed
values for specific codes. When they exist we also include a summary of
stakeholder reactions to our approach. We note that many commenters and
stakeholders have expressed concerns over the years with our ongoing
adjustment of work RVUs based on changes in the best information we had
regarding the time resources involved in furnishing individual
services. We have been particularly concerned with the RUC's and
various specialty societies' objections to our approach given the
significance of their recommendations to our process for valuing
services and since much of the information we used to make the
adjustments is derived from their survey process. We are obligated
under the statute to consider both time and intensity in establishing
work RVUs for PFS services. As explained in the CY 2016 PFS final rule
with comment period (80 FR 70933), we recognize that adjusting work
RVUs for changes in time is not always a straightforward process, so we
have applied various methodologies to identify several potential work
values for individual codes.
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been the
case for
[[Page 40566]]
a significant portion of codes for which we recently established or
proposed work RVUs that are based on refinements to the RUC-recommended
values. When we have adjusted work RVUs to account for significant
changes in time, we have started by looking at the change in the time
in the context of the RUC-recommended work RVU. When the recommended
work RVUs do not appear to account for significant changes in time, we
have employed the different approaches to identify potential values
that reconcile the recommended work RVUs with the recommended time
values. Many of these methodologies, such as survey data, building
block, crosswalks to key reference or similar codes, and magnitude
estimation have long been used in developing work RVUs under the PFS.
In addition to these, we sometimes use the relationship between the old
time values and the new time values for particular services to identify
alternative work RVUs based on changes in time components.
In so doing, rather than ignoring the RUC-recommended value, we
have used the recommended values as a starting reference and then
applied one of these several methodologies to account for the
reductions in time that we believe were not otherwise reflected in the
RUC-recommended value. If we believe that such changes in time are
already accounted for in the RUC's recommendation, then we do not make
such adjustments. Likewise, we do not arbitrarily apply time ratios to
current work RVUs to calculate proposed work RVUs. We use the ratios to
identify potential work RVUs and consider these work RVUs as potential
options relative to the values developed through other options.
We do not imply that the decrease in time as reflected in survey
values should always equate to a one-to-one or linear decrease in newly
valued work RVUs. Instead, we believe that, since the two components of
work are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, significant decreases in time should be reflected in
decreases to work RVUs. If the RUC's recommendation has appeared to
disregard or dismiss the changes in time, without a persuasive
explanation of why such a change should not be accounted for in the
overall work of the service, then we have generally used one of the
aforementioned methodologies to identify potential work RVUs, including
the methodologies intended to account for the changes in the resources
involved in furnishing the procedure.
Several stakeholders, including the RUC, have expressed general
objections to our use of these methodologies and deemed our actions in
adjusting the recommended work RVUs as inappropriate; other
stakeholders have also expressed general concerns with CMS refinements
to RUC-recommended values in general. In the CY 2017 PFS final rule (81
FR 80272 through 80277), we responded in detail to several comments
that we received regarding this issue. In the CY 2017 PFS proposed rule
(81 FR 46162), we requested comments regarding potential alternatives
to making adjustments that would recognize overall estimates of work in
the context of changes in the resource of time for particular services;
however, we did not receive any specific potential alternatives. As
described earlier in this section, crosswalks to key reference or
similar codes are one of the many methodological approaches we have
employed to identify potential values that reconcile the RUC-recommend
work RVUs with the recommended time values when the RUC-recommended
work RVUs did not appear to account for significant changes in time. In
response to comments in the CY 2019 PFS final rule (83 FR 59515), we
clarify that terms ``reference services'', ``key reference services'',
and ``crosswalks'' as described by the commenters are part of the RUC's
process for code valuation. These are not terms that we created, and we
do not agree that we necessarily must employ them in the identical
fashion for the purposes of discussing our valuation of individual
services that come up for review. However, in the interest of
minimizing confusion and providing clear language to facilitate
stakeholder feedback, we will seek to limit the use of the term,
``crosswalk,'' to those cases where we are making a comparison to a CPT
code with the identical work RVU.
We look forward to continuing to engage with stakeholders and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes; and will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to the detailed discussion in this section of the proposed
valuation considered for specific codes. Table 20 contains a list of
codes and descriptors for which we are proposing work RVUs; this
includes all codes for which we received RUC recommendations by
February 10, 2019. The proposed work RVUs, work time and other payment
information for all CY 2020 payable codes are available on the CMS
website under downloads for the CY 2020 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, and consultation with physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC's recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, are consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended PE inputs to better reflect our estimate of the PE
resources required for the service. We also confirm whether CPT codes
should have facility and/or nonfacility direct PE inputs and refine the
inputs accordingly.
Our review and refinement of the RUC-recommended direct PE inputs
includes many refinements that are common across codes, as well as
refinements that are specific to particular services. Table 21 details
our proposed refinements of the RUC's direct PE recommendations at the
code-specific level. In section II.B. of this proposed rule,
Determination of Practice Expense Relative Value Units (PE RVUs), we
address certain proposed refinements that would be common across codes.
Proposed refinements to particular codes are addressed in the portions
of this section that are dedicated to particular codes. We note
[[Page 40567]]
that for each refinement, we indicate the impact on direct costs for
that service. We note that, on average, in any case where the impact on
the direct cost for a particular refinement is $0.35 or less, the
refinement has no impact on the PE RVUs. This calculation considers
both the impact on the direct portion of the PE RVU, as well as the
impact on the indirect allocator for the average service. We also note
that approximately half of the refinements listed in Table 21 result in
changes under the $0.35 threshold and are unlikely to result in a
change to the RVUs.
We also note that the proposed direct PE inputs for CY 2020 are
displayed in the CY 2020 direct PE input files, available on the CMS
website under the downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs
displayed there have been used in developing the proposed CY 2020 PE
RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We appreciate the RUC's willingness to provide
us with these additional inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We clarified this principle
over several years of rulemaking, indicating that we consider equipment
time as the time within the intraservice period when a clinician is
using the piece of equipment plus any additional time that the piece of
equipment is not available for use for another patient due to its use
during the designated procedure. For those services for which we
allocate cleaning time to portable equipment items, because the
portable equipment does not need to be cleaned in the room where the
service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up
postoperative visits included in the global period for a service, the
equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also note that we believe these same assumptions would
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question would be available if the
room is not being occupied by a particular patient. For additional
information, we refer readers to our discussion of these issues in the
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there is a standardized number of minutes, depending on the type
of procedure, its typical setting, its global period, and the other
procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice clinical labor
tasks to avoid duplicative inputs and to reflect the resource costs of
furnishing the typical service.
We refer readers to section II.B. of this proposed rule,
Determination of Practice Expense Relative Value Units (PE RVUs), for
more information regarding the collaborative work of CMS and the RUC in
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. However, some recommendations include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2020, we received invoices for several new supply and
equipment items. Tables 22 and 23 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this proposed rule, Determination of Practice Expense Relative
Value Units, we encouraged stakeholders to review the prices associated
with these new and existing items to determine whether these prices
appear to be accurate. Where prices appear inaccurate, we encouraged
stakeholders to submit invoices or other information to improve the
accuracy of pricing for these items in the direct PE database by
February 10th of the following year for consideration in future
rulemaking, similar to our process for consideration of RUC
recommendations.
[[Page 40568]]
We remind stakeholders that due to the relativity inherent in the
development of RVUs, reductions in existing prices for any items in the
direct PE database increase the pool of direct PE RVUs available to all
other PFS services. Tables 22 and 23 also include the number of
invoices received and the number of nonfacility allowed services for
procedures that use these equipment items. We provide the nonfacility
allowed services so that stakeholders will note the impact the
particular price might have on PE relativity, as well as to identify
items that are used frequently, since we believe that stakeholders are
more likely to have better pricing information for items used more
frequently. A single invoice may not be reflective of typical costs and
we encourage stakeholders to provide additional invoices so that we
might identify and use accurate prices in the development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we included the item in the direct PE input database without any
associated price. Although including the item without an associated
price means that the item does not contribute to the calculation of the
final PE RVU for particular services, it facilitates our ability to
incorporate a price once we obtain information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our direct PE inputs do not include clinical
labor minutes assigned to the service period because the cost of
clinical labor during the service period for a procedure in the
facility setting is not considered a resource cost to the practitioner
since Medicare makes separate payment to the facility for these costs.
We address proposed code-specific refinements to clinical labor in the
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the public use files for the PFS proposed and final
rules for each year display the services subject to the MPPR for
diagnostic cardiovascular services, diagnostic imaging services,
diagnostic ophthalmology services, and therapy services. We also
include a list of procedures that meet the definition of imaging under
section 1848(b)(4)(B) of the Act, and therefore, are subject to the
OPPS cap for the upcoming calendar year. The public use files for CY
2020 are available on the CMS website under downloads for the CY 2020
PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For more information regarding the history of the MPPR policy, we refer
readers to the CY 2014 PFS final rule with comment period (78 FR 74261
through 74263). For more information regarding the history of the OPPS
cap, we refer readers to the CY 2007 PFS final rule with comment period
(71 FR 69659 through 69662).
4. Proposed Valuation of Specific Codes for CY 2020
(1) Tissue Grafting Procedures (CPT Codes 15X00, 15X01, 15X02, 15X03,
and 15X04)
CPT code 20926 (Tissue grafts, other (e.g., paratenon, fat,
dermis)), was identified through a review of services with anomalous
sites of service when compared to Medicare utilization data. The CPT
Editorial Panel subsequently replaced CPT code 20926 with five codes in
the Integumentary section to better describe tissue grafting
procedures.
We are proposing the RUC-recommended work RVUs of 6.68 for CPT code
15X00 (Grafting of autologous soft tissue, other, harvested by direct
excision (e.g., fat, dermis, fascia)), 6.73 for CPT code 15X01
(grafting of autologous fat harvested by liposuction technique to
trunk, breasts, scalp, arms, and/or legs; 50cc or less injectate), 2.50
for CPT code 15X02 (grafting of autologous fat harvested by liposuction
technique to trunk, breasts, scalp, arms, and/or legs; each additional
50cc injectate, or part thereof (list separately in addition to code
for primary procedure)), 6.83 for CPT code 15X03 (grafting of
autologous fat harvested by liposuction technique to face, eyelids,
mouth, neck, ears, orbits, genitalia, hands, and/or feet; 25cc or less
injectate), and 2.41 for CPT code 15X04 (grafting of autologous fat
harvested by liposuction technique to face, eyelids, mouth, neck, ears,
orbits, genitalia, hands, and/or feet; each additional 25cc injectate,
or part thereof (list separately in addition to code for primary
procedure)).
We are proposing the RUC-recommended direct PE inputs for this code
family without refinement.
(2) Drug Delivery Implant Procedures (CPT Codes 11981, 11982, 11983,
206X0, 206X1, 206X2, 206X3, 206X4, and 206X5)
CPT codes 11980-11983 were identified as potentially misvalued
since the majority specialty found in recent claims data differs from
the two specialties that originally surveyed the codes. The current
valuation of CPT code 11980 (Subcutaneous hormone pellet implantation
(implantation of estradiol and/or testosterone pellets beneath the
skin)) was reaffirmed by the RUC as the physician work had not changed
since the last review. The CPT Editorial Panel revised the other three
existing codes in the family and created six additional add-on codes to
describe orthopaedic drug delivery. These codes were surveyed and
reviewed for the October 2018 RUC meeting.
CPT code 11980 (Subcutaneous hormone pellet implantation
(implantation of estradiol and/or testosterone pellets beneath the
skin)) with the current work value of 1.10 RVUs and 12 minutes of
intraservice time, and 27 minutes of total time, was determined to be
unchanged since last reviewed and was recommended by the RUC to be
maintained. We concur. We also are not proposing any direct PE
refinements to CPT code 11980. CPT code 11981 (Insertion, non-
biodegradable drug delivery implant) has a current work RVU of 1.48,
with 39 minutes of total physician time. The specialty society survey
recommended a work RVU of 1.30, with 31 minutes of total physician time
and 5 minutes of intraservice time. The RUC recommended a work RVU of
1.30 (25th percentile), with 30 minutes of total physician time and 5
minutes of intraservice time. For comparable reference CPT codes to CPT
code 11981, the RUC and the survey respondents had selected CPT code
55876 (Placement of interstitial device(s) for radiation therapy
guidance (e.g., fiducial markers, dosimeter), prostate (via needle, any
approach), single or multiple (work RVU = 1.73, 20 minutes intraservice
time and 59 total minutes)) and CPT code 57500 (Biopsy of cervix,
[[Page 40569]]
single or multiple, or local excision of lesion, with or without
fulguration (separate procedure) (work RVU = 1.20, 15 minutes
intraservice time and 29 total minutes)). The RUC further offers for
comparison, CPT code 67515 (Injection of medication or other substance
into Tenon's capsule (work RVU = 1.40 (from CY 2018), 5 minutes
intraservice time and 21 minutes total time)), CPT code 12013 (Simple
repair of superficial wounds of face, ears, eyelids, nose, lips and/or
mucous membranes; 2.6 cm to 5.0 cm (work RVU = 1.22 and 27 total
minutes)) and CPT code 12004 (Simple repair of superficial wounds of
scalp, neck, axillae, external genitalia, trunk and/or extremities
(including hands and feet); 7.6 cm to 12.5 cm) (work RVU = 1.44 and 29
total minutes)). In addition, we offer CPT code 67500 (Injection of
medication into cavity behind eye) (work RVU = 1.18 and 5 minutes
intraservice time and 33 total minutes) for reference. Given that the
CPT code 11981 incurs a 23 percent reduction in the new total physician
time and with reference to CPT code 67500, we are proposing a work RVU
of 1.14, and accept the survey recommended 5 minutes for intraservice
time and 30 minutes of total time. We are not proposing any direct PE
refinements to CPT code 11981.
CPT code 11982 (Removal, non-biodegradable drug delivery implant)
has a current work RVU of 1.78, with 44 minutes of total physician
time. The specialty society survey recommended a work RVU of 1.70 RVU,
with 10 minutes of intraservice time and 34 minutes of total physician
time. The RUC also recommended a work RVU of 1.70, with 10 minutes of
intraservice time and 33 minutes of total physician time. The RUC
confirmed that removal (CPT code 11982), requires more intraservice
time to perform than the insertion (CPT code 11981). For comparable
reference codes to CPT code 11982, the RUC and the survey respondents
had selected CPT code 54150 (Circumcision, using clamp or other device
with regional dorsal penile or ring block) (work RVU = 1.90, 15 minutes
intraservice time and 45 total minutes)) and CPT code 12004 (Simple
repair of superficial wounds of scalp, neck, axillae, external
genitalia, trunk and/or extremities (including hands and feet); 7.6 cm
to 12.5 cm) (work RVU = 1.44, with 17 minutes intraservice time and 29
minutes total time)). We offer CPT code 64486 (Injections of local
anesthetic for pain control and abdominal wall analgesia on one side)
(work RVU = 1.27, 10 minutes intraservice time and 35 total minutes))
for reference. Given that the CPT code 11982 incurs a 25 percent
reduction in the new total physician time and with reference to CPT
code 64486, we are proposing a work RVU of 1.34, and accept the RUC-
recommended 10 minutes for intraservice time and 33 minutes of total
time. We are not proposing any direct PE refinements to CPT code 11982.
CPT code 11983 (Removal with reinsertion, non-biodegradable drug
delivery implant) has a current work RVU of 3.30, with 69 minutes of
total physician time. The specialty society survey recommended a work
RVU of 2.50 RVU, with 15 minutes of intraservice time and 41 minutes of
total physician time. The RUC also recommended a work RVU of 2.10, with
15 minutes of intraservice time and 40 minutes of total physician time.
The RUC confirmed that CPT code 11983 requires more intraservice time
to perform than the insertion CPT code 11981. For comparable reference
codes to CPT code 11983, the RUC and the survey respondents had
selected CPT code 55700 (Biopsy, prostate; needle or punch, single or
multiple, any approach) (work RVU = 2.50, 15 minutes intraservice time
and 35 total minutes)), CPT code 54150 (Circumcision, using clamp or
other device with regional dorsal penile or ring block) (work RVU =
1.90, 15 minutes intraservice time and 45 total minutes)) and CPT code
52281 (Cystourethroscopy, with calibration and/or dilation of urethral
stricture or stenosis, with or without meatotomy, with or without
injection procedure for cystography, male or female) (work RVU = 2.75
and 20 minutes intraservice time and 46 minutes total time)). We offer
CPT code 62324 (Insertion of indwelling catheter and administration of
substance into spinal canal of upper or middle back) (work RVU = 1.89,
15 minutes intraservice time and 43 total minutes)) for reference.
Given that the CPT code 11983 incurs a 42 percent reduction in new
total physician time and with reference to CPT code 62324, we are
proposing a work RVU of 1.91, and accept the RUC-recommended 15 minutes
for intraservice time and 40 minutes of total time. We are not
proposing any direct PE refinements to CPT code 11983.
The new proposed add-on CPT codes 206X0-206X5 are intended to be
typically reported with CPT codes 11981-11983, with debridement or
arthrotomy procedures done primarily by orthopedic surgeons. The
specialty society's survey for CPT code 206X0 (Manual preparation and
insertion of drug delivery device(s), deep (e.g., subfascial)) found a
2.00 work RVU value at the median and a 1.50 work RVU value at the 25th
percentile, with 20 minutes of intraservice time and 30 minutes of
total physician time, for the preparation of the antibiotic powder and
cement, rolled into beads and threaded onto suture for insertion into
the infected bone. The RUC recommended a work RVU of 1.50, with 20
minutes of intraservice time and 27 minutes of total physician time.
The RUC's reference CPT codes included CPT code 11047 (Debridement,
bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or
fascia, if performed); each additional 20 sq cm, or part thereof) (work
RVU = 1.80, and 30 minutes intraservice time)), CPT codes 64484
(Injection(s), anesthetic agent and/or steroid, transforaminal
epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral,
each additional level) (work RVU = 1.00 and 10 minutes intraservice
time)), and CPT code 36227 (Selective catheter placement, external
carotid artery, unilateral, with angiography of the ipsilateral
external carotid circulation and all associated radiological
supervision and interpretation) (work RVU = 2.09 and 20 minutes
intraservice time)). Our review of similar add-on CPT codes yielded CPT
code 64634 (Destruction of upper or middle spinal facet joint nerves
with imaging guidance) (work RVU = 1.32 and 20 minutes intraservice
time)). We are proposing for CPT code 206X0, a work RVU of 1.32, and
accept the RUC-recommended 20 minutes of intraservice time and 20
minutes of total time.
The specialty society's survey for CPT code 206X1 (Manual
preparation and insertion of drug delivery device(s), intramedullary)
found a 3.25 work RVU value at the median and a 2.50 work RVU value at
the 25th percentile, with 25 minutes of intraservice time and 38
minutes of total physician time, for the preparation of the
``antibiotic nail'' ready for insertion into the intramedullary canal
with fluoroscopic guidance. The RUC recommended a work RVU of 2.50,
with 25 minutes of intraservice time and 32 minutes of total physician
time. The RUC's reference CPT codes included CPT code 11047
(Debridement, bone (includes epidermis, dermis, subcutaneous tissue,
muscle and/or fascia, if performed); each additional 20 sq cm, or part
thereof) (work RVU = 1.80, and 30 minutes intraservice time)), CPT code
57267 (Insertion of mesh or other prosthesis for repair of pelvic floor
defect, each site (anterior, posterior compartment), vaginal approach
(work
[[Page 40570]]
RVU = 4.88 and 45 minutes intraservice time)), and CPT code 36227
(Selective catheter placement, external carotid artery, unilateral,
with angiography of the ipsilateral external carotid circulation and
all associated radiological supervision and interpretation (work RVU =
2.09 and 15 minutes intraservice time)). We find that the reference CPT
code 11047, with 30 minutes of intraservice time, is suitable, but we
adjust our proposed work RVU of 1.70 to account for the 25 minutes,
instead of our reference code's 30 minutes of intraservice time (and
the 32 minutes of total time), for CPT code 206X1.
The specialty society's survey for CPT code 206X2 (Manual
preparation and insertion of drug delivery device(s), intra-articular)
found a 4.00 work RVU value at the median and a 2.60 work RVU value at
the 25th percentile, with 30 minutes of intraservice time and 45
minutes of total physician time, for the preparation of the antibiotic
cement inserted into a pre-fabricated silicone mold, when after setting
up, will be cemented to the end of the bone (with the joint). The RUC
recommended a work RVU of 2.60, with 30 minutes of intraservice time
and 37 minutes of total physician time. The RUC's reference CPT codes
included CPT code 11047 (Debridement, bone (includes epidermis, dermis,
subcutaneous tissue, muscle and/or fascia, if performed); each
additional 20 sq cm, or part thereof (work RVU = 1.80, and 30 minutes
intraservice time)), CPT code 57267 (Insertion of mesh or other
prosthesis for repair of pelvic floor defect, each site (anterior,
posterior compartment), vaginal approach (work RVU = 4.88 and 45
minutes intraservice time)), and CPT code 36227 (Selective catheter
placement, external carotid artery, unilateral, with angiography of the
ipsilateral external carotid circulation and all associated
radiological supervision and interpretation (work RVU = 2.09 and 20
minutes intraservice time)). We find that the reference CPT code 11047,
with 30 minutes of intraservice time, is a suitable guide and we are
proposing the work RVU of 1.80 with the RUC-recommended 30 minutes of
intraservice time and 37 minutes of total time, for CPT code 206X2.
The specialty society's survey for CPT code 206X3 (Removal of drug
delivery device(s), deep (e.g., subfascial)) found a 1.75 work RVU
value at the median and a 1.13 work RVU value at the 25th percentile,
with 15 minutes of intraservice time and 18 minutes of total physician
time. The work includes a marginal dissection to expose the drug
delivery device and to remove it. The RUC recommended a work RVU of
1.13, with 18 minutes of total physician time and 15 minutes of
intraservice time. The RUC's reference CPT codes included CPT code
11047 (Debridement, bone (includes epidermis, dermis, subcutaneous
tissue, muscle and/or fascia, if performed); each additional 20 sq cm,
or part thereof (work RVU = 1.80, and 30 minutes intraservice time)),
CPT code 64484 (Injection(s), anesthetic agent and/or steroid,
transforaminal epidural, with imaging guidance (fluoroscopy or CT);
lumbar or sacral, each additional level (work RVU = 1.00 and 10 minutes
intraservice time)), and CPT code 64480 (Injection(s), anesthetic agent
and/or steroid, transforaminal epidural, with imaging guidance
(fluoroscopy or CT); cervical or thoracic, each additional level (work
RVU = 1.20 and 15 minutes intraservice time)). We are proposing the
RUC-recommended work RVU of 1.13 with 15 minutes of intraservice time
and 18 minutes of total time for 206X3.
The specialty society's survey for CPT code 206X4 (Removal of drug
delivery device(s), intramedullary) found a 2.50 work RVU value at the
median and a 1.80 work RVU value at the 25th percentile, with 20
minutes of intraservice time and 28 minutes of total physician time.
The work includes a marginal dissection, in addition to what was in the
base procedure, to loosen and expose the drug delivery device and to
remove it, any remaining drug delivery device shards that may have
broken off. The RUC recommended a work RVU of 1.80, with 20 minutes of
intraservice time and 23 minutes of total physician time. The RUC's
reference CPT codes included CPT code 11047 (Debridement, bone
(includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia,
if performed); each additional 20 sq cm, or part thereof (work RVU =
1.80, and 30 minutes intraservice time)), CPT codes 37253
(Intravascular ultrasound (noncoronary vessel) during diagnostic
evaluation and/or therapeutic intervention, including radiological
supervision and interpretation; each additional noncoronary vessel
(work RVU = 1.44 and 20 minutes intraservice time)), and CPT code 36227
(Selective catheter placement, external carotid artery, unilateral,
with angiography of the ipsilateral external carotid circulation and
all associated radiological supervision and interpretation (work RVU =
2.09 and 15 minutes intraservice time)). We are proposing the RUC-
recommended work RVU of 1.80 with 20 minutes of intraservice time and
23 minutes of total time for 206X4.
The specialty society's survey for CPT code 206X5 (Removal of drug
delivery device(s), intra-articular) found a 3.30 work RVU value at the
median and a 2.15 work RVU value at the 25th percentile, with 25
minutes of intraservice time and 28 minutes of total physician time.
The work includes the removal of the intra-articular drug delivery
device that is cemented to both sides of the joint without removing too
much bone in the process. The RUC recommended a work RVU of 2.15, with
25 minutes of intraservice time and 28 minutes of total physician time.
The RUC's reference CPT codes included CPT code 11047 (Debridement,
bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or
fascia, if performed); each additional 20 sq cm, or part thereof (work
RVU = 1.80, and 30 minutes intraservice time)), CPT code 36476
(Endovenous ablation therapy of incompetent vein, extremity, inclusive
of all imaging guidance and monitoring, percutaneous, radiofrequency;
subsequent vein(s) treated in a single extremity, each through separate
access sites (work RVU = 2.65 and 30 minutes intraservice time)), and
CPT code 36227 (Selective catheter placement, external carotid artery,
unilateral, with angiography of the ipsilateral external carotid
circulation and all associated radiological supervision and
interpretation (work RVU = 2.09 and 15 minutes intraservice time)). We
are proposing the RUC-recommended work RVU of 2.15 with 25 minutes of
intraservice time and 28 minutes of total time for 206X5.
(3) Bone Biopsy Trocar-Needle (CPT Codes 20220 and 20225)
In October 2017, CPT code 20225 (Biopsy, bone, trocar, or needle;
deep (e.g., vertebral body, femur)) was identified as being performed
by a different specialty than the one that originally surveyed this
service. CPT code 20220 (Biopsy, bone, trocar, or needle; superficial
(e.g., ilium, sternum, spinous process, ribs)) was added as part of the
family, and both codes were surveyed and reviewed for the January 2019
RUC meeting.
We disagree with the RUC-recommended work RVU of 1.93 for CPT code
20220 and we are proposing a work RVU of 1.65 based on a crosswalk to
CPT code 47000 (Biopsy of liver, needle; percutaneous). CPT code 47000
shares the same intraservice time of 20 minutes with CPT code 20220 and
has slightly higher total time at 55 minutes as compared to 50 minutes.
It
[[Page 40571]]
is also one of the top reference codes selected by the survey
respondents. In our review of CPT code 20220, we noted that the
recommended intraservice time is decreasing from 22 minutes to 20
minutes (9 percent reduction), and that the recommended total time is
increasing from 49 minutes to 50 minutes (2 percent increase). However,
the RUC-recommended work RVU is increasing from 1.27 to 1.93, which is
an increase of 52 percent. Although we do not imply that the decrease
in time as reflected in survey values must equate to a one-to-one or
linear decrease in the valuation of work RVUs, we believe that since
the two components of work are time and intensity, changes in surveyed
work time should be appropriately reflected in the proposed work RVUs.
In the case of CPT code 20220, we believe that it would be more
accurate to propose a work RVU of 1.65, based on a crosswalk to CPT
code 47000, to account for the decrease in the surveyed intraservice
work time. We believe that the work carried out by the practitioner in
CPT code 47000 is potentially more intense than the work performed in
CPT code 20220, as the reviewed code is a superficial bone biopsy as
opposed to the non-superficial biopsy taking place on an internal organ
(the liver) described by CPT code 47000. We also note that the survey
respondents considered CPT code 47000 to have similar intensity to CPT
code 20220: 50 percent or more of the survey respondents rated the two
codes as ``identical'' under the categories of Mental Effort and
Judgment, Physical Effort Required, and Psychological Stress, along
with a plurality of survey respondents rating the two codes as
identical in the category of Technical Skill Required. We believe that
this provides further support for our belief that CPT code 20220 should
be crosswalked to CPT code 47000 at the same work RVU of 1.65.
We disagree with the RUC-recommended work RVU of 3.00 for CPT code
20225 and we are proposing a work RVU of 2.45 based on a crosswalk to
CPT code 30906 (Control nasal hemorrhage, posterior, with posterior
nasal packs and/or cautery, any method; subsequent). CPT code 30906
shares the same intraservice time of 30 minutes and has 1 fewer minute
of total time as compared to CPT code 20225. When reviewing this code,
we observed a pattern similar to what we had seen with CPT code 20220.
We note that the recommended intraservice time for CPT code 20225 is
decreasing from 60 minutes to 30 minutes (50 percent reduction), and
the recommended total time is decreasing from 135 minutes to 64 minutes
(53 percent reduction); however, the RUC-recommended work RVU is
increasing from 1.87 to 3.00, which is an increase of about 60 percent.
As we noted earlier, we do not believe that the decrease in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, and we are not proposing a
linear decrease in the work valuation based on these time ratios.
Indeed, we agree with the RUC recommendation that the work RVU of CPT
code 20225 should increase over the current valuation. However, we
believe that since the two components of work are time and intensity,
significant decreases in time should be appropriately reflected in
changes to the work RVUs, and we do not believe that it would be
accurate to propose the recommended work RVU of 3.00 given the
significant decreases in surveyed work time.
Instead, we believe that it would be more accurate to propose a
work RVU of 2.45 for CPT code 20225 based on a crosswalk to CPT code
30906. We note that this proposed work RVU is a very close match to the
intraservice time ratio between the two codes in the family; we are
proposing a work RVU of 1.65 for CPT code 20220 with 20 minutes of
intraservice work time, and a work RVU of 2.45 for CPT code 20225 with
30 minutes of intraservice work time. (The exact intraservice time
ratio calculates to a work RVU of 2.47.) We believe that the proposed
work RVUs maintain the relative intensity of the two codes in the
family, and better preserve relativity with the rest of the codes on
the PFS.
For the direct PE inputs, we are proposing to replace the bone
biopsy device (SF055) supply with the bone biopsy needle (SC077) in CPT
code 20225. We note that this code currently makes use of the bone
biopsy needle, and there was no rationale provided in the recommended
materials to explain why it would now be typical for the bone biopsy
needle to be replaced by the bone biopsy device. We are proposing to
maintain the use of the current supply item. We are also proposing to
adopt a 90 percent utilization rate for the use of the CT room (EL007)
equipment in CPT code 20225. We previously finalized a policy in the CY
2010 PFS final rule (74 FR 61754 through 61755) to increase the
equipment utilization rate to 90 percent for expensive diagnostic
equipment priced at more than $1 million, and specifically cited the
use of CT and MRI equipment which would be subject to this utilization
rate.
(4) Trigger Point Dry Needling (CPT Codes 205X1 and 205X2)
For CY 2020, the CPT Editorial Panel approved two new codes to
report dry needling of musculature trigger points. These codes were
surveyed and reviewed by the HCPAC for the January 2019 RUC meeting.
We disagree with the HCPAC-recommended work RVU of 0.45 for CPT
code 205X1 (Needle insertion(s) without injection(s), 1 or 2 muscle(s))
and we are proposing a work RVU of 0.32 based on a crosswalk to CPT
code 36600 (Arterial puncture, withdrawal of blood for diagnosis). CPT
code 36600 shares the identical intraservice time, total time, and
intensity with CPT code 205X1, which makes it an appropriate choice for
a crosswalk. In our review of CPT code 205X1, we compared the procedure
to the top reference code chosen by the survey participants, CPT code
97140 (Manual therapy techniques (e.g., mobilization/manipulation,
manual lymphatic drainage, manual traction), 1 or more regions, each 15
minutes). This therapy procedure has 50 percent more intraservice time
than CPT code 205X1, as well as higher total time; however, the
recommended work RVU of 0.45 was higher than the work RVU of 0.43 for
the top reference code from the survey. We did not agree that CPT code
205X1 should be valued at a higher rate, and therefore, we are
proposing a work RVU of 0.32 based on the aforementioned crosswalk to
CPT code 36600.
We disagree with the HCPAC-recommended work RVU of 0.60 for CPT
code 205X2 (Needle insertion(s) without injection(s), 3 or more
muscle(s)) and we are proposing a work RVU of 0.48 based on a crosswalk
to CPT codes 97113 (Therapeutic procedure, 1 or more areas, each 15
minutes; aquatic therapy with therapeutic exercises) and 97542
(Wheelchair management (e.g., assessment, fitting, training), each 15
minutes). Both of these codes share the same work RVU of 0.48 and the
same intraservice time of 15 minutes as CPT code 205X2, with CPT code
97113 having two fewer minutes of total time and CPT code 97542 having
two additional minutes of total time. We note that this proposed work
RVU is an exact match of the intraservice time ratio between the two
codes in the family; we are proposing a work RVU of 0.32 for CPT code
205X1 with 10 minutes of intraservice work time, and a work RVU of 0.48
for CPT code 205X2 with 15 minutes of intraservice work time. We also
considered crosswalking the work RVU of CPT code 205X2 to the
[[Page 40572]]
top reference code from the survey, CPT code 97140, at a work RVU of
0.43. However, we chose to employ the crosswalk to CPT codes 97113 and
97542 at a work RVU of 0.48 instead, due to the fact that the survey
respondents indicated that CPT code 205X2 was more intense than CPT
code 97140.
We are also proposing to designate CPT codes 205X1 and 205X2 as
``always therapy'' procedures, and we are soliciting comments on this
designation. We are proposing the RUC-recommended direct PE inputs for
all codes in the family.
(5) Closed Treatment Vertebral Fracture (CPT Code 22310)
This service was identified through a screen of services with a
negative IWPUT and Medicare utilization over 10,000 for all services or
over 1,000 for Harvard valued and CMS/Other source codes.
For CPT code 22310 (Closed treatment of vertebral body fracture(s),
without manipulation, requiring and including casting or bracing), we
disagree with the recommended work RVU of 3.75 because we do not
believe that this reduction in work RVU from the current value of 3.89
is commensurate with the RUC-recommended a 33-minute reduction in
intraservice time and a 105-minute reduction in total time. While we
understand that the RUC considers the current Harvard study time values
for this service to be invalid estimations, we believe that a further
reduction in work RVUs is warranted given the significance of the RUC-
recommended reduction in physician time. We believe that it would be
more accurate to propose a work RVU of 3.45 with a crosswalk to CPT
code 21073 (Manipulation of temporomandibular joint(s) (TMJ),
therapeutic, requiring an anesthesia service (i.e., general or
monitored anesthesia care)), which has an identical intraservice time
and similar total time as those proposed by the RUC for CPT code 22310,
as we believe that this better accounts for the decrease in the
surveyed work time.
For the direct PE inputs, we are proposing to refine the equipment
time for the power table (EF031) to conform to our established standard
for non-highly technical equipment.
(6) Tendon Sheath Procedures (CPT Codes 26020, 26055, and 26160)
The RUC identified these services through a screen of services with
a negative IWPUT and Medicare utilization over 10,000 for all services
or over 1,000 for Harvard valued and CMS/Other source codes. For CPT
code 26020 (Drainage of tendon sheath, digit and/or palm, each), we do
not agree with the RUC-recommended work RVU of 7.79 based on the survey
median. While we agree that the survey data validate an increase in
work RVU, we see no compelling reason that this service would be
significantly more intense to furnish than services of similar time
values. Therefore, we are proposing a work RVU of 6.84 which is the
survey 25th percentile. As further support for this value, we note that
it falls between the work RVUs of CPT code 28122 (Partial excision
(craterization, saucerization, sequestrectomy, or diaphysectomy) bone
(e.g., osteomyelitis or bossing); tarsal or metatarsal bone, except
talus or calcaneus), with a work RVU of 6.76, and CPT code 28289
(Hallux rigidus correction with cheilectomy, debridement and capsular
release of the first metatarsophalangeal joint; without implant), with
a work RVU of 6.90; both codes have intraservice time values that are
identical to, and total time values that are similar to, the RUC-
recommended time values for CPT code 26020.
For CPT code 26055 (Tendon sheath incision (e.g., for trigger
finger)), we do not agree with the RUC recommendation to increase the
work RVU to 3.75 despite a reduction in physician time. Instead, we are
proposing to maintain the current work RVU of 3.11; we are supporting
this based on a total time increment methodology between the CPT code
26020 and CPT code 26055. The total time ratio between the recommended
time of 119 minutes and the recommended 262 minutes for code 26020
equals 45 percent, and 45 percent of our proposed RVU of 6.84 for CPT
code 26020 equals a work RVU of 3.10, which we believe validates the
current work RVU of 3.11. We are proposing the RUC-recommended work RVU
of 3.57 for CPT code 26160 (Excision of lesion of tendon sheath or
joint capsule (e.g., cyst, mucous cyst, or ganglion), hand or finger).
We note that our proposed work RVUs validate the RUC's contention that
CPT code 26160 is slightly more intense to perform than CPT code 26055.
For the direct PE inputs, we are proposing to refine the quantity
of the impervious staff gown (SB027) supply from 2 to 1 for CPT codes
26055 and 26160. We believe that the second impervious staff gown
supply is duplicative due to the inclusion of this same supply in the
surgical cleaning pack (SA043). The recommended materials state that a
gown is worn by the practitioner and one assistant, which are provided
by one standalone gown and a second gown in the surgical cleaning pack.
(7) Closed Treatment Fracture--Hip (CPT Code 27220)
This service was identified through a screen of services with a
negative IWPUT and Medicare utilization over 10,000 for all services or
over 1,000 for Harvard valued and CMS/Other source codes. For CPT code
27220 (Closed treatment of acetabulum (hip socket) fracture(s); without
manipulation), we disagree with the RUC-recommended work RVU of 6.00
based on the survey median value, because we do not believe that this
reduction in work RVU from the current value of 6.83 is commensurate
with the RUC-recommended a 19-minute reduction in intraservice time and
an 80-minute reduction in total time. While we understand that the RUC
considers the current Harvard study time values for this service to be
invalid estimations, we believe that a further reduction in work RVUs
is warranted given the significance of the RUC-recommended reduction in
physician time. We believe that it would be more accurate to propose
the survey 25th percentile work RVU of 5.50, and we are supporting this
value with a crosswalk to CPT code 27267 (Closed treatment of femoral
fracture, proximal end, head; without manipulation) to account for the
decrease in the surveyed work time.
For the direct PE inputs, we are proposing to refine the equipment
time for the power table (EF031) to conform to our established standard
for non-highly technical equipment.
(8) Arthrodesis--Sacroliliac Joint (CPT Code 27279)
In the CY 2018 PFS final rule (82 FR 53017), CPT code 27279
(Arthrodesis, sacroiliac joint, percutaneous or minimally invasive
(indirect visualization), with image guidance, includes obtaining bone
graft when performed, and placement of transfixing device) was
nominated for review by stakeholders as a potentially misvalued
service. We stated that CPT code 27279 is potentially misvalued, and
that a comprehensive review of the code values was warranted. This code
was subsequently reviewed by the RUC. According to the specialty
societies, the previous 2014 survey of CPT code 27279, was based on
flawed methodology that resulted in an underestimation of
intraoperative intensity. When CPT code 27279 was surveyed in 2014,
there was a low rate of response. Due to the dearth of survey data and
the RUC's agreement with the specialty society at the time that the
[[Page 40573]]
survey respondents had somewhat overvalued the work involved in
performing this service, the RUC used a crosswalk to CPT code 62287
(Decompression procedure, percutaneous, of nucleus pulposus of
intervertebral disc, any method utilizing needle based technique to
remove disc material under fluoroscopic imaging or other form of
indirect visualization, with discography and/or epidural injection(s)
at the treated level(s), when performed, single or multiple levels,
lumbar) to recommend a work RVU of 9.03. The specialty societies
indicated that with increased and broader utilization of this
technique, the 2018 survey is a more robust assessment of physician
work and intensity and provides more data with which to make a
crosswalk recommendation. According to the RUC, there is no compelling
evidence that the physician work, intensity or complexity has changed
for this service.
We are proposing to maintain the current work RVU of 9.03 as
recommended by the RUC. A stakeholder stated that maintaining this RVU
would constitute the continued undervaluation of this service, and that
this would incentivize use of a more intensive and invasive procedure,
CPT code 27280 (Arthrodesis, open, sacroiliac joint, including
obtaining bone graft, including instrumentation, when performed), as
well as incentivize this service to be inappropriately furnished on an
inpatient basis. This stakeholder has requested that, in the interest
of protecting patient access, we implement payment parity between the
two services by proposing to crosswalk the work RVU of CPT code 27279
to that of CPT code 27280, which has a work RVU of 20.00. While we are
proposing the RUC-recommended work RVU, we are soliciting public
comment on whether an alternative valuation of 20.00 would be more
appropriate. This alternative valuation would recognize relative parity
between these two services in terms of the work inherent in furnishing
them.
We are proposing the RUC-recommended direct PE inputs for CPT code
27279.
(9) Pericardiocentesis and Pericardial Drainage (CPT Code 3X000, 3X001,
3X002, and 3X003)
CPT code 33015 (Tube pericardiostomy) was identified as potentially
misvalued on a Relativity Assessment Workgroup (RAW) screen of codes
with a negative IWPUT and Medicare utilization over 10,000 for all
services or over 1,000 for Harvard valued and CMS or other source
codes. In September 2018, the CPT Editorial Panel deleted four existing
codes and created four new codes to describe periodcardiocentesis
drainage procedures to differentiate by age and to include imaging
guidance.
We are proposing to refine the work RVU for all four codes in the
family. We disagree with the RUC-recommended work RVU of 5.00 for CPT
code 3X000 (Pericardiocentesis, including imaging guidance, when
performed) and are proposing a work RVU of 4.40 based on a crosswalk to
CPT code 43244 (Esophagogastroduodenoscopy, flexible, transoral; with
band ligation of esophageal/gastric varices). CPT code 43244 shares the
same intraservice time of 30 minutes with CPT code 3X000 and has a
slightly longer total time of 81 minutes as compared to 75 minutes for
the reviewed code. In our review of CPT code 3X000, we noted that the
recommended intraservice time as compared to the current initial
pericardiocentesis procedure (CPT code 33010) is increasing from 24
minutes to 30 minutes (25 percent), and the recommended total time is
remaining the same at 75 minutes; however, the RUC-recommended work RVU
is increasing from 1.99 to 5.00, which is an increase of 151 percent.
Although we did not imply that the decrease in time as reflected in
survey values must equate to a one-to-one or linear increase in the
valuation of work RVUs, we believe that since the two components of
work are time and intensity, modest increases in time should be
appropriately reflected with a commensurate increase the work RVUs. We
also conducted a search in the RUC database among 0-day global codes
with 30 minutes of intraservice time and comparable total time of 65-85
minutes. Our search identified 49 codes and all 49 of these codes had a
work RVU lower than 5.00. We do not believe that it would serve the
interests of relativity to establish a new maximum work RVU for this
range of time values.
As a result, we believe that it is more accurate to propose a work
RVU of 4.40 for CPT code 3X000 based on a crosswalk to CPT code 43244
to account for these modest increases in the surveyed work time as
compared to the predecessor pericardiocentesis codes. We are aware that
CPT code 3X000 is bundling imaging guidance into the new procedure,
which was not included in the previous pericardiocentesis codes.
However, we do not believe that the recoding of the services in this
family has resulted in an increase in their intensity, only a change in
the way in which they will be reported, and therefore, we do not
believe that it would serve the interests of relativity to propose the
RUC-recommended work values for all of the codes in this family. We
also note that, through the bundling of some of these frequently
reported services, it is reasonable to expect that the new coding
system will achieve savings via elimination of duplicative assumptions
of the resources involved in furnishing particular servicers. For
example, a practitioner would not be carrying out the full preservice
work twice for CPT codes 33010 and 76930, but preservice times were
assigned to both codes under the old coding. We believe the new coding
assigns more accurate work times, and thus, reflects efficiencies in
resource costs that existed but were not reflected in the services as
they were previously reported. If the addition of imaging guidance had
made the new CPT codes significantly more intense to perform, we
believe that this would have been reflected in the surveyed work times,
which were largely unchanged from the predecessor codes.
We disagree with the RUC-recommended work RVU of 5.50 for CPT code
3X001 (Pericardial drainage with insertion of indwelling catheter,
percutaneous, including fluoroscopy and/or ultrasound guidance, when
performed; 6 years and older without congenital cardiac anomaly) and
are proposing a work RVU of 4.62 based on a crosswalk to CPT code 52234
(Cystourethroscopy, with fulguration (including cryosurgery or laser
surgery) and/or resection of; SMALL bladder tumor(s) (0.5 up to 2.0
cm)). CPT code 52234 shares the same intraservice time of 30 minutes
with CPT code 3X001 and has 2 additional minutes of total time at 79
minutes as compared to 77 minutes for the reviewed code. In our review
of CPT code 3X001, we noted many of the same issues that we had raised
with CPT code 3X000, in particular with the increase in the work RVU
greatly exceeding the increase in the surveyed work times as compared
to the predecessor pericardiocentesis codes. We searched the RUC
database again for 0-day global codes with 30 minutes of intraservice
time and comparable total time of 67-87 minutes. Our search identified
43 codes and again all 43 of these codes had a work RVU lower than
5.50. As we stated with regard to CPT code 3X000, we do not believe
that it would serve the interests of relativity to establish a new
maximum work RVU for this range of time values. We believe that it is
more accurate to propose a work RVU of 4.62 for CPT code 3X001 based on
a crosswalk to CPT code 52234 based on the same rationale that we
[[Page 40574]]
detailed with regards to CPT code 3X000.
We disagree with the RUC-recommended work RVU of 6.00 for CPT code
3X002 (Pericardial drainage with insertion of indwelling catheter,
percutaneous, including fluoroscopy and/or ultrasound guidance, when
performed; birth through 5 years of age, or any age with congenital
cardiac anomaly) and are proposing a work RVU of 5.00 based on the
survey 25th percentile value. In our review of CPT code 3X002, we noted
many of the same issues that we had raised with CPT codes 3X000 and
3X001, in particular with the increase in the work RVU greatly
exceeding the increase in the surveyed work times as compared to the
predecessor pericardiocentesis codes. The recommended work RVU of 6.00
was based on a crosswalk to CPT code 31603 (Tracheostomy, emergency
procedure; transtracheal), which shares the same intraservice time of
30 minutes with CPT code 3X002 and very similar total time. While we
agree that CPT code 31603 is a close match to the surveyed work times
for CPT code 3X002, we do not believe that it is the most accurate
choice for a crosswalk due to the fact that CPT code 31603 is a clear
outlier in work valuation. We searched for 0-day global codes in the
RUC database with 30 minutes of intraservice time and a comparable 90-
120 minutes of total time. There were 21 codes that met this criteria,
and the recommended crosswalk to CPT code 31603 had the highest work
RVU of any of these codes at the recommended 6.00. Furthermore, there
was only one other code with a work RVU above 5.00, another
tracheostomy procedure described by CPT code 31600 (Tracheostomy,
planned (separate procedure)) at a work RVU of 5.56. None of the other
codes had a work RVU higher than 4.69, and the median work RVU of the
group comes out to only 4.00. The two tracheostomy procedures have work
RVUs more than a full standard deviation above any of the other codes
in this group of 0-day global procedures.
We do not mean to suggest that the work RVU for a given service
must always fall in the middle of a range of codes with similar time
values. We recognize that it would not be appropriate to develop work
RVUs solely based on time given that intensity is also an element of
work. Were we to disregard intensity altogether, the work RVUs for all
services would be developed based solely on time values and that is
definitively not the case, as indicated by the many services that share
the same time values but have different work RVUs. However, we also do
not believe that it would serve the interests of relativity by
crosswalking the work RVU of CPT code 3X002 to tracheostomy procedures
that are higher than anything else in this group of codes, procedures
that we believe to be outliers due to the serious risk of patient
mortality associated with their performance. We believe that it is this
patient risk which is responsible for the otherwise anomalously high
intensity in CPT codes 31600 and 31603. Therefore, we are proposing a
work RVU of 5.00 for CPT code 3X002 based on the survey 25th
percentile, which we believe more accurately captures both the time and
intensity associated with the procedure.
We disagree with the RUC-recommended work RVU of 5.00 for CPT code
3X003 (Pericardial drainage with insertion of indwelling catheter,
percutaneous, including CT guidance) and are proposing a work RVU of
4.29 based on the survey 25th percentile value. In our review of CPT
code 3X003, we noted many of the same issues that we had raised with
CPT codes 3X000-3X002, in particular with the increase in the work RVU
greatly exceeding the increase in the surveyed work times as compared
to the predecessor pericardiocentesis codes. We searched for 0-day
global codes in the RUC database with 30 minutes of intraservice time
(slightly higher than the 28 minutes of intraservice time in CPT code
3X003) and a comparable 70-100 minutes of total time. Our search
identified 45 codes and again all 45 of these codes had a work RVU
lower than 5.00, which led us to believe that the recommended work RVU
for CPT code 3X003 was overvalued. We also compared CPT code 3X003 to
the most similar code in the family, CPT code 3X001, and noted that the
survey respondents indicated that CPT code 3X003 should have a lower
work RVU at both the survey 25th percentile and survey median values.
Therefore, we are proposing a work RVU of 4.29 for CPT code 3X003 based
on the survey 25th percentile value. We are supporting this proposal
with a reference to CPT code 31254 (Nasal/sinus endoscopy, surgical
with ethmoidectomy; partial (anterior)), a recently-reviewed code with
an intraservice work time of 30 minutes, a total time of 84 minutes,
and a work RVU of 4.27.
The RUC did not recommend and we are not proposing any direct PE
inputs for the codes in this family.
(10) Pericardiotomy (CPT Codes 33020 and 33025)
CPT code 33020 (Pericardiotomy for removal of clot or foreign body
(primary procedure)) was identified as potentially misvalued on a
Relativity Assessment Workgroup (RAW) screen of codes with a negative
IWPUT and Medicare utilization over 10,000 for all services or over
1,000 for Harvard valued and CMS or other source codes. The RAW
determined that CPT code 33020 should be surveyed for April 2018; CPT
code 33025 (Creation of pericardial window or partial resection for
drainage) was included for review as part of this code family.
We disagree with the RUC-recommended work RVU of 14.31 (25th
percentile survey value) for CPT code 33020 and are proposing a work
RVU of 12.95. Our proposed work RVU is based on a crosswalk to CPT code
58700 (Salpingectomy, complete or partial, unilateral or bilateral
(separate procedure)), which has an identical work RVU of 12.95,
identical 60 minutes intraservice time, and near identical total time
values as CPT code 33020.
In our review of CPT code 33020, we note that the RUC-recommended
intraservice time is decreasing from 85 minutes to 60 minutes (29
percent reduction), and that the RUC- recommended total time is
decreasing from 565 minutes to 321 minutes (43 percent reduction).
However, the RUC-recommended work RVU is only decreasing from 14.95 to
14.31, which is a reduction of less than 5 percent. Although we do not
imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be appropriately
reflected in decreases to work RVUs. In the case of CPT code 33020, we
believe that it would be more accurate to propose a work RVU of 12.95,
based on a crosswalk to CPT code 58700 to account for these decreases
in surveyed work times.
For CPT code 33025, the RUC recommended a work RVU of 13.20 (survey
25th percentile value). Although we disagree with the RUC-recommended
work RVU of 13.20, based on RUC survey results and the time resources
involved in furnishing these two procedures we agree that the relative
difference in work RVUs between CPT codes 33020 and 33025 is equivalent
to the RUC-recommended incremental difference of 1.11 less work RVUs.
Therefore, we are proposing a work RVU of 11.84 based on a reference to
CPT code 34712 (Transcatheter delivery of enhanced fixation devices(s)
to the endograft (e.g., anchor, screw,
[[Page 40575]]
tack) and all associated radiological supervision and interpretation),
which has a work RVU of 12.00, identical intraservice time of 60
minutes, and similar total time as CPT code 33025.
In reviewing CPT code 33025, we note that the RUC-recommended
intraservice time is decreasing from 66 minutes to 60 minutes (9
percent reduction), and that the RUC-recommended total time is
decreasing from 410 minutes to 301 minutes (27 percent reduction).
However, the RUC-recommended work RVU is only decreasing from 13.70 to
13.20, which is a reduction of less than 5 percent. Although we do not
imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be appropriately
reflected in decreases to work RVUs. In the case of CPT code 33025, we
believe that it would be more accurate to propose a work RVU of 11.84,
based on less the incremental difference of 1.11 work RVUs between CPT
codes 33020 and 33025 and a crosswalk to CPT code 34712 to account for
these decreases in surveyed work times.
We are proposing the RUC-recommended direct PE inputs for all the
codes in this family.
(11) Transcatheter Aortic Valve Replacement (TAVR) (CPT Codes 33361,
33362, 33363, 33364, 33365, and 33366)
In October 2016, the RUC's RAW reviewed codes that had been flagged
in the period from October 2011 to April 2012, using 3 years of
available Medicare claims data (2013, 2014 and preliminary 2015 data).
The RUC workgroup determined that the technology for these
transcatheter aortic valve replacement (TAVR) services was evolving, as
the typical site of service had shifted from being provided in academic
centers to private centers, and the RUC recommended that CPT codes
33361-33366 be resurveyed for physician work and practice expense.
These six codes were surveyed and reviewed at the April 2018 RUC
meeting using a survey methodology that reflected the unique nature of
these codes. CPT codes 33361-33366 are currently the only codes on the
PFS where the -62 co-surgeon modifier is required 100 percent of the
time.
We are proposing the RUC-recommended work RVU for all six of the
codes in this family. We are proposing a work RVU of 22.47 for CPT code
33361 (Transcatheter aortic valve replacement (TAVR/TAVI) with
prosthetic valve; percutaneous femoral artery approach), a work RVU of
24.54 for CPT code 33362 (Transcatheter aortic valve replacement (TAVR/
TAVI) with prosthetic valve; open femoral artery approach), a work RVU
of 25.47 for CPT code 33363 (Transcatheter aortic valve replacement
(TAVR/TAVI) with prosthetic valve; open axillary artery approach), a
work RVU of 25.97 for CPT code 33364 (Transcatheter aortic valve
replacement (TAVR/TAVI) with prosthetic valve; open iliac artery
approach), a work RVU of 26.59 for CPT code 33365 (Transcatheter aortic
valve replacement (TAVR/TAVI) with prosthetic valve; transaortic
approach (e.g., median sternotomy, mediastinotomy)), and a work RVU of
29.35 for CPT code 33366 (Transcatheter aortic valve replacement (TAVR/
TAVI) with prosthetic valve; transapical exposure (e.g., left
thoracotomy)).
Although we have some concerns that the RUC-recommended work RVUs
for these six codes do not match the decreases in surveyed work time,
we recognize that the technology described by the TAVR procedures is in
the process of being adopted by a much wider audience, and that there
will be greater intensity on the part of the practitioner when this
particular new technology is first being adopted. However, we intend to
continue examining whether these services are appropriately valued, in
light of the proposed national coverage determination proposing to use
TAVR for the treatment of symptomatic aortic valve stenosis that we
posted on March 26, 2019. We will also consider any further
improvements to the valuation of these services, as their use becomes
more commonplace, through future notice and comment rulemaking. The
text of the proposed national coverage determination is available on
the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=293.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(12) Aortic Graft Procedures (CPT Codes 338XX, 338X1, 33863, 33864,
338X2, and 33866)
In 2017, CPT created a new add-on code, CPT code 33866 (Aortic
hemiarch graft including isolation and control of the arch vessels,
beveled open distal aortic anastomosis extending under one or more of
the arch vessels, and total circulatory arrest or isolated cerebral
perfusion (List separately in addition to code for primary procedure)).
For CY 2019, we finalized the RUC's recommended work RVU for this code
on an interim basis (83 FR 59528). CPT revised the code set to develop
distinct codes for ascending aortic repair for dissection and ascending
aortic repair for other ascending aortic disease such as aneurysms and
congenital anomalies, creating two new codes, as well as revaluating
the two other codes in the family.
For CPT code 338XX (Ascending aorta graft, with cardiopulmonary
bypass, includes valve suspension, when performed; for aortic
dissection), we disagree with the RUC-recommended work RVU of 65.00,
because the RUC is recommending an increase in work RVU that is not
commensurate with a reduction in physician time, and because we do not
believe that the RUC's recommendation that this service be increased to
a value that would place it among the highest valued of all services of
similar physician time is appropriate; we think a comparison to other
services of similar time indicates that the RUC's recommended increase
overstates the work. Instead, we are proposing to increase the work RVU
to 63.40 based on a crosswalk to CPT code 61697 (Surgery of complex
intracranial aneurysm, intracranial approach; carotid circulation). For
CPT code 338X1 (Ascending aorta graft, with cardiopulmonary bypass,
includes valve suspension, when performed; for aortic disease other
than dissection (e.g., aneurysm)), we disagree with the RUC-recommended
work RVU of 50.00, because we do not believe it adequately reflects the
recommended decrease in physician time, and because we do not believe
this service should be assigned a value that is among the highest of
all 90-day global services with similar physician time values. Instead,
we are proposing a work RVU of 45.13 based on a crosswalk to CPT code
33468 (Tricuspid valve repositioning and plication for Ebstein
anomaly), which is a code with an identical intraservice time and
similar total time value.
For CPT code 33863 (Ascending aorta graft, with cardiopulmonary
bypass, with aortic root replacement using valved conduit and coronary
reconstruction (e.g., Bentall)), according to the RUC, the survey
respondents underestimated the intraservice time of the procedure and
the RUC recommended a work RVU of 59.00 based on the 75th percentile of
survey responses for intraservice time. We believe the use of the
survey 75th percentile value to be problematic, as the intraservice
time values should generally reflect the survey median. We are
requesting that this code be
[[Page 40576]]
resurveyed to determine more accurate physician time values, and we are
proposing to maintain the current RVU of 58.79 for CY 2020. For CPT
code 33864 (Ascending aorta graft, with cardiopulmonary bypass with
valve suspension, with coronary reconstruction and valve-sparing aortic
root remodeling (e.g., David Procedure, Yacoub procedure)), we do not
agree with the RUC-recommended work RVU of 63.00, because we believe
this increase is not justified given that the intraservice time is not
changing from its current value, and the physician total time value is
decreasing. Therefore, we are proposing to maintain the current work
RVU of 60.08 for this service.
For CPT code 338X2 (Transverse aortic arch graft, with
cardiopulmonary bypass, with profound hypothermia, total circulatory
arrest and isolated cerebral perfusion with reimplantation of arch
vessel(s) (e.g., island pedicle or individual arch vessel
reimplantation)), we disagree with the RUC's recommended work RVU of
65.75. While we agree that an increase in work RVU is justified, as
discussed above, we believe that the use of the 75th percentile of
physician intraservice work time is problematic, and believe such a
significant increase in work RVU is not validated. Therefore, we are
proposing a less significant increase to 60.88 using the RUC-
recommended difference in work value between CPT code 338X1 and the
code in question, CPT code 338X2 (a difference of 15.75). As further
support for this value, we note that it falls between CPT codes 33782
(Aortic root translocation with ventricular septal defect and pulmonary
stenosis repair (i.e., Nikaidoh procedure); without coronary ostium
reimplantation), which has a work RVU of 60.08, and CPT code 43112
(Total or near total esophagectomy, with thoracotomy; with
pharyngogastrostomy or cervical esophagogastrostomy, with or without
pyloroplasty (i.e., McKeown esophagectomy or tri-incisional
esophagectomy)), which has a work RVU of 62.00. Both of these
bracketing reference codes have similar intraservice and total time
values. For CPT code 33X01 (Aortic hemiarch graft including isolation
and control of the arch vessels, beveled open distal aortic anastomosis
extending under one or more of the arch vessels, and total circulatory
arrest or isolated cerebral perfusion (List separately in addition to
code for primary procedure)), we are proposing the RUC-recommended work
RVU of 17.75.
For the direct PE inputs, we are proposing to refine the clinical
labor to align with the number of post-operative visits. Thus, we are
proposing to add 12 minutes of clinical labor time for ``Discharge day
management'' for CPT codes 338X1, 33863, 33864, and 338X2, as each of
these codes include a 99238 discharge visit within their global periods
that should be reflected in the clinical labor inputs.
(13) Iliac Branched Endograft Placement (CPT Codes 34X00 and 34X01)
For CY 2018, the CPT Editorial Panel created a family of 20 new and
revised codes that redefined coding for endovascular repair of the
aorta and iliac arteries. The iliac branched endograft technology has
become more mainstream over time, and two new CPT codes were created to
capture the work of iliac artery endovascular repair with an iliac
branched endograft. These two new codes were surveyed and reviewed for
the January 2019 RUC meeting.
We are proposing the RUC-recommended work RVU of 9.00 for CPT code
34X00 (Endovascular repair of iliac artery at the time of aorto-iliac
artery endograft placement by deployment of an iliac branched endograft
including pre-procedure sizing and device selection, all ipsilateral
selective iliac artery catheterization(s), all associated radiological
supervision and interpretation, and all endograft extension(s)
proximally to the aortic bifurcation and distally in the internal
iliac, external iliac, and common femoral artery(ies), and treatment
zone angioplasty/stenting, when performed, for rupture or other than
rupture (e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous
malformation, penetrating ulcer, traumatic disruption), unilateral) and
the RUC-recommended work RVU of 24.00 for CPT code 34X01 (Endovascular
repair of iliac artery, not associated with placement of an aorto-iliac
artery endograft at the same session, by deployment of an iliac
branched endograft, including pre-procedure sizing and device
selection, all ipsilateral selective iliac artery catheterization(s),
all associated radiological supervision and interpretation, and all
endograft extension(s) proximally to the aortic bifurcation and
distally in the internal iliac, external iliac, and common femoral
artery(ies), and treatment zone angioplasty/stenting, when performed,
for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection,
arteriovenous malformation, penetrating ulcer), unilateral).
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(14) Exploration of Artery (CPT Codes 35701, 35X01, and 35X01)
CPT code 35701 (Exploration not followed by surgical repair,
artery; neck (e.g., carotid, subclavian)) was identified via a screen
for services with a ne.g.ative IWPUT and Medicare utilization over
10,000 for all services or over 1,000 for Harvard valued and CMS/Other
source codes. In September 2018, the CPT Editorial Panel revised one
code, added two new codes, and deleted three existing codes in the
family to report major artery exploration procedures and to condense
the code set due to low frequency.
We are proposing the RUC-recommended work RVU for all three codes
in the family. We are proposing a work RVU of 7.50 for CPT code 35701,
a work RVU of 7.12 for CPT code 35X00 (Exploration not followed by
surgical repair, artery; upper extremity (e.g., axillary, brachial,
radial, ulnar)), and a work RVU of 7.50 for CPT code 35X01 (Exploration
not followed by surgical repair, artery; lower extremity (e.g., common
femoral, deep femoral, superficial femoral, popliteal, tibial,
peroneal)).
For the direct PE inputs, we are proposing to refine the clinical
labor, supplies, and equipment to match the number of office visits
contained in the global periods of the codes under review. We are
proposing to refine the clinical labor time for the ``Post-operative
visits (total time)'' (CA039) activity from 36 minutes to 27 minutes
for CPT codes 35701 and 35X00, and from 63 minutes to 27 minutes for
CPT code 35X01. Each of these CPT codes contains a single postoperative
level 2 office visit (CPT code 99212) in its global period, and 27
minutes of clinical labor is the time associated with this office
visit. We are proposing to refine the equipment time for the exam table
(EF023) to the same time of 27 minutes for each code to match the
clinical labor time. Finally, we are also proposing to refine the
quantity of the minimum multi-specialty visit pack (SA048) from 2 to 1
for CPT code 35X01 to match the single postoperative visit in the
code's global period. We believe that the additional direct PE inputs
in the recommended materials were an accidental oversight due to
revisions that took place at the RUC meeting following the approval of
the PE inputs for these codes.
(15) Intravascular Ultrasound (CPT Codes 37252 and 37253)
In CY 2014, the CPT Editorial Panel deleted CPT codes 37250
(Ultrasound evaluation of blood vessel during
[[Page 40577]]
diagnosis or treatment )and 37251 (Ultrasound evaluation of blood
vessel during diagnosis or treatment) and created new bundled codes
37252 (Intravascular ultrasound (noncoronary vessel) during diagnostic
evaluation and/or therapeutic intervention, including radiological
supervision and interpretation; initial noncoronary vessel) and 37253
(Intravascular ultrasound (noncoronary vessel) during diagnostic
evaluation and/or therapeutic intervention, including radiological
supervision and interpretation; each additional noncoronary vessel) to
describe intravascular ultrasound (IVUS). CPT codes 37252 and 37253
were reviewed at the January 2015 RUC meeting. The RUC's recommendation
for these codes were to result in an overall work savings that should
have been redistributed back to the Medicare conversion factor. The
codes have had a 44 percent increase in work RVUs over the old codes,
CPT codes 37250 and 37251, from 2015 to 2016 and the utilization has
doubled from that of the previous coding structure, not considering the
radiological activities. In April 2018, the RUC reviewed this code
family and determined the utilization of the bundling of these services
was underestimated. Consequently, the RUC recommended that these
services be surveyed for October 2018. The RUC indicated that the
specialty societies should research why there was such an increase in
the utilization. Accordingly, the specialty society surveyed these ZZZ-
day global codes, and the survey results indicated the intraservice and
total work times, along with the work RVU should remain the same
despite the underestimation in utilization.
We disagreed with the RUC-recommended work RVU of 1.80 for CPT code
37252 and are proposing a work RVU of 1.55 based on a crosswalk to CPT
code 19084. CPT code 19084 is a recently reviewed code with 20 minutes
of intraservice time and 25 minutes of total time. In reviewing CPT
code 37252, we note, as mentioned above, that in CY 2015 the specialty
society stated that bundling this service would achieve savings.
However, since 2015 observed utilization for CPT code 37252 has greatly
exceeded proposed estimates, thus we are proposing to restore work
neutrality to the intravascular ultrasound code family to achieve the
initial estimated savings.
For CPT code 37253, we disagreed with the RUC-recommended work RVU
of 1.44 and we are proposing a work RVU of 1.19. Although we disagreed
with the RUC-recommended work RVU, we note the relative difference in
work between CPT codes 37252 and 37253 is an interval of 0.36 RVUs.
Therefore, we are proposing a work RVU of 1.19 for CPT code 37253,
based on the recommended interval of 0.36 fewer RVUs than our proposed
work RVU of 1.55 for CPT code 37252.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(16) Stab Phlebectomy of Varicose Veins (CPT Codes 37765 and 37766)
These services were identified in February 2008 via the High Volume
Growth screen, for services with a total Medicare utilization of 1,000
or more that have increased by at least 100 percent from 2004 through
2006. The RUC subsequently recommended monitoring and reviewing changes
in utilization over multiple years. In October 2017, the RUC
recommended that this service be surveyed for April 2018. We are
proposing the RUC-recommended work RVUs of 4.80 for CPT code 37765
(Stab phlebectomy of varicose veins, 1 extremity; 10-20 stab incisions)
and 6.00 for CPT code 37766 (Stab phlebectomy of varicose veins, 1
extremity; more than 20 incisions). We are proposing the RUC-
recommended direct PE inputs for all codes in the family.
(17) Biopsy of Mouth Lesion (CPT Code 40808)
CPT code 40808 (Biopsy, vestibule of mouth) was identified via a
screen for services with a negative IWPUT and Medicare utilization over
10,000 for all services or over 1,000 for Harvard valued and CMS/Other
source codes.
We disagree with the RUC's recommended work RVU of 1.05 with a
crosswalk to CPT code 11440 (Excision, other benign lesion including
margins, except skin tag (unless listed elsewhere), face, ears,
eyelids, nose, lips, mucous membrane; excised diameter 0.5 cm or less),
as we believe this increase in work RVU is not commensurate with the
RUC-recommended 5-minute reduction in intraservice time and a 10-minute
reduction in total time. While we understand that the RUC considers the
current time values for this service to be invalid estimations, we do
not see compelling evidence that would indicate that an increase in
work RVU that would be concurrent with a reduction in physician time is
appropriate. Therefore, we are proposing to maintain the current work
RVU of 1.01, and note that implementing the current work RVU with the
RUC-recommended revised physician time values would correct the
negative IWPUT anomaly.
For the direct PE inputs, we are proposing to refine the clinical
labor time for the ``Prepare room, equipment and supplies'' (CA013)
activity to 3 minutes and to refine the clinical labor time for the
``Confirm order, protocol exam'' (CA014) activity to 0 minutes. As we
detailed when discussing this issue in the CY 2019 PFS final rule (83
FR 59463 through 59464), CPT code 40808 does not include the old
clinical labor task ``Patient clinical information and questionnaire
reviewed by technologist, order from physician confirmed and exam
protocoled by radiologist'' on a prior version of the PE worksheet, nor
does the code contain any clinical labor for the CA007 activity
(``Review patient clinical extant information and questionnaire''). CPT
code 40808 does not appear to be an instance where an old clinical
labor task was split into two new clinical labor activities, and we
continue to believe that in these cases the 3 total minutes of clinical
staff time would be more accurately described by the CA013 ``Prepare
room, equipment and supplies'' activity code. We also note that there
is no effect on the total clinical labor direct costs in these
situations, since the same 3 minutes of clinical labor time is still
being furnished.
We are also proposing to refine the equipment time for the
electrocautery-hyfrecator (EQ110) to conform to our established
standard for non-highly technical equipment.
(18) Transanal Hemorrhoidal Dearterialization (CPT Codes 46945, 46946,
and 46X48)
We are proposing the RUC-recommended work RVU for all three codes
in the family. We are proposing a work RVU of 3.69 for CPT code 46945
(Hemorrhoidectomy, internal, by ligation other than rubber band; single
hemorrhoid column/group, without imaging guidance), a work RVU of 4.50
for CPT code 46946 (2 or more hemorrhoid columns/groups, without
imaging guidance), and a work RVU of 5.57 for CPT code 46X48
(Hemorrhoidectomy, internal, by transanal hemorrhoidal
dearterialization, 2 or more hemorrhoid columns/groups, including
ultrasound guidance, with mucopexy when performed).
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(19) Preperitoneal Pelvic Packing (CPT Codes 490X1 and 490X2)
In May 2018, the CPT Editorial Panel approved the addition of two
codes for preperitoneal pelvic packing, removal
[[Page 40578]]
and/or repacking for hemorrhage associated with pelvic trauma. These
new codes were surveyed and reviewed for the October 2018 RUC meeting.
We disagree with the RUC-recommended work RVU of 8.35 for CPT code
490X1 (Preperitoneal pelvic packing for hemorrhage associated with
pelvic trauma, including local exploration) and are proposing a work
RVU of 7.55 based on a crosswalk to CPT code 52345 (Cystourethroscopy
with ureteroscopy; with treatment of ureteropelvic junction stricture
(e.g., balloon dilation, laser, electrocautery, and incision)). We are
also proposing to reduce the immediate postservice work time from 60
minutes to 45 minutes, which results in a total work time of 140
minutes for this procedure. We believe that the survey respondents
overstated the immediate postservice work time that would typically be
required to perform CPT code 490X1, which we investigated by comparing
this new service against the existing 0-day global codes on the PFS. We
found that among the roughly 1,100 codes with 0-day global periods,
only 21 codes had an immediate postservice work time of 60 minutes or
longer. The 21 codes that fell into this category had significantly
higher intraservice work times than CPT code 490X1, with an average
intraservice work time of 111 minutes as compared to the 45 minutes of
intraservice work time in CPT code 490X1. Generally speaking, it is
extremely rare for a service to have more immediate postservice work
time than intraservice work time, and in fact only 28 out of the
roughly 1,100 codes with 0-day global periods had more immediate
postservice work time than intraservice work time. While we agree that
each service on the PFS is its own unique entity, these comparisons to
other 0-day global codes suggest that the survey respondents
overestimated the amount of immediate postservice work time that would
typically be associated with CPT code 490X1.
As a result, we believe that it would be more accurate to reduce
the immediate postservice work time to 45 minutes and to propose a work
RVU of 7.55 based on a crosswalk to CPT code 52345. This crosswalk code
shares an intraservice work time of 45 minutes and a similar total time
of 135 minutes after taking into account the reduced immediate
postservice work time that we are proposing for CPT code 490X1. We
searched the RUC database for 0-day global procedures with 45 minutes
of intraservice work time, and at the recommended work RVU of 8.35, CPT
code 490X1 would establish a new maximum value, higher than all of the
79 other codes that fall into this category. We recognize that CPT code
490X1 describes a preperitoneal pelvic packing service associated with
pelvic trauma, and that this is a difficult and intensive procedure
that rightly has a higher work RVU than many of these other 0-day
global codes. However, we believe that it better maintains relativity
to propose a crosswalk to CPT code 52345 at a work RVU of 7.55, which
would still assign this code the second-highest work RVU among all 0
day global codes with 45 minutes of intraservice work time, as opposed
to proposing the survey median work RVU of 8.35 at a rate higher than
anything in the current RUC database.
We disagree with the RUC-recommended work RVU of 6.73 for CPT code
490X2 (Re-exploration of pelvic wound with removal of preperitoneal
pelvic packing including repacking, when performed) and are proposing a
work RVU of 5.70 based on the 25th percentile survey value. We believe
that the survey 25th percentile work RVU more accurately describes the
work of re-exploring this type of pelvic wound, and by proposing the
survey 25th percentile we are maintaining the general increment in RVUs
between the two codes in the family (a difference of 1.62 RVUs as
recommended by the RUC as compared to 1.85 RVUs as proposed here). We
are supporting this valuation with a reference to CPT code 39401
(Mediastinoscopy; includes biopsy(ies) of mediastinal mass (e.g.,
lymphoma), when performed), a recently reviewed code from CY 2015 which
shares the same intraservice time of 45 minutes, a slightly higher
total time of 142 minutes and a lower work RVU of 5.44.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(20) Cystourethroscopy Insertion Transprostatic Implant (CPT Codes
52441 and 52442)
In 2005, the AMA RUC began the process of flagging services that
represent new technology or new services as they were presented to the
AMA/Specialty Society RVS Update Committee. This service was reviewed
at the October 2018 RAW meeting, and the RAW indicated that the
utilization is increasing and questioned the time required to perform
these services. These two codes were surveyed and reviewed for the
January 2019 RUC meeting.
We disagree with the RUC-recommended work RVU of 4.50 (current
value) for CPT code 52441 (Cystourethroscopy, with insertion of
permanent adjustable transprostatic implant; single implant) and are
proposing a work RVU of 4.00. This proposed work RVU is based on a
crosswalk from recently reviewed CPT code 58562 (Hysterscopy, surgical;
with removal of impacted foreign body), which has a work RVU of 4.00,
and an identical 25 minutes of intraservice time as CPT code 52441.
We disagree with the RUC-recommended work RVU of 1.20 (current
value) for CPT code 52442 (Cystourethroscopy, with insertion of
permanent adjustable transprostatic implant; each additional permanent
adjustable transprostatic implant (List separately in addition to code
for primary procedure)) and are proposing a work RVU of 1.01. This
proposed work RVU is based on a crosswalk from CPT code 36218
(Selective catheter placement, arterial system; additional second
order, third order, and beyond, thoracic or brachiocephalic branch,
within a vascular family (List in addition to code for initial second
or third order vessel as appropriate)), which has a work RVU of 1.01,
and an identical 15 minutes of intraservice time as CPT code 52442. The
RUC survey showed a reduction in time, and the work should reflect
these changes.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family without refinement.
(21) Orchiopexy (CPT Code 54640)
The CPT Editorial Panel revised existing CPT code 54640 to describe
an additional approach for orchiopexy (scrotal) and to clearly indicate
that hernia repair is separately reportable. This code was surveyed and
reviewed for the January 2019 RUC meeting.
We are proposing to maintain the current work RVU of 7.73 as
recommended by the RUC. We are proposing the RUC-recommended direct PE
inputs for CPT code 54640 without refinement.
(22) Radiofrequency Neurootomy Sacroiliac Joint (CPT Codes 6XX00,
6XX01)
In September 2018, the CPT Editorial Panel created two new codes to
describe injection and radiofrequency ablation of the sacroiliac joint
with image guidance for somatic nerve procedures. We are proposing the
RUC-recommended work RVU of 1.52 for CPT code 6XX00 (Injection(s),
anesthetic agent(s) and/or steroid; nerves innervating the sacroiliac
joint, with image guidance (i.e., fluoroscopy or computed tomography))
and the RUC-recommended work RVU of 3.39 for CPT code 6XX01
(Radiofrequency ablation, nerves innervating the sacroiliac joint, with
[[Page 40579]]
image guidance (i.e., fluoroscopy or computed tomography)).
For the direct PE inputs, we are proposing to refine the quantity
of the ``needle, 18-26g 1.5-3.5in, spinal'' (SC028) supply from 3 to 1
for CPT code 6XX00. There are no spinal needles in use in the reference
code associated with CPT code 6XX00, and there was no explanation in
the recommended materials explaining why three such needles would be
typical for this procedure. We agree that the service being performed
in CPT code 6XX00 would require a spinal needle, but we do not believe
that the use of three such needles would be typical.
We are proposing to refine the quantity of the ``cannula
(radiofrequency denervation) (SMK-C10)'' (SD011) supply from 4 to 2 for
CPT code 6XX01. We do not believe that the use of 4 of these cannula
would be typical for the procedure, as the reference code currently
used for destruction by neurolytic agent contains only a single
cannula. We believe that the nerves would typically be ablated one at a
time using this cannula, as opposed to ablating four of them
simultaneously as suggested in the recommended direct PE inputs. We
also searched in the RUC database for other CPT codes that made use of
the SD011 supply, and out of the seven codes that currently use this
item, none of them include more than 2 cannula. As a result, we are
proposing to refine the supply quantity to 2 cannula to match the
highest amount contained in an existing code on the PFS. We are also
refining the equipment time for the ``radiofrequency kit for
destruction by neurolytic agent'' (EQ354) equipment from 164 minutes to
82 minutes. The RUC's equipment time recommendation was predicated on
the use of 4 of the SD011 supplies for 41 minutes apiece, and we are
refining the equipment time to reflect our supply refinement to 2
cannula. It was unclear in the recommended materials as to whether the
radiofrequency kit equipment was in use simultaneously or sequentially
along with the cannula supplies, and therefore, we are soliciting
comments on the typical use of this equipment.
Finally, we are proposing to refine the equipment time for the
technologist PACS workstation (ED050) equipment to match our standard
equipment time formulas, which results in an increase of 5 minutes of
equipment time for both codes.
(23) Lumbar Puncture (CPT Codes 62270, 622X0, 62272, and 622X1)
In October 2017, these services were identified as being performed
by a different specialty than the specialty that originally surveyed
this service. In January 2018, the RUC recommended that these services
be referred to CPT to bundle image guidance. At the September 2018 CPT
Editorial Panel meeting, the Panel created two new codes to bundle
diagnostic and therapeutic lumbar puncture with fluoroscopic or CT
image guidance and revised the existing diagnostic and therapeutic
lumbar puncture codes so they would only be reported without
fluoroscopic or CT guidance.
For CPT code 62270 (Spinal puncture, lumbar, diagnostic), we
disagree with the RUC-recommended work RVU of 1.44 and we are proposing
a work RVU of 1.22 based on a crosswalk to CPT code 40490 (Biopsy of
lip). CPT code 40490 has the same intraservice time of 15 minutes and 2
additional minutes of total time. In reviewing CPT code 62270, we noted
that the recommended intraservice time is decreasing from 20 minutes to
15 minutes (25 percent reduction), and the recommended total time is
decreasing from 40 minutes to 32 minutes (20 percent reduction);
however, the RUC-recommended work RVU is increasing from 1.37 to 1.44,
which is an increase of just over 5 percent. Although we do not imply
that the decrease in time as reflected in survey values must equate to
a one-to-one or linear decrease in the valuation of work RVUs, we
believe that since the two components of work are time and intensity,
significant decreases in time should be appropriately reflected in
decreases to work RVUs. In the case of CPT code 62270, we believed that
it was more accurate to propose a work RVU of 1.22 based on a crosswalk
to CPT code 40490 to account for these decreases in the surveyed work
time.
For CPT code 622X0 (Spinal puncture, lumbar, diagnostic; with
fluoroscopic or CT guidance), we disagree with the RUC-recommended work
RVU of 1.95 and we are proposing a work RVU of 1.73. Although we
disagree with the RUC-recommended work RVU, we note that the relative
difference in work between CPT codes 62270 and 622X0 is equivalent to
an interval of 0.51 RVUs. Therefore, we are proposing a work RVU of
1.73 for CPT code 622X0, based on the recommended interval of 0.51
additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.
For CPT code 62272 (Spinal puncture, therapeutic, for drainage of
cerebrospinal fluid (by needle or catheter), we disagree with the RUC-
recommended work RVU of 1.80 and we are proposing a work RVU of 1.58.
Although we disagree with the RUC-recommended work RVU, we note that
the relative difference in work between CPT codes 62270 and 622X0 is
equivalent to the RUC-recommended interval of 0.36 RVUs. Therefore, we
are proposing a work RVU of 1.58 for CPT code 62272, based on the
recommended interval of 0.36 additional RVUs above our proposed work
RVU of 1.22 for CPT code 62270.
For CPT code 622X1 (Spinal puncture, therapeutic, for drainage of
cerebrospinal fluid (by needle or catheter); with fluoroscopic or CT
guidance), we disagree with the RUC-recommended work RVU of 2.25 and we
are proposing a work RVU of 2.03. Although we disagree with the RUC-
recommended work RVU, we note that the relative difference in work
between CPT codes 62270 and 622X1 is equivalent to the recommended
interval of 0.81 RVUs. Therefore, we are proposing a work RVU of 2.03
for CPT code 622X1, based on the recommended interval of 0.81
additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.
(24) Electronic Analysis of Implanted Pump (CPT Codes 62367, 62368,
62369, and 62370)
CPT code 62368 (Electronic analysis of programmable, implanted pump
for intrathecal or epidural drug infusion (includes evaluation of
reservoir status, alarm status, drug prescription status); with
reprogramming) was identified by the RUC on a list of services which
were originally surveyed by one specialty but are now typically
performed by a different specialty. It was reviewed along with three
other codes in the family for PE only at the April 2018 RUC meeting.
The RUC did not recommend work RVUs for these codes and we are not
proposing to change the current work RVUs.
For the direct PE inputs, we are proposing to remove the minimum
multi-specialty visit pack (SA048) from CPT code 62370 as a duplicative
supply due to the fact that this code is typically billed with an E/M
or other evaluation service.
(25) Somatic Nerve Injection (CPT Codes 64400, 64408, 64415, 64416,
64417, 64420, 64421, 64425, 64430, 64435, 64445, 64446, 64447, 64448,
64449, and 64450)
In May 2018, the CPT Editorial Panel approved the revision of
descriptors and guidelines for the codes in this family and the
deletion of three CPT codes to clarify reporting (i.e., separate
reporting of imaging guidance, number of units and a change from a 0-
day global to ZZZ for one of the CPT codes in this
[[Page 40580]]
family). This family of services describe the injection of an
anesthetic agent(s) and/or steroid into a nerve plexus, nerve, or
branch; reported once per nerve plexus, nerve, or branch as described
in the descriptor regardless of the number of injections performed
along the nerve plexus, nerve, or branch described by the code.
CPT codes 64400 (Injection(s), anesthetic agent(s); trigeminal
nerve, each branch (ie ophthalmic, maxillary, mandibular)), 64408
(Injection(s), anesthetic agent(s), and/or steroid; vagus nerve), 64415
(Injection(s), anesthetic agent(s) and/or steroid; brachial plexus),
64416 (Injection(s), anesthetic agent(s) and/or steroid; brachial
plexus, continuous infusion by catheter (including catheter
placement)), 64417 (Injection(s), anesthetic agent(s) and/or steroid;
axillary nerve), 64420 (Injection(s), anesthetic agent(s) and/or
steroid; intercostal nerve, single level), 64421 (Injection(s),
anesthetic agent(s) and/or steroid; intercostal nerves, each additional
level (List separately in addition to code for primary procedure)),
64425 (Injection(s), anesthetic agent(s) and/or steroid; ilioinguinal,
iliohypogastric nerves), 64430 (Injection(s), anesthetic agent(s) and/
or steroid; pudendal nerve), 64435 (Injection(s), anesthetic agent(s)
and/or steroid; paracervical (uterine) nerve), 64445 (Injection(s),
anesthetic agent(s) and/or steroid; sciatic nerve), 64446
(Injection(s), anesthetic agent(s) and/or steroid; sciatic nerve,
continuous infusion by catheter (including catheter placement)), 64447
(Injection(s), anesthetic agent(s); femoral nerve), 64448
(Injection(s), anesthetic agent(s) and/or steroid; femoral nerve,
continuous infusion by catheter (including catheter placement)), 64449
(Injection(s), anesthetic agent(s) and/or steroid; lumbar plexus,
posterior approach, continuous infusion by catheter (including catheter
placement)), and 64450 (Injection(s), anesthetic agent(s); other
peripheral nerve or branch) were reviewed for work and PE at the
October 2018 RUC meeting. The PE for CPT code 64450 was re-reviewed
during the RUC January 2019 meeting.
During the October 2018 RUC presentation for this family of
services, the specialty societies stated that CPT codes 64415, 64416,
64417, 64446, 66447, and 64448 were reported with CPT code 76942
(Ultrasonic guidance for needle placement (e.g., biopsy, aspiration,
injection, localization device), imaging supervision and
interpretation) more than 50 percent of the time. Specifically, 76
percent with CPT code 64415, 85 percent with CPT code 64416, 68 percent
with CPT code 64417, 77 percent with CPT code 64446, 77 percent with
CPT code 66447, and 79 percent with CPT code 64448. It was also noted
in the RUC recommendations that this overlap was accounted for in the
RUC recommendations submitted for these services. Furthermore, the RUC
recommendations sated that the RUC referred CPT codes 64415, 64416,
64417, 64446, 64447 and 64448 to be bundled with ultrasound guidance,
CPT code 76942 to the CPT Editorial Panel for CPT 2021.
In reviewing this family of services, our proposed work and PE
values for CPT codes 64415, 64416, 64417, 64446, 64447 and 64448 do not
consider the overlap of imaging as noted in the RUC recommendations. We
note that the RUC recommendations did not include values to support the
valuation for the bundling of imaging in their work or PE
recommendations and that the CPT code descriptors do not state that
imaging is included.
For CY 2020, we are proposing the RUC-recommended work RVUs for CPT
codes 64417 (work RVU of 1.27), 64435 (work RVU of 0.75), 64447 (work
RVU of 1.10), and 64450 (work RVU of 0.75), the RUC reaffirmed work RVU
of 0.94 for CPT code 64405 (Injection, anesthetic agent; greater
occipital nerve), which is the current work RVU finalized in the CY
2019 final rule (83 FR 59542), and the RUC reaffirmed work RVU of 1.10
for CPT code 64418 (Injection, anesthetic agent; suprascapular nerve),
which is the current work RVU value finalized in the CY 2018 final rule
(82 FR 53054). Although we are proposing the RUC reaffirmed work RVUs
for these two codes, as submitted in the RUC recommendations, we note
that comparable codes in this family of services have lower work RVUs.
Thus, these two codes may have become misvalued since their last
valuation, as they were not resurveyed under this code family during
the October 2018 RUC meeting.
In continuing our review of this code family, we disagree with the
RUC-recommended work RVU of 1.00 for CPT code 64400 and are proposing a
work RVU of 0.75, to maintain rank order in this code family. Our
proposed work RVU is based on a crosswalk to another code in this
family, CPT code 64450, which has an identical work RVU of 0.75 and
near identical intraservice and total time values to CPT code 64400.
We note that the RUC-recommended intraservice time decreased from
37 to 6 minutes (84 percent reduction) and the RUC-recommended total
time decreased from 69 to 20 minutes (71 percent reduction) for CPT
code 64400. However, the RUC-recommended work RVU only decreased by
0.11, a 10 percent reduction. We do not believe the RUC-recommended
work RVU appropriately accounts for the substantial reductions in the
surveyed work times for the procedure. Although we do not imply that
the decrease in time as reflected in survey values must always equate
to a one-to-one or linear decrease in the valuation of work RVUs, we
believe that since the two components of work and time are intensity,
absent an obvious or explicitly stated rationale for why the relative
intensity of a given procedure has increased, significant decreases in
time should be reflected in decreases to work RVUs. In the case of CPT
code 64400, we believe that it would be more accurate to propose a work
RVU of .075 based on a crosswalk to CPT code 64450, which has an
identical work RVU of 0.75 and near identical intraservice and total
times to CPT code 64400. We further note that our proposed work RVU
maintains rank order in this code family among comparable codes.
For CPT code 64408, we disagree with the RUC-recommended work RVU
of 0.90 and are proposing a work RVU of 0.75, to maintain rank order in
this code family. Our proposed work RVU is based on a crosswalk to
another code in this family, CPT code 64450, which has an identical
work RVU of 0.75, and near identical intraservice and total time values
to CPT code 64408.
We note that the RUC-recommended intraservice time decreased from
16 to 5 minutes (69 percent reduction) and RUC-recommended total time
decreased from 36 to 20 minutes (44 percent reduction) for CPT code
64408. Although the RUC-recommended work RVU decreased by 0.51, a 36
percent reduction, we do not believe the RUC-recommended work RVU
appropriately accounts for the substantial reductions in the surveyed
work times for the procedure. Although we do not imply that the
decrease in time as reflected in survey values must always equate to a
one-to-one or linear decrease in the valuation of work RVUs, we believe
that since the two components of work and time are intensity, absent an
obvious or explicitly stated rationale for why the relative intensity
of a given procedure has increased, significant decreases in time
should be reflected in decreases to work RVUs. In the case of CPT code
64408, we believe that it would be more accurate to propose a work RVU
of .075, based on a crosswalk CPT code 64450,
[[Page 40581]]
to account for these decrease in the surveyed work times. We further
note that our proposed work RVU maintains rank order in this code
family among comparable codes.
For CPT code 64415, we disagree with the RUC-recommended work RVU
of 1.42 and are proposing a work RVU of 1.35, based on our time ratio
methodology and further supported by a reference to CPT code 49450
(Replacement of gastrostomy or cecostomy (or other colonic) tube,
percutaneous, under fluoroscopic guidance including contrast
injections(s), image documentation and report), which has a work RVU of
1.36 and similar intraservice and total time values to CPT code 64415.
We note that the RUC-recommended intraservice time decreased from
15 to 12 minutes (20 percent reduction) and RUC-recommended total time
decreased from 44 to 40 minutes (9 percent reduction). However, the
RUC-recommended work RVU only decreased by 0.06, which is a 4 percent
reduction. We do not believe the RUC-recommended work RVU appropriately
accounts for the substantial reductions in the surveyed work times for
the procedure. Although we do not imply that the decrease in time as
reflected in survey values must always equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work and time are intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should be
reflected in decreases to work RVUs. In the case of CPT code 64415, we
believe that it would be more accurate to propose a work RVU of 1.35,
based on our time ratio methodology and a reference to CPT code 49450,
to account for these decrease in the surveyed work times.
For CPT code 64416, we disagree with the RUC-recommended work RVU
of 1.81 and are proposing a work RVU of 1.48, based on our time ratio
methodology and further supported by a bracket of CPT code 62270
(Spinal puncture, lumbar, diagnostic), which has a work RVU of 1.37,
identical intraservice, and similar total time to CPT code 64416 and
CPT code 91035 (Esophagus, gastroesophageal reflux test; with mucosal
attached telemetry pH electrode placement, recording, analysis and
interpretation), which has a work RVU of 1.59, identical intraservice,
and near identical total time values to CPT code 64416.
We note that while the RUC-recommended intraservice time remained
unchanged, the RUC-recommended total time decreased from 60 to 49
minutes (18 percent reduction). However, the RUC recommended
maintaining the current work RVU of 1.81. We do not believe the RUC-
recommended work RVU appropriately accounts for the substantial
reductions in the surveyed total time for the procedure. Although we do
not imply that the decrease in time as reflected in survey values must
always equate to a one-to-one or linear decrease in the valuation of
work RVUs, we believe that since the two components of work and time
are intensity, absent an obvious or explicitly stated rationale for why
the relative intensity of a given procedure has increased, significant
decreases in time should be reflected in decreases to work RVUs. In the
case of CPT code 64416, we believe that it would be more accurate to
propose a work RVU of 1.48, based on our time ratios methodology and a
bracket of CPT code 62270 and CPT code 91035, to account for these
decreases in the surveyed work times.
For CPT code 64420, we disagree with the RUC-recommended work RVU
of 1.18 and are proposing a work RVU of 1.08, based on our time ratio
methodology and further supported by a reference to CPT code 12011
(Simple repair of superficial wounds of face, ears, eyelids, nose, lips
and/or mucous membranes; 2.5 cm or less), which has a work RVU of 1.07
and similar intraservice and total time values to CPT code 64420.
We note that the RUC-recommended intraservice time decreased from
17 to 10 minutes (41 percent reduction) and the RUC-recommended total
time decreased from 37 to 34 minutes (8 percent reduction). However,
the RUC recommended to maintaining the current work RVU of 1.18. We do
not believe the RUC-recommended work RVU appropriately accounts for the
substantial reductions in the surveyed work times for the procedure.
Although we do not imply that the decrease in time as reflected in
survey values must always equate to a one-to-one or linear decrease in
the valuation of work RVUs, we believe that since the two components of
work and time are intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, significant decreases in time should be reflected in
decreases to work RVUs. In the case of CPT code 64420, we believe that
it would be more accurate to propose a work RVU of 1.08 based on our
times ratio methodology and a crosswalk to CPT code 12011, to account
for these decreases in the surveyed work times.
For CPT code 64421, we disagree with the RUC-recommended work RVU
of 0.60 and are proposing a work RVU of 0.50, based on our time ratio
methodology and to maintain rank order among comparable codes in the
family. Our proposed work RVU is further supported by a crosswalk to
CPT code 15276 (Application of skin substitute graft to face, scalp,
eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or
multiple digits, total wound surface area up to 100 sq cm; each
additional 25 sq cm wound surface area, or part thereof (List
separately in addition to code for primary procedure)), which has a
work RVU of 0.50 and identical intraservice and total times to CPT code
64421.
We note that our time ratio methodology suggests the code is better
valued at 0.50. Furthermore, the RUC-recommended work RVU of 0.60
creates a rank order anomaly in the code family. In the case of CPT
code 64421, we believe that it would be more accurate to propose a work
RVU of 0.50, based on our time ratio methodology and a crosswalk to CPT
code 15276, to maintain rank order among comparable codes in the
family.
For CPT code 64425, we disagree with the RUC-recommended work RVU
of 1.19 and are proposing a work RVU of 1.00, to maintain rank order
among comparable codes in the family, based on a bracket of CPT code
12001 (Simple repair of superficial wounds of scalp, neck, axillae,
external genitalia, trunk and/or extremities (including hands and
feet); 2.5 cm or less) which has a work RVU of 0.84 and near identical
intraservice and total time values to CPT code 64425 and CPT code 30901
(Control nasal hemorrhage, anterior, simple (limited cautery and/or
packing) any method), which has a work RVU of 1.10 and near identical
intraservice and total times to CPT code 64425.
We note that the RUC-recommended work RVU of 1.19 creates a rank
order anomaly in the code family. In the case of CPT code 64425, we
believe that it would be more accurate to propose a work RVU of 1.00,
based on a bracket of CPT codes 12001 and 30901 to maintain rank order
among comparable codes in the family.
For CPT code 64430, we disagree with the RUC-recommended work RVU
of 1.15 and are proposing a work RVU of 1.00, to maintain rank order
among comparable codes in the family, based on a bracket of CPT code
45330 (Sigmoidoscopy, flexible; diagnostic, including collection of
specimen(s) by brushing or washing, when performed (separate
procedure)), which has a work RVU of 0.84 and near identical
[[Page 40582]]
intraservice and total time values to CPT code 64430 and CPT code 31576
(Laryngoscopy, flexible; with biopsy(ies)), which has a work RVU of
1.89 and near identical intraservice and total time values to CPT code
64430.
We note that the RUC-recommended intraservice time decreased from
17 to 10 minutes (41 percent reduction) and the RUC-recommended total
time increased from 39 to 43 minutes (10 percent increase). While the
RUC-recommended work RVU is decreasing by 0.31, a 21 percent reduction,
we do not believe the RUC-recommended work RVU appropriately accounts
for the substantial reductions in the surveyed intraservice work time
for the procedure. Although we do not imply that the decrease in time
as reflected in survey values must always equate to a one-to-one or
linear decrease in the valuation of work RVUs, we believe that since
the two components of work and time are intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should be
reflected in decreases to work RVUs. In the case of CPT code 64430, we
believe that it would be more accurate to propose a work RVU of 1.00,
based on a bracket of CPT codes 45300 and 31576 to account for these
decreases in surveyed work times and to maintain rank order among
comparable codes in this family.
For CPT code 64445, we disagree with the RUC-recommended work RVU
of 1.18 and are proposing a work RVU of 1.00, based on our time ratio
methodology and to maintain rank order among comparable codes in the
family. Our proposed work RVU is based on a bracket of CPT code 12001
(Simple repair of superficial wounds of scalp, neck, axillae, external
genitalia, trunk and/or extremities (including hands and feet); 2.5 cm
or less), which has a work RVU of 0.84 and near identical intraservice
and total times to CPT code 64445 and CPT code 30901 (Control nasal
hemorrhage, anterior, simple (limited cautery and/or packing) any
method), which has a work RVU of 1.10 and near identical intraservice
and total time values to CPT code 64445.
We note that the RUC-recommended intraservice time decreased from
15 to 10 minutes (33 percent reduction) and the RUC-recommended total
time decreased from 48 to 24 minutes (50 percent reduction). While the
RUC-recommended work RVU is decreasing by 0.30, a 21 percent reduction,
we do not believe the RUC-recommended work RVU appropriately accounts
for the substantial reductions in the surveyed intraservice work time
for the procedure. Although we do not imply that the decrease in time
as reflected in survey values must always equate to a one-to-one or
linear decrease in the valuation of work RVUs, we believe that since
the two components of work and time are intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should be
reflected in decreases to work RVUs. In the case of CPT code 64445, we
believe that it would be more accurate to propose a work RVU of 1.00,
based on a bracket of CPT codes 12001 and 30901 to account for these
decreases in surveyed work times and to maintain rank order among
comparable codes in the family.
For CPT code 64446, we disagree with the RUC-recommended work RVU
of 1.54 and are proposing a work RVU of 1.36 based on our time ratios
methodology and further supported by a reference to CPT code 51710
(Change of cystostomy tube; complicated), which has a near identical
work RVU of 1.35 and near identical intraservice and total time values
to CPT code 64446.
We note that RUC-recommended intraservice time decreased from 20 to
15 minutes (25 percent reduction) and the RUC-recommended total time
decreased from 64 to 40 minutes (38 percent reduction). While the RUC-
recommended work RVU is decreasing by 0.27, a 15 percent reduction, we
do not believe the RUC-recommended work RVU appropriately accounts for
the substantial reductions in the surveyed intraservice work time for
the procedure. Although we do not imply that the decrease in time as
reflected in survey values must always equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work and time are intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should be
reflected in decreases to work RVUs. In the case of CPT code 64446, we
believe that it would be more accurate to propose a work RVU of 1.36,
based on our time ratios methodology and a reference to CPT code 51710
to account for these decreases in surveyed times and to maintain rank
order among comparable codes in the family.
For CPT code 64448, we disagree with the RUC-recommended work RVU
of 1.55 and are proposing a work RVU of 1.41, based our time ratio
methodology and a reference to CPT code 27096 (Injection procedure for
sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy
or CT) including arthrography when performed), which has a work RVU of
1.48 and near identical intraservice time and identical total time
values to CPT code 64448.
We note that RUC-recommended intraservice time decreased from 15 to
13 minutes (13 percent reduction) and the RUC-recommended total time
decreased from 55 to 38 minutes (62 percent reduction). While the RUC-
recommended work RVU is only decreasing by 0.08, which is only a 5
percent reduction. We do not believe the RUC-recommended work RVU
appropriately accounts for the substantial reductions in the surveyed
intraservice work time for the procedure. Although we do not imply that
the decrease in time as reflected in survey values must always equate
to a one-to-one or linear decrease in the valuation of work RVUs, we
believe that since the two components of work and time are intensity,
absent an obvious or explicitly stated rationale for why the relative
intensity of a given procedure has increased, significant decreases in
time should be reflected in decreases to work RVUs. In the case of CPT
code 64448, we believe that it would be more accurate to propose a work
RVU of 1.41, based on our time ratios methodology and a crosswalk to
CPT code 27096 to account for these decreases in surveyed times and to
maintain rank order among comparable codes in the family.
For CPT code 64449, we disagree with the RUC-recommended work RVU
of 1.55 and are proposing a work RVU of 1.27, based our time ratio
methodology and a reference to CPT code 11755 (Biopsy of nail unit (eg,
plate, bed, matrix, hyponychium, proximal and lateral nail folds)
(separate procedure)), which has a work RVU of 1.25 and near identical
intraservice and total times to CPT code 64449.
We note that RUC-recommended intraservice time decreased from 20 to
14 minutes (30 percent reduction) and the RUC-recommended total time
decreased from 60 to 38 minutes (37 percent reduction). While the RUC-
recommended work RVU is decreasing by 0.26, a 14 percent reduction, we
do not believe the RUC-recommended work RVU appropriately accounts for
the substantial reductions in the surveyed intraservice work time for
the procedure. Although we do not imply that the decrease in time as
reflected in survey values must always equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work and time are intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should be
reflected in decreases to
[[Page 40583]]
work RVUs. In the case of CPT code 64449, we believe that it would be
more accurate to propose a work RVU of 1.27, based on our time ratios
methodology and a reference to CPT code 11755 to account for these
decreases in surveyed times and to maintain rank order among comparable
codes in the family.
For the direct PE inputs, we are proposing to remove the clinical
labor time for the ``Confirm availability of prior images/studies''
(CA006) activity for CPT code 64450. This code does not currently
include this clinical labor time, and unlike the new code, CPT code
64XX1, in the Genicular Injection and RFA code family, in which the PE
for CPT code 64450 was resurveyed at the January 2019 RUC for PE, CPT
code 64450 does not include imaging guidance in its code descriptor.
When CPT code 64450 is performed with imaging guidance, it would be
billed together with a separate imaging code that already includes
clinical labor time for confirming the availability of prior images. As
a result, it would be duplicative to include this clinical labor time
in CPT code 64450. We are also proposing to refine the clinical labor
time for the ``Assist physician or other qualified healthcare
professional--directly related to physician work time (100 percent)''
(CA018) activity from 10 to 5 minutes for CPT code 64450, to match the
intraservice work time and proposing to refine the equipment times in
accordance with our standard equipment time formulas for CPT code
64450.
Additionally, we are proposing to refine the clinical labor time
for the ``provide education/obtain consent'' (CA011) from 3 minutes to
2 minutes, for CPT codes 64400, 64408, 64415, 64417, 64420, 64425,
64430, 64435, 64445, 64447 and 64450, to conform to the standard for
this clinical labor task. We are also proposing to refine the equipment
time in accordance with our standard equipment time formula for these
codes. We note that there were no RUC-recommended direct PE inputs
provided for CPT codes 64416, 64446, and 64448.
(26) Genicular Injection and RFA (CPT Codes 64640, 64XX0, and 64XX1)
In May 2018, the CPT Editorial Panel approved the addition of two
codes to report injection of anesthetic and destruction of genicular
nerves by neurolytic agent. In October 2018, the RUC discussed the
issues surrounding the survey of this family of services and supported
the specialty societies' request for CPT codes 64640 (Destruction by
neurolytic agent; other peripheral nerve or branch), 64XX0
(Injection(s), anesthetic agent(s) and/or steroid; genicular nerve
branches including imaging guidance, when performed), and 64XX1
(Destruction by neurolytic agent genicular nerve branches including
imaging guidance, when performed) to be resurveyed and presented at the
January 2019 RUC meeting, based on their concern that many survey
respondents appeared to be confused about the number of nerve branch
injections involved with these three codes. The RUC resurveyed these
services at the January 2019 RUC meeting.
For CY 2020, we are proposing the RUC-recommended work RVUs for two
of the three codes in this family. We are proposing the RUC-recommended
work RVU of 1.98 (25th percentile survey value) for CPT code 64640 and
the RUC-recommended work RVU of 1.52 (25th percentile survey value) for
CPT code of 64XX0.
For CPT code 64XX1, we disagree with the RUC-recommended work RVU
of 2.62, which is higher than the 25th percentile survey value, a work
RVU 2.50, and are proposing a work RVU of 2.50 (25th percentile survey
value) based on a reference to CPT code 11622 (Excision, malignant
lesion including margins, trunk, arms, or legs; excised diameter 1.1 to
2.0 cm), which has a work RVU of 2.41 and near identical intraservice
and total times to CPT code 64XX1.
In our review of CPT code 64XX1, we examined the intraservice time
ratio for the new code, CPT code 64XX1, in relation to an existing code
in this family of services, CPT code 64640. CPT code 64XX1 has a RUC-
recommended work RVU of 2.62, 25 minutes of intraservice time, and 74
minutes of total time. CPT code 64640 has a RUC-recommended work RVU of
1.98, 20 minutes of intraservice time, and 64 minutes of total time. To
derive our proposed work RVU of 2.50, we calculated the intraservice
time ratio between these two codes, which is a calculated value of
1.25, and applied this ratio times the RUC-recommended work RVU of 1.98
for CPT code 64650, which resulted in a calculated value of 2.48. This
value is nearly identical to the January 2018 RUC 25th percentile
survey value for CPT code 64XX1, a work RVU of 2.50. Our proposed work
RVU of 2.50 is further supported by a reference to CPT code 11622.
For the direct PE inputs, we are proposing to remove the clinical
labor time for the ``Confirm availability of prior images/studies''
(CA006) activity for CPT code 64640. This code does not currently
include this clinical labor time, and unlike the new code in the family
(CPT code 64XX1), CPT code 64640 does not include imaging guidance in
its code descriptor. When CPT code 64640 is performed with imaging
guidance, it would be billed together with a separate imaging code that
already includes clinical labor time for confirming the availability of
prior images. As a result, it would be duplicative to include this
clinical labor time in CPT code 64640. We are proposing to refine the
clinical labor time for the ``Assist physician or other qualified
healthcare professional--directly related to physician work time (100
percent)'' (CA018) activity from 25 to 20 minutes for CPT code 64640,
to match the intraservice work time. We are also proposing to refine
the equipment times in accordance with our standard equipment time
formulas for CPT code 64640.
We are proposing the RUC-recommended direct PE inputs for CPT code
64XX0 without refinement.
For CPT code 64XX1, we are proposing to refine the quantity of the
``cannula (radiofrequency denervation) (SMK-C10)'' (SD011) supply from
3 to 1. We do not believe that the use of 3 of this supply item would
be typical for the procedure. We note that the RUC recommendations for
another code in this family, CPT code 64640 only contains 1 of this
supply item. We believe that the nerves would typically be ablated one
at a time using this cannula, as opposed to ablating three of them
simultaneously as suggested in the recommended direct PE inputs. We
also searched in the RUC database for other CPT codes that made use of
the SD011 supply, and out of the seven codes that currently use this
item, none of them include more than 2 cannula. As a result, we are
proposing to refine the supply quantity to 2 cannula to match the
highest amount contained in an existing code on the PFS. We are also
refining the equipment time for the ``radiofrequency kit for
destruction by neurolytic agent'' (EQ354) equipment from 141 minutes to
47 minutes. The equipment time recommendation was predicated on the use
of 3 of the SD011 supplies for 47 minutes apiece, and we are refining
the equipment time to reflect our supply refinement to 1 cannula. It
was unclear in the RUC recommendation materials as to whether the
radiofrequency kit equipment was in use simultaneously or sequentially
along with the cannula supplies, and therefore, we are soliciting
comments on the typical use of this equipment.
[[Page 40584]]
(27) Cyclophotocoagulation (CPT Codes 66711, 66982, 66983, 66984,
66X01, and 66X02)
In October 2017, CPT codes 66711 (Ciliary body destruction;
cyclophotocoagulation, endoscopic) and 66984 (Extracapsular cataract
removal with insertion of intraocular lens prosthesis (1 stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification) were identified as codes reported
together 75 percent of the time or more. The RUC reviewed action plans
to determine whether a code bundle solution should be developed for
these services. In January 2018, the RUC recommended to refer to CPT to
bundle 66711 with 66984 for CPT 2020. In May 2018, the CPT Editorial
Panel revised three codes and created two new codes, CPT codes 66X01
(Extracapsular cataract removal with insertion of intraocular lens
prosthesis (1-stage procedure), manual or mechanical technique (e.g.,
irrigation and aspiration or phacoemulsification), complex, requiring
devices or techniques not generally used in routine cataract surgery
(e.g., iris expansion device, suture support for intraocular lens, or
primary posterior capsulorrhexis) or performed on patients in the
amblyogenic developmental stage; with endoscopic cyclophotocoagulation)
and 66X02 (Extracapsular cataract removal with insertion of intraocular
lens prosthesis (1 stage procedure), manual or mechanical technique
(e.g., irrigation and aspiration or phacoemulsification); with
endoscopic cyclophotocoagulation) to differentiate cataract procedures
performed with and without endoscopic cyclophotocoagulation.
The codes discussed above and CPT codes 66982 (Extracapsular
cataract removal with insertion of intraocular lens prosthesis (1-stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification), complex, requiring devices or
techniques not generally used in routine cataract surgery (e.g., iris
expansion device, suture support for intraocular lens, or primary
posterior capsulorrhexis) or performed on patients in the amblyogenic
developmental stage) and 66983 (Intracapsular cataract extraction with
insertion of intraocular lens prosthesis (1 stage procedure)) were
reviewed at the January 2019 RUC meeting.
For CY 2020, we are proposing the RUC-recommended work RVU of 10.25
for CPT code 66982, the RUC recommendation to contractor-price CPT code
66983, and the RUC-recommended work RVU of 7.35 for CPT code 66984. We
disagree with the RUC recommendations for CPT codes 66711, 66X01, and
66X02.
For CPT code 66711, we disagree with the RUC-recommended work RVU
of 6.36 and are proposing a work RVU of 5.62, based on crosswalk to CPT
code 28285 (Correction, hammertoe (e.g., interphalangeal fusion,
partial or total phalangectomy), which has an identical work RVU of
5.62, and similar intraservice and total times.
In our review of CPT code 66711, we note that the recommended
intraservice time is decreasing from 20 minutes to 10 minutes (33
percent reduction), and that the recommended total time is decreasing
from 192 minutes to 191 minutes (0.5 percent reduction). While the RUC-
recommended work RVU is decreasing from 7.93 to 6.36, which is a 20
percent reduction, we do not believe it appropriately accounts for the
decreases in survey time. Time ratio methodology suggest that CPT code
66711 is better valued at a work RVU of 5.29, thus it is overvalued
with consideration to the decreases in survey times. Although we do not
imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be appropriately
reflected in decreases to work RVUs. In the case of CPT code 66711, we
believe that it would be more accurate to propose a work RVU of 5.62,
based on our time ratio methodology and a crosswalk to CPT code 28285
to account for these decreases in surveyed work times.
For CPT code 66X01, the RUC recommended a work RVU of 13.15, we
disagree with the RUC-recommended work RVU and are proposing
contractor-pricing for this code. In reviewing this code, we note that
the RUC recommendation survey values do not support the RUC-recommended
work RVU of 13.15 and furthermore, the RUC recommendations do not
include a crosswalk to support the RUC-recommended work RVU. The RUC
recommendations noted a lack of potential crosswalk codes due to the
complete lack of similarly intense major surgical procedures comparable
in the amount of skin-to-skin time, operating room time and amount of
post-operative care. We note that the RUC-recommended work RVU of 13.15
is higher than similarly timed codes on the PFS. Given that lack of
both survey data and a crosswalk to support the RUC-recommended work
RVU for this new code, and that the RUC-recommended work RVU of 13.15
is higher than similarly timed codes on the PFS, we believe it is more
appropriate to propose contractor-pricing for CPT code 66X01. We also
note that the RUC recommended contractor-pricing for another code in
this family, CPT code 66983, which we are proposing for CY 2020.
For CPT code 66X02, the RUC recommended a work RVU of 10.25, we
disagree with the RUC-recommended work RVU and are proposing
contractor-pricing for this code. In reviewing this code, we note that
the RUC recommendation survey values do not support the RUC-recommended
work RVU of 10.25. Furthermore, we are concerned with the RUC
recommended crosswalk, CPT code 67110 (Repair of retinal detachment; by
injection of air or other gas (e.g., pneumatic retinopexy), which is
the same crosswalk used to support the RUC-recommended work RVU of
10.25 for another code in this family, CPT code 66982. CPT code 67110
has 30 minutes of intraservice time and 196 minutes of total time.
Although CPT code 67110 has the identical intraservice time to CPT
codes 66982 and 66X02, we note that CPT code 67110 has 196 minutes of
total time, which is 21 minutes less than the 175 minutes of total time
of CPT code 66982, and 6 minutes less than the 202 minutes of total
time of CPT Code 66X02. However, the RUC is recommending the same work
RVU of 10.25 for CPT codes 66982 and 66X02, supported by the same
crosswalk to CPT code 67110.
Given that lack of survey data and our concern for the RUC-
recommended crosswalk to support the RUC-recommended work RVU of 10.25
for CPT code 66X02, we believe it is appropriate to propose contractor-
pricing for CPT code 66X02. We also note that the RUC recommended
contractor-pricing for another code in this family, CPT code 66983,
which we are prosing for CY 2020.
We are proposing to remove all the direct PE inputs for CPT codes
66X01 and 66X02, given our proposal for contractor-pricing for these
codes. We are proposing the RUC-recommended direct PE inputs for the
other codes in this family.
(28) X-Ray Exam--Sinuses (CPT Codes 70210 and 70220)
CPT code 70210 (Radiologic examination, sinuses, paranasal, less
than 3 views) and CPT code 70220 (Radiologic examination, sinuses,
paranasal, complete, minimum of 3 views) were identified as potentially
misvalued through a screen for
[[Page 40585]]
Medicare services with utilization of 30,000 or more annually. These
two codes were first reviewed by the RUC in April 2018, but were
subsequently surveyed by the specialty societies and reviewed again by
the RUC in January 2019.
The RUC recommended a work RVU for CPT code 70210 of 0.20, which is
a slight increase over the current work RVU for this code (0.17). The
RUC's recommendation is consistent with 25th percentile of survey
results and is based on a comparison of the survey code with the two
key reference services. The first key reference service, CPT code 71046
(Radiologic examination, chest; 2 views), has a work RVU of 0.22, 4
minutes of intraservice time, and 6 minutes of total time. The RUC
noted that the survey code has one minute less intraservice and total
time compared with the first key reference service (CPT code 71046),
which accounts for the slightly lower work RVU for the survey code. The
RUC also compared CPT code 70210 to CPT code 70355 (Orthopantogram
(e.g., panoramic X-ray)), with a work RVU of 0.20, 5 minutes of
intraservice time, and 6 minutes of total time. Although the
intraservice and total times are lower for CPT code 70210 than for CPT
code 70355, the work is slightly more intense for the survey code,
according to the RUC, justifying an identical work RVU of 0.20 for CPT
code 70210. We disagree with the RUC's recommendation to increase the
work RVU for CPT code 70210 from the current value (0.17) to 0.20 for
two main reasons. First, the total time (5 minutes) for this code has
not changed from the current total time and without a corresponding
explanation for an increase in valuation despite maintaining the same
total time, we do are not convinced that the work RVU for this code
should increase. In addition, we note that based on a general
comparison of CPT codes with identical intraservice time and total time
(approximately 23 comparison codes, excluding those currently under
review), a work RVU of 0.20 would establish a new upper threshold among
this cohort. We are proposing to maintain the work RVU for CPT code
70210 of 0.17 work RVUs, bracketed by two services. On the upper side,
we identified CPT code 73501 (Radiologic examination, hip, unilateral,
with pelvis when performed; 1 view) with a work RVU of 0.18, and on the
lower side, we identified CPT code 73560 (Radiologic examination, knee;
1 or 2 views) with a work RVU of 0.16. For CPT code 70220, we are
proposing the RUC-recommended work RVU of 0.22.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(29) X-Ray Exam--Skull (CPT Codes 70250 and 70260)
CPT code 70250 (Radiologic examination, skull, less than 4 views)
was identified as potentially misvalued through a screen of Medicare
services with utilization of 30,000 or more annually. CPT code 70260
(Radiologic examination, skull; complete, minimum of 4 views) was
included as part of the same family. These two codes were first
reviewed by the RUC in April 2018, but were subsequently surveyed by
the specialty societies and reviewed by the RUC again in January 2019.
The RUC-recommended work RVU for CPT code 70250 is 0.20, which is a
slight decrease from the current work RVU for this code (0.24). The
decrease, according to the RUC, reflects a slightly lower total time
required to furnish the service (from 7 minutes to 5 minutes) and is
consistent with the 25th percentile work RVU from the survey results.
The RUC-recommended work RVU is bracketed by two CPT codes: Top key
reference service, CPT code 71046 (Radiologic examination, chest; 2
views) with 4 minutes of intraservice time, 6 minutes total time, and a
work RVU of 0.22; and key reference service, CPT code 73562 (Radiologic
examination, knee; 3 views), with intraservice time of 4 minutes, total
time of 6 minutes, and a work RVU of 0.18. The RUC noted that while the
survey code has less time than CPT code 71046, the work is slightly
more intense due to anatomical and contextual complexity. The survey
code is also more intense compared with the second key reference
service, CPT code 73562, according to the RUC, because of the higher
level of technical skill involved in an X-ray of the skull (axial
skeleton) compared with an X-ray of the knee (appendicular skeleton).
The RUC further indicated that a comparison between the survey code and
CPT codes with a work RVU of 0.18 would not be appropriate given the
higher level of complexity associated with an X-ray of the skull than
with other CPT codes that have similar times. We disagree with the
recommended work RVU of 0.20 for CPT code 70250. The total time for
furnishing the service has decreased by 2 minutes while the description
of the work involved in furnishing the service has not changed. This
suggests that a value closer to the total time ratio (TTR) calculation
(0.17 work RVU) might be more appropriate. In addition, a search of CPT
codes with 3 minutes of intraservice time and 5 minutes of total time
indicates that the maximum work RVU for codes with these times is 0.18,
meaning that a work RVU of 0.20 would establish a new relative high
work RVU for codes with these times. We believe that a crosswalk to CPT
code 73501 (Radiologic examination, hip, unilateral, with pelvis when
performed; 1 view) with a work RVU of 0.18, 3 minutes of intraservice
time, and 5 minutes of total time, accurately reflects both the time
and intensity of furnishing the service described by CPT code 70250.
Therefore, we are proposing a work RVU of 0.18 for CPT code 70250.
The RUC recommended a work RVU of 0.29 for CPT code 70260, which is
lower than the current work RVU of 0.34. The survey times for
furnishing the service are 4 minutes of intraservice time and 7 minutes
total time, compared with the current intraservice time and total time
of 7 minutes. However, in developing their recommendation, the RUC
reduced the total time for this code from 7 minutes to 6 minutes.
Although the RUC's recommended work RVU reflects the 25th percentile of
survey results, the survey 25th percentile is based on an additional
minute of total time compared with the RUC's total time for this CPT
code. Moreover, since we are proposing a lower work RVU for the base
code for this family (work RVU of 0.18 for CPT code 70250), we believe
a lower work RVU for CPT code 70260 is warranted. To identify an
alternative value, we calculated the increment between the current work
RVU for CPT code 72050 (work RVU of 0.24) and the current work RVU for
CPT code 72060 (work RVU of 0.34) and applied it to the CMS proposed
work RVU for CPT code 70250 (0.18 + 0.10) to calculate a work RVU of
0.28. We believe that applying this increment is a better reflection of
the work time and intensity involved in furnishing CPT code 70260. We
are proposing a work RVU for CPT code 70260 of 0.28.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(30) X-Ray Exam--Neck (CPT Code 70360)
CPT code 70360 (Radiologic examination; neck, soft tissue) was
identified as potentially misvalued through a screen of CPT codes with
annual Medicare utilization of 30,000 or more. CPT code 70360 was first
reviewed by the RUC in April 2018 but was subsequently surveyed by the
specialty societies and reviewed by the RUC again in January 2019.
The RUC recommended a work RVU of 0.20 for CPT code 70360, which is
an increase over the current work RVU
[[Page 40586]]
(0.17). To support their recommendation, the RUC cited the survey key
reference service, CPT code 71046 (Radiologic examination, chest; 2
views), with a work RVU of 0.22, 4 minutes of intraservice time, and 6
minutes of total time. They noted that the key reference code has one
minute higher intraservice and total time, accounting for the slightly
higher work RVU compared with the survey code, CPT code 70360. The RUC
also cited the second highest key reference service, CPT code 73562
(Radiologic examination, knee; 3 views) with a work RVU of 0.18,
intraservice time of 4 minutes, and total time of 6 minutes. They noted
that, while the survey code has lower intraservice time (3 minutes) and
total time (5 minutes) compared with CPT code 73562, the survey code is
more complex than the key reference service, thereby supporting a
higher work RVU for the survey code (CPT code 70360) of 0.20. We do not
agree with the RUC that the work RVU for CPT code 70360 should increase
from 0.17 to 0.20. The total time for the CPT code, as recommended by
the RUC (5 minutes), is unchanged from the existing total time. Without
a corresponding discussion of why the current work RVU is insufficient,
we do not agree that there should be an increase in the work RVU.
Furthermore, although the RUC's recommendation is consistent with the
25th percentile of survey results for the work RVU, the total time from
the survey results was 6 minutes, not the RUC-recommended time of 5
minutes. When we looked at CPT codes with identical times to the survey
code for a crosswalk, we identified CPT code 73552 (Radiologic
examination, femur; minimum 2 views), with a work RVU of 0.18. We
believe this is a more appropriate valuation for CPT code 70360 and we
are proposing a work RVU for this CPT code of 0.18.
We are proposing the RUC-recommended direct PE inputs for CPT code
70360.
(31) X-Ray Exam--Spine (CPT Codes 72020, 72040, 72050, 72052, 72070,
72072, 72074, 72080, 72100, 72110, 72114, and 72120)
CPT codes 72020 (Radiologic examination spine, single view, specify
level) and 72072 (Radiologic examination, spine; thoracic, 3 views)
were identified through a screen of CMS/Other Source codes with
Medicare utilization greater than 100,000 services annually. The code
family was expanded to include 10 additional CPT codes to be reviewed
together as a group: CPT code 72040 (Radiologic examination, spine,
cervical; 2 or 3 views), CPT code 72050 (Radiologic examination, spine,
cervical; 4 or 5 views), CPT code 72052 (Radiologic examination, spine
cervical; 6 or more views), CPT code 72070 (Radiologic examination
spine; thoracic, 2 views), CPT code 72074 (Radiologic examination,
spine; thoracic, minimum of 4 views), CPT code 72080 (Radiologic
examination, spine; thoracolumbar junction, minimum of 2 views), CPT
code 72100 (Radiologic examination, spine, lumbosacral; 2 or 3 views),
CPT code 72110 (Radiologic examination, spine, lumbosacral; minimum of
4 views), CPT code 72114 (Radiologic examination, spine, lumbosacral;
complete, including bending views, minimum of 6 views), and CPT code
72120 (Radiologic examination, spine, lumbosacral; bending views only,
2 or 3 views). This family of CPT codes was originally valued by the
specialty societies using a crosswalk methodology approved by the RUC
Research Subcommittee. However, after we expressed concern about the
use of this approach for valuing work and PE, the specialty society
agreed to survey these codes and the RUC reviewed them again in January
2019.
For the majority of CPT codes in this family, the RUC recommended a
work RVU that is slightly different (higher or lower) than the current
work RVU. Three CPT codes in this family are maintaining the current
work RVU. We are proposing the RUC-recommended work RVU for all 12 CPT
codes in this family as follows: CPT code 72020 (work RVU = 0.16); CPT
code 72040 (work RVU = 0.22); CPT code 72050 (work RVU = 0.27); CPT
code 72052 (work RVU = 0.30); CPT code 72070 (work RVU = 0.20); CPT
code 72072 (work RVU = 0.23); CPT code 72074 (work RVU = 0.25); 72080
(work RVU = 0.21); CPT code 72100 (work RVU = 0.22); CPT code 72110
(work RVU =0.26); CPT code 72114 (work RVU = 0.30); and CPT code 72120
(work RVU = 0.22).
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(32) CT-Orbit-Ear-Fossa (CPT Codes 70480, 70481, and 70482)
In October 2017, the RAW requested that AMA staff develop a list of
CMS/Other codes with Medicare utilization of 30,000 or more. CPT code
70480 (Computed tomography (CT), orbit, sella, or posterior fossa or
outer, middle, or inner ear; without contrast material) was identified.
In addition, the code family was expanded to include two related CT
codes, CPT code 70481 (Computed tomography, orbit, sella, or posterior
fossa or outer, middle, or inner ear; with contrast material) and CPT
code 70482 (Computed tomography, orbit, sella, or posterior fossa or
outer, middle, or inner ear; without contrast material followed by
contrast material(s) and further sections). In 2018, the RUC
recommended this code family be surveyed.
For CPT code 70840, we disagree with the RUC-recommended work RVU
of 1.28 and propose instead a work RVU of 1.13. We are proposing a
lower work RVU because 1.13 represents the commensurate 12 percent
decrease in work time reflected in survey values. We reference the work
RVUs of CPT codes 72128 (Computed tomography, chest, spine; without
dye) and 71250 (Computed tomography, thorax without dye) both of which
have the same intraservice time (that is, 15 minutes) as CPT code 70840
but longer total times (that is, 25 minutes versus 22 minutes). We
believe that CPT code 72128 with a work RVU of 1.0 and CPT code 71250
with a work RVU of 1.16 more accurately reflect the relative work
values of CPT code 70840.
We also disagree with the RUC-recommended work RVU of 1.13 for CPT
code 70481. Instead, we are proposing a work RVU of 1.06 for CPT code
70481. As with CPT code 70840, we are proposing a lower work RVU for
CPT code 70481 because a work RVU of 1.06 is commensurate with the 23
percent decrease in surveyed total time from 26 to 20 minutes. We
believe CPT code 76641 (Ultrasound, breast, unilateral) with a work RVU
of 0.73 and CPT code 70460 (Computed Tomography, head or brain, without
contrast) with a work RVU of 1.13 serve as appropriate references for
our proposed work RVU for CPT code 70841. Although CPT codes 76641 and
70460 have longer total times at 22 minutes and lower intraservice
times at 12 minutes, we believe they better reflect the relative work
value of CPT code 70481 with a proposed work RVU of 1.06, total time of
20 minutes, and intraservice time of 13 minutes.
For the third code in the family, CPT code 70482, we are proposing
the RUC-recommended work RVU of 1.27.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(33) CT Spine (CPT Codes 72125, 72126, 72127, 72128, 72129, 72130,
72131, 72132, and 72133)
CPT code 72132 (Computed tomography, lumbar spine; with contrast
material) was identified as potentially misvalued on a screen of CMS/
Other codes with Medicare
[[Page 40587]]
utilization of 30,000 or more. Eight other spine CT codes were
identified as part of the family, and they were surveyed and reviewed
together at the April 2018 RUC meeting.
We are proposing the RUC-recommended work RVU for eight of the nine
codes in the family. We are proposing a work RVU of 1.22 for CPT code
72126 (Computed tomography, cervical spine; with contrast material), a
work RVU of 1.27 for CPT code 72127 (Computed tomography, cervical
spine; without contrast material, followed by contrast material(s) and
further sections), a work RVU of 1.00 for CPT code 72128 (Computed
tomography, thoracic spine; without contrast material), a work RVU of
1.22 for CPT code 72129 (Computed tomography, thoracic spine; with
contrast material), a work RVU of 1.27 for CPT code 72130 (Computed
tomography, thoracic spine; without contrast material, followed by
contrast material(s) and further sections), a work RVU of 1.00 for CPT
code 72131 (Computed tomography, lumbar spine; without contrast
material), a work RVU of 1.22 for CPT code 72132 (Computed tomography,
lumbar spine; with contrast material), and a work RVU of 1.27 for CPT
code 72133 (Computed tomography, lumbar spine; without contrast
material, followed by contrast material(s) and further sections).
We disagree with the RUC-recommended work RVU of 1.07 for CPT code
72125 (Computed tomography, cervical spine; without contrast material)
and we are proposing a work RVU of 1.00 to match the other without
contrast codes in the family. The cervical spine CT procedure described
by CPT code 72125 shares the identical surveyed work time as the
thoracic spine CT procedure described by CPT code 72128 and the lumbar
spine CT procedure described by CPT code 72131, and we believe that
this indicates that these three CPT codes should share the same work
RVU of 1.00. Our proposed work RVU would also match the pattern
established by the rest of the codes in this family, in which the
contrast procedures (CPT codes 72126, 72129, and 72132) share a
proposed work RVU of 1.22 and the without/with contrast procedures (CPT
codes 72127, 72130, and 72133) share a proposed work RVU of 1.27.
We recognize that the RUC has stated that they believe CPT code
72125 to be a more complex study than CPT codes 72128 and 72131 because
the cervical spine is subject to an increased number of injuries and
there are a larger number of articulations to evaluate. This was the
basis for their recommendation that this code should be valued slightly
higher than the other without contrast codes. However, if CPT code
72125 has a more difficult patient population and requires a larger
number of articulations to evaluate as compared to CPT codes 72128 and
72131, we do not understand why this was not reflected in the surveyed
work times, which were identical for the three procedures. We believe
that if the intensity of the procedure were higher due to these
additional difficulties, it would be reflected in a longer surveyed
work time. In addition, the survey respondents selected a higher work
RVU for CPT code 72131 than CPT code 72125 at both the survey 25th
percentile (1.20 to 1.18) and survey median values (1.39 to 1.28),
which does not suggest that CPT code 72125 should be valued at a higher
rate.
We also note that the surveyed intraservice work time for CPT code
72125 is decreasing from 15 minutes to 12 minutes, and we believe that
this provides additional support for a slight reduction in the work RVU
to match the other without contrast codes in the family. We recognize
that adjusting work RVUs for changes in time is not always a
straightforward process and that the intensity associated with changes
in time is not necessarily always linear, which is why we apply various
methodologies to identify several potential work values for individual
codes. However, we want to reiterate that we believe it would be
irresponsible to ignore changes in time based on the best data
available and that we are statutorily obligated to consider both time
and intensity in establishing work RVUs for PFS services. For
additional information regarding the use of prior work time values in
our methodology, we refer readers to our discussion of the subject in
the CY 2017 PFS final rule (81 FR 80273 through 80274).
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(34) X-Ray Exam--Pelvis (CPT Codes 72170 and 72190)
CPT code 72190 (Radiologic examination, pelvis; complete, minimum
of 3 views) was identified as potentially misvalued through a screen of
CMS/Other codes with Medicare utilization of 30,000 or more annually.
CPT code 72170 (Radiologic examination, pelvis; 1 or 2 views) was added
as part of the family. The RUC originally reviewed these two codes
after specialty societies employed a crosswalk methodology to value
work and PE. However, after we expressed concern about the use of this
approach, the specialty society agreed to survey the codes and the RUC
reviewed them again at the meeting in January 2019.
The RUC recommended a work RVU of 0.17 for CPT code 72170, which
maintains the current value. For CPT code 72190, the RUC recommended a
work RVU of 0.25, which is slightly higher than the current value
(0.21). We are proposing the RUC-recommended values for these two CPT
codes.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(35) X-Ray Exam--Sacrum (CPT Codes 72200, 72202, and 72220)
CPT code 72220 (Radiologic examination, sacrum and coccyx, minimum
of 2 views) was identified on a screen of CMS/Other source codes with
Medicare utilization greater than 100,000 annually. CPT codes 72200
(Radiologic examination, sacroiliac joints; less than 3 views) and
72202 (Radiologic examination, sacroiliac joints; 3 or more views) were
also included for review as part of the same family of codes. These
three codes were originally valued by the specialty societies using a
crosswalk methodology approved by the RUC Research Subcommittee.
However, after we expressed concern about the use of this approach for
valuing work and PE, the specialty society agreed to survey these codes
and the RUC reviewed them again in January 2019.
For CPT code 72200, the RUC is recommending a work RVU of 0.20,
which is higher than the current work RVU (0.17). To support their
recommendation, the RUC compared the survey code to the key reference
service, CPT code 73522 (Radiologic examination, hips, bilateral, with
pelvis when performed; 3-4 views), with a work RVU of 0.29, 5 minutes
of intraservice time and 7 minutes of total time. The intraservice and
total times for the key reference service are one minute higher than
the survey code (4 minutes intraservice time, 6 minutes total time for
CPT code 72200) and the survey code is less intense, according to the
RUC, thereby supporting a slightly lower work RVU of 0.20 for CPT code
72200. The second key reference service is CPT code 73562 (Radiologic
examination, knee; 3 views), with 4 minutes of intraservice time, 6
minutes of total time, and a work RVU of 0.18. The RUC noted that this
second key reference service is less intense to furnish than the survey
code, which justifies a slightly lower work RVU despite identical
intraservice time (4 minutes) and total time (6 minutes). The
[[Page 40588]]
RUC supported their recommendation of a work RVU for CPT code 72200 of
0.20 with two bracketing codes: CPT code 93042 (Rhythm ECG, 1-3 leads;
interpretation and report only) with work RVU of 0.15, and CPT code
70355 (Orthopantogram (e.g. panoramic x-ray)) with a work RVU of 0.20
(which is identical to the RUC-recommended work RVU for CPT code 72200
but has one additional minute of intraservice time). A work RVU of 0.20
is consistent with the work RVU estimated by the TTR and reflects the
25th percentile of survey results. Nevertheless, we do not agree that
there is sufficient justification for an increase in work RVU for CPT
code 72200. We are concerned that the large variation in specialty
societies' survey times is indicative of differences in patient
population, practice workflow, or even possibly some ambiguity
associated with the survey vignette. We also note that the 25th
percentile of survey results are based on the overall survey total
time, which is 8 minutes, rather than the RUC's recommended 6 minutes.
The time parameters for furnishing the service affect all other points
of comparison for purpose of valuing the code, including TTR,
identification of potential crosswalks, and increment calculations. We
found no corresponding explanation for the variability in survey times,
leading us to question why there should be an increase in work RVU from
the current value. Therefore, we are proposing to maintain the current
work RVU for CPT code 72200 at 0.17.
For CPT code 72202, the RUC recommended a work RVU of 0.26, which
is considerably higher than the current work RUV for this code of 0.19.
The RUC supported their recommendation with two key reference services.
The first is CPT code 73522 (Radiologic examination, hips, bilateral,
with pelvis when performed; 3-4 views) with 5 minutes intraservice
time, 7 minutes total time, and a work RVU of 0.29. They note that this
code has an additional minute for intraservice and total time compared
with the survey code, reflecting the additional views associated with
evaluating bilateral hip joints. The second key reference service is
CPT code 73562 (Radiologic examination, knee; 3 views) with 4 minutes
intraservice time, 6 minutes total time, and a work RVU of 0.18. The
RUC notes that the survey code has the same times but requires more
intensity and includes an additional view compared with the reference
service, which justifies a higher work RVU for the survey code. We
disagree with the RUC's recommended work RVU for CPT code 72202. Given
that there is no change in the total time required to furnish the
service and there is no corresponding description of an increase in the
intensity of the work relative to the existing value, we do not believe
an increase of 0.07 work RVUs is warranted. The TTR calculation yields
a work RVU of .019, suggesting that a value closer to the current work
RVU would be more appropriate. In addition, since we consider the RUC-
recommended work RVU for this code as an incremental change from the
prior code in this family, we believe that an increase of 0.06 over the
proposed work RVU of 0.18 for CPT code 72200, which yields a work RVU
of 0.23, is a better reflection of the time and intensity required to
furnish CPT code 72202. Our proposed value work RVU of 0.23 is
bracketed by CPT code 73521 (Radiologic examination, hips, bilateral,
with pelvis when performed; 2 views) on the lower end (work RVU = .22),
and CPT code 74021 (Radiologic examination, abdomen; 3 or more views),
on the higher end (work RVU = 0.27). CPT code 73521 has the same times
as the survey code but describes a bilateral service with 2 views,
which is slightly less intense. CPT code 74021 also has identical times
but involves X-ray of the abdomen with 3 views, a slightly higher
intensity than the survey code.
The RUC-recommended work RVU for CPT code 72220 is 0.20, which
reflects an increase over the current work RVU for this code (0.17).
The key reference service from the survey results is CPT code 73522
(Radiologic examination, hips, bilateral, with pelvis when performed,
2-4 views), with a work RVU of 0.29, 5 minutes intraservice time, and 7
minutes total time. The RUC noted that the recommended work RVU for CPT
code 72220 has a lower value than the top key reference code (CPT code
73522) because of the shorter time and lower intensity involved in
furnishing the survey code. The second highest key reference service,
CPT code 73562 (Radiologic examination, knee; 3 views) has a work RVU
of 0.18 with 4 minutes of intraservice time and 6 minutes of total
time. The RUC notes that this second key reference service has a lower
work RVU than the survey code despite having a slightly higher
intraservice time and total time because it involves an X-ray of just
one knee. We disagree with the RUC's recommended increase in the work
RVU for CPT code 72220 from 0.17 to 0.20. We note that there is no
change in the total time required to furnish the service. We also note
that a work RVU of 0.20 for CPT code 72220 would place it near the
maximum work RVU for CPT codes with identical intraservice time (3
minutes) and total time (5 minutes). Instead, we are proposing to
maintain the work RVU for this service at 0.17, which is consistent
with our proposal to maintain the current work RVU for CPT code 72200
at 0.17 as well.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(36) X-Ray Exam--Clavicle-Shoulder (CPT Codes 73000, 73010, 73020,
73030, and 73050)
CPT code 73030 (Radiologic examination, shoulder; complete, minimum
of 2 views) was identified as potentially misvalued through a screen of
services with more than 100,000 utilization annually. CPT codes 73000
(Radiologic examination; clavicle, complete), 73010 (Radiologic
examination; scapula, complete), 73020 (Radiologic examination,
shoulder; 1 view), and 73050 (Radiologic examination, acromioclavicular
joints, bilateral, with or without weighted distraction) were included
for review as part of the same family. We are proposing the RUC-
recommended work RVUs for all five codes in this family as follows: CPT
code 73000 (work RVU = 0.16); CPT code 73010 (work RVU = 0.17); CPT
code 73020 (work RVU = 0.15); CPT code 73030 (work RVU = 0.18); and CPT
code 73050 (work RVU = 0.18).
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(37) CT Lower Extremity (CPT Codes 73700, 73701, and 73702)
CPT code 73701 (Computed tomography, lower extremity; with contrast
material(s)) was identified as potentially misvalued on a screen of
CMS/Other codes with Medicare utilization of 30,000 or more. Two other
lower extremity CT codes were identified as part of the family, and
they were surveyed and reviewed together at the April 2018 RUC meeting.
We are proposing the RUC-recommended work RVU for all three codes
in this family. We are proposing a work RVU of 1.00 for CPT code 73700
(Computed tomography, lower extremity; without contrast material), a
work RVU of 1.16 for CPT code 73701 (Computed tomography, lower
extremity; with contrast material(s)), and a work RVU of 1.22 for CPT
code 73702 (Computed tomography, lower extremity; without contrast
material, followed by contrast material(s) and further sections).
[[Page 40589]]
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(38) X-Ray Elbow-Forearm (CPT Codes 73070, 73080, and 73090)
CPT codes 73070 (Radiologic examination, elbow; 2 views) and 73090
(Radiologic examination; forearm, 2 views) were identified on a screen
of CMS/Other source codes with Medicare utilization greater than
100,000 services annually. CPT code 73080 (Radiologic examination,
elbow; complete, minimum of 3 views) was included for review as part of
the same code family. All three CPT codes in this family were
originally valued by the specialty societies using a crosswalk
methodology approved by the RUC research committee. However, after we
expressed concern about the use of this approach for valuing work and
PE, the specialty society agreed to survey the codes and the RUC
reviewed them again at the meeting in January 2019. We are proposing
the RUC-recommended work RVU for all three codes in this family as
follows: CPT code 73070 (work RVU = 0. 16); CPT code 73080 (work RVU =
0.17); and CPT code 73090 (work RVU = 0.16).
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(39) X-Ray Heel (CPT Code 73650)
CPT code 73650 (Radiologic examination; calcaneous, minimum of 2
views) was identified on a screen of CMS/Other source codes with
Medicare utilization greater than 100,000 services annually. CPT code
73650 was originally valued by the specialty societies using a
crosswalk methodology approved by the RUC Research Subcommittee.
However, after we expressed concern about the use of this approach for
valuing work and PE, the specialty society agreed to survey the code
and the RUC reviewed it again in January 2019. For CPT code 73650, we
are proposing the RUC-recommended work RVU of 0.16. We are also
proposing the RUC-recommended direct PE inputs for CPT code 73650.
(40) X-Ray Toe (CPT Code 73660)
CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views)
was identified on a screen of CMS/Other source codes with Medicare
utilization greater than 100,000 services annually. CPT code 73660 was
originally valued by the specialty societies using a crosswalk
methodology approved by the RUC Research Subcommittee. However, after
we expressed concern about the use of this approach for valuing work
and PE, the specialty society agreed to survey the code and the RUC
reviewed it again in January 2019. We are proposing the RUC-recommended
work RVU for this code of 0.13 for CPT code 73660. We are also
proposing the RUC-recommended direct PE inputs for CPT code 73660.
(41) Upper Gastrointestinal Tract Imaging (CPT Codes 74210, 74220,
74230, 74X00, 74240, 74246, and 74X01)
These services were identified through a list of list of CMS/Other
codes with Medicare utilization of 30,000 or more. The CPT Editorial
Panel subsequently revised this code set in order to conform to other
families of radiologic examinations.
We are proposing the RUC-recommended work RVUs of 0.59 for CPT code
74210 (Radiologic examination, pharynx and/or cervical esophagus,
including scout neck radiograph(s) and delayed image(s), when
performed, contrast (e.g., barium) study), 0.60 for CPT code 74220
(Radiologic examination, esophagus, including scout chest radiograph(s)
and delayed image(s), when performed; single-contrast (e.g., barium)
study), 0.70 for CPT code 74X00 (Radiologic examination, esophagus,
including scout chest radiograph(s) and delayed image(s), when
performed; double-contrast (e.g., high-density barium and effervescent
agent) study), 0.53 for CPT code 74230 (Radiologic examination,
swallowing function, with cineradiography/videoradiography, including
scout neck radiograph(s) and delayed image(s), when performed, contrast
(e.g., barium) study), 0.80 for CPT code 74240 (Radiologic examination,
upper gastrointestinal tract, including scout abdominal radiograph(s)
and delayed image(s), when performed; single-contrast (e.g., barium)
study) 0.90 for CPT code 74246 (Radiologic examination, upper
gastrointestinal tract, including scout abdominal radiograph(s) and
delayed image(s), when performed; double-contrast (e.g., high-density
barium and effervescent agent) study, including glucagon, when
administered), and 0.70 for CPT code 74X01 (Radiologic examination,
upper gastrointestinal tract, including scout abdominal radiograph(s)
and delayed image(s), when performed; with small intestine follow-
through study, including multiple serial images (List separately in
addition to code for primary procedure)). We are also proposing the
reaffirmed work RVU of 0.59 for CPT code 74210 (Radiologic examination,
pharynx and/or cervical esophagus, including scout neck radiograph(s)
and delayed image(s), when performed, contrast (e.g., barium) study)
and the reaffirmed work RVU of 0.53 for CPT code 74230 (Radiologic
examination, swallowing function, with cineradiography/
videoradiography, including scout neck radiograph(s) and delayed
image(s), when performed, contrast (e.g., barium) study).
For the direct PE clinical labor input CA021 ``Perform procedure/
service--NOT directly related to physician work time,'' we note that no
rationale was given for the RUC-recommended times for these codes, and
we are requesting comment on the appropriateness of the RUC-recommended
clinical labor times for this activity of 13 minutes, 13 minutes, 15
minutes, 15 minutes, 19 minutes, 22 minutes, and 15 minutes for CPT
codes 74210, 74220, 74X00, 74230, 74240, and 74246, respectively. In
addition, for CPT code 74230, we are proposing to refine the clinical
labor times for the ``Prepare room, equipment and supplies'' (CA013)
and ``Prepare, set-up and start IV, initial positioning and monitoring
of patient'' (CA016) activity codes to the standard values of 2 minutes
each, as well as to refine the equipment times to reflect these changes
in clinical labor.
(42) Lower Gastrointestinal Tract Imaging (CPT Codes 74250, 74251,
74270, and 74280)
These services were identified through a list CMS/Other codes with
Medicare utilization of 30,000 or more. We are proposing the RUC-
recommended work RVUs of 0.81 for CPT code 74250 (Radiologic
examination, small intestine, including multiple serial images and
scout abdominal radiograph(s), when performed; single-contrast (e.g.,
barium) study), 1.17 for CPT code 74251 (Radiologic examination, small
intestine, including multiple serial images and scout abdominal
radiograph(s), when performed; double-contrast (e.g., high-density
barium and air via enteroclysis tube) study, including glucagon, when
administered), 1.04 for 74270 (Radiologic examination, colon, including
scout abdominal radiograph(s) and delayed image(s), when performed;
single-contrast (e.g., barium) study), and 1.26 for CPT code 74280
(Radiologic examination, colon, including scout abdominal radiograph(s)
and delayed image(s), when performed; double-contrast (e.g., high
density barium and air) study, including glucagon, when administered).
[[Page 40590]]
For the direct PE clinical labor input CA021 ``Perform procedure/
service--NOT directly related to physician work time,'' we note that no
rationale was given for the recommended times for these codes, and we
are requesting comment on the appropriateness of the RUC-recommended
clinical labor times for this activity of 19 minutes, 30 minutes, 25
minutes, and 36 minutes for CPT codes 74250, 74251, 74270, and 74280,
respectively. In addition, we are proposing to refine the equipment
time for the room, radiographic-fluoroscopic (EL014) for CPT code 74250
to conform to our established standard for highly technical equipment
and to match the rest of the codes in the family.
(43) Urography (CPT Code 74425)
The physician time and work described by CPT code 74425 (Urography,
antegrade (pyelostogram, nephrostogram, loopogram), radiological
supervision and interpretation) was combined with services describing
genitourinary catheter procedures in CY 2016, resulting in CPT codes
50431 (Injection procedure for antegrade nephrostogram and/or
ureterogram, complete diagnostic procedure including imaging guidance
(e.g., ultrasound and fluoroscopy) and all associated radiological
supervision and interpretation; existing access) and 50432 (Placement
of nephrostomy catheter, percutaneous, including diagnostic
nephrostogram and/or ureterogram when performed, imaging guidance
(e.g., ultrasound and/or fluoroscopy) and all associated radiological
supervision and interpretation). CPT code 74425 was not deleted at the
time, but the RUC agreed with the specialty societies that 2 years of
Medicare claims data should be available for analysis before the code
was resurveyed for valuation to allow for any changes in the
characteristics and process involved in furnishing the service
separately from the genitourinary catheter procedures. The specialty
society surveyed CPT code 74425 and reviewed the results with the RUC
in October 2018.
The results of the specialty society surveys indicated a large
increase in the amount of time required to furnish the service and,
correspondingly, to the work RVU. The total time for CPT code 74425
based on the survey results was 34 minutes, an increase of 25 minutes
over the current total time of 9 minutes. In reviewing the survey
results, the RUC revised the total time for this CPT code to 24
minutes, with a recommended work RVU of 0.51. The reason for the large
increase in time according to the RUC, is a change in the typical
patient profile in which the typical patient is one with an ileal
conduit through which nephrostomy tubes have been placed for post-
operative obstruction. Based on the described change in patient
population and increased time required to furnish the service, we are
proposing the RUC-recommended work RVU of 0.51 for CPT code 74425.
We are proposing the RUC-recommended direct PE inputs for CPT code
74425.
(44) Abdominal Aortography (CPT Codes 75625 and 75630)
In October 2017, the RAW requested that AMA staff compile a list of
CMS/Other codes with Medicare utilization of 30,000 or more. In January
2018, the RUC recommended to survey these services for the October 2018
RUC meeting. Subsequently, the specialty society surveyed these codes.
We disagree with the RUC-recommended work RVU of 1.75 for CPT code
75625 (Aortography, abdominal, by serialography, radiological
supervision and interpretation). In reviewing CPT code 75625, we note
that the key reference service, CPT Code 75710 (Angiography, extremity,
unilateral, radiological supervision and interpretation), has 10
additional minutes of intraservice time, 10 additional minutes of total
time and the same work RVU, which would indicate the RUC-recommended
work RVU of 1.75 appears to be overvalued. When we compared the
intraservice time ratio between the RUC-recommended time of 30 minutes
and the reference code intraservice time of 40 minutes we found a ratio
of 25 percent. 25 percent of the reference code work RVU of 1.75 equals
a work RVU of 1.31. When we compared the total service time ratio
between the RUC-recommended time of 60 minutes and the reference code
total service time of 70 minutes we found a ratio of 14 percent. 14
percent of the reference code work RVU of 1.75 equals a work RVU of
1.51. Therefore, we believe an accurate value would lie between 1.31
and 1.52 RVUs. In looking for a comparative code, we have identified
CPT code 38222. CPT Code 38222 is a recently reviewed CPT code with the
identical intraservice and total times. As a result, we believe that it
is more accurate to propose a work RVU of 1.44 based on a crosswalk to
CPT code 38222.
In case of CPT code 75630 (Aortography, abdominal plus bilateral
iliofemoral lower extremity, catheter, by serialography, radiological
supervision and interpretation), we are proposing the RUC-recommended
value of 2.00 RVUs.
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(45) Angiography (CPT Codes 75726 and 75774)
We are proposing the RUC-recommend work RVU for both codes in this
family. We are proposing a work RVU of 2.05 for CPT code 75726
(Angiography, visceral, selective or supraselective (with or without
flush aortogram), radiological supervision and interpretation), a work
RVU of 1.01 for CPT code 75774 (Angiography, selective, each additional
vessel studied after basic examination, radiological supervision and
interpretation (List separately in addition to code for primary
procedure).
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(46) X-Ray Exam Specimen (CPT Code 76098)
CPT code 70098 was reviewed by the RUC based on a request from the
American College of Radiology (ACR) to determine whether CPT code 76098
was undervalued because of the assumption that the service is typically
furnished concurrently with a placement of localization device service
(CPT codes 19281 through 19288 each representing a different imaging
modality). In a letter to the RUC, ACR expressed concern about the
appropriateness of a codes valuation process in which physician time
and intensity for a code are reduced to account for overlap with codes
that are furnished to a patient on the same day. During the April 2018
RUC meeting, the specialty societies requested a work RVU of 0.40 for
CPT code 76098, with intraservice time of 5 minutes and total time of
15 minutes. Currently, this service has a work RVU of 0.16, with 5
minutes of total time and no available intraservice time. In April
2018, the RUC and the specialty society agreed that additional analysis
of the data was warranted in consideration of the relatively large
change in survey time and work RVU for this service. The RUC agreed to
review the CPT code (CPT code 76098) again in October 2018.
The RUC recommended a work RVU, based on the October 2018 meeting,
of 0.31 for CPT code 76098, which represents an increase over the
current value (0.16) but a decrease relative to the specialty society's
original request of 0.40. The intraservice time for this CPT code is 5
minutes, and the total time is 11 minutes. Based on the parameters we
[[Page 40591]]
typically use to review and evaluate RUC recommendations, which rely
heavily on survey data, we agree that a work RVU of 0.31 for a CPT code
with 5 minutes intraservice and 11 minutes total time is consistent
with other CPT codes with similar times and levels of intensity. We are
proposing the RUC-recommended work RVU for CPT code 76098 of 0.31.
We share the ACR's interest in establishing or clarifying
parameters that indicate when CPT codes that are furnished concurrently
by the same provider should be valued to account for the overlap in
physician work time and intensity, and even PE. We are broadly
interested in stakeholder feedback and suggestions about what those
parameters might be and whether or how they should affect code
valuation.
We are proposing the RUC-recommended direct PE inputs for CPT code
76098.
(47) 3D Rendering (CPT Code 76376)
CPT code 76376 (3D rendering with interpretation and reporting of
computed tomography, magnetic resonance imaging, ultrasound, or other
tomographic modality with image postprocessing under concurrent
supervision; not requiring image postprocessing on an independent
workstation) was identified as potentially misvalued on a screen of
codes with a negative intraservice work per unit of time (IWPUT), with
2016 estimated Medicare utilization over 10,000 for RUC reviewed codes
and over 1,000 for Harvard valued and CMS/Other source codes. It was
surveyed and reviewed at the April 2018 RUC meeting.
We are proposing the RUC-recommended work RVU of 0.20 for CPT code
76376. We are also proposing the RUC-recommended direct PE inputs for
CPT code 76376.
(48) Ultrasound Exam--Chest (CPT Code 76604)
CPT code 76604 (Ultrasound, chest (includes mediastinum), real time
with image documentation) was identified as potentially misvalued on a
screen of CMS/Other codes with Medicare utilization of 30,000 or more.
It was surveyed and reviewed for the April 2018 RUC meeting.
We are proposing the RUC-recommended work RVU of 0.59 for CPT code
76604. We are also proposing the RUC-recommended direct PE inputs for
CPT code 76604.
(49) X-Ray Exam--Bone (CPT Codes 77073, 77074, 77075, 77076, and 77077)
CPT codes 77073 (Bone length studies (orthoroentgenogram,
scanogram)), 77075 (Radiologic examination, osseous survey; complete
(axial and appendicular skeleton)), and 77077 (Joint survey, single
view, 2 or more joints) were identified as potentially misvalued on a
screen of CMS/Other codes with Medicare utilization of 30,000 or more.
CPT codes 77074 (Radiologic examination, osseous survey; limited (e.g.,
for metastases)) and 77076 (Radiologic examination, osseous survey,
infant) were reviewed as part of the same family.
We are proposing the RUC-recommended work RVUs for all five CPT
codes in this family as follows: CPT code 77073 (work RVU = 0.26); CPT
code 77074 (work RVU = 0.44); CPT code 77075 (work RVU = 0.55); CPT
code 77076 (work RVU = 0.70); and CPT code 77077 (work RVU = 0.33).
We are proposing the RUC-recommended direct PE inputs for all codes
in the family.
(50) SPECT-CT Procedures (CPT Codes 78800, 78801, 78802, 78803, 78804,
788X0, 788X1, 788X2, and 788X3)
The CPT Editorial Panel revised five codes, created four new codes
and deleted nine codes to better differentiate between planar
radiopharmaceutical localization procedures and SPECT, SPECT-CT and
multiple area or multiple day radiopharmaceutical localization/
distribution procedures.
For CPT code 78800 (Radiopharmaceutical localization of tumor,
inflammatory process or distribution of radiopharmaceutical agent(s),
(includes vascular flow and blood pool imaging when performed); planar
limited single area (e.g., head, neck, chest pelvis), single day of
imaging), we disagree with the RUC recommendation to assign a work RVU
of 0.70 based on the survey 25th percentile to this code, because we
believe that it is inconsistent with the RUC-recommended reduction in
physician time. We are proposing a work RVU of 0.64 based on the
following total time ratio: The RUC-recommended 27 minutes divided by
the current 28 minutes multiplied by the current work RVU of 0.66,
which results in a work RVU of 0.64. We note that this value is
bracketed by the work RVUs of CPT code 93287 (Peri-procedural device
evaluation (in person) and programming of device system parameters
before or after a surgery, procedure, or test with analysis, review and
report by a physician or other qualified health care professional;
single, dual, or multiple lead implantable defibrillator system), with
a work RVU of 0.45, and CPT code 94617 (Exercise test for bronchospasm,
including pre- and post-spirometry, electrocardiographic recording(s),
and pulse oximetry), with a work RVU of 0.70. Both of these supporting
crosswalks have intraservice time values of 10 minutes, and they have
similar total time values.
For CPT code 78801 (Radiopharmaceutical localization of tumor,
inflammatory process or distribution of radiopharmaceutical agent(s),
(includes vascular flow and blood pool imaging when performed); planar,
2 or more areas (e.g., abdomen and pelvis, head and chest), 1 or more
days of imaging or single area imaging over 2 or more days), we
disagree with the RUC recommendation to maintain the current work RVU
of 0.79 despite a 22-minute reduction in intraservice time. We believe
a reduction from the current value is warranted given the recommended
reduction in physician time, and also to be consistent with other
services of similar time values. We are proposing a work RVU of 0.73
based on the RUC-recommended incremental relationship between this code
and CPT code 78800 (a difference of 0.09 RVU), which we apply to our
proposed value for the latter code. As support for our proposed work
RVU of 0.73, we note that it falls between the work RVUs of CPT code
94617 (Exercise test for bronchospasm, including pre- and post-
spirometry, electrocardiographic recording(s), and pulse oximetry) with
a work RVU of 0.70, and CPT code 93280 (Programming device evaluation
(in person) with iterative adjustment of the implantable device to test
the function of the device and select optimal permanent programmed
values with analysis, review and report by a physician or other
qualified health care professional; dual lead pacemaker system) with a
work RVU of 0.77.
For CPT code 78802 (Radiopharmaceutical localization of tumor,
inflammatory process or distribution of radiopharmaceutical agent(s),
(includes vascular flow and blood pool imaging when performed); planar,
whole body, single day of imaging), we disagree with the RUC
recommendation to maintain the current work RVU of 0.86, as we believe
that it is inconsistent with a reduction in time values, and because we
do not agree that a work RVU that is among the highest of other
services of similar intraservice time values is appropriate. We are
proposing a work RVU of 0.80 based on the RUC-recommended incremental
[[Page 40592]]
relationship between this code and CPT code 78800 (a difference of 0.16
RVU), which we apply to our proposed value for the latter code. As
support for our proposed work RVU of 0.80, we note that it falls
between the work RVUs of CPT code 92520 (Laryngeal function studies
(i.e., aerodynamic testing and acoustic testing)) with a work RVU of
0.75, and CPT code 93282 (Programming device evaluation (in person)
with iterative adjustment of the implantable device to test the
function of the device and select optimal permanent programmed values
with analysis, review and report by a physician or other qualified
health care professional; single lead transvenous implantable
defibrillator system) with a work RVU of 0.85.
For CPT code 78804 (Radiopharmaceutical localization of tumor,
inflammatory process or distribution of radiopharmaceutical agent(s),
(includes vascular flow and blood pool imaging when performed); planar,
whole body, requiring 2 or more days of imaging), we disagree with the
RUC recommendation to maintain the current work RVU of 1.07, as we
believe that it is inconsistent with a reduction in time values, and
because this work RVU appears to be valued highly relative to other
services of similar time values. We are proposing a work RVU of 1.01
based on the RUC-recommended incremental relationship between this code
and CPT code 78800 (a difference of 0.37 RVU), which we apply to our
proposed value for the latter code. As support for our proposed work
RVU of 1.01, we reference CPT code 91111 (Gastrointestinal tract
imaging, intraluminal (e.g., capsule endoscopy), esophagus with
interpretation and report), which has a work RVU of 1.00 and similar
physician time values.
For CPT code 78803 (Radiopharmaceutical localization of tumor,
inflammatory process or distribution of radiopharmaceutical agent(s),
(includes vascular flow and blood pool imaging when performed);
tomographic (SPECT), single area (e.g., head, neck, chest pelvis),
single day of imaging), we disagree with the RUC recommendation to
increase the work RVU to 1.20 based on the survey 25th percentile to
this code, because we believe that it is inconsistent with the RUC-
recommended reduction in physician time. We are proposing to maintain
the current work RVU of 1.09. We support this value with a reference to
CPT code 78266 (Gastric emptying imaging study (e.g., solid, liquid, or
both); with small bowel and colon transit, multiple days), which has a
work RVU of 1.08, and similar time values.
For CPT code 788X0 (Radiopharmaceutical localization of tumor,
inflammatory process or distribution of radiopharmaceutical agent(s),
(includes vascular flow and blood pool imaging when performed);
tomographic (SPECT) with concurrently acquired computed tomography (CT)
transmission scan for anatomical review, localization and
determination/detection of pathology, single area (e.g., head, neck,
chest or pelvis), single day of imaging), we disagree with the RUC
recommendation to assign a work RVU of 1.60 based on the survey 25th
percentile to this code, as this would value this code more highly than
services of similar time values. To maintain relativity among services
in this family, we are proposing a work RVU of 1.49 for CPT code 788X0
based on the RUC-recommended incremental relationship between CPT code
788X0 and CPT code 78803 (a difference of 1.09 RVU), which we apply to
our proposed value for the latter code. As support for our proposed
work RVU of 1.49, we note that it is bracketed by the work RVUs of CPT
codes 72195 (Magnetic resonance (e.g., proton) imaging, pelvis; without
contrast material(s)) with a work RVU of 1.46, and 95861 (Needle
electromyography; 2 extremities with or without related paraspinal
areas) with a work RVU of 1.54. The physician time values of these
services bracket those recommended for CPT code 778X0.
For CPT code 788X1 (Radiopharmaceutical localization of tumor,
inflammatory process or distribution of radiopharmaceutical agent(s),
(includes vascular flow and blood pool imaging when performed);
tomographic (SPECT), minimum 2 areas (e.g., pelvis and knees, abdomen
and pelvis), single day of imaging, or single area of imaging over 2 or
more days), we disagree with the RUC recommendation to assign a work
RVU of 1.93 based on the survey 50th percentile to this code, as this
would value this code more highly than services of similar time values.
To maintain relativity among services in this family, we are proposing
a work RVU of 1.82 based on the RUC-recommended incremental
relationship between this code and CPT code 78803 (a difference of 0.73
RVU), which we apply to our proposed value for the latter code. As
support for our proposed work RVU of 1.82, we note that it is bracketed
by the work RVUs of the CPT codes which are members of the same code
families referenced for the previous CPT code, 788X0: CPT codes 72191
(Computed tomographic angiography, pelvis, with contrast material(s),
including noncontrast images, if performed, and image postprocessing)
with a work RVU of 1.81, and 95863 (Needle electromyography; 3
extremities with or without related paraspinal areas) with a work RVU
of 1.87. The physician time values of these services bracket those
recommended for CPT code 778X1.
For CPT code 788X2 (Radiopharmaceutical localization of tumor,
inflammatory process or distribution of radiopharmaceutical agent(s),
(includes vascular flow and blood pool imaging when performed);
tomographic (SPECT) with concurrently acquired computed tomography (CT)
transmission scan for anatomical review, localization and
determination/detection of pathology, minimum 2 areas (e.g., pelvis and
knees, abdomen and pelvis), single day of imaging, or single area of
imaging over 2 or more days imaging), we disagree with the RUC
recommendation to assign a work RVU of 2.23 based on the survey 50th
percentile to this code, as this would value this code more highly than
services of similar time values. To maintain relativity among services
in this family, we are proposing a work RVU of 2.12 based on the RUC-
recommended incremental relationship between this code and CPT code
78803 (a difference of 1.03 RVU), which we apply to our proposed value
for the latter code. As support for our proposed work RVU of 2.12, we
reference CPT code 70554 (Magnetic resonance imaging, brain, functional
MRI; including test selection and administration of repetitive body
part movement and/or visual stimulation, not requiring physician or
psychologist administration), which has a work RVU of 2.11 and
physician intraservice and total time values that are identical to
those recommended for this service.
For CPT code 788X3 (Radiopharmaceutical quantification
measurement(s) single area), we disagree with the RUC recommendation to
assign a work RVU of 0.51 based on the survey 25th percentile to this
code, because we wish to maintain relativity and proportionality among
codes of this family. We based our values for the other codes in this
family on their relative relationship to either CPT code 78800 or
788X2, depending on the type of service described by the code. For CPT
code 788X0, which describes a single day of imaging and is thus
analagous to CPT code 788X3 in terms of units of service, our analysis
indicates a reduction from the RUC value of approximately 7 percent is
appropriate. Therefore, we apply a
[[Page 40593]]
similar reduction of 7 percent to the RUC-recommended work RVU of 0.51
to arrive at an RVU of 0.47. We support this value by noting that it is
bracketed by add-on CPT codes 77001 (Fluoroscopic guidance for central
venous access device placement, replacement (catheter only or
complete), or removal (includes fluoroscopic guidance for vascular
access and catheter manipulation, any necessary contrast injections
through access site or catheter with related venography radiologic
supervision and interpretation, and radiographic documentation of final
catheter position) (List separately in addition to code for primary
procedure)) with a work RVU of 0.38, and 77002 (Fluoroscopic guidance
for needle placement (e.g., biopsy, aspiration, injection, localization
device) (List separately in addition to code for primary procedure)),
with a work RVU of 0.54. Both of these reference CPT codes have
intraservice time values that are similar to, and total time values
that are identical to, those recommended for CPT code 788X3.
For the direct PE inputs, we are refining the number of minutes of
clinical labor allocated to the activity ``Prepare, set-up and start
IV, initial positioning and monitoring of patient'' to the 2-minute
standard for CPT codes 78800, 78801, 78802, 78804, 78803, 788X0, 788X1,
and 788X2, as no rationale was provided for these codes to have times
above the standard for this activity. We are also refining the
equipment time formulas to reflect this clinical labor refinement for
these codes. For CPT codes 78800, 78801, 78802, 78804, 78803, 788X0,
788X1, and 788X2, we are proposing to refine the equipment times to
match our standard equipment time formula for the professional PACS
workstation. For the supply item SM022 ``sanitizing cloth-wipe
(surface, instruments, equipment),'' we are refining these supplies to
quantities of 5 each for CPT codes 78801, 78804, and 788X2 to conform
with other codes in the family.
(51) Myocardial PET (CPT Codes 78459, 78X29, 78491, 78X31, 78492,
78X32, 78X33, 78X34, and 78X35)
CPT code 78492 was identified via the High Volume Growth screen
with total Medicare utilization over 10,000 that increased by at least
100 percent from 2009 through 2014. The CPT Editorial Panel revised
this code set to reflect newer technology aspects such as wall motion,
ejection fraction, flow reserve, and technology updates for hardware
and software. The CPT Editorial Panel deleted a Category III code,
added six Category I codes, and revised the three existing codes to
separately identify component services included for myocardial imaging
using positron emission tomography.
For CPT code 78491 (Myocardial imaging, positron emission
tomography, perfusion study (including ventricular wall motion(s), and/
or ejection fractions(s), when performed); single study, at rest or
stress (exercise or pharmacologic)), we disagree with the RUC-
recommended work RVU of 1.56, which is the survey 25th percentile
value, as we believe that the 30-minute reduction in intraservice time
and 15-minute reduction in physician total time does not validate an
increase in work RVU, and we believe that the significance of the
reductions in recommended physician time values warrants a reduction in
work RVU. We are proposing a work RVU of 1.00 based on the following
total time ratio: The recommended 30 minutes divided by the current 45
minutes multiplied by the current work RVU of 1.50, which results in a
work RVU of 1.00. As further support for this value, we note that it
falls between CPT code 78278 (Acute gastrointestinal blood loss
imaging), with a work RVU of 0.99, and CPT code 10021 (Fine needle
aspiration biopsy, without imaging guidance; first lesion), with a work
RVU of 1.03.
For CPT code 78X31 (Myocardial imaging, positron emission
tomography, perfusion study (including ventricular wall motion(s), and/
or ejection fractions(s), when performed); single study, at rest or
stress (exercise or pharmacologic), with concurrently acquired computed
tomography transmission scan), we disagree with the RUC recommendation
of 1.67 based on the survey 25th percentile, as we do not agree this
service would be appropriately valued with an RVU that is among the
highest of all services of similar times with this global period. We
are proposing a work RVU of 1.11 by applying the RUC-recommended
increment between CPT code 78491 and this code, an increment of 0.11,
to our proposed value of 1.00 for CPT code 78491, thus maintaining the
RUC's recommended incremental relationship between these codes. As
further support for this value, we note that it falls between CPT codes
95977 (Electronic analysis of implanted neurostimulator pulse
generator/transmitter (e.g., contact group[s], interleaving, amplitude,
pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with complex
cranial nerve neurostimulator pulse generator/transmitter programming
by physician or other qualified health care professional)), with a work
RVU of 0.97, and CPT code 93284 (Programming device evaluation (in
person) with iterative adjustment of the implantable device to test the
function of the device and select optimal permanent programmed values
with analysis, review and report by a physician or other qualified
health care professional; multiple lead transvenous implantable
defibrillator system), with a work RVU of 1.25; both of these codes
have similar physician time values.
For CPT code 78459 (Myocardial imaging, positron emission
tomography (PET), metabolic evaluation study (including ventricular
wall motion(s), and/or ejection fraction(s), when performed) single
study), we disagree with the RUC recommendation to increase the work
RVU to 1.61 based on the survey 25th percentile. We believe that the
magnitude of the recommended reductions in physician time (a 50-minute
reduction in intraservice time and a 32-minute reduction in total time)
suggests that this value is overestimated; furthermore, we note that
the RUC's recommendation is among the highest for all XXX-global period
codes with similar time values. We are proposing a work RVU of 1.05 by
applying the RUC-recommended increment between this code and CPT code
78491, a difference of 0.05, which we apply to our proposed value for
the latter code. We support our RVU of 1.05 by referencing two CPT
codes: 10021 (Fine needle aspiration biopsy, without imaging guidance;
first lesion), and 36440 (Push transfusion, blood, 2 years or younger),
both of which have work RVUs of 1.03, as well as identical intraservice
and similar total time values.
We disagree with the RUC's recommended valuation of 1.76 for CPT
code 78X29 (Myocardial imaging, positron emission tomography (PET),
metabolic evaluation study (including ventricular wall motion(s), and/
or ejection fraction(s), when performed) single study; with
concurrently acquired computed tomography transmission scan), which is
based on the survey 25th percentile, because we believe a work RVU that
is greater than those of all other services of similar intraservice
time values is not appropriate. We are proposing a work RVU of 1.20 for
CPT code 78X29. We are proposing to value CPT code 78X29 with an
incremental methodology, which preserves the RUC-recommended
relationship among the codes in this family; the RUC
[[Page 40594]]
recommends an increment of 0.20 between CPT code 78X29 and CPT code
78491. We are proposing to apply this increment to our proposed value
of 1.00 for CPT code 78491 to arrive at our value of 1.20.
We disagree with the RUC's recommendation of 1.80 for CPT code
78492 (Myocardial imaging, positron emission tomography, perfusion
study (including ventricular wall motion(s), and/or ejection
fractions(s), when performed); multiple studies at rest and stress
(exercise or pharmacologic)) given the magnitude of the recommended
reduction in physician time values (a 35-minute reduction in
intraservice time and a 17-minute reduction in total time), and also
given the fact that the RUC's recommended value would be the highest of
all codes of this intraservice time and global period. We are proposing
a work RVU of 1.24 based on the RUC-recommended incremental difference
between 78491 and 78492 of 0.24, which we add to our proposed value for
78491 for a work RVU of 1.24. As further support for this value, we
reference CPT code 95908 (Nerve conduction studies; 3-4 studies), with
a work RVU of 1.25, similar physician time values.
We disagree with the RUC's recommendation of 1.90 for CPT code
78X32 (Myocardial imaging, positron emission tomography, perfusion
study (including ventricular wall motion(s), and/or ejection
fractions(s), when performed); multiple studies at rest and stress
(exercise or pharmacologic), with concurrently acquired computed
tomography transmission scan) which is based on a crosswalk to CPT code
64617 (Chemodenervation of muscle(s); larynx, unilateral, percutaneous
(e.g., for spasmodic dysphonia), includes guidance by needle
electromyography, when performed), because the fact that this work RVU
that is greater than those of all other services of similar
intraservice time values suggests that it is an overestimate. Instead
we are proposing a work RVU of 1.34 for CPT code 78X32, based on an
incremental methodology. We apply the RUC-recommended increment between
78491 and CPT code 78X32, a difference of 0.34, to our proposed value
of 1.00 for CPT code 78491, for a value of 1.34. We support this value
by referencing CPT code 77261 (Therapeutic radiology treatment
planning; simple), with a work RVU of 1.30, and CPT code 94003
(Ventilation assist and management, initiation of pressure or volume
preset ventilators for assisted or controlled breathing; hospital
inpatient/observation, each subsequent day), with a work RVU of 1.37.
These codes have similar physician time values.
We disagree with the RUC's recommendation of 2.07 for CPT code
78X33 (Myocardial imaging, positron emission tomography, combined
perfusion with metabolic evaluation study (including ventricular wall
motion(s), and/or ejection fraction(s), when performed), dual
radiotracer (e.g., myocardial viability)), because we believe the fact
that this work RVU is greater than those of all other services of
similar intraservice time values suggests that it is an overestimate.
We are proposing a work RVU of 1.51 for CPT code 78X33, based on an
incremental methodology. We apply the RUC-recommended increment between
78491 and CPT code 78X33, a difference of 0.51, to our proposed value
of 1.00 for CPT code 78491, for a value of 1.51. We support this value
by referencing CPT code 10005 (Fine needle aspiration biopsy, including
ultrasound guidance; first lesion), with a work RVU of 1.46, and
similar physician time values.
Similarly for CPT code 78X34 (Myocardial imaging, positron emission
tomography, combined perfusion with metabolic evaluation study
(including ventricular wall motion(s), and/or ejection fraction(s),
when performed), dual radiotracer (e.g., myocardial viability); with
concurrently acquired computed tomography transmission scan), we
disagree with the RUC's recommendation of 2.26 based on a crosswalk to
CPT code 71552 (Magnetic resonance (e.g., proton) imaging, chest (e.g.,
for evaluation of hilar and mediastinal lymphadenopathy); without
contrast material(s), followed by contrast material(s) and further
sequences), because we believe the fact that this work RVU is among the
highest among services of similar intraservice time values suggests
that it is an overestimate. We are proposing a work RVU of 1.70 by
applying the RUC-recommended increment between CPT code 78X34 and CPT
code 78491, which is a difference of 0.70, to our proposed value for
CPT code 78491 for a value of 1.70. We support this value by
referencing CPT codes 95924 (Testing of autonomic nervous system
function; combined parasympathetic and sympathetic adrenergic function
testing with at least 5 minutes of passive tilt) and 74182 (Magnetic
resonance (e.g., proton) imaging, abdomen; with contrast material(s)),
both of which have work RVUs of 1.73.
For CPT code 78X35 (Absolute quantitation of myocardial blood flow
(AQMBF), positron emission tomography, rest and pharmacologic stress
(List separately in addition to code for primary procedure)), we
disagree with the RUC recommendation to assign a work RVU of 0.63 to
this code based on the survey 25th percentile, because we believe a
comparison to other codes with a global period of ZZZ suggests that
this is somewhat overvalued, and because we wish to maintain relativity
and proportionality to other codes in this series. We based our values
for the other codes in this family on their relative relationships to
CPT code 78491; for that code our analysis indicates that a reduction
from the RUC value of roughly \1/3\ is appropriate, based on a ratio of
the decrease in total time to the current work RVU. Therefore, we apply
a similar reduction of \1/3\ to the RUC-recommended work RVU of 0.63 to
arrive at an RVU of approximately 0.42. Applying a reduction that is
similar to the reduction we think is warranted from the RUC value for
CPT code 78491 to CPT code 78X35 will maintain consistency in value
among these services. We believe this work RVU is validated by noting
that it is bracketed by CPT codes 15272 (Application of skin substitute
graft to trunk, arms, legs, total wound surface area up to 100 sq cm;
each additional 25 sq cm wound surface area, or part thereof (List
separately in addition to code for primary procedure)), with a work RVU
of 0.33, and 11105 (Punch biopsy of skin (including simple closure,
when performed); each separate/additional lesion (List separately in
addition to code for primary procedure)), with a work RVU of 0.45. A
work RVU of 0.42 is thus consistent with ZZZ global period codes of
similar physician times.
For the direct PE inputs, for several of the equipment items, we
are proposing to refine the equipment times to conform to our
established policies for non-highly, as well as for highly technical
equipment. In addition, we are proposing to refine the equipment times
to conform to our established policies for PACS Workstation. For the
new equipment items ER110: ``PET Refurbished Imaging Cardiac
Configuration'' and ER111: ``PET/CT Imaging Camera Cardiac
Configuration,'' we are proposing to assume that a 90 percent equipment
utilization rate is typical, as this would be consistent with our
equipment utilization assumptions for expensive diagnostic imaging
equipment. For the supply item SM022 ``sanitizing cloth-wipe (surface,
instruments, equipment),'' we are refining these supplies to quantities
of 5 each for CPT codes 78X33 and 78X34 to conform with other codes in
the family. We are proposing that we will
[[Page 40595]]
not price the ``Software and hardware package for Absolute
Quantitation'' as a new equipment item, due to the fact that the
submitted invoices included a service contract and a combined software/
hardware bundle with no breakdown on individual pricing. Based on our
lack of specific pricing data, we believe that this software is more
accurately characterized as an indirect PE input that is not
individually allocable to a particular patient for a particular
service.
(52) Cytopathology, Cervical-Vaginal (CPT Code 88141, HCPCS Codes
G0124, G0141, and P3001)
CPT code 88141 (Cytopathology, cervical or vaginal (any reporting
system), requiring interpretation by physician), HCPCS code G0124
(Screening cytopathology, cervical or vaginal (any reporting system),
collected in preservative fluid, automated thin layer preparation,
requiring interpretation by physician), HCPCS code G0141 (Screening
cytopathology smears, cervical or vaginal, performed by automated
system, with manual rescreening, requiring interpretation by
physician), and HCPCS code P3001 (Screening Papanicolaou smear,
cervical or vaginal, up to three smears, requiring interpretation by
physician) were identified as potentially misvalued on a list of CMS or
other source codes with Medicare utilization of 30,000 or more.
In the CY 2000 PFS final rule (64 FR 59408), we finalized a policy
that it was more appropriate to evaluate the work, PE, and MP RVUs for
HCPCS codes P3001, G0124, and G0141 identical or comparable to the
values of CPT code 88141.
For CY 2020, the RUC recommended a work RVU of 0.42 for CPT code
88141 and HCPCS codes G0124, G0141, and P3001, based on the current
value. We disagree with the RUC-recommended work RVU and are proposing
a work RVU of 0.26 for all four codes in this family, based on our time
ratio methodology and a crosswalk to CPT code 93313 (Echocardiography,
transesophageal, real-time with image documentation (2D) (with or
without M-mode recording); placement of transesophageal probe only),
which has an identical work RVU of 0.26, identical intraservice and
total work times values to CPT code 88141 and HCPCS codes G0124, and
G0141, and similar intraservice and total time values to HCPCS code
P3001.
In reviewing this family of codes, we note that the intraservice
and total work times for CPT code 88141 and HCPCS codes G0124, and
G0141 are decreasing from 16 minutes to 10 minutes (38 percent
reduction) and the intraservice and total work times for HCPCS code
P3001 are decreasing from 16 minutes to 12 minutes (25 percent
reduction). However, the RUC recommended a work RVU of 0.42 for all
four codes in this family, based on the maintaining the current work
RVU. Although we do not imply that the decrease in time as reflected in
survey values must equate to a one-to-one or linear decrease in the
valuation of work RVUs, we believe that since the two components of
work are time and intensity, significant decreases in time should be
appropriately reflected in decreases to work RVUs. In the case of CPT
code 88141 and HCPCS codes G0124, G0141, and P3001, we believe that it
would be more accurate to propose a work RVU of 0.26, based on our time
ratio methodology and a crosswalk to CPT code 93313 to account for
these decreases in the surveyed work times.
For the direct PE inputs, we are proposing to refine the clinical
labor time for the ``Perform regulatory mandated quality assurance
activity'' (CA033) activity from 7 minutes to 5 minutes for all four
codes in the family. We believe that these quality assurance activities
would not typically take 7 minutes to perform, given that similar
federally mandated MQSA activities were recommended and finalized at a
time of 4 minutes for CPT codes 77065-77067 in CY 2017 (81 FR 80314-
80316), and other related regulatory compliance activities were
recommended and finalized at a time of 5 minutes for CPT codes 78012-
78014 in CY 2013 (77 FR 69037). To preserve relativity between
services, we are proposing a clinical labor time of 5 minutes for the
codes in this family based on this prior allocation of clinical labor
time.
We are also proposing to remove the 1-minute of clinical labor time
for the ``File specimen, supplies, and other materials'' (PA008)
activity from all four codes under the rationale that this task is a
form of indirect PE. As we stated in the CY 2017 PFS final rule (81 FR
80324), we agree that filing specimens is an important task, and we
agree that these would take more than zero minutes to perform. However,
we continue to believe that these activities are correctly categorized
under indirect PE as administrative functions, and therefore, we do not
recognize the filing of specimens as a direct PE input, and we do not
consider this task as typically performed by clinical labor on a per-
service basis.
We are proposing to refine the equipment time for the compound
microscope (EP024) equipment to 10 minutes for all four codes in the
family to match the work time of the procedures. The recommended
materials for this code family state that the compound microscope is
utilized by the pathologist, and therefore, we believe that the 10-
minute work time of the procedures would be the most accurate equipment
time to propose.
(53) Biofeedback Training (CPT Codes 908XX and 909XX)
CPT code 90911 (Biofeedback training, perineal muscles, anorectal
or urethral sphincter, including EMG and/or manometry) was identified
as potentially misvalued on a RAW screen of codes with a negative IWPUT
and Medicare utilization over 10,000 for all services or over 1,000 for
Harvard valued and CMS or other source codes. In September 2018, the
CPT Editorial Panel replaced this code with two new codes to describe
biofeedback training initial 15 minutes of one-on-one patient contact
and each additional 15 minutes of biofeedback training.
We are proposing the RUC-recommended work RVU of 0.90 for CPT code
908XX (Biofeedback training, perineal muscles, anorectal or urethral
sphincter, including EMG and/or manometry when performed; initial 15
minutes of one-on-one patient contact), as well as the RUC-recommended
work RVU of 0.50 for CPT code 909XX (Biofeedback training, perineal
muscles, anorectal or urethral sphincter, including EMG and/or
manometry when performed; each additional 15 minutes of one-on-one
patient contact). For the direct PE inputs, we are proposing to refine
the equipment time for the power table (EF031) equipment in CPT code
908XX to conform to our established standard for non-highly technical
equipment.
We are also proposing to designate CPT codes 908XX and 909XX as
``sometimes therapy'' procedures which means that an appropriate
therapy modifier is always required when this service is furnished by
therapists. For more information we direct readers to the Therapy Code
List section of the CMS website at https://www.cms.gov/Medicare/Billing/TherapyServices/AnnualTherapyUpdate.html.
(54) Corneal Hysteresis Determination (CPT Code 92145)
In 2005, the AMA RUC began the process of flagging services that
represent new technology or new services as they were presented to the
AMA/Specialty Society RVS Update Committee. The AMA RUC reviewed this
service at the October 2018 RAW meeting, and indicated that the
[[Page 40596]]
utilization is continuing to increase for this service. This code was
surveyed and reviewed for the January 2019 RUC meeting.
We are proposing the work RVU of 0.10 as recommended by the RUC. We
are also proposing the RUC-recommended direct PE inputs for CPT code
92145 without refinement.
(55) Computerized Dynamic Posturography (CPT Codes 92548 and 92XX0)
CPT code 92548 (Computerized dynamic posturography) was identified
via the negative IWPUT screen. CPT revised one code and added another
code to more accurately describe the current clinical work and
equipment necessary to provide this service.
We do not agree with the RUC's recommended work RVUs of 0.76 for
CPT code 92548 (Computerized dynamic posturography sensory organization
test (CDP-SOT), 6 conditions (i.e., eyes open, eyes closed, visual
sway, platform sway, eyes closed platform sway, platform and visual
sway), including interpretation and report), or 0.96 for CPT code 92XX0
(Computerized dynamic posturography sensory organization test (CDP-
SOT), 6 conditions (i.e., eyes open, eyes closed, visual sway, platform
sway, eyes closed platform sway, platform and visual sway), including
interpretation and report; with motor control test (MCT) and adaptation
test (ADT)). For CPT code 92548, we agree that an increase in work RVU
is warranted; however, we believe the surveyed time values suggest an
increase of a less significant magnitude than that recommended. We are
proposing a work RVU of 0.67 based on the intraservice time ratio: we
divide the RUC-recommended intraservice time value of 20 by the current
value of 15 and multiply the product by the current work RVU of 0.50
for a ratio of 0.67. As a supporting crosswalk, we note that our value
is greater than the work RVU of 0.60 for CPT code 93316
(Transesophageal echocardiography for congenital cardiac anomalies;
placement of transesophageal probe only), which has identical
intraservice and total times.
We are proposing to maintain relativity between these two codes by
valuing CPT code 92XX0 by applying the RUC-recommended incremental
difference between the two codes, a difference of 0.20, to our proposed
value of 0.66 for CPT code 93316; therefore, we are proposing a work
RVU of 0.87 for CPT code 92XX0. As further support for this value, we
note that it falls between the work RVUs of CPT codes 95972 (Electronic
analysis of implanted neurostimulator pulse generator/transmitter
(e.g., contact group[s], interleaving, amplitude, pulse width,
frequency [Hz], on/off cycling, burst, magnet mode, dose lockout,
patient selectable parameters, responsive neurostimulation, detection
algorithms, closed loop parameters, and passive parameters) by
physician or other qualified health care professional; with complex
spinal cord or peripheral nerve (e.g., sacral nerve) neurostimulator
pulse generator/transmitter programming by physician or other qualified
health care professional), with a work RVU of 0.80, and CPT code 38207
(Transplant preparation of hematopoietic progenitor cells;
cryopreservation and storage), with a work RVU of 0.89.
We are proposing the RUC-recommended direct PE inputs for these
codes without refinement.
(56) Auditory Function Evaluation (CPT Codes 92626 and 92627)
CPT code 92626 (Evaluation of auditory function for surgically
implanted device(s), candidacy or post-operative status of a surgically
implanted device(s); first hour) appeared on the RAW 2016 high volume
growth screen. In 2017, it was identified through a CMS request. CPT
code 92627 (Evaluation of auditory function for surgically implanted
device(s), candidacy or post-operative status of a surgically implanted
device(s); each additional 15 minutes) the add-on code for CPT code for
92626, also was included in the CMS request to review audiology
services.
For CY 2020, we are proposing the HCPAC-recommended work RVU of
1.40 for CPT code 92626, which is identical to its current RVU. We are
also proposing the HCPAC-recommended work RVU of 0.33 for the add-on
code, CPT code 92627. We are proposing the RUC-recommended direct PE
inputs for all codes in the family.
(57) Septostomy (CPT Codes 92992 and 92993)
CPT codes 92992 (Atrial septectomy or septostomy; transvenous
method, balloon (e.g., Rashkind type) (includes cardiac
catheterization)) and 92993 (Atrial septectomy or septostomy; blade
method (Park septostomy) (includes cardiac catheterization)) were
nominated as potentially misvalued services. These services are
typically performed on children, a non-Medicare population, and are
currently contractor-priced. These codes were surveyed and reviewed for
the January 2019 RUC meeting.
We are proposing to maintain contractor pricing for CPT codes 92992
and 92993, as recommended by the RUC. These codes will be referred to
the CPT Editorial Panel for revision and potential deletion. We are
also proposing a change from 90-day to 0-day global period status for
these two procedures, also as recommended by the RUC.
(58) Opthalmoscopy (CPT Codes 92X18 and 92X19)
CPT code 92225 was identified as potentially misvalued on a screen
of codes with a negative IWPUT, with 2016 estimated Medicare
utilization over 10,000 for RUC reviewed codes and over 1,000 for
Harvard valued and CMS/Other source codes. In February 2018, the CPT
Editorial Panel deleted CPT codes 92225 and 92226 and created two new
codes to specify what portion of the eye is examined for a service
beyond the normal comprehensive eye exam.
We are proposing the RUC-recommended work RVUs of 0.40 for CPT code
92X18 (Ophthalmoscopy, extended, with retinal drawing and scleral
depression of peripheral retinal disease (e.g., for retinal tear,
retinal detachment, retinal tumor) with interpretation and report,
unilateral or bilateral) and 0.26 for CPT code 92X19 (Ophthalmoscopy,
extended, with drawing of optic nerve or macula (e.g., for glaucoma,
macular pathology, tumor) with interpretation and report, unilateral or
bilateral).
We are proposing the RUC-recommended direct PE inputs for this code
family without refinement.
(59) Remote Interrogation Device Evaluation (CPT Codes 93297, 93298,
93299, and HCPCS Code GTTT1)
When the RUC previously reviewed the CPT code 93299 at the January
2017 RUC meeting, the specialty society submitted PE inputs for CPT
code 93299 (Interrogation device evaluation(s), (remote) up to 30 days;
implantable cardiovascular physiologic monitor system or subcutaneous
cardiac rhythm monitor system, remote data acquisitions(s), receipt of
transmissions and technician review, technical support and distribution
of results); the PE Subcommittee and RUC accepted the society
recommendations. In the CY 2018 PFS final rule (82 FR 53064), we did
not finalize our proposal to establish national pricing for CPT code
93299 and the code remained contractor-priced.
At the October 2018 RUC meeting, the RUC re-examined CPT code
93299. CPT codes 93297 (Interrogation device evaluation(s), (remote) up
to 30 days; implantable cardiovascular physiologic
[[Page 40597]]
monitor system, including analysis of 1 or more recorded physiologic
cardiovascular data elements from all internal and external sensors,
analysis, review(s) and report(s) by a physician or other qualified
health care professional) and 93298 (Interrogation device
evaluation(s), remote up to 30 days; subcutaneous cardiac rhythm
monitor system, including analysis or recorded heart rhythm data,
analysis, review(s) and report(s) by a physician or other qualified
health care professional) were added to this family of services. These
three codes were reviewed for practice expense only.
CPT codes 93297 and 93298 are work-only codes and CPT code 93299 is
meant to serve as the catch-all for both 30-day remote monitoring
services. The RUC is unclear why the code family was designed this way,
noting it may have been a way to allow for the possibility that the
technical work would be provided by vendors, but they noted that this
is not how the service is currently provided. Stating that in the
decade since these codes were created, it has become clear that
implantable cardiovascular monitor (ICM) and implantable loop recorder
(ILR) services are very different and the PE cannot be appropriately
captured for both services in a single technical code. They noted that
CPT codes 93297-93299 will be placed on the new technology/new services
list and be re-reviewed by the RUC in 3 years to ensure correct
calculation and utilization assumptions. It was noted in the RUC
recommendations that the specialty society intended to submit a coding
proposal to the CPT Editorial Panel to delete CPT code 93299, as it
will no longer be necessary to have a separate code for PE if CPT codes
93297 and 93298 are allocated direct PE in CY 2020.
In our review of these services, we note that the RUC
recommendations did not provide a detailed description of the clinical
labor tasks being performed or detailed information on the typical use
of the supply and equipment used when furnishing these services. These
details are important in order for us to review if the RUC-recommended
PE inputs are appropriate to furnish these services. The RUC submitted
PE inputs (which were not previously included) for the work-only CPT
codes 93297 and 93298, but did not include details to substantiate
these recommended PE inputs for any of the three codes in this family.
Additionally, we are concerned with the appropriateness of the
RUC's reference code, CPT code 93296 (Interrogation device
evaluation(s) (remote), up to 90 days; single, dual, or multiple lead
pacemaker system, leadless pacemaker system, or implantable
defibrillator system, remote data acquisition(s), receipt of
transmissions and technician review, technical support and distribution
of results). CPT code 93296 is for remote monitoring over a 90-day
period, but was used as a reference to derive the RUC-recommended
direct PE inputs for CPT codes 93297-93299, which are for remote
monitoring over a 30-day period.
For the CY 2020 direct PE inputs, we are proposing to remove the
clinical labor time for ``Perform procedure/service--not directly
related to physician work time'' (CA021); to remove the requested
quantity for the supply ``Paper, laser printing (each sheet)'' (SK057);
and to refine the equipment times in accordance with our standard
equipment time formulas for CPT codes 93297 and 93298.
Although we are not proposing to allocate direct PE inputs for CPT
codes 93297 and 93298, we are seeking additional comment on the
appropriateness of CPT code 93296 as the reference code, details on the
clinical labor tasks, and more information on the typical use of the
supply and equipment used to furnish these services. For example, it
was unclear in the RUC recommendations how many patients are monitored
concurrently. As an additional example, it was unclear in the RUC
recommendations as to what tasks are involved when clinical staff
engage with the patient throughout the month to perform education about
the device and re-education protocols after the initial enrollment.
The CPT Editorial Panel is deleting CPT code 93299 for CY 2020. We
note this differs from the RUC recommendations for this code from the
October 2018 meeting, which stated that the specialty society intended
to submit a coding proposal to the CPT Editorial Panel to delete CPT
code 93299, as it would no longer be necessary to have a separate code
for PE, if CPT codes 93297 and 93298 are allocated direct PE for CY
2020. Given that we are proposing to not allocate direct PE inputs for
CPT code 93297 and 93298 for CY 2020 and CPT code 93299 is being
deleted for CY 2020, we are proposing to create a G-code to describe
the services previously furnished under CPT code 93299. We are
proposing to create HCPCS code GTTT1 (Interrogation device
evaluation(s), (remote) up to 30 days; implantable cardiovascular
physiologic monitor system, implantable loop recorder system, or
subcutaneous cardiac rhythm monitor system, remote data acquisition(s),
receipt of transmissions and technician review, technical support and
distribution of results), to describe the services previously furnished
under CPT code 93299, effective for CY 2020.
(60) Duplex Scan Arterial Inflow-Venous Outflow (CPT Codes 93X00 and
93X01)
In September 2018, the CPT Editorial Panel recommended replacing
one HCPCS code (G0365) with two new codes to describe the duplex scan
of arterial inflow and venous outflow for preoperative vessel
assessment prior to creation of hemodialysis access for complete
bilateral and unilateral study. We are proposing the RUC-recommended
work RVU of 0.80 for CPT code 93X00 (Duplex scan of arterial inflow and
venous outflow for preoperative vessel assessment prior to creation of
hemodialysis access; complete bilateral study), as well as the RUC-
recommended work RVU of 0.50 for CPT code 93X01 (Duplex scan of
arterial inflow and venous outflow for preoperative vessel assessment
prior to creation of hemodialysis access; complete unilateral study).
For the direct PE inputs, we are proposing to refine the clinical
labor time for the ``Prepare room, equipment and supplies'' (CA013)
activity from 4 minutes to 2 minutes for both codes in the family. Two
minutes is the standard time for this clinical labor activity, and 2
minutes is also the time assigned for this activity in the reference
code, CPT code 93990 (Duplex scan of hemodialysis access (including
arterial inflow, body of access and venous outflow)). There was no
rationale provided in the recommended materials indicating why this
additional clinical labor time would be typical for the procedures, and
therefore, we are proposing to refine to the standard time of 2
minutes. We are also proposing to adjust the equipment times to conform
to this change in the clinical labor time.
(61) Myocardial Strain Imaging (CPT Code 933X0)
The CPT Editorial Panel deleted one Category III code and created
one new Category I add-on code CPT code 933X0 to describe the work of
myocardial strain imaging performed in supplement to transthoracic
echocardiography services. We are proposing the RUC-recommended work
RVU of 0.24.
We are proposing the RUC-recommended direct PE inputs for CPT code
933X0. However, we note that no rationale was given for the RUC-
recommended 12 minutes of clinical labor time for the activity CA021
[[Page 40598]]
``Perform procedure/service,'' and we are requesting comment on the
appropriateness of this allocated time value.
(62) Lung Function Test (CPT Code 94200)
The RUC recommended this service for survey because it appeared on
a list of CMS/Other codes with Medicare utilization of 30,000 or more.
According to the RUC, this service is typically reported with an E/M
service and another pulmonary function test, and the RUC-recommended
times would appropriately account for any overlap with other services.
The RUC stated that the intraservice time involves reading and
interpreting the test to determine if a significant interval change has
occurred and then generating a report, which supports the 5 minutes of
physician work indicated in the survey. The RUC did not agree with the
specialty society that communication of the report required an
additional 2 minutes of physician time over the postservice time
included in the other services reported on the same day. The RUC
reduced the postservice time from 2 minutes to 1 minute because the
service requires minimal time to enter the results into the medical
record and communicate the results to the patient and the referring
physician. Based in part on these reductions in physician time, the RUC
recommended a reduction in work RVU from the current value with a
crosswalk to CPT code 95905 (Motor and/or sensory nerve conduction,
using preconfigured electrode array(s), amplitude and latency/velocity
study, each limb, includes F-wave study when performed, with
interpretation and report).
For CPT code 94200 (Maximum breathing capacity, maximal voluntary
ventilation), we are proposing the RUC-recommended work RVU of 0.05. A
stakeholder stated that the RUC's recommended work RVU understates the
costs inherent in performing this service, and that the survey 25th
percentile value of 0.10 is more accurate for this service. While we
are proposing the RUC-recommended 0.05, we are soliciting public
comment on this stakeholder-recommended potential alternative value.
We are proposing the RUC-recommended direct PE inputs for CPT code
94200 without refinement.
(63) Long-Term EEG Monitoring (CPT Codes 95X01, 95X02, 95X03, 95X04,
95X05, 95X06, 95X07, 95X08, 95X09, 95X10, 95X11, 95X12, 95X13, 95X14,
95X15, 95X16, 95X17, 95X18, 95X19, 95X20, 95X21, 95X22, and 95X23)
In January 2017, the RUC identified CPT code 95951 via the high
volume growth screen, which considers if the service has total Medicare
utilization of 10,000 or more and if utilization has increased by at
least 100 percent from 2009 through 2014. The RUC recommended that this
service be referred to the CPT Editorial Panel for needed changes,
including code deletions, revision of code descriptors, and the
addition of new codes to this family. In May 2018, the CPT Editorial
Panel approved the revision of one code, deletion of five codes, and
addition of 23 new codes for reporting long-term EEG professional and
technical services.
We are proposing the RUC-recommended work RVU for six of the
professional component codes in this family. We are proposing a work
RVU of 3.86 for CPT code 95X18 (Electroencephalogram, continuous
recording, physician or other qualified health care professional review
of recorded events, complete study; greater than 36 hours, up to 60
hours of EEG recording, without video), a work RVU of 4.70 for CPT code
95X19 (Electroencephalogram, continuous recording, physician or other
qualified health care professional review of recorded events, complete
study; greater than 36 hours, up to 60 hours of EEG recording, with
video), a work RVU of 4.75 for CPT code 95X20 (Electroencephalogram,
continuous recording, physician or other qualified health care
professional review of recorded events, complete study; greater than 60
hours, up to 84 hours of EEG recording, without video), a work RVU of
6.00 for CPT code 95X21 (Electroencephalogram, continuous recording,
physician or other qualified health care professional review of
recorded events, complete study; greater than 60 hours, up to 84 hours
of EEG recording, with video), a work RVU of 5.40 for CPT code 95X22
(Electroencephalogram, continuous recording, physician or other
qualified health care professional review of recorded events, complete
study; greater than 84 hours of EEG recording, without video) and a
work RVU of 7.58 for CPT code 95X23 (Electroencephalogram, continuous
recording, physician or other qualified health care professional review
of recorded events, complete study; greater than 84 hours of EEG
recording, with video).
We are also proposing the RUC-recommended work RVU of 0.00 for the
13 technical component codes in the family: CPT code 95X01
(Electroencephalogram (EEG) continuous recording, with video when
performed, set-up, patient education, and take down when performed,
administered in-person by EEG technologist, minimum of 8 channels), CPT
code 95X02 (Electroencephalogram (EEG) without video, review of data,
technical description by EEG technologist, 2-12 hours; unmonitored),
CPT code 95X03 (Electroencephalogram (EEG) without video, review of
data, technical description by EEG technologist, 2-12 hours; with
intermittent monitoring and maintenance), CPT code 95X04
(Electroencephalogram (EEG) without video, review of data, technical
description by EEG technologist, 2-12 hours; with continuous, real-time
monitoring and maintenance), CPT code 95X05 (Electroencephalogram (EEG)
without video, review of data, technical description by EEG
technologist, each increment of 12-26 hours; unmonitored), CPT code
95X06 (Electroencephalogram (EEG) without video, review of data,
technical description by EEG technologist, each increment of 12-26
hours; with intermittent monitoring and maintenance), CPT code 95X07
(Electroencephalogram (EEG) without video, review of data, technical
description by EEG technologist, each increment of 12-26 hours; with
continuous, real-time monitoring and maintenance), CPT code 95X08
(Electroencephalogram with video (VEEG), review of data, technical
description by EEG technologist, 2-12 hours; unmonitored), CPT code
95X09 (Electroencephalogram with video (VEEG), review of data,
technical description by EEG technologist, 2-12 hours; with
intermittent monitoring and maintenance), CPT code 95X10
(Electroencephalogram with video (VEEG), review of data, technical
description by EEG technologist, 2-12 hours; with continuous, real-time
monitoring and maintenance), CPT code 95X11 (Electroencephalogram with
video (VEEG), review of data, technical description by EEG
technologist, each increment of 12-26 hours; unmonitored), CPT code
95X12 (Electroencephalogram with video (VEEG), review of data,
technical description by EEG technologist, each increment of 12-26
hours; with intermittent monitoring and
[[Page 40599]]
maintenance), and CPT code 95X13 (Electroencephalogram with video
(VEEG), review of data, technical description by EEG technologist, each
increment of 12-26 hours; with continuous, real-time monitoring and
maintenance).
We disagree with the RUC-recommended work RVU of 2.00 for CPT code
95X14 (Electroencephalogram, continuous recording, physician or other
qualified health care professional review of recorded events, 2-12
hours of EEG recording; without video) and we are proposing a work RVU
of 1.85 based on a crosswalk to CPT code 93314 (Echocardiography,
transesophageal, real-time with image documentation (2D) (with or
without M-mode recording); image acquisition, interpretation and report
only). CPT code 93314 is a recently-reviewed code with 2 additional
minutes of intraservice time and 4 additional minutes of total time as
compared to CPT code 95X14. When considering the work RVU for CPT code
95X14, we looked to the second reference code chosen by the survey
participants, CPT code 95957 (Digital analysis of electroencephalogram
(EEG) (e.g., for epileptic spike analysis)). This code has 2 additional
minutes of intraservice time and 9 additional minutes of total time as
compared to CPT code 95X14, yet has a work RVU of 1.98, lower than the
recommended work RVU of 2.00. These time values suggested that CPT code
95X14 would be more accurately valued at a work RVU slightly below the
1.98 of CPT code 95957. We also looked at the intraservice time ratio
between CPT code 95X14 and some of its predecessor codes. The
intraservice time ratio with CPT code 95953 (Monitoring for
localization of cerebral seizure focus by computerized portable 16 or
more channel EEG, electroencephalographic (EEG) recording and
interpretation, each 24 hours, unattended) suggests a similar potential
work RVU of 1.91 (28 minutes divided by 45 minutes times a work RVU of
3.08). Based on this information, we are proposing a work RVU of 1.85
for CPT code 95X14 based on the aforementioned crosswalk to CPT code
93314.
We disagree with the RUC-recommended work RVU of 2.50 for CPT code
95X15 (Electroencephalogram, continuous recording, physician or other
qualified health care professional review of recorded events, analysis
of spike and seizure detection, interpretation, and report, 2-12 hours
of EEG recording; with video (VEEG)) and we are proposing a work RVU of
2.35. Although we disagree with the RUC-recommended work RVU, we concur
that the relative difference in work between CPT codes 95X14 and 95X15
is equivalent to the recommended interval of 0.50 RVUs. Therefore, we
are proposing a work RVU of 2.35 for CPT code 95X15, based on the
recommended interval of 0.50 additional RVUs above our proposed work
RVU of 1.85 for CPT code 95X14. We are supporting this work RVU with a
reference to CPT code 99310 (Subsequent nursing facility care, per day,
for the evaluation and management of a patient, which requires at least
2 of the 3 key components), which shares the same intraservice time of
35 minutes and the identical work RVU of 2.35. CPT code 99310 is a
lower intensity procedure but has increased total work time as compared
to CPT code 95X15.
We disagree with the RUC-recommended work RVU of 3.00 for CPT code
95X16 (Electroencephalogram, continuous recording, physician or other
qualified health care professional review of recorded events, analysis
of spike and seizure detection, each increment of greater than 12
hours, up to 26 hours of EEG recording, interpretation and report after
each 24-hour period; without video) and we are proposing a work RVU of
2.60 based on a crosswalk to CPT code 99219 (Initial observation care,
per day, for the evaluation and management of a patient, which requires
3 key components). CPT code 99219 shares the same intraservice time of
40 minutes and has a slightly higher total time as compared to CPT code
95X16. We also note that the observation care described by CPT code
99219 shares some clinical similarities to the long term EEG monitoring
described by CPT code 95X16, although we note as always that the nature
of the PFS relative value system is such that all services are
appropriately subject to comparisons to one another, and that codes do
not need to share the same site of service, patient population, or
utilization level to serve as an appropriate crosswalk.
In addition, we believe that the proposed crosswalk to CPT code
99219 at a work RVU of 2.60 more accurately captures the intensity of
CPT code 95X16. At the recommended work RVU of 3.00, the intensity of
CPT code 95X16 is anomalously high in comparison to the rest of the
family, higher than any of the other professional component codes. We
have no reason to believe that the 24-hour EEG monitoring done without
video as described in CPT code 95X16 would be notably more intense than
the other codes in the same family. Furthermore, the recommendations
for this code family specifically state that the codes that describe
video EEG monitoring are more intense than the codes that describe non-
video EEG monitoring. However, at the recommended work RVU for CPT code
95X16, this non-video form of EEG monitoring had the highest intensity
in the family. At our proposed work RVU of 2.60, the intensity of CPT
code 95X16 is no longer anomalously high in comparison to the rest of
the family, and also remains lower than the intensity of the 24 hour
EEG monitoring with video procedure described by CPT code 95X17.
We disagree with the RUC-recommended work RVU of 3.86 for CPT code
95X17 (Electroencephalogram, continuous recording, physician or other
qualified health care professional review of recorded events, analysis
of spike and seizure detection, each increment of greater than 12
hours, up to 26 hours of EEG recording, interpretation and report after
each 24-hour period; with video (VEEG)) and we are proposing a work RVU
of 3.50 based on the survey 25th percentile value. The RUC-recommended
work RVU of 3.86 was based on a crosswalk to CPT code 99223 (Initial
hospital care, per day, for the evaluation and management of a patient,
which requires 3 key components), a code that shares the same
intraservice time of 55 minutes but has 15 additional minutes of total
time as compared to CPT code 95X17, at 90 minutes as compared to 75
minutes. We disagree with the use of this crosswalk, as the 15 minutes
of additional total time in CPT code 99223 result in a higher work
valuation that overstates the work RVU of CPT code 95X17. These 15
additional minutes of preservice and postservice work time in the
recommended crosswalk code have a calculated work RVU of 0.34 under the
building block methodology; subtracting out this work RVU of 0.34 from
the crosswalk code's work RVU of 3.86 results in an estimated work RVU
of 3.52, which is nearly identical to the survey 25th percentile work
RVU of 3.50. Similarly, if we were to calculate a total time ratio
between CPT code 95X17 and the recommended crosswalk code 99223, it
would produce a noticeably lower work RVU of 3.22 (75 minutes divided
by 90 minutes times a work RVU of 3.86). Based on this rationale, we do
not believe that it would serve the interests of relativity to propose
a work RVU of 3.86 based on the recommended crosswalk.
Instead, we are proposing a work RVU of 3.50 for CPT code 95X17
based on the
[[Page 40600]]
survey 25th percentile value. We note that among the predecessor codes
for this family, CPT code 95956 (Monitoring for localization of
cerebral seizure focus by cable or radio, 16 or more channel telemetry,
electroencephalographic (EEG) recording and interpretation, each 24
hours, attended by a technologist or nurse) has a higher intraservice
time of 60 minutes and a higher total time of 105 minutes at a work RVU
of 3.61. This prior valuation of CPT code 95956 does not support the
RUC-recommended work RVU of 3.86 for CPT code 95X17, but does support
the proposed work RVU of 3.50 at the slightly lower newly surveyed work
times. We also note that at the recommended work RVU of 3.86, the
intensity of CPT code 95X17 was anomalously high in comparison to the
rest of the family, the second-highest intensity as compared to the
other professional component codes. We have no reason to believe that
the 24 hour EEG monitoring done with video as described in CPT code
95X17 would be notably more intense than the other codes in the same
family. At our proposed work RVU of 3.50, the intensity of CPT code
95X17 is no longer anomalously high in comparison to the rest of the
family, while still remaining slightly higher than the intensity of the
24 hour EEG monitoring performed without video procedure described by
CPT code 95X16.
For the direct PE inputs, we are proposing to make a series of
refinements to the clinical labor times of CPT code 95X01. Many of the
clinical labor times for this CPT code were derived using a survey
process and were recommended to CMS at the survey median values. This
was in contrast to the typical process for recommended direct PE
inputs, where the inputs are usually based on either standard times or
carried over from reference codes. We believe that when surveys are
used to recommended direct PE inputs, we must apply a similar process
of scrutiny to that used in assessing the work RVUs that are
recommended based on a survey methodology. We have long expressed our
concerns over the validity of the survey results used to produce work
RVU recommendations, such as in the CY 2011 PFS final rule (75 FR
73328), and we have noted that over the past decade the AMA RUC has
increasingly chosen to recommend the survey 25th percentile work RVU
over the survey median value, potentially responding to the same
concerns that we have identified.
As a result, we believe that when assessing the survey of direct PE
inputs used to produce many of the recommendations for CPT code 95X01,
it would be more accurate to propose the survey 25th percentile direct
PE inputs as opposed to the recommended survey median direct PE inputs.
Therefore, we are proposing to refine the clinical labor time for the
``Provide education/obtain consent'' (CA011) activity from 13 minutes
to 7 minutes and to refine the clinical labor time for the ``Review
home care instructions, coordinate visits/prescriptions'' (CA035)
activity from 10 minutes to 7 minutes. In both of these cases, the
recommended clinical labor times based on the survey median values are
more than double the standard time for these activities. Although we
agree that additional clinical labor time would be required to carry
out these activities for CPT code 95X01, we do not believe that the
survey median times would be typical. We are proposing the survey 25th
percentile times of 7 minutes for each activity as we believe that this
time would be more typical for obtaining consent and reviewing home
care instructions.
We are also proposing to refine the clinical labor time for the
``Complete pre-procedure phone calls and prescription'' (CA005)
activity from 10 minutes to 3 minutes for CPT code 95X01. This is
another situation where we are proposing the survey 25th percentile
clinical labor time of 3 minutes instead of the survey median clinical
labor time of 10 minutes. However, we also note that many of the tasks
that fell under the CA005 activity code as described in the PE
recommendations appear to constitute forms of indirect PE, such as
collecting supplies for setup and loading equipment and supplies into
vehicles. Collecting supplies and loading equipment are administrative
tasks that are not individually allocable to a particular patient for a
particular service, and therefore, constitute indirect PE under our
methodology. Due to the fact that many of the tasks described under the
CA005 activity code are forms of indirect PE, we believe that the RUC-
recommended survey median clinical labor time of 10 minutes overstates
the amount of direct clinical labor taking place. We believe that it is
more accurate to propose the survey 25th percentile clinical labor time
of 3 minutes for this activity code to reflect the non-administrative
tasks performed by the clinical staff.
We are also proposing to refine the quantity of the non-sterile
gloves (SB022) supply from 3 to 2 for CPT code 95X01. We note that the
current reference code, CPT code 95953, uses 2 of these pairs of gloves
and the survey also stated that 2 pairs of gloves were typical for the
procedure. Although the recommended materials state that a pair of
gloves is needed to set up the equipment, to take down the equipment,
and a third is required for electrode changes, we do not agree that the
use of a third pair of gloves would be typical given their usage in the
reference code and in the responses from the survey.
We note that we are not proposing to refine many of the other
clinical labor times for CPT code 95X01, which remain at the survey
median clinical labor times. Due to the nature of the continuous
recording EEG service taking place, we agree that the survey median
clinical labor times of 12 minutes for the ``Prepare room, equipment
and supplies'' (CA013) activity, 45 minutes for the ``Prepare, set-up
and start IV, initial positioning and monitoring of patient'' (CA016)
activity, and 22 minutes for the ``Clean room/equipment by clinical
staff'' (CA024) activity would be typical for this procedure. We
reiterate that we assess the direct PE inputs for each procedure
individually based on our methodology of what would be reasonable and
medically necessary for the typical patient.
For CPT codes 95X02-95X13, we are proposing to refine the clinical
labor time for the ``Coordinate post-procedure services'' (CA038)
activity from either 11 minutes to 5 minutes or from 22 minutes to 10
minutes as appropriate for the CPT code in question. The recommended
materials for these procedures state that the tasks taking place
constitute ``Merge EEG and Video files (partially automated program),
confirm transfer of data, delete from laptop/computer if necessary''.
We believe that many of the tasks detailed here are administrative in
nature, consisting of forms of data entry, and therefore, would be
considered types of indirect PE. We note that when CPT code 95812
(Electroencephalogram (EEG) extended monitoring; 41-60 minutes) was
recently reviewed for CY 2017, we finalized the recommended clinical
labor time of 2 minutes for ``Transfer data to reading station &
archive data'', a task which we believe to be highly similar. Due to
the longer duration of the procedures in CPT codes 95X02-95X13, we are
proposing clinical labor times of 5 minutes and 10 minutes for the
CA038 activity for these CPT codes. We are also refining the equipment
time for the Technologist PACS workstation (ED050) to match the
clinical labor time proposed for the CA038 activity.
For the four continuous monitoring procedures, CPT codes 95X04,
95X07, 95X10, and 95X13, we are proposing to refine the equipment time
for the
[[Page 40601]]
ambulatory EEG review station (EQ016) equipment. The recommended
equipment time for the ambulatory EEG review station was equal to four
times the ``Perform procedure/service'' (CA021) clinical labor time
plus a small amount of extra prep time. We do not agree that it would
be typical to assign this much equipment time, as it is our
understanding that one ambulatory EEG review station can be hooked up
to as many as four monitors at a time for continuous monitoring.
Therefore, we do not believe that each monitor would require its own
review station, and that the equipment time should not be equal to four
times the clinical labor of the ``Perform procedure/service'' (CA021)
activity. As a result, we are proposing to refine the ambulatory EEG
review station equipment time from 510 minutes to 150 minutes for CPT
code 95X04, from 1,480 minutes to 400 minutes for CPT code 95X07, from
514 minutes to 154 minutes for CPT code 95X10, and from 1,495 minutes
to 415 minutes for CPT code 95X13.
For the 10 professional component procedures, CPT codes 95X14-
95X23, we are again proposing to refine the equipment time for the
ambulatory EEG review station (EQ016) equipment. We believe that the
use of the ambulatory EEG review station is analogous in these
procedures to the use of the professional PACS workstation (ED053) in
other procedures, and we are proposing to refine the equipment times
for these 10 procedures to match our standard equipment time formula
for the professional PACS workstation. Therefore, we are proposing an
equipment time for the ambulatory EEG review station equal to half the
preservice work time (rounded up) plus the intraservice work time for
CPT codes 95X14 through 95X23. We believe that this equipment time is
more accurate than the recommended equipment time, which was equal to
the total work time of the procedures, as the work descriptors for CPT
codes 95X14-95X23 make no mention of the ambulatory EEG review station
in the postservice work period.
Finally, we are proposing to price the new ``EEG, digital,
prolonged testing system with remote video, for patient home use''
(EQ394) equipment at $26,410.95 based on an invoice submission. We did
not use a second invoice submitted for the new equipment for pricing,
as it contained a disaggregated list of equipment components and it was
not clear if they represented the same equipment item as the first
invoice.
(64) Health and Behavioral Assessment and Intervention (CPT Codes
961X0, 961X1, 961X2, 961X3, 961X4, 961X5, 961X6, 961X7, and 961X8)
The 2001 Health and Behavior Assessment and Intervention (HBAI) RUC
valuations were based on the old CPT code 90801 (Psychiatric diagnostic
interview evaluation), a 60-minute service. The RUC originally
recommended the Health and Behavior Assessment and Intervention
procedures to be 15-minute services, approximately equal to one-quarter
of the value of CPT code 90801, which we finalized without refinements.
While the RUC may have assumed that these services would typically be
reported in four, 15-minute services per single patient encounter, in
actual claims data, there is wide variation in the number of services
provided and submitted. The RUC reconsidered their rationale for the
original RUC-recommended valuation of this family of codes in September
2018. The CPT Editorial Panel deleted the six existing Health and
Behavior Assessment and Intervention procedure CPT codes and replaced
them with nine new CPT codes.
The six deleted CPT codes include CPT code 96150 (Health and
behavior assessment (e.g., health-focused clinical interview,
behavioral observations, psychophysiological monitoring, health-
oriented questionnaires), each 15 minutes face-to-face with the
patient; initial assessment), CPT code 96151 (Health and behavior
assessment (e.g., health-focused clinical interview, behavioral
observations, psychophysiological monitoring, health-oriented
questionnaires), each 15 minutes face-to-face with the patient; re-
assessment), CPT code 96152 (Health and behavior intervention, each 15
minutes, face-to-face; individual), CPT code 96153 (Health and behavior
intervention, each 15 minutes, face-to-face; group (2 or more
patients)), CPT code 96154 (Health and behavior intervention, each 15
minutes, face-to-face; family (with the patient present)), and CPT code
96155 (Health and behavior intervention, each 15 minutes, face-to-face;
family (without the patient present)).
The nine replacement HBAI CPT codes include CPT code 961X0 (Health
behavior assessment, including re-assessment (i.e., health-focused
clinical interview, behavioral observations, clinical decision
making)), CPT code 961X1 (Health behavior intervention, individual,
face-to-face; initial 30 minutes), CPT code 961X2 (Health behavior
intervention, individual, face-to-face; each additional 15 minutes
(list separately in addition to code for primary service)), CPT code
961X3 (Health behavior intervention, group (2 or more patients), face-
to-face; initial 30 minutes), CPT code 961X4 (Health behavior
intervention, group (2 or more patients), face-to-face; each additional
15 minutes (list separately in addition to code for primary service)),
CPT code 961X5 (Health behavior intervention, family (with the patient
present), face-to-face; initial 30 minutes), CPT code 961X6 (Health
behavior intervention, family (with the patient present), face-to-face
each additional 15 minutes (list separately in addition to code for
primary service)), CPT code 961X7 (Health behavior intervention, family
(without the patient present), face-to-face; initial 30 minutes), CPT
code 961X8 (Health behavior intervention, family (without the patient
present), face-to-face; each additional 15 minutes (list separately in
addition to code for primary service)).
We are proposing the RUC-recommended work RVUs for each of the
codes in this family as follows.
For CPT code 961X0, we are proposing a work RVU of 2.10.
For CPT code 961X1, we are proposing a work RVU of 1.45.
For CPT code 961X2, we are proposing a work RVU of 0.50.
For CPT code 961X3, we are proposing a work RVU of 0.21.
For CPT code 961X4, we are proposing a work RVU of 0.10.
For CPT code 961X5, we are proposing a work RVU of 1.55.
For CPT code 961X6, we are proposing a work RVU of 0.55.
For CPT code 961X7, we are proposing a work RVU of 1.50
(but this code will be non-covered by Medicare).
For CPT code 961X8, we are proposing a work RVU of 0.54
(but this code will be non-covered by Medicare).
We are proposing the RUC-recommended direct PE inputs for all of
the CPT codes in this family without refinement.
(66) Cognitive Function Intervention (CPT Codes 971XX and 9XXX0)
In 2017, we received HCPAC recommendations for new CPT code 97127
(Development of cognitive skills to improve attention, memory, problem
solving, direct patient contact, 1) that described the services under
CPT code 97532 (Development of cognitive skills to improve attention,
memory, problem solving, direct patient contact, each 15 minutes). CPT
code 97532 was scheduled to be deleted and replaced by the new untimed
code CPT code 97127. In the CY 2018 PFS final rule (82 FR 53074 through
53076); however, we
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suggested that CPT code 97127 as an untimed/per day code did not
appropriately account for the variable amounts of time spent with a
patient depending upon the discipline and/or setting and assigned the
code a procedure status of ``I'' (Invalid). In place of CPT code 97127,
we established a new HCPCS G-code, G0515 (Development of cognitive
skills to improve attention, memory, problem solving, direct patient
contact, each 15 minutes), with a work RVU of 0.44. HCPCS code G0515
maintained the descriptor and values from the former CPT code 97532.
In September 2018, the CPT Editorial Panel revised CPT code 971XX
(Therapeutic interventions that focus on cognitive function (e.g.,
attention, memory, reasoning, executive function, problem solving and/
or pragmatic functioning) and compensatory strategies to manage the
performance of an activity (e.g., managing time or schedules,
initiating, organizing and sequencing tasks), direct (one-to-one)
patient contact; initial 15 minutes) and created an add-on code, CPT
code 9XXX0 (Therapeutic interventions that focus on cognitive function
(e.g., attention, memory, reasoning, executive function, problem
solving and/or pragmatic functioning) and compensatory strategies to
manage the performance of an activity (e.g., managing time or
schedules, initiating, organizing and sequencing tasks), direct (one-
to-one) patient contact; each additional 15 minutes (list separately in
addition to code for primary procedure)).
We are proposing the RUC-recommended work RVUs of 0.50 for CPT code
971XX and 0.48 for CPT code 9XXX0. We are proposing the RUC-recommended
direct PE inputs for all codes in the family. We are also proposing to
designate CPT codes 971XX and 9XXX0 as sometime therapy codes because
the services might be appropriately furnished by therapists under the
outpatient therapy services benefit (includes physical therapy,
occupational therapy, or speech-language pathology) or outside the
therapy benefit by physicians, NPPs, and psychologists.
(67) Open Wound Debridement (CPT Codes 97597 and 97598)
CPT code 97598 (Debridement (e.g., high pressure waterjet with/
without suction, sharp selective debridement with scissors, scalpel and
forceps), open wound, (e.g., fibrin, devitalized epidermis and/or
dermis, exudate, debris, biofilm), including topical application(s),
wound assessment, use of a whirlpool, when performed and instruction(s)
for ongoing care, per session, total wound(s) surface area; each
additional 20 sq cm, or part thereof) was identified by the RUC on a
list of services that were originally surveyed by one specialty but are
now typically performed by a different specialty. It was reviewed along
CPT code 97597 (Debridement (e.g., high pressure waterjet with/without
suction, sharp selective debridement with scissors, scalpel and
forceps), open wound, (e.g., fibrin, devitalized epidermis and/or
dermis, exudate, debris, biofilm), including topical application(s),
wound assessment, use of a whirlpool, when performed and instruction(s)
for ongoing care, per session, total wound(s) surface area; first 20 sq
cm or less) at the October 2018 RUC meeting.
We disagree with the RUC-recommended work RVU of 0.88 for CPT code
97597 and we are proposing a work RVU of 0.77 based on a crosswalk to
CPT code 27369 (Injection procedure for contrast knee arthrography or
contrast enhanced CT/MRI knee arthrography). CPT code 27369 is a
recently-reviewed code with the same intraservice time of 15 minutes
and a total time of 28 minutes, one minute fewer than CPT code 97597.
In reviewing this code, we noted that the recommended intraservice time
is increasing from 14 minutes to 15 minutes (7 percent), and the
recommended total time is increasing from 24 minutes to 29 minutes (21
percent); however, the RUC-recommended work RVU is increasing from 0.51
to 0.88, which is an increase of 73 percent. Although we did not imply
that the decrease in time as reflected in survey values must equate to
a one-to-one or linear increase in the valuation of work RVUs, we
believe that since the two components of work are time and intensity,
modest increases in time should be appropriately reflected with a
commensurate increase the work RVUs. In the case of CPT code 97597, we
believed that it is more accurate to propose a work RVU of 0.77 based
on a crosswalk to CPT code 27369 to account for these modest increases
in the surveyed work time. We also note that even at the proposed work
RVU of 0.77 the intensity of this procedure as measured by IWPUT is
increasing by more than 50 percent over the current value.
We are proposing the RUC-recommended work RVU of 0.50 for CPT code
97598. We are also proposing the RUC-recommended direct PE inputs for
all codes in the family.
(68) Negative Pressure Wound Therapy (CPT Codes 97607 and 97608)
In the CY 2013 final rule with comment period, we created two HCPCS
codes to provide a payment mechanism for negative pressure wound
therapy services furnished to beneficiaries using equipment that is not
paid for as durable medical equipment: G0456 (Negative pressure wound
therapy, (for example, vacuum assisted drainage collection) using a
mechanically powered device, not durable medical equipment, including
provision of cartridge and dressing(s), topical application(s), wound
assessment, and instructions for ongoing care, per session; total
wound(s) surface area less than or equal to 50 square centimeters) and
G0457 (Negative pressure wound therapy, (for example, vacuum assisted
drainage collection) using a mechanically-powered device, not durable
medical equipment, including provision of cartridge and dressing(s),
topical application(s), wound assessment, and instructions for ongoing
care, per session; total wound(s) surface area greater than 50 sq. cm).
For CY 2015, the CPT Editorial Panel created CPT codes 97607 (Negative
pressure wound therapy, (e.g., vacuum assisted drainage collection),
utilizing disposable, non-durable medical equipment including provision
of exudate) and 97608 (Negative pressure wound therapy, (e.g., vacuum
assisted drainage collection), utilizing disposable, non-durable
medical equipment including provision of exudate) to describe negative
pressure wound therapy with the use of a disposable system. In
addition, CPT codes 97605 (Negative pressure wound therapy (e.g.,
vacuum assisted drainage collection), utilizing durable medical
equipment (DME), including topical application(s), wound assessment,
and instruction(s) for ongoing care, per session; total wound(s)
surface area less than or equal to 50 square centimeters) and 97606
(Negative pressure wound therapy (e.g., vacuum assisted drainage
collection), utilizing durable medical equipment (DME), including
topical application(s), wound assessment, and instruction(s) for
ongoing care, per session; total wound(s) surface area greater than 50
square centimeters) were revised to specify the use of durable medical
equipment. Based upon the revised coding scheme for negative pressure
wound therapy, we deleted the G-codes. Due to concerns that we had with
these services, we contractor priced CPT codes 97607 and 97608
beginning in CY 2015 (79 FR 67670). In the CY 2016 Final Rule (80 FR
71005),
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in response to comment expressing disappointment with CMS' decision to
contractor price these codes, we noted that there were obstacles to
developing accurate payment rates for these services within the PE RVU
methodology, including the indirect PE allocation for the typical
practitioners who furnish these services and the diversity of the
products used in furnishing these services.
We have received repeated requests from stakeholders, including in
comment received in response to the CY 2019 PFS final rule, to assign
an active status to these codes, meaning we would assign rates to the
codes rather than allowing them to be contractor priced. In that rule,
(83 FR 59473), we noted that we received a request that CMS should
assign direct cost inputs and PE RVUs to CPT codes 97607 and 97608, and
we indicated that we would take this feedback from commenters under
consideration for future rulemaking.
In response to stakeholder feedback, we evaluated the codes and
determined there was adequate volume to assign an active status. We are
proposing to assign an active status to CPT codes 97607 and 97608 and
we are proposing the work RVUs as recommended by the RUC that we
received for CY 2015 when the CPT Editorial Panel created these codes.
Thus, we are proposing a work RVU of 0.41 for CPT code 97607 and a work
RVU of 0.46 for CPT code 97608. Similarly, we are proposing the RUC-
recommended direct PE inputs originally for CY 2015 with the following
refinement: For the clinical labor activity ``check dressings & wound/
home care instructions/coordinate office visits/prescriptions,'' we are
refining the clinical labor time to the standard 2 minutes for this
task. In addition, the direct inputs for these codes include the new
supply item, ``kit, negative pressure wound therapy, disposable.'' A
search of publicly available commercial pricing data indicates that a
unit price of approximately $100 is appropriate, and therefore, we are
proposing this price for this supply item. If more accurate invoices
are available, we are soliciting such invoices to more accurately price
it.
(69) Ultrasonic Wound Assessment (CPT Code 97610)
In 2005, the AMA RUC began the process of flagging services that
represent new technology or new services as they were presented to the
Committee. CPT code 97610 (Low frequency, non-contact, non-thermal
ultrasound, including topical application(s), when performed, wound
assessment, and instruction(s) for ongoing care, per day) was flagged
for CPT 2015 and reviewed at the October 2018 RAW meeting. The
Workgroup indicated that the utilization is continuing to increase for
this service, and recommended that it be resurveyed for physician work
and practice expense for the January 2019 RUC meeting.
We are proposing the RUC-recommend work 0.40 for CPT code 97610. We
are also proposing the RUC-recommended direct PE inputs for CPT code
97610.
(70) Online Digital Evaluation Service (e-Visit) (CPT Codes 98X00,
98X01, and 98X02)
In September 2018, the CPT Editorial Panel deleted two codes and
replaced them with six new non-face-to-face codes to describe patient-
initiated digital communications that require a clinical decision that
otherwise typically would have been provided in the office. The HCPAC
reviewed and made recommendations for CPT code 98X00 (Qualified
nonphysician healthcare professional online digital evaluation and
management service, for an established patient, for up to seven days,
cumulative time during the 7 days; 5-10 minutes), CPT code 98X01
(Qualified nonphysician healthcare professional online digital
evaluation and management service, for an established patient, for up
to seven days, cumulative time during the 7 days; 11-20 minutes), and
CPT code 98X02 (Qualified nonphysician qualified healthcare
professional online digital evaluation and management service, for an
established patient, for up to seven days, cumulative time during the 7
days; 21 or more minutes). CPT codes 9X0X1-9X0X3 are for practitioners
who can independently bill E/M services while CPT codes 98X00-98X02 are
for practitioners who cannot independently bill E/M services.
The statutory requirements that govern the Medicare benefit are
specific regarding which practitioners may bill for E/M services. As
such, when codes are established that describe E/M services that fall
outside the Medicare benefit category of the practitioners who may bill
for that service, we have typically created parallel HCPCS G-codes with
descriptors that refer to the performance of an ``assessment'' rather
than an ``evaluation''. We acknowledge that there are qualified non-
physician health care professionals who will likely perform these
services. Therefore, for CY 2020, we are proposing separate payment for
online digital assessments via three HCPCS G-codes that mirror the RUC
recommendations for CPT codes 98X00-98X02. The proposed HCPCS G codes
and descriptors are as follows:
HCPCS code GNPP1 (Qualified nonphysician healthcare
professional online assessment, for an established patient, for up to
seven days, cumulative time during the 7 days; 5-10 minutes);
HCPCS code GNPP2 (Qualified nonphysician healthcare
professional online assessment service, for an established patient, for
up to seven days, cumulative time during the 7 days; 11-20 minutes);
and
HCPCS code GNPP3 (Qualified nonphysician qualified
healthcare professional assessment service, for an established patient,
for up to seven days, cumulative time during the 7 days; 21 or more
minutes).
For CY 2020, we are proposing a work RVU of 0.25 for CPT code
GNPP1, which reflects the RUC-recommended work RVU for CPT code 98X00.
For HCPCS codes GNPP2 and GNPP3, we believe that the 25th percentile
work RVU associated with CPT codes 98X01 and 98X02 respectively, better
reflects the intensity of performing these services, as well as the
methodology used to value the other codes in the family, all of which
use the 25th percentile work RVU. Therefore, we are proposing a work
RVU of 0.44 for HCPCS code GNPP1 and a work RVU of 0.69 for HCPCS code
GNPP2.
We are proposing the direct PE inputs associated with CPT codes
98X00, 98X01, and 98X02 for GNPP1, GNPP2, and GNPP3 respectively.
(71) Emergency Department Visits (CPT Codes 99281, 99282, 99283, 99284,
and 99285)
In the CY 2018 PFS final rule, we finalized a proposal to nominate
CPT codes 99281-99285 as potentially misvalued based on information
suggesting that the work RVUs for emergency department visits may not
appropriately reflect the full resources involved in furnishing these
services (FR 82 53018.) These five codes were surveyed and reviewed for
the April 2018 RUC meeting. For CY 2020 we are proposing the RUC-
recommended work RVUs of 0.48 for CPT code 99281, a work RVU of 0.93
for CPT code 99282, a work RVU of 1.42 for 99283, a work RVU of 2.60
for 99284, and a work RVU of 3.80 for CPT code 99285.
The RUC did not recommend and we are not proposing any direct PE
inputs for the codes in this family.
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(72) Self-Measured Blood Pressure Monitoring (CPT Codes 99X01, 99X02,
93784, 93786, 93788, and 93790)
In September 2018, the CPT Editorial Panel created two new codes
and revised four other codes to describe self-measured blood pressure
monitoring services and to differentiate self-measured blood pressuring
monitoring services from ambulatory blood pressure monitoring services.
The first of the two new codes that describe self-measured blood
pressure monitoring is CPT code 99X01 (Self-measured blood pressure
using a device validated for clinical accuracy; patient education/
training and device calibration) and is a PE only code. The second code
is 99X02 (Self-measured blood pressure using a device validated for
clinical accuracy; separate self-measurements of two readings, one
minute apart, twice daily over a 30-day period (minimum of 12
readings), collection of data reported by the patient and/or caregiver
to the physician or other qualified health care professional, with
report of average systolic and diastolic pressures and subsequent
communication of a treatment plan to the patient).
The remaining four codes, which monitor ambulatory blood pressure,
include CPT code 93784 (Ambulatory blood pressure monitoring, utilizing
report-generating software, automated, worn continuously for 24 hours
or longer; including recording, scanning analysis, interpretation and
report), CPT code 93786 (Ambulatory blood pressure monitoring,
recording only), CPT code 93788 (Ambulatory blood pressure monitoring,
scanning analysis with report), and CPT code 93790 (Ambulatory blood
pressure monitoring, review with interpretation and report). CPT code
93784 is a composite code that is the sum of CPT codes 93786, 93788,
and 93790. CPT codes 93786 and 93788 are PE only codes.
We are proposing the RUC-recommended work RVU of 0.18 for CPT code
99X02, the RUC-recommended work RVU of 0.38 for CPT code 93784, and the
RUC-recommended work RVU of 0.38 for CPT code 93790. We are proposing
the RUC-recommended work RVU of 0.00 for CPT codes 93786, 93788, and
99X01. We are also proposing the RUC-recommended direct PE inputs for
all codes in the family.
(73) Online Digital Evaluation Service (e-Visit) (CPT Codes 9X0X1,
9X0X2, and 9X0X3)
In September 2018, the CPT Editorial Panel deleted two codes and
replaced them with six new non-face-to face codes to describe patient-
initiated digital communications that require a clinical decision that
otherwise typically would have been provided in the office. The RUC
reviewed and made recommendations for CPT code 9X0X1 (Online digital
evaluation and management service, for an established patient, for up
to 7 days, cumulative time during the 7 days; 5-10 minutes), CPT code
9X0X2 (Online digital evaluation and management service, for an
established patient, for up to 7 days, cumulative time during the 7
days; 11-20 minutes), and CPT code 9X0X3 (Online digital evaluation and
management service, for an established patient, for up to 7 days,
cumulative time during the 7 days; 21 or more minutes).
For CY 2020, we are proposing the RUC-recommended work RVUs of 0.25
for CPT code 9X0X1, 0.50 for CPT code 9X0X2, and 0.80 for CPT code
9X0X3. We are proposing the RUC-recommended direct PE inputs for all
codes in the family.
(74) Radiation Therapy Codes (HCPCS Codes G6001, G6002, G6003, G6004,
G6005, G6006, G6007, G6008, G6009, G6010, G6011, G6012, G6013, G6014,
G6015, G6016 and G6017)
For CY 2015, CPT revised the radiation therapy code set for
following identification of some of the codes as potentially misvalued
and the affected specialty society's contention that the provision of
radiation therapy could not be accurately reported under the existing
code set. In the CY 2015 PFS final rule, we finalized that we were
delaying implementation of this revised code set, citing concerns with
our potentially having finalized a substantial coding revision on an
interim final basis. In addition, we stated that substantial work
needed to be done to assure the new valuations for these codes
accurately reflect the coding changes. We finalized that we would
maintain inputs at CY 2014 levels by creating G-codes as necessary to
allow practitioners to continue to report services to CMS in CY 2015 as
they did in CY 2014 and for payments to be made in the same way.
Following the publication of the CY 2015 PFS final rule, the Patient
Access and Medicare Protection Act (Pub. L. 114-115, December 28, 2015)
was enacted, which included the provision that the code definitions,
the work relative value units and the direct inputs for the PE RVUs for
radiation treatment delivery and related imaging services (identified
in 2016 by HCPCS G-codes G6001 through G6015) for the fee schedule
established under this subsection for services furnished in 2017 and
2018 shall be the same as such definitions, units, and inputs for such
services for the fee schedule established for services furnished in
2016. In CY 2018, Congress extended this ``freeze'' in coding
descriptions and inputs through CY 2019 as a provision of the
Bipartisan Budget Act of 2018. For CY 2020, in the interest of payment
stability, we are proposing to continue using these G-codes, as well as
their current work RVUs and direct PE inputs. We are also proposing
that, for CY 2020, our PE methodology will continue to include a
utilization rate assumption of 60 percent for the equipment item:
ER089, ``IMRT Accelerator.''
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
O. Comment Solicitation on Opportunities for Bundled Payments Under the
PFS
Under the PFS, Medicare typically makes a separate payment for each
individual service furnished to a beneficiary consistent with section
1848 of the Act, which requires CMS to establish payment for
physicians' services based on the relative resources involved in
furnishing the service. The statute defines ``services'' broadly, with
reference to the uniform procedure coding system established by CMS for
the purpose of Medicare FFS payments, called the Healthcare Common
Procedure Coding System (HCPCS). There are sets of HCPCS codes that
represent health care procedures, supplies, medical equipment,
products, and services. The majority of physicians' services for which
payment is made under the PFS are described using HCPCS Level I codes
and descriptors that are the AMA's Current Procedural Terminology (CPT)
code set. CPT codes generally describe an individual item or service,
while some codes describe a combination of services (a procedure and
imaging guidance, for example) bundled together. Some HCPCS codes
explicitly encompass multiple services (global surgery codes, for
example), and the PFS payment for some services is reduced when a
combination of services is furnished to the same patient on the same
day (through multiple procedure payment reduction policies). However,
payment for most services under the PFS is made based on rates
established for individual services, each described by a CPT code.
Identifying and developing appropriate payment policies that aim to
achieve better care and improved health for Medicare beneficiaries is a
priority for CMS. Consistent with that goal, we are interested in
exploring new options for establishing PFS payment rates or adjustments
for services that are furnished together. For purposes of this
discussion, we will refer to the circumstances where a set of services
is grouped together for purposes of ratesetting and payment as
``bundled payment.''
One of the mechanisms through which we support innovative payment
and service delivery models, for Medicare and other beneficiaries, is
through CMS' Center for Medicare and Medicaid Innovation (the
Innovation Center). The Innovation Center is currently testing models
in which payment for physicians' services is bundled on a per-
beneficiary population basis, or is based on episodes of care that
usually begin with a triggering event and extend for a specified period
of time thereafter. An example of a model in which payment is made on a
per-beneficiary population basis is Comprehensive Primary Care Plus
(CPC+), in which participating practices receive prospective per-
beneficiary care management fees and Comprehensive Primary Care
Payments for certain primary care services such as chronic care
management and evaluation and management services. An example of an
episode payment model is the Oncology Care Model (OCM), in which
participating physician practices receive a per-beneficiary Monthly
Enhanced Oncology Services payment for care management and care
coordination surrounding chemotherapy administration to cancer
patients. We are actively exploring the extent to which these basic
principles of bundled payment, such as establishing per-beneficiary
payments for multiple services or condition-specific episodes of care,
can be applied within the statutory framework of the PFS.
We are seeking public comments on opportunities to expand the
concept of bundling to recognize efficiencies among physicians'
services paid under the PFS and better align Medicare payment policies
with CMS's broader goal of achieving better care for patients, better
health for our communities, and lower costs through improvement in our
health care system. We believe that the statute, while requiring CMS to
pay for physicians' services based on the relative resources involved
in furnishing the service, allows considerable flexibility for
developing payments under the PFS.
P. Payment for Evaluation and Management (E/M) Visits
1. Background
a. E/M Visits Coding Structure
Physicians and other practitioners who are paid under the PFS bill
for common office visits for evaluation and management (E/M) services
under a relatively generic set of CPT codes (Level I HCPCS codes) that
distinguish visits based on the level of complexity, site of service,
and whether the patient is new or established. These CPT codes are
broadly referred to as E/M visit codes and have three key components
within their code descriptors: History of present illness (History),
physical examination (Exam), and medical decision-making (MDM).\80\
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\80\ 2019 CPT Codebook, Evaluation and Management, pp. 6-13.
---------------------------------------------------------------------------
The CPT code descriptors recognize counseling, care coordination,
and the nature of the presenting problem as additional service
components, but these are contributory factors in determining which
code to report.\81\ Per the CPT code descriptors, counseling and/or
care coordination are provided consistent with the nature of the
problem and the patient's and/or family's needs. Counseling and care
coordination are not required at every patient encounter and can be
accounted for in separate coding.\82\
---------------------------------------------------------------------------
\81\ 2019 CPT Codebook, Evaluation and Management, pp. 6-13.
\82\ 2019 CPT Codebook, Evaluation and Management, pp. 4-56.
---------------------------------------------------------------------------
As finalized in the CY 2019 PFS final rule, the amount of time
spent by the billing practitioner is not a determining factor in code
level selection unless (1) counseling and care coordination dominate
the visit, in which case time becomes the key factor in determining
visit level; and/or (2) the service is a prolonged (or beginning in
2021, ``extended'') (83 FR 59630) E/M visit. Typical times for each
level of E/M visit are included in each of the CPT code descriptors,
are used for PFS rate setting purposes, and provide a reference point
for the reporting of prolonged visits. Separate add-on codes describe,
and can be reported for, visits that take prolonged (or beginning in
2021, ``extended'') (83 FR 59630) amounts of time.
There are 3 to 5 E/M visit code levels, depending upon site of
service and the extent of the three components of history, exam, and
MDM. For example, there are 3 to 4 levels of E/M visit codes in the
inpatient hospital and nursing facility settings based on a relatively
narrow range of complexity in those settings. In contrast, there are 5
levels of E/M visit codes in the office or other outpatient setting
based on a broader range of complexity in those settings.
PFS payment rates for E/M visit codes generally increase with the
level of visit billed, although in the CY 2019 PFS final rule (83 FR
59638), for reasons discussed below, we finalized the assignment of a
single payment rate for levels 2 through 4 office/outpatient E/M visits
beginning in CY 2021. As for all services under the PFS, the payment
rates for E/M visits are based on the work (time and intensity),
practice expense, and malpractice expense resources required to furnish
the typical case of the service.
In total, E/M visits comprise approximately 40 percent of allowed
charges for PFS services, and office/outpatient E/M visits comprise
[[Page 40671]]
approximately 20 percent of allowed charges for PFS services. Within
the E/M services represented in these percentages, there is wide
variation in the volume and level of E/M visits billed by different
specialties. According to Medicare claims data, E/M visits are
furnished by nearly all specialties, but represent a greater share of
total allowed services for physicians and other practitioners who do
not routinely furnish procedural interventions or diagnostic tests.
Generally, these practitioners include both primary care practitioners
and certain specialists such as neurologists, endocrinologists and
rheumatologists. Certain specialties, such as podiatry, tend to furnish
lower level E/M visits more often than higher level E/M visits. Some
specialties, such as dermatology and otolaryngology, tend to bill more
E/M visits on the same day as they bill minor procedures.
b. E/M Documentation Guidelines
For CY 2019 and 2020, when coding and billing E/M visits to
Medicare, practitioners may use one of two versions of the E/M
Documentation Guidelines for a patient encounter, commonly referenced
based on the year of their release: the ``1995'' or ``1997'' E/M
Documentation Guidelines (hereafter, the 1995 and 1997 Guidelines).\83\
These Guidelines specify the medical record information within each of
the three key components (such as number of body systems reviewed) that
serves as support for billing a given level of E/M visit. The 1995 and
1997 Guidelines are very similar to the guidelines for E/M visits that
currently reside within the AMA's CPT codebook for E/M visits. For
example, the core structure of what comprises or defines the different
levels of history, exam, and medical decision-making in the 1995 and
1997 Guidelines are the same as those in the CPT codebook. However, the
1995 and 1997 Guidelines include extensive examples of clinical work
that comprise different levels of medical decision-making that do not
appear in the AMA's CPT codebook. Also, the 1995 and 1997 Guidelines do
not contain references to preventive care that appear in the AMA's CPT
codebook. We provide an example of how the 1995 and 1997 Guidelines
distinguish between level 2 and level 3 E/M visits in Table 25.
---------------------------------------------------------------------------
\83\ See https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf;
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf; and the
Evaluation and Management Services guide at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf.
Table 25--Key Component Documentation Requirements for Level 2 vs. 3 E/M Visit
----------------------------------------------------------------------------------------------------------------
Key component * Level 2 (1995) Level 3 (1995) Level 2 (1997) Level 3 (1997)
----------------------------------------------------------------------------------------------------------------
History (History of Present Review of Systems Problem Pertinent No change from No change from
Illness or HPI). (ROS) n/a. ROS: Inquires 1995. 1995.
about the system
directly related
to the problem(s)
identified in the
HPI.
Physical Examination (Exam)..... A limited A limited General multi- General multi-
examination of examination of system exam: system exam:
the affected body the affected body Performance and Performance and
area or organ area or organ documentation of documentation of
system. system and other one to five at least six
symptomatic or elements in one elements in one
related organ or more organ or more organ
system(s). system(s) or body system(s) or body
area(s). area(s).
Single organ Single organ
system exam: system exam:
Performance and Performance and
documentation of documentation of
one to five at least six
elements. elements.
Medical Decision Making (MDM). Straightforward: Low complexity: No change from 1995.
Measured by: **
1. Problem--Number of 1. Minimal..... 1. Limited.
diagnoses/treatment options.
2. Data--Amount and/or 2. Minimal or 2. Limited data
complexity of data to be no data review. review.
reviewed.
3. Risk--Risk of 3. Minimal risk 3. Low risk.
complications and/or
morbidity or mortality.
----------------------------------------------------------------------------------------------------------------
* For certain settings and patient types, each of these three key components must be met or exceeded (for
example, new patients; initial hospital visits). For others, only two of the three key components must be met
or exceeded (for example, established patients, subsequent hospital or other visits).
** Two of three met or exceeded.
According to both Medicare claims processing manual instructions
and CPT coding rules, when counseling and/or coordination of care
accounts for more than 50 percent of the face-to-face physician/patient
encounter (or, in the case of inpatient E/M services, the floor time)
the duration of the visit can be used as an alternative basis to select
the appropriate E/M visit level (Pub. 100-04, Medicare Claims
Processing Manual, Chapter 12, Section 30.6.1.C available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf; see also 2019 CPT Codebook Evaluation and Management
Services Guidelines, page 10). Pub. 100-04, Medicare Claims Processing
Manual, Chapter 12, Section 30.6.1.B states, ``Instruct physicians to
select the code for the service based
[[Page 40672]]
upon the content of the service. The duration of the visit is an
ancillary factor and does not control the level of the service to be
billed unless more than 50 percent of the face-to-face time (for non-
inpatient services) or more than 50 percent of the floor time (for
inpatient services) is spent providing counseling or coordination of
care as described in subsection C.'' Subsection C states that ``the
physician may document time spent with the patient in conjunction with
the medical decision-making involved and a description of the
coordination of care or counseling provided. Documentation must be in
sufficient detail to support the claim.'' The example included in
subsection C further states, ``The code selection is based on the total
time of the face-to-face encounter or floor time, not just the
counseling time. The medical record must be documented in sufficient
detail to justify the selection of the specific code if time is the
basis for selection of the code.''
Both the 1995 and 1997 Guidelines address time, stating that, ``In
the case where counseling and/or coordination of care dominates (more
than 50 percent of) the physician/patient and/or family encounter
(face-to-face time in the office or other outpatient setting or floor/
unit time in the hospital or nursing facility), time is considered the
key or controlling factor to qualify for a particular level of E/M
services.'' The Guidelines go on to state that, ``If the physician
elects to report the level of service based on counseling and/or
coordination of care, the total length of time of the encounter (face-
to-face or floor time, as appropriate) should be documented and the
record should describe the counseling and/or activities to coordinate
care.'' \84\ Additional manual provisions regarding E/M visits are
housed separately within Medicare's internet-Only Manuals, and are not
contained within the 1995 or 1997 Guidelines.
---------------------------------------------------------------------------
\84\ Page 16 of the 1995 E/M guidelines and page 48 of the 1997
guidelines.
---------------------------------------------------------------------------
In accordance with section 1862(a)(1)(A) of the Act, which requires
services paid under Medicare Part B to be reasonable and necessary for
the diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member, medical necessity is a
prerequisite to Medicare payment for E/M visits. Pub. 100-04, Medicare
Claims Processing Manual, Chapter 12, Section 30.6.1.B states,
``Medical necessity of a service is the overarching criterion for
payment in addition to the individual requirements of a CPT code. It
would not be medically necessary or appropriate to bill a higher level
of evaluation and management service when a lower level of service is
warranted. The volume of documentation should not be the primary
influence upon which a specific level of service is billed.
Documentation should support the level of service reported.''
c. Summary of Changes to Coding, Payment and Documentation of Office/
Outpatient E/M Visits Finalized for CY 2021 in the CY 2019 PFS Final
Rule
In the CY 2019 PFS final rule (83 FR 59452 through 60303), we
finalized a number of coding, payment, and documentation changes under
the PFS for office/outpatient E/M visits (CPT codes 99201-99215) to
reduce administrative burden, improve payment accuracy, and update this
code set to better reflect the current practice of medicine. In
summary, we finalized the following policy changes for office/
outpatient E/M visits under the PFS effective January 1, 2021:
Reduction in the payment variation for office/outpatient
E/M visit levels by paying a single rate (also referred to as a blended
rate) for office/outpatient E/M visit levels 2 through 4 (one rate for
established patients and another rate for new patients), while
maintaining the payment rate for office/outpatient E/M visit level 5 in
order to better account for the care and needs of complex patients.
Practitioners will still report the appropriate code for the level of
service they furnished, since we did not replace these CPT codes with
HCPCS G codes and will continue to use typical times associated with
each individual CPT code when time is used to document the office/
outpatient E/M visit.
Permitting practitioners to choose to document office/
outpatient E/M level 2 through 5 visits using MDM or time, or the
current framework based on the 1995 or 1997 Guidelines.
As a corollary to the uniform payment rate for level 2-4
E/M visits, when using MDM or the current framework to document the
office/outpatient E/M visit, a minimum supporting documentation
standard associated with level 2 office/outpatient E/M visits will
apply. For these cases, Medicare will require information to support a
level 2 office/outpatient E/M visit code for history, exam, and/or MDM.
When time is used to document, practitioners will document
the medical necessity of the office/outpatient E/M visit and that the
billing practitioner personally spent the required amount of time face-
to-face with the beneficiary. The required face-to-face time will be
the typical time for the reported code, except for extended or
prolonged visits where extended or prolonged times will apply.
Implementation of HCPCS add-on G codes that describe the
additional resources inherent in visits for primary care and particular
kinds of non-procedural specialized medical care (HCPCS codes GPC1X and
GCG0X, respectively). These codes were finalized in order to reflect
the differential resource costs associated with performing certain
types of office/outpatient E/M visits. These codes will only be
reportable with office/outpatient E/M level 2 through 4 visits.
Adoption of a new ``extended visit'' add-on G code (HCPCS
code GPRO1) for use only with office/outpatient E/M level 2 through 4
visits, to account for the additional resources required when
practitioners need to spend extended time with the patient for these
visits. The existing prolonged E/M codes can continue to be used with
levels 1 and 5 office/outpatient E/M visits.
We stated that we believed these policies would allow practitioners
greater flexibility to exercise clinical judgment in documentation so
they can focus on what is clinically relevant and medically necessary
for the beneficiary. We believed these policies will reduce a
substantial amount of administrative burden (83 FR 60068 through 60070)
and result in limited specialty-level redistributive impacts (83 FR
60060). We stated our intent to continue engaging in further
discussions with the public over the next several years to potentially
further refine our policies for 2021. We finalized the coding, payment,
and documentation changes to reduce administrative burden, improve
payment accuracy, and update the code set to better reflect the current
practice of medicine.
2. Continued Stakeholder Feedback
In January and February 2019, we hosted a series of structured
listening sessions on the forthcoming changes that CMS finalized for
office/outpatient E/M visit coding, documentation and payment for CY
2021. These sessions provided an opportunity for CMS to gain further
input and information from the wide range of affected stakeholders on
these important policy changes. Our goal was to continue to listen and
consider perspectives from individual practicing clinicians, specialty
associations, beneficiaries and their advocates, and other interested
stakeholders to prepare for implementation of the office/outpatient
[[Page 40673]]
E/M visit policies that we finalized for CY 2021.
In these listening sessions, although stakeholders supported our
intention to reduce burdensome, clinically outdated documentation
requirements, they noted that in response to the office/outpatient E/M
visit policies CMS finalized for CY 2021, the AMA/CPT established the
Joint AMA CPT Workgroup on E/M to develop an alternative solution. This
workgroup developed an alternative approach, similar to the one we
finalized, for office/outpatient E/M coding and documentation. That
approach was approved by the CPT Editorial Panel in February 2019, with
an effective date of January 1, 2021 and is available on the AMA's
website at https://www.ama-assn.org/cpt-evaluation-and-management.
Effective January 1, 2021, the CPT Editorial Panel adopted
revisions to the office/outpatient E/M code descriptors, and
substantially revised both the CPT prefatory language and the CPT
interpretive guidelines that instruct practitioners on how to bill
these codes. The AMA has approved an accompanying set of interpretive
guidelines governing and updating what determines different levels of
MDM for office/outpatient E/M visits. Some of the changes made by the
CPT Editorial Panel parallel our finalized policies for CY 2021, such
as the choice of time or MDM in determination of code level. Other
aspects differ, such as the number of code levels retained, presumably
for purposes of differential payment; the times, and inclusion of all
time spent on the day of the visit; and elimination of options such as
the use of history and exam or time in combination with MDM, to select
code level.
Many stakeholders have continued to express objections to our
assignment of a single payment rate to level 2-4 office/outpatient E/M
visits stating that this inappropriately incentivizes multiple, shorter
visits and seeing less complex patients. Many stakeholders also stated
that the purpose and use of the HCPCS add-on G codes that we
established for primary care and non-procedural specialized medical
care remain ambiguous, expressed concern that the codes are potentially
contrary to current law prohibiting specialty-specific payment, and
asserted that Medicare's coding approach is unlikely to be adopted by
other payers.
In meetings with stakeholders since we issued the CY 2019 PFS final
rule, some stakeholders suggested that only time should be used to
select the service level because time is easy to audit, simple to
document, and better accounts for patient complexity, in comparison to
the CPT Editorial Panel revised MDM interpretive guidance. These
stakeholders stated that the implementation of the CPT Editorial Panel
revised MDM interpretive guidance will result in the likely increase in
the selection of levels 4 and 5, relative to current typical coding
patterns. They suggested that to more accurately distinguish varying
levels of patient complexity, either the visit levels should be
recalibrated so that levels 4 and 5 no longer represent the most often
billed visit, or a sixth level should be added. In these meetings, some
stakeholders also stated that the office/outpatient E/M codes fail to
capture the full range of services provided by certain specialties,
particularly primary care and other specialties that rely heavily on
office/outpatient E/M services rather than procedures, systematically
undervaluing primary care visits and visits furnished in the context of
non-procedural specialty care, thereby creating payment disparities
that have contributed to workforce shortages and beneficiary access
challenges across a range of specialties. They reiterated that office/
outpatient E/M visit codes have not been extensively examined since the
creation of the PFS and recommended that CMS conduct an extensive
research effort to revise and revalue office/outpatient E/M services
through a major research initiative akin to that undertaken when the
PFS was first established.
The AMA believes its approach will accomplish greater burden
reduction, is more clinically intuitive and reflects the current
practice of medicine, and is more likely to be adopted by all payers
than the policies CMS finalized for CY 2021. The AMA has posted an
estimate of the burden reduction associated with the policies approved
at CPT on the AMA's website, available at https://www.ama-assn.org/cpt-evaluation-and-management.
Given the CPT coding changes that will take effect in 2021, the AMA
RUC has conducted a resurvey and revaluation of the office/outpatient
E/M visit codes, and provided us with its recommendations. We discuss
our proposal to adopt the CPT coding for office/outpatient E/M visits
below, noting that the CPT coding changes will also necessitate some
changes to CMS' policies for CY 2021, due to forthcoming changes in
code descriptors. In addition, we address revaluation of the codes,
proposing new values for the codes as revised by CPT. We propose to
assign separate payment rather than a blended rate, to each of the
office/outpatient E/M visit codes (except CPT code 99201, which CPT is
deleting) and the new prolonged visit add-on CPT code (CPT code 99XXX).
We propose to delete the HCPCS add-on code we finalized last year for
CY 2021 for extended visits (GPRO1). We propose to simplify,
consolidate and revalue the HCPCS add-on codes we finalized last year
for CY 2021 for primary care (GPC1X) and non-procedural specialized
medical care (GCG0X), and to allow the new code to be reported with all
office/outpatient E/M visit levels (not just levels 2 through 4). All
of these changes would be effective January 1, 2021. We believe our
proposed policies will further our ongoing effort to reduce
administrative burden, improve payment accuracy, and update the office/
outpatient EM visit code set to better reflect the current practice of
medicine.
3. Proposed Policies for CY 2021 for Office/Outpatient E/M Visits
a. Office/Outpatient E/M Visit Coding and Documentation
For CY 2021, for office/outpatient E/M visits (CPT codes 99201-
99215) we are proposing to adopt the new coding, prefatory language,
and interpretive guidance framework that has been issued by the AMA/CPT
(see https://www.ama-assn.org/cpt-evaluation-and-management) because we
believe it would accomplish greater burden reduction than the policies
we finalized for CY 2021 and would be more intuitive and consistent
with the current practice of medicine. We note that this includes
deletion of CPT code 99201 (Level 1 office/outpatient visit, new
patient), which the CPT Editorial Panel decided to eliminate as CPT
codes 99201 and 99202 are both straightforward MDM and only
differentiated by history and exam elements.
Under this new framework, history and exam would no longer select
the level of code selection for office/outpatient E/M visits. Instead,
an office/outpatient E/M visit would include a medically appropriate
history and exam, when performed. The clinically outdated system for
number of body systems/areas reviewed and examined under history and
exam would no longer apply, and these components would only be
performed when, and to the extent medically necessary and clinically
appropriate. Level 1 visits would only describe or include visits
performed by clinical staff for established patients.
For levels 2 through 5 office/outpatient E/M visits, the code level
reported would be decided based on
[[Page 40674]]
either the level of MDM (as redefined in the new AMA/CPT guidance
framework) or the total time personally spent by the reporting
practitioner on the day of the visit (including face-to-face and non-
face-to-face time). Because we would no longer assign a blended payment
rate (discussed below), we would no longer adopt the minimum supporting
documentation associated with level 2 office/outpatient E/M visits,
which we finalized as a corollary to the uniform payment rate for level
2-4 office/outpatient E/M visits when using MDM or the current
framework to document the office/outpatient E/M visit.
We would adopt the new time ranges within the CPT codes as revised
by the CPT Editorial Panel. We interpret the revised CPT prefatory
language and reporting instructions to mean that there would be a
single add-on CPT code for prolonged office/outpatient E/M visits (CPT
code 99XXX) that would only be reported when time is used for code
level selection and the time for a level 5 office/outpatient visit (the
floor of the level 5 time range) is exceeded by 15 minutes or more on
the date of service. The long descriptor for CPT code 99XXX is
Prolonged office or other outpatient evaluation and management
service(s) (beyond the total time of the primary procedure which has
been selected using total time), requiring total time with or without
direct patient contact beyond the usual service, on the date of the
primary service; each 15 minutes (List separately in addition to codes
99205, 99215 for office or other outpatient Evaluation and Management
services). We demonstrate below how prolonged office/outpatient E/M
visit time would be reported:
Table 26--Total Proposed Practitioner Times for Office/Outpatient E/M
Visits When Time Is Used To Select Visit Level
------------------------------------------------------------------------
Established patient office/outpatient E/
M visit (total practitioner time, when
time is used to select code level) CPT code
(minutes)
------------------------------------------------------------------------
40-54.................................. 99215.
55-69.................................. 99215x1 and 99XXXx1.
70-84.................................. 99215x1 and 99XXXx2.
85 or more............................. 99215x1 and 99XXXx3 or more for
each additional 15 mintues.
------------------------------------------------------------------------
New patient office/outpatient E/M visit
(total practitioner time, when time is CPT code
used to select code level) (minutes)
------------------------------------------------------------------------
60-74.................................. 99205.
75-89.................................. 99205x1 and 99XXXx1.
90-104................................. 99205x1 and 99XXXx2.
105 or more............................ 99205x1 and 99XXXx3 or more for
each additional 15 minutes.
------------------------------------------------------------------------
We are proposing to adopt our interpretation of the revised CPT
prefatory language and reporting instructions, that CPT codes 99358-9
(Prolonged E/M without Direct Patient Contact) would no longer be
reportable in association or ``conjunction'' with office/outpatient E/M
visits. In other words, when using time to select office/outpatient E/M
visit level, any additional time spent by the reporting practitioner on
a prior or subsequent date of service (such as reviewing medical
records or test results) could not count towards the required times for
reporting CPT codes 99202-99215 or 99XXX, or be reportable using CPT
codes 99358-9. This interpretation would be consistent with the way the
office/outpatient E/M visit codes were resurveyed, where the AMA/RUC
instructed practitioners to consider all time spent 3 days prior to, or
7 days after, the office/outpatient E/M visit (see below for a
discussion of revaluation proposals). Moreover we note that CPT codes
99358-9 describe time spent beyond the ``usual'' time (CPT prefatory
language), and it is not clear what would comprise ``usual'' time given
the new time ranges for the office/outpatient E/M visit codes and new
CPT code 99XXX (prolonged office/outpatient E/M visit). New CPT
prefatory language specifies, ``For prolonged services on a date other
than the date of a face-to-face encounter, including office or other
outpatient services (99202, 99203, 99204, 99205, 99211, 99212, 99213,
99214, 99215), see 99358, 99359 . . . Do not report 99XXX in
conjunction with . . . 99358, 99359''. We do not believe CPT code 99211
should be included in this list of base codes since it will only
include clinical staff time. Also given that CPT codes 99358, 99359 can
be used to report practitioner time spent on any date (the date of the
visit or any other day), the CPT reporting instruction ``see 99358,
99359'' seems circular. The new prefatory language seems unclear
regarding whether CPT codes 99358, 99359 could be reported instead of,
or in addition to, CPT code 99XXX, and whether the prolonged time would
have to be spent on the visit date, within 3 days prior or 7 days after
the visit date, or outside of this new 10-day window relevant for the
base code. We are seeking public input on this proposal and whether it
would be appropriate to interpret the CPT reporting instructions for
CPT codes 99358-9 as proposed, as well as how this interpretation may
impact valuation. We believe CPT codes 99358 and 99359 may need to be
redefined, resurveyed and revalued. After internal review, we believe
that when time is used to select visit level, having one add-on code
(CPT code 99XXX) instead of multiple add-on codes for additional time
may be administratively simpler and most consistent with our goal of
documentation burden reduction.
HCPCS code GPRO1 (extended office/outpatient E/M time) would no
longer be needed because the time described by this code would instead
be described by a level 3, 4 or 5 office/outpatient E/M visit base code
and, if applicable, the single new add-on CPT code for prolonged
office/outpatient E/M visits (CPT code 99XXX). Therefore, we propose to
delete HCPCS code GPRO1 for CY 2021. We propose to adopt the AMA/CPT
prefatory language that lists qualifying activities that could be
included when time is used to select the visit level. Alternatively, if
MDM is used to choose the visit level, time would not be relevant to
code selection.
[[Page 40675]]
b. Office/Outpatient E/M Visit Revaluation (CPT Codes 99201 Through
99215)
We have received valuation recommendations from the AMA RUC for the
revised office/outpatient E/M codes (CPT codes 99201 through 99215)
following completion of its survey and revaluation process for these
codes. Although these codes do not take effect until CY 2021, we
believe that it is appropriate to follow our usual process of
addressing the valuation of the revised office/outpatient E/M codes
through rulemaking after we receive the RUC recommendations.
Additionally, establishing values for the new codes through rulemaking
this year will allow more time for clinicians to make any necessary
process and systems adjustments before they begin using the codes. In
recent years, we have considered how best to update and revalue the
office/outpatient E/M codes as they represent a significant proportion
of PFS expenditures.
MedPAC has had longstanding concerns that office/outpatient E/M
services are undervalued in the PFS, and in its March 2019 Report to
Congress, further asserted that the office/outpatient E/M code set has
become passively devalued as values of these codes have remained
unchanged, while the coding and valuation for other types of services
under the fee schedule have been updated to reflect changes in medical
practice (see pages 120 through 121 at http://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch4_sec.pdf?sfvrsn=0).
In April 2019, the RUC provided us the results of its review, and
recommendations for work RVUs, practice expense inputs and physician
time (number of minutes) for the revised office/outpatient E/M code
set. Please note that these proposed changes in coding and values are
for the revised office/outpatient E/M code set and a new 15-minute
prolonged services code. That code set is effective beginning in CY
2021, and the proposed values would go into effect with those codes as
of January 1, 2021.
We are proposing to adopt the RUC-recommended work RVUs for all of
the office/outpatient E/M codes and the new prolonged services add-on
code. Specifically, we are proposing a work RVU of 0.93 for CPT code
99202 (Office or other outpatient visit for the evaluation and
management of a new patient, which requires a medically appropriate
history and/or examination and straightforward medical decision making.
When using time for code selection, 15-29 minutes of total time is
spent on the date of the encounter), a work RVU of 1.6 for CPT code
99203 (Office or other outpatient visit for the evaluation and
management of a new patient, which requires a medically appropriate
history and/or examination and low level of medical decision making.
When using time for code selection, 30-44 minutes of total time is
spent on the date of the encounter), a work RVU of 2.6 for CPT code
99204 (Office or other outpatient visit for the evaluation and
management of a new patient, which requires a medically appropriate
history and/or examination and moderate level of medical decision
making. When using time for code selection, 45-59 minutes of total time
is spent on the date of the encounter), a work RVU of 3.5 for CPT code
99205 (Office or other outpatient visit for the evaluation and
management of a new patient, which requires a medically appropriate
history and/or examination and high level of medical decision making.
When using time for code selection, 60-74 minutes of total time is
spent on the date of the encounter. (For services 75 minutes or longer,
see Prolonged Services 99XXX)), a work RVU of 0.18 for CPT code 99211
(Office or other outpatient visit for the evaluation and management of
an established patient, that may not require the presence of a
physician or other qualified health care professional. Usually, the
presenting problem(s) are minimal)), a work RVU of 0.7 for CPT code
99212 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and straightforward medical
decision making. When using time for code selection, 10-19 minutes of
total time is spent on the date of the encounter), a work RVU of 1.3
for CPT code 99213 (Office or other outpatient visit for the evaluation
and management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. When using time for code selection, 20-29 minutes of
total time is spent on the date of the encounter), a work RVU of 1.92
for CPT code 99214 (Office or other outpatient visit for the evaluation
and management of an established patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using time for code selection, 30-39 minutes of
total time is spent on the date of the encounter), a work RVU of 2.8
for CPT code 99215 (Office or other outpatient visit for the evaluation
and management of an established patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making. When using time for code selection, 40-54 minutes of
total time is spent on the date of the encounter. (For services 55
minutes or longer, see Prolonged Services 99XXX)) and a work RVU of
0.61 for CPT code 99XXX (Prolonged office or other outpatient
evaluation and management service(s) (beyond the total time of the
primary procedure which has been selected using total time), requiring
total time with or without direct patient contact beyond the usual
service, on the date of the primary service; each 15 minutes (List
separately in addition to codes 99205, 99215 for office or other
outpatient Evaluation and Management services)).
Regarding the RUC recommendations for practice expense inputs for
these codes, we are proposing to remove equipment item ED021 (computer,
desktop, with monitor), as we do not believe that this item would be
allocated to the use of an individual patient for an individual
service; rather, we believe this item is better characterized as part
of indirect costs similar to office rent or administrative expenses.
The information we reviewed on the RUC valuation exercise was based
on an extensive survey the RUC conducted of over 50 specialty
societies. For purposes of valuation, survey respondents were asked to
consider the total time spent on the day of the visit, as well as any
pre- and post-service time occurring within a time frame of 3 days
prior to the visit and 7 days after, respectively. This is different
from the way codes are usually surveyed by the RUC for purposes of
valuation, where pre-, intra-, and post-service time were surveyed, but
not within a specific time frame. The RUC then separately averaged the
survey results for pre-service, day of service, and post-service times,
and the survey results for total time, with the result that, for some
of the codes, the sum of the times associated with the three service
periods does not match the RUC-recommended total time. The RUC's
approach sometimes results in two conflicting sets of times: The
component times as surveyed and the total time as surveyed. Although we
are proposing to adopt the RUC-recommended times as explained below, we
are seeking comment on how CMS should address the discrepancies in
times, which have implications both for for valuation of individual
codes and for PFS ratesetting in general, as the intra-service times
and total times are used as references for valuing many other services
under the PFS and that the programming used for PFS ratesetting
requires that the
[[Page 40676]]
component times sum to the total time. Specifically, we request comment
on which times should CMS use, and how we should resolve differences
between the component and total times when they conflict. Table 27A
illustrates the surveyed times for each service period and the surveyed
total time. It also shows the actual total time if summed from the
component times.
Table 27A--RUC-Recommended Pre-, Intra-, Post-Service Times, RUC-Recommended Total Times for CPT Codes 99202-
99215 and Actual Total Time
----------------------------------------------------------------------------------------------------------------
RUC-
HCPCS Pre-service Intra-service Immediate post- Actual total recommended
time time service time time total time
----------------------------------------------------------------------------------------------------------------
99202........................... 2 15 3 20 22
99203........................... 5 25 5 35 40
99204........................... 10 40 10 60 60
99205........................... 14 59 15 88 85
99211........................... .............. 5 2 7 7
99212........................... 2 11 3 16 18
99213........................... 5 20 5 30 30
99214........................... 7 30 10 47 49
99215........................... 10 45 15 70 70
----------------------------------------------------------------------------------------------------------------
Table 27B summarizes the current office/outpatient E/M services
code set, and the new prolonged services code physician work RVUs and
total time compared to what CMS finalized in CY 2019 for CY 2021, and
the RUC-recommended work RVU and total time.
Table 27B--Side by Side Comparison of Work RVUs and Physician Time for the Office/Outpatient E/M Services Code Set, and the New Prolonged Services Code
[Current versus revised]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current total Current work CY 2021 total CY 2021 work RUC rec total RUC rec work
HCPCS code time (mins) RVU time (mins) RVU time (mins) RVU
--------------------------------------------------------------------------------------------------------------------------------------------------------
99201................................................... 17 0.48 17 0.48 N/A N/A
99202................................................... 22 0.93 22 1.76 22 0.93
99203................................................... 29 1.42 29 1.76 40 1.6
99204................................................... 45 2.43 45 1.76 60 2.6
99205................................................... 67 3.17 67 3.17 85 3.5
99211................................................... 7 0.18 7 0.18 7 0.18
99212................................................... 16 0.48 16 1.18 18 0.7
99213................................................... 23 0.97 23 1.18 30 1.3
99214................................................... 40 1.5 40 1.18 49 1.92
99215................................................... 55 2.11 55 2.11 70 2.8
99XXX................................................... N/A N/A N/A N/A 15 0.61
--------------------------------------------------------------------------------------------------------------------------------------------------------
The RUC recommendations reflect a rigorous robust survey approach,
including surveying over 50 specialty societies, demonstrate that
office/outpatient E/M visits are generally more complex, for most
clinicians. In the CY 2019 PFS final rule, we finalized for CY 2021 a
significant reduction in the payment variation in office/outpatient E/M
visit levels by paying a single blended rate for E/M office/outpatient
visit levels 2 through 4 (one for established and another for new
patients). We also maintained the separate payment rates for E/M
office/outpatient level 5 visits in order to better account for the
care and needs of particularly complex patients. We believed that the
single blended payment rate for E/M office/outpatient visit levels 2-4
better accounted for the resources associated with the typical visit.
After reviewing the RUC recommendations, in conjunction with the
revised code descriptors and documentation guidelines for CPT codes
99202 through 99215, we believe codes and recommended values would more
accurately account for the time and intensity of office/outpatient E/M
visits than either the current codes and values or the values we
finalized in the CY 2019 PFS final rule for CY 2021. Therefore, we are
proposing to establish separate values for Levels 2-4 office/outpatient
E/M visits for both new and established patients rather than continue
with the blended rate. We are proposing to accept the RUC-recommended
work and time values for the revised office/outpatient E/M codes
without refinement for CY 2021. With regard to the RUC's
recommendations for practice expense inputs, we are proposing to remove
equipment item ED021 (computer, desktop, with monitor), as this item is
included in the overhead costs. Note that these changes to codes and
values would go into effect January 1, 2021.
c. Simplification, Consolidation and Revaluation of HCPCS Codes GCG0X
and GPC1X
Although we believe that the RUC-recommended values for the revised
office/outpatient E/M visit codes would more accurately reflect the
resources involved in furnishing a typical office/outpatient E/M visit,
we believe that the revalued office/outpatient E/M code set itself
still does not appropriately reflect differences in resource costs
between certain types of office/outpatient E/M visits. In the CY 2019
PFS proposed rule we articulated that, based on stakeholder comments,
clinical examples, and our review of the literature on office/
outpatient E/M
[[Page 40677]]
services, there are three types of office/outpatient E/M visits that
differ from the typical office/outpatient E/M visit and are not
appropriately reflected in the current office/outpatient E/M code set
and valuation. These three types of office/outpatient E/M visits can be
distinguished by the mode of care provided and, as a result, have
different resource costs. The three types of office/outpatient E/M
visits that differ from the typical office/outpatient E/M service are
(1) separately identifiable office/outpatient E/M visits furnished in
conjunction with a global procedure, (2) primary care office/outpatient
E/M visits for continuous patient care, and (3) certain types of
specialist office/outpatient E/M visits. We proposed, but did not
finalize, the application of an MPPR to the first category of visits,
to account for overlapping resource costs when office/outpatient E/M
visits were furnished on the same day as a 0-day global procedure. To
address the shortcomings in the E/M code set in appropriately
describing and reflecting resource costs for the other two types of
office/outpatient E/M visits, we proposed and finalized the two HCPCS G
codes: HCPCS code GCG0X (Visit complexity inherent to evaluation and
management associated with non-procedural specialty care including
endocrinology, rheumatology, hematology/oncology, urology, neurology,
obstetrics/gynecology, allergy/immunology, otolaryngology,
interventional pain management, cardiology, nephrology, infectious
disease, psychiatry, and pulmonology (Add-on code, list separately in
addition to level 2 through 4 office/outpatient evaluation and
management visit, new or established) which describes the inherent
complexity associated with certain types of specialist visits and GPC1X
(Visit complexity inherent to evaluation and management associated with
primary medical care services that serve as the continuing focal point
for all needed health care services (Add-on code, list separately in
addition to level 2 through 4 office/outpatient evaluation and
management visit, new or established), which describes additional
resources associated with primary care visits.
Although we finalized two separate codes, we valued both HCPCS
codes GCG0X and GPC1X via a crosswalk to 75 percent of the work and
time value of CPT code 90785 (Interactive complexity (List separately
in addition to the code for primary procedure)). Interactive complexity
is an add-on code that may be billed when a psychotherapy or
psychiatric service requires more work due to the complexity of the
patient, and we believed that 75 percent of its work and time values
accurately captured the additional resource costs of primary care
office/outpatient visits and certain types of specialty office/
outpatient visits when billed with the single, blended payment rate for
office/outpatient E/M visit levels 2-4.
In the CY 2019 PFS final rule, we stated that, due to the variation
among the types of visits performed by certain specialties, we did not
believe that the broad office/outpatient E/M code set captured the
resource costs associated with furnishing primary care and certain
types of specialist visits (FR 83 59638). As we stated above, we
believe that the revised office/outpatient E/M code set and RUC-
recommended values more accurately reflect the resources associated
with a typical visit. However, we believe the typical visit described
by the revised code set still does not adequately describe or reflect
the resources associated with primary care and certain types of
specialty visits.
As such, we believe that there is still a need for add-on coding
because the revised office/outpatient E/M code set does not recognize
that there are additional resource costs inherent in furnishing some
kinds of office/outpatient E/M visits. However, based on previous
public comments and ongoing engagement with stakeholders, we understand
the need for the add-on code(s) and descriptor(s) to be easy to
understand and report when appropriate, including in terms of medical
record documentation and billing. We also want to make it clear that
the add-on coding is not intended to reflect any difference in payment
based on the billing practitioner's specialty, but rather the
recognition of different per-visit resource costs based on the kinds of
care the practitioner provides, regardless of their specialty.
Therefore, we are proposing to simplify the coding by consolidating the
two add-on codes into a single add-on code and revising the single code
descriptor to better describe the work associated with visits that are
part of ongoing, comprehensive primary care and/or visits that are part
of ongoing care related to a patient's single, serious, or complex
chronic condition.
We are proposing to revise the descriptor for HCPCS code GPC1X and
delete HCPCS code GCG0X. The proposed descriptor for GPC1X appears in
Table 28. We are seeking comment from the public and stakeholders
regarding these proposed changes, particularly the proposed new code
descriptor for GPC1X and whether or not more than one code, similar to
the policy finalized last year, would be necessary or beneficial.
We have also reconsidered the appropriate valuation for this HCPCS
add-on G-code in the context of the revised office/outpatient E/M
service code set and proposed values. Upon further review and in light
of the other proposed changes to the office/outpatient E/M service code
set, we believe that valuing the add-on code at 75 percent of CPT code
90785 would understate the additional inherent intensity associated
with furnishing primary care and certain types of specialty visits. As
CPT code 90785 also describes additional work associated with certain
psychotherapy or psychiatric services, we believe its work and time
values are the most appropriate crosswalk for the revised HCPCS code
GPC1X. Therefore, we are proposing to value HCPCS code GPC1X at 100
percent of the work and time values for CPT code 90785, and proposing a
work RVU of 0.33 and a physician time of 11 minutes. We are also
proposing that this HCPCS add-on G code could be billed as applicable
with every level of office and outpatient E/M visit, and that we would
revise the code descriptor to reflect that change. See Table 28 for the
proposed changes to the code descriptor. We note that if the CPT
Editorial Panel makes any further changes to the office and outpatient
E/M codes and descriptors, or creates one or more CPT codes that
duplicate this add-on code, or if the RUC and/or stakeholders or other
public commenters recommend values for these or other related codes, we
would consider them through subsequent rulemaking.
[[Page 40678]]
Table 28--Proposed Revaluation of HCPCS Add-On G Code Finalized for CY 2021
----------------------------------------------------------------------------------------------------------------
Proposed code FR 2019 total FR 2019 work Proposed total Proposed work
HCPCS code descriptor revisions time (mins) RVU time (mins) RVU
----------------------------------------------------------------------------------------------------------------
GPC1X.............. Visit complexity 8.25 0.25 11 0.33
inherent to evaluation
and management
associated with
medical care services
that serve as the
continuing focal point
for all needed health
care services and/or
with medical care
services that are part
of ongoing care
related to a patient's
single, serious, or
complex chronic
condition. (Add-on
code, list separately
in addition to office/
outpatient evaluation
and management visit,
new or established).
----------------------------------------------------------------------------------------------------------------
d. Valuation of CPT Code 99xxx (Prolonged Office/Outpatient E/M)
The RUC also provided a recommendation for new CPT code 99XXX
(Prolonged office or other outpatient evaluation and management
service(s) (beyond the total time of the primary procedure which has
been selected using total time), requiring total time with or without
direct patient contact beyond the usual service, on the date of the
primary service; each 15 minutes (List separately in addition to codes
99205, 99215 for office or other outpatient Evaluation and Management
services). The RUC recommended 15 minutes of physician time and a work
RVU of 0.61. We are proposing to delete to the HCPCS add-on code we
finalized last year for CY 2021 for extended visits (GPRO1) and adopt
the new CPT code 99XXX. Further, as discussed above we are proposing to
accept the RUC recommended values for CPT code 99XXX without
refinement.
We are seeking comment on these proposals, as well as any
additional information stakeholders can provide on the appropriate
valuation for these services.
e. Implementation Timeframe
We propose that these policy changes for office/outpatient E/M
visits would be effective for services furnished starting January 1,
2021. We believe this would allow sufficient time for practitioner and
provider education and further feedback; changes in clinical workflows,
EHRs and any other impacted systems; and corresponding changes that may
be made by other payers. In summary, we propose to adopt the following
policies for office/outpatient E/M visits effective January 1, 2021:
Separate payment for the five levels of office/outpatient
E/M visit CPT codes, as revised by the CPT Editorial Panel effective
January 1, 2021 and resurveyed by the AMA RUC, with minor refinement.
This would include deletion of CPT code 99201 (Level 1 new patient
office/outpatient E/M visit) and adoption of the revised CPT code
descriptors for CPT codes 99202-99215;
Elimination of the use of history and/or physical exam to
select among code levels;
Choice of time or medical decision making to decide the
level of office/outpatient E/M visit (using the revised CPT
interpretive guidelines for medical decision making);
Payment for prolonged office/outpatient E/M visits using
the revised CPT code for such services, including separate payment for
new CPT code 99xxx and deletion of HCPCS code GPRO1 (extended office/
outpatient E/M visit) that we previously finalized for 2021;
Revise the descriptor for HCPCS code GPC1X and delete
HCPCS code GCG0X; and
Increase in value for HCPCS code GCG1X and allowing it to
be reported with all office/outpatient E/M visit levels.
f. Global Surgical Packages
In addition to their recommendations regarding physician work,
time, and practice expense for office/outpatient E/M visits, the AMA
RUC also recommended adjusting the office/outpatient E/M visits for
codes with a global period to reflect the changes made to the values
for office/outpatient E/M visits. Procedures with a 10- and 90-day
global period have post-operative visits included in their valuation.
These post-operative visits are valued with reference to values for the
E/M visits and each procedure has at least a half of an E/M visit
included the global period. However, these visits are not directly
included in the valuation. Rather, work RVUs for procedures with a
global period are generally valued using magnitude estimation.
In the CY 2015 PFS final rule, we discussed the challenges of
accurately accounting for the number of visits included in the
valuation of 10- and 90-day global packages. (79 FR 67548, 67582.) We
finalized a policy to change all global periods to 0-day global
periods, and to allow separate payment for post-operative follow-up E/M
visits. Our concerns were based on a number of key points including:
The lack of sufficient data on the number of visits typically furnished
during the global periods, questions about whether we will be able to
adjust values on a regular basis to reflect changes in the practice of
medicine and health care delivery, and concerns about how our global
payment policies could affect the services that are actually furnished.
In finalizing a policy to transform all 10- and 90-day global codes to
0-day global codes in CY 2017 and CY 2018, respectively, to improve the
accuracy of valuation and payment for the various components of global
packages, including pre- and post-operative visits and the procedure
itself, we stated that we were adopting this policy because it is
critical that PFS payment rates be based upon RVUs that reflect the
relative resources involved in furnishing the services. We also stated
our belief that transforming all 10- and 90-day global codes to 0-day
global packages would:
Increase the accuracy of PFS payment by setting payment
rates for individual services that more closely reflect the typical
resources used in furnishing the procedures;
Avoid potentially duplicative or unwarranted payments when
a beneficiary receives post-operative care from a different
practitioner during the global period;
Eliminate disparities between the payment for E/M services
in global periods and those furnished individually;
Maintain the same-day packaging of pre- and post-operative
physicians' services in the 0-day global packages; and
Facilitate the availability of more accurate data for new
payment models and quality research.
Section 523(a) of MACRA added section 1848(c)(8)(A) of the Act,
which
[[Page 40679]]
prohibited the Secretary from implementing the policy described above,
which would have transformed all 10-day and 90-day global surgery
packages to 0-day global packages. Section 1848(c)(8)(B) of the Act,
which was also added by section 523(a) of the MACRA, required us to
collect data to value surgical services. Section 1848(c)(8)(B)(i) of
the Act requires us to develop a process to gather information needed
to value surgical services from a representative sample of physicians,
and requires that the data collection begin no later than January 1,
2017. The collected information must include the number and level of
medical visits furnished during the global period and other items and
services related to the surgery and furnished during the global period,
as appropriate. Section 1848(c)(8)(B)(iii) of the Act specifies that
the Inspector General shall audit a sample of the collected information
to verify its accuracy. Section 1848(c)(8)(C) of the Act, which was
also added by section 523(a) of the MACRA, requires that, beginning in
CY 2019, we must use the information collected as appropriate, along
with other available data, to improve the accuracy of valuation of
surgical services under the PFS.
Resource-based valuation of individual physicians' services is a
critical foundation for Medicare payment to physicians. It is essential
that the RVUs under the PFS be based as closely and accurately as
possible on the actual resources used in furnishing specific services
to make appropriate payment and preserve relativity among services. For
global surgical packages, this requires using objective data on all of
the resources used to furnish the services that are included in the
package. Not having such data for some components may significantly
skew relativity and create unwarranted payment disparities within the
PFS. The current valuations for many services valued as global packages
are based upon the total package as a unit rather than by determining
the resources used in furnishing the procedure and each additional
service/visit and summing the results. As a result, we do not have the
same level of information about the components of global packages as we
do for other services. To value global packages accurately and relative
to other procedures, we need accurate information about the resources--
work, PEs and malpractice--used in furnishing the procedure, similar to
what is used to determine RVUs for all services. In addition, we need
the same information on the postoperative services furnished in the
global period (and pre-operative services the day before for 90-day
global packages).
In response to the MACRA amendments to section 1848(c)(8 of the
Act), CMS required practitioners who work in practices that include 10
or more practitioners in Florida, Kentucky, Louisiana, Nevada, New
Jersey, North Dakota, Ohio, Oregon, and Rhode Island to report using
CPT 99024 on post-operative visits furnished during the global period
for select procedures furnished on or after July 1, 2017. The specified
procedures are those that are furnished by more than 100 practitioners
and either are nationally furnished more than 10,000 times annually or
have more than $10 million in annual allowed charges.
RAND analyzed the data collected from the post-operative visits
through this claim-based reporting for the first year of reporting,
July 1, 2017-June 30, 2018. They found that only 4 percent of
procedures with 10-day global periods had any post-operative visits
reported. While 71 percent of procedures with 90-day global periods had
at least one associated post-operative visit, only 39 percent of the
total post-operative visits expected for procedures with 90-day global
periods were reported. (A complete report on this is available at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html).
In addition to the claims-based data collection, RAND collected
data on the level of visits. They began with an attempt to collect data
via a survey from all specialties as described in the 2017 final rule.
Given the low rate of response from practitioners, we shifted the study
and focused on three high-volume procedures with global periods that
were common enough to likely result in a robust sample size: (1)
Cataract surgery; (2) hip arthroplasty; and (3) complex wound repair. A
total of 725 physicians billing frequently for cataract surgery, hip
arthroplasty, and complex wound repair reported on the time,
activities, and staff involved in 3,469 visits. Our findings on
physician time and work from the survey were broadly similar to what we
expected based on the Time File for cataract surgery and hip
replacement and somewhat different for complex wound repair. (For the
complete report, see https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html).
The third report in the series looks at ways we could consider
revaluing procedures using the collected data. To provide us with
estimates to frame a discussion, RAND modeled how valuation for
procedures would change by adjusting work RVUs, physician time, and
direct PE inputs based on the difference between the number of post-
operative visits observed via claims-based reporting and the expected
number of post-operative visits used during valuation. RAND looked at
three types of changes: (1) Updated work RVUs based on the observed
number of post-operative visits measured four ways (median, 75th
percentile, mean, and modal observed visits); (2) Allocated PE RVUs
reflecting direct PE inputs updated to reflect the median number of
reported post-operative visits; and (3) Modeled total RVUs reflecting
(a) updated work RVUs, (b) updated physician time, and (c) updated
direct PE inputs, and including allocated PE and malpractice RVUs. This
report is designed to inform further conversations about how to revalue
global procedures. (For the complete report, see https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.) We will give the public and
stakeholders time to study the reports we are making available along
with this rule and consider an appropriate approach to revaluing global
surgical procedures. We also note that the Office of the Inspector
General (OIG) has published a number of reports on this topic. We will
continue to study and consider alternative ways to address the values
for these services.
g. Comment Solicitation on Revaluing the Office/Outpatient E/M Visit
Within TCM, Cognitive Impairment Assessment/Care Planning and Similar
Services
We recognize there are services other than the global surgical
codes for which the values are closely tied to the values of the
office/outpatient E/M visit codes, such as transitional care management
services (CPT codes 99495, 99496); cognitive impairment assessment and
care planning (CPT code 99483); certain ESRD monthly services (CPT
codes 90951 through 90961); the Initial Preventive Physical Exam
(G0438) and the Annual Wellness Visit (G0439). In future rulemaking, we
may consider adjusting the RVUs for these services and are seeking
public input on such a policy. We note that unlike the global surgical
codes, these services always include an office/outpatient E/M visit(s)
furnished by the reporting practitioner as part of the service, and it
may therefore be appropriate to adjust their valuation commensurate
with any
[[Page 40680]]
changes to the values for the revised codes for office/outpatient E/M
visits. While some of these services do not involve an E/M visit, we
valued them using a direct crosswalk to the RVUs assigned to an office/
outpatient E/M visit(s) and for this reason they are closely tied to
values for office/outpatient E/M visits.
We are also seeking comment on whether or not the public believes
it would be necessary or beneficial to make systematic adjustments to
other related PFS services to maintain relativity between these
services and office/outpatient E/M visits. We are particularly
interested in whether it would be beneficial or necessary to make
corresponding adjustments to E/M codes describing visits in other
settings, such as home visits, or to codes describing more specific
kinds of visits, like counseling visits. For example, CPT code 99348
(Home visit for the evaluation and management of an established
patient, which requires at least 2 of these 3 key components: An
expanded problem focused interval history; An expanded problem focused
examination; Medical decision making of low complexity. Counseling and/
or coordination of care with other physicians, other qualified health
care professionals, or agencies are provided consistent with the nature
of the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are of low to moderate severity. Typically, 25
minutes are spent face-to-face with the patient and/or family) is
commonly used to report home visits, and like CPT code 99214, the code
describes approximately 45 minutes of time with the patient and has a
work RVU of 1.56. Under the proposal to increase the work RVU of CPT
code 99214 from 1.5 to 1.92, the proportional value of CPT code 99348
would decrease relative to the work RVU for CPT code 99214. To maintain
the same proportional value to CPT code 99214, the work RVU for CPT
code 99348 would need to increase from 1.56 to 2.00. We understand that
certain other services, such as those that describe ophthalmological
examination and evaluation, as well as psychotherapy visit codes, are
used either in place of or in association with office/outpatient visit
codes. For example, CPT code 92012 (Ophthalmological services: Medical
examination and evaluation, with initiation or continuation of
diagnostic and treatment program; intermediate, established patient)
currently has a work RVU of 0.92. Under the proposal to increase the
work RVU of CPT code 99213 from 0.97 to 1.30, the proportional value of
CPT code 92012 would decrease relative to the work RVU for CPT code
99213, as both codes describe around 30 minutes of work. To maintain
the same proportional value to CPT code 99213, the work RVU for CPT
code 92012 would need to increase from 0.92 to 1.23. Similarly,
behavioral health professionals report several codes to describe
psychiatric diagnostic evaluations and visits they furnish. When
furnished with an evaluation and management service, practitioners
report psychotherapy add-on codes instead of stand-alone psychotherapy
codes that would otherwise be reported. Because the overall work RVUs
for the combined service, including the value for the office/outpatient
visit code, would increase under the proposal, we are interested in
comments regarding whether or not it would be appropriate to reconsider
the value of the psychotherapy codes, as well as the psychiatric
diagnostic evaluations relative to the proposed values for the office/
outpatient visit codes. Under the proposed revaluation of the office/
outpatient E/M visits, the proportional value of CPT code 90834
(Psychotherapy, 45 minutes with patient) would decrease relative to
work RVUs for CPT code 99214 plus CPT code 90836. The current work RVU
for CPT code 99214 when reported with CPT code 90836 is 3.40 (1.90 +
1.50) and the current work RVU for CPT code 90834 is 2.0. Under the
proposed revaluation of the office/outpatient E/M visits, the combined
work RVU for CPT codes 99214 and 90836 would be 3.82 (1.90 + 1.92). In
order to maintain the proportionate difference between these services,
the work RVU for CPT code 90834 would increase from 2.00 to 2.25. Based
on these three examples, we are seeking public comment on whether we
should make similar adjustments to E/M codes in different settings, and
other types of visits, such as counseling services.
III. Other Provisions of the Proposed Regulations
A. Changes to the Ambulance Physician Certification Statement
Requirement
Under our ongoing initiative to identify Medicare regulations that
are unnecessary, obsolete, or excessively burdensome on health care
providers and suppliers, we are proposing to revise Sec. Sec. 410.40
and 410.41. Importantly, we first clarify that these requirements apply
to ambulance providers, as well as suppliers. The proposed revisions
would give certain clarity to ambulance providers and suppliers
regarding the physician or non-physician certification statement and
add staff who may sign certification statements when the ambulance
provider or supplier is unable to obtain a signed statement from the
attending physician.
1. Exceptions to Certification Statement Requirement
Under section 1861(s)(7) of the Act, ambulance services are covered
where the use of other methods of transportation is contraindicated by
the individual's condition, but only to the extent provided in
regulations. Currently, Sec. 410.40(d) specifies the medical necessity
requirements for both nonemergency, scheduled, repetitive ambulance
services and nonemergency ambulance services that are either
unscheduled or that are scheduled on a nonrepetitive basis. In the
final rule with comment period that appeared in the January 25, 1999
Federal Register (64 FR 3637) (hereinafter referred to as the ``January
25, 1999 final rule with comment period''), we stated that a physician
certification statement (PCS) must be obtained as evidence that the
attending physician has determined that other means of transportation
are contraindicated and that the transport is medically necessary (64
FR 3639). In the final rule with comment period that appeared in the
February 27, 2002 Federal Register (67 FR 9100) (hereinafter referred
to as the ``February 27, 2002 final rule with comment period'') we
added that a certification statement (hereinafter referred to as non-
physician certification statement) could be obtained from other
authorized staff should the attending physician be unavailable. (67 FR
9111)
Currently there are no circumstances, other than those specified at
Sec. 410.40(d)(3)(ii) and (iv), granting exceptions to the need for a
PCS or non-physician certification statement, and we have received
feedback from ambulance providers, suppliers, and their industry
representatives (``stakeholders'') that various situations exist where
the need for a PCS or non-physician certification is excessive, or at
least redundant to similar existing documentation requirements. Two of
the most prominent circumstances identified by the stakeholders include
interfacility transports (IFTs), commonly referred to as hospital to
hospital transports and specialty care transports (SCTs), and it has
been requested that we incorporate additional exceptions into the
regulatory framework.
Upon reviewing the need for a PCS and non-physician certification
[[Page 40681]]
statement, stakeholders' concerns, and our commitment to reducing the
burden placed on providers and suppliers, we have determined that
instead of incorporating additional exceptions, our efforts would be
better served by minorly altering the structure of the existing
regulatory framework. These changes are intended to maximize
flexibility for ambulance providers and suppliers to obtain the
requisite certification statements and maintain the focus on the
determination that other means of transportation are contraindicated
and that the transport is medically necessary.
To accomplish this, we are proposing to add a new paragraph (a) in
Sec. 410.40 in which we would define both PSCs, as well as non-
physician certification statements. Therefore, we are proposing to
redesignate existing paragraph (a) ``Basic rules'' as paragraph (b) and
redesignate the remaining paragraphs, respectively. Most significantly,
paragraph (d) ``Medical necessity requirements'' will be redesignated
as paragraph (e).
For new proposed paragraph (a), the two definitions, PCSs and non-
physician certification statements, would clarify that: (1) The focus
is on the certification of the medical necessity provisions contained
in proposed newly redesignated paragraph (e)(1); and (2) the form of
the certification statement is not prescribed, thus affording maximum
flexibility to ambulance providers and suppliers. Since the two
definitions incorporate the requirement to obtain a certification of
medical necessity, we are proposing a conforming change to newly
redesignated paragraph (e)(2) to remove the language requiring that an
order certifying medical necessity be obtained.
We have repeatedly been told by stakeholders that there are ample
opportunities for ambulance providers and suppliers to convey the
information required in the certification statement. Stakeholders have
mentioned, for example, that for transports such as IFTs and SCTs other
requirements of federal, state, or local law require them to obtain
other documentation, such as Emergency Medical Treatment & Labor Act
(EMTALA) forms and medical transport forms, that can serve the same
purpose as the PCS or non-physician certification statement. There is
every likelihood that other ambulance transports require similarly
styled documentation that likewise could serve the same purpose.
To be clear, our regulations have never prescribed the precise form
or format of this required documentation. To satisfy the requirements
of section 1861(s)(7) of the Act, ambulance providers' and suppliers'
focus should be on clearly documenting the threshold determination that
other means of transportation are contraindicated and that the
transport is medically necessary. The precise form or format by which
that information is conveyed has never been prescribed. We aim here to
ensure that ambulance providers and suppliers understand they have
flexibility in the form by which they convey the requirements of
proposed Sec. 410.40(e), so long as that threshold determination is
clearly expressed.
The definition of non-physician certification statement in proposed
Sec. 410.40(a) would incorporate the existing requirements that apply
when an ambulance provider or supplier is unable to obtain a signed PCS
from the attending physician and, instead, obtains a non-physician
certification statement, including: (1) That the staff have personal
knowledge of the beneficiary's condition at the time the ambulance
transport is ordered or the service is furnished; (2) the employment
requirements; and (3) the specific staff that can sign in lieu of the
attending physician. Included within the proposed definition of non-
physician certification statement, and as further discussed below, is
an expansion of the list of staff who may sign when the attending
physician is unavailable. In light of the staff being listed as part of
the definition of non-physician certification statement proposed at
Sec. 410.40(a), we are proposing a corresponding change to proposed
and newly redesignated paragraph (e)(3)(iii) to remove the reference to
the staff currently listed within the paragraph. Moreover, in
paragraphs (e)(3)(i) and (iv) we have proposed changes to refer to the
newly redesignated paragraph (e) and in paragraph (e)(3)(v) we have
proposed changes to refer to the newly defined terms in paragraph (a),
specifically the physician or non-physician certification statement.
Lastly, we are also proposing a corresponding change to Sec.
410.41(c)(1) to add that ambulance providers or suppliers must indicate
on the claims form that, ``when applicable, a physician certification
statement or non-physician certification statement is on file.''
In the CY 2013 PFS final rule with comment period (77 FR 69161), we
stated that the Secretary is the final arbiter of whether a service is
medically necessary for Medicare coverage. We believe that the proposed
changes would better enable contractors to establish the medical
necessity of these transports by focusing more on the threshold medical
necessity determination as opposed to the form or format of the
documentation used. We do not anticipate that this clarification will
alter the frequency of claim denials.
2. Addition of Staff Authorized To Sign Non-Physician Certification
Statements
In the January 25, 1999 final rule with comment period (64 FR
3637), we finalized language at Sec. 410.40 to require ambulance
providers or suppliers, in the case of nonemergency unscheduled
ambulance services (Sec. 410.40(d)(3)) to obtain a PCS. In that rule,
we explained that: (1) Nonemergency ambulance service is a Medicare
service furnished to a beneficiary for whom a physician is responsible,
therefore, the physician is responsible for the medical necessity
determination; and (2) the PCS will help to ensure that the claims
submitted for ambulance services are reasonable and necessary, because
other methods of transportation are contraindicated (64 FR 3641). We
further stated that we believed the requirement would help to avoid
Medicare payment for unnecessary ambulance services that are not
medically necessary even though they may be desirable to beneficiaries.
In that final rule with comment period, however, we also addressed
the ability of ambulance providers or suppliers to obtain a written
order from the beneficiary's attending physician within 48 hours after
the transport to avoid unnecessary delays. We agreed with stakeholders
that while it is reasonable to expect that an ambulance supplier could
obtain a pretransport PCS for routine, scheduled trips, it is less
reasonable to impose such a requirement on unscheduled transports, and
that it was not necessary that the ambulance suppliers have the PCS in
hand prior to furnishing the service. To avoid unnecessary delays for
unscheduled transports, we therefore finalized the requirement that
required documentation can be obtained within 48 hours after the
ambulance transportation service has been furnished.
In the February 27, 2002 final rule with comment period (67 FR
9111), we noted that we had been made aware of instances in which
ambulance suppliers, despite having provided ambulance transports,
were, through no fault of their own, experiencing difficulty in
obtaining the necessary PCS within the required 48-hour timeframe. We
stated that the 48-hour period remained the appropriate period of time,
but created alternatives for ambulance providers and suppliers unable
to obtain a PCS. We finalized an alternative at Sec. 410.40(d)(3)(iii)
where ambulance providers and suppliers
[[Page 40682]]
unable to obtain a PCS from the attending physician could obtain a
signed certification (not a physician certification statement) from
certain other staff. At that time, we identified several staff members,
including a physician assistant (PA), nurse practitioner (NP), clinical
nurse specialist (CNS), registered nurse (RN), and a discharge planner
as staff members able to sign such a non-physician certification
statement. The only additional constraints are: (1) That the staff be
employed by the beneficiary's attending physician or by the hospital or
facility where the beneficiary is being treated and from which the
beneficiary is transported; and (2) that the staff have personal
knowledge of the beneficiary's condition at the time the ambulance
transport is ordered or the service is furnished.
In the intervening years, we have received feedback from
stakeholders that other staff, such as licensed practical nurses
(LPNs), social workers, and case managers, should be included in the
list of staff that can sign a certification statement. Similar to the
currently designated staff, we now believe that LPNs, social workers,
and case managers who have personal knowledge of a beneficiary's
condition at the time ambulance transport is ordered and the service is
furnished have a skill set largely equal or similar to the other staff
members. Thus, we are proposing as part of the new proposed definition
of non-physician certification statement at Sec. 410.40(a)(2)(iii) to
add LPNs, social workers, and case managers to the list of staff who
may sign a certification statement when the ambulance provider or
supplier is unable to obtain a signed PCS from the attending physician.
As with the staff currently listed in Sec. 410.40(d)(3)(iii), LPNs,
social workers, and case managers would need to be employed by the
beneficiary's attending physician or the hospital or facility where the
beneficiary is being treated and from which the beneficiary is
transported, and have personal knowledge of the beneficiary's condition
at the time the ambulance transport is ordered or the service is
furnished. We also request comments on whether other staff should be
included in this regulation, and request that commenters identify such
staff's licensure and position and the reason it would be appropriate
for such staff to sign a certification statement.
B. Proposal To Establish a Medicare Ground Ambulance Services Data
Collection System
1. Background
Section 1861(s)(7) of the Act establishes an ambulance service as a
Medicare Part B service where the use of other methods of
transportation is contraindicated by the individual's condition, but
only to the extent provided in regulations. Since April 1, 2002,
payment for ambulance services has been made under the ambulance fee
schedule (AFS), which the Secretary established under section 1834(l)
of the Act. Payment for an ambulance service is made at the lesser of
the actual billed amount or the AFS amount, which consists of a base
rate for the level of service, a separate payment for mileage to the
nearest appropriate facility, a geographic adjustment factor, and other
applicable adjustment factors as set forth at section 1834(l) of the
Act and 42 CFR 414.610 of the regulations. In accordance with section
1834(l)(3) of the Act and Sec. 414.610(f), the AFS rates are adjusted
annually based on an inflation factor. The AFS also incorporates two
permanent add-on payments and three temporary add-on payments to the
base rate and/or mileage rate. The two permanent add-on payments are:
(1) A 50 percent increase in the standard mileage rate for ground
ambulance transports that originate in rural areas where the travel
distance is between 1 and 17 miles; and (2) a 50 percent increase to
both the base and mileage rate for rural air ambulance transports. The
three temporary add-on payments are: (1) A 3 percent increase to the
base and mileage rate for ground ambulance transports that originate in
rural areas; (2) a 2 percent increase to the base and mileage rate for
ground ambulance transports that originate in urban areas; and (3) a
22.6 percent increase in the base rate for ground ambulance transports
that originate in ``super rural'' areas. Our regulations relating to
coverage of and payment for ambulance services are set forth at 42 CFR
part 410, subpart B, and 42 CFR part 414, subpart H.
2. Statutory Requirement for Ground Ambulance Providers and Suppliers
To Submit Cost and Other Information
Section 50203(b) of the BBA of 2018 added a new paragraph (17) to
section 1834(l) of the Act, which requires ground ambulance providers
of services and suppliers to submit cost and other information.
Specifically, section 1834(l)(17)(A) of the Act requires the Secretary
to develop a data collection system (which may include use of a cost
survey) to collect cost, revenue, utilization, and other information
determined appropriate by the Secretary for providers and suppliers of
ground ambulance services. Such system must be designed to collect
information: (1) Needed to evaluate the extent to which reported costs
relate to payment rates under the AFS; (2) on the utilization of
capital equipment and ambulance capacity, including information
consistent with the type of information described in section 1121(a) of
the Act; and (3) on different types of ground ambulance services
furnished in different geographic locations, including rural areas and
low population density areas described in section 1834(l)(12) of the
Act (super rural areas).
Section 1834(l)(17)(B)(i) of the Act requires the Secretary to
specify the data collection system by December 31, 2019, and to
identify the ground ambulance providers and suppliers that would be
required to submit information under the data collection system,
including the representative sample defined at clause (ii).
Under section 1834(l)(17)(B)(ii) of the Act, not later than
December 31, 2019, for the data collection for the first year and for
each subsequent year through 2024, the Secretary must determine a
representative sample to submit information under the data collection
system. The sample must be representative of different types of ground
ambulance providers and suppliers (such as those providers and
suppliers that are part of an emergency service or part of a government
organization) and the geographic locations in which ground ambulance
services are furnished (such as urban, rural, and low population
density areas), and not include an individual ground ambulance provider
or supplier in the sample for 2 consecutive years, to the extent
practicable.
Section 1834(l)(17)(C) of the Act requires that for each year, a
ground ambulance provider or supplier identified by the Secretary in
the representative sample as being required to submit information under
the data collection system for a period for the year must submit to the
Secretary the information specified under the system in a form and
manner, and at a time specified by the Secretary.
Section 1834(l)(17)(D) of the Act requires that beginning January
1, 2022, the Secretary apply a 10 percent payment reduction to payments
made under section 1834(l) of the Act for the applicable period to a
ground ambulance provider or supplier that is required to submit
information under the data collection system and does not
[[Page 40683]]
sufficiently submit such information. The term ``applicable period'' is
defined under section 1834(l)(17)(D)(ii) of the Act to mean, for a
ground ambulance provider or supplier, a year specified by the
Secretary not more than 2 years after the end of the period for which
the Secretary has made a determination that the ground ambulance
provider or supplier has failed to sufficiently submit information
under the data collection system. A hardship exemption to the payment
reduction is authorized under section 1834(l)(17)(D)(iii) of the Act,
which provides that the Secretary may exempt a ground ambulance
provider or supplier from the payment reduction for an applicable
period in the event of significant hardship, such as a natural
disaster, bankruptcy, or other similar situation that the Secretary
determines interfered with the ability of the ground ambulance provider
or supplier to submit such information in a timely manner for the
specified period. Lastly, section 1834(l)(17)(D)(iv) of the Act
requires the Secretary to establish an informal review process under
which a ground ambulance provider or supplier may seek an informal
review of a determination that the provider or supplier is subject to
the payment reduction.
Section 1834(l)(17)(E)(i) allows the Secretary to revise the data
collection system as appropriate and, if available, taking into
consideration the report (or reports) that the Medicare Payment
Advisory Commission (MedPAC) will submit to Congress. Section
1834(l)(17)(E)(ii) of the Act specifies that, to continue to evaluate
the extent to which reported costs relate to payment rates under
section 1834(l) of the Act and other purposes as the Secretary deems
appropriate, the Secretary shall require ground ambulance providers and
suppliers to submit information for years after 2024, but in no case
less often than once every 3 years, as determined appropriate by the
Secretary.
As required by section 1834(l)(17)(F) of the Act, not later than
March 15, 2023, and as determined necessary by MedPAC, MedPAC must
assess, and submit to Congress a report on, information submitted by
providers and suppliers of ground ambulance services through the data
collection system, the adequacy of payments for ground ambulance
services and geographic variations in the cost of furnishing such
services. The report must contain the following:
An analysis of information submitted through the data
collection system;
An analysis of any burden on ground ambulance providers
and suppliers associated with the data collection system;
A recommendation as to whether information should continue
to be submitted through such data collection system or if such system
should be revised by the Secretary, as provided under section
1834(l)(17)(E)(i) of the Act; and
Other information determined appropriate by MedPAC.
Section 1834(l)(17)(G) of the Act requires the Secretary to post
information on the results of the data collection on the CMS website,
as determined appropriate by the Secretary.
Section 1834(l)(17)(H) of the Act requires the Secretary to
implement the provisions of section 1834(l)(17) of the Act through
notice and comment rulemaking.
Section 1834(l)(17)(I) of the Act provides that the Paperwork
Reduction Act (Title 44, Chapter 35 of the U.S. Code) does not apply to
collection of information required under section 1834(l)(17) of the
Act.
Section 1834(l)(17)(J) of the Act provides that there shall be no
administrative or judicial review under sections 1869 or 1878 of the
Act, or otherwise, of the data collection system or identification of
respondents.
We note that while the requirements of section 1834(l)(17) of the
Act are specific to ground ambulance organizations, many stakeholders
have expressed interest to us in making this type of information
available for other providers and suppliers of ambulance services. For
example, air ambulance organizations have suggested they are interested
in making this information available. We recognize that the regulation
of air ambulances spans multiple federal agencies, and note that
section 418 of the FAA Reauthorization Act of 2018 (Pub. L. 115-254,
enacted October 5, 2018) requires the Secretary of HHS, in consultation
with the Secretary of Transportation, to establish an advisory
committee that includes HHS, DOT, and others to review options to
improve the disclosure of charges and fees for air medical services,
better inform consumers of insurance options for those services, and
better inform and protect consumers of these services. We welcome
comments on the state of the air ambulance industry and how CMS can
work within its statutory authority to ensure that appropriate payments
are made to air ambulance organizations serving the Medicare
population.
3. Research To Inform the Development of a Ground Ambulance Data
Collection System
To inform the development of a ground ambulance data collection
system, including a representative sampling plan, our contractor
developed recommendations regarding the methodology for collecting
cost, revenue, utilization and other information from ground ambulance
providers and suppliers (collectively referred to in this proposed rule
as ``ground ambulance organizations'') and a sampling plan consistent
with sections 1834(l)(17)(A) and (B) of the Act. Our contractor also
developed recommendations for the collection and reporting of data with
the least amount of burden possible to ground ambulance organizations.
The recommendations took into consideration the following:
An environmental scan consisting of a review of existing
peer-reviewed literature, government and association reports, and
targeted web searches. The purpose of the environmental scan was to
collect information on costs and revenues of ground ambulance
transportation services, identify background information regarding the
differences among ground ambulance organizations including state and
local requirements that may impact the costs of providing ambulance
services, and describe financial challenges facing the ambulance
industry. Five previously fielded ambulance cost collection tools were
also identified and analyzed and are described below.
Interviews with ambulance providers and suppliers, billing
companies, and other stakeholders to determine all major cost, revenue,
and utilization components, and differences in these components across
ground ambulance organizations. These discussions provided valuable
information on the process for developing a data collection system,
including how to best elicit valid responses and limit burden on
respondents, as well as the timing of the data collection.
Analyses of Medicare claims and enrollment data, including
all fee-for-service (FFS) Medicare claims with dates of service in
2016, the most recent complete year of claims data for ground ambulance
services.
Our contractor also analyzed the following five data collection
tools that currently collect or have collected data from ground
ambulance organizations:
The Moran Company Statistical and Financial Data Survey
(the ``Moran
[[Page 40684]]
survey'').\85\ In 2012, American Ambulance Association (AAA)
commissioned a study with the goal of developing a data collection
instrument and making recommendations for collecting data to determine
the costs of delivering ground ambulance services to Medicare
beneficiaries. The result was the Moran survey, which is a two-step
data collection method in which all ambulance providers and suppliers
first complete a short survey with basic descriptive information on
their characteristics, and second, a representative sample of ambulance
providers and suppliers report more specific cost information.
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\85\ The Moran Company (2014). Detailing ``Hybrid Data
Collection Method'' for the Ambulance Industry: Beta Test Results of
the Statistical & Financial Data Survey & Recommendations, [Online].
Available at https://s3.amazonaws.com/americanambulance-advocacy/AAA+Final+Report+Detailing+Hybrid+Data+Collection+Method.pdf.
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Ground Emergency Medical Transportation (GEMT) Cost Report
form and instructions from California's Medicaid program.\86\ The GEMT
Cost Report form and instructions is used by some states to determine
whether ambulance providers and suppliers should receive supplemental
payments from state Medicaid programs to cover shortfalls between
revenue and costs. This data collection instrument is geared toward
government entities, as private ambulance providers and suppliers do
not qualify for the supplemental payments.
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\86\ State of California--Health and Human Services Agency
Department of Health Care Services Ground Emergency Medical
Transportation (2013). Ground Emergency Medical Transportation
Services Cost Report General Instructions for Completing Cost Report
Forms, [Online]. Available at http://www.dhcs.ca.gov/provgovpart/documents/gemt/gemt_cstrptinstr.pdf.
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The Emergency Medical Services Cost Analysis Project
(EMSCAP) framework.\87\ The National Highway Traffic Safety
Administration funded EMSCAP in 2007 to develop a framework for
determining the cost for an EMS system at the community level.
Subsequently, EMSCAP researchers used this framework to develop a cost
workbook and pilot test the instrument on three communities
representing rural, urban, and suburban areas. EMS services within the
three communities included volunteer, paid, and combination EMS
agencies, both fire department and third service-based. Third service-
based refers to services provided by a local government that include a
fire department, police department and a separate EMS, forming an
emergency trio.
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\87\ Lerner, E.B., Nichol, G., Spaite, D.W., Garrison, H.G., &
Maio, R.F. (2007). A comprehensive framework for determining the
cost of an emergency medical services system. Available at https://www.mcw.edu/departments/emergency-medicine/research/emergency-medical-services-cost-analysis-project.
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A 2012 Government Accountability Office (GAO) ambulance
survey.\88\ To examine ground ambulance suppliers' costs for
transports, in 2012 GAO administered a web-based survey to a random
sample of 294 eligible ambulance suppliers. GAO collected data on their
2010 costs, revenues, transports, and organizational characteristics.
Although the GAO survey collected data for each domain at the summary
level, it also prompted respondents to take into account multiple
factors when calculating their summary costs.
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\88\ U.S. Government Accountability Office (2012). Survey of
Ambulance Services. Available at https://www.gao.gov/assets/650/649018.pdf.
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The Rural Ambulance Service Budget Model.\89\ This tool
was developed by a task force of the Rural EMS and Trauma Technical
Assistance Center with funds from the Health Resources and Services
Administration (HRSA) in the early 2000s. The purpose was to provide
assistance to rural ambulance entities in establishing an annual budget
and to calculate the value of services donated by other entities, as
well as services donated by the ambulance entity's staff to the
community. The tool was last updated in 2010 and has been cited as a
resource for rural ground ambulance organizations by state and national
government agencies. However, use of the tool is not required by any of
these agencies.
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\89\ Health Resources and Services Administration. The Rural
Ambulance Service Budget Model, [Online]. Available at https://www.ruralcenter.org/resource-library/rural-ambulance-service-budget-model.
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Our contractor's analysis of these tools revealed that while there
was overlap of the broad cost categories collected (for example, labor,
vehicles, and facilities costs) via these tools, there were significant
differences in the more specific data collected within these broad
categories. Overall, there was a large amount of variability regarding
whether the tools allowed for detailed accounting of costs and whether
the tools used respondent-defined or survey-defined categories for
reporting. The five tools also differed in terms of their instructions,
format, and design in terms of how a portion of organizations' total
costs were allocated to ground ambulance costs, the time frame for
reporting, and the flexibility of reporting.
Based on these activities, our contractor prepared a report
entitled, ``Medicare Ground Ambulance Data Collection System--Sampling
and Data Collection Instrument Considerations and Recommendations''
(referred to as ``the CAMH \90\ report'') which is referenced
throughout this proposed rule. It is available at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html and provides more
detail on the research, findings and recommendations concerning the
data collection instrument and sampling. This report, in addition to
other considerations we describe below, informed our proposals for the
data collection instrument.
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\90\ CMS Alliance to Modernize Healthcare.
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4. Proposals for the Data Collection Instrument
a. Proposed Format
We considered several options for collecting the data including a
survey, a cost report spreadsheet like the GEMT, and the Medicare Cost
Report (MCR). During interviews with ambulance providers and suppliers,
some participants stated that they would prefer that data collection be
done through a cost report spreadsheet, rather than a survey, such as
the GEMT and other similar data collection tools utilized by state
Medicaid programs. They noted that data cost collection spreadsheets
such as the GEMT are used in some states where supplemental payments
are made to ground ambulance organizations based on costs and revenue
reported via a cost reporting template. Although these tools are
valuable to the ambulance suppliers that utilize them for Medicaid
payment purposes, we note that only a small number of states make use
of these tools for the purpose of providing supplemental payments and
that they are generally geared toward government run entities that
provide a broad range of emergency medical services and not just ground
ambulance services. For these reasons, we do not believe that these
tools could be used by all ground ambulance organizations for Medicare
payment purposes without significant revision.
Other ambulance providers and suppliers stated their preference for
survey-based reporting, such as the Moran survey, because they believe
survey reporting is less burdensome and allows more flexibility for
reporting. We agree that survey reporting can be designed to provide
greater flexibility of reporting with reduced reporting burden.
However, the Moran survey recommended excluding small ground ambulance
organizations with limited capacity or those which relied heavily
[[Page 40685]]
on volunteer services, which would exclude a large percentage of ground
ambulance organizations from our sample. It would also not take into
account the unique differences of government run ground ambulance
entities, and specifically ground ambulance entities that provide other
emergency services such as fire services, and could not be used by all
ground ambulance organizations without significant revisions. Some
ambulance organizations that favored using the Moran survey also
recommended using cost reporting guidelines that are similar to the CMS
requirements for the MCR. Although we agree that standardization is
important for data analysis, many smaller ground ambulance
organizations have said they would have difficulty complying with
complex cost reporting guidelines. We believe that requiring ground
ambulance organizations to complete and submit an MCR for the purpose
of the data collection required in section 1834(l)(17) of the Act would
be unnecessarily resource intensive and burdensome.
We also considered using multiple instruments or staged data
collection as recommended in the Moran Report, where we would first
collect organizational characteristic data from all ground ambulance
organizations, use that information for sampling purposes, and then
collect cost and revenue information from a sample of ambulance
providers and suppliers. Using this approach, we would need 100 percent
participation from all ground ambulance organizations in reporting the
organizational characteristic data in order for the data to be used for
sampling purposes. We are not proposing this approach because we
believe multiple data collections would increase respondent burden and
may not align with sections 1834(l)(17)(A) and (B) of the Act which
requires CMS to collect data from a random sample and prohibits data
collection from the same ground ambulance organizations in 2
consecutive years to the extent practicable. We will discuss this more
in the options we considered for sampling section of this proposed
rule.
Based on our analysis of the existing or previously used data
collection instruments described above, we do not believe that any of
them would be sufficient to adequately capture the data required by
section 1834(l) of the Act. Therefore, we are proposing to collect
ground ambulance organization data using a survey that we developed
specifically for this purpose, which we will refer to from this point
forward in this proposed rule as the data collection instrument, and
which we would make available via a secure web-based system. We believe
that the data collection instrument should be usable by all ground
ambulance organizations, regardless of their size, scope of operations
and services offered, and structure. The proposed data collection
instrument includes screening questions and skip patterns that direct
ground ambulance organizations to only view and respond to questions
that apply to their specific type of organization. We also believe that
the proposed data collection instrument is easier to navigate and less
time consuming to complete than a cost report spreadsheet. The proposed
secure web-based survey would be available before the start of the
first data reporting period to allow time for users to register,
receive their secure login information, and receive training from CMS
on how to use the system. We are also proposing to codify these
policies at Sec. 414.626.
b. Proposed Scope of Cost, Revenue, and Utilization Data
Section 1834(l)(17)(A) of the Act requires CMS to develop a data
collection system to collect data related to cost, revenue,
utilization, and other information determined appropriate by the
Secretary for ground ambulance organizations. Section 1834(1)(17)(A)(i)
of the Act further specifies that the information collected through the
system should be sufficient to evaluate the extent to which reported
costs relate to payment rates.
We considered several options regarding the scope of collecting
data on ground ambulance cost, revenue, and utilization. One option
would be to require ground ambulance organizations to report on their:
(1) Total costs related to ground ambulance services; (2) total revenue
from ground ambulance services; and (3) total ground ambulance service
utilization. This approach would consider all ground ambulance costs,
revenue, and utilization, regardless of whether the service was
billable to Medicare or related to a Medicare beneficiary. The
advantage of this approach is that ground ambulance organizations
already track information at their organizational level on total costs,
revenue, and utilization for their own internal budgeting and planning.
This method was also used to calculate an organization-level average
cost per transport in two previous studies described below:
In a 2012 study entitled, ``Ambulance Providers: Costs and Medicare
Margins Varied Widely; Transports of Beneficiaries has Increased'',\91\
the GAO performed an analysis to assess how Medicare payments,
including the temporary add-on payments, compared to costs reported
using a survey. The GAO collected information via a survey on
organizations' total costs, including operating and capital costs,
without restriction to costs associated with Medicare transports or
costs incurred in responding to calls for service from Medicare
beneficiaries. GAO then divided reported total costs by the reported
number of transports (regardless of whether Medicare paid for the
transport) to calculate an average cost per transport for each
organization, and reported summary statistics across these averages,
including a median cost per transport of $429. However, to simplify
data collection and analysis, the analysis was limited to ambulance
suppliers that did not share operational costs with a fire department,
hospital, or other entity. GAO stated that its calculations assumed
that this average cost per transport was constant for all of an
organization's transports regardless of whether or not the patient
transported was a Medicare beneficiary. This approach implicitly loads
the costs associated with activities that did not result in a
transport, such as responses by a ground ambulance where the patient
could not be located, refused transport, or was treated on the scene,
into the estimated cost per transport.
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The second study, ``Report to Congress Evaluation of Hospitals'
Ambulance Data on Medicare Cost Reports and Feasibility of Obtaining
Cost Data from All Ambulance Providers and Suppliers,'' \92\ was
conducted by HHS as required under the American Taxpayer Relief Act of
2012 (ATRA) (Pub. L. 112-240, enacted January 2, 2013). This report
used data from Medicare cost reports as its data source, rather than a
survey, and included only ambulance providers, rather than ambulance
providers and suppliers. It described substantially higher costs per
transports for ambulance providers compared to the estimate from GAO,
with a median of approximately $1,750 per transport. It did not compare
reported total costs to Medicare revenue tallied in claims data with
and without the temporary add-on payments. Neither the GAO nor the HHS
report compared costs and AFS payment rates for specific Healthcare
Common Procedure Coding System
[[Page 40686]]
(HCPCS) codes because the available cost data in both studies did not
support that level of analysis.
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Another option would be to consider only those costs that are
relevant to ground ambulance services furnished to Medicare
beneficiaries. Collecting costs associated with specific services (such
as Medicare transports) and excluding other services (such as Medicaid
transports or responses that did not result in transport) would require
either a much more intensive and costly data collection approach (such
as time and motion studies) or assumptions on which portions of total
costs were related to the specific activity. We believe this approach
would be overly burdensome and complex for ground ambulance
organizations, especially those who provide other services in addition
to ground ambulance services.
A third option would be to consider only those costs that are
related to the specific ground ambulance transport services that are
paid under the AFS. This would require ground ambulance organizations
to report costs, revenue, and utilization related to specific levels of
services reported with HCPCS codes, but not costs, revenue, and
utilization for other services such as responses that did not result in
a transport (which is not covered under the AFS). We believe this
option would also be overly burdensome and complex.
In discussions with ambulance providers and suppliers, we were
informed that ground ambulance organizations most often track
organization-level total costs, revenue, and utilization across all
activities and services furnished to all patients, and that most would
find it difficult to report costs, revenue, and utilization associated
with services furnished exclusively to Medicare beneficiaries or
associated with Medicare services covered under the AFS.
Therefore, we propose the first option as discussed above, which
would require ground ambulance organizations to report on their: (1)
Total costs related to ground ambulance services; (2) total revenue
from ground ambulance services; and (3) total ground ambulance service
utilization. This approach would consider all ground ambulance costs,
revenue, and utilization, regardless of whether the service was
billable to Medicare or related to a Medicare beneficiary to collect
total cost, total revenue, and total utilization data.
Although we are proposing to collect a ground ambulance
organization's total costs and total revenues, we are aware that many
ground ambulance organizations share operational costs with fire
departments, other public service organizations, air ambulance
services, hospitals, and other entities. For these organizations, only
a portion of certain capital and operational costs contribute to total
ground ambulance costs, and only a portion of revenue is from ground
ambulance services. We are also aware that some ground ambulance
suppliers deploy emergency medical technicians (EMTs) in fire trucks,
which would make it difficult to determine whether the fire truck costs
should be factored into the total ground ambulance costs, and if so,
how that would be calculated.
One option to address these challenges is to limit data collection
to ground ambulance organizations that do not share operational costs
with fire departments, hospitals, or other entities, as GAO did for
their 2012 report. However, we do not believe this approach meets the
requirement in section 1834(l)(17)(B)(ii) of the Act for a
representative sample because many ambulance suppliers and all
ambulance providers share operational costs with fire, police, health
care delivery or other activities. We also considered including
providers' and suppliers' total costs and revenues across all
activities. While this would simplify cost and revenue data reporting,
the resulting data would not be limited to ground ambulance activities,
and therefore, would result in biased estimates of ground ambulance
costs or require significant assumptions to estimate ground ambulance
costs alone.
To more accurately define total costs and total revenues related to
ground ambulance services for those ground ambulance organizations that
provide other services in addition to ground ambulance services, we are
proposing an approach where the data collection instrument instructions
would separately address three further refined proposed categories of
total ground ambulance costs and revenues:
Cost and revenue components completely unrelated to ground
ambulance services. These costs and revenues would be unrelated to this
data collection and not reported. Examples include administrative staff
without ground ambulance responsibilities, health care delivery outside
of ground ambulance, community paramedicine, community education and
outreach, and fire and police public safety response.
Cost and revenue components partially related to ground
ambulance services. These costs and revenue would be reported in full,
but respondents would report additional information that can be used to
allocate a portion of the costs to ground ambulance services. Depending
on how the data would be utilized, certain costs could be included or
excluded from an analysis after data are collected. Examples include
EMTs who are also firefighters and facilities with both ground
ambulance and fire department functions. (We considered an alternative
where respondents would allocate costs and report only costs associated
with ground ambulance services but believe that would pose an
additional burden on the respondent to calculate allocated amounts, and
would result in an allocation process that is less transparent and
standardized).
Cost and revenue components entirely related to ground
ambulance services. These costs are reported in full. Examples include
EMTs with only ground ambulance responsibilities and ground ambulance
vehicles.
We believe that this approach would enable us to collect the data
necessary to evaluate the adequacy of payments for ground ambulance
services, the utilization of capital equipment and ambulance capacity,
and the geographic variation in the cost of furnishing such services.
The data could be analyzed in the same manner as the data in the GAO
report, for example, calculating an average per-transport cost for each
organization and calculating Medicare margins with and without add-on
payments, or could provide the basis for other analyses to link
reported costs to AFS rates. For example, an analysis could use
reported total costs and information on the volume of transports by
levels of services to estimate a cost for each HCPCS code reported for
the AFS, or regression-based approaches to estimate the marginal cost
of furnishing each HCPCS code on the AFS. We believe that under our
proposed approach, the collected data would be available to estimate
total costs and revenue relevant to ground ambulance services.
c. Proposed Data Collection Elements
The draft data collection instrument is available on the CMS
website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html. An overview of the elements of the data
collection instrument we are proposing is in Table 29, including
information on costs, revenues, utilization (which we define for the
purposes of the instrument as service volume and service mix), as well
as the characteristics of ground ambulance organizations.
To help structure the data collection instrument, we organized
costs by category (for example, labor, vehicles, and facilities), which
is the approach
[[Page 40687]]
used in the GEMT and the AAA/Moran survey.
Table 29--Proposed Components for the Data Collection Instrument
------------------------------------------------------------------------
Component (data collection
instrument section) Broad description
------------------------------------------------------------------------
Ground ambulance organization Information regarding the identity of the
characteristics (2-4). organization and respondent(s), service
area, ownership, response time, and
other characteristics; broad questions
about offered services to serve as
screening questions.
Utilization: Ground ambulance Number of responses and transports, level
service volume and service of services reported by HCPCS code.
mix (5 and 6).
Costs (7-12)................. Information on all costs partially or
entirely related to ground ambulance
services.
Staffing and Number and costs associated with EMTs
Labor Costs (7). administrative staff, and facilities
staff; separate reporting of volunteer
staff and associated costs.
Facilities Costs Number of facilities; rent and mortgage
(8). payments, insurance, maintenance, and
utility costs.
Vehicle Costs Number of ground ambulances; number of
(9). other vehicles used in ground ambulance
responses; annual depreciation; total
fuel, maintenance, and insurance costs.
Equipment & Capital medical and non-medical
Supply Costs (10). equipment; medical and non-medical
supplies and other equipment.
Other Costs (11) All other costs not reported elsewhere.
Total Cost (12). Total costs for the ground ambulance
organization included as a way to cross-
check costs reported in the instrument.
Revenue (13)................. Revenue from health insurers (including
Medicare); revenue from all other
sources including communities served.
------------------------------------------------------------------------
The following sections describe our proposed approach for data
collection in each of these categories.
(1) Collecting Data on Ground Ambulance Provider and Supplier
Characteristics
CMS is required to collect information regarding the geographic
location of ground ambulance organizations to meet the requirement at
section 1834(l)(17)(A)(iii) of the Act that the collected data include
information on services furnished in different geographic locations,
including rural areas and low population density areas. We also
recognize that there are differences between and among ground ambulance
organizations on several key characteristics, including geographic
location; ownership (for-profit or non-profit, government or non-
government, etc.); service volume, organization type (including whether
costs are shared with fire or police response or health care delivery
operations); EMS responsibilities; and staffing models. Research
conducted for this proposal indicates that:
There are differences in costs per transport by ground
ambulance organizations with a different ownership status;
EMS level of service and staffing models often have an
important impact on costs, with higher EMS levels of service (for
example, quicker response times) and static staffing models (that is,
mainatining a constant response capability 24 hours a day, 7 days a
week, 365 days a year) involving higher fixed costs; and
Utilization varies significantly across ambulance
providers and suppliers of different characteristics.
Due to this variation in characteristics and the effect it has on
costs and revenues, we believe it is important for ground ambulance
organizations to report additional characterictics, as described below,
to adequately analyze the differences in costs and revenue among
different types of ambulance providers and suppliers. We also believe
collecting this information directly through the proposed data
collection instrument will improve data quality with minimal burden on
the respondents because the proposed data collection instrument is
designed to tailor later sections and questions based on respondents'
characteristics through programmed ``skip patterns''. We considered
relying exclusively on the Medicare enrollment form CMS 855A for ground
ambulance providers or CMS 855B for ground ambulance suppliers to
capture this information, but believe that data accuracy would be more
robust if reported directly by respondents for the specific purpose of
this data collection.
The proposed data collection questions related to organizational
characteristics and service area are in sections 2, 3, and 4 of the
data collection instrument. We are proposing to collect information on
ownership and organization type through a sequence of questions in
section 2 of the data collection instrument. Some of the questions in
this section are adapted in part from prior surveys (such as the GAO
and Moran surveys) with changes as necessary to fit scenarios reported
during interviews with ground ambulance organizations. The first
question related to organizational characteristics, question 6, asks
about the organizations' ownership status. This item aligns closely
with a similar question on the Medicare enrollment form CMS 855B for
ambulance suppliers. Question 7 asks whether the respondent's
organization uses any volunteer labor. While this question could have
been asked later in the data collection instrument around the
collection of labor data, we opted to include it here because many
ground ambulance organizations informed CMS that they view the use of
volunteer labor as a defining organizational characteristic, on par
with ownership status, and that a volunteer labor question was expected
by respondents at this early point in the data collection instrument.
Question 8 asks respondents to select a category that best describes
their ambulance organization. The response options for this item are
mutually exclusive and align with the ambulance provider and supplier
taxonomy described in the CAMH report. The next two questions, 9 and
10, more directly ask whether the respondent has shared operational
costs with an entity of another type, including a fire department,
hospital, or other entity. We are proposing these questions in addition
to the organization type question to account for situations where a
respondent might primarily identify as an organization of one type
(with implications for shared operational costs) but then might have
shared
[[Page 40688]]
operational costs with another entity type. Responses to questions 9
and 10 play an important role in skip logic later in the data
collection instrument regarding questions and response options relevant
only to ground ambulance organizations with shared operational costs
with an entity of another type.
Other proposed questions regarding organizational characteristics
are necessary to tailor later parts of the data collection instrument
to the respondent. These include proposed questions in section 2 of the
data collection instrument on whether the respondent's ambulance
organization:
Is part of a broader corporation or other entity billing
under multiple National Provider Identifiers (NPIs) (question 2).
Routinely responds to emergency calls for service
(question 11).
Operates land, water, and air ambulances (questions 12-
14).
Has a staffing model that is static (that is, consistent
staffing over the course of a day/week) or dynamic (that is, staffing
varies over the course of a day/week) or combined deployment (certain
times of the day have a fixed number of units, and other times are
dynamic depending on need) (question 15).
Provides continuous (also known as ``24/7/365'') emergency
services) (question 16).
Provides paramedic or other emergency response staff to
meet ambulances from other organizations in the course of a response
(questions 17 and 18).
In our interviews with ambulance providers and suppliers, some
participants indicated that their staffing model is an organizational
characteristic that would likely be associated with costs per
transport. Organizations that need to maintain fixed staffing levels
over time (for example, to maintain an emergency response capability to
serve a community) would likely have higher costs than those that do
not.
Section 1834(l)(17)(A)(iii) of the Act requires collecting data
from ambulance providers and suppliers in different geographic
locations, including rural areas and low population density areas. The
area served by ambulance providers and suppliers is an important
characteristic and we are proposing to collect information on the
geographic area served by each ambulance provider and supplier in
section 3 of the data collection instrument.
Many ground ambulance organizations have a primary service area in
which they are responsible for a certain type of service (for example,
ALS-1 emergency response within the borders of a county, town, or other
municipality) and may have secondary services areas for a variety
reasons, such as providing mutual or auto aid, or providing a different
service in a secondary area (for example, non-emergency transports
state-wide). We considered several alternatives to collect information
on service area. One option would be to utilize Medicare claims data,
but this would limit the information to Medicare billed transports only
and would also not differentiate between primary and other service
areas. Another option would be to allow respondents to write in a
description of their primary and other service areas, but this would
require converting written responses to a format that can be used for
analysis. A third option would be for respondents to report the ZIP
codes that constitute their primary and other service area. This
approach aligns with the Medicare enrollment process requirement to
submit ZIP codes where the ground ambulance organization operates. It
would also collect ZIP code-based information on service area that can
be easily linked to the ZIP Code to Carrier Locality file \93\ that
lists each ZIP code and its designation as urban; rural; or super-
rural. This file is used by the MACs to determine if the temporary add-
on payments should apply to a transport under the AFS. The main
limitation of this approach is that ZIP codes would not always align to
service areas, because ZIP codes routinely cross town, county, and
other boundaries that are likely relevant for defining ground ambulance
organizations' service areas.
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We are proposing to require ground ambulance organizations that are
selected during sampling to identify their primary service area by
either: (1) Providing a list of ZIP codes that constitute their primary
service area; or (2) selecting a primary service area using pre-
populated drop-down menus at the county and municipality level in
question 1, section 3 of the data collection instrument. We are also
proposing to require respondents to specify whether they have a
``secondary'' service area, which are areas where services are
regularly provided under mutual aid, auto-aid, or other agreements in
section 3, question 4 of the data collection instrument and if so, to
identify the secondary service area using ZIP codes or other regions as
described above for the primary service area (section 3, question 5).
Mutual aid agreements are joint agreements with neighboring areas in
which they can ask each other for assistance. Auto-aid arrangements
allow a central dispatch to send the closest ambulance to the scene. We
are not proposing to collect information on areas served only in
exceptional circumstances, such as areas rarely served under mutual or
auto-aid agreements or deployments in response to natural disasters or
mass casualty events because we believe reporting on rarely-served
areas would involve significant additional burden and would add to
instrument complexity without generating data that would be useful for
analysis.
The proposed approach distinguishes between primary and secondary
service areas. This would allow subsequent questions on the balance of
transports in a respondent's primary versus secondary service area and
whether average trip time and response times are substantively longer
in the secondary versus primary service area. We believe this approach
results in data that can be easily analyzed and eliminates the need to
ask certain other questions (such as the population and square mileage
of the respondent's service area) because this information can be
inferred using the reported geographic service area boundaries.
We are proposing to ask the following questions in sections 3 and 4
of the of the data collection instrument, service area and subsequent
emergency response time, because the responses to these questions are
closely related to the area served by the organization:
Whether the respondent is the primary emergency ambulance
organization for at least one type of service in their primary service
area (section 3, question 2).
Average trip time in primary and secondary service areas
(section 3, questions 3 and 6).
Average response time (for organizations responding to
emergency calls for service) for primary and secondary service areas
(section 4, questions 1-2).
Whether the organization is required or incentivized to
meet response time targets by contract or other arrangement (for
organizations responding to emergency calls for service) (section 4,
question 3).
Average trip and response time are necessary to understand how
geographic distance between the ground ambulance organization's
facilities and patients affects costs. In interviews, ground ambulance
organizations recommended the collection of average trip time in
addition to mileage because some rural and remote areas may have
relatively
[[Page 40689]]
long average trip times even though mileage may be more modest due to
terrain, the quality of roads, and other factors. We believe that
collecting information on average response time would allow the
analysis of whether communities with different response time
expectations and targets have systematically different costs.
(2) Collecting Data on Ground Ambulance Utilization
CMS is required to collect information on the utilization of ground
ambulance services. While we could collect information on the volume of
ground ambulance services that can be billed to Medicare, this approach
would not provide information needed to determine total utilization of
ground ambulance organizations. Another option would be to utilize
Medicare claims data for estimates of ground ambulance transport volume
and separately collect information on services not payable by Medicare
(such as responses that did not result in a transport). This approach
would also not provide complete information on total transport volume,
since other services, such as responses that do not result in a
transport, would not be included.
Based on information provided during interviews with ground
ambulance organizations, we identified several distinct utilization
categories, such as total responses and ground ambulance responses.
This is particularly important for fire-based and police-based
organizations that may have a significant volume of fire and police
responses that do not involve a ground ambulance. The number of
responses that did not result in a transport can be separately tallied.
Other important utilization categories are ground ambulance transports
(that is, responses during which a patient is loaded in a ground
ambulance), which can be measured in terms of total transports (that
is, all ground ambulance transports regardless of payor) or paid
transports (that is, transports for which the ambulance provider or
supplier was paid in part or in full). Another utilization category
would include information on ambulance providers and suppliers that
furnish paramedic intercept services or provide paramedic-level staff
in the course of a BLS response where another organization provides the
ground ambulance transport.
We believe it is important to collect utilization data related to
all services, not just transports, because other services that
contribute to the total volume of responses have direct implications
for costs. Collecting utilization information related to transports but
not other services could omit important cost information. Some
utilization measures, such as the ratio of ground ambulance to total
responses, may be one basis for allocating certain costs reported
elsewhere in the data collection instrument. Another example would be
the difference between total and paid transport, as this would provide
information on services that were provided to patients but for which no
payment is received.
To best capture the full range of utilization data, we are
proposing a two-pronged approach to collect data on the volume and the
mix of services. First, we are proposing to collect total volume of
services for each of the categories listed below in section 5 of the
proposed data collection instrument:
Total responses, including those where a ground ambulance
was not deployed (question 1).
Ground ambulance responses, that is, responses where a
ground ambulance was deployed (question 2).
Ground ambulance responses that did not result in a
transport (question 4).
Ground ambulance transports (question 5).
Paid ground ambulance transports, that is, ground
ambulance transports where the ambulance provider or supplier was paid
for a billed amount in part or in full (question 6).
Standby events (question 7).
Paramedic intercept services as defined by Medicare
(question 8).
Other situations where paramedic staff contributes to a
response where another organization provides the ground ambulance
transport (question 9).
The CAMH report describes several cases where an ambulance provider
or suppliers' mix of services within one of the utilization categories
described above could affect costs or revenue. Most importantly, within
billed transports, variation in the mix of specific ground ambulance
services (for example, ALS versus BLS services) will affect both costs
(because ALS transports require more and more costly inputs) and
revenue (because ALS services are generally paid at a higher rate).
Ground ambulance organizations with a higher share of responses that
are emergency responses may also face higher fixed costs, and that the
costs for organizations furnishing larger shares of water ambulance
transports are likely different than costs from organizations that do
not furnish water ambulance transports. There is a subset of ground
ambulance organizations that specialize in non-emergency transports or
inter-facility transports, which suggests that this business model may
result in different per-transport costs compared to EMS-focused
ambulance providers and suppliers.
Second, to account for this significant variation, we are proposing
to collect the following information related to service mix:
The share of responses that were emergency versus non-
emergency (section 6 question 1).
The share of transports that were land versus water (asked
only of organizations reporting that they operate water ambulances;
section 6 question 2).
The share of transports by service level (section 6
question 3).
The share of transports that were inter-facility
transports (section 6 question 4).
We are not proposing that respondents report on their mix of
services in primary and secondary service areas (as defined above)
separately because this would double the length of this section of the
data collection instrument and require complex calculations or use of
assumptions by respondents that do not separately track services by
area. Instead, we are proposing that respondents report the share of
total ground ambulance responses that were in a secondary rather than
primary service area in a single item (section 5 question 3). We also
are not proposing to collect detailed information regarding the mix of
services for total transports (versus paid transports) and paid
transports (versus total transports) because collecting information on
the mix of services for total and paid transports separately would
double the reporting burden in this section and because we believe,
based on discussions with stakeholders, that it is reasonable to assume
that the distribution of transports across categories would be the
same.
(3) Collecting Data on Costs
Section 1834(l)(17)(A) of the Act requires CMS to collect cost
information from ground ambulance organizations, and we previously
discussed our proposal to collect data on a ground ambulance
organization's total costs. This part of the proposed rule describes
the data in each cost category that we are proposing to collect, as
well as alternatives that we considered.
The costs reported separately in the categories of costs we are
proposing to collect would sum to an organization's total ground
ambulance costs. In addition to ground ambulance costs, we are
proposing to ask all respondents in the proposed data collection
instrument
[[Page 40690]]
to report their total annual costs (that is, operating and capital
expenses), inclusive of costs unrelated to ground ambulance services,
in a single survey item (section 12, question 1). For ground ambulance
organizations that do not have costs from other activities (such as
from operating a fire or police department), the reported total costs
are a way to cross-check costs reported in individual cost categories
throughout the instrument, and we can compare the reported total to the
sum of costs across categories. Such a cross-check may also be
appropriate for ground ambulance organizations with costs from other
activities, as the sum of costs across ground ambulance cost categories
should always be less than the ground ambulance organization's reported
total costs. We believe that this cross-check will improve data quality
and is consistent with existing survey-based data collection tools.
This approach will also provide a better understanding of the overall
size and scope of ground ambulance organizations, including activities
other than providing ground ambulance services. Relatively larger
organizations may have lower ground ambulance costs due to due to
economies of scale and scope.
To avoid reporting the same costs multiple times, there are
instructions and reminders throughout the proposed data collection
instrument to avoid double-counting of costs. From a design
perspective, we believe it is less important where a particular cost is
reported on the survey data collection instrument and more important
that the cost is reported only once.
We are making two proposals that have important implications for
reporting in all cost sections in the proposed data collection
instrument. First, in the case where a sampled organization is part of
a broader organization (such as when a single parent company operates
different ground ambulance suppliers), we propose to ask the
respondents to report an allocated portion of the relevant ground
ambulance labor, facilities, vehicle, supply/equipment, and other costs
from the broader parent organization level in separate questions in
several places in the cost sections of the data collection instrument
(section 7.2 question 3, section 8.2 question 2, section 8.3 question
2, section 9.2 question 5, section 9.3 question 6, section 10.2
question 4, and section 11 questions 2 and 5). This scenario is
discussed in more detail in the sampling section below. In exploratory
analyses, we found that a small share of NPIs were part of broader
parent organizations. Due to the rarity of this scenario and the
complexity of calculations required, we are proposing to allow the
respondent to report an allocated amount directly for these questions
using an allocation approach they regularly use for this purpose. We
believe that while proposing a specific allocation approach would yield
more uniform and transparent data, we believe that these benefits are
not worth the additional respondent burden.
Second, we are proposing to include a general instruction stating
that in cases where costs are paid by another entity with which the
respondent has an ongoing business relationship, the respondent must
collect and report these costs to ensure that the data reported
reflects all costs relevant to ground ambulance services. Examples
include when a municipality pays rent, utilities, or benefits directly
for a government or non-profit ambulance organization, or when
hospitals provide supplies and/or medications to ground ambulance
operations at no cost. During interviews with ground ambulance
organizations, we were told that there are many nuanced arrangements
that fit this broad scenario. Although we recognize this would be an
additional step for some ground ambulance organizations, we are
concerned that the lack of reported cost data in one of these major
categories could significantly affect calculated total cost.
Because some ambulances, other vehicles, and buildings are donated
to ground ambulance organizations, we considered asking respondents to
report fair market values for these vehicles and buildings. However, we
are aware that while the lack of reported cost data in one of these
major categories could affect calculated total cost, it is not always
clear what cost is appropriate to report. To avoid the subjectivity and
burden involved in asking respondents to report fair market value, we
propose instead that respondents report which ambulances, other
vehicles, and buildings have been donated, but not an estimate of the
fair market value of those donations. We believe fair market values
could be imputed using publicly available sources of data to facilitate
comparison of data between organizations that have donations and those
that do not. For the same reasons, we are also proposing not to collect
an estimate of fair market value for donated equipment, supplies, and
costs collected in the ``other costs'' section of the instrument. As
noted above, for those organizations with costs that were paid by
another entity with which the respondent has an ongoing business
relationship, such as a ground ambulance organization that is part of
or owned by a government entity, respondents would obtain the cost
information directly from that entity since we would not consider these
to be donated items.
The following sections describe each cost category, alternative for
data collection, and our proposals related to each category of costs
separately.
(i.) Collecting Data on Staffing and Labor Costs
In interviews with ambulance providers and suppliers, they stated
that labor is one the largest contributors to total ground ambulance
costs (especially medical staff such as EMTs, paramedics, and medical
directors) and that they use a broad mix of labor types and hiring
arrangements. There is also significant variation in tracking staffing
and labor cost inputs that are needed to calculate costs. We were also
informed by ambulance providers and suppliers that data on the number
of ground ambulance staff and associated labor costs were often
available at one of three levels: The individual employee level;
aggregated by category such as EMT-Basic or Medical Director; or
aggregated across all staff. Additionally, we were told by ambulance
providers and suppliers that ground ambulance organizations typically
face challenges in tracking ground ambulance staff and costs by
category when staff had multiple ground ambulance responsibilities (for
example, EMTs with supervisory responsibilities, EMTs who are also
firefighters, etc.).
We agree that labor costs are an important component of total costs
and believe that it is necessary to collect information on both
staffing levels, that is, the quantity of labor used, and the labor
costs resulting from these labor inputs. Without information on
staffing levels, we would not be able to gauge whether differences in
labor costs are due to compensation or different levels of staffing.
Collecting information on staffing levels also allows the use of
imputed labor rates from other sources (such as the Bureau of Labor
Statistics). We also acknowledge the practical need to balance the
burden involved in reporting extremely detailed staffing and labor
costs information against the usefulness of detailed data for
explaining variation in ground ambulance costs. Therefore, we are
proposing to collect information in the proposed data collection
instrument on the number of staff and labor costs for several detailed
categories of response staff (for example, EMT-basic, EMT-intermediate,
and EMT-paramedic) (section 7.1), and for a single category for paid
administrative and facilities
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staff (for example, executives, billing staff, and maintenance staff)
(section 7.2), and (c) separately for medical directors (section 7.2).
We believe this approach involves less respondent burden compared to
reporting on each individual staff member. If more detailed categories
were used for reporting staffing levels and costs, we believe the
burden involved in assigning paid administrative and facilities staff
with multiple roles to individual categories or apportioning their
labor and costs to separate categories would increase.
The main limitation of the proposed approach is that we would not
collect detailed information on specific paid administration and
facilities labor categories. Therefore, we are also proposing to
collect some information that would help explain variation in labor
costs by asking whether the ground ambulance organization has some
staff in more specific paid administration and facilities categories
such as billing, dispatch, and maintenance staff (section 7, question
1). This question also serves as a screening question to determine
which response options appear to the respondent in several other
questions in this section of the proposed data collection instrument.
We also propose to ask for information on why individual labor
categories are not used (section 7, question 1) and if there is at
least one individual with 20 hours a week or more of effort devoted to
specific activities such as training and quality assurance (section
7.2, question 2).
Reporting Staffing Levels
In reporting staffing levels in the proposed data collection
instrument, we considered several approaches. One approach we
considered was asking the respondent to report only the number of staff
(that is, counts of people). Under this approach, a part-time employee
would count as ``1'' to the number of staff even if they worked a small
number of hours per week. We believe this approach would result in less
accurate reporting of labor inputs, especially from organizations
relying heavily on part-time staff or staff with responsibilities
unrelated to ground ambulance services. We also considered allowing
respondents to report full-time-equivalent (FTE) staff on a 40-hour per
week basis, but ground ambulance organizations informed us that
reporting FTEs would be burdensome. As a third approach, we considered
asking respondents to report ground ambulance staffing levels in terms
of hours over a reporting year. Reporting labor hours over the entire
reporting year allows for more accurate reporting of staff working
part-time and may involve less burden for respondents that already
tally annual labor hours (for example, via payroll records), but would
likely be difficult for those who do not already track labor hours in
this manner. As a fourth approach, we considered asking respondents to
report ground ambulance staffing levels in terms of hours worked during
a typical week. Reporting staffing levels in terms of hours worked
either over a reporting year or during a typical week allows detailed
accounting of part-time staff and staff with ground ambulance and other
responsibilities and involves fewer calculations and adjustments than
reporting FTEs. Reporting in terms of hours over a typical week has the
additional advantage of simplifying reporting for staff that start or
stop work during the 12-month reporting period. The main limitation of
reporting staffing levels in terms of hours over a typical week is that
the week that the respondent selects for reporting may not be
generalizable to other weeks in the reporting period.
In the interest of minimizing reporting burden, we are proposing to
collect information on the number of staff in terms of hours worked
over a typical week (sections 7.1 and 7.2). The instructions in the
proposed data collection instrument ask respondents to ``select a week
for reporting that is typical, in terms of seasonality, in the volume
of services that you offer (if any) and staffing levels during the
reporting year.''
Scope of Reported Labor Costs
For the purposes of collecting information on labor costs, we are
proposing to define labor costs to include compensation, benefits (for
example, healthcare, paid time off, retirement contributions, etc.),
stipends, overtime pay, and all other compensation to staff. We refer
to these costs as fully-burdened costs. Some ambulance providers and
suppliers track compensation but not benefits because another entity,
such as a municipality, pays for benefits, and that the ability of
these ambulance providers and suppliers to report fully burdened costs
may be limited. Despite this limitation, due to the importance of labor
costs as a component of total ground ambulance costs, we believe that
information on fully burdened costs (sections 7.1 and 7.2) must be
reported so that all relevant ground ambulance transport costs are
collected. Ambulance providers and suppliers selected to report data
may need to implement new tracking systems or request information from
other entities (such as municipalities) to be able to report fully-
burdened labor costs.
Volunteer Labor
Ground ambulance organizations have also informed CMS that a
significant share of ambulance providers and suppliers rely in part or
entirely on volunteer labor and that the systems and data available to
track the number of volunteers and the time that they devote to ground
ambulance services varies. We are proposing to collect information on
the total number of volunteers and the total volunteer hours in a
typical week using the same EMT/response staff and administrative and
facilities staff categories used elsewhere in the proposed data
collection instrument (section 7.3, questions 1-5). Although some
suggested that assigning a value to volunteer labor hours may be
important, the proposed data collection instrument collects information
only on the amount of volunteer labor (measured in hours in a typical
week) and not a market value for that labor. We believe reported hours
can be converted, if necessary, to market rates using data from other
sources. We are also proposing to collect the total realized costs
associated with volunteer labor such as stipends, honorariums, and
other benefits to ensure all costs associated with ground ambulance
transport are collected (section 7.3, question 6).
Allocation and Reporting Staff With Other Non-Ground Ambulance
Responsibilities
Since firefighter/EMTs are common in many ambulance suppliers, we
are proposing to ask respondents that share costs with a fire or police
department to report total hours in a typical week for paid EMT/
response staff with fire/police duties only (section 7.1). We believe
this information can be used to subtract a portion of associated labor
costs when calculating ground ambulance labor costs. We believe our
proposed approach is more consistent and involves less burden than
asking respondents to perform their own allocation calculations
necessary to report only the hours or full-time equivalents related to
ground ambulance services.
As already noted, many ground ambulance organizations have staff
with responsibilities beyond ground ambulance and fire/police response.
To account for these scenarios, we are proposing to ask respondents to
report the total hours in a typical week unrelated to ground ambulance
or fire/police response duties (which are
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addressed separately as described in section 7.1), as the costs
associated with this labor can be subtracted by those analyzing the
data when calculating ground ambulance labor costs. We believe this
proposed approach provides both transparency and consistency in the
data with minimal burden, and may avoid scenarios where all of the
costs associated with staff with limited ground ambulance
responsibilities contribute to total ground ambulance costs.
(ii.) Collecting Data on Facility Costs
Facility costs may include rent, mortgage payments, depreciation,
property taxes, utilities, insurance, and maintenance, and the
associated costs vary widely across ambulance providers and suppliers.
Some ground ambulance organizations own facilities while for others,
rent, mortgage, or leasing is an important component of total
operational costs. Some ground ambulance organizations share facilities
with other operations (such as fire and rescue services), and
individual ground ambulance organizations often operate out of several
facilities of different types, sizes, and share of space related to
ground ambulance operations.
We considered proposing to require respondents to report facilities
costs aggregated across all facilities. We believe this approach would
minimize burden on the respondent by eliminating the need to break
costs down by facility; however, it may also increase the risk for
inconsistencies in how respondents report total facilities costs. Under
this approach, respondents whose ground ambulance organizations share
operational costs with a fire department or other entity would need to
calculate and report an estimate of facilities costs that was relevant
only to ground ambulance services.
We also considered proposing to require respondents to report all
costs on a per-facility basis. We believe this approach would allow the
most flexibility in reporting complex facility arrangements from ground
ambulance organizations operating out of multiple facilities. However,
this approach may also involve more burden, particularly for larger
organizations, to report costs on a facility-by-facility basis, and
many organizations do not track costs such as maintenance or utilities
on a per-facility basis.
We are proposing a hybrid approach involving both per-facility and
aggregate reporting of different information. First, respondents report
the total number of facilities (section 8., questions 1-2) and then
indicate for each facility whether they paid rent, mortgage, or neither
during the reporting period, total square footage, and share of square
footage related to ground ambulance services (section 8.1, question 3).
Second, respondents report their per-facility rent, mortgage, or annual
depreciation (section 8.2). Third, respondents report facilities-
related insurance, maintenance, utilities, and property taxes
aggregated across all facilities (section 8.3).
We believe this proposed approach allows for the collection of the
information needed to calculate a total facilities cost related to
ground ambulance services while avoiding a burden on respondents to
calculate allocated facility costs. Total insurance, maintenance,
utility, and property tax costs can be allocated using reported square
footage and shares of square footage related to ground ambulance
services. The proposed approach requires respondents to provide both
the square footage of each facility, and the share of square footage
for the facility that is related to ground ambulance operations. We
expect that some ground ambulance organizations would have this
information available and others would need to collect this square
footage information to report along with facilities costs, but do not
believe this information would be difficult to collect.
(iii.) Collecting Data on Vehicle Costs
Section 1834(l)(17)(A)(ii) of the Act requires CMS to collect
information on ``the utilization of capital equipment and ambulance
capacity.'' We are proposing to collect information on the number of
ground ambulances and other vehicles related to providing ground
ambulance services, as well as the costs associated with these vehicles
to meet these requirements.
Ambulance providers and suppliers operate ground ambulances, as
well as other vehicles to support their ground ambulance operation, and
some may have a variety of other vehicles that are associated with
ground ambulance responses. For example, a fire truck staffed with fire
personnel cross-trained as EMTs may respond with a ground ambulance to
an emergency call. Other vehicles might be used in responses and may be
referred to as a non-transporting EMS vehicle, a quick response
vehicle, a fly-car, or an SUV that carries a paramedic to meet a BLS
ambulance from another organization during the course of a response.
We considered two alternatives for collecting vehicle costs. One
alternative would be to only include the costs for ambulances and
exclude other certain non-ambulance response vehicles from reported
costs. We believe that excluding other certain non-ambulance response
vehicles from reported costs could potentially result in underreporting
of total ground ambulance costs, particularly among those providers or
suppliers that rely heavily on these vehicles to support their ground
ambulance services. Another alternative would be to include the costs
of all vehicles that are used as part of ambulance services, such as
quick response vehicles that are used to supplement ambulances.
For all vehicles, vehicle costs can be reported either in aggregate
or on a per-vehicle basis. We believe that while reporting vehicle
costs in aggregate may involve less burden for some respondents, those
respondents that do not track aggregated costs would still require a
tool to enter information on per-vehicle basis. Furthermore, we believe
that aggregated costs for vehicles other than ground ambulances offer
analysts with fewer alternatives to allocate a share of vehicle costs
to ground ambulance services.
We are proposing to collect data on vehicle costs in the proposed
data collection instrument in two parts: Ground ambulance vehicles
(section 9.1); and all other vehicles related to ground ambulance
operations (section 9.2). For ground ambulance vehicles, we are
proposing to collect information on the number of vehicles, total miles
traveled, and per-vehicle information on annual depreciated value (and
remounting costs if applicable) for owned vehicles, and annual lease
payments for rented vehicles (section 9.1, questions 1-4). We
considered proposing to collect the necessary information to calculate
annual depreciated value using a standardized approach. However, we are
proposing to allow respondents with owned vehicles to use their own
accounting approach to calculate annual depreciated value per vehicle.
We believe that allowing flexibility for respondents to use their
standard approach for this calculation would result in more accurate
data and less reporting burden.
We are also proposing to use a similar approach to collect per-
vehicle information for owned and leased vehicles of any other type
that contribute to ground ambulance operations, including fire trucks,
quick response vehicles, all-terrain vehicles, etc. (section 9.2,
questions 1-5). The proposed instructions in section 9.2 of the data
collection instrument specify that reported vehicles must support
ground ambulance services. We are proposing to collect the type of each
vehicle in broad categories in addition
[[Page 40693]]
to the annual depreciated value or lease payment amount for each
vehicle.
In addition to the above costs, we also are proposing to collect
aggregate costs associated with licensing, registration, maintenance,
fuel, insurance costs for all vehicles combined (ambulance and non-
ambulance) (section 9.3, questions 1-5). We believe that these costs
are often aggregated within providers' and suppliers' records and that
reporting in aggregate form may reduce respondent burden with minimum
risk for reporting error.
When estimating total ground ambulance vehicle costs for ground
ambulance organizations that share operational costs with fire and
police response or other non-ground ambulance activities, a share of
vehicle costs reported via the instrument will need to be allocated as
vehicle costs related to ground ambulance services. One alternative we
considered to do this was simply to ask respondents about the share of
costs associated with ground ambulance services as we thought this
would be the least burdensome approach; however, we believe data
collected in this manner would not allow for estimation of costs
associated with non-ground ambulance vehicles that support ambulance
services. We considered another alternative where (1) the ratio of
ground ambulance to total responses would be used to allocate costs
associated with non-ambulance vehicles, (2) the total number of
vehicles would be used to allocate aggregate costs associated with
licensing, registration, maintenance, and fuel costs, and (3)
depreciated annual costs and/or lease payment amounts would be used to
allocate insurance costs. The main limitation of this approach is that
maintenance and fuel costs could vary significantly across vehicle
categories. For example, maintenance and fuel costs may be
significantly different for ground ambulance than for other types of
vehicles. As a result, we are proposing a modification of this
alternative where we also ask respondents to list percent of total
maintenance and fuel costs attributable to each type of vehicle (that
is, ground ambulances, fire trucks, land rescue vehicles, water rescue
vehicle, other vehicles that respond to emergencies such as quick
response vehicles, and other vehicles; section 9.3, questions 4 and 5).
We propose to also ask respondents to report total mileage for ground
ambulance (land and water separately) and total mileage for other
vehicles related to ground ambulance responses (land and water
separately) as a potential alternative means to allocate fuel and
maintenance costs.
(iv.) Collecting Data on Equipment and Supply Costs
In our interviews with ground ambulance organizations, we were told
that not all ground ambulance organizations would be able to report
detailed item-by-item equipment and supply information, and that some
organizations have far more sophisticated inventory tracking systems
than others that would allow them to report detailed information within
a category.
We considered alternative approaches related to reporting equipment
and supply costs that varied primarily on the level of detail for
reporting. We considered extremely detailed data reporting as it would
be potentially useful to identify variability in costs across
organizations. However, as noted above, many ground ambulance
organizations may not keep detailed records of all their individual
equipment and supply costs. Taking those factors into account, we are
proposing to request total costs in a small number of equipment and
supply categories rather than itemized information for all equipment
and supply categories (section 10). These would include:
Capital medical equipment.
Medications.
All other medical equipment, supplies, and consumables.
Capital non-medical equipment.
Uniforms.
All other non-medical equipment and supplies.
We also considered whether to have respondents report both medical
and non-medical equipment and supplies together. We believe that the
majority of medical supplies are more likely to be related to ground
ambulance services than non-medical supplies for organizations with
shared services, and therefore, we are proposing to collect this
information separately.
Reporting of Capital Versus Non-Capital Equipment
To meet the requirement in section 1834(l)(17)(A)(ii) of the Act to
collect information to facilitate the analysis of ``the utilization of
capital equipment,'' we are proposing to separately collect information
on capital equipment expenses (rather than equipment-related operating
expenses). Capital equipment (both medical and non-medical) yield
utility over time, which can vary depending on the expected service
life of the specific good. In addition to the cost of purchasing or
leasing durable goods equipment, depreciation and maintenance costs
must be considered in the total cost calculations. Since ground
ambulance organizations often track capital equipment on an itemized
level, separating items of significantly different age and cost is
necessary to calculate depreciation. Therefore, to minimize burden by
aligning reporting with the accounting approaches used by respondents,
we are proposing to ask for capital (section 10.1, question 1; section
10.2, question 1) and non-capital costs (section 10.1, questions 2-3;
section 10.2, questions 2-3) separately so that respondents can report
annual depreciated costs for capital equipment and total annual costs
otherwise. We also are proposing to allow respondents to report annual
maintenance and service costs for capital equipment because ground
ambulance organizations have stated during interviews that these costs
can be significant compared to purchase costs or annual depreciated
costs. Finally, we are proposing to allow respondents to use their own
standard accounting practice to categorize equipment as capital or non-
capital. While we believe it would be possible to ask respondents to
use a standard approach, we believe this would require respondents with
another practice to recalculate annual depreciated cost and potentially
increase respondent burden and reporting errors.
Allocation of Shared Costs
During interviews with ground ambulance organizations, it was noted
that although the vast majority of equipment and supplies are for
ground ambulance services, some costs are shared with hospitals or
clinics. We believe separate reporting on medical and non-medical
equipment and supplies would facilitate allocation (section 10.1,
versus section 10.2). For organizations that indicate the use of shared
services, we are proposing to ask separately what share of medical and
non-medical equipment and supply costs are related to ground ambulance
services (section 10.1, questions 1c, 2a; section 10.2, questions 1c,
2a, 3a). The share of non-medical equipment and supplies used for
ambulance services may vary for respondents with operations beyond
ambulance services. While other allocation methods (such as the share
of responses that are ground ambulance responses) may be appropriate to
allocate equipment and supply costs, asking respondents to provide
their estimate of the share of equipment and supply costs related to
ambulance services reduces assumptions made about how best to apply
allocation across the various equipment and supplies reported.
[[Page 40694]]
(v.) Collecting Data on Other Costs
In addition to core costs for ambulance providers and suppliers
that are associated with labor, vehicles, facilities, and equipment or
supplies, ground ambulance organizations have indicated that these
entities incur costs associated with contracted services (for example,
for billing, vehicle maintenance, accounting, dispatch or call center
services, facilities maintenance, and IT support), as well as other
miscellaneous costs (for example, administrative expenses, fees and
taxes) to support ground ambulance services.
We considered including contracted services as part of the labor
section, since many of the contracted services related to costs that
would otherwise be labor-related if the tasks were performed by
employed staff. However, we were concerned that ground ambulance
organizations might report this information in multiple instrument
sections (for example, both labor and miscellaneous costs). As a
result, we separated contracted services into their own categories.
While we considered allowing respondents to report in the aggregate any
other miscellaneous costs associated with ground ambulance services
because we believed this approach may be less burdensome for
organizations that track miscellaneous costs in aggregate, we believe
this would introduce a large amount of reporting bias and inconsistency
in reporting across organizations. Our proposals related to reporting
contracted services and miscellaneous costs are described below.
Reporting Contracted Services
For contracted services, we are proposing that respondents indicate
whether their organization utilizes contracted services to support a
variety of tasks (section 11, question 1), the associated total annual
cost for these services, and the percentage of costs attributable to
ground ambulance services. The proposed data collection instrument
would provide instructions to ensure that respondents do not report on
contracted costs multiple times.
Reporting of Miscellaneous Costs
For other miscellaneous costs not otherwise captured in prior
sections of the data collection instrument, we are proposing that
respondents be able to report additional costs first using an extensive
list of other potential cost categories (section 11, question 2) and
then use write-in fields if necessary. Providing a pre-populated check
list would help ensure the consistency and completeness of reporting
across respondents.
Allocation of Miscellaneous Shared Costs
Information from ground ambulance organizations indicates that
there are a number of miscellaneous costs associated with the overall
operation of organizations that are shared across services. To account
for these shared costs, we are proposing that respondents report an
allocation factor for each contracted service, (section 11, question
1), as well as for each reported miscellaneous expense (section 11,
questions 3-4) as described in the data collection instrument. We
considered the alternative of asking for an overall share of
miscellaneous costs associated with ground ambulance services or
utilizing information gathered about the share of ground ambulance
responses versus total responses to determine an overall allocation
factor. While this would present less burden on respondents, the share
of miscellaneous costs and share of contracted services varies widely
across organizations with shared services.
d. Proposed Data Collection on Revenue
Section 1834(l)(17)(A) of the Act requires the development of a
data collection system to collect revenue information for ground
ambulance provider and suppliers. Payments from Medicare and other
health care payers are important components of total revenue for some
ambulance providers and suppliers. Most ambulance providers and
suppliers also have other sources of revenue in addition to payments
for billed services. Based on review of existing literature and
discussions with ground ambulance organizations, these primary sources
of revenue include, but are not limited to: Patient out-of-pocket
payments; direct public financing of fire, EMS, or other agencies;
subsidies, grants, and other revenue from local, state, or federal
government sources; revenue from providing services under contract; and
fundraising and donations. We view total revenue as the sum of payments
from health care payers and all other sources of revenue, including
those listed above.
While collecting information on total revenue is essential to
understanding variations in how EMS services are financed across the
country, this information is not collected by Medicare or by any other
entity of which we are aware. Similar to other sections of the data
collection instrument, we also considered what level of data to request
in this section. We are proposing to ask for total revenue in aggregate
(section 13, question 1) and total revenue from paid ground ambulance
transports for Medicare and, if possible, broken down by payer category
for other payers (section 13, questions 2-5). We are proposing this
level of detail because we believe understanding payer mix would be
helpful to assess Medicare's contributions to total revenue. Based on
information provided by ambulance providers and suppliers, there is
variation in how patient-paid amounts were recorded in ambulance
billing systems. We are proposing to ask respondents whether revenue by
payer includes corresponding patient cost sharing or whether cost-
sharing amounts are included in a self-pay category. For other revenue
(for example, contracts from facilities and membership fees (such as
those associated with community members that enroll in ambulance
clubs), we are proposing to request information on additional revenue
in predetermined categories and using write-in fields if necessary
(section 13, question 5).
Allocation of Shared Revenues. Ground ambulance organizations vary
widely in the types of other revenue sources (as noted in section 13,
question 6) they receive and their share of allocated costs. For this
reason, we are proposing to have respondents report the share of
revenue for each category that is attributable to ground ambulance
services (section 13). Similar to miscellaneous costs, we considered
the alternative of asking for an overall share of other revenue sources
associated with ground ambulance services or utilizing information
gathered about the share of ground ambulance responses versus total
responses to determine an overall allocation factor. While this would
present less burden on respondents, we do not believe it would not
adequately capture the revenue only associated with ground ambulance
services, especially for organization with shared services.
To collect information on uncompensated care, including charity
care and bad debt, we are proposing to collect information on both
total and paid transports. These two measures of volume can be used to
provide insight into the share of transports that are not paid. The
proposed data collection instrument broadly collects information on
total costs (including costs incurred in furnishing services that are
ultimately paid and not paid) and total transports (again including
transports that are both paid and not paid). The collected data could
be used to estimate per-transport costs that can be estimated by
dividing total costs by total transports, so we do
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not believe it is necessary to directly collect information on
uncompensated care in the revenue section of the data collection
instrument.
We invite comments regarding all the proposals for data collection
described in this section, including our proposals on the format,
scope, elements (characteristics, utilization, and costs), collection
of equipment and supply costs, and other costs.
5. Proposals for Sampling
Section 1834(l)(17)(B)(i) of the Act requires that CMS identify the
ground ambulance providers and suppliers organizations that would be
required to submit information under the data collection system,
including the representative sample. Section 1834(l)(17)(B)(ii)(II) of
the Act requires the representative sample must be representative of
the different types of providers and suppliers of ground ambulance
services (such as those providers and suppliers that are part of an
emergency service or part of a government organization) and the
geographic locations in which ground ambulance services are furnished
(such as urban, rural, and low population density areas). Under section
1834(l)(17)(B)(ii)(III) of the Act, the Secretary cannot include an
individual ambulance provider and supplier in 2 consecutive years, to
the extent practicable. In addition to meeting the requirements set
forth in the statute, including developing a representative sample, our
proposals around sampling aim to balance our need for statistical
precision with reporting burden. Our proposals to meet these statutory
requirements are described below, and were developed with the intention
of obtaining statistical precision with the least amount of reporting
burden.
Eligible Organizations. A sampling frame drawing on all ground
ambulance organizations in the United States and its territories that
provide ground ambulance services (that is, not just those enrolled in
Medicare or billing Medicare in a given year) may be of interest
conceptually, but we have not identified a data source listing all
ambulance providers and suppliers that could be used as the source for
a broader sampling frame. Since sections 1834(l)(17)(A) of the Act
requires the Secretary to collect cost, revenue, and utilization
information from providers of services and suppliers of ground
ambulance services (which are Medicare specific terms with specific
meaning) with the purpose of determining the adequacy of payment rates
and section 1834(l)(17)(D) of the Act requires the Secretary to reduce
payments to ground ambulance organizations that do not sufficiently
report, we believe that the intent of the statute is to collect
information under the data collection system from ground ambulance
organizations that bill Medicare. Therefore, we are proposing to sample
ground ambulance organizations that are enrolled in Medicare and that
billed for at least one Medicare ambulance transport in the most recent
year for which we have a full year of claims data prior to sampling.
Since ground ambulance organizations have a full year to submit their
claims to Medicare after the date of service, claims data for a
calendar year are generally not considered complete until the end of
the following calendar year. As a result, we would use 2017 Medicare
claims and enrollment data to determine the sample for the 2020 data
collection period because 2018 Medicare claims data could not be
considered complete in late 2019 when the sample for the 2020 data
collection period would be selected.
Sampling at the NPI level: Section 1834(l)(17) of the Act
prohibits, to the extent practicable, sampling the same ambulance
provider or supplier in 2 consecutive years. Although we considered
sampling at a broader parent organization level for those that bill
Medicare under more than one NPI, we found it was difficult to tease
out of the Medicare enrollment data all the complexities of the
business relationships and identify all NPIs that may be affiliated
with the same parent organization. Therefore, we are proposing to
select the sample at the NPI level and to include the specific NPI
selected to report information. Furthermore, we propose to collect the
name of the ground ambulance organization and the name and contact
information of the person responsible for completing the data
collection instrument for the purposes of confirming that the data
submitted aligns with the intended NPI (section 2, questions 3 and 4).
Organizations using volunteer labor: Some stakeholders have
suggested that ground ambulance organizations relying on volunteer
labor above a certain threshold (for example, more than 10 percent of
volunteer labor) should be exempt from sampling. Others have suggested
that ground ambulance organizations using volunteer labor should not be
excluded because those organizations that use volunteer labor are
likely to be smaller and that a large share of ambulance suppliers
(particilarly those in rural and super rural areas) would be exempt
from sampling, and therefore, our sample would not be representative as
required by section 1834(l)(17)(B)(ii) of the Act. We acknowledge that
analysis of the data may require additional steps to combine data
submitted from ground ambulance organzations that do and do not rely on
volunteers since reported labor costs would be significantly lower for
ground ambulance organizations that use volunteer labor compared to
those that do not. Ground ambulance organizations that use volunteer
labor might have some costs related to their volunteer labor, such as
stipends, but may not have others, such as an hourly wage. Therefore,
we are proposing to collect information on paid and unpaid volunteer
hours during a typical week using the same EMT/response staff
categories used elsewhere in the data collection instrument. We believe
reported hours can be converted to market rates using data from other
sources, such as the Bureau of Labor Statistics' wage data. Ambulance
providers and supplies that rely on volunteer labor report that it is
becoming increasingly difficult to find volunteers and they are having
to hire paid staff in their place, especially for the more costly labor
categories, such as paramedics. Therefore, we are proposing that
ambulance providers and suppliers that use any amount of volunteer
labor be included in sampling. We invite comments as to whether
organanizations that rely on volunteer labor should be exempt from
sampling.
Sampling file. The organizational characteristics being proposed
for the specific strata (volume of Medicare billed transports, service
area population density, ownership, provider versus supplier status,
and the share of transports that are non-emergency) can be obtained
from available Medicare data. We are proposing to develop sampling
files using the most recent full year of data available. For the first
sample notified in 2019 and reporting in 2020, we are proposing to use
2017 claims and enrollment data. Another alternative we considered was
using 2018 data, however we are not proposing this because such data
may not be complete for all 2018 service dates at the time the sample
for the initial year of data reporting is selected. We invite comments
on our proposal to use the most recent full year of available Medicare
data for sampling purposes, as described above.
Implications of historical sampling files. We expect there may be
instances in which some ground ambulance organizations that were in
operation at the time they were selected for the sample may cease
operations by the
[[Page 40696]]
time data reporting begins. Similarily, we expect that some new ground
ambulance organizations would start operating between the time the
sample was pulled and when reporting begins. Since we propose to
collect a full 12 continous months of data, these organizations would
not have the data we are proposing to collect. Therefore, we are
proposing that ground ambulance providers and suppliers organizations
selected for the sample that were not in business for the full 12
continuous months of the data collection period would be exempt from
reporting for the applicable data collection period; however, for newer
ground ambulance organizations, they would be eligible for sampling and
reporting in future years when they did have a full continuous 12
months of data.
We believe the above scenerios are inevitable given the significant
amount of time between sampling and data reporting and invite comments
on our proposed approach regarding exempting ground ambulance
organizations who do not have a full 12-month continuous period of
data.
Sampling rate: We are also proposing that 25 percent of ground
ambulance organizations be sampled from all strata (as described below)
in each of the first 4 years of reporting without replacement; that is,
if an organization is sampled in Year 1, it would not be eligible for
sampling again in the subsequent 3 years of data collection. We are
proposing a 25 percent sampling rate because if a lower sampling rate
is used, estimates of cost, revenue, and utilization from the data
collected via the instrument for subgroups of ground ambulance
suppliers would be of inadequate precision as described in the
following section. Furthermore, our analyses illustrated that using 50
percent sampling rate yielded only marginal gains in precision over a
corresponding strategy that involves sampling NPIs at a 25 percent rate
while doubling the response burden. In our view, these gains are not
sufficient to merit the increased burden that would be imposed by
implementing a higher sampling rate. Our proposal was informed by
analyses regarding the alternative sampling rates in Chapter 7 of the
CAMH report. We invite comments on the proposed sampling rate of 25
percent each year.
We are also proposing to notify ground ambulance organizations that
have been selected for the representative sample by listing such ground
ambulance organizations on the CMS website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html and providing
written notification to each selected ground ambulance organization via
email or U.S. mail. Notification on the CMS website would be provided
at least 30 days prior to the time the selected ambulance organization
would be required to begin collecting data. For purposes of CY 2020, we
will post such information on the website when the CY 2020 PFS final
rule is issued. A discussion of the proposed collection and reporting
requirements can be found in the next section. We are also proposing to
codify the representative sample requirements in Sec. 414.626(c).
Approach for Sampling: We considered several alternatives for
developing a stratified sampling approach to facilitate data collection
from specific types of ground ambulance oragnizations. Section
1834(l)(17)(B)(ii)(II) of the Act requires that the sample be
representative of the different types of providers and suppliers of
ground ambulance services, such as those providers and suppliers that
are part of an emergency service or part of a government organization
and the geographic locations in which ground ambulance services are
funished (such as urban, rural, and low population density areas). One
approach we considered was to sample ground ambulance organizations in
proportion to their volume of Medicare-billed ground ambulance
services. Under this approach, organizations with more billed Medicare
ground ambulance transports would be more likely to be sampled than
organizations with fewer billed Medicare ground ambulance transports.
The analysis of our 2016 data described in the CAMH report shows that a
small number of ground ambulance organizations provided a large share
of total Medicare transports. Specifically, the top 10 percent of
ground ambulance organizations by volume accounted for nearly 70
percent of total Medicare ground ambulance transports. In contrast, the
bottom 50 percent of ambulance providers and suppliers by volume
accounted for only 3 percent of total Medicare ground ambulance
transports. Under this approach, the ambulance providers and suppliers
in the top 10 percent by volume would therefore be much more likely to
be sampled compared to those in the bottom 50 percent by volume. While
this approach would efficiently collect data on the majority of
Medicare ground ambulance transports, we do not believe that this
approach would comport with the requirements in section
1834(l)(17)(B)(ii)(II) of the Act to develop a representative sample of
ground ambulance organizations based on the characteristics (such as
ownership and geographic location) of ambulance providers and
suppliers. Therefore, we do not believe that data we would be
collecting using this approach would meet the requirements in section
1834(l)(17)(B)(ii)(II) of the Act.
Other alternatives for a sampling methodology include simple and
stratified random samples of ground ambulance organizations. A simple
random sample would include a fixed share of all ground ambulance
organizations, regardless of any differences in characteristics, in
each year's sample. Unlike sampling in proportion to Medicare-billed
ground ambulance services, a simple random sample by definition
provides a representative sample. A stratified random sample first
stratifies all ground ambulance organizations based on selected
characteristics and then a sample is seleced at random from the strata.
The rate at which these organizations are sampled would be the same for
organizations in the same stratum; however, the sampling rate may vary
across strata. So long as the sampling rate is not zero within any
stratum and so long as appropriate weighting adjustments are used, the
sample can be considered representative.
Stratified random sampling has several advantages in that it is
easy to implement and it meets the requirement that the sample be
representative. It also can be used to target sampling of ambulance
organziations with specific characteristics, such as ownership and
geographic location, to specifically meet the requirements in section
1834(l)(17)(B)(ii)(II) of the Act that the sample be representative of
the different types of providers and suppliers of ground ambulance
services, such as those providers and suppliers that are part of an
emergency service or part of a government organziation and the
geographic locations in which ground ambulance services are funished
(such as urban, rural, and low population density areas). It is also
possible to oversample from less prevelant strata using this approach
in order to facilitate more precise estimates for certain groups or
comparisons between subgroups. Furthermore, unlike a simple random
sample, the flexibility to vary sampling rates across strata allows the
ability to account for anticipated and unanticipated rates of
nonresponse.
We believe that use of a stratified random sample would comport
with the statutory requirements. Therefore, we are proposing a
stratified random
[[Page 40697]]
sample approach. Specifically, we are proposing to sample from each
strata at the same rate (25 percent, as described above). We believe
that data collected from a sample of this type can be adjusted via
statistical weighting to be representative of all ground ambulance
organizations billing Medicare for ground ambulance services even if
response rates vary across the characteristics used for stratification.
For the purposes of estimating the number of responses from the
sampled ground ambulance organizations, we assumed that all ground
ambulance providers and suppliers organizations sampled will report,
because: (1) Reporting is a requirement; (2) there is a 10 percent
payment reduction for failure to sufficiently report; and (3) we
believe every ground ambulance organization would want its data
accounted for in the evaluation of the extent to which reported costs
relate to payment rates.
Variables for Stratification: Section 1834(l)(17)(B)(ii)(II) of the
Act requires that the sample be representative of the different types
of providers and suppliers of ground ambulance services, such as those
providers and suppliers that are part of an emergency service or part
of a government organization, and the geographic locations in which
ground ambulance services are funished (such as urban, rural, and low
population density areas). As discussed above, we are proposing a
stratified sampling approach under which we would first sample based on
a set of charactericistcs of ground ambulance organizations that are
described below (that is, strata) and then assess response rates based
on those characteristics. Based on our analysis of information provided
by ground ambulance organizations, we believe there are several
important characteristics that vary among ground ambulance
organizations that have implications for their costs and revenues and
that could serve as strata for the purposes of sampling:
Provider versus supplier status. The GAO (2012) \94\ and
HHS (2015) \95\ reports found much higher per-transport costs for
ambulance providers than those of ambulance suppliers. This suggests
that the ground ambulance cost structures for ambulance providers and
suppliers are fundamentally different.
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\94\ This report is available at https://www.gao.gov/assets/650/649018.pdf.
\95\ This report is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/Downloads/Report-To-Congress-September-2015.pdf.
---------------------------------------------------------------------------
Service area population density. Ground ambulance
organizations operate in urban, rural, and super-rural settings. As
described in the CAMH report, rural and super-rural organizations tend
to be smaller, transport patients at greater distances, are more likely
to be government owned, and rely more heavily on volunteer labor. The
population density of the area in which a ground ambulance organization
is operating is expected to affect costs and revenues in a number of
ways. Organizations serving rural and super-rural areas generally are
likely to face lower demand for services, and thus, deliver a smaller
number of transports. In addition, in rural and super-rural areas the
average distance traveled per transport tends to be greater. Payment
rates will also differentially impact revenue by population density
because the Medicare AFS accounts for mileage and, in addition, rural
and super-rural providers and suppliers receive higher temporary add-on
payments.
Volume of transports. If there are economies of scale,
organizations providing a larger volume of services typically would
face lower per-transport costs. Our analysis found that the volume
distribution is highly skewed. In other words, the majority of ground
ambulance organizations have a low volume of transports, but there are
a small number of organizations with a very high volume of transports.
Suppliers providing a large volume of transports are more likely to be
for-profit organizations.
Ownership. For-profit (non-government), non-profit (non-
government), and government ground ambulance organizations have
different business models and mixes of services, leading to different
costs. Conceptually, for-profit organizations maximize profit and
operate only in markets and service lines with positive margins. Non-
profit and government ground ambulance organizations more broadly
provide emergency service to communities and may be organized and
operated in a way that does not maximize profits. The 2012 GAO report
found ground ambulance organizations with more limited government
support are more likely to have incentives to keep costs lower. They
found that for each 2 percent decline in the average length of
government subsidy there was a 2 percent decline in the average cost
per transport. As a result, we expect that costs will differ based on
ownership.
Types of services provided. One key distinction in the
types of services provided is between emergency transports and non-
emergency (for example, scheduled or inter-facility) transports. For-
profit suppliers are more likely than others to specialize in non-
emergency scheduled transports. Another key distinction is between the
level of service provided (for example BLS versus ALS).
Staffing. The level of staff training (for example, EMTs
versus paramedics) and the number of staff deployed is driven in part
by the type and volume of calls, the availability and proximity of the
nearest providers, and resources available in that community. Some
suppliers use static staffing models that use set staff schedules,
whereas others use a dynamic, or flexible, staffing model that calls
upon staff if there is a surge in demand.
Use of volunteer labor. Volunteer labor tends to be more
common among small, government-based ambulance suppliers operating in
rural and super-rural settings.
Response times. In many cases, response times are related
to the population density of the area in which they operate, with rural
areas having response times more than double those of urban areas.
Rural and super-rural ambulance providers and suppliers generally
travel greater distances to get to patients and transport them to a
hospital or the nearest appropriate facility. Variation in response
times within urban areas might also occur, for example if there is
significant emergency department crowding, or in extreme cases
diversion that requires the ambulance to travel further to another
hospital or wait with the patient until a bed is available. This extra
time affects the availability of the ambulance and the staff for
subsequent trips, potentially increasing response times.
As previously discussed, we are not aware of any existing data
source that lists all ground ambulance organzations or one that
encompasses all the characteristics that impact costs and revenues
described above. Medicare claims and enrollment data is the only source
of data for which we are aware that has all the providers and suppliers
that bill Medicare in a given year. Several of the organizational
characteristics we discuss above (including provider versus supplier
status, ownership, service area population density, Medicare billed
transport volume, and type of services provided) are available from
Medicare data while others, such as the use of volunteer labor,
staffing model, and response times are not.
We are proposing to stratify the sample based on provider versus
supplier status, ownership (for-profit, non-profit, and government),
service area population density (transports originating in primarily
urban, rural,
[[Page 40698]]
and super rural zip codes), and Medicare billed transport volume
categories. Based on our analysis of the number and distribution of
ground ambulance organizations' transports in 2016, we are proposing
volume categories of 1 to 200, 201 to 800, 801 to 2,500, and 2,501 or
more paid Medicare transports. The proposed volume categories aim to
divide ground ambulance organizations into roughly similar-sized
groups, while separating ground ambulance organizations with very high
volume (that is, greater than 2,500 Medicare transports per year) into
a separate category. We would expect that these highest-volume ground
ambulance organizations may face different costs than lower-volume
organizations due to economies of scale.
We are proposing to focus on these four characteristics due to data
availability, and our analyses that show these to be key defining
characteristics of ground ambulance organizations (which are also
described in the CAMH report). Also, service area population density
and Medicare billed transport volume have a direct impact on ground
ambulance revenue, which is one of the categories of data that we are
required to collect by section 1834(l)(17)(A) of the Act. Through
Medicare claims and enrollment data, we believe we have enough
information to stratify ground ambulance organizations on these four
characteristics. This stratification approach results in 36 groupings
of ground ambulance suppliers (defined by combinations of the three
ownership categories, three service area population density categories,
and four Medicare billed transport volume categories) and the same
number of groupings for ambulance providers.
In some of these groupings, there are only a handful of ground
ambulance organizations providing ground ambulance services with a
specific set of the four characteristics. This could result in
situations where few or no ground ambulance organizations with the
specific set of characteristics were sampled. To minimize this risk and
avoid situations where we are sampling from strata that contain only a
few ambulance providers and suppliers in the entire population, we
propose to stratify ground ambulance providers, which account for only
6 percent of ground ambulance organizations combined, based on service
area population density only. We are proposing to use this
characteristic to stratify providers rather than another characteristic
because section 1834(l)(17)(A) of the Act specifically requires the
Secretary to develop a data collection system to collect information on
ground ambulance services furnished in different geographic locations,
including rural areas and low population density areas described in
section 1834(l)(12) of the Act (super rural areas).
We are also proposing to collapse the two highest Medicare ground
ambulance transport volume categories (801-2500 and 2501 and more
transports) into a single category (801 and more transports) for for-
profit ground ambulance suppliers that primarily service super-rural
areas due to the small number of ground ambulance organizations in
these two volume categories. The proposed sampling rate of 25 percent
aims to meet a threshold that will provide an adequate degree of
precision for estimates within each strata subgroup (that is, provider
versus supplier status, ownership (for-profit, non-profit, and
government), service area population density (transports originating in
primarily urban, rural, and super rural zip codes), and Medicare billed
transport volume categories). The specific threshold is 200 expected
responses in each subgroup. This number of expected responses will
ensure that small to medium differences in means between groups (that
is, affect size) can be detected.
A 25 percent sampling rate is expected to result in more than 200
responses in each subgroup except for ground ambulance providers (where
we expect 153 responses with a 25 percent sampling rate). A 25 percent
sampling rate will also result in more than 200 expected responses for
other organizations not represented in the strata, including
organizations providing primarily non-emergency transports and
transports to and from dialysis facilities. We also expect that a 25
percent sampling rate will result in more than 200 responses for
organizations that rely primarily on volunteer labor, as well as for
those who do not.
We invite comments on all our proposals for sampling as described
in this section, including our proposals on eligible organizations,
methods for sampling, sampling at the NPI level, sampling of
organizations using volunteer labor, sampling files, and sampling
rates. We also invite comments on our proposals to collect data from
ground ambulance organizations that bill Medicare, and the use of a
stratified random sample.
6. Proposals for Collecting and Reporting of Information Under the Data
Collection System
For each data collection year, section 1834(l)(17)(C) of the Act
requires ground ambulance organizations identified as part of the
representative sample to submit information specified under the system,
with respect to a period for the year (referred to as the ``data
collection period''), in a form and manner and at a time (referred to
as the ``data reporting period'') specified by the Secretary. In this
section, we are proposing to define the data collection period and the
data reporting period. In determining when the proposed data collection
and reporting periods should fall, our objectives were to: (1) Allow
selected ground ambulance organizations sufficient time to collect and
report the required information; and (2) collect the data for analysis
in the least burdensome manner.
We considered annual (that is, 12-month) data collection periods
and shorter data collection periods (for example, a 6-month period). We
are proposing a 12-month data collection period because a shorter
period could result in biased data due to seasonality in costs,
revenue, or utilization among ground ambulance organizations.
As we stated previously, ambulance providers and suppliers
constitute a diverse group of organizations with varied annual
accounting practices. Accordingly, we are proposing to define the data
collection period as a continuous 12-month period of time, which is
either the calendar year aligning with the data collection year, or
when an organization uses another fiscal year for accounting purposes
and the organization elects to collect and report data over this period
rather than the calendar year, the 12-month period that is their fiscal
year that begins during the data collection year. We are proposing this
data collection period based on feedback from ground ambulance
organizations that stated that they prefer to collect data based on an
annual accounting period (either calendar year or fiscal year) already
used by the organization, and that requiring all organizations to
report on the same 12-month period (for example, calendar year) could
involve significant additional burden in terms of data collection and
reporting. We believe that providing flexibility in collecting
information under the data collection system would reduce the burden on
ground ambulance organizations.
Therefore, we are proposing that the first data collection period
be January 1, 2020 through December 31, 2021, with
[[Page 40699]]
organizations reporting on a calendar year basis collecting data from
January 1, 2020 through December 31, 2021, and organizations reporting
on a fiscal year basis collecting data over a continuous 12-month
period of time from the start of the fiscal year beginning in calendar
year 2020. Upon being notified that they are selected as part of the
sample, ground ambulance organizations must notify CMS of their annual
accounting period within 30 days according to the instructions in the
notification letter, so that CMS is aware of when their data collection
and data reporting periods would begin. We propose that respondents
would additionally confirm the data collection period when reporting
data via the data collection instrument (section 2, question 5).
We also propose that ground ambulance organizations would have up
to 5 months to report to CMS (data reporting period) the data following
the end of its 12-month data collection period. For example, if a
ground ambulance organization is selected as part of the representative
sample for the CY 2020 data collection year, and notifies CMS that its
annual accounting period is based on a calendar year, the data
collection period for this ground ambulance organization would begin on
January 1, 2020 and end on December 31, 2020, and the data reporting
period would be January 1, 2021 through May 31, 2021. A ground
ambulance organization selected for CY 2020 that notifies CMS that its
annual accounting period is based on a fiscal year basis with a fiscal
year beginning on June 1, 2020 would have a data collection period from
June 1, 2020 through May 31, 2021 and a data reporting period from June
1, 2021 through October 1, 2021. Since a 5-month reporting period is
enough time for entities that file cost reports with Medicare to
complete and submit their data, we believe it should also provide
adequate time for ground ambulance organizations to report information
under the data collection system to CMS. This proposal will allow
providers and suppliers time to validate the information and certify
the accuracy of their data required under the data collection before
reporting it to CMS.
We propose to codify the data collection and reporting requirements
for selected ground organizations at Sec. 414.626(b).
Tables 30 and 31 illustrate various examples of data collection
periods and the data reporting periods under our proposal. Please note
that an individual ground ambulance organization would only be selected
to participate in one data collection and reporting period, and that
the specific data collection and reporting period dates might vary for
each organization and be different than the dates noted in the tables.
Table 30--Example of a Data Collection and Reporting Period for a Ground
Ambulance Organization With a Calendar Year Accounting Period
------------------------------------------------------------------------
Data collection Data reporting
Year period period
------------------------------------------------------------------------
1................................. 01/01/2020-12/31/ 01/01/2021-05/31/
2020 2021
2................................. 01/01/2021-12/31/ 01/01/2022-05/31/
2021 2022
3................................. 01/01/2022-12/31/ 01/01/2023-05/31/
2022 2023
4................................. 01/01/2023-12/31/ 01/01/2024-05/31/
2023 2024
------------------------------------------------------------------------
Table 31--Example of a Data Collection and Reporting Period for a Ground
Ambulance Organization With an Accounting Period Not Based on a Calendar
Year
------------------------------------------------------------------------
Data collection Data reporting
Year period period
------------------------------------------------------------------------
1................................. 06/01/2020-05/31/ 06/01/2021-10/31/
2021 2021
2................................. 06/01/2021-05/31/ 06/01/2022-10/31/
2022 2022
3................................. 06/01/2022-05/31/ 06/01/2023-10/31/
2023 2023
4................................. 06/01/2023-05/31/ 06/01/2024-10/31/
2024 2024
------------------------------------------------------------------------
We invite comments on our proposal to use a 12-month data
collection period. We also invite comments on our proposal to give
sampled ground ambulances the flexibility to collect data on either a
calendar year basis or on the basis of the ground ambulance
organization's fiscal year. In addition, we invite comments on our
proposal to allow a ground ambulance organization 5 months to report
the data collected during data collection period to CMS through the
data collection system. We plan on addressing section 1834(l)(17)(E) of
the Act, ongoing data collection, in future rulemaking.
7. Proposed Payment Reduction for Failure To Report
a. General Information and Applicable Period
Section 1834(l)(17)(D)(i) of the Act requires that beginning
January 1, 2022, subject to clause (ii), the Secretary reduce the
payments made to a ground ambulance organization under section
1834(l)(17) of the Act for the applicable period by 10 percent if the
ground ambulance organization is required to submit data under the data
collection system with respect to a data collection period and does not
sufficiently submit such data. Section 1834(l)(17)(D)(ii) of the Act
defines the applicable period as a year specified by the Secretary not
more than 2 years after the end of the period for which the Secretary
has made a determination that the ground ambulance provider or supplier
failed to sufficiently submit information under the data collection
system.
As previously discussed, we are proposing to define the data
collection and data reporting periods based on the ground ambulance
organization's annual accounting period (either calendar year or fiscal
year). The timeline for the determination of the 10 percent reduction
to payments would depend on: (1) The 12-month data collection period
based on the organization's accounting period; (2) the end of the data
reporting period that corresponds with the selected data collection
period; and (3) the time it would take CMS to review the data to
determine whether it had been sufficiently submitted. We are proposing
that we would make a determination that the ground ambulance
organization is subject to the 10 percent payment reduction no later
than the date that is 3 months following the date that the ambulance
organization's data reporting period ends. This timeframe will allow
CMS to assess whether the required data was sufficiently submitted.
For example, if a ground ambulance organization is selected in the
first sampling year and it reports to CMS that its annual accounting
period is an October 1 through September 30th fiscal year, then its
data collection period would be October 1, 2020 through September 30,
2021, and the data reporting period that would apply to the ground
ambulance organization would be from October 1, 2021-February 28 (or
29, if a leap year), 2022. We would make a determination regarding the
sufficiency of that ground ambulance organization's reporting no later
than June 1, 2022. With this timeframe, we would propose to apply the
10 percent reduction in payments, if applicable, for ambulance services
provided by that ground ambulance organization between January 1, 2023
and December 31, 2023, because under section 1834(l)(17)(D)(iii) of the
Act, the applicable period must be one year in length. As another
example, if a ground ambulance organization's annual accounting period
is the calendar year, its data collection period would be January 1,
2020 through December 31, 2020, the data reporting period that would
apply to the ground ambulance organization would be from January 1,
2021-May 31, 2021,
[[Page 40700]]
and we would make a determination regarding the sufficiency of that
ambulance organization's reporting no later than August 31, 2021. With
this timeframe, we would propose to apply the 10 percent reduction in
payments, if applicable, for ambulance services provided between
January 1, 2022 and December 31, 2022. The payment reduction would
always be applied to ground ambulance transports provided during the
calendar year that begins following the date that we determine that the
ground ambulance organization is subject to the payment reduction.
We propose that if we find the data reported is not sufficient, we
would notify the ground ambulance organization that it will be subject
to the 10 percent payment reduction for ambulance services provided
during the next calendar year. We would interpret ``sufficient'' to
mean that the data reported by the ground ambulance organization is
accurate and includes all required data requested on the data
collection instrument.
We are proposing to apply the 10 percent payment reduction for the
appropriate calendar year as described above to ambulance fee schedule
payments as described in Sec. 414.610. The payment reduction would
apply to claims for dates of service during the applicable calendar
year and would be applied to the final ambulance fee schedule payment,
after all other adjustments have been applied under Sec. 414.610(c).
We are proposing to codify the payment reduction by adding a new
paragraph (c)(9) in Sec. 414.610.
b. Proposed Hardship Exemption
Section 1834(l)(17)(A)(D)(iii) of the Act authorizes the Secretary
to exempt a ground ambulance provider or supplier from the 10 percent
payment reduction for an applicable period in the event of significant
hardship, such as a natural disaster, bankruptcy, or other similar
situation that the Secretary determines interfered with the ability of
the ground ambulance provider or supplier to submit such information in
a timely manner for the specified period.
We recognize that there may be some ground ambulance organizations
that have limited resources that affect their ability to report the
required information, and that for these ground ambulance
organizations, a 10 percent payment reduction in Medicare payments
could result in significant financial hardship.
An example of this situation could be a ground ambulance
organization that is located in a super rural area with such limited
resources that it cannot report the required information without
significantly increasing the possibility that it would need to file for
bankruptcy.
Another example could be a ground ambulance organization that is
located in an area that had recently experienced a natural disaster
such as widespread flooding that caused the closure of a local
emergency room or other facilities. Due to the increased demand for
services and rerouting of patients, this ground ambulance organization
might be unable to collect and report information in a timely manner.
We are proposing that ground ambulance organizations in these or
other similar situations could request that CMS grant a hardship
exemption, and CMS could consider granting an exemption if the ground
ambulance organization could demonstrate that the significant hardship
interfered with its ability to submit the required data under the data
collection system.
To request a hardship exemption, we propose that a ground ambulance
organization submit to CMS a completed request form, which can be found
on the Ambulance Services Center website (https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html), and that the following
information be included:
Ambulance Provider or Supplier Name;
NPI Number;
Ambulance Provider or Supplier Location Address;
CEO and any other designated personnel contact
information, including name, email address, telephone number and
mailing address (must include a physical address, a post office box
address is not acceptable);
Reason for requesting a hardship exemption;
Evidence of the impact of the hardship exemption (such as
photographs, newspaper, other media articles, financial data,
bankruptcy filing, etc.); and
Date when the ground ambulance organization would be able
to begin submitting information under the data collection system.
We are proposing that the completed hardship exemption request form
be signed and dated by the Chief Executive Officer (CEO) or designee of
the ambulance company, and be submitted as soon as possible, and not
later than 90 calendar days of the date that the ground ambulance
organization was notified that it will be subject to the 10 percent
payment reduction as a result of not sufficiently submitting
information under the data collection system. We propose that the
request form be submitted to the Ambulance ODF mailbox at
[email protected]. Following receipt of the request form, we are
proposing to provide: (1) A written acknowledgement that the request
has been received; and (2) a written response to the CEO and any
designated personnel using the contact information provided in the
request within 30 days of the date that we received the request. We are
also proposing to codify the hardship exemption requirement at Sec.
414.626(d).
c. Informal Review
Section 1834(l)(17)(D)(iv) of the Act requires the Secretary to
establish a process under which a sampled ground organization may seek
an informal review of a determination that it is subject to the 10
percent reduction. To request an informal review, we propose that a
ground ambulance organization must submit the following information:
Ground Ambulance Organization Name;
NPI Number;
CEO and any other designated personnel contact
information, including name, email address, telephone number and
mailing address (must include a physical address, a post office box
address is not acceptable);
Ground ambulance organization's selected data collection
period and data reporting period; and
A statement of the reasons why the ground ambulance
organization does not agree with CMS's determination and any supporting
documentation.
We propose that the informal review request must be signed by the
CEO/designee of the ground ambulance organization and be submitted
within 90 calendar days of the date that the ground ambulance
organization received notice regarding the 10 percent reduction in
payments. We are proposing 90 calendar days to submit an informal
review request to allow time for the ground ambulance organization to
gather the information needed to support the request for informal
review. We are proposing that the request be submitted to the Ambulance
ODF mailbox at [email protected]. Following receipt of the
request for informal review, we would provide: (1) A written
acknowledgement using the contact information provided in the request,
to the CEO and any additional designated personnel, notifying them that
the ambulance provider or supplier's request has been received; and (2)
a written response to the CEO and any designated personnel using the
contact information provided in the request within 30 days. We are
seeking comments on our proposed
[[Page 40701]]
informal review process. We are also proposing to codify the informal
review process in Sec. 414.610(e).
We invite comments regarding all the proposals on the payment
reduction for failure to report, including the applicable period,
hardship exemption, and informal review.
8. Public Availability
Section 1834(l)(17)(G) of the Act requires that the results of the
data collection be posted on the CMS website, as determined appropriate
by the Secretary. We are proposing to post on our website a report that
includes summary statistics, respondent characteristics, and other
relevant results in the aggregate so that individual ground ambulance
organizations are not identifiable.
We are also proposing that the data proposed above will be made
available to the public through posting on our website at least every 2
years. The 2-year timeframe would allow CMS time to analyze the data
that is being reported, factoring in the various accounting periods of
the first group of sampled ground ambulance organizations (which have
early accounting periods in the CY 2020 data collection year).
We are proposing to post summary results by the last quarter of
2022, because we believe we may have most or all of the data requested
by then. We invite comments on our proposals regarding the type of
information that should be posted from the data collected and the
timeline in which the results of the data collection should be posted
on our website.
We invite comments regarding our proposals for public availability
of the data.
9. Limitations on Review
Section 1834(l)(17)(J) of the Act provides that there shall be no
administrative or judicial review under sections 1869 or 1878 of the
Act, or otherwise, of the data collection system or identification of
respondents. We are proposing to codify the limitations on review at
Sec. 414.626(g).
C. Expanded Access to Medicare Intensive Cardiac Rehabilitation (ICR)
Section 51004 of the Bipartisan Budget Act of 2018 (BBA of 2018)
(Pub. L. 115-123, enacted February 9, 2018) amended section
1861(eee)(4)(B) of the Act directing CMS to add covered conditions for
intensive cardiac rehabilitation (ICR). This proposed rule includes our
proposals for implementing this expansion of coverage through revisions
to Sec. 410.49(b)(1).
1. Background
Cardiac rehabilitation (CR) was developed in the 1950s from the
concept of early mobilization after acute myocardial infarction (heart
attack).\96\ The standard of care prior to the widespread adoption of
CR was bed-rest and inactivity after acute myocardial infarction.\97\
In the 1970s, cardiac rehabilitation developed into highly structured,
physician supervised, electrocardiographically-monitored exercise
programs. However, the programs consisted almost solely of exercise
alone.\98\ Referencing 1998 guidelines \99\ from the American
Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR),
Forman (2000) stated that ``over subsequent years the objectives of
cardiac rehabilitation broadened beyond exercise into a composite of
cardiac risk modification. Lipid, blood pressure, and stress reduction,
smoking cessation, diet change, and weight loss were coupled to goals
of exercise training.''
---------------------------------------------------------------------------
\96\ Pashkow, FJ. Issues in Contemporary Cardiac Rehabilitation:
A Historical Perspective. JACC 1993 Mar 1;21(3):822-34.
\97\ Forman DE. Cardiac rehabilitation and secondary prevention
programs for elderly cardiac patients. Clin Geriatr Med. 2000
Aug;16(3):619-29.
\98\ Ades PA. A controlled trial of cardiac rehabilitation in
the home setting using electrocardiographic and voice
transtelephonic monitoring. Am Heart J. 2000 Mar;139(3):543-8.
\99\ AACWR Guidelines for Cardiac Rehabilitation and Secondary
Prevention Programs, ed 3. Windsor, ON, Human Kinetics, 1998.
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ICR, also commonly referred to as a ``lifestyle modification''
program, typically involves the same elements as traditional CR
programs, but are furnished in highly structured environments in which
sessions of the various components may be combined for longer periods
of CR and also may be more rigorous.
Section 144(a) of the Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA) (Pub. L. 110-275, enacted July 15, 2008)
amended Title XVIII to add new section 1861(eee) of the Act to provide
coverage of CR and ICR under Medicare part B. The statute specified
certain conditions for these services and an effective date of January
1, 2010, for coverage of these services. Conditions of coverage for CR
and ICR consistent with the statutory provisions of section 144(a) of
the MIPPA were codified in Sec. 410.49 through the CY 2010 PFS final
rule with comment period (74 FR 61872-61879 and 62004-62005). These
programs were designed to improve the health care of Medicare
beneficiaries with cardiovascular disease.
Under Sec. 410.49(b), Medicare part B covers CR and ICR program
services for beneficiaries who have experienced one or more of the
following: (1) An acute myocardial infarction within the preceding 12
months; (2) a coronary artery bypass surgery; (3) current stable angina
pectoris; (4) heart valve repair or replacement; (5) percutaneous
transluminal coronary angioplasty (PTCA) or coronary stenting; or (6) a
heart or heart-lung transplant. For CR only, other cardiac conditions
may be added as specified through a national coverage determination
(NCD). Effective February 18, 2014, we expanded coverage of CR in NCD
20.10.1, Cardiac Rehabilitation Programs for Chronic Heart Failure
(Pub. 100-03 20.10.1), to beneficiaries with stable, chronic heart
failure, defined as patients with left ventricular ejection fraction of
35 percent or less and New York Heart Association (NYHA) class II to IV
symptoms despite being on optimal heart failure therapy for at least 6
weeks. Stable patients are defined as patients who have not had recent
( The same set of measures that are identified as high
priority measures for reporting on the quality performance category for
eligible clinicians participating in MIPS.
All e-specified measures from the previous year's core set
of quality measures for Medicaid and the Children's Health Insurance
Program (CHIP) (Child Core Set) or the core set of health care quality
measures for adults enrolled in Medicaid (Adult Core Set) (hereinafter
together referred to as ``Core Sets'') that are also included on the
MIPS list of eCQMs.
Sections 1139A and 1139B of the Act require the Secretary to
identify and publish core sets of health care quality measures for
child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries.
These measure sets are required by statute to be updated annually and
are voluntarily reported by states to CMS. These Core Sets are composed
of measures that specifically focus on populations served by the
Medicaid and CHIP programs and are of particular importance to their
care. The MIPS eCQM list includes several, but not all, of the measures
in the Core Sets. Because the Core Sets are released at the beginning
of each year, it is not possible to update the list of high-priority
eCQMs with those added to the current year's Core Sets.
The eCQMs that would be available for Medicaid EPs to report in
2020, that are both part of the Core Sets and on the MIPS list of
eCQMs, and that would be considered high priority measures under our
proposal are: CMS2, ``Preventive Care and Screening: Screening for
Depression and Follow-Up Plan''; CMS122, ``Diabetes: Hemoglobin A1c
(HbA1c) Poor Control (>9%)''; CMS125, ``Breast Cancer Screening'';
CMS128, ``Anti-depressant Medication Management''; CMS136, ``Follow-Up
Care for Children Prescribed ADHD Medication (ADD)''; CMS137,
``Initiation and Engagement of Alcohol and Other Drug Dependence
Treatment''; CMS153, ``Chlamydia Screening for Women''; CMS155,
``Weight Assessment and Counseling for Nutrition and Physical Activity
for Children and Adolescents''; and CMS165, ``Controlling High Blood
Pressure.''
Through an amendment to Sec. 495.332(f), we gave each
state the flexibility to identify which of the eCQMs available for
reporting in the Medicaid Promoting Interoperability Program are high
priority measures for Medicaid EPs in that state, with review and
approval by CMS, through the State Medicaid HIT Plan (SMHP). States are
thus able to identify high priority measures that align with their
state health goals or other programs within the state.
All eCQMs identified via any of these three methods are high
priority measures for EPs participating in the Medicaid Promoting
Interoperability Program for 2019. As noted above, we propose to use
the same three methods for identifying high priority eCQMs for the
Medicaid Promoting Interoperability Program for 2020. We invite
comments as to whether any of these methods should be altered or
removed, or whether any additional methods should be considered for
2021.
We also propose that the 2020 eCQM reporting period for Medicaid
EPs who have demonstrated meaningful use in a prior year be a minimum
of any continuous 274-day period within CY 2020. This 274-day eCQM
reporting period corresponds to the 9-month period from January 1, 2020
to September 30, 2020. Medicaid EPs would not be required to use that
exact reporting period, but would be able to use any continuous 274-day
period within CY 2020. Medicaid EPs could also use a longer eCQM
reporting period in CY 2020, up to the full calendar year. In addition,
states would be required to allow sufficient time for EPs to attest for
program year 2020 beyond January 1, 2021 so that EPs may, should they
choose to do so, select EHR and eCQM reporting periods that take place
at any time within the 2020 calendar year through December 31, 2020.
We are proposing this eCQM reporting period for 2020 to improve
state flexibility in the penultimate year of the Medicaid Promoting
Interoperability Program, and to facilitate an orderly end of the
program in 2021. In the CY 2019 PFS final rule, we established that the
eCQM reporting period for Medicaid EPs in 2021 will be a minimum of any
continuous 90-day period within CY 2021, and also established that the
end date for this period must fall before October 31, 2021, to help
ensure that states can issue all Medicaid Promoting Interoperability
payments to EPs by the December 31, 2021 statutory deadline (83 FR
59704 through 59706). When proposing that policy, we received comments
that asked us to consider an eCQM reporting period shorter than a full
year in 2020. Commenters stated that a full-year reporting period may
create significant backlogs of 2020 and 2021 attestations in 2021 that
may create difficulty for states to issue payments by the statutory
deadline (83 FR 59705). We continue to believe that longer reporting
periods create more useful data for quality measurement and improvement
because they give states a broader picture of a health care provider's
care and patient outcomes. However, we agree that a full-year eCQM
reporting period in 2020 might unnecessarily burden states as they
would need to issue incentive payments and implement systems changes
for 2021 in a timely manner.
This proposal would allow states to accept attestations for program
year 2020 as early as October 1, 2020 from Medicaid EPs who choose to
use an eCQM reporting period early in the year, and thus could give
states additional time to prepare for 2021 and the end of the Medicaid
Promoting Interoperability Program. Even though states would also still
have to allow EPs to submit attestations for 2020 in 2021, we believe
that allowing some EPs to attest sooner could accelerate states' pre-
payment verification and payment process. We considered whether to
propose a Medicaid EP eCQM reporting period for 2020 from January 1,
2020 through September 30, 2020, with no flexibility for EPs to select
an alternative 274-day eCQM reporting period. We also
[[Page 40704]]
considered whether to propose a date prior to December 31, 2020 by
which all Medicaid EP EHR and eCQM reporting periods for 2020 must end.
While either of these alternatives might have further helped to ensure
that all states would have additional time to prepare for 2021, we
decided not to propose either of them because we wanted to preserve as
much flexibility as possible for Medicaid EPs. However, we seek
comment, especially from states and Medicaid EPs, about whether either
of these alternatives might be preferable to our proposal.
We note that states submit their attestation deadlines to CMS each
year as part of their SMHPs. We do not believe that this proposal would
create any additional burden on EPs or CEHRT vendors, as CEHRT should
be able to report eCQM data from any length of time.
We propose that, in 2020, the eCQM reporting period for Medicaid
EPs demonstrating meaningful use for the first time, which was
established in the final rule entitled ``Medicare and Medicaid
Programs; Electronic Health Record Incentive Program-Stage 3 and
Modifications to Meaningful Use in 2015 Through 2017'' (80 FR 62762,
62892) (hereinafter known as the ``Stage 3 final rule''), would remain
any continuous 90-day period within the calendar year, as in previous
years.
3. Objective 1: Protect Patient Health Information in 2021
In the Stage 3 final rule (80 FR 62762, 62832), we established
Meaningful Use Objective 1 as ``Protect electronic protected health
information (ePHI) created or maintained by the CEHRT through the
implementation of appropriate technical, administrative, and physical
safeguards.'' As specified at Sec. 495.24(d)(1)(i)(B), to meet that
objective, EPs must meet the associated measure to conduct or review a
security risk analysis in accordance with the requirements under 45 CFR
164.308(a)(1), including addressing the security (including encryption)
of data created or maintained by CEHRT in accordance with requirements
under 45 CFR 164.312(a)(2)(iv) and 164.306(d)(3), implement security
updates as necessary, and correct identified security deficiencies as
part of the provider's risk management process.
In the Stage 3 final rule, we explained that this measure must be
completed in the same calendar year as the EHR reporting period. This
may occur before, during, or after the EHR reporting period, though if
it occurs after the EHR reporting period it must occur before the
provider attests to meaningful use of CEHRT or before the end of the
calendar year, whichever comes first (80 FR 62831). In practice, this
means that EPs do not attest to meaningful use of CEHRT before
completing this measure.
As discussed above, states must issue all Medicaid Promoting
Interoperability Program incentive payments by the statutory deadline
of December 31, 2021. States can establish state-specific deadlines for
Medicaid EPs to attest to the state regarding meaningful use of CEHRT
in CY 2021. However, due to changes CMS made in prior rulemaking to the
Medicaid Promoting Interoperability Program EHR and eCQM reporting
periods for 2021, all states must set attestation deadlines on or
before October 31, 2021. See 42 CFR 495.4 (definition of ``EHR
reporting period'') and 495.332(f)(3) and (4), and 83 FR 59704 through
59705. Because all EPs are therefore expected to attest to meaningful
use of CEHRT before the end of CY 2021, Medicaid EPs would no longer
have the option of completing the security risk analysis at the end of
the calendar year, and would likely have to complete it well before
December 2021. For example, in a state with an attestation deadline of
October 1, 2021, a Medicaid EP would have to conduct the security risk
analysis by September 30, 2021. Stakeholders have given us feedback
that most security risk analyses are conducted on a clinic or practice
level, which may include EPs and non-EPs. As we noted in the Stage 3
final rule, ``[a]n organization may conduct one security risk analysis
or review which is applicable to all EPs within the organization,
provided it is within the same calendar year and prior to any EP
attestation for that calendar year. However, each EP is individually
responsible for their own attestation and for independently meeting the
objective. Therefore, it is incumbent on each individual EP to ensure
that any security risk analysis or review conducted for the group is
relevant to and fully inclusive of any unique implementation or use of
CEHRT relevant to their individual practice'' (80 FR 62794).
If an EP or practice typically conducts the security risk analysis
at the end of each year, the CY 2021 timeline for attesting to
meaningful use of CEHRT may create burden for all Medicaid EPs and for
non-EP health care providers within the same organization as Medicaid
EPs, and may not be optimal for protecting information security,
because it could disrupt the intervals between security risk analyses.
As we explained in the Stage 3 final rule, a security risk analysis is
not a discrete item in time, but a comprehensive analysis covering the
full period of time for which it is applicable; and the annual review
of such an analysis is similarly comprehensive. In other words, the
analysis and review, no matter when they are conducted, should not be
just a ``point in time'' exercise, and instead should cover a span of
the entire year, including a review planning for future system changes
within the year or a review of prior system changes within the year (80
FR 62831). However, EPs that typically conduct the security risk
analysis in December of each calendar year might conduct one security
risk analysis in December 2020, and then have to conduct another one
well before December 2021, if the analysis must be completed before the
EP attests to meaningful use of CEHRT for CY 2021. We believe that
security risk analyses are most effective for data security when
conducted on a regular schedule. In addition, practice locations may
have ongoing contracts or processes in place to perform a security risk
analysis at the same time each year. We do not wish to create burden
for EPs and non-EPs related to changing those processes to meet the CY
2021 Medicaid Promoting Interoperability Program attestation timelines.
Therefore, we are proposing to allow Medicaid EPs to conduct a
security risk analysis at any time during CY 2021, even if the EP
conducts the analysis after the EP attests to meaningful use of CEHRT
to the state. A Medicaid EP who has not completed a security risk
analysis for CY 2021 by the time he or she attests to meaningful use of
CEHRT for CY 2021 would be required to attest that he or she will
complete the required analysis by December 31, 2021. Under this
proposal, states could require Medicaid EPs to submit evidence that the
security risk analysis has been completed as promised, even after the
incentive payment has been issued. In addition, states could require
EPs to attest that if a security risk analysis is not completed by
December 31, 2021, they will voluntarily rescind their attestation to
meaningful use of CEHRT and return the incentive payment. If this
proposal is finalized as proposed, we would work with states to develop
post-payment verification and audit processes that meet CMS due
diligence requirements, including those in Sec. Sec. 495.318 and
495.368, and generally to ensure that incentive payments are made
properly. We remind states that as a condition of receiving enhanced
federal financial participation (FFP), they are required to demonstrate
to the satisfaction of HHS that they are conducting adequate
[[Page 40705]]
oversight of the program, including routine tracking of meaningful use
attestations (See Sec. 495.318(b)). States are also reminded that they
must submit a description of the methodology used to verify that EPs
have meaningfully used CEHRT for CMS approval as part of their SMHP.
(See Sec. 495.332(c)). In the final rule titled ``Medicare and
Medicaid Programs; Electronic Health Record Incentive Program'' (75 FR
44313), CMS explained that states are expected to ``look behind''
provider attestations, and that this would require audits both pre- and
post-payment (75 FR 44515). These requirements and expectations would
not change under this proposal.
4. Clarification
In the CY 2019 PFS final rule (83 FR 59702), in the list of high
priority eCQMs that are available for Medicaid EPs to report in 2019
because they are both part of the Core Sets and on the MIPS list of
eCQMs, we inadvertently listed ``Initiation and Engagement of Alcohol
and Other Drug Dependence Treatment'' as ``CMS4.'' It should have read
``CMS137, `Initiation and Engagement of Alcohol and Other Drug
Dependence Treatment.' ''
E. Medicare Shared Savings Program
As required under section 1899 of the Act, we established the
Medicare Shared Savings Program (Shared Savings Program) to facilitate
coordination and cooperation among health care providers to improve the
quality of care for Medicare fee-for-service (FFS) beneficiaries and
reduce the rate of growth in expenditures under Medicare Parts A and B.
Eligible groups of providers and suppliers, including physicians,
hospitals, and other health care providers, may participate in the
Shared Savings Program by forming or participating in an Accountable
Care Organization (ACO). The final rule establishing the Shared Savings
Program appeared in the November 2, 2011 Federal Register (Medicare
Program; Medicare Shared Savings Program: Accountable Care
Organizations; final rule (76 FR 67802) (hereinafter referred to as the
``November 2011 final rule'')). A subsequent major update to the
program rules appeared in the June 9, 2015 Federal Register (Medicare
Program; Medicare Shared Savings Program: Accountable Care
Organizations; final rule (80 FR 32692) (hereinafter referred to as the
``June 2015 final rule'')). The final rule entitled, ``Medicare
Program; Medicare Shared Savings Program; Accountable Care
Organizations--Revised Benchmark Rebasing Methodology, Facilitating
Transition to Performance-Based Risk, and Administrative Finality of
Financial Calculations,'' which addressed changes related to the
program's financial benchmark methodology, appeared in the June 9, 2016
Federal Register (81 FR 37950) (hereinafter referred to as the ``June
2016 final rule'')). A final rule redesigning the Shared Savings
Program appeared in the December 31, 2018 Federal Register (Medicare
Program: Medicare Shared Savings Program; Accountable Care
Organizations-Pathways to Success; final rule) (83 FR 67816)
(hereinafter referred to as the ``December 2018 final rule''). In the
December 2018 final rule, we finalized a number of policies including
redesign of the participation options available under the program to
encourage ACOs to transition to two-sided models; new tools to support
coordination of care across settings and strengthen beneficiary
engagement; and revisions to ensure rigorous benchmarking.
We have also made use of the annual CY PFS rules to address quality
reporting for the Shared Savings Program and certain other issues. In
the CY 2019 PFS final rule, we finalized a voluntary 6-month extension
for existing ACOs whose participation agreements would otherwise expire
on December 31, 2018; allowed beneficiaries greater flexibility in
selecting their primary care provider and in the use of that selection
for purposes of assigning the beneficiary to an ACO if the clinician
they align with is participating in an ACO; revised the definition of
primary care services used in beneficiary assignment; provided relief
for ACOs and their clinicians impacted by extreme and uncontrollable
circumstances in performance year 2018 and subsequent years;
established a new Certified Electronic Health Record Technology (CEHRT)
threshold requirement; and reduced the Shared Savings Program quality
measure set from 31 to 23 measures (83 FR 59940 through 59990 and 59707
through 59715). In the CY 2018 PFS final rule (82 FR 53209 through
53226), we finalized revisions to several different policies under the
Shared Savings Program, including the assignment methodology, quality
measure validation audit process, use of the skilled nursing facility
(SNF) 3-day waiver, and handling of demonstration payments for purposes
of financial reconciliation and establishing historical benchmarks. In
addition, in the CY 2017 and CY 2018 Quality Payment Program final
rules (81 FR 77255 through 77260, and 82 FR 53688 through 53706,
respectively), we finalized policies related to the Alternative Payment
Model (APM) scoring standard under the Merit-Based Incentive Payment
System (MIPS), which reduced the reporting burden for MIPS eligible
clinicians who participate in MIPS APMs, such as the Shared Savings
Program.
As a general summary, in this CY 2020 PFS proposed rule, we:
Discuss aligning the Shared Savings Program quality
measure set with proposed changes to the Web Interface measure set
under MIPS per previously-finalized policy;
Propose a change to the claims-based measures;
Solicit comment on aligning the Shared Savings Program
quality score with the MIPS quality performance category score; and
Propose a technical change to correct a cross-reference
within a provision of the Shared Savings Program's regulations on the
skilled nursing facility (SNF) 3-day rule waiver, to conform with
amendments to Sec. 425.612 that were adopted in the December 2018
final rule;
1. Quality Measurement
a. Background
Section 1899(b)(3)(C) of the Act states that the Secretary shall
establish quality performance standards to assess the quality of care
furnished by ACOs and seek to improve the quality of care furnished by
ACOs over time by specifying higher standards, new measures, or both.
In the November 2011 final rule, we established a quality measure set
spanning four domains: Patient experience of care, care coordination/
patient safety, preventive health, and at-risk population (76 FR 67872
through 67891). Since the Shared Savings Program was established, we
have updated the measures that comprise the quality performance measure
set for the Shared Savings Program through the annual rulemaking in the
CY 2015, 2016, 2017, and 2019 PFS final rules (79 FR 67907 through
67920, 80 FR 71263 through 71268, 81 FR 80484 through 80489, and 83 FR
59707 through 59715 respectively).
As we stated in the November 2011 final rule establishing the
Shared Savings Program (76 FR 67872), our principal goal in selecting
quality measures for ACOs has been to identify measures of success in
the delivery of high-quality health care at the individual and
population levels, with a focus on outcomes. For performance year 2019,
23 quality measures will be used to determine ACO quality performance
(83 FR 59707 through
[[Page 40706]]
59715). The information used to determine ACO performance on these
quality measures will be submitted by the ACO through the CMS Web
Interface, calculated by us from administrative claims data, and
collected via a patient experience of care survey referred to as the
Consumer Assessment of Healthcare Provider and Systems (CAHPS) for ACOs
Survey.
Eligible clinicians who are participating in an ACO and who are
subject to MIPS (MIPS eligible clinicians) will be scored under the APM
scoring standard under MIPS (81 FR 77260). These MIPS eligible
clinicians include any eligible clinicians who are participating in an
ACO in a track (or payment model within a track, such as Levels A-D of
the BASIC Track) of the Shared Savings Program that is not an Advanced
APM, as well as those participating in an ACO in a track (or payment
model within a track) that is an Advanced APM, but who do not become
Qualifying APM Participants (QPs) as specified in Sec. 414.1425, and
are not otherwise excluded from MIPS.
b. Proposed Changes to the CMS Web Interface and Claims-Based Measures
Since the Shared Savings Program was first established in 2012, we
have updated the quality measure set to reduce reporting burden and
focus on more meaningful, outcome-based measures. The most recent
updates to the Shared Savings Program quality measure set were made in
the CY 2019 PFS final rule (83 FR 59711). In the CY 2019 PFS final
rule, we explained that in developing the proposed changes to the
quality measure set for 2019, we had considered the agency's efforts to
streamline quality measures, reduce regulatory burden and promote
innovation as part of the agency's Meaningful Measures initiative (see
CMS Press Release, CMS Administrator Verma Announces New Meaningful
Measures Initiative and Addresses Regulatory Reform; Promotes
Innovation at LAN Summit, October 30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). We also noted that under the
Meaningful Measures initiative, we have committed to assessing only
those core issues that are most vital to providing high-quality care
and improving patient outcomes, with the aim of focusing on high-
priority measures, reducing unnecessary burden on providers, and
putting patients first. The changes made in the CY 2019 PFS final rule
reduced the Shared Savings Program quality measure set from 31 to 23
measures. Currently, more than half of the 23 Shared Savings Program
quality measures are outcome and high-priority measures, including:
Patient-experience of care measures collected through the
CAHPS for ACOs Survey that strengthen patient and caregiver experience.
Outcome measures supporting effective communication and
care coordination, such as unplanned admission and readmission
measures.
Intermediate outcome measures that address the effective
treatment of chronic disease, such as hemoglobin A1c control for
patients with diabetes.
As we stated in the CY 2019 PFS final rule (83 FR 59713), we seek
to align the Shared Savings Program measure set with changes made to
the CMS Web Interface measures under the Quality Payment Program. In
the 2017 PFS final rule, we stated that we do not believe it is
beneficial to propose CMS Web interface measures for ACO quality
reporting separately (81 FR 80499). Therefore, to avoid confusion and
duplicative rulemaking, we adopted a policy that any future changes to
the CMS Web interface measures would be proposed and finalized through
rulemaking for the Quality Payment Program, and that such changes would
be applicable to ACO quality reporting under the Shared Savings
Program. In accordance with the policy adopted in the CY 2017 PFS final
rule (81 FR 80501), we are not making any specific proposals related to
changes in CMS Web Interface measures reported under the Shared Savings
Program. Rather, we refer readers to Appendix 1, Table C (Existing
Quality Measures Proposed for Removal Beginning with the 2022 MIPS
Payment Year) and Table Group A (New Quality Measures Proposed for
Addition Beginning with the 2022 MIPS Payment Year) of this proposed
rule for a complete discussion of the proposed changes to the CMS Web
Interface measures for performance year 2020 (2022 MIPS Payment Year).
Based on the changes being proposed in Appendix 1, Table C of this
proposed rule, ACOs would no longer be responsible for reporting the
following measure for purposes of the Shared Savings Program starting
with reporting for performance year 2020:
ACO-14 Preventive Care and Screening Influenza Immunization
In the event we do not finalize the removal of this measure, we
would maintain the measure with the ``substantive'' change described in
Appendix 1, Table C (Previously Finalized Quality Measures Proposed for
Removal in the 2022 Payment Year and Future Years) of this proposed
rule. We have reviewed the proposed ``substantive'' change and we do
not believe that this change to the measure would require that we
revert the measure to pay-for-reporting for the 2020 performance year
as we could create a historical benchmark.
Additionally, in section III.I.3.B.(1) of this proposed rule, we
are proposing to add the following measure to the CMS Web Interface for
purposes of the Quality Payment Program:
ACO-47 Adult Immunization Status
Based on the policies being proposed for purposes of MIPS in
Appendix 1, Table Group A of this proposed rule, Shared Savings Program
ACOs would be responsible for reporting the Adult Immunization Status
measure (ACO-47) starting with quality reporting for performance year
2020. Consistent with our existing policy regarding the scoring of
newly introduced quality measures, this measure would be pay-for-
reporting for all ACOs for 2 years (performance years 2020 and
performance year 2021). The measure would then phase into pay-for-
performance beginning in performance year 2022 (Sec. 425.502(a)(4)).
In section III.J.3.c.(1)(d) of this rule, we note that as discussed
in Table DD (Previously Finalized Quality Measures with Substantive
Changes Proposed for the 2021 MIPS Payment Year), we have determined
based on extensive stakeholder feedback that the 2018 CMS Web Interface
measure numerator guidance for the Preventive Care and Screening:
Tobacco Use: Screening and Cessation Intervention (ACO-17) measure is
inconsistent with the intent of the CMS Web Interface version of this
measure as modified in the CY 2018 Quality Payment Program final rule
(82 FR 54164) and is unduly burdensome on clinicians. Moreover, due to
the current guidance, we are unable to rely on historical data to
benchmark the measure. Therefore, for the 2018 performance year we are
designating the measure pay-for-reporting in accordance with Sec.
425.502(a)(5). Additionally, in section III.J.3.c.(1)(d) of this
proposed rule, we are proposing to update the CMS Web Interface measure
numerator guidance for purposes of the Quality Payment Program. To the
extent that this proposed change constitutes a change to the Shared
Savings Program measure set after the start of the 2019 performance
period, we believe that, consistent with section 1871(e)(1)(A)(ii) of
the Act, it would be contrary to the public interest not to modify the
measure as proposed in Table DD because the current guidance is
inconsistent with the intent of the CMS Web Interface version of this
measure,
[[Page 40707]]
as modified in the CY 2018 QPP final rule, and unduly burdensome on
clinicians. If this modification is finalized as proposed, consistent
with our discussion in the CY 2018 PFS final rule, we expect we would
be able to use historical data reported on the measure to establish an
appropriate 2019 benchmark that aligns with the updated specifications
(82 FR 53214 and 53215) and the measure would be pay-for-performance
for performance year 2019 and subsequent year.
In addition, we note that AHRQ, which is the measure steward for
ACO-43--Ambulatory Sensitive Condition Acute Composite (AHRQ Prevention
Quality Indicator (PQI) #91) (version with additional Risk Adjustment),
made an update to the measure that will require a change to the measure
specifications for performance year 2020.\100\ Currently, ACO-43
assesses the risk adjusted rate of hospital discharges for acute PQI
conditions with a principal diagnosis of dehydration, bacterial
pneumonia, and urinary tract infection. The updated measure will only
include two conditions, bacterial pneumonia and urinary tract
infection. This measure is a composite measure and the rate of hospital
discharges is approximately equal to the sum of the rates of hospital
discharges for each of its components. Therefore, the removal of
dehydration will likely decrease the composite rate by approximately
the rate of dehydration discharges. Based on this substantive change,
we propose to redesignate ACO-43 as pay-for-reporting for 2020 and 2021
consistent with our policy under Sec. 425.502(a)(4), which provides
that a newly introduced measure is set at the level of complete and
accurate reporting for the first two reporting periods the measure is
required. However, we also considered creating a benchmark using
historical data for bacterial pneumonia and urinary tract infection and
keeping the measure pay-for-performance. As this is a claims-based
measure, we have access to historical data for both bacterial pneumonia
and urinary tract infection so we would be able to create a historical
benchmark for the revised measure. However, we believe that changes to
measures impact how ACOs, their ACO participants, and ACO provider/
suppliers allocate their resources and redesign their care process to
improve quality of care for their beneficiaries. As a result, our
proposal to revert the measure to pay-for-reporting for 2 years will
give ACOs time to refine care processes and educate clinicians while
also gaining experience with the refined composite measure and
understanding of performance under revised benchmarks prior to the
start of a pay for performance year.
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\100\ https://www.qualityindicators.ahrq.gov/News/Retirement%20Notice_v2019_Indicators.pdf.
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We seek comment on this proposal and the alternative approach
considered.
Table 32 shows the Shared Savings Program quality measure set for
performance year 2020 and subsequent performance years that would
result if the proposals in section III.I.3.B.(1) of this proposed rule
are finalized, including the phase-in schedule for the proposed Adult
Immunization Status measure (ACO-47).
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The net result, if the proposals in section III.I.3.b.(1) of this
proposed rule are finalized, would be a set of 23 measures on which
ACOs' quality performance would be assessed for performance year 2020
and subsequent performance years. The 4 domains would include the
following numbers of quality measures (See Table 33):
Patient/Caregiver Experience of Care-10 measures.
Care Coordination/Patient Safety-4 measures.
Preventive Health-6 measures.
At Risk Populations-3 measures.
Table 33 provides a summary of the number of measures by domain and
the total points and domain weights that would be used for scoring
purposes.
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c. Seeking Comment on Aligning the Shared Savings Program Quality Score
With the MIPS Quality Score
As discussed above, our principal goal in selecting quality
measures for the Shared Savings Program has been to identify measures
of success in the delivery of high-quality health care at the
individual and population levels, with a focus on outcomes. The Shared
Savings Program quality measure set currently consists of 23 measures
spanning four domains that are submitted by the ACO through the CMS Web
Interface, calculated by us for ACOs from administrative claims data,
and collected via a patient experience of care survey referred to as
the CAHPS for ACOs Survey. The number of measures within the four
domains has changed over time to reflect changes in clinical practice,
move towards more outcome and high-priority measures, align with other
quality reporting programs, and reduce burden; however, the overall
structure of four equally weighted measure domains has remained
consistent in determining ACOs' quality performance since the Shared
Savings Program was established in 2012. As provided in section
1899(d)(2) of the Act and Sec. 425.502(a) of the Shared Savings
Program regulations, ACOs must meet a quality performance standard to
qualify to share in savings. Currently, the quality performance
standard is based on an ACO's performance year rather than financial
track. The quality performance standard is defined at the level of full
and complete reporting (pay-for-reporting (P4R)) for the first
performance year of an ACO's first agreement period. In the second or
subsequent years of the first agreement period and all years of
subsequent agreement periods, quality measures are scored as pay-for-
performance (P4P) according to the phase-in schedule for the specific
measure and the ACO's performance year in the Shared Savings Program:
For all performance years, ACOs must completely and
accurately report all quality data used to calculate and assess their
quality performance.
CMS designates a performance benchmark and minimum
attainment level for each P4P measure and establishes a point scale for
the measure. An ACO's quality performance for a measure is evaluated
using the appropriate point scale, and these measure specific scores
are used to calculate the final quality score for the ACO.
ACOs must meet minimum attainment (defined as the 30th
percentile benchmark for P4P measures) on at least one measure in each
domain
[[Page 40710]]
to be eligible to share in any savings generated (Sec.
425.502(d)(2)(iii)(A)).
ACOs are rewarded for their quality performance on a sliding scale
on which higher levels of quality performance translate to higher rates
of shared savings and, depending on the track under which an ACO is
participating, may result in lower rates of shared losses. In addition,
ACOs that demonstrate significant quality improvement on measures in a
domain are eligible to receive a quality improvement reward (Sec.
425.502(e)(4)). Specifically, for each domain, ACOs can be awarded up
to four additional points for quality performance improvement on the
quality measures within the domain. These bonus points are added to the
total points that an ACO achieves for the quality measures within that
domain, but the total number of points cannot exceed the maximum total
points for the domain.
In the CY 2018 Quality Payment Program final rule, we finalized a
policy for the 2018 performance period and subsequent performance
periods that the quality performance category under the MIPS APM
Scoring Standard for MIPS eligible clinicians participating in a Shared
Savings Program ACO will be assessed based on measures collected
through the CMS Web Interface and the CAHPS for ACOs survey measures
(82 FR 53688 through 53706). We assign the same MIPS quality
performance category score to each Tax Identification Number (TIN)/
National Provider Identifier (NPI) in a Shared Savings Program ACO
based on the ACO's total quality score derived from the measures
reported via the CMS Web Interface and the CAHPS for ACOs survey.
Eligible clinicians in a Shared Savings Program ACO will receive full
credit for the improvement activities performance category in 2020
based on their performance of improvement activities required under the
Shared Savings Program. In addition, ACO participants report on the
Promoting Interoperability performance category at the group or solo
practice level for eligible clinicians subject to Promoting
Interoperability performance category. Data for the Promoting
Interoperability performance category is reported by ACO participants
at the TIN level and is then weighted and aggregated to get a single
ACO score for the performance category that applies to all eligible
clinicians participating in the ACO. These three categories in the APM
scoring standard are weighted as follows: Quality is 50 percent,
Improvement Activities is 20 percent, and Promoting Interoperability is
30 percent. Eligible Clinicians participating in the Shared Savings
Program are not assessed under the MIPS cost performance category as
these eligible clinicians are already subject to cost and utilization
performance assessments as part of the Shared Savings Program.
Therefore, the cost performance category is weighted at zero percent.
Eligible clinicians who reassign their billing rights to an ACO
Participant TIN in an Advanced APM (Track 2, Track 1+ ACO Model, BASIC
Track Level E, and ENHANCED Track) and who are included on the Advanced
APM Participation List on at least one of three snapshot dates (March
31, June 30, and August 31) during the performance year may become
Qualifying APM Participants (QPs) for the year, if they meet payment or
patient count thresholds. If these eligible clinicians attain QP status
for the performance year via their participation in the Shared Savings
Program ACO, they would receive an APM incentive payment and would not
be subject to the MIPS reporting requirements or payment adjustment for
the related payment year. However, they would be required to report
quality for purposes of the Shared Savings Program financial
reconciliation.
We recognize that ACOs and their participating providers and
suppliers have finite resources to dedicate to engaging in efforts to
improve quality and reduce costs for their assigned beneficiary
population. Although CMS has worked to align policies under the Shared
Savings Program with the Quality Payment Program, we recognize that
some differences in program methodologies for the Shared Savings
Program and MIPS remain and could potentially create conflicts for MIPS
eligible clinicians in an ACO who are attempting to strategically
transform their respective practices to earn shared savings under the
terms of the Shared Savings Program and a positive payment adjustment
under MIPS. Currently, under the Shared Savings Program, ACOs in
performance years other than the first performance year of their first
agreement period are allocated up to two points for quality measures
that are pay-for-performance, according to where their performance
falls, relative to benchmark deciles. Incomplete reporting of any CMS
Web Interface measure will result in zero points for all CMS Web
Interface measures and the ACO will fail to meet the quality
performance standard for the performance year. Similarly, if a CAHPS
for ACOs Survey is not administered and/or no data is transmitted to
CMS, zero points will be earned for all Patient/Caregiver Experience
measures and the ACO will fail to meet the quality standard for the
performance year. The quality measure set for the Shared Savings
Program also includes certain claims-based measures that are not part
of the MIPS quality performance category, and we currently calculate
performance rates on these claims-based measures for purposes of
determining an ACO's overall quality score under the Shared Savings
Program.
In contrast, when a group submits measures for the MIPS quality
performance category via the CMS Web Interface, each measure is
assessed against its benchmark to determine how many points the measure
earns. For the 2019 MIPS performance period, a group can receive
between 3 and 10 points for each MIPS measure (not including bonus
points) that meets the data completeness and case minimum requirements
by comparing measure performance to established benchmarks. If a group
fails to meet the data completeness requirement on one of the CMS Web
Interface measures, it receives zero points for that measure; however,
all other CMS Web Interface measures that meet the data completeness
requirement are assessed against the measure benchmarks, and the points
earned across all measures are included in the quality performance
category score. Currently, the only administrative claims-based measure
used in MIPS is the All-Cause Readmission measure, which is only
calculated for groups with 16 or more eligible clinicians. These
differences between the Shared Savings Program quality measure set and
the MIPS quality measure set highlight the different quality
measurement approaches for which Shared Savings Program ACOs must
simultaneously evaluate, prioritize, and target resources that may be
better directed toward patient care if the quality measurement
approaches under the Shared Savings Program and MIPS were more closely
aligned.
We believe that using a single methodology to measure quality
performance under both the Shared Savings Program and the MIPS would
allow ACOs to better focus on increasing the value of healthcare,
improving care, and engaging patients, and reduce burden as ACOs would
be able to track to a smaller measure set under a unified scoring
methodology. Accordingly, we are soliciting comment on how to
potentially align the Shared Savings Program quality reporting
requirements and scoring methodology more closely with the MIPS quality
reporting requirements and scoring methodology.
[[Page 40711]]
First, we are requesting comments on replacing the Shared Savings
Program quality score with the MIPS quality performance category score,
for ACOs in Shared Savings Program tracks (or payment models within a
track) that do not meet the definition of an Advanced APM (currently,
Track 1 and BASIC Track Levels A, B, C and D). Allowing for a single
quality performance score for both programs would eliminate the need
for ACOs to focus their resources for quality improvement on maximizing
performance under two separate quality reporting requirements with
distinct scoring methodologies. Currently, for ACOs in tracks (or
payment models within a track) that do not meet the definition of an
Advanced APM, the MIPS quality performance category score is calculated
based on the measures reported by the ACO via the CMS Web Interface and
the CAHPS for ACO survey measures. For Shared Savings Program quality
scoring purposes, we could utilize the MIPS quality performance
category score, converted to a percentage of points earned out of the
total points available, as the ACO's quality score for purposes of
financial reconciliation under the Shared Savings Program. We note that
for performance year 2017 (the only year from which we have complete
data available), the weighted mean MIPS quality performance category
score for ACOs in Shared Savings Program tracks (or payment models
within a track) that do not meet the definition of an Advanced APM) was
45.01 and the weighted median MIPS quality performance score for these
ACOs was 46.8, out of a possible 50 points assigned for the quality
performance category.
ACOs in tracks (or payment models within a track) that meet the
definition of an Advanced APM whose eligible clinicians are QPs for the
year and thus are excluded from the MIPS reporting requirements, do not
receive a quality performance category score under MIPS. Instead the
quality data the ACO reports to the CMS Web Interface is used along
with the ACO's CAHPS data and the administrative claims-based measures
calculated by us, solely for the purpose of scoring the quality
performance of the ACO under the Shared Savings Program quality scoring
methodology. As an alternative, given that we currently collect the
necessary data from these ACOs, we could also calculate a quality score
for these ACOs under the MIPS scoring methodology, and use this score
to assess the quality performance of the ACO for purposes of the Shared
Savings Program. Using this score would also inform eligible clinicians
participating in these ACOs of their MIPS quality score in the event
that they lose QP status and are scored under the MIPS APM scoring
standard.
Utilizing a MIPS quality performance category score to assess the
quality performance for purposes of the Shared Savings Program ACOs in
tracks (or payment models within a track) that qualify as an Advanced
APM would not change whether eligible clinicians participating in the
ACO obtain QP status and are excluded from MIPS, nor would it change
the ACO participant TINs' eligibility to receive Advanced APM incentive
payments. Rather, under this approach we would utilize the same scoring
methodology to determine the quality performance, for Shared Savings
Program ACOs that are participating in Advanced APMs as would be used
to assess the quality performance of ACOs in Shared Savings Program
tracks (or payment models within a track) that do not meet the
definition of an Advanced APM, creating further alignment of
performance results and further synergies between the Shared Savings
Program and MIPS. We welcome comment on the approach of using the MIPS
quality performance category score to assess quality performance for
purposes of the Shared Savings Program quality performance standard for
ACOs that are in tracks (or payment models within a track) that qualify
as Advanced APMs. We also welcome comment on potential alternative
approaches for scoring Shared Savings Program quality performance in a
way that more closely aligns with MIPS.
In addition, we note that we are also soliciting comment on
simplifying MIPS by implementing a core measure set using
administrative claims-based measures that can be broadly applied to
communities or populations and developing measure set tracks around
specialty areas or public health conditions to standardize and provide
more cohesive reporting and participation. We refer readers to section
III.I.3.a.(3) of this proposed rule for more information on these
approaches.
Currently, for ACOs in tracks (or payment models within a track)
that do not meet the definition of an Advanced APM, the MIPS quality
performance category score is calculated based on the measures reported
by the ACO via the CMS Web Interface and the CAHPS for ACO survey
measures. In section III.I.3.b.(1)(ii) of this proposed rule, we are
proposing to add the MIPS All-Cause Unplanned Admission for Patients
with Multiple Chronic Conditions (MCC) measure to the MIPS quality
performance category. If this measure were to be added to MIPS quality
performance category, implementation of the measure would be delayed
until the 2021 performance period for MIPS as explained in section
III.I.3.B.(1)(ii). If the MCC measure were to be included in the MIPS
quality performance category, we would also consider including the MIPS
claims-based measures (MCC and MIPS All-Cause Readmission measure) in
the MIPS APM scoring standard for ACOs in tracks (or payment models
within a track) that are not Advanced APMs and in the MIPS quality
performance category equivalent score for ACOs in tracks that are
Advanced APMs, in order to fully align the quality scoring methodology
under the Shared Savings Program with the MIPS scoring methodology to
reduce the burden on ACOs and their eligible clinicians of tracking to
multiple quality reporting requirements and quality scoring
methodologies. We would then use this score for purposes of assessing
quality performance under the Shared Savings Program for all ACOs.
These MIPS claims-based measures are similar to those currently used to
assess ACO quality under the Shared Savings Program. The proposed MIPS
MCC and ACO MCC are similar because they both target patients with
multiple chronic conditions but the cohort, outcome, and risk model for
the proposed MIPS MCC measure would vary from the ACO MCC measure. The
cohort for the ACO MCC includes eight conditions whereas the MIPS MCC
measure includes nine conditions, where the additional condition is
diabetes. The ACO MCC measure does not adjust for social risk factors
whereas the MIPS MCC measure adjusts for two area-level social risk
factors: (1) AHRQ socioeconomic status (SES) index; and (2) specialist
density. For more detailed information on the MIPS MCC measure please
refer to Appendix 1 Table AA (New Quality Measures Proposed for
Addition for the 2023 Payment Year and Future Years) of this proposed
rule. Both the MIPS and Shared Savings Program versions of the All-
Cause Readmission measure were developed to fully align with the
original hospital measure of Hospital-Wide Readmission. The MIPS and
Shared Savings Program versions of the All Cause Readmission measure
are essentially re-specifications of the same hospital measure and are
updated annually to maintain that alignment. Because of this, the
measures have a very similar, or identical, definition for included
patients, outcome definition, and risk adjustment model. The primary
[[Page 40712]]
difference among the measures is only the entity that is accountable--
either an ACO or a MIPS-eligible clinician--but the specifications are
otherwise aligned. We also welcome comment on potentially including all
of the MIPS claims-based measures in the MIPS quality performance
category score for ACOs (instead of the 3 claims-based measures that
are currently included in the Shared Savings Program quality score),
and using this score (converted to a percentage of points earned out of
the total points available) in place of the current Shared Savings
Program quality score to assess quality performance for all ACOs for
purposes of the Shared Savings Program. We note that we would also
continue to assess ACOs on the CAHPS for ACOs survey but quality
performance would be calculated by MIPS based on the methodology used
for scoring the CAHPS for MIPS survey and included in the MIPS quality
performance category score. The scoring and benchmarking approach for
the CAHPS for MIPS is to assign points based on each summary survey
measure (SSM) and then average the points for all the scored SSMs to
calculate the overall CAHPS score. In contrast, ACOs currently, receive
up to 2 points for each of the 10 SSMs for a total of 20 points.
In addition, we are soliciting comment on determining the threshold
for minimum attainment in the Shared Savings Program using the MIPS APM
quality performance category scoring. As noted previously in this
section, ACOs in the first performance year of their first agreement
period are considered to have met the quality performance standard and
therefore to be eligible to share in savings or minimize shared losses,
if applicable, when they completely and accurately report all quality
measures. ACOs in all other performance years are required to
completely and accurately report and meet the minimum attainment level
on at least one measure in each domain, to be determined to have met
the quality performance standard and to be eligible to share in
savings. For these ACOs, minimum attainment is defined as a score that
is at or above 30 percent or the 30th percentile of the performance
benchmark. The 30th percentile for the Shared Savings Program is the
equivalent of the 4th decile performance benchmark under MIPS APM
quality performance category scoring. As we look to more closely align
with MIPS quality performance category scoring in future years, we are
considering how to determine whether ACOs have met the minimum
attainment level. For example, minimum attainment could continue to be
defined as complete and accurate reporting for ACOs in their first
performance year of their first agreement period, while a MIPS quality
performance category score that is at or above the 4th decile across
all MIPS quality performance category scores would be required for ACOs
in all other performance years under the Shared Savings Program. ACOs
with quality scores under the 4th decile of all MIPS quality
performance category scores would not meet the quality performance
standard for the Shared Savings Program and thus would not be eligible
to share in savings or would owe the maximum shared losses, if
applicable. In addition, ACOs with quality scores under the 4th decile
of all MIPS quality performance category scores would be subject to
compliance actions and possible termination. We recognize that a
requirement that ACOs achieve an overall MIPS quality performance
category score (or equivalent score) that meets or exceeds the 4th
decile across all MIPS quality performance category scores is a higher
standard than the current requirement that ACOs meet the 30th
percentile on one measure per Shared Savings Program quality domain;
however, section 1899(b)(3)(C) of the Act not only gives us discretion
to establish quality performance standards for the Shared Savings
Program, but also indicates that we should seek to improve the quality
of care furnished by ACOs over time by specifying higher standards. We
believe that increasing the minimum attainment level would incentivize
improvement in the quality of care provided to the beneficiaries
assigned to an ACO. Furthermore, consistent with section 1899(b)(3)(C)
of the Act, it is appropriate to require a higher standard of care in
order for ACOs to continue to share in any savings they achieve. Given
the maturity of the Shared Savings Program, we are also considering
setting a higher threshold, such as the median or mean quality
performance category score across all MIPS quality category scores, for
determining eligibility to share in savings under the Shared Savings
Program for all ACOs, other than those ACOs in their first performance
year of their first agreement period. We welcome comment on these
potential approaches or other approaches for determining Shared Savings
Program quality minimum attainment using MIPS data.
We are also seeking comment on how to potentially utilize the MIPS
quality performance category score to adjust shared savings and shared
losses under the Shared Savings Program, as applicable. Currently, for
all Shared Savings Program ACOs and Track 1+ Model ACOs, the ACO's
quality score is multiplied with the maximum sharing rate of the track
to determine the final sharing rate and therefore the amount of shared
savings, if applicable. For some ACOs under two-sided models,
specifically ACOs in Track 2 and the ENHANCED track, the ACO's quality
score is also used in determining the amount of shared losses owed, if
applicable. Under Track 2 and the ENHANCED track, the loss sharing rate
is determined as 1 minus the ACO's final sharing rate based on quality
performance, up to a maximum of 60 percent or 75 percent, respectively.
Under the Track 1+ Model and two-sided models of the BASIC track
(Levels C, D and E), the amount of shared losses is determined based on
a fixed 30 percent loss sharing rate, regardless of the ACO's quality
score. Thus, a higher quality score results in the ACO receiving a
higher proportion of shared savings in all Shared Savings Program
tracks and the Track 1+ Model, or greater mitigation of shared losses
in Track 2 and the ENHANCED track. We could apply the MIPS quality
performance category score to determine ACOs' shared savings and shared
losses, if applicable, in the same manner. For instance, as an
alternative to the current approach to determining shared savings
payments for Shared Savings Program ACOs, we could establish a minimum
attainment threshold, such as a score at or above the 4th decile of all
MIPS quality performance category scores or the median or mean quality
performance category score, that if met would allow ACOs to share in
savings based on the full sharing rate of their track. We welcome
comment on these or other potential approaches for utilizing the MIPS
quality performance category score or an alternative score in
determining shared savings or shared losses under the Shared Savings
Program.
In addition, we are considering an option under which we would
determine the MIPS quality performance category score for all Shared
Savings Program ACOs as it is currently calculated for non-ACO group
reporters using the CMS Web Interface. That is, ACOs would receive a
score for each of the measures they report and zero points for those
measures they do not report. This would be a change from the current
methodology under which ACOs must report all Web Interface measures to
complete quality reporting. We note that currently, for ACOs in the
first year of their first agreement period,
[[Page 40713]]
minimum attainment is set at the level of complete and accurate
reporting of all measures. If we were to adopt the MIPS quality
performance category score as the Shared Savings Program quality score,
we would consider no longer imposing a different quality standard for
ACOs in the first year of their first participation agreement versus
ACOs in later performance years. Given that the Shared Savings Program
is evolving and many Medicare quality programs including MIPS are
incentivizing performance rather than reporting, we are considering no
longer transitioning from pay-for-reporting to pay-for-performance
during an ACO's first agreement period in the Shared Savings Program.
We believe that requiring all ACOs regardless of time in the program to
be assessed on quality performance would be an appropriate policy since
nearly 100 percent of ACOs consistently satisfactorily report all
quality measures. We welcome comment on this alternative for
determining the MIPS quality performance category score.
Lastly, we are seeking comment on using the MIPS quality
improvement scoring methodology rather than the Shared Savings Program
Quality Improvement Reward to reward ACOs for quality improvement.
Under the Shared Savings Program, we currently allow ACOs not in their
first performance year in the program to earn a Quality Improvement
Reward in each of the four quality domains. In contrast, under MIPS
improvement points are generally awarded as part of the MIPS quality
performance category score if a MIPS eligible clinician (1) has a
quality performance category achievement percent score for the previous
performance period and the current performance period; (2) fully
participates in the quality performance category for the current
performance period; and (3) submits data under the same identifier for
the 2 consecutive performance periods. If we were to adopt the MIPS
quality performance category score for the Shared Savings Program
quality score, quality improvement points earned under MIPS would be
included in that score, and we would not have a need to add additional
points to it. We welcome public comment on this or other approaches to
considering improvement as part of using the MIPS quality performance
category or an equivalent score, to determine quality performance under
the Shared Savings Program.
We are seeking stakeholder feedback on the approaches discussed in
this section of the proposed rule and any other recommendations
regarding the potential alignment of the Shared Savings Program quality
performance standard with the MIPS quality performance category in the
assessment of ACO quality performance in the future for purposes of the
Shared Savings Program.
2. Technical Change To Correct Reference in SNF-3 Day Rule Waiver
Provision
In the December 2018 final rule, we made a number of amendments to
Sec. 425.612 (83 FR 68080). As part of these amendments, we
redesignated paragraphs (a)(1)(v)(A) through (C) of Sec. 425.612 as
paragraphs (a)(1)(v)(C) through (E). In making these amendments, we
inadvertently omitted a necessary update to a cross-reference to one of
these provisions. Accordingly, we propose to remove the phase
``paragraph (a)(1)(v)(B)'' from Sec. 425.612(a)(1)(v)(E), and in its
place add the phrase ``paragraph (a)(1)(v)(D).''
F. Open Payments
1. Background
a. Open Payments Policies
The Open Payments program is a statutorily-mandated program that
promotes transparency by providing information about the financial
relationships between the pharmaceutical and medical device industry
and certain types of health care providers and makes the information
available to the public. Section 1128G of the Act requires
manufacturers of covered drugs, devices, biologicals, or medical
supplies (referred to as ``applicable manufacturers'') to annually
submit information for the preceding calendar year about certain
payments or other transfers of value made to ``covered recipients,''
currently defined as physicians and teaching hospitals.
Payments or other transfers of value that must be reported include
such things as research, honoraria, gifts, travel expenses, meals,
grants, and other compensation. The type of information required to be
reported includes, but is not limited to, the date and amount of the
payment or other transfer of value, identifying information about the
covered recipient, and details about products associated with the
transaction. When a payment or other transfer of value is related to
marketing, education, or research specific to a covered drug, device,
biological or medical supply, the name of that covered drug, device,
biological or medical supply also must be reported under section 1128G
of the Act. The estimated burden of these reporting requirements, as
outlined under OMB control number 0938-1237, is just over 1 million
hours over the course of 1 year.
Section 1128G of the Act establishes certain minimum dollar
thresholds for required reporting, with two bases for reporting,
individual and aggregate payments or transfers of value. To determine
if small individual payments or other transfers of value made to a
covered recipient exceed the aggregate threshold and must be reported,
applicable manufacturers and applicable GPOs must aggregate all
individual payments made across all payment categories within a given
reporting year. The statutory threshold established in 2013 was $10 for
individual payments, and $100 for aggregated payments, and this amount
has increased with the consumer price index each year. For CY 2019, the
annual reporting thresholds for individual payments or other transfers
of value is $10.79 and the aggregate amount is $107.91.
The Open Payments program yields transparency that provides
information to the general public that may influence their health care
decision-making and choice of providers, as well as information that
researchers looking into potential correlations between financial
relationships and provider behaviors may use. More than 51 million
records have been disclosed under the Open Payments program since
August 2013, enabling significant transparency into covered exchanges
of value. We have been committed to stakeholder engagement in an effort
to limit burden in the Open Payments program reporting processes and
improve clarity for the public. Additional background about the program
and guidance, including FAQs, about how the program works and what type
of information is required to be reported is available at www.cms.gov/OpenPayments.
In the February 8, 2013 Federal Register (78 FR 9458), we issued
regulations implementing section 1128G of the Act to create the Open
Payments program. Section 1128G of the Act requires manufacturers of
covered drugs, devices, biologicals, or medical supplies (referred to
as ``applicable manufacturers'') to submit information annually about
certain payments or other transfers of value made to ``covered
recipients,'' currently defined as physicians and teaching hospitals,
during the course of the preceding calendar year. Additionally, section
1128G of the Act defines covered drugs, devices, biologicals, or
medical supplies as those covered under Medicare or a State plan under
Medicaid or the CHIP
[[Page 40714]]
(or a waiver of such a plan); and requires applicable manufacturers and
applicable GPOs to disclose any ownership or investment interests in
such entities held by physicians or physician's immediate family
members, as well as information on any payments or other transfers of
value provided to such physician owners or investors. Under section
1128G(e)(10)(A) of the Act, the term ``payment or other transfer of
value'' refers to a transfer of anything of value, though some
exclusions apply.
In the CY 2015 PFS final rule with comment period (79 FR 67548), we
revised the regulations by standardizing reporting in the Open Payments
program. Specifically, we: (1) Deleted the definition of ``covered
device''; (2) removed the special rules for payments or other transfers
of value related to continuing education programs; (3) clarified the
marketed name reporting requirements for devices and medical supplies;
and (4) required stock, stock options, and any other ownership
interests to be reported as distinct forms of payment.
In the CY 2017 PFS proposed rule (81 FR 46395), we solicited
information from the public on a wide variety of information regarding
the Open Payments program. Since the implementation of the program and
changes made in the CY 2015 PFS final rule with comment period, various
commenters have provided us feedback. Consequently, we identified areas
in the rule that might benefit from revision and solicited public
comments to inform future rulemaking. We sought comment on whether the
nature of payment categories listed at Sec. 403.904(e)(2) are
adequately inclusive to facilitate reporting of all payments or
transfers of value, and sought ways to streamline or make the reporting
process more efficient while facilitating our role in oversight,
compliance, and enforcement, along with posing other program-specific
questions. A summary of solicited comments was published in the CY 2017
PFS final rule (81 FR 80428-80429).
On October 24, 2018, the Substance Use-Disorder Prevention that
Promotes Opioid Recovery and Treatment for Patients and Communities Act
(SUPPORT Act) (Pub. L. 115-270) was signed into law. Section 6111 of
the SUPPORT Act amended the definition of ``covered recipient'' under
section 1128G(e)(6) of the Act with respect to information required to
be submitted on or after January 1, 2022, to include physician
assistants (PA), nurse practitioners (NP), clinical nurse specialists
(CNS), certified registered nurse anesthetists (CRNA), and certified
nurse midwives (CNM), in addition to the previously listed covered
recipients of physicians and teaching hospitals. This rule proposes to
codify the Open Payments provisions from the SUPPORT Act, proposes to
address public comments received from the CY 2017 PFS proposed rule by
simplifying the process for reporting data by adjusting the nature of
payment categories, and proposes changes to standardize data on
reported covered drugs, devices, biologicals, or medical supplies.
b. Legal Authority
Three principal legal authorities from the Social Security Act
ground our proposed provisions:
Sections 1102 and 1871, which provide general authority
for the Secretary to prescribe regulations for the efficient
administration of the Medicare program.
Section 1861, which defines providers and suppliers.
Section 1128G, as amended by section 6111 of the SUPPORT
Act, which requires applicable manufacturers of drugs, devices,
biologicals, or medical supplies covered under Medicare or a State plan
under Medicaid or CHIP to report annually to the Secretary certain
payments or other transfers of value to physicians and teaching
hospitals, and to PAs, NPs, CNSs, CRNAs, and CNMs for information
required to be submitted under section 1128G of the Act on or after
January 1, 2022.
c. Proposed Changes
In this rule, we propose to revise several Open Payments
regulations at 42 CFR part 403. We are proposing that the following
provisions be effective for data collected beginning in CY 2021 and
reported in CY 2022: (1) Expanding the definition of a covered
recipient to include the categories specified in the SUPPORT Act; (2)
expanding the nature of payment categories; and (3) standardizing data
on reported covered drugs, devices, biologicals, or medical supplies.
We are also proposing a correction to the national drug codes (NDCs)
reporting requirements for drugs and biologicals that, should the rule
be finalized as proposed, would be effective 60 days following the
publication of the final rule. We believe this would give all
stakeholders sufficient time to prepare for these requirements.
(1) Expanding the Definition of a Covered Recipient
Section 1128G of the Act requires applicable manufacturers and
applicable GPOs to report annually information about certain payments
or other transfers of value made to covered recipients, as well as
ownership or investment interests held by physicians or their immediate
family members in such entities, though at section 1128G(e)(7) of the
Act it excepts physicians who are employed by the reporting
manufacturer, such that manufacturers do not report payments to their
own employees. As we noted previously, section 6111 of the SUPPORT Act
expanded the definition of covered recipients from physicians and
teaching hospitals to include PAs, NPs, CNSs, CRNAs, and CNMs; it
likewise expanded to these individuals the same exception for
manufacturer-employment. The SUPPORT Act requires these changes to be
in effect for information required to be submitted on or after January
1, 2022. In short, applicable manufacturers will be required to report
transfers of value pertaining to these additional provider types in the
same way they have been required to report transfers of value to
physicians and teaching hospitals. Since the information is reported to
CMS in the calendar year following the year in which it was collected,
this means that the data would be collected by the industry during CY
2021.
We are proposing to revise Sec. 403.902 to align with the
statutory requirements in sections 1128G(e)(6)(A) and (B) of the Act.
Specifically, we are proposing to revise the definition of ``covered
recipient'' in Sec. 403.902 to include PAs, NPs, CNSs, CRNAs, and
CNMs. In addition, we are proposing at Sec. 403.902 to reference the
definitions of these additional provider types as defined in sections
1861(aa)(5)(A), 1861(aa)(5)(B), 1861(bb)(2), and 1861(gg)(2) of the
Act.
We are also proposing to update certain provisions in part 403,
subpart I to include provider and supplier types other than physicians
as specified in sections 1128G(e)(6)(A) and (B) of the Act.
Specifically, we propose the following revisions:
In Sec. 403.902, to add the definitions of ``certified
nurse midwife,'' ``certified registered nurse anesthetist,'' ``clinical
nurse specialist,'' ``non-teaching hospital covered recipient,''
``nurse practitioner,'' and ``physician assistant.''
In Sec. 403.902, to revise the definition of ``covered
recipient'' by adding physician assistant, nurse practitioner, clinical
nurse specialist, certified registered nurse anesthetist, or certified
nurse-midwife'' after the phrase ``Any physician.''
In Sec. 403.904(c)(1), (f)(1)(i)(A), and (h)(7), to
replace the term ``physician''
[[Page 40715]]
with the phrase ``non-teaching hospital.''
In Sec. 403.904(c)(3), to replace the term ``physician''
in the title with the phrase ``non-teaching hospital,'' add the phrase
``non-teaching hospital'' after ``In the case of a,'' and remove the
phrase ``who is a physician'' from the text.
In Sec. 403.904(c)(3)(ii) and (iii), (f)(1)(i)(A)(1),
(f)(1)(i)(A)(3) and (5), and (f)(1)(v), to change the term
``physician'' to the phrase ``non-teaching hospital covered
recipient.''
In Sec. 403.904(h)(13), to remove the phrase ``who is a
physician'' and add the phrase ``non-teaching hospital'' after ``In the
case of.''
In Sec. 403.904(f)(1), to remove the phrase ``(either
physicians or teaching hospitals).''
In Sec. 403.908(g)(2)(ii), to change the words
``physicians and teaching hospitals'' to the term ``Covered
recipients.''
(2) Nature of Payment Categories
Applicable manufacturers and applicable GPOs must characterize the
nature of payments made to covered recipients by selecting the ``Nature
of Payment'' category that most closely describes the reported payment.
Some of the ``Nature of Payment'' categories, as specified at Sec.
403.904(e)(2), are specifically required by section 1128G(a)(1)(A)(vi)
of the Act, while the statute also allows the Secretary to define any
other nature of payment or other transfer of value.
Based upon information we obtained from the public comments
solicited in the CY 2017 PFS proposed rule (81 FR 46395), stakeholders
have identified debt forgiveness, long term medical supply or device
loan, and acquisitions (among others) as useful categories to add to
comply with the general reporting requirement under section
1128G(a)(1)(A) of the Act. Therefore, and so as to add clarity to the
types of payments or transfers of value made by applicable manufactures
and applicable GPOs to covered recipients, we are proposing to revise
the ``Nature of Payment'' categories in Sec. 403.904(e)(2) by
consolidating two duplicative categories and by adding the three new
categories described below.
First, the categories that we are proposing to consolidate include
two separate categories for continuing education programs. Section
1128G(a)(1)(A)(vi)(XIII) of the Act requires manufacturers to report
direct compensation for serving as faculty or a speaker for medical
education programs. The current Sec. 403.904(e)(2)(xiv) and (xv)
distinguish between accredited/certified and unaccredited/non-certified
continuing education programs. At proposed revised Sec.
403.904(e)(2)(xv), we are proposing to consolidate these categories and
make the regulatory wording match the statutory language ``medical
education programs,'' which we believe would streamline the reporting
requirements while not detracting from the underlying context of the
data. Although we defined separate categories at the inception of the
Open Payments program, we no longer believe that the distinction in
this category is necessary.
In addition, we are proposing three additional categories that
would operate prospectively and would not require the updating of
previously reported payments or other transfers of value that may fall
within these new categories.
The three new categories are as follows:
Debt Forgiveness (proposed Sec. 403.904(e)(2)(xi)): This
would be used to categorize transfers of value related to forgiving the
debt of a covered recipient, a physician owner, or the immediate family
of the physician who holds an ownership or investment interest.
Long-Term Medical Supply or Device Loan (proposed new
Sec. 403.904(e)(2)(xiv)): Section 403.904 currently contains an
exclusion from reporting for the loan of a covered device, or the
provision of a limited quantity of medical supplies for a short-term
trial period, not to exceed a loan period of 90 days, or a quantity of
90 days of average use, respectively. This new category would be used
to characterize the loans of covered devices or medical supplies for
longer than 90 days. (Note: We are proposing to combine current
paragraphs on continuing education programs Sec. 403.904(e)(2)(xiv)
and (xv) to replace paragraph (e)(2)(xv) as noted in the consolidating
continuing education programs above.)
Acquisitions (proposed Sec. 403.904(e)(2)(xviii)): This
addition would provide a category for characterizing buyout payments
made to covered recipients in relation to the acquisition of a company
in which the covered recipient has an ownership interest.
We also are proposing to add the definition of ``long-term medical
supply or device loan'' to Sec. 403.902 as ``the loan of supplies or a
device for 91 days or longer.'' For consistency within the definitions
section, we propose to redesignate Sec. 403.904(h)(5)--which contains
the definition of ``short-term medical supply or device loan'' to Sec.
403.902. As a result, we are proposing a new Sec. 403.904(h)(5) to be
``short-term medical supply or device loan.''
(3) Standardizing Data on Reported Covered Drugs, Devices, Biologicals,
or Medical Supplies
When applicable manufacturers or applicable GPOs report payments or
transfers of value related to specific drugs and biologicals, we
currently require names and NDCs to be reported to the Open Payments
program. However, based upon the lack of federally-recognized
identifiers when we started the Open Payments program, we have not
required analogous reporting for medical devices from the
manufacturers. However, the Food and Drug Administration (FDA)
established and continues to implement a system for the use of
standardized unique device identifiers (UDIs) for medical devices and
has issued regulations at 21 CFR part 801, subpart B, and 21 CFR part
830, requiring, among other things, that a UDI be included on the label
of most devices distributed in the United States. (See 78 FR 58785,
September 24, 2013.) Based upon the FDA's UDI regulatory requirements
and the HHS Office of the National Coordinator's requirement that UDIs
form part of the Common Clinical Data Set (45 CFR part 170), we believe
that the use of UDIs and device identifiers (DIs), a subcomponent of
the UDI, have become more standardized. Moreover, the HHS Office of
Inspector General (OIG) included a recommendation for Open Payments to
require more specific information about devices in an August 2018
report (OEI-03-15-00220).
With the standardization and typical use of UDIs and based upon
OIG's recommendation, we propose that the DI component, the mandatory
fixed portion of the UDI assigned to a device, if any, should be
incorporated into Open Payments reporting that applicable manufacturers
or applicable GPOs provide. We do not propose to require a full UDI. We
believe such a step would substantially aid in enhancing the quality of
the Open Payments data because the identifiers can be used to validate
submitted device information. This effort would also enhance the
usefulness of Open Payments data to the public by providing more
precise information about the medical supplies and devices associated
with a transaction. Specifically, we are proposing to revise Sec.
403.904(c)(8) to require applicable manufacturers and applicable GPOs
to provide the DIs (if any) to identify reported devices in a
comprehensive fashion meaningful to the users of Open Payments data and
reorganize the section accordingly.
[[Page 40716]]
We also seek to further clarify the reporting requirements with
regard to drugs and biologicals. Since the outset of the Open Payments
program, NDCs have been required for both research and non-research
payments. In Sec. 403.904(f)(1)(iv), we require that NDCs be reported
for drugs and biologicals used in research. However, in the CY 2015 PFS
final rule with comment period (79 FR 67548), the non-research payment
NDC requirement was erroneously removed when changes were made to the
rule text regarding marketed names. We propose to correct this error in
order to reiterate that NDCs are required for both research and non-
research payments and to make the change effective 60 days from
publishing the final rule.
We propose to revise Sec. 403.904(c)(8) to require DIs (if any) to
identify reported devices in a comprehensive fashion meaningful to the
users of Open Payments data and reorganize the section accordingly. We
also propose to reincorporate language that specifically requires
reporting of NDCs.
As a result of the proposed changes to Sec. 403.904(c)(8), we are
also proposing technical changes to Sec. 403.904(f)(1)(iv) and to add
mirrored definitions from 21 CFR 801.3 for ``device identifier'' and
``unique device identifier'' to Sec. 403.902.
G. Solicitation of Public Comments Regarding Notification of Infusion
Therapy Options Available Prior To Furnishing Home Infusion Therapy
Section 5012 of the 21st Century Cures Act (Cures Act) (Pub. L.
114-255; enacted December 13, 2016) created a separate Medicare Part B
benefit under section 1861(s)(2)(GG) and section 1861(iii) of the Act
to cover home infusion therapy-associated professional services for
certain drugs and biologicals administered intravenously or
subcutaneously through a pump that is an item of durable medical
equipment in the beneficiary's home, effective for January 1, 2021.
Section 5012 of the Cures Act also added section 1834(u) to the Act
that establishes the payment and related requirements for home infusion
therapy under this benefit.
Specifically, section 1834(u)(6) of the Act requires that prior to
the furnishing of home infusion therapy to an individual, the physician
who establishes the plan described in section 1861(iii)(1) of the Act
for the individual shall provide notification (in a form, manner, and
frequency determined appropriate by the Secretary) of the options
available (such as home, physician's office, hospital outpatient
department) for the furnishing of infusion therapy under this part.
We recognize there are several possible forms, manners, and
frequencies that physicians may use to notify patients of their
infusion therapy treatment options. For example, a physician may
verbally discuss the treatment options with the patient during the
visit and annotate the treatment decision in the medical records before
establishing the infusion plan. Some physicians may also provide
options in writing to the patient in the hospital discharge papers or
office visit summaries, as well as retain a written patient attestation
that all options were provided and considered. The frequency of
discussing these options could vary based on a routine scheduled visit
or according to the individual's clinical needs.
We are soliciting comments regarding the appropriate form, manner
and frequency that any physician must use to provide notification of
the treatment options available to their patient for the furnishing of
infusion therapy under Medicare Part B as required under section
1834(u)(6) of the Act. We also invite comments on any additional
interpretations of this notification requirement.
H. Medicare Enrollment of Opioid Treatment Programs and Enhancements to
General Enrollment Policies Concerning Improper Prescribing and Patient
Harm
1. Enrollment of Opioid Treatment Programs
a. Legislative and Regulatory Background
As previously explained in more detail in this proposed rule, the
SUPPORT Act was designed to alleviate the nationwide opioid crisis by:
(1) Reducing the abuse and supply of opioids; (2) helping individuals
recover from opioid addiction and supporting the families of these
persons; and (3) establishing innovative and long-term solutions to the
crisis. The SUPPORT Act attempts to fulfill these objectives, in part,
by establishing a new Medicare benefit category for opioid treatment
programs (OTPs) pursuant to section 2005 thereof. Section 2005(d) of
the SUPPORT Act amended section 1866(e) of the Act by adding a new
paragraph (3) classifying OTPs as Medicare providers (though only with
respect to the furnishing of opioid use disorder treatment services).
This will enable OTPs that meet all applicable statutory and regulatory
requirements to bill and receive payment under the Medicare program for
furnishing such services to Medicare beneficiaries.
b. Definition of and Certain Requirements for OTPs
As already mentioned, an OTP is currently defined in 42 CFR 8.2 as
a program or practitioner engaged in opioid treatment of individuals
with an opioid agonist treatment medication registered under 21 U.S.C.
823(g)(1). Section 2005(b) of the SUPPORT Act added a new section
1861(jjj)(2) to the Act defining an OTP as an entity that meets, among
other things, the definition of an OTP in Sec. 8.2 (or any successor
regulation). Section 1861(jjj)(2) of the Act also outlines certain
additional requirements that an OTP must meet to qualify as such. These
requirements include the following:
(1) Accreditation
Consistent with new section 1861(jjj)(2)(C) of the Act, as added by
section 2005(b) of the SUPPORT Act, and also required under 42 CFR
8.11(a)(2), an OTP must have a current, valid accreditation by an
accrediting body or other entity approved by the SAMHSA, the federal
agency that oversees OTPs. A core purpose of OTP accreditation is to
ensure that an OTP meets: (1) Certain minimum requirements for
furnishing medication-assisted treatment (MAT); and (2) the applicable
accreditation standards of SAMHSA-approved accrediting bodies, of which
there presently are six. The accreditation process includes, but is not
limited to, an accreditation survey, which involves an onsite review
and evaluation of an OTP to determine compliance with applicable
federal standards.
(2) Certification
A second requirement addressed in section 1861(jjj)(2)(B) of the
Act, as added by section 2005(b) of the SUPPORT Act, is also in current
regulations referenced in 42 CFR 8.11(a). Along with accreditation, an
OTP must have a current, valid certification by SAMHSA for such a
program. The prerequisites for certification (as well as the
certification process itself) are outlined in 42 CFR 8.11 and include,
but are not restricted to, the following:
Current and valid accreditation (as described previously);
Adherence to the federal opioid treatment standards
described in Sec. 8.12;
Compliance with all pertinent state laws and regulations,
as stated in Sec. 8.11(f)(1);
Per Sec. 8.11(f)(6), compliance with all regulations
enforced by the Drug Enforcement Administration (DEA)
[[Page 40717]]
under 21 CFR chapter II; this includes registration by the DEA before
administering or dispensing opioid agonist treatment medications; and
As stated in Sec. 8.11(a)(2), compliance with all other
conditions for certification established by SAMHSA.
Under Sec. 8.11(a)(3), certification is generally for a maximum 3-
year period, though this may be extended by 1 year if an application
for accreditation is pending. SAMHSA may revoke or suspend an OTP's
certification if any of the applicable grounds identified in Sec.
8.14(a) or (b), respectively, exist. Under Sec. 8.11(e)(1), an OTP
that has no current certification from SAMHSA but has applied for
accreditation with an accreditation body may obtain a provisional
certification for up to 1 year.
At the time of application for certification or any time
thereafter, an OTP may request from SAMHSA an exemption from the
regulatory requirements of Sec. Sec. 8.11 and 8.12. Section 8.11(h),
which governs the exemption process, cites an example of a private
practitioner who wishes to treat a limited number of patients in a non-
metropolitan area with few physicians and no rehabilitative services
geographically accessible; he or she may choose to seek an exemption
from some of the staffing and service standards.
According to SAMHSA statistics, there are currently about 1,677
active OTPs; of these, approximately 1,585 have full certifications and
92 have provisional certifications.
(3) OTP Enrollment
Most pertinent to the discussion and proposals below, section
2005(b) of the SUPPORT Act, which added a new section 1861(jjj)(2)(A)
to the Act, requires that an OTP be enrolled in the Medicare program
under section 1866(j) of the Act to qualify as an OTP and to bill and
receive payment from Medicare for opioid use disorder treatment
services. Per section 1861(jjj)(2)(A) of the Act, the provisions of
this proposed rule would establish requirements that OTPs must meet in
order to enroll in Medicare.
c. Current Medicare Enrollment Process
(1) Background
Section 1866(j)(1)(A) of the Act requires the Secretary to
establish a process for the enrollment of providers and suppliers in
the Medicare program. The overarching purpose of the enrollment process
is to help ensure that providers and suppliers that seek to bill the
Medicare program for services or items furnished to Medicare
beneficiaries are qualified to do so under federal and state laws. The
process is, to an extent, a ``gatekeeper'' that prevents unqualified
and potentially fraudulent individuals and entities from being able to
enter and inappropriately bill Medicare. As further explained below,
CMS and its Medicare Administrative Contractors (MACs; hereafter
occasionally referred to as ``contractors'') carefully and closely
screen and review Medicare enrollment applicants to verify that they
meet all applicable legal requirements.
CMS has taken various steps via regulation to outline a process for
enrolling providers and suppliers in the Medicare program. In the April
21, 2006 Federal Register (71 FR 20754), we published the ``Medicare
Program; Requirements for Providers and Suppliers to Establish and
Maintain Medicare Enrollment'' final rule that set forth certain
requirements in 42 CFR part 424, subpart P (currently Sec. Sec.
424.500 through 424.570) that providers and suppliers must meet to
obtain and maintain Medicare billing privileges. In the April 21, 2006
final rule, we cited sections 1102 and 1871 of the Act as general
authority for our establishment of these requirements, which were
designed for the efficient administration of the Medicare program.
Subsequent to the April 21, 2006 final rule, we published
additional provider enrollment regulations. These were intended not
only to clarify or strengthen certain components of the enrollment
process but also to enable us to take further action against providers
and suppliers: (1) Engaging (or potentially engaging) in fraudulent or
abusive behavior; (2) presenting a risk of harm to Medicare
beneficiaries or the Medicare Trust Funds; or (3) that are otherwise
unqualified to furnish Medicare services or items.
One of the provider enrollment regulations was the ``Medicare,
Medicaid, and Children's Health Insurance Programs; Additional
Screening Requirements, Application Fees, Temporary Enrollment
Moratoria, Payment Suspensions and Compliance Plans for Providers and
Suppliers'' final rule published in the February 2, 2011 Federal
Register (76 FR 5862). This final rule implemented various provisions
of the Affordable Care Act, including the following:
Added a new Sec. 424.514 that required submission of
application fees by institutional providers (as that term is defined in
Sec. 424.502) as part of the Medicare, Medicaid, and Children's Health
Insurance Program (CHIP) provider enrollment processes.
Added a new Sec. 424.518 that established Medicare,
Medicaid, and CHIP provider enrollment screening categories and
requirements based on the CMS-assessed level of risk of fraud, waste,
and abuse posed by a particular category of provider or supplier.
We also published the ``Medicare Program; Requirements for the
Medicare Incentive Reward Program and Provider Enrollment'' final rule
in the December 5, 2014 Federal Register (79 FR 72499) wherein we
addressed several vulnerabilities in the provider enrollment process.
As part of the December 2014 final rule--
We expanded the number of reasons for which we can: (1)
deny a prospective provider's or supplier's enrollment in the Medicare
program under Sec. 424.530; or (2) revoke the Medicare enrollment of
an existing provider or supplier under Sec. 424.535.
We supplemented the existing denial reason in Sec.
424.530(a)(3) such that we could deny a prospective provider's or
supplier's Medicare enrollment if a managing employee (as that term is
defined in Sec. 424.502) of the provider or supplier has, within the
10 years preceding enrollment or revalidation of enrollment, been
convicted of a federal or state felony offense that we determined to be
detrimental to the best interests of the Medicare program and its
beneficiaries.
We expanded the existing revocation reason in Sec.
424.535(a)(8) to allow us to revoke a provider's or supplier's
enrollment if we determine that the provider or supplier has a pattern
or practice of submitting claims that fail to meet Medicare
requirements.
In addition to these final rules, we have also made several other
regulatory changes to 42 CFR part 424, subpart P to address various
program integrity issues that have arisen.
(2) Form CMS-855--Medicare Enrollment Application
Under Sec. 424.510, a provider or supplier must complete, sign,
and submit to its assigned MAC the appropriate Form CMS-855 (OMB
Control No. 0938-0685) application in order to enroll in the Medicare
program and obtain Medicare billing privileges. The Form CMS-855, which
can be submitted via paper or electronically through the internet-based
Provider Enrollment, Chain, and Ownership System (PECOS) process (SORN:
09-70-0532, Provider Enrollment, Chain, and Ownership System) captures
information about the provider or supplier that is needed for CMS or
its MACs to determine whether the provider or supplier meets all
Medicare
[[Page 40718]]
requirements. Data collected on the Form CMS-855 is carefully reviewed
and verified by CMS or its MACs and includes, but is not limited to:
General identifying information (for example, legal
business name, tax identification number).
Licensure and/or certification data.
Any final adverse actions (as that term is defined in
Sec. 424.502) of the provider or supplier, such as felony convictions,
exclusions by the HHS Office of Inspector General (OIG), or state
license suspensions or revocations.
Practice locations and other applicable addresses of the
provider or supplier.
Information regarding the provider's or supplier's owning
and managing individuals and organizations and any final adverse
actions those parties may have.
As applicable, information about the provider's or
supplier's use of a billing agency.
The Form CMS-855 application is used for a number of provider
enrollment transactions, such as:
Initial enrollment: The provider or supplier is enrolling
in Medicare for the first time, enrolling in another MAC's
jurisdiction, or seeking to enroll in Medicare after having previously
been enrolled.
Change of ownership: The provider or supplier is reporting
a change in its ownership.
Revalidation: The provider or supplier is revalidating its
Medicare enrollment information in accordance with Sec. 424.515.
Reactivation: The provider or supplier is seeking to
reactivate its Medicare billing privileges after being deactivated
under Sec. 424.540.
Change of information: The provider or supplier is
reporting a change in its existing enrollment information in accordance
with Sec. 424.516.
After receiving a provider's or supplier's initial enrollment
application, reviewing and confirming the information thereon, and
determining whether the provider or supplier meets all applicable
Medicare requirements, CMS or the MAC will either: (1) Approve the
application and grant billing privileges to the provider or supplier
(or, depending upon the provider or supplier type involved, simply
recommend approval of the application and refer it to the state agency
or to the CMS regional office, as applicable); or (2) deny enrollment
under Sec. 424.530.
d. Proposed OTP Enrollment Provisions
(1) Legal Basis and Necessity
As mentioned earlier, section 1861(jjj)(2)(A) of the Act requires
OTPs to enroll in Medicare to bill and receive payment. In the
proposals discussed in this section III.I.3. of this proposed rule, we
outline the proposed requirements and procedures with which OTPs must
comply to enroll and remain enrolled in Medicare. In doing so, we are
relying on the authority granted to us not only under section
1861(jjj)(2)(A) of the Act but also under several other statutory
provisions. First, section 1866(j) of the Act provides specific
authority with respect to the enrollment process for providers and
suppliers. Second, sections 1102 and 1871 of the Act furnish general
authority for the Secretary to prescribe regulations for the efficient
administration of the Medicare program.
We believe, and it has been our longstanding experience, that the
provider enrollment process is invaluable in helping to ensure that:
(1) All potential providers and suppliers are carefully screened for
compliance with all applicable requirements; (2) problematic providers
and suppliers are kept out of Medicare; and (3) beneficiaries are
protected from unqualified providers and suppliers. Indeed, without
this process, the Medicare program and Medicare beneficiaries are
endangered, and billions of Trust Fund dollars may be paid to
unqualified or fraudulent parties.
Nor, we add, are our general concerns restricted to the mere need
and desire to establish provider enrollment requirements for OTPs.
Though a very critical one, provider enrollment is only a single
component of CMS' much broader program integrity efforts. We emphasize
that in establishing and implementing an overall Medicare OTP process
per the SUPPORT Act and implementing an overall program integrity
strategy, our objectives will extend to matters such as: (1) Monitoring
OTP billing patterns; (2) ensuring the proper payment of OTP claims;
(3) performing OTP audits as required by law; (4) making certain that
OTP beneficiaries receive quality care; and (5) taking action
(enrollment-related or otherwise) against non-compliant or abusive OTP
providers. In other words, it should not be assumed for purposes of the
OTP process that the term ``program integrity'' is limited to the
provider enrollment concept, for it actually applies to many other
types of payment safeguards as well.
(2) OTP Enrollment Requirements
(a) Addition of 42 CFR 424.67 and General OTP Requirement To Enroll
We propose to establish a new 42 CFR 424.67 that would include most
of our proposed OTP provisions. In paragraph (a), we are proposing that
in order for a program to receive Medicare payment for the provision of
opioid use disorder treatment services, the provider must qualify as an
OTP (as that term is defined in Sec. 8.2) and enroll in the Medicare
program under the provisions of subpart P of this part and this
section. As previously indicated, subpart P outlines the requirements
and procedures of the enrollment process. All providers and suppliers
that seek to bill Medicare must enroll in Medicare and adhere to all
enrollment requirements in subpart P. Proposed Sec. 424.67 would
implement the above-mentioned requirement stated in section
1861(jjj)(2)(A) of the Act.
(b) OTPs--Procedures and Compliance
In paragraph (b) of Sec. 424.67, we are proposing several specific
enrollment requirements that OTPs must meet that either clarify or
supplement those contained in subpart P.
(i) OTPs: Form CMS-855B
In Sec. 424.67(b)(1), we propose that an OTP must complete in full
and submit the Form CMS-855B application (``Medicare Enrollment
Application: Clinics/Group Practices and Certain Other Suppliers'')
(OMB Control No.: 0938-0685) and any applicable supplement or
attachment thereto (which would be submitted to OMB under control
number 0938-0685) to its applicable Medicare contractor. While we
recognize that the Form CMS-855B is typically completed by suppliers
rather than providers, we believe that certain unique characteristics
of OTPs (for example, OTPs would only bill Medicare Part B) make the
Form CMS-855B the most suitable enrollment application for OTPs. The
supplement or attachment would capture certain information that is: (1)
Unique to OTPs but not obtained via the Form CMS-855B; and (2)
necessary to enable CMS to effectively screen their applications and
confirm their qualifications.
As part of this general requirement concerning CMS-855 form
completion, we propose two subsidiary requirements as part of the
aforementioned supplement/attachment.
First, in Sec. 424.67(b)(1)(i), we propose that the OTP must
maintain and submit to CMS (via the applicable supplement or
attachment) a list of all physicians and other eligible professionals
(as the
[[Page 40719]]
term ``eligible professional'' is defined in section 1848(k)(3)(B) of
the Act) who are legally authorized to prescribe, order, or dispense
controlled substances on behalf of the OTP. The list must include the
physician's or other eligible professional's first and last name and
middle initial, Social Security Number, National Provider Identifier,
and (4) license number (if applicable). This requirement, in our view,
would enable us to: (1) Confirm that these individuals are qualified to
perform the activities in question; and (2) screen their prescribing
practices, the latter being an especially important consideration in
light of the nationwide opioid epidemic.
Second, we propose in Sec. 424.67(b)(1)(ii) that the OTP must
certify via the Form CMS-855B and/or the applicable supplement or
attachment thereto that the OTP meets and will continue to meet the
specific requirements and standards for enrollment described in Sec.
424.67(b) and (d) (discussed below). This is to help ensure that the
OTP fully understands its obligation to maintain constant compliance
with the requirements associated with OTP enrollment.
We do not believe that the requirements addressed in proposed Sec.
424.67(b)(1) duplicate any other information collection effort
involving OTPs. Indeed, the OTP enrollment process will capture various
data elements not collected via other means, such as the SAMHSA
certification process. Such data elements include the name, social
security number (SSN) and National Provider Identification (NPI) number
of all eligible professionals at the OTP who are legally authorized to
prescribe, order, or dispense controlled substances. While SAMHSA's
approved accreditation bodies do verify that these individuals have
appropriate licensure, they do not collect this information on a form,
screen against federal databases, or have a database that keeps this
information. CMS, however, intends to conduct these activities.
(ii) OTPs: Application Fee
As mentioned previously in our discussion of the February 2, 2011
final rule, under Sec. 424.514, prospective and revalidating
institutional providers that are submitting an enrollment application
generally must pay the applicable application fee. (For CY 2019, the
fee amount is $586.) Section 424.502 defines an institutional provider
as any provider or supplier that submits a paper Medicare enrollment
application using the Form CMS-855A, Form CMS-855B (not including
physician and non-physician practitioner organizations, which are
exempt from the fee requirement if they are enrolling as a physician or
non-physician practitioner organization), Form CMS-855S, Form CMS-
20134, or an associated internet-based PECOS enrollment application.
Since an OTP, as a specialized facility, would be required to complete
the Form CMS-855B to enroll in Medicare as an OTP (and would not be
enrolling as a physician and non-physician organization), we believe
that an OTP would meet the definition of an institutional provider
under Sec. 424.502. It would therefore be required to pay an
application fee consistent with Sec. 424.514; we are proposing to
clarify this requirement to pay the fee in new Sec. 424.67(b)(2).
(c) OTPs: Categorical Risk Designation
We previously referenced Sec. 424.518, which outlines screening
categories and requirements based on a CMS assessment of the level of
risk of fraud, waste, and abuse posed by a particular category of
provider or supplier. In general, the higher the level of risk that a
certain provider or supplier type poses, the greater the level of
scrutiny with which CMS will screen and review providers or suppliers
within that category.
There are three categories of screening in Sec. 424.518: High,
moderate, and limited. Irrespective of which category a provider or
supplier type falls within, the MAC performs the following screening
functions upon receipt of an initial enrollment application, a
revalidation application, or an application to add a new practice
location:
Verifies that a provider or supplier meets all applicable
federal regulations and state requirements for their provider or
supplier type.
Conducts state license verifications.
Conducts database checks on a pre- and post-enrollment
basis to ensure that providers and suppliers continue to meet the
enrollment criteria for their provider or supplier type.
However, providers and suppliers at the moderate and high
categorical risk levels must also undergo a site visit. Furthermore,
for those in the high categorical risk level, the MAC performs two
additional functions under Sec. 424.518(c)(2). First, the MAC requires
the submission of a set of fingerprints for a national background check
from all individuals who maintain a 5 percent or greater direct or
indirect ownership interest in the provider or supplier. Second, it
conducts a fingerprint-based criminal history record check of the
Federal Bureau of Investigation's Integrated Automated Fingerprint
Identification System on all individuals who maintain a 5 percent or
greater direct or indirect ownership interest in the provider or
supplier. These additional verification activities are intended to
correspond to the heightened risk involved.
There currently are only three provider or supplier types that fall
within the high categorical risk level under Sec. 424.518(c)(1):
Newly/initially enrolling home health agencies (HHAs); newly/initially
enrolling suppliers of durable medical equipment, prosthetics,
orthotics, and supplies (DMEPOS); and newly/initially enrolling
Medicare Diabetes Prevention Program (MDPP) suppliers. We are now
proposing to assign newly enrolling OTPs to the high categorical risk
level.
A principal concern is that, as indicated previously, we have no
historical information on OTPs (either from an enrollment, billing, or
claims payment perspective) upon which we can fairly estimate the
degree of risk they may pose. This is because OTP services are an
entirely new Medicare benefit. We expressed similar concerns regarding
our inclusion of MDPP suppliers in Sec. 424.518(c)(1). That is, in the
CY 2017 PFS proposed rule (81 FR 46162), we proposed to assign MDPP
suppliers to the high categorical risk level because the MDPP could
bring organization types that are entirely new to Medicare.
Our concerns about OTPs go well beyond the above-referenced lack of
historical information, though. The opioid epidemic has, in our view,
increased the potential for unscrupulous providers to take advantage of
Medicare beneficiaries through fraudulent billing schemes and abusive
prescribing practices; recent examples include ``patient brokers'' in
Massachusetts, as well as excessive stays in ``sober homes'' in
Florida. Furthermore, there is a heightened risk in OTP facilities
compared to other types of providers due to: (1) The core service
provided at the facilities--the prescribing and dispensing of methadone
and other opioids as part of medication-assisted treatment for opioid
addiction; and (2) the nature of the patients at the facilities, that
is, individuals grappling with opioid addiction. By assigning OTPs to
the ``high-risk'' screening level--thereby capturing fingerprints of
all 5 percent or greater owners and conducting site visits--we would be
taking a preventative approach to stopping fraudulent billing and
prescribing practices and keeping Medicare beneficiaries safe.
Given the foregoing, we are proposing four regulatory provisions.
First, we are
[[Page 40720]]
proposing to state in new Sec. 424.67(b)(3) that newly enrolling OTP
providers will be screened at the high categorical risk level in
accordance with the requirements of Sec. 424.518(c). Second, we are
proposing to add a new paragraph (iv) to Sec. 424.518(c)(1) that would
add newly enrolling OTPs to the types of providers and suppliers
screened at the high categorical risk level. Third, we are proposing to
add a new paragraph (xii) to Sec. 424.518(b)(1) whereby OTPs that are
revalidating their current Medicare enrollment (under Sec. 424.515)
would be screened at the moderate categorical risk level (which
involves a site visit but does not include the fingerprint submission
requirement of the high categorical risk level). This would be
consistent with our approach towards DMEPOS suppliers, HHAs, and MDPPs,
which are screened at the high categorical risk level when newly
enrolling and at the moderate level when revalidating. Fourth, and
consistent with the addition of new Sec. 424.518(b)(1)(xii), we
propose to require that, upon revalidation, the OTP successfully
complete the moderate categorical risk level screening required under
Sec. 424.518(b) in order to remain enrolled in Medicare. This
provision would be designated as new Sec. 424.67(d)(1)(iii); as
discussed below, proposed paragraph (d) addresses ongoing obligations
and standards with which enrolled OTPs must comply.
(d) OTPs: Certification
We are proposing in new Sec. 424.67(b)(4) that to enroll in
Medicare, an OTP must have in effect a current, valid certification by
SAMHSA for such a program. This requirement is consistent with both
section 1861(jjj)(2)(B) of the Act and Sec. 8.11. We consider SAMHSA
certification to be extremely important because it would: (1) Assist us
in ensuring that the provider is qualified to furnish OTP services; and
(2) help confirm that the provider is in compliance with the relevant
provisions of part 8 and other applicable requirements (such as federal
opioid treatment standards).
We noted earlier that, under Sec. 8.11(e), OTPs with no current
SAMHSA certification that have applied for accreditation with an
accreditation body are eligible to receive a provisional certification
for up to 1 year. To receive a provisional certification, an OTP must
submit to SAMHSA certain information required under Sec. 8.11(e),
along with:
A statement identifying the accreditation body to which
the OTP has applied for accreditation;
The date on which the OTP applied for accreditation;
The dates of any accreditation surveys that have taken
place or are expected to take place; and
The expected schedule for completing the accreditation
process.
Under proposed Sec. 424.67(b)(4)(ii), we state that we would not
accept a provisional certification under Sec. 8.11(e) in lieu of the
certification described in Sec. 8.11(a). As already mentioned, section
1861(jjj)(2)(B) of the Act states that an OTP must have in effect a
certification by SAMHSA, a requirement we interpret to mean full SAMHSA
certification rather than provisional certification. Indeed,
provisional certification under Sec. 8.11(e) applies to OTPs that do
not have a current SAMHSA certification but have applied for
accreditation with an accreditation body. Section 1861(jjj)(2)(C) of
the Act, however, requires actual accreditation rather than the mere
application for accreditation. Thus, we believe that full certification
should be required.
(e) OTPs: Managing Employees
Consistent with sections 1124 and 1124A of the Act, an enrolling
provider or supplier must disclose all of its managing employees on the
Form CMS-855 application. Section 424.502 of our regulations defines a
managing employee as a general manager, business manager,
administrator, director, or other individual that exercises operational
or managerial control over (or who directly or indirectly conducts) the
day-to-day operation of the provider or supplier, either under contract
or through some other arrangement, whether or not the individual is a
W-2 employee of the provider or supplier. We are proposing in new Sec.
424.67(b)(5) that all of the OTP's staff that meet the regulatory
definition of managing employee must be reported on the Form CMS-855
application and/or any applicable supplement. Such individuals would
include, but not be limited to, the OTP's medical director and program
sponsor (both as described in Sec. 8.2).
(f) Standards Specific to OTPs
Given the previously mentioned concerns about the nationwide opioid
crisis and the need for drugs to be prescribed and, moreover,
dispensed, in a careful, reasonable manner, we believe that OTPs should
adhere to certain standards unique to the services they provide. In
particular, we wish to ensure that problematic providers and personnel
are not prescribing or dispensing drugs on behalf of the OTP. To this
end, we propose the following additional requirements with which OTPs
must comply in order to enroll in Medicare.
In new Sec. 424.67(b)(6)(i), we propose that an OTP must not
employ or contract with a prescribing or ordering physician or other
eligible professional or with any individual legally authorized to
dispense narcotics who, within the preceding 10 years, has been
convicted (as that term is defined in 42 CFR 1001.2) of a federal or
state felony that we deem detrimental to the best interests of the
Medicare program and its beneficiaries, based on the same categories of
detrimental felonies, as well as case-by-case detrimental
determinations, found at 42 CFR 424.535(a)(3). This provision would
apply irrespective of whether the individual in question is: (1)
Currently dispensing narcotics at or on behalf of the OTP; or (2) a W-2
employee of the OTP. We note that SAMHSA recognizes the importance of
dispensing personnel in an OTP's operations by requiring, as part of
the certification process, disclosure of the names and state license
numbers of all OTP personnel (other than program physicians) who
legally dispense narcotic drugs even if they are not, at present,
responsible for administering or dispensing methadone at the program.
Such individuals include pharmacists, registered nurses, and licensed
practical nurses. (See https://www.samhsa.gov/medication-assisted-treatment/opioid-treatment-programs.apply.) We, too, acknowledge the
crucial roles of such persons in ensuring the safe dispensing of
medicines and believe that those with felonious histories pose a
potential risk to the health and safety of Medicare beneficiaries.
This overarching concern regarding possible patient harm also lies
behind our proposed standards in new Sec. 424.67(b)(6)(ii) and (iii).
In the former paragraph, we propose that the OTP must not employ or
contract with any personnel, regardless of whether the individual is a
W-2 employee of the OTP, who is revoked from Medicare under Sec.
424.535 or any other applicable section in Title 42, or who is on the
preclusion list under Sec. Sec. 422.222 or 423.120(c)(6). In Sec.
424.67(b)(6)(iii), we propose that the OTP must not employ or contract
with any personnel (regardless of whether the individual is a W-2
employee of the OTP) who has a current or prior adverse action imposed
by a state oversight board, including, but not limited to, a reprimand,
fine, or restriction, for a case or situation involving patient harm
that CMS deems detrimental to the best interests of the Medicare
program and its beneficiaries. We would consider the
[[Page 40721]]
factors enumerated at Sec. 424.535(a)(22) in each case of patient harm
that potentially applies to this provision.
Concerning Sec. 424.67(b)(6)(ii), we believe that OTP personnel
who are revoked from Medicare for problematic behavior present a
potential threat to the OTP's patients. We hold a similar view
regarding persons on the preclusion list (as that term is defined in
Sec. Sec. 422.2 and 423.100). Indeed, such individuals are precluded
from receiving payment for Medicare Advantage (MA) items and services
or Part D drugs furnished or prescribed to Medicare beneficiaries
under, respectively, Sec. Sec. 422.222 or 423.120(c)(6), due to, in
general, a prior felony conviction, a current revocation, or behavior
that would warrant a revocation if the person were enrolled in
Medicare. As for Sec. 424.67(b)(6)(iii), we discuss in detail our
proposed new revocation reason at Sec. 424.535(a)(22) in section
III.H.2. of this proposed rule. This proposed new revocation ground
pertains to improper conduct that led to patient harm. In light of the
aforementioned and critical need to preserve the safety of Medicare
beneficiaries, we believe that Sec. 424.67(b)(6)(iii) is an
appropriate requirement.
(g) Provider Agreement
(i) General Requirement
As previously mentioned, section 2005(d) of the SUPPORT Act amended
section 1866(e) of the Act by adding a new paragraph (3) classifying
OTPs as Medicare providers, though only with respect to the furnishing
of opioid use disorder treatment services. Under section 1866(a)(1) of
the Act, all Medicare providers (as that term is defined in section
1866(e) of the Act) must enter into a provider agreement with the
Secretary. Section 1866(a)(1) outlines required terms of the provider
agreement, such as allowed charges for furnished services.
Consistent with these requirements, and as previously discussed in
more detail in this proposed rule, we are proposing to revise various
sections of 42 CFR part 489 to include OTPs within the category of
providers that must sign a provider agreement in order to participate
in Medicare. To incorporate this requirement into Sec. 424.67 as a
prerequisite for enrollment, we propose to state in new Sec.
424.67(b)(7)(i) that an OTP must, in accordance with the provisions of
42 CFR part 489, sign (and adhere to the terms of) a provider agreement
with CMS in order to participate and enroll in Medicare.
(ii) Appeals
Under Sec. 489.53, we may terminate a provider agreement if any of
the circumstances outlined in that section apply (for example, the
provider under Sec. 489.53(a)(1) fails to comply with the provisions
of Title XVIII of the Act). The provider may, however, appeal any such
termination pursuant to 42 CFR part 498. This process is akin to what
occurs with Medicare revocations, whereby: (1) Medicare may revoke a
provider's or supplier's Medicare enrollment for any of the reasons
identified in Sec. 424.535; and (2) the provider or supplier may
appeal said revocation under part 498. There is, though, an additional
important result of the revocation process; under Sec. 424.535(b),
when a provider's or supplier's billing privileges are revoked, any
provider agreement in effect at the time of revocation is terminated
effective with the date of revocation.
Given this linkage in Sec. 424.535(b) between a revocation of
enrollment and the termination of a provider agreement, we are
concerned about the potential for duplicate appeals processes (that is,
one for the revocation and the other for the provider agreement
termination) involving a revoked OTP. The same concern, of course,
would apply in the reverse situation, in which a termination of the
provider agreement under Sec. 489.53 led to a revocation under Sec.
424.535 because a provider agreement is a requirement for enrollment
pursuant to proposed Sec. 424.67(b)(7)(i). We believe that having dual
appeals processes for OTPs would impose unnecessary administrative
burdens on OTPs and CMS. A single appeals process would, in our view,
be more efficient. To this end, we propose in new Sec.
424.67(b)(7)(ii) that an OTP's appeals under 498 of a Medicare
revocation (under Sec. 424.535) and a provider agreement termination
(under Sec. 489.53) must be filed jointly and, as applicable,
considered jointly by CMS under part 498 of this chapter. We note that
there is precedence for such a consolidated approach. Under Sec. Sec.
422.222(a)(2)(ii)(B) and 423.120(c)(6)(v)(B)(2) (which apply to
Medicare Part C and D, respectively), if a provider's or prescriber's
inclusion on the preclusion list (see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/PreclusionList.html for background information on the preclusion list)
is based on a contemporaneous Medicare revocation under Sec.
[thinsp]424.535, the appeals of the preclusion list inclusion and the
revocation must be filed jointly and considered jointly under part 498.
We would appreciate comment on our proposed consolidated appeals
process, including suggestions of alternative processes and the
potential operational components thereof.
(h) OTPs: Other Applicable Requirements
To ensure that the OTP meets all other applicable requirements for
enrollment, we are proposing at Sec. 424.67(b)(8)) that the OTP must
comply with all other applicable requirements for enrollment specified
in Sec. 424.67 and in part 424, subpart P.
(i) OTPs: Denial of Enrollment and Appeals Thereof
We are proposing to state in new Sec. 424.67(c)(1)(i) and (ii)
that CMS may deny an OTP's enrollment application on either of the
following grounds:
The provider does not have in effect a current, valid
certification by SAMHSA as required under Sec. 424.67(b)(4) or fails
to meet any other applicable requirement in Sec. 424.67.
Any of the reasons for denial of a prospective provider's
or supplier's enrollment application in Sec. 424.530 applies.
In new Sec. 424.67(c)(2), we are proposing that an OTP may appeal
the denial of its enrollment application under part 498.
We believe that Sec. 424.67(c)(1)(i) is necessary so as to comply
with the previously mentioned statutory and regulatory requirements
that an OTP be SAMHSA-certified. Concerning paragraphs (c)(1)(ii) and
(2), we note that because an OTP is a Medicare provider, it must be
treated in the same manner as any other provider or supplier for
purposes of enrollment and appeal rights; that is, subpart P and the
appeals provisions in part 498 apply to OTPs to the same extent they do
to all other providers and suppliers. We accordingly believe it is
appropriate to include paragraphs (c)(1)(ii) and (2) in this proposed
rule.
(j) OTPs: Continued Compliance, Standards, and Reasons for Revocation
For reasons identical to those behind our proposed addition of
paragraph (c), we propose several provisions in new Sec. 424.67(d).
In paragraph (d)(1), we are proposing to state that, upon and after
enrollment, an OTP:
Must remain validly certified by SAMHSA as required under
Sec. 8.11.
Remains subject to, and must remain in full compliance
with, the provisions of part 424, subpart P and
[[Page 40722]]
those in Sec. 424.67. This includes, but is not limited to, the
provisions of Sec. 424.67(b)(6), the revalidation provisions in Sec.
424.515, and the deactivation and reactivation provisions in Sec.
424.540.
In paragraph (d)(2), we are proposing that CMS may revoke an OTP's
enrollment if:
The provider does not have a current, valid certification
by SAMHSA or fails to meet any other applicable requirement or standard
in Sec. 424.67, including, but not limited to, the OTP standards in
Sec. Sec. 424.67(b)(6) and (d)(1).
Any of the revocation reasons in Sec. 424.535 applies.
Finally, in new paragraph (d)(3), we are proposing that an OTP may
appeal the revocation of its enrollment under part 498.
(k) OTPs: Prescribing Individuals
We believe it is important for us to be able to monitor the
prescribing and dispensing practices occurring at an OTP. We have an
obligation to ensure that beneficiary safety is maintained and the
Trust Funds are protected. Accordingly, we propose under new Sec.
424.67(e)(1) (and with respect to payment to OTP providers for
furnished drugs) that the prescribing or medication ordering
physician's or other eligible professional's National Provider
Identifier must be listed on Field 17 (the ordering/referring/other
field) of the Form CMS-1500 (Health Insurance Claim Form; 0938-1197)
(or the digital equivalent thereof)). We note that our use of the term
``medication ordering'' is merely intended to reiterate that our
proposed provision applies to any physician or other eligible
professional who prescribes or orders drugs in the OTP arena.
Section 424.67(e)(1), in our view, would help us: (1) Ensure that
the physician or other eligible professional in question is qualified
to prescribe drugs on behalf of the OTP; and (2) monitor the
prescribing individual in relation to each claim. This requirement
would have to be met in order for an OTP claim for a prescribed drug to
be paid. So as to avoid the impression, however, that this is the only
requirement necessary for claim payment, we propose to further clarify
in new paragraph (e)(2) that all other applicable requirements in Sec.
424.67, part 424, and part 8 must also be met.
(l) OTPs: Relationship to 42 CFR Part 8
To help ensure that OTPs understand their continuing need to comply
with the provisions in part 8 (several of which are referenced above)
and to clarify that the provisions in Sec. 424.67 are generally
restricted to the enrollment process, we propose to state in new Sec.
424.67(f) that Sec. 424.67 shall not be construed as: (1) Supplanting
any of the provisions in part 8; or (2) eliminating an OTP's obligation
to maintain compliance with all applicable provisions in part 8.
(m) Effective and Retrospective Date of OTP Billing Privileges
Section 424.520 of Title 42 outlines the effective date of billing
privileges for provider and supplier types that are eligible to enroll
in Medicare. Paragraph (d) thereof sets forth the applicable effective
date for physicians, non-physician practitioners, physician and non-
physician practitioner organizations, and ambulance suppliers. This
effective date is the later of: (1) The date of filing of a Medicare
enrollment application that was subsequently approved by a Medicare
contractor; or (2) the date that the supplier first began furnishing
services at a new practice location In a similar vein, Sec. 424.521(a)
states that physicians, non-physician practitioners, physician and non-
physician practitioner organizations, and ambulance suppliers may
retrospectively bill for services when the supplier has met all program
requirements (including state licensure requirements), and services
were provided at the enrolled practice location for up to:
30 days prior to their effective date if circumstances
precluded enrollment in advance of providing services to Medicare
beneficiaries; or
90 days prior to their effective date if a Presidentially-
declared disaster under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5206 (Stafford Act) precluded
enrollment in advance of providing services to Medicare beneficiaries.
To clarify the effective date of billing privileges for OTPs and to
account for circumstances that could prevent an OTP's enrollment prior
to the furnishing of Medicare services, we propose to include newly
enrolling OTPs within the scope of both Sec. 424.520(d) and Sec.
424.521(a). We believe that the effective and retrospective billing
dates addressed therein achieves a proper balance between the need for
the prompt provision of OTP services and the importance of ensuring
that each prospective OTP enrollee is carefully and closely screened
for compliance with all applicable requirements.
2. Revision(s) and Addition(s) to Denial and Revocation Reasons in
Sec. Sec. 424.530 and 424.535
a. Improper Prescribing
Under Sec. 424.535(a)(14), CMS may revoke a physician's or other
eligible professional's enrollment if he or she has a pattern or
practice of prescribing Part D drugs that:
Is abusive, and/or represents a threat to the health and
safety of Medicare beneficiaries; or
Fails to meet Medicare requirements.
This revocation reason was finalized in the ``Medicare Program;
Contract Year 2015 Policy and Technical Changes to the Medicare
Advantage and the Medicare Prescription Drug Benefit Programs'' final
rule that was published in the May 23, 2014 Federal Register (79 FR
29844). It was designed to address situations, which we discussed in
that final rule, where prescribers of Part D drugs engaged in
prescribing activities that were or could be harmful to Medicare
beneficiaries and the Trust Funds or were otherwise inconsistent with
Medicare policies. Since the provision's inception, we have revoked the
enrollments of practitioners who have engaged in a variety of improper
prescribing practices. We believe these administrative actions have
helped to shield beneficiaries and the program at large from improper
prescribing practices.
The dispensing of drugs in the treatment of opioid use disorder is,
as indicated previously, an important component of an OTP's function.
Akin to our rationale for the establishment of Sec. 424.535(a)(14) in
2014, we are concerned about potential instances where OTP physicians
and other eligible professionals prescribe drugs in an improper
fashion. This is an especially important consideration given the
nationwide opioid epidemic and the need to reduce opioid abuse. Given
this, we believe that Sec. 424.535(a)(14) should no longer be
restricted to Part D drugs but must extend to all Medicare drugs,
including Part B drugs. Improper prescribing in the Part B context is
no less troubling or potentially dangerous than prescribing in the Part
D context. Thus, only through such an expansion can we, on a much
broader and necessary scale, further deter parties from improper
Medicare prescribing practices.
In the introductory text of Sec. 424.535(a)(14), we currently
state that CMS determines that the physician or other eligible
professional has a pattern or practice of prescribing Part D drugs.
Consistent with the above discussion,
[[Page 40723]]
we are proposing to revise this paragraph to include Part B drugs so we
would specify the prescribing of ``Part B or D drugs.'' We note that
this proposal would affect prescriptions of any Part B or D drugs, not
merely those prescriptions given to beneficiaries using OTPs.
b. Patient Harm
As referenced previously, and due to the importance of ensuring
patient safety in all provider and supplier settings (not merely those
involving OTPs), we are also proposing to add Sec. 424.535(a)(22) as a
new revocation reason; this would be coupled with a concomitant new
denial reason in Sec. 424.530(a)(15). These two paragraphs would
permit us to revoke or deny, as applicable, a physician's or other
eligible professional's (as that term is defined in 1848(k)(3)(B) of
the Act) enrollment if he or she has been subject to prior action from
a state oversight board, federal or state health care program,
Independent Review Organization (IRO) determination(s), or any other
equivalent governmental body or program that oversees, regulates, or
administers the provision of health care with underlying facts
reflecting improper physician or other eligible professional conduct
that led to patient harm. In determining whether a revocation or denial
on this ground is appropriate, CMS would consider the following
factors:
The nature of the patient harm.
The nature of the physician's or other eligible
professional's conduct.
The number and type(s) of sanctions or disciplinary
actions that have been imposed against the physician or other eligible
professional by a state oversight board, IRO, federal or state health
care program, or any other equivalent governmental body or program that
oversees, regulates, or administers the provision of health care. Such
actions include, but are not limited to in scope or degree:
++ License restriction(s) pertaining to certain procedures or
practices,
++ Required compliance appearances before state oversight board
members,
++ Required participation in rehabilitation or mental/behavioral
health programs,
++ Required abstinence from drugs or alcohol and random drug
testing,
++ License restriction(s) regarding the ability to treat certain
types of patients (for example, cannot be alone with members of a
different gender after a sexual offense charge).
++ Administrative/monetary penalties; or
++ Formal reprimand(s).
If applicable, the nature of the IRO determination(s).
The number of patients impacted by the physician's or
other eligible professional's conduct and the degree of harm thereto or
impact upon.
Any other information that CMS deems relevant to its
determination.
We currently lack the legal basis to take administrative action
against a physician or other eligible professional for a matter related
to patient harm based solely on an IRO determination or an
administrative action (excluding a state medical license suspension or
revocation) imposed by a state oversight board, a federal or state
health care program, or any other equivalent governmental body or
program that oversees, regulates, or administers the provision of
health care. We believe, however, that our general rulemaking authority
under sections 1102, 1866(j)(1)(A), and 1871 of the Act gives us the
ability to establish such legal grounds. As alluded to in this proposed
rule and in previous rulemaking efforts, we have long been concerned
about instances of physician or other eligible professional misconduct,
and we believe our authority to take action to stem such behavior
should be expanded to include the scenarios identified in proposed
Sec. 424.530(a)(15) and Sec. 424.535(a)(22). Indeed, state oversight
boards, such as medical boards and other administrative bodies, have
found certain physicians and other eligible professionals to have
engaged in professional misconduct and/or negligent or abusive behavior
involving patient harm. IRO determinations, too, have offered valuable,
independent analyses and findings of provider misconduct that we should
have the opportunity to use to promote the best interests of Medicare
beneficiaries. We believe that our proposed revocation and denial
authorities would improve overall patient care by preventing certain
problematic physicians and other eligible professionals from treating
Medicare patients.
We recognize that situations could arise where a state oversight
board has chosen to impose a relatively minor sanction on physician or
other eligible professional for conduct that we deem more serious. We
note, however, that we, rather than state boards, is ultimately
responsible for the administration of the Medicare program and the
protection of its beneficiaries. State oversight of licensed physicians
or practitioners is, in short, a function entirely different from
federal oversight of Medicare. We accordingly believe that we should
have the discretion to review such cases to determine whether, in the
agency's view, the physician's or other eligible professional's conduct
warrants revocation or denial. Yet it should in no way be assumed, on
the other hand, that a very modest sanction would automatically result
in revocation or denial action. We emphasize that we would only take
such a measure after the most careful consideration of all of the
factors outlined above.
A number of these factors, we add, are not altogether dissimilar
from those which we presently use for determining whether a revocation
under Sec. 424.535(a)(14) is appropriate (for example, general
frequency and degree of the behavior in question, number of prior
sanctions). We have found them to be useful in our Sec. 424.535(a)(14)
determinations and, for this reason, believe they will prove likewise
with respect to Sec. 424.530(a)(15) and Sec. 424.535(a)(22). Certain
of our other proposed criteria are designed to pertain to the unique
facts addressed in these two provisions (for example, the extent of
patient harm) and, in our view, would help ensure a thorough review of
the case at hand.
Sections 424.530(a)(15) and 424.535(a)(22) would apply to
physicians and other eligible professionals in OTP and non-OTP
settings. Revocation or denial action could be taken against physicians
and other eligible professionals in solo practice or who are part of a
group or any other provider or supplier type.
To clarify the scope of the term ``state oversight board'' in the
context of Sec. Sec. 424.530(a)(15) and 424.535(a)(22), we propose to
define this term in Sec. 424.502. Specifically, we would state that,
for purposes of Sec. Sec. 424.530(a)(15) and 424.535(a)(22) only,
``state oversight board'' means ``any state administrative body or
organization, such as (but not limited to) a medical board, licensing
agency, or accreditation body, that directly or indirectly oversees or
regulates the provision of health care within the state.''
We welcome comment not only on our proposed definition of ``state
oversight board'' but also on our proposed revocation and denial
authorities. We are especially interested in securing public feedback
on additional means of preventing fraud, waste, and abuse in OTP
setting; for instance, we would appreciate suggestions--based on
stakeholder experience in the OUD and OTP arenas--from which we could
develop further regulatory authority to take action against problematic
OTPs.
[[Page 40724]]
I. Deferring to State Scope of Practice Requirements
When the Medicare program was signed into law in 1965, most skilled
medical professional services in the United States were provided by
physicians, with the assistance of nurses. Over the decades, the
medical professional field has diversified and allowed for a wider
range of certifications and specialties, including the establishment of
mid-level practitioners such as nurse practitioners (NPs) and physician
assistants (PAs). These practitioners are also known as advanced
practice providers (APPs) or non-physician practitioners (NPPs).
Medicare policies and regulations have been updated over recent years
to make changes to allow NPPs to provide services in Medicare-certified
facilities within the extent of their scope of practice as defined by
state law. In recognition of the qualifications of these practitioners,
we seek to continue this effort.
1. Ambulatory Surgical Centers
a. Background
Ambulatory surgical centers (ASCs), as defined at 42 CFR 416.2, are
distinct entities that operate exclusively for the purpose of providing
surgical services to patients not requiring hospitalization, in which
the expected duration of services would not exceed 24 hours following
an admission. The surgical services performed at ASCs are scheduled,
primarily elective, non-life-threatening procedures that can be safely
performed in an ambulatory setting. Currently, there are approximately
5,767 Medicare certified ASCs in the United States.
Section 1832(a)(2)(F)(i) of the Act specifies that ASCs must meet
health, safety, and other requirements specified by the Secretary in
order to participate in Medicare. The Secretary is responsible for
ensuring that the ASC Conditions for Coverage (CfCs) protect the health
and safety of all individuals treated by ASCs, whether they are
Medicare beneficiaries or other patients. The ASC regulations were
established in the ``Medicare Program; Ambulatory Surgical Services''
final rule published in the August 5, 1982 Federal Register (47 FR
34082), and have since been amended several times.
The regulations for Medicare and Medicaid participating ASCs are
set forth at 42 CFR part 416. Section 416.42, ``Condition for
coverage--Surgical services'', states that surgical procedures must be
performed in a safe manner by qualified physicians who have been
granted clinical privileges by the governing body of the ASC in
accordance with approved policies and procedures of the ASC.
Currently, the ASC CfCs have two conditions that include patient
assessment requirements for patients having surgery in an ASC,
anesthetic risk and pre-surgery evaluation, and pre-discharge
evaluation. In the November 18, 2008 final rule, ``Medicare Program;
Changes to the Hospital Outpatient Prospective Payment System and CY
2009 Payment Rates final rule (73 FR 68502), which revised some
existing standards and created some new requirements. One of the new
conditions added in 2008 was Sec. 416.52, ``Conditions for coverage--
Patient admission, assessment and discharge''. This condition sets
standards pertaining to patient pre-surgical assessment, post-surgical
assessment, and discharge requirements that must be met before patients
leave the ASC. Specifically, the discharge requirements at Sec.
416.52(b)(1) require that a post-surgical assessment be completed by a
physician, or other qualified practitioner, or a registered nurse with,
at a minimum, post-operative care experience in accordance with
applicable state health and safety laws, standards of practice, and ASC
policy. The other discharge condition, at Sec. 416.42(a)(2), also
finalized in the November 18, 2008 final rule, allows anesthetists, in
addition to physicians, to evaluate each patient for proper anesthesia
recovery. The requirement at Sec. 416.42(a)(1) requires a physician to
examine the patient immediately before surgery to evaluate the risk of
anesthesia and the procedure to be performed.
Through various inquiries from ASCs and communication with CMS by
industry associations, we have received many requests to align the
anesthetic risk and pre-surgery evaluation standard at Sec.
416.42(a)(1) with the pre-discharge standard at Sec. 416.42(a)(2) by
allowing an anesthetist, in addition to a physician, to examine the
patient immediately before surgery to evaluate the risk of anesthesia
and the risk of the procedure. For those ASCs that utilize non-
physician anesthetists, also known as certified registered nurse
anesthetists (CRNAs), this revision would allow them to perform the
anesthetic risk and evaluation on the patient they are anesthetizing
for the procedure to be performed by the physician. CRNAs are advanced
practice registered nurses who administer more than 43 million
anesthetics to patients each year in the United States. CRNAs are
Medicare Part B providers and since 1989, have billed Medicare directly
for 100 percent of the PFS amount for services. CRNAs provide
anesthesia for a wide variety of surgical cases and in some states are
the sole anesthesia providers in most rural hospitals. A study
published by Nursing Economic$ in May/June 2010, found that CRNAs
acting as the sole anesthesia provider are the most cost-effective
model for anesthesia delivery, and there is no measureable difference
in the quality of care between CRNAs and other anesthesia providers or
by anesthesia delivery model.\101\ We believe this alignment provides
for continuity of care for the patient and allows the patient's
anesthesia professional to have familiarity with the patient's health
characteristics and medical history.
---------------------------------------------------------------------------
\101\ Paul F. Hogan et al., ``Cost Effectiveness Analysis of
Anesthesia Providers.'' Nursing Economic$. 2010; 28:159-169.
---------------------------------------------------------------------------
b. Proposed Provisions
We are proposing to revise Sec. 416.42(a), Surgical services, to
allow either a physician or an anesthetist, as defined at Sec.
410.69(b), to examine the patient immediately before surgery to
evaluate the risk of anesthesia and the risk of the procedure to be
performed. By amending the CfCs to allow an anesthetist or a physician
to examine and evaluate the patient before surgery for anesthesia risk
and the planned procedure risk, we would be making ASC patient
evaluations more consistent by allowing the option for the same
clinician to complete both pre- and post-procedure anesthesia
evaluations.
This proposed change is a continuation of our efforts to reduce
regulatory burden. This change would increase supplier flexibility and
reduce burden, while allowing qualified clinicians to focus on
providing high-quality healthcare to their patients. We are also
requesting comments and suggestions for other ASC requirements that
could be revised to allow greater flexibility in the use of NPPs, and
reduce burden while maintaining high quality health care.
2. Hospice
a. Background
Hospice care is a comprehensive, holistic approach to treatment
that recognizes the impending death of a terminally ill individual, and
warrants a change in the focus from curative care to palliative care
for relief of pain and for symptom management. Medicare regulations
define ``palliative care'' as patient and family centered care that
optimizes quality of life by anticipating, preventing, and treating
suffering. Palliative care throughout the continuum of illness involves
addressing physical, intellectual,
[[Page 40725]]
emotional, social, and spiritual needs and to facilitate patient
autonomy, access to information, and choice (42 CFR 418.3). The goal of
hospice care is to help terminally ill individuals continue life with
minimal disruption to normal activities while remaining primarily in
the home environment. A hospice uses an interdisciplinary approach to
deliver medical, nursing, social, psychological, emotional, and
spiritual services through a collaboration of professionals and other
caregivers, with the goal of making the beneficiary as physically and
emotionally comfortable as possible. The hospice interdisciplinary
group works with the patient, family, caregivers, and the patient's
attending physician (if any) to develop a coordinated, comprehensive
care plan; reduce unnecessary diagnostics or ineffective therapies; and
maintain ongoing communication with individuals and their families and
caregivers about changes in their condition. The care plan will shift
over time to meet the changing needs of the patient, family, and
caregiver(s) as the patient approaches the end of life.
The regulations for Medicare and Medicaid participating hospices
are set forth at 42 CFR part 418. Section 418.3 defines the term
``attending physician'' as being a doctor of medicine or osteopathy, an
NP, or a PA in accordance with the statutory definition of an attending
physician at section 1861(dd)(3)(B) of the Act. Section 51006 of the
Bipartisan Budget Act of 2018 revised the statute to add PAs to the
statutory definition of the hospice attending physician for services
furnished on or after January 1, 2019. As a result, PAs were added to
the definition of a hospice attending physician as part of the
``Medicare Program; FY 2019 Hospice Wage Index and Payment Rate Update
and Hospice Quality Reporting Requirements'' final rule which was
published in the August 6, 2018 Federal Register (83 FR 38622, 38634)
(hereinafter referred to as the ``FY 2019 Hospice final rule'').
The role of the patient's attending physician, if the patient has
one, is to provide a longitudinal perspective on the patient's course
of illness, care preferences, psychosocial dynamics, and generally
assist in assuring continuity of care as the patient moves from the
traditional curative care model to hospice's palliative care model. The
attending physician is not meant to be a person offered by, selected
by, or appointed by the hospice when the patient elects to receive
hospice care. Section 418.64(a) of the hospice regulations requires the
hospice to provide physician services to meet the patient's hospice-
related needs and all other care needs to the extent that those needs
are not met by the patient's attending physician. Thus, if a patient
does not have an attending physician relationship prior to electing
hospice care, or if the patient's attending physician chooses to not
participate in the patient's care after the patient elects to receive
hospice care, then the hospice is already well-suited to provide
physician care to meet all of the patient's needs as part of the
Medicare hospice benefit. If the patient has an attending physician
relationship prior to electing hospice care and that attending
physician chooses to continue to be involved in the patient's care
during the period of time when hospice care is provided, the role of
the attending physician is to consult with the hospice
interdisciplinary group (also known as the interdisciplinary team) as
described in Sec. 418.56, and to furnish care for conditions
determined by the hospice interdisciplinary group to be unrelated to
the terminal prognosis. The hospice interdisciplinary group must
include the following members of the hospice's staff: A physician; a
nurse; a social worker; and a counselor. The interdisciplinary group
may also include other members based on the specific services that the
patient receives, such as hospice aides and speech language
pathologists. The hospice interdisciplinary group, as a whole, in
consultation with the patient's attending physician (if any), the
patient, and the patient's family and caregivers, are responsible for
determining the course of the patient's hospice care and establishing
the individualized plan of care for the patient that is used to guide
the delivery of holistic hospice services and interventions, both
medical and non-medical in nature.
b. Proposed Provisions
In the role of a consultant to the hospice interdisciplinary group,
the hospice patient's chosen attending physician may, at times, write
orders for services and medications as they relate to treating
conditions determined to be unrelated to the patient's terminal
prognosis. The law allows for circumstances in which services needed by
a hospice beneficiary would be completely unrelated to the terminal
prognosis, but we believe that this situation would be the rare
exception rather than the norm. Section 418.56(e) requires hospices to
coordinate care with other providers who are also furnishing care to
the hospice patient, including the patient's attending physician who is
providing care for conditions determined by the hospice
interdisciplinary group to be unrelated to the patient's terminal
prognosis. As part of this coordination of care, it is possible that
hospices may receive orders from the attending physician for drugs that
are unrelated to the patient's terminal prognosis.
The FY 2019 Hospice final rule amended the regulatory definition of
attending physician, as required by the statute, to include physician
assistant. Following publication of the FY 2019 Hospice final rule,
stakeholders raised concerns regarding the requirements of Sec.
418.106(b). As currently written, hospices may not accept orders for
drugs from attending physicians who are PAs because Sec. 418.106(b)
specifies that hospices may accept drug orders from physicians and NPs
only. This regulatory requirement may impede proper care coordination
between hospices and attending physicians who are PAs, and we believe
that it should be revised.
Therefore, we propose to revise Sec. 418.106(b)(1) to permit a
hospice to accept drug orders from a physician, NP, or PA. We propose
that the PA must be an individual acting within his or her state scope
of practice requirements and hospice policy. We also propose that the
PA must be the patient's attending physician, and that he or she may
not have an employment or contractual arrangement with the hospice. The
role of physicians and NPs as hospice employees and contractors is
clearly defined in the hospice CoPs; however, the CoPs do not address
the role of PAs. Therefore, we believe that it is necessary to limit
the hospice CoPs to accepting only those orders from PAs that are
generated outside of the hospice's operations.
The role of a PA is not defined in the hospice CoPs because the
statute does not include PA services as being part of the Medicare
hospice benefit. As such, there are no provisions in the hospice CoPs
to address specific PA issues such as personnel requirements,
descriptions of whether such services would be considered core or non-
core, or provisions to address issues of co-signatures. To more fully
understand the current and future role of NPPs, including PAs, in
hospice care and the hospice CoPs, we request public comment on the
following questions:
What is the role of a NPP in delivering safe and effective
hospice care to patients? What duties should they perform? What is
their role within the hospice interdisciplinary group and how is it
distinct from the role of the physician, nurse, social work, and
counseling members of the group?
[[Page 40726]]
Nursing services are a required core service within the
Hospice benefit, as provided in section 1861(dd)(B)(i) of the Act,
which resulted in the defined role for NPs in the Hospice COPs. Should
other NPPs also be considered core services on par with NP services? If
not, how should other NPP services be classified?
In light of diverse existing state supervision
requirements, how should NPP services be supervised? Should this
responsibility be part of the role of the hospice medical director or
other physicians employed by or under contract with the hospice? What
constitutes adequate supervision, particularly when the NPP and
supervising physician are located in different offices, such as hospice
multiple locations?
What requirements and time frames currently exist at the
state level for physician co-signatures of NPP orders? Are these
existing requirements appropriate for the hospice clinical record? If
not, what requirements are appropriate for the hospice clinical record?
What are the essential personnel requirements for PAs and
other NPPs?
J. Advisory Opinions on the Application of the Physician Self-Referral
Law
1. Statutory and Regulatory Background
Section 4314 of the Balanced Budget Act of 1997 (Pub. L. 105-33,
enacted August 5, 1997), added section 1877(g)(6) to the Act. Section
1877(g)(6) of the Act requires the Secretary to issue written advisory
opinions concerning whether a referral relating to designated health
services (other than clinical laboratory services) is prohibited under
section 1877 of the Act. On January 9, 1998, the Secretary issued a
final rule with comment period in the Federal Register to implement and
interpret section 1877(g)(6) of the Act (the 1998 CMS advisory opinions
rule). (See Medicare Program; Physicians' Referrals; Issuance of
Advisory Opinions (63 FR 1646).) The regulations are codified in
Sec. Sec. 411.370 through 411.389 (the physician self-referral
advisory opinion regulations).
Section 1877(g)(6)(A) of the Act states that each advisory opinion
issued by the Secretary shall be binding as to the Secretary and the
party or parties requesting the opinion. Section 1877(g)(6)(B) of the
Act requires the Secretary, in issuing advisory opinions regarding the
physician self-referral law, to apply the rules in paragraphs (b)(3)
and (4) of section 1128D of the Act, to the extent practicable. This
paragraph also requires the Secretary to take into account the
regulations promulgated under paragraph (b)(5) of section 1128D of the
Act.
Section 1128D of the Act was added to the statute by section 205 of
the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
(Pub. L. 104-191, effective August 21, 1996). Among other things,
section 1128D of the Act requires the Secretary, in consultation with
the Attorney General, to issue written advisory opinions as to
specified matters related to the anti-kickback statute in section
1128B(b) of the Act, the safe harbor provisions in Sec. 1001.952, and
other provisions of the Act under the authority of the Office of
Inspector General (OIG). To implement and interpret section 1128D of
the Act, the Office of Inspector General (OIG) issued an interim final
rule with comment period in the February 19, 1997 Federal Register
entitled Medicare and State Health Care Programs: Fraud and Abuse;
Issuance of Advisory Opinions by the OIG (62 FR 7350), revised and
clarified its regulations in the July 16, 1998 Federal Register (68 FR
38311), and updated its regulations in a final rule published in the
July 17, 2008 Federal Register that solely revised certain procedural
requirements for submitting payments for advisory opinion costs (73 FR
40982) (collectively, the OIG advisory opinion rule). The regulations
are codified in part 1008 of this title of the Code of Federal
Regulations (the OIG advisory opinion regulations).
Section 1128D(b)(3) of the Act prohibits the Secretary from
addressing in an advisory opinion whether: (1) Fair market value shall
be or was paid or received for any goods, services, or property; or (2)
an individual is a bona fide employee within the requirements of
section 3121(d)(2) of the Internal Revenue Code of 1986. In the 1998
CMS advisory opinions rule, we incorporated these provisions into the
physician self-referral law regulations (63 FR 1646). Section
1128D(b)(4)(A) of the Act states that an advisory opinion related to
OIG authorities is binding as to the Secretary and the party or parties
requesting the opinion. This section is redundant of the provision in
section 1877(g)(6)(A) of the Act, and therefore, not incorporated into
the physician self-referral advisory opinion regulations. Section
1128D(b)(4)(B) of the Act provides that the failure of a party to seek
an advisory opinion may not be introduced into evidence to prove that
the party intended to violate the provisions of sections 1128, 1128A,
or 1128B of the Act. We incorporated section 1128D(b)(4)(B) of the Act
in the physician self-referral regulations at Sec. 411.388.
As discussed previously, section 1877(g)(6)(B) of the Act requires
the Secretary, to the extent practicable, to take into account the
regulations issued under the authority of section 1128D(b)(5) of the
Act (that is, the OIG advisory opinion regulations). Section
1128D(b)(5)(A) requires that the OIG advisory opinion regulations must
provide for: (1) The procedure to be followed by a party applying for
an advisory opinion; (2) the procedure to be followed by the Secretary
in responding to a request for an advisory opinion; (3) the interval in
which the Secretary will respond; (4) the reasonable fee to be charged
to the party requesting an advisory opinion; and (5) the manner in
which advisory opinions will be made available to the public. We
interpret Congress' directive to take into account OIG regulations to
mean that we should use the OIG regulations as our model, but that we
are not bound to follow them (63 FR 1647). Nonetheless, in the 1998 CMS
advisory opinions rule, we largely adopted OIG's approach to issuing
advisory opinions, stating that we intend for physician self-referral
law advisory opinions to provide the public with meaningful advice
regarding whether, based on specific facts, a physician's referral for
a designated health service (other than a clinical laboratory service)
is prohibited under section 1877 of the Act (63 FR 1648).
2. Proposed Revisions to the CMS Advisory Opinion Process and
Regulations
In the June 25, 2018 Federal Register, we published a Request for
Information Regarding the Physician Self-Referral Law (83 FR 29524)
(June 2018 CMS RFI) that sought recommendations from the public on how
to address any undue impact and burden of the physician self-referral
statute and regulations. Although we did not specifically request
comments on the CMS advisory opinion regulations, we received a number
of comments urging that CMS reconsider its approach to advisory
opinions and transform the process such that the regulated industry may
obtain expeditious guidance on whether a physician's referrals to an
entity with which he or she has a financial relationship would be
prohibited under section 1877 of the Act. These commenters stated their
belief that the current advisory opinion process could be improved.
Some commenters stated also that the process is too restrictive, noting
that CMS has placed what the commenters see as unreasonable limits on
the types of questions that qualify for
[[Page 40727]]
an advisory opinion (for example, CMS will not issue an advisory
opinion where the arrangement at issue is hypothetical and does not
issue advisory opinions on general questions of interpretation) and CMS
advisory opinions apply only to the specific circumstances of the
requestor. These commenters asserted that the OIG's advisory opinion
process, upon which the CMS advisory opinion process is modeled, is
inappropriate for a payment statute. These commenters noted that OIG
opines on matters related to a felony criminal statute, whereas the
physician self-referral law, by contrast, is a payment rule. The
commenters highlighted the complexity of the physician self-referral
regulations, the strict liability nature of the physician self-referral
law, and the need for certainty before arrangements are initiated and
claims submitted as reasons why an advisory opinion process related to
a felony criminal statute is inappropriate for the physician self-
referral law. Other commenters asserted that the process is arduous and
inefficient. These commenters noted that the advisory opinion process
can extend beyond the 90-day timeframe provided for at Sec. 411.380
and asserted that it lags behind the OIG process in terms of
efficiency.
In designing its advisory opinion process, OIG carefully balanced
stakeholders' desire for an accessible process and meaningful and
informed opinions with its need to closely scrutinize arrangements to
insure that requesting parties are not inappropriately granted
protection from sanctions. (63 FR 38312 through 38313). We appreciate
that there are important differences between the physician self-
referral law, a strict liability statute designed to prevent payment
for services where referrals are affected by inherent financial
conflicts of interest, and the anti-kickback statute, which is a
criminal law designed to prosecute intentional acts of fraud and abuse.
More than 20 years have passed since the CMS advisory opinion
regulations were issued. In those 20 years, we have issued 30 advisory
opinions,\102\ 15 of which addressed the 18-month moratorium on
physician self-referrals to specialty hospitals in which they have an
ownership or investment interest. In light of the comments received on
the RFI, we have undertaken a fresh review of the CMS advisory opinion
process. We agree that it is important to have an accessible process
that produces meaningful opinions on the applicability of section 1877
of the Act, especially in light of the perceived complexity of the
physician self-referral regulations, including the requirements of the
various exceptions and the key terminology applicable to many of the
exceptions, and we recognize that our current advisory opinion process
has not been utilized by stakeholders or resulted in a significant
number of issued opinions to date. Accordingly, we have reviewed our
advisory opinion regulations in an effort to identify limitations and
restrictions that may be unnecessarily serving as an obstacle to a more
robust advisory opinion process.
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\102\ These advisory opinions are available on CMS' website, at
https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/advisoryopinions.html. This number does not include advisory opinion
requests that were withdrawn.
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Failure to satisfy the requirements of an exception to the
physician self-referral law carries significant consequences,
regardless of a party's intent.\103\ The safe harbors under the anti-
kickback statute are voluntary, and the failure of an arrangement to
fit squarely within a safe harbor does not mean that the arrangement
violates the anti-kickback statute. By contrast, the physician self-
referral law prohibits a physician's referral if there is a financial
relationship that does not satisfy the requirements of one of the
enumerated exceptions. In other words, the physician self-referral law
is a strict liability law, and parties that act in good faith may
nonetheless face significant financial exposure if they misunderstand
or misapply the law's exceptions.
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\103\ The CMS Voluntary Self-Referral Disclosure Protocol (SRDP)
allows providers of services and suppliers to self-disclose actual
or potential violations of the physician self-referral statute.
Under the SRDP, CMS may reduce the amount due and owing for
violations of section 1877 of the Act. Information about the SRDP
can be found at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Downloads/CMS-Voluntary-Self-Referral-Disclosure-Protocol.pdf.
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Regulated parties' desire for certainty must be balanced with CMS'
interest in maintaining the integrity of the advisory opinion process,
and ensuring that it is not used to inappropriately shield improper
financial arrangements. But we believe that the risk of such misuse is
acceptably low with respect to the section 1877 of the Act advisory
opinion process because the advisory opinion authority at section
1877(g) of the Act is narrowly tailored. CMS can only issue favorable
advisory opinions for arrangements that do not violate section 1877 of
the Act--for example, because there is no referral for designated
health services, there is no financial relationship, or the arrangement
meets an exception. In contrast, OIG has issued favorable advisory
opinions for arrangements that do not fit within a safe harbor where it
has concluded, based on a totality of the facts and circumstances, that
the arrangement poses a sufficiently low risk of fraud and abuse under
the anti-kickback statute. CMS cannot similarly extend protection
beyond the exceptions, so there is a built-in safeguard against
protecting an arrangement that the law would not otherwise protect.
Furthermore, a favorable advisory opinion from CMS does not immunize
parties from liability under the anti-kickback statute.
a. Matters Subject to Advisory Opinions (Sec. 411.370)
Section 1877(g)(6) of the Act requires the Secretary to issue
advisory opinions concerning ``whether a referral relating to
designated health services (other than clinical laboratory services) is
prohibited under this section.'' In accordance with section
1877(g)(6)(B) of the Act, CMS adopted in regulation the rules in
paragraphs (b)(3) and (4) of section 1128D of the Act, which prohibit
the OIG from opining on whether an arrangement is fair market value and
whether an individual is a bona fide employee within the requirements
of section 3121(d)(2) of the Internal Revenue Code. In addition to
these statutory restrictions on matters that are not subject to
advisory opinions, our current regulation at Sec. 411.370(b)(1) states
that CMS does not consider, for purposes of an advisory opinion,
requests that present a general question of interpretation, pose a
hypothetical situation, or involve the activities of third parties.
When explaining this regulation, we stated that we interpret section
1877(g)(6) of the Act to allow for opinions on specific referrals
involving physicians in specific situations (63 FR 1649). We also noted
our reasons for avoiding opinions on generalized arrangements, stating
that it would not be possible for an advisory opinion to reliably
identify all the possible hypothetical factors that might lead to
different results (Id.).
Under our current regulations, CMS accepts requests for advisory
opinions that involve existing arrangements, as well as requests that
involve arrangements into which the requestor plans to enter. Some
commenters on the June 2018 CMS RFI suggested that CMS expand the scope
of the requests that it will consider for an advisory opinion to
include requests that involve hypothetical fact patterns and general
questions of interpretation. It is our position that some requests are
not appropriate for an advisory opinion.
[[Page 40728]]
Further, although we are proposing a number of changes to improve the
advisory opinion process for stakeholders, we believe that expanding
the process to include questions regarding hypothetical fact patterns
or general interpretation could overwhelm the agency. Thus, we are not
proposing an expansion of the scope of requests at this time; however,
we are soliciting comments on whether we should do so in the future. We
are proposing minor clarifications to Sec. 411.370(b) regarding
matters that qualify for advisory opinions and the parties that may
request them. Specifically, we are proposing to clarify that the
request for an advisory opinion must ``relate to'' (rather than
``involve'') an existing arrangement or one into which the requestor,
in good faith, specifically plans to enter. Requestors continue to be
obligated to disclose all facts relevant to the arrangement for which
an advisory opinion is sought. We are also proposing revisions to the
regulation text for grammatical purposes.
We note that CMS currently responds to questions pertaining to the
physician self-referral law through the CMS Physician Self-Referral
Call Center. Although we are unable to provide formal guidance or an
opinion regarding whether a specific referral is permissible or whether
a financial relationship satisfies the requirements of an exception, we
are able to assist parties with identifying relevant guidance. The CMS
Physician Self-Referral Call Center is free to the public, and
inquiries may be sent to [email protected]s.gov. For additional
information, see https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Call-Center.html. CMS also responds to frequently
asked questions (FAQs) regarding the physician self-referral law from
time to time. FAQs issued to date may be found on our website at
https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/FAQs.html.
Current Sec. 411.370(e) states that CMS does not accept an
advisory opinion request or issue an advisory opinion if: (1) The
request is not related to a named individual or entity; (2) CMS is
aware that the same or substantially the same course of action is under
investigation or is or has been the subject of a proceeding involving
HHS or another governmental agency; or (3) CMS believes that it cannot
make an informed opinion or could only make an informed opinion after
extensive investigation, clinical study, testing, or collateral
inquiry. We are proposing changes to this regulation. First, we are
proposing to add to the reasons that CMS will not accept an advisory
opinion request or issue an advisory opinion. Specifically, we are
proposing that CMS will reject an advisory opinion request or not issue
an advisory opinion with respect to a request that does not describe
the arrangement at issue with a level of detail sufficient for CMS to
issue an opinion, and the requestor does not timely respond to CMS
requests for additional information. We believe that this is important
to the agency's ability to focus its resources on complete requests.
Second, we are proposing to amend current Sec. 411.370(e)(2),
which states that CMS will not issue an advisory opinion if it is aware
that the same, or substantially the same, course of action is under
investigation or is or has been the subject of a proceeding involving
HHS or other government entities. Although CMS consults with other HHS
components and governmental agencies, including OIG and DOJ, on pending
advisory opinion requests, we believe the current regulation is too
restrictive, and unnecessarily limits CMS' flexibility to issue timely
guidance to requestors engaged in or considering legitimate business
arrangements. Therefore, we are proposing to ease the restriction at
Sec. 411.370(e)(2) that prohibits the acceptance of an advisory
opinion request or issuance of an advisory opinion if CMS is aware of
pending or past investigations or proceedings involving a course of
action that is ``substantially the same'' as the arrangement or
proposed arrangement between or among the parties requesting an
advisory opinion, and instead allow CMS more discretion to determine,
in consultation with OIG and DOJ, whether acceptance of the advisory
opinion request or issuance of the advisory opinion is appropriate.
Specifically, we propose at Sec. 411.370(e)(2) that CMS may elect not
to accept an advisory opinion request or issue an advisory opinion if,
after consultation with OIG and DOJ, it determines that the course of
action described in the request is substantially similar to conduct
that is under investigation or is the subject of a proceeding involving
HHS or other law enforcement agencies, and issuing an advisory opinion
could interfere with the investigation or proceeding. We propose to
retain at renumbered Sec. 411.370(e)(1)(iii) the restriction on
accepting requests if CMS is aware that the specific course of action
(involving the same specific parties) is under investigation or is, or
has been the subject of a proceeding involving the Department or
another governmental agency. We also propose to clarify that CMS would
consult with OIG and DOJ regarding investigations or proceedings
involving the same course of conduct described in an advisory opinion
request. We seek comments on this approach.
Although we are not proposing changes to Sec. 411.370(f) which
describes the effects of an advisory opinion on other government
authority, we note that a determination regarding whether a referral is
prohibited by section 1877 of the Act is a determination that rests
solely and exclusively with the Secretary (and, in this case, the
Administrator, to whom the Secretary has delegated this authority).
Under section 1877(g)(6) of the Act, an advisory opinion is binding on
the Secretary, and if the Secretary determines that a particular fact
pattern does not trigger liability under section 1877 of the Act, that
determination is binding on the Secretary, as well as any component of
HHS that exercised the authority delegated by the Secretary. Such a
determination would preclude the imposition of sanctions under section
1877(g) of the Act.\104\ A favorable advisory opinion would not,
however, insulate parties from liability under the anti-kickback
statute or any other laws or regulations outside of section 1877 of the
Act. It would also not preclude OIG from exercising its authority under
the Inspector General Act of 1978 (Pub. L. 95-452, as amended by Pub.
L. 115-254, enacted October 05, 2018). In a physician self-referral law
advisory opinion, CMS may opine on whether an arrangement is
``commercially reasonable'' as defined by the physician-self-referral
law regulations. Such a determination by CMS may not apply in the
context of the anti-kickback statute and should not be interpreted as
such. A CMS determination that an arrangement is or is not a
``financial relationship,'' as defined at section 1877(a)(2) of the Act
and Sec. 411.354(a), or that an arrangement satisfies a specific
requirement of an exception to the physician self-referral law (for
example, whether a compensation arrangement is ``commercially
reasonable''), would be a separate and distinct inquiry from any
determination by law enforcement that the arrangement does or does not
violate the anti-kickback statute.
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\104\ The Secretary has delegated the civil monetary penalty
authority under section 1877 of the Act to the OIG.
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b. Timeline for Issuing an Advisory Opinion (Sec. 411.380)
Section 1877(g)(6) of the Act does not impose any deadlines by
which the
[[Page 40729]]
agency must respond to an advisory opinion request, but section
1128D(b)(5)(B)(i) of the Act provides that the Secretary shall be
required to issue an advisory opinion no later than 60 days after the
request is received. In the 1998 CMS advisory opinions rule, we adopted
a 90-day timeframe for most requests. In addition, for requests that we
determine, in our discretion, involve complex legal issues or highly
complicated fact patterns, we reserved the right to issue an advisory
opinion within a reasonable timeframe. We created this timeframe based
upon our estimates on the volume and complexity of expected requests,
and based upon our then-current staffing situation.
We are proposing to modify this time period and establish a 60-day
timeframe for issuing advisory opinions. The 60-day period would begin
on the date that CMS formally accepts a request for an advisory
opinion. The 60 days would be tolled during any time periods in which
the request is being revised or additional information compiled and
presented by the requestor. We are also considering whether CMS should
provide requestors with the option to request expedited review. We
believe that a more efficient and expeditious process could give
stakeholders more certainty and encourage innovative care delivery
arrangements. We seek comment on the proposed changes to the timeframe,
whether CMS in the final rule should include a provision on expedited
review and, if so, the parameters for expedited review.
c. Certification Requirement (Sec. 411.373)
In the 1998 CMS advisory opinions rule, we adopted a requirement
identical to OIG's requirement that a requestor must certify to the
truthfulness of its submissions, including its good faith intent to
enter into proposed arrangements. CMS finalized regulations that
require a requestor to make two certifications as part of its request
for an advisory opinion. Under current Sec. 411.373(a), the requestor
must certify that, to the best of the requestor's knowledge, all of the
information provided as part of the request is true and correct and
constitutes a complete description of the facts regarding which an
advisory opinion is being sought. If the request relates to a proposed
arrangement, current Sec. 411.373(b) states that the request must also
include a certification that the requestor intends in good faith to
enter into the arrangement described in the request. A requestor may
make this certification contingent upon receiving a favorable advisory
opinion from CMS or from both CMS and OIG. Under current Sec.
411.372(b)(8), if the requestor is an individual, the individual must
sign the certification; if the requestor is a corporation, the
certification must be signed by the Chief Executive Officer, or a
comparable officer; if the requestor is a partnership, the
certification must be signed by a managing partner; and, if the
requestor is a limited liability company, the certification must be
signed by a managing member. We are proposing to revise Sec.
411.372(b)(8) to clarify that the certification must be signed by an
officer that is authorized to act on behalf of the requestor. We are
also considering whether it would be appropriate to eliminate the
certification requirement in our regulations, given that section 1001
of Title 18 of the United States Code prohibits material false
statements in matters within the jurisdiction of a federal agency. We
seek comment on whether the existing certification requirement creates
undue burden for requestors, and whether the requirement is necessary
given Section 1001.
d. Fees for the Cost of Advisory Opinions (Sec. 411.375)
In the 1998 CMS advisory opinions rule, we established a fee that
is charged to requestors to cover the actual costs incurred by CMS in
responding to a request for an advisory opinion. Under current Sec.
411.375, there is an initial fee of $250, and parties are responsible
for any additional costs incurred that exceed the initial $250 payment.
A requestor may designate a triggering dollar amount, and CMS will
notify the requestor if CMS estimates that the costs of processing the
request have reached or are likely to exceed the designated triggering
amount. This fee structure was modeled after OIG regulations that were
in effect at that time.
Since CMS issued the 1998 CMS advisory opinions rule, OIG has
updated its regulations to eliminate the initial fee, and instead
charges requesting parties a consolidated final payment based on costs
associated with preparing an opinion (73 FR 15936). We believe it is
appropriate to adopt an hourly fee of $220 for preparation of an
advisory opinion. We believe this amount reflects the costs incurred by
the agency in processing an advisory opinion request. We are also
considering adding a provision establishing an expedited pathway for
requestors that seek an advisory opinion within 30 days of the request.
If we establish such a pathway, we would consider charging $440 an hour
to process the request, reflecting the extra resources necessary to
produce an advisory opinion within the abbreviated timeframe. We
request comments on this approach. To ensure that obtaining an advisory
opinion is affordable, and to prevent unfair surprises to requestors at
the end of the process, we are considering promulgating a cap on the
amount of fees charged for an advisory opinion. We solicit comments on
the amount of the cap. We also request comments on whether CMS should
eliminate the initial $250 fee.
e. Reliance on an Advisory Opinion (Sec. 411.387)
As we consider improvements to the advisory opinion process, we are
also considering regulatory changes to clarify current CMS policies and
practices, and make our advisory opinions more useful compliance tools
for stakeholders. Specifically, we are soliciting comment on proposals,
described in more detail below, to remove some of the regulatory
provisions limiting the universe of individuals and entities that can
rely on an advisory opinion, and to add language expressing what we
believe are permissible uses of an advisory opinion.
Section 1877(g)(6)(A) of the Act states that an advisory opinion
shall be binding on the Secretary and on the party or parties
requesting an opinion. Consistent with the policy adopted by OIG, CMS
took the view that an advisory opinion may legally be relied upon only
by the requestors. While section 1877 of the Act is silent on how third
parties may use an advisory opinion, in regulation, CMS has precluded
legal reliance on the opinion by non-requestor third parties. At the
time, we stated that advisory opinions are capable of being misused by
persons not a party to the transaction in question in order to
inappropriately escape liability (63 FR 1648). While such a preclusion
may be appropriate for purposes of an OIG advisory opinion on the
application of a criminal statute, we believe it may be unduly
restrictive in the context of a strict liability payment rule that
applies regardless of a party's intent.
In practice, CMS does anticipate that parties to an arrangement
that is subject to a favorable advisory opinion will rely on the
opinion, even if the parties did not join in the request. If, for
instance, CMS determines that an arrangement does not constitute a
financial relationship because it satisfies all requirements of an
applicable exceptions to the physician self-referral law, that
determination would necessarily apply equally to any individuals and
entities that are parties to the specific arrangement, for example, the
referring physician and the entity to which he or she refers patients
[[Page 40730]]
for designated health services. Thus, even if the physician party to
the arrangement was not a requestor of the advisory opinion, the
physician party is entitled to rely on that advisory opinion. We are
proposing changes to Sec. 411.387 to reflect this view. Specifically,
we are proposing at Sec. 411.387(a) that an advisory opinion would be
binding on the Secretary and that a favorable advisory opinion would
preclude the imposition of sanctions under section 1877(g) of the Act
with respect to the party or parties requesting the opinion and any
individuals or entities that are parties to the specific arrangement
with respect to which the advisory opinion is issued.
We are proposing at Sec. 411.387(b) that the Secretary will not
pursue sanctions under section 1877(g) of the Act against any
individuals or entities that are parties to an arrangement that CMS
determines is indistinguishable in all material aspects from an
arrangement that was the subject of the advisory opinion. Even though a
favorable advisory opinion with respect to one arrangement would not
legally preclude CMS from pursuing violations against parties to a
different arrangement, in practice, the Secretary would not consider
using enforcement resources for purposes of imposing sanctions under
section 1877(g) of the Act to investigate the actions of parties to an
arrangement that CMS believes is materially indistinguishable from an
arrangement that has received a favorable advisory opinion. As
discussed above, such a determination would not preclude a finding by
DOJ or OIG that the arrangement violates the anti-kickback statute or
any other law. All facts relied on and influencing a legal conclusion
in an issued favorable advisory opinion are material; deviation from
that set of facts would result in a party not being able to claim the
protection proposed in Sec. 411.387(b). If parties to an arrangement
are uncertain as to whether CMS would view it as materially
indistinguishable from an arrangement that has received a favorable
advisory opinion, then those parties can submit an advisory opinion
request to query whether a referral is prohibited under section 1877 of
the Act because the arrangement is materially indistinguishable from an
arrangement that received a favorable advisory opinion. We seek comment
on this approach.
Finally, we are also proposing at Sec. 411.387(c) to recognize
that individuals and entities may reasonably rely on an advisory
opinion as non-binding guidance that illustrates the application of the
self-referral law and regulations to specific facts and circumstances.
We believe that stakeholders already look to advisory opinions issued
by OIG and CMS to inform their decision-making, and these proposed
changes would make clear that CMS acknowledges that such reliance is
permissible and reasonable. We request comments on all aspects of these
proposals.
f. Rescission (Sec. 411.382)
Under current Sec. 411.382, CMS may rescind or revoke an advisory
opinion after it is issued. To date, CMS has not rescinded an advisory
opinion. At the time we finalized this regulation, which is modeled on
OIG's rescission authority regulation, we sought comment on whether
this approach reasonably balanced the government's need to ensure that
advisory opinions are legally correct and the requestor's interest in
finality (63 FR 1653). We are again requesting comment on this issue.
Specifically, we are soliciting comments on whether CMS should retain a
more limited right to rescind an advisory opinion; that is, CMS could
rescind an advisory opinion only when there is a material regulatory
change that impacts the conclusions reached, or when a party has
received a negative advisory opinion and wishes to have the agency
reconsider the request in light of new facts or law.
g. Other Modifications to Procedural Requirements
We are proposing minor modifications to Sec. 411.372 to improve
readability and clarity. We are also proposing to eliminate the
reference to the provision of stock certificates as part of the
advisory opinion request submission, as these are typically electronic
and may not necessarily list the name of the owner. We are requesting
comments on these and other updates to the procedure for submitting an
advisory opinion request that will improve the efficiency of the review
process.
K. CY 2020 Updates to the Quality Payment Program
1. Executive Summary
a. Overview
This section of the proposed rule sets forth changes to the Quality
Payment Program starting January 1, 2020, except as otherwise noted for
specific provisions. The 2020 performance period of the Quality Payment
Program should build upon the foundation that has been established in
the first 3 years of the program, which provides a trajectory for
clinicians moving to performance-based payments, and will gradually
prepare clinicians for the 2022 performance period of the program and
the 2024 MIPS payment year. Participation in both tracks of the Quality
Payment Program--Advanced Alternative Payment Models (APMs) and Merit-
based Incentive Payment System (MIPS)--have increased from 2017 to
2018.\105\ The number of QPs--Qualifying APM Participations--nearly
doubled from 2017 to 2018, from 99,076 to 183,306 clinicians. In MIPS,
98 percent of eligible clinicians participated in 2018, up from 95
percent in 2017. As the Quality Payment Program continues to mature,
CMS recognizes additional long-term improvements will need to occur.
Beginning with the 2024 MIPS payment year, the cost performance
category will be weighted at 30 percent, which has been gradually
increased in the last few years, and the performance threshold will be
set at the mean or median of the final scores for all MIPS eligible
clinicians with respect to a prior period specified by the Secretary.
Beginning in the 2022 performance period, there will no longer be the
same flexibility in establishing the weight of the cost performance
category or in establishing the performance threshold. Refer readers to
sections III.K.3.c.(2)(a) and III.K.3.e.(2) of this proposed rule for
more information about the statutory requirements related to these
provisions.
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\105\ Quality Payment Program (QPP) Participation in 2018:
Results at a Glance https://qpp-cm-prod-content.s3.amazonaws.com/uploads/586/2018%20QPP%20Participation%20Results%20Infographic.pdf.
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b. Summary of Major Proposals
(1) MIPS Value Pathways Request for Information
CMS is committed to the transformation of MIPS, which will allow
for: More streamlined and cohesive reporting; enhanced and timely
feedback; and the creation of MIPS Value Pathways (MVPs) of integrated
measures and activities that are meaningful to all clinicians from
specialists to primary care clinicians and patients. The new MVPs would
remove barriers to APM participation and promote value by focusing on
quality, interoperability, and cost. Additionally, MVPs would create a
cohesive and meaningful participation experience for clinicians by
moving away from siloed activities and measures and towards an aligned
set of measures that are more relevant to a clinician's scope of
practice, while further reducing reporting burden and
[[Page 40731]]
easing the transition to APMs. MVPs are described in greater detail at
section III.K.1.b.(2) and the full Request for Information at section
III.K.3.a. of this proposed rule.
(2) Major MIPS Proposals
The major MIPS proposals in this year's proposed rule include a
focus on a strategic vision to further transform MIPS by empowering
patients and simplifying MIPS to improve value and reduce burden. We
envision a future state of the program where patients have the
information needed to make informed decisions about their healthcare,
clinicians improve health outcomes and quality of care for their
patients in alignment with the Meaningful Measures initiative,\106\ and
the data collection burden is limited in alignment with the Patients
over Paperwork initiative.\107\ Hence, we are proposing to apply a new
MVPs framework to future proposals beginning with the 2021 MIPS
Performance Year. MVPs would utilize sets of measures and activities
that incorporate a foundation of promoting interoperability and
administrative claims-based population health measures and layered with
specialty/condition specific clinical quality measures to create both
more uniformity and simplicity in measure reporting. The MVP framework
will also connect quality, cost, and improvement activities performance
categories to drive toward value; integrate the voice of patients; and
reduce clinician barriers to movement into Advanced APMs. Further, the
MVP framework would reduce the number of performance measures and
activities clinicians may select. Ultimately, we believe this would
decrease clinician burden and improve performance data quality, while
still accounting for different types of specialties and practices. In
addition to comments requested on the framework, we are seeking
feedback on several implementation elements within section III.K.3.a.
of this proposed rule. Within this section, we describe our vision that
includes the following:
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\106\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
\107\ https://www.cms.gov/About-CMS/story-page/patients-over-paperwork.html.
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Furthering the application of the Meaningful Measures
framework.
Implementing a measure set using additional administrative
claims-based quality measures.
Developing MVPs, using an approach which connects measures
and activities from the quality, cost, and improvement activities
performance categories; requiring completion of the Promoting
Interoperability performance category to maintain alignment with
hospitals; and focusing on a specialty or condition to standardize and
provide more cohesive reporting and participation.
Providing timely quality and cost performance data
feedback using administrative claims, registry, and electronically
submitted data to enhance a clinician self-tracking to facilitate care
improvements.
Enhancing information available to patients to inform
decision making, including increasing the patient reported measures in
MVPs.
This vision will ultimately help us to better measure and
incentivize value, ensure participation is more meaningful to
clinicians and their patients, provide information to patients to
assist with clinician selection, reduce clinician reporting burden,
respond to program concerns, and increase alignment with APMs, and
increase alignment with APMs. The RFI solicits comment on the types of
information that would be useful to patients (Medicare beneficiaries)
and individual clinicians reporting data for purposes of sharing on CMS
public websites. We have assessed new opportunities, such as,
implementation of a foundational claims-based population health core
measure set using administrative claims-based quality measures that can
be broadly applied to communities or populations, development of MVP
measure tracks to provide uniformity in measure reporting and to unify
performance categories, and enhancement of the patient voice, to
increase simplicity, reduce burden, and increase the value of MIPS
performance data. We strongly encourage feedback on how we can best
realize our path to value vision of MIPS Value Pathways.
In addition to this framework, we are making two significant
proposals for the 2020 MIPS performance period:
As discussed in section III.K.3.g.(2) of this proposed
rule, we are proposing to strengthen the Qualified Clinical Data
Registry (QCDR) measure standards for MIPS to require measure testing,
harmonization, and clinician feedback to improve the quality of QCDR
measures available for clinician reporting. These policies relate to CY
2020 and CY 2021 for QCDRs.
As discussed in section III.K.3.c.(2)(b)(iii) of this
proposed rule, we are proposing to add new episode-based measures in
the cost performance category to more accurately reflect the cost of
care that specialists provide. Further, we are proposing to revise the
total per capita cost and the Medicare Spending Per Beneficiary (MSPB)
measures in response to stakeholders' feedback suggestions.
While we continue efforts to strengthen the Quality Payment
Program, we remain interested in clinician participation and engagement
in the program. Finally, as the Bipartisan Budget Act of 2018 (BBA of
2018) (Pub. L. 115-123, enacted February 9, 2018) extended the
flexibility and transition years within the Quality Payment Program, we
believe these proposed policies for Year 4 and our strategic vision
will assist us in working towards a more robust program in the future.
(3) Major APM Proposals
(a) Aligned Other Payer Medical Home Models
We are proposing to add the defined term, Aligned Other Payer
Medical Home Model, to Sec. 414.1305. The proposed definition of
Aligned Other Payer Medical Home Model includes the same
characteristics as the definitions of Medical Home Model and Medicaid
Medical Home Model, but it applies to other payer payment arrangements.
We believe that structuring this proposed definition in this manner is
appropriate because we recognize that other payers could have payment
arrangements that may be appropriately considered medical home models
under the All-Payer Combination Option.
Neither the current Medical Home Model financial risk and nominal
amount standards nor the Medicaid Medical Home Model financial risk and
nominal amount standards apply to other payer payment arrangements.
Consistent with our proposal to define the term Aligned Other Payer
Medical Home Model, we are proposing to amend Sec. 414.1420(d)(2),
(d)(4), and (d)(8) of our regulations to also apply the Medicaid
Medical Home Model financial risk and nominal amount standards,
including the 50 eligible clinician limit, to Aligned Other Payer
Medical Home Models.
(b) Marginal Risk for Other Payer Advanced APMs
We are proposing to modify our definition of marginal risk when
determining whether a payment arrangement is an Other Payer Advanced
APM. We propose that in event that the marginal risk rate varies
depending on the amount by which actual expenditures exceed expected
expenditures, the average marginal risk rate across all possible levels
of actual
[[Page 40732]]
expenditures would be used for comparison to the marginal risk rate
specified in with exceptions for large losses and small losses as
described in Sec. 414.1420(d). Average marginal risk would be computed
by adding the marginal risk rate at each percentage of level to
determine to determine participants' losses, and dividing it by the
percentage above the benchmark to get the average marginal risk. When
considering average marginal risk in the context of total risk, we
believe that certain risk arrangements can create meaningful and
significant risk-based incentives for performance and at the same time
ensure that the payment arrangement has strong financial risk
components.
(c) Estimated APM Incentive Payments and MIPS Payment Adjustments
As we discuss in section VI.E.10.a. of this proposed rule, for the
2022 payment year and based on estimated Advanced APM participation
during the 2020 QP Performance Period, we estimate that between 175,000
and 225,000 clinicians will become Qualifying APM Participants (QPs).
As a QP for the 2022 payment year, an eligible clinician is excluded
from the MIPS reporting requirements and payment adjustment and
qualifies for a lump sum APM Incentive Payment equal to 5 percent of
their aggregate payment amounts for covered professional services for
the year prior to the payment year. We estimate that the total lump sum
APM Incentive Payments will be approximately $500-600 million for the
2022 Quality Payment Program payment year.
We estimate that approximately 818,000 clinicians would be MIPS
eligible clinicians for the 2020 MIPS performance period in section
VI.E.10.b.(1)(b) of this proposed rule. The final number will depend on
several factors, including the number of eligible clinicians excluded
from MIPS based on their status as QPs or Partial QPs, the number that
report as groups, and the number that elect to opt into MIPS. In the
2022 MIPS payment year, MIPS payment adjustments, which only apply to
payments for covered professional services furnished by a MIPS eligible
clinician, will be applied based on a MIPS eligible clinician's
performance on specified measures and activities within four integrated
performance categories. We estimate that MIPS payment adjustments will
be approximately equally distributed between negative MIPS payment
adjustments ($584 million) and positive MIPS payment adjustments ($584
million) to MIPS eligible clinicians, as required by the statute to
ensure budget neutrality. Up to an additional $500 million is also
available for the 2022 MIPS payment year for additional positive MIPS
payment adjustments for exceptional performance for MIPS eligible
clinicians whose final score meets or exceeds the additional
performance threshold of 80 points that we are proposing in section
III.K.3.e.(3) of this proposed rule. However, the distribution will
change based on the final population of MIPS eligible clinicians for
the 2022 MIPS payment year and the distribution of final scores under
the program.
2. Definitions
At Sec. 414.1305, we are proposing to define the following terms:
Aligned Other Payer Medical Home Model.
Hospital-based MIPS eligible clinician.
MIPS Value Pathway.
We are additionally proposing to revise at Sec. 414.1305 the
following term:
Rural area.
These terms and definitions are discussed in detail in relevant
sections of this proposed rule.
3. MIPS Program Details
a. Transforming MIPS: MIPS Value Pathways Request for Information
(1) Overview
In this proposed rule, we are proposing to apply a new MIPS Value
Pathways (MVP) framework to future proposals beginning with the 2021
MIPS performance period/2023 MIPS payment year to simplify MIPS,
improve value, reduce burden, help patients compare clinician
performance, and better inform patient choice in selecting clinicians.
As discussed in section III.K.3.a.(3)(a) of this proposed rule, the MVP
framework would be implemented as early as feasible to produce a MIPS
program that more effectively meets the 7 strategic objectives
described in the CY 2018 QPP final rule (82 FR 53570) and drives
continued progress and improvement. The MVP framework would connect
measures and activities across the 4 MIPS performance categories,
incorporate a set of administrative claims-based quality measures that
focus on population health, provide data and feedback to clinicians,
and enhance information provided to patients. As discussed in section
III.K.3.a.(3)(a) of this proposed rule, we are proposing to apply this
MVP framework to future proposals beginning with the 2021 MIPS
performance period rather than the 2020 MIPS performance period, so
that we can seek necessary feedback on the details of implementing this
transformative approach and address additional details of the
methodology in next year's rulemaking cycle. We understand that
clinicians want timely performance feedback data on quality and cost to
track their performance and prepare to take on risk, as required in
Advanced APMs, and we intend to provide enhanced feedback and data
analysis information to clinicians in the future. We plan to engage
with clinician professional organizations and front-line clinicians to
develop the MVPs.
(2) MVP Framework
(a) MVP Overview
We believe the MVPs will reduce the complexity of the MIPS program
and the burden to participate. We intend to simplify MIPS while
continuing to reward high value clinicians and help all clinicians
improve care and engage patients. While we emphasized flexibility
during the initial years of MIPS, we believe we must balance
flexibility with a degree of standardization to hold clinicians
accountable for the quality of care, identify and reward high value
care, and limit clinician burden. Any solution to improving MIPS
performance measurement data must account for the large variation in
specialty, size, and composition of clinician practices. MVPs allow for
a more cohesive participation experience by connecting activities and
measures from the 4 MIPS performance categories that are relevant to
the population they are caring for, a specialty or medical condition.
The MIPS program aims to drive quality and value through the
collection, assessment, and public reporting of data that informs and
rewards the delivery of high-value care. For purposes of this
discussion, we define ``value'' as a measurement of quality as related
to cost, ``value-based care'' as paying for health care services in a
manner that directly links performance on cost, quality, and the
patient's experience of care, and ``high value clinicians'' as
clinicians that perform well on applicable measures of quality and
cost. We believe implementing a ``path to value'' framework will
transform the MIPS program by better informing and empowering patients
to make decisions about their healthcare and helping clinicians to
achieve better outcomes, and also by promoting robust and accessible
healthcare data, and interoperability.
We are targeting policies that remove APM participation barriers as
clinicians
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and practices prepare to take on and successfully manage risk as
practices build out their quality infrastructures with components that
align with the MIPS performance categories. Critical practice
infrastructure components that support higher value care and readiness
to join APMs include performance measurement tracking, performance
improvement processes, interoperability, and data information systems
that assist clinicians and practices in monitoring performance and
adopting new workflows and care delivery methods. Performance measure
reporting for specific populations encourages practices to build an
infrastructure with capabilities to compile and analyze population
health data, a critical capability in assuming and managing risk. For
example, quality measurement can bolster the development of a practice
infrastructure that rapidly integrates evidence-based best practices
into the structure and execution of care delivery, to leverage a value-
based payment, and to produce achievement of better health outcomes.
Improvement Activities add a continuous clinical practice improvement
component, that can help clinicians use the experiences and
perspectives of front-line staff and beneficiaries to constantly
assess, reconfigure, and innovate processes and systems of care
delivery to better manage revenue and risk expenditure. Sensitivity to
cost and experience with cost measures within a practice infrastructure
is critical to managing value based payment and APM risk, while
awareness of and sensitivity to cost from the beneficiary perspective
(out-of-pocket cost, cost of time off from work for the patient and/or
caregiver, cost of disruption of normal activities/relationships) can
help support shared decision-making. An interoperability infrastructure
component supports the development of a practice infrastructure that
recognizes the critical role of information exchange in supporting
safe, effective, and efficient coordination and transitions of care
through a complex health care system, and better management of costs
and risk. We believe that experience with MVPs, in which there is
measurement of quality (of care and of experience of care) and cost-
efficiency, continuous improvement/innovation within the practice, and
efficient management and transfers of information, will remove barriers
to APM participation.
We believe it is important to transform the MIPS program. We must
change the current program to move along the path to value and enter a
future state of MIPS, which includes a more cohesive and simplified
participation experience for clinicians, increased voice of the
patient, increased CMS provided data and feedback to clinicians to
reduce reporting burden, and facilitated movement to Alternative
Payment Models. Please refer to the on line MVP graphic (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/587/MIPS%20Value%20Pathways%20Diagrams.zip) that provides an overview of
our vision for the MIPS future state.
We have built the MIPS program recognizing the large variation in
specialty, size, and composition of clinician practices, providing
broad flexibility for clinician choice of measures and activities, data
submission types, and individual or group level participation. Although
we believe this flexibility contributed to Year 1 participation of 95
percent of MIPS eligible clinicians, including 94 percent of rural
practices and 81 percent of small practices,\108\ and the increase in
Year 2 participation to 98 percent of MIPS eligible clinicians.\109\ we
also believe there is room to improve upon the program. Specifically,
we believe this flexibility has inadvertently resulted in a complex
MIPS program that is not producing the level of robust clinician
performance information we envision providing to meet patient needs and
spur clinician care improvements.
---------------------------------------------------------------------------
\108\ 2017 Quality Payment Program Reporting Experience, March
20, 2019 (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/491/2017%20QPP%20Experience%20Report.pdf).
\109\ Quality Payment Program (QPP) Participation in 2018:
Results at a Glance, https://qpp-cm-prod-content.s3.amazonaws.com/uploads/586/2018%20QPP%20Participation%20Results%20Infographic.pdf.
---------------------------------------------------------------------------
Although we have been reducing the numbers of MIPS quality measures
in accordance with the Meaningful Measures initiative (see 83 FR 59763
through 59765), we have heard concerns from some stakeholders that MIPS
presents clinicians with too much complexity and choice (for example,
of several hundred MIPS and QCDR quality measures), causing unnecessary
burden. As noted in the CY 2019 PFS final rule (83 FR 59720), we have
received feedback that some clinicians find the performance
requirements confusing, and that it is difficult for them to choose
measures that are meaningful to their practices and have a direct
benefit to beneficiaries.
We have also heard concerns from stakeholders that MIPS does not
allow for sufficient differentiation of performance across practices
due to clinician quality measures selection bias. This detracts from
the program's ability to effectively measure and compare performance,
provide meaningful feedback, and incentivize quality. For example, in
its June 2017 Report to Congress, MedPAC documented the need for
changes to the MIPS program to increase clarity, reduce complexity, and
make the burden of data submission worthwhile through higher impact.
MedPAC recommended in their March 2018 Report to Congress using a
uniform set of population-based measures for clinicians paid by
Medicare who are not participating in an advanced APM, and provided an
illustrative voluntary value model that used administrative claims and
patient experience surveys. The MedPAC model did not include any
specific clinical specialty or practice level measures.
We believe a hybrid approach is warranted--where clinicians are
measured on a unified set of measures and activities around a clinician
condition or specialty, layered on top of a base of population health
measures, which would be included in virtually all of the MVPs. Over
time, the information clinicians and groups are required to submit will
be less burdensome and more meaningful to clinicians and patients. At
the same time, we intend to analyze Medicare information to provide to
clinicians and patients more information to improve the health of the
Medicare beneficiaries. Finally, we anticipate capturing additional
information important to patients. We envision applying this framework
to future proposals beginning with the 2021 MIPS performance period/
2023 MIPS payment year as we integrate new MVPs, so that eventually,
all MIPS eligible clinicians would have to participate through an MVP
or a MIPS APM. We seek feedback on numerous elements related to the
MVPs in sections III.K.3.a.(3)(a)(i) through III.K.3.a.(3)(a)(iv) of
this proposed rule.
(b) Clinician Data Feedback
Clinicians have expressed an interest in leveraging data, such as
timely claims data, to track performance and inform care improvements.
We understand that performance data feedback on administrative claims-
based quality and cost measures would potentially assist clinicians in
understanding their performance and preparing to take on risk as
required in Advanced APMs. We see the critical need for data feedback
and intend to provide enhanced clinician driven data feedback and
analysis information under the future MVP approach. We are interested
in
[[Page 40734]]
whether clinicians would like to see outlier analysis or other types of
actionable data feedback and are seeking comments on clinician data
feedback content and timing needs in section III.K.3.a.(6) of this
proposed rule.
(c) Enhancing Information for Patients
The MIPS program aims to drive quality and value through the
collection, assessment, and public reporting of data that informs and
rewards the delivery of high-value care. We believe that our
performance measurement should focus more on patient reported measures,
including patient experience and satisfaction measures and clinical
outcomes measures, as we believe that clinicians can use feedback from
the patient perspective to inform care improvement efforts. We believe
that MVPs should include patient reported measures when feasible. We
believe implementing an MVP framework will transform the MIPS program
by better informing and empowering patients to make decisions about
their healthcare and helping clinicians achieve better outcomes, and
also by promoting robust and accessible healthcare data and
interoperability.
We are dedicated to putting patients first and providing the
information they need to be engaged and active decision-makers in their
care. We believe that whenever feasible the MIPS program should provide
meaningful information at the individual clinician level. We believe we
need specific specialty information from multispecialty groups and are
considering approaches to use the MVPs to require reporting relevant to
multiple specialty types within a group to provide more comprehensive
information for patients. We seek comment, as discussed in section
III.K.3.a.(3)(b) of this proposed rule, on the best ways to identify
which MVPs should be reported by multispecialty groups and how we
should balance the need for information at the individual clinician
level with the burden of reporting.
We are also looking at ways that we can gather and display
information that is useful to patients. We are considering approaches,
as discussed in section III.K.3.a.(6) of this proposed rule, to
developing and reporting on Physician Compare a ``value indicator''
representing each clinician's performance on cost, quality, and the
patient's experience of care. We are committed to learning more about
the types of information patients use in making decisions and
determining what information can be derived from the data reported or
gathered as part of MIPS.
(3) Implementing MVPs
(a) MVP Definition, Development, Specification, Assignment, and
Examples
We are seeking comments on the development and structure of MVPs,
which would connect measures and activities across the quality, cost,
and improvement activities performance categories. We believe that
interoperability is a foundational element and thus would generally
apply to all clinicians, regardless of the specific MVP, for whom the
Promoting Interoperability performance category is required. MVPs would
support our vision to measure value, reduce burden, simplify the MIPS
performance measurement and scoring approaches, and ensure strong
alignment of quality and cost measures. The four guiding principles we
would use to define MVPs are:
1. MVPs should consist of limited sets of measures and activities
that are meaningful to clinicians, which will reduce or eliminate
clinician burden related to selection of measures and activities,
simplify scoring, and lead to sufficient comparative data.
2. MVPs should include measures and activities that would result in
providing comparative performance data that is valuable to patients and
caregivers in evaluating clinician performance and making choices about
their care.
3. MVPs should include measures that encourage performance
improvements in high priority areas.
4. MVPs should reduce barriers to APM participation by including
measures that are part of APMs where feasible, and by linking cost and
quality measurement.
We request public comments on the MVP guiding principles noted
above. We also request public comments on how to best develop MVPs to
allow for the development of better comparative data, reduce burden,
and provide valuable information to patients and clinicians.
MVPs would be organized around clinician specialty or health
condition and encompass a set of related measures and activities. We
intend to ensure equity in MVPs so that clinicians are not advantaged
by reporting one MVP over another (for example, in terms of reporting
burden and scoring), but also want to include measures that have
opportunities for improvement. Bundling quality and cost measures and
improvement activities that are highly correlated in addition to the
measures from the Promoting Interoperability performance category will
strengthen clinical improvement and streamline reporting. As an initial
step, we are proposing to require that beginning with the 2020 Call for
measures process, MIPS quality measure stewards must link their MIPS
quality measures to existing and related cost measures and improvement
activities, as applicable and feasible. We refer readers to section
III.K.3.c.(1)(d)(i) of this proposed rule for further discussion of our
proposal.
We believe that MVPs can be created with significant input from
clinicians and specialty societies, to ensure that measures and
activities within MVPs are relevant and important to clinician
practices. The most significant change with MVPs is that eventually all
MIPS eligible clinicians would no longer be able to select quality
measures or improvement activities from a single inventory. Instead,
measures and activities in an MVP would be connected around a clinician
specialty or condition (see examples of potential MVPs in section
III.K.3.a.(3)(a) of this proposed rule). We also intend that a
population health measure/administrative claims-based measures would be
layered into measuring the quality performance category, applied
whenever there is a sufficient case minimum. Cost measures would be
specific to the MVP and applied only when a clinician or group meets
the case minimum. MVPs could potentially also allow for the use of
multi-category measures, should they be developed, as clinician
feedback has indicated there is an interest in the development of these
performance measures that simultaneously address two or three of the
MIPS performance categories (83 FR 35932).
As outlined in our goals for the Promoting Interoperability
performance category in section III.K.3.c.(4)(b), we look to continue
MIPS alignment with the Medicare Promoting Interoperability Program for
eligible hospitals and CAHs, where appropriate. We envision Promoting
Interoperability performance category measures, which focus on the
meaningful use of certified EHR technology to support care coordination
and electronic health information exchange, to be a key structural part
of any MVP. Initially, there would be a uniform set of Promoting
Interoperability measures in each MVP, though in future years we may
consider customizing the Promoting Interoperability measures in each
MVP. At this time, we are not considering making modifications to the
Promoting Interoperability performance category as it becomes
incorporated into the MVP framework. We believe that interoperability
is a foundational element and thus would apply to all
[[Page 40735]]
clinicians, regardless of MVP, for whom the Promoting Interoperability
performance category is required. However, we are seeking comment on
how the Promoting Interoperability performance category could evolve in
the future to meet our goal of greater cohesion between the MIPS
performance categories. We believe that eligible clinicians could
benefit from more targeted approaches to assessing the meaningful use
of health IT which aligns with clinically relevant MVPs cutting across
the MIPS performance categories. One approach we could consider is
exploring which measures for the Promoting Interoperability performance
category would be directly aligned with measures in other MIPS
performance categories. For instance, many improvement activities are
enabled by, or could be enabled by, the use of certified health IT
including care coordination and patient engagement through health
information exchange. We could develop Promoting Interoperability
measures which measure the use of health IT in conducting these
improvement activities, while relevant quality measures for a given MVP
could assess quality outcomes associated with these activities. We
invite comment on these concepts, as well as other suggestions for how
the Promoting Interoperability performance category can be better
integrated into MVPs.
We also believe that improvement activities can be closely linked
to the quality and cost measures, to encourage improvement on
performance of those measures. As clinicians report on a stable set of
measures, there is an inherent incentive to change practice patterns to
increase performance on required quality and cost measures. We are
seeking feedback in section III.K.3.a.(3)(a)(ii) of this proposed rule
on how many improvement activities should be included in an MVP and how
much flexibility there should be in selecting improvement activities.
We also seek feedback on the extent to which improvement activities in
MVPs should be specialty-specific, condition-focused improvement
activities, versus other areas relevant to the practice such as patient
experience and engagement, team-based care, and care coordination. More
generally, we would like to understand how improvement activities are
used to improve quality measure performance within clinical practices.
Our goal in using MVPs is to standardize which measures and
activities are reported, both to reduce clinician burden and better
measure performance among comparable clinicians while appropriately
recognizing the variability of clinician practices and potentially
reducing barriers to moving into APMs, which generally measure quality
for their respective participants using the same quality measures. We
can also look to APMs for methods of linking quality and value
measurement as APMs are designed around value, and address quality,
cost, and care redesign for a specific population.
We realize that there are numerous issues on which we need
stakeholder feedback to fully implement MVPs, but we believe the basic
approach could start in the 2021 MIPS performance period/2023 MIPS
payment year. We are requesting public comments on the following
issues:
How to construct MVPs, including approach, definition,
development, specification, and examples referenced at
III.K.3.a.(3)(a)(i) of this proposed rule;
How to select measures and activities for MVPs, referenced
at III.K.3.a.(3)(a)(ii) of this proposed rule;
How to determine MVP assignment, referenced at
III.K.3.a.(3)(a)(iii) of this proposed rule; and
How to transition to MVPs, referenced at
III.K.3.a.(3)(a)(iv) of this proposed rule.
To begin implementing MVPs, we are proposing to define a MIPS Value
Pathway at Sec. 414.1305 as a subset of measures and activities
specified by CMS. We anticipate that MVPs may include, but would not be
limited to, administrative claims-based population health, care
coordination, patient-reported (which may include patient reported
outcomes, or patient experience and satisfaction measures), and/or
specialty/condition specific measures. MVPs would include a population
health quality measure set, and measures and activities such that all 4
MIPS performance categories are addressed, and each performance
category would be scored according to its current methodology. Under
MVPs, the current MIPS performance measure collection types would
continue to be used to the extent possible, but these details need to
be worked out and would be addressed in next year's rulemaking cycle.
We request comment on performance measure collection types for MVPs in
section III.K.3.a.(3)(a)(ii) of this proposed rule.
We provide 4 illustrative examples of MVPs in Table 34. The
examples demonstrate how MVPs could be constructed and show the types
of measures and activities that might be assigned to each MVP. We
present 2 example MVPs for primary care and general medicine, which
includes preventive health and diabetes prevention and treatment, as
well as two example MVPs for procedural specialties, which include
major surgery and general ophthalmology. Within our sample MVPs, we
present no more than 4 quality or cost measures or improvement
activities for each performance category. However, the exact number of
measures and activities could vary across MVPs. We envision that we
would no longer require the same number of measures or activities for
all clinicians but focus on what is needed to best assess the quality
and value of care within a particular specialty or condition. To assign
quality measures in these examples, we prioritized outcome and patient
reported measures, non-topped out measures, and eCQMs. To assign cost
measures, we reviewed existing measures and selected those that fit
into the MVP topic. We also included population health measures, which
are described in section III.K.3.a.(4) of this proposed rule. We
reviewed and selected relevant improvement activities that align with
the quality and cost measures in the MVPs. We are interested in
feedback on whether improvement activities should focus on improving
the quality and cost measures within an MVP or be much broader
including any improvement activities that are relevant to the practice.
We are interested in exploring approaches to leverage participation in
specialty accreditation programs, such as the American College of
Surgeons' Commission on Cancer accreditation program. Since specialty
accreditation programs may promote the evaluation and improvement of
clinical processes and care, we believe it may be appropriate to
incorporate attestation to participation in such programs as an
approach to satisfy the requirements of the improvement activities
performance category, for example, by proposing to specify such
participation as an improvement activity for all MVPs or specific MVPs
in future rulemaking. To align with the statutory requirement that a
practice that is certified or recognized as a patient-centered medical
home or comparable specialty practice be given the highest potential
score for the improvement activities performance category, we have also
included an illustrative example under the Preventive Health MVP to
depict how patient-centered medical homes or comparable specialty
practices would receive credit under the improvement activities
performance category. We anticipate that all measures in the Promoting
Interoperability performance category would initially be applicable to
[[Page 40736]]
each MVP unless an exclusion applies; thus, we assigned all Promoting
Interoperability measures to all MVPs. We welcome comments on the
examples of possible MVPs and on options for encouraging
interoperability to promote improvements in care and performance
measurement results.
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BILLING CODE 4120-01-C
The examples in Table 34 are illustrative only, but we envision
that we would start building MVPs by reviewing the existing specialty
measure sets for the quality performance category. However, some
specialty measure sets contain multiple conditions or concepts, so we
do not envision a one-to-one correlation between the specialty measure
sets and MVPs.
We anticipate that eventually many clinicians would have at least
one relevant MVP, while other clinicians may have several. In
particular, we believe that multispecialty groups will have more than
one relevant MVP. If technically feasible, we would like to establish a
methodology that allows us to identify and assign in advance the
relevant MVP(s) for MIPS eligible clinicians or groups and require the
clinician or groups to report on those MVPs. In addition, we would
consider folding MIPS APM measures and activities into MVPs and develop
an assignment process as described in the CY 2018 Quality Payment
Program final rule (82 FR 53785 through 53787), applying a hierarchy
which applies APM entity final scores over any other final score.
We are interested in feedback on the level of choice that should be
provided to clinicians for MVP selection or selection of measures and
activities within an MVP. We have heard from some clinicians that they
would prefer a clear list of what specific measures and activities they
have to perform versus various options of measures and activities to
report. We believe a methodology in which clinicians are informed of
the potential MVP(s) that are available for a clinician or group to
report on would be simpler to communicate and allow for both clinicians
and CMS to better understand what measures and activities should be
submitted. We are considering assigning MVPs to clinicians and groups,
if technically feasible, starting with the 2021 MIPS performance period
as MVPs become available and would propose the MVP assignment process
in next year's rulemaking cycle. We are considering the feasibility of
potential data sources or methods to use to assign clinicians to an
MVP, such as the specialty reported on Part B claims or use of Medicare
Provider Enrollment, Chain, and Ownership System (PECOS) data. We seek
comment on circumstances when we should allow clinicians and groups to
select an alternative MVP, rather than the one or more MVP(s) assigned.
Those clinicians and groups who would not have an applicable MVP for
the 2021 MIPS performance period would continue the current process of
reporting MIPS measures and activities for the 4 performance
categories. As an alternate option, we could consider self-assignment
of MVPs for the 2021 MIPS performance year period with the intention of
assigning MVPs to clinicians starting in the 2022 MIPS performance
period. Clinicians have had flexibility in choosing MIPS quality
measures to date, and we expect retaining a degree of choice will be
welcome by some clinicians as we transition to MVPs. We anticipate that
the number of available MVPs would increase in the 2022 MIPS
performance period and subsequent years, which would allow for MVP
assignment for all clinicians and groups. We are requesting public
comments on whether clinicians and groups should be able to self-select
an MVP or if an MVP should be assigned. If assigned, we are requesting
comments on the best way to assign an MVP--should it be based on place
of service codes, specialty designation on Part B claims, or in the
case of groups, should the assigned MVP(s) be based on the specialty
designation of the majority of clinicians in the group, specific
services, or other factors?
We are considering approaches to assigning MVPs to multispecialty
groups to be inclusive of the different specialties providing care to
patients. Alternatively, we are also considering approaches that would
allow for self-assignment of MVPs where multispecialty groups would
select one or more MVPs that are most relevant to the specialty mix
within the group.
We believe the approach to MVPs must find the right balance between
having a sufficient number of MVPs to allow clinicians to report on
measures and activities relevant to their practices, without developing
so many MVPs that reporting is diluted and developing benchmarks is
hampered. For example, we would not want to have several MVPs for the
same specialty or condition because then only a portion of the MIPS
eligible clinicians are reporting on the quality measures, which limits
the ability to develop benchmarks and to make meaningful comparisons of
clinicians.
In addition, due to differences in collection types for many
quality measures, we can have multiple benchmarks for each measure,
which further complicates the ability to make meaningful comparisons.
The diversity of MVPs and collection types of quality measures may
hamper MIPS in meeting its vision of effectively measuring and
comparing performance, providing meaningful feedback, incentivizing
quality, and providing patients with enhanced information for making
clinician selection choices.
We believe Electronic Clinical Quality Measures (eCQMs) have the
potential to decrease reporting burden within MVPs. Stakeholders have
previously supported eCQMs and the associated reduction in information
collection burden under a variety of CMS programs and have made
recommendations for improving eCQMs (83 FR 41593). While we support the
reporting of eCQMs through the MIPS program, we have identified certain
eCQMs for removal. We may propose to remove measures that are extremely
topped out, duplicative of a new measure, or are low-adopted measures
that have been in the program for 2 or more years. We refer readers to
Table Group C of Appendix 1 for the list of previously finalized
quality measures proposed for removal in the 2022
[[Page 40739]]
payment year. Through our Call for Measures process, and related
measure development resources, such as the CMS BluePrint at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf and the CMS Measure Development
Plan at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/2018-MDP-annual-report.PDF, we encourage stakeholders to
submit electronically specified measures for CMS consideration. We
recognize that there are challenges related to development of new eCQMs
and technical aspects, however, we are interested in eCQMs and their
potential use in MVPs to reduce reporting burden. For further
discussion of strategies for reducing burden associated with reporting
eCQMs, refer to the Office of the National Coordinator for Health
Information Technology draft report, Strategy of Reducing Regulatory
and Administrative Burden Relating to the Use of Health IT and EHRs
(https://www.healthit.gov/sites/default/files/page/2018-11/Draft%20Strategy%20on%20Reducing%20Regulatory%20and%20Administrative%20Burden%20Relating.pdf).
We are interested in feedback on our timeframe for transitioning
into MVPs. We anticipate that we will have a number of MVPs proposed
for the 2021 MIPS performance period. However, we understand that there
are many operational considerations that should be taken into account.
We request comment on approaches to accelerate the development and
implementation of MVPs, as well as any comments on the optimal timeline
for transition.
Over the next year, we may consider convening public forum
listening sessions, webinars, and office hours, or use additional
opportunities such as the pre-rulemaking measures process to understand
what is important to clinicians, patients, and stakeholders, as we
develop MVPs.
(i) Request for Feedback on MVP Approach, Definition, Development,
Specification, Assignment, and Examples
We are requesting public comments on how MVPs are developed.
We have stated MVP guiding principles regarding reducing
burden, providing comparative performance data to patients and
caregivers, encouraging improvements in high priority areas, and
reducing barriers to APM participation. Should we consider other
guiding principles as we define and develop MVPs?
In addition to gathering feedback from this proposed rule,
how do we best engage stakeholders in the development of MVPs?
++ How would stakeholders like to be engaged in MVP development?
What type of outreach would be the most effective in gathering the
voice of the patient in the MVP concept and the selection of measures?
++ For quality measures, should we initiate a ``Call for MVPs''
that aligns with policies developed for the Call for Measures and
Measure Selection Process, described in section III.K.3.c.(1)(d)(i) of
this proposed rule, or should we use an approach similar to the process
used to solicit recommendations for new specialty measure sets and
revisions to existing specialty measure sets, as described in section
III.K.3.c.(1)(d)(i) of this proposed rule?
How should MVPs be organized, for example, around
specialties and areas of practice? Alternatively, should MVPs be
organized to address a small number of public health priorities, for
example, HIV care or healthcare-associated infections? Please refer to
Table 34 for examples of specialty MVPs.
How can we ensure the right number of MVPs that result in
comparable and comprehensive information that is meaningful for the
clinicians, patients, and the Medicare program? How should we limit the
number of MVPs? Should each specialty have a single MVP?
How should we build on Promoting Interoperability, a
foundational component of MVPs, as we link the 4 categories within
MVPs? How could we best promote the use of health information
technology and interoperability in practices not yet using electronic
health records?
How can MVPs effectively reduce barriers to clinician
movement into APMs, such as practice inexperience with cost measurement
and lack of readiness to take on financial risk?
(ii) Request for Feedback on Selection of Measures and Activities for
MVPs
We are requesting public comments on the selection of measures and
activities in MVPs.
Please provide feedback on the Example MVPs in Table 34
that might help us in our development of additional MVPs. In the
example, there is a list of required quality measures and improvement
activities. Should MVPs include only required measures and activities,
or a small list of quality measures and activities from which
clinicians could choose what to report?
What criteria should be used for determining which
measures and activities should be included in an MVP, such as
prioritizing outcome, high priority and patient-reported measures;
limiting the number of quality measures to 4, including only cost
measures that align with quality measures, etc.? How should performance
categories and associated measures and activities be linked (e.g.,
quality measures aligned with cost measures)?
For the quality measures, should clinicians and groups be
required to use a certain collection type (eCQMs, MIPS Clinical Quality
Measures [MIPS CQMs], CMS Web Interface, or QCDR measures) in order to
have a comparable data set in the MVPs? What will clinicians'
administrative burden be for changing to a new, specific collection
type for a measure, for example, changing from MIPS CQM to an eCQM?
Currently we have similar measures addressing the same
clinical topic, with different collection types (for example, eCQMs,
MIPS CQMs, QCDR measures, etc.) that have different specifications and
separate benchmarks. What methodology could be used to develop a single
benchmark when multiple collection types are used? Another solution we
may consider to ensure comparable measure data and request feedback on
is to require a single collection type. Please also refer to section
III.K.3.a.(3)(c) of this proposed rule for more about QCDR measures in
MVP.
Should improvement activities in MVPs be restricted to
activities directly related to the clinical outcomes of the quality and
cost measures in the MVP, for example, IA_PM_4 ``Glycemic Management
Services'' for a Diabetes MVP, or should the selection of improvement
activities include cross-cutting activities, for example, IA_EPA_1
Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have
Real-Time Access to Patient's Medical Record? Should attestation to
participation in a specialty accreditation program satisfy the
improvement activities performance category requirements for an MVP?
Should this option be available for all MVPs or limited to specific
MVPs, such as particular specialties for which accreditation programs
are available? What criteria should we use to identify such programs?
(iii) Request for Feedback on MVP Assignment
We are requesting public comments on how we determine the most
relevant MVP for clinicians and groups.
[[Page 40740]]
How should we identify which MVP(s) are most appropriate
for a clinician? Would it be based on the clinician specialty as
identified in PECOS or the specialty reported on claims? If we assign
an MVP, how would we be able to verify the applicability of the
assigned MVP?
Should we provide clinicians and groups more than one
applicable MVP and allow clinicians to select their MVP(s) from those
identified? What tools would be helpful for clinicians to understand
what MVP(s) might be applicable, for example NPI lookup, measure
shopping cart, etc.?
(iv) Request for Feedback on Transition to MVPs
We are requesting public comments on how we transition to MVPs
beginning with the 2021 MIPS performance period/2023 MIPS payment year.
What practice level operational considerations do we need
to account for in the timeline for implementing MVPs?
(b) Adjusting MVPs for Different Practice Characteristics
(i) Small and Rural Practices Participation in MVPs
We realize that reporting burden associated with MIPS can vary by
the size of the practice. Under current quality performance category
submission requirements, the same number of measures and activities are
reported regardless of group size, which may impose a high burden on
small practices, given their very limited resources to address program
requirements. Another challenge for small and rural group practices is
the lack of a sufficient case mix to report measures that can be
reliably scored, which makes the use of a set of administrative claims-
based quality and cost measures especially challenging. Policies for
submission of measures and scoring for MVPs may need to account for
these challenges. As we move towards MVPs, we will be evaluating other
policies (such as eligibility requirements, including the low-volume
threshold (Sec. 414.1305), submission requirements (Sec. 414.1325),
scoring (Sec. 414.1380), etc.) for further modification.
We also want to adopt policies that reduce barriers for small
practices transitioning into APMs where available. We have seen that
there are innovative small groups including over 83,000 clinicians (in
small practices with less than 4 clinicians) that joined the
Transforming Clinical Practice Initiative (TCPI) Practice
Transformation Networks (PTNs), who followed tailored, targeted and
disciplined practices, and transitioned into advanced practices, for
example, practices that met APM readiness milestones in their practice
assessments and considers itself ready for migrating into an
alternative based payment arrangement. Presently, there are a total of
60,311 clinicians that have transitioned to APMs. Within TCPI, these
APMs, in alignment with the CMS Healthcare Payment Learning and Action
Network APM Framework, are Category 3 (APMs Built on Fee For-Service
Architecture) and Category 4 (Population-Based Payment) payment
arrangements.\110\ We understand that there are certain factors that
enable clinicians to make the transition into APMs, including the
readiness to take on additional risk, the ability to use timely
feedback to make practice changes, willingness to engage in peer-to-
peer learning and community of practices, accessing technical
assistance, and an ability to invest in infrastructure to enable care
improvement and efficiencies. Developing MVPs in alignment with APM
measures may assist small practices by providing experience with some
APM requirements, and enhanced CMS feedback data on quality and cost
performance can help clinicians make practice improvements and increase
readiness to participate in Advanced APMs.
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\110\ http://hcp-lan.org/workproducts/apm-framework-onepager.pdf.
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(A) Request for Feedback on Small and Rural Practices Participation in
MVPs
We are requesting public comments on policies to support small
practices.
How should we structure the MVPs to provide flexibility
for small and rural practices and reduce participation burden? What MVP
related policies could best assist small and/or rural groups when
submitting measures and activities? Should we have alternate measures
and activities submission requirements for small and/or rural
practices? For example, should small and/or rural practices be allowed
to report fewer measures and activities within an MVP?
How can we mitigate challenges small and/or rural
practices have in reporting? What types of technical assistance would
be most helpful to help small and/or rural practices to have successful
participation in MVPs?
How can we reduce barriers to small and/or rural groups to
transitioning into APMs, such as lack of information on performance on
quality and cost measures and limited resources? What approaches could
help small practices transition to MVPs?
(ii) Multispecialty Practices Participation in MVPs
At Sec. 414.1305, a group is defined as a single TIN with two or
more eligible clinicians (including at least one MIPS eligible
clinician), as identified by their individual NPI, who have reassigned
their billing rights to the TIN. Section 1848(q)(1)(D)(ii) of the Act
requires that the MIPS process, for assessing group practices, must to
the extent practicable reflect the range of items and services
furnished by the MIPS eligible clinicians in the group practice
involved. Multispecialty groups, especially those groups with a large
number of clinicians, often provide an array of services that may not
be captured in a single set of measures or in a single MVP. We have
also heard similar concerns from stakeholders. In the CY 2019 PFS
proposed rule (83 FR 35891), we acknowledged one of the overarching
themes we have heard from stakeholders is that we make an option
available to groups that would allow a portion of a group to report as
a separate sub-group on measures and activities that are more
applicable to the sub-group and be assessed and scored accordingly
based on the performance of the sub-group. We solicited comment on
specific options and questions for implementation of sub-group level
reporting in future years in response to some stakeholders who
requested the ability to report quality data for a portion of a TIN so
that they can report measures and activities more relevant to their
practice. However, as we noted in the CY 2019 PFS final rule (83 FR
59742), because there are numerous operational challenges with
implementing such a sub-group option, we did not propose any such
changes to our established reporting policies regarding the use of a
sub-group identifier. In the CY 2018 Quality Payment Program final rule
(82 FR 53593), we stated that in future rulemaking we intend to explore
the feasibility of establishing group-related policies that would
permit participation in MIPS at a sub-group level and create such
functionality through a new identifier.
As we consider this transition to MVPs, we are seeking public
comment on whether we can use the MVP approach as an alternative to
sub-group reporting to more comprehensively capture the range of the
items and services furnished by the group practice. This approach could
address
[[Page 40741]]
stakeholder concerns about reporting on meaningful measures which are
related to their practice without adding undue operational and data
collection burden associated with creating and maintaining identifiers
for sub-groups. Under this approach, multispecialty groups would report
on multiple assigned or selected MVPs, where assignment or selection of
MVPs would be proposed in future rulemaking, at the group level.
Depending on how the MVPs are then combined and scored at the group
level, this may eliminate the need for groups to create sub-TIN
identifiers and apply eligibility criteria at the sub-TIN level.
We are interested in developing criteria to identify which MVPs are
applicable to multispecialty groups and whether or not we should
require the reporting of multiple MVPs. Such an approach would provide
patients with better information about care and services provided by
multispecialty groups. If we require reporting on more than one MVP, we
may consider putting a cap on the number of MVPs, measures, and
activities to ensure there is no undue burden for multispecialty
practices. We are interested in how to improve both large and small
multispecialty group reporting of MIPS performance measures and
activities.
(A) Request for Feedback on Multispecialty Practices Participation in
MVPs
We are requesting public comments on MVP policies for
multispecialty practices.
We are considering a requirement in future years that
multiple specialty types within a group report relevant MVPs to provide
more comprehensive information for patients. We are seeking comment on
whether we can use the MVP approach as an alternative to sub-group
reporting to more comprehensively capture the range of the items and
services furnished by the group practice. For example, would it better
for multispecialty groups to report and be scored on multiple MVPs to
offer patients a more comprehensive picture of group practice
performance or for multispecialty groups to create sub-groups which
would break the overall group into smaller units which would
independently report MVPs? How should we balance the need for
information for patients on clinicians within the multispecialty
practice with the clinician burden of reporting?
What criteria should be used to identify which MVPs are
applicable to multispecialty groups? For example, should it be based on
the number or percentage of clinicians from the same specialty in the
group? Should a group be able to identify which clinicians will report
which MVP?
Should there be a limit on the number of MVPs that could
be reported by a multispecialty group?
What mechanisms should be used to assess a group's
specialty composition to determine which MVPs are applicable? For
example, would groups need to submit identifying information to assure
that measure MVPs aligned with the number or percent of clinicians of
different specialties within a group? Is there information (such as
specialty as identified in PECOS or the specialty reported on claims)
we could leverage to ensure the appropriateness of MVPs for groups?
In section III.E.1.c. of this proposed rule, we seek
public comment on whether to align Shared Savings Program quality
reporting requirements and quality scoring methodology with MIPS. As
MIPS transitions to MVPs and addresses multispecialty practices, What
MVP policies should be applied to MIPS APM participants?
(c) Incorporating QCDR Measures Into MVPs
As part of our path to value focus, we want participation in MIPS
to become more meaningful to patients and clinicians. QCDR measures are
not included in our proposals for annual rulemaking and are separate
from MIPS measures, which are finalized through the rulemaking process.
We refer readers to section III.K.3.g.(2)(c) of this rule for
discussion of proposals to strengthen QCDR measures.
Both QCDR and MIPS measures are currently available for clinicians
to choose from to fulfill the requirements under the quality
performance category. We have been encouraged by clinician adoption of
QCDRs and their measures in the time since the Quality Payment Program
became operational. Clinicians are interested and dedicated to quality
improvement and have worked with QCDRs to foster an innovative and
flexible approach to quality measurement and improvement. We continue
to believe that participation in these QCDR quality improvement
programs is a strong sign of a commitment to quality and improvement.
While this environment has encouraged a flexible approach to
quality improvement, we believe it has also contributed to confusion
and lack of consistency in measurement as our list of MIPS measures is
greatly outpaced by the number of QCDR measures.
As noted in section III.K.3.a.(3)(a) of this rule, we are
considering a major change in the submission requirements for MIPS
eligible clinicians beginning with the 2021 MIPS performance period. We
believe that a smaller and more focused set of quality measures
assembled into an MVP, integrated with cost measures and improvement
activities, will better serve the program by reducing the complexity of
identifying how to participate in the program for clinicians, improving
our ability to compare clinicians, and improving beneficiaries' ability
to identify high quality practices. A proliferation of measures that
are different for every modest variation in practice is contrary to
such a goal. Therefore, we need to consider the role of QCDR measures
in such an environment.
(i) Request for Feedback on Incorporating QCDR Measures Into MVPs
We are requesting public comments on policies for how QCDR measures
would be used in MVPs:
Should QCDR measures be integrated into MVPs along with
MIPS measures, or should they be limited to specific MVPs consisting of
only QCDR measures? How do we continue to encourage clinicians to use
QCDRs under MVPs?
(d) Scoring MVP Performance
As we are proposing to apply the MVP framework to future proposals
beginning with the 2021 MIPS performance period/2023 MIPS payment year,
we may propose scoring changes in future rulemaking. We anticipate that
our basic approach to scoring measures and activities would remain
stable with MVPs. In particular, we believe that both quality and cost
performance category measures within MVPs would be scored using a scale
of 0 to 10 and performance assessed by comparing to a benchmark, using
the current approach to calculate benchmarks. We refer readers to
sections III.K.3.c.(1)(b) and III.K.3.c.(2)(a) of this proposed rule
for further discussion on how the quality and cost performance
categories respectively contribute to the final score. For quality
measures, we anticipate, when possible, that MVPs would use a single
benchmark for each measure and that all clinicians and groups in the
MVP would be compared against the same standard. In addition, we would
no longer need special scoring policies and bonuses to incent selection
of certain measures because clinicians would be required to report
[[Page 40742]]
all measures and activities in the MVP. Finally, we could align
improvement scoring for quality and cost performance measures, because
clinicians would use a stable set of measures, allowing for comparison
year-to-year at the measure level. We believe the standardized sets of
measures in MVPs would enable us to smoothly integrate new measures and
collect data to develop robust benchmarks before scoring these measures
on performance. We believe that scoring under the MVPs will potentially
reduce barriers to clinicians' movement into APMs, which generally
score their respective participants using the same quality measures and
strongly align quality and cost measures.
We believe that small practices will continue to face challenges
with meeting case minimums that allow reliable scoring of quality
measures. Our scoring policies will need to take into account that not
all measures reported by small practices can be scored based on the
case mix available for reporting.
We anticipate that the underlying scoring framework for scoring
improvement activities referenced in III.K.3.d.(1)(d) of this proposed
rule would not change for clinicians; however, there could be the
potential to better link cost and quality measures and the associated
improvement activities. We do not anticipate that the underlying
framework for scoring Promoting Interoperability measures referenced in
III.K.3.d.(1)(e) of this proposed rule would change because of the
introduction of the MVP framework. Promoting Interoperability is a
foundational component of MVPs. Scoring policies may be developed as
more details of the implementation of MVPs are developed.
We would also consider proposing scoring policies to evaluate MVPs
holistically, making sure that scoring across MVPs is equitable and
that clinicians are not unfairly advantaged by reporting a specific
MVP. We seek feedback on scoring policies that will help us create
level comparability across MVPs.
Additionally, if we propose in the future to allow or require
multispecialty groups to submit more than a single MVP of measures and
activities, we would need to develop scoring policies to fairly score
such groups.
(i) Request for Feedback on Scoring MVP Performance
We are requesting comments on the following:
What scoring policies can be simplified or eliminated with
the introduction of MVPs? For example, we may consider eliminating
scoring available for 2021 MIPS performance period providing a 3-point
floor for each submitted measure that can be reliably scored (83 FR
59842). Additionally, we may consider eliminating the scoring bonuses
available for the 2021 MIPS performance period for submitting high-
priority measures and use of CEHRT to support quality performance
category submissions (83 FR 59850 to 59852). Are there other scoring
policies that could be simplified or eliminated?
We seek feedback on scoring policies that will help us
create level comparability across MVPs. Are there approaches we should
take to create equity across MVPs and across clinician types, for
example, that regardless of the number of measures and activity, no
single MVP would ``outperform'' others? For example, should there be an
MVP adjustment added to the performance category scores?
How should we score multispecialty groups reporting
multiple MVPs? Should scores be consolidated for a single group score
or scored separately (and with separate MIPS payment adjustments) for
specialists within the group? Alternatively, should we have an
aggregate score for the multispecialty group?
(4) MVP Population Health Quality Measure Set
Section 1848(q)(2)(C)(iii) of the Act provides that the Secretary
may use global measures, such as global outcome measures, and
population-based measures, for purposes of the MIPS quality performance
category. Currently, the MIPS program has one administrative claims-
based quality measure, the all-cause readmission measure, which is
calculated and scored for groups with 16 or more clinicians that meet a
200-patient case minimum (81 FR 77300). In the CY 2019 PFS proposed
rule (83 FR 59719), we discussed our intent to use the Meaningful
Measures Initiative within the Quality Payment Program to help address
clinician reporting burden and improve patient outcomes through MIPS
performance measurement. The Meaningful Measures Initiative represents
an approach to quality measures that fosters operational efficiencies,
reduces costs associated with collection and reporting burden, and
produces quality measurement focused on meaningful outcomes. As we
apply the Meaningful Measures framework within MIPS to reduce reporting
burden and strengthen the use of measures that matter to patients and
clinicians, we are considering how to implement a population health
administrative claims-based quality measure set.
Global or population quality measures calculated from
administrative claims-based quality data can be used as a foundational
measure set to help improve patient outcomes, reduce data reporting
burden and costs, better align clinician quality improvement efforts,
and increase alignment with APMs and other payer performance
measurement. The April 2019 Health Care Payment Learning & Action
Network's Roadmap for Driving High Performance in Alternative Payment
Models (https://hcp-lan.org/workproducts/roadmap-final.pdf), intended
as a tool to begin identifying promising practices for implementing
successful APMs, points out that:
Payers use HEDIS[supreg] quality measures along with
administrative claims-based quality measures, such as preventable
admissions and readmissions, in designing ACOs and primary care model
APMs
Providers are more likely to participate in APMs if the
required measures align with measures they already track (see Roadmap
page 19), and
There is room for improvement in the area of quality
measurement to meaningfully assess health and quality-of-life outcomes
(see Roadmap page 60).
We believe an administrative claims-based quality measure set
consisting of a small number of quality measures focused on outcomes
and intermediate outcomes can move MIPS towards population health
measurement.
We have heard from some stakeholders that we should drive quality
measurement towards a set of population-based outcome measures. We
believe increasing the number of population health measures that
utilize administrative claims data in the MIPS program while reducing
the number of required condition and specialty specific measures would
reduce the burden associated with quality reporting. However, we
recognize that the use of an administrative claims-based quality
measure set would entail certain tradeoffs. These measures historically
have been applicable to primary care clinicians, with less relevance
for some specialists. They have also been limited to Medicare fee for
service patients, excluding other payer patients, and therefore, have
not provided a picture of a clinician's entire practice and patient
base. In addition, administrative claims-based quality measures require
a large sample to produce reliable results, which presents challenges
in a clinician program that allows for participation by individuals
[[Page 40743]]
and groups with relatively few patients in a specific measure
denominator. However, given the opportunity to reduce burden (because
clinicians do not need to report the administrative claims-based
quality measures themselves), apply measures across different clinician
types, focus on important public health priorities, and reduce barriers
to APM participation, we want to find ways to effectively use
administrative claims-based population health quality measures in MIPS.
We are working on multiple fronts to find the best and most
appropriate measures for the MIPS program. For example, we are working
with measure stewards on technical specifications to ensure the
measures are reliable and broadly applicable to MIPS eligible
clinicians. We intend to have the measures reviewed by a consensus-
based entity, for example, the National Quality Forum (NQF) Measure
Applications Partnership (MAP). We have looked at the use of
administrative claims-based quality measures in the Shared Savings
Program and the Comprehensive Primary Care Plus (CPC+) model to
identify examples of measures that could be included as MIPS measures.
As one example, in addition to an all-cause readmission measure
(similar to the one currently used in MIPS), the Shared Savings Program
has a measure (ACO--38), the All-Cause Unplanned Admissions for
Patients with Multiple Chronic Conditions, that we are in the process
of adapting and testing for the MIPS program. In section
III.K.3.c.(1)(d)(ii) of this proposed rule, we are proposing to add
All-Cause Unplanned Admissions for Patients with Multiple Chronic
Conditions measure to MIPS for the 2021 MIPS performance period. The
Shared Savings Program also has a risk adjusted measure, (ACO--43), the
Ambulatory Sensitive Condition Acute Composite (AHRQ Prevention Quality
Indicator (PQI) #91), which assesses the risk adjusted rate of hospital
discharges for acute PQI conditions with a principal diagnosis of
dehydration, bacterial pneumonia, or urinary tract infection among ACO
assigned Medicare fee-for-service (FFS) beneficiaries 18 years and
older. In section III.E.1.b., we recognize that the measure steward,
AHRQ, has made ``substantive'' change to the measure and propose to
redesignate ACO--43 to a pay-for-reporting measure for the 2020 and
2021 performance years, while seeking comment on other approaches
including developing historic benchmarks.
As we work to improve and develop a foundational population health
quality measure set, we are reviewing measures that we could propose in
future rulemaking. We are reviewing whether it would be appropriate to
add a measure similar to the ACO--43 Ambulatory Sensitive Condition
Acute Composite (AHRQ Prevention Quality Indicator (PQI) #91) to MIPS.
We are also reviewing two risk adjusted utilization measures that are
included in the CPC+ Model Quality and Utilization Measure Set for the
2019 Performance Period for potential inclusion in the MIPS program:
The HEDIS[supreg] Acute Hospital Utilization (AHU) (this is the
inpatient hospital utilization measure in CPC+ Model that was updated
by NCQA in 2018); and the HEDIS[supreg] Emergency Department
Utilization (EDU).\111\ These measures assess the risk-adjusted ratio
of observed-to-expected acute inpatient and observation stay discharges
during the measurement year reported by surgery, medicine and total
among members 18 years of age and older. These measures are currently
specified for health plans, but we intend to work with the measure
steward, NCQA, for appropriateness for the MIPS program.
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\111\ The Acute Hospital Utilization and Emergency Department
Utilization measures and specifications were developed by the
National Committee for Quality Assurance (``NCQA'') under the
Performance Measurements contract (HHSM-500-2006-00060C) with CMS
and are included in HEDIS[supreg] with permission of CMS. HEDIS is a
registered trademark of NCQA.
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Clinicians raised concerns in response to previously proposed
administrative claims-based quality measures. These concerns included
measure reliability and applicability case size, attribution, risk
adjustment, application at the clinician or group level, and degree of
actionable feedback for improvements (81 FR 77130 through 77136). We
finalized use of the all-cause readmission measure but limited its
applicability to groups of 16 or more clinicians with a minimum of 200
cases to mitigate some of the concerns. We did not finalize the
proposed AHRQ Acute Conditions Composite and Chronic Conditions
Composite measures (81 FR 28192 and 28447). Our intention is to address
the technical challenges as we test the Ambulatory Sensitive Condition
Acute Composite measure and present to a consensus-based entity (for
example NQF) to ensure the measure is reliable. We seek feedback on
additional steps to ensure the measure addresses the concerns noted
above.
Clinician feedback also called for the examination of potential
sociodemographic status risk adjustment for administrative claims-based
quality measures. Please refer to section III.K.3.d.(2)(a) of this
proposed rule for information on our approach to accounting for risk
factors in MIPS, including the complex patient bonus which was
finalized for the 2020 MIPS payment year (82 FR 53771 through 53776),
as well as plans to take into consideration a second report by ASPE
expected in October 2019 on accounting for risk factors in quality,
resource use and other measures in Medicare. We are proposing to
continue the complex patient bonus in MIPS and would continue to assess
the need for and effectiveness of such a scoring adjustment to ensure
fair performance comparisons between clinicians.
In summary, we plan to increase the use of global and population
based administrative claims-based quality measures as we develop a
population health quality measure set and are outlining our proposal to
add at least one additional administrative claims-based quality measure
starting in the 2021 MIPS performance period in section
III.K.3.c.(1)(d)(ii) of this proposed rule.
(a) Request for Feedback on Population Health Quality Measure Set
We are requesting public comments on the use of a population health
quality measure set.
In addition to the quality measures described above, are
there specific administrative claims-based quality measures we should
consider, including, but not limited to, any that assess specialty care
that are specified and/or tested at the clinician/group practice level?
We would like to balance the desire for quality measures
specific to a clinical practice with a reduction in administrative
burden for submission. Should administrative claims-based quality
measures be used to replace some of the reporting requirements in the
quality performance category? For example, if two additional
administrative claims-based quality measures were added to MVPs should
we reduce the required quality measures by 1 measure for each of the
MVPs?
In addition to testing, what other information or methods
should be used to mitigate concerns about administrative claims-based
quality measure reliability, applicability, and degree of actionable
feedback for clinician performance improvement? What concerns should be
prioritized?
(5) Clinician Data Feedback
Clinicians have expressed an interest in leveraging data to track
performance and inform care improvements. We see the critical need for
data feedback and
[[Page 40744]]
intend to provide enhanced clinician driven data feedback and analysis
information under the future MVP approach. We understand that
performance data feedback on administrative claims-based quality and
cost measures would potentially assist clinicians in understanding
their performance and preparing to take on risk as required in Advanced
APMs. We are interested in whether clinicians would benefit from
receiving feedback on administrative data that is available to us, such
as information on the services that their patients receive or
information on the clinician's volume of services in comparison to
their peers to determine if the clinician is an outlier. Clinicians may
also benefit from timely actionable clinical data feedback from
registries, and we have proposed to enhance data feedback requirements
for QCDRs and registries in sections III.K.3.g.(2)(a)(iii) and
III.K.3.g.(3)(a)(ii) respectively of this proposed rule. We also
understand the need for timely data feedback and are seeking comments
on clinician data feedback content and timing needs.
(a) Request for Feedback on Clinician Data Feedback
We are requesting public comments on the Clinician Feedback.
We would like to provide meaningful clinician feedback on
administrative claims-based quality and cost measures. As clinicians
and groups move towards joining APMs, is there particular data from
quality and cost measures that would be helpful?
Would it be useful to clinicians to have feedback based on
an analysis of administrative claims data that includes outlier
analysis or other types of actionable data feedback? What type of
information about practice variation, such as the number of procedures
performed compared to other clinicians within the same specialty or
clinicians treating the same type of patients, would be most useful?
What level of granularity (for example, individual clinician or group
performance) would be appropriate?
(6) Enhanced Information for Patients
(a) Patient Reported Measures
We intend to incorporate more patient reported outcomes and care
experience measures into MVPs. We want to learn how patient reported
information is being effectively used in the field to improve care to
assist patients with clinician selection and to incentivize high value
care. We believe that feedback from the patient perspective can inform
care improvement efforts as clinicians assess patient reported feedback
to identify ways to elevate quality of care.
MIPS currently includes patient reported measures, including
optimal asthma control and measures for functional status assessment
following hip and knee replacements, and other patient reported
measures are being added. We recognize current limitations with the
availability of patient reported measures. Patient reported measures
are often specific to a clinical condition or procedure, and we do not
have measures that are available or applicable to the majority of
clinicians in the MIPS program. The Consumer Assessments of Healthcare
Providers and Systems (CAHPS) for MIPS survey, a patient experience
survey, is offered to group practices as an optional quality measure
and is a high-weighted improvement activity. Section
III.K.3.c.(1)(c)(i) of this proposed rule discusses initiatives to
expand the information collected in the CAHPS for MIPS survey.
We have assessed additional approaches to gathering information on
experience and satisfaction from work both within and outside of the
health care environment. The Robert Wood Johnson Foundation working
with Patients Like Me, a health information sharing website for
patients, has provided guidance on what should be measured through a
publication entitled ``Development of a Conceptual Framework of ``Good
Healthcare'' from The Patient's Perspective'' \112\ We understand that
some organizations such as Patients Like Me are working with patients
throughout the measure development process to enhance their ability to
capture information that is useful to patients. Outside of healthcare,
many industries are approaching the measurement of satisfaction as a
business priority. Service industries have pioneered single question
``surveys'' asked at each encounter to learn if they are meeting
customer expectations and satisfying their customers, that could
include a question about the service provided or whether the assistance
provided addressed their problems. We are interested in how information
from single question or brief surveys to measure the quality of patient
experience and satisfaction with health care delivery could be better
incorporated into MVPs.
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\112\ https://patientslikeme_posters.s3.amazonaws.com/2017_Development%20of%20a%20Conceptual%20Framework%20of%20%E2%80%9CGood%20Healthcare%E2%80%9D%20from%20The%20Patient%E2%80%99s%20Perspective.pdf.
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(i) Request for Feedback on Patient Reported Measures
We are requesting public comments on enhancing the patient voice in
MVPs. Specifically, we seek comment on:
What patient experience/satisfaction measurement tools or
approaches to capturing information would be appropriate for inclusion
in MVPs? How could current commercial approaches for measuring the
customer experience outside of the health care sector (for example,
single measures of satisfaction or experience) be developed and
incorporated into MVPs to capture patient experience and satisfaction
information?
What approaches should we take to get reliable performance
information for patients using patient reported data, in particular at
the individual clinician level? Given the current TIN reporting
structure, are there recommendations for ensuring clinician level
specific information in MVPs? Should clinicians be incentivized to
report patient experience measures at the individual clinician level to
facilitate patients making informed decisions when selecting a
clinician, and, if so, how?
How should patient-reported measures be included in MVPs?
How can the patient voice be better incorporated into public reporting
under the MVP framework, in particular at the individual clinician
level?
(b) Publicly Reporting MVP Performance Information
We believe implementing a path to value will transform our
healthcare system by empowering well-informed patients to make
decisions about their healthcare and helping clinicians achieve better
outcomes. As we consider publicly reporting MVP performance
information, we want to ensure that patients have information that is
important and useful, which we believe includes information on
clinician performance on cost, quality, patient experience, and
satisfaction with care.
Currently, all MIPS quality measure information is displayed on
Physician Compare clinician and group profile pages at the individual
quality measure level. User testing with patients and caregivers has
shown that performance on certain individual quality measures is
particularly useful for selecting clinicians for their healthcare
needs. However, testing has also shown that patients and caregivers are
interested in a single overall rating called a ``value indicator'' for
a clinician or group when making comparisons across groups or
clinicians. To date, a ``value indicator'' to compare the performance
of a
[[Page 40745]]
clinician or group has not been possible due to the current approach in
which clinicians can select from an inventory of measures across a
variety of collection types and activities. Since clinicians are not
all reporting on the same quality measures, we have been unable to
develop direct overall comparisons under our public reporting
standards. However, we believe that MVPs, in which clinicians of a
particular specialty are held accountable for a uniform set of quality
and cost measures, would better allow for such comparisons.
Related to the MVP approach, we seek comment on the types of
clinician performance information we should include in the display for
a single ``value indicator''. As we think about value and information
that is important to patients, we want to incorporate measurement of
cost, quality, and patient experience and satisfaction in a way that is
meaningful to patients. We have heard that Medicare patients and
caregivers greatly desire information such as a value indicator, to
help make decisions about their healthcare. We seek comment on whether
displaying an overall indicator for the MVP for a clinician or group
would be useful for patients' making healthcare decisions. We refer
readers to the Public Reporting on Physician Compare at section
III.K.3.h.(4) of this proposed rule for additional considerations for
publicly reporting these types of information such as a value
indicator, patient narratives, and patient reported outcome measures.
(i) Request for Feedback on Publicly Reporting MVP Performance
Information
We seek feedback on approaches to publicly reporting MVP
performance information:
What considerations should be taken into account if we
publicly report a value indicator, as well as corresponding measures
and activities included in the MVPs?
If we develop a value indicator, what data elements should
be included? For example, should all reported measures and activities
be aggregated into the value indicator?
How would a value indicator, based on information from
MVPs, be useful for patients making health care decisions?
What methods of displaying MVP performance information
should we consider other than our current approach to using star
ratings for quality measure information on clinician profile pages?
What factors should be considered to ensure publicly
reported MVP information is comparable across relevant clinicians and
groups?
b. Group Reporting
For previous discussions of the policies for group reporting, we
refer readers to the CY 2017 Quality Payment Program final rule (81 FR
77070 through 77073) and the CY 2018 Quality Payment Program final rule
(82 FR 53592 through 53593). In addition, for previous discussions of
the policies for group reporting related to the Promoting
Interoperability performance category, we refer readers to the CY 2017
Quality Payment Program final rule (81 FR 77214 through 77216) and the
CY 2018 Quality Payment Program final rule (82 FR 53687).
It has come to our attention that the regulation text regarding
group reporting at Sec. 414.1310(e)(3) through (5) contains
duplicative language. Specifically, it is duplicative of the regulation
text at Sec. 414.1310(e)(2)(ii) through (iv). To avoid redundancy and
potential confusion, we are proposing to remove Sec. 414.1310(e)(3)
through (5). In addition, we have noticed that previously established
policies for group reporting with regard to the Promoting
Interoperability performance category (81 FR 77214 through 77216, 82 FR
53687) are not reflected in the regulation text for group reporting at
Sec. Sec. 414.1310(e)(2)(ii) and for virtual groups at Sec.
414.1315(d)(2). In the CY 2017 Quality Payment Program final rule (81
FR 77215), we stated that to report as a group for the Promoting
Interoperability performance category, the group will need to aggregate
data for all of the individual MIPS eligible clinicians within the
group for whom they have data in CEHRT. In an effort to more clearly
and concisely capture our existing policy for the Promoting
Interoperability performance category, we are proposing to revise
Sec. Sec. 414.1310(e)(2)(ii) and 414.1315(d)(2. Specifically, we are
proposing to revise Sec. 414.1310(e)(2)(ii) to state that individual
eligible clinicians that elect to participate in MIPS as a group must
aggregate their performance data across the group's TIN, and for the
Promoting Interoperability performance category, must aggregate the
performance data of all of the MIPS eligible clinicians in the group's
TIN for whom the group has data in CEHRT.
Similarly, we are proposing to revise Sec. 414.1315(d)(2) to state
that solo practitioners and groups of 10 or fewer eligible clinicians
that elect to participate in MIPS as a virtual group must aggregate
their performance data across the virtual group's TINs, and for the
Promoting Interoperability performance category, must aggregate the
performance data of all of the MIPS eligible clinicians in the virtual
group's TINs for whom the virtual group has data in CEHRT.
We request comments on these proposals.
c. MIPS Performance Category Measures and Activities
(1) Quality Performance Category
(a) Background
We refer readers to Sec. 414.1330 through Sec. 414.1340 and the
CY 2018 Quality Payment Program final rule (82 FR 53626 through 53641)
for our previously established policies regarding the quality
performance category.
In the CY 2020 PFS proposed rule, we seek to:
Propose to weigh the quality performance category at 40
percent for the 2022 MIPS payment year, 35 percent for the 2023 MIPS
payment year, 30 percent for the 2024 MIPS payment year as described in
Sec. 414.1330(b)(4), (5), and (6); The associated increases to the
weight of the cost performance category are discussed in section
III.K.3.c.(2) of this proposed rule;
Seek comment on adding narratives to the CAHPS for MIPS
survey and on whether the survey should collect data at the individual
eligible clinician level;
Propose to increase the data completeness criteria to 70
percent for the 2022 MIPS payment year as described in Sec.
414.1340(b)(3);
Propose to require MIPS quality measure stewards to link
their MIPS quality measures to existing and related cost measures and
improvement activities, as applicable and feasible;
Seek comment as to whether we should consider realigning
the MIPS quality measure update cycle with that of the eCQM annual
update process;
Propose changes to the MIPS quality measure set as
described in Appendix 1 of this proposed rule, including: Substantive
changes to existing measures, addition of new measures, removal of
existing measures, and updates to specialty sets.
Seek comment on whether we should increase the data
completeness threshold for extremely topped out quality measures that
are retained in the program due to limited availability of measures for
a specific specialty and potential alternative solutions in addressing
extremely topped out measures;
Propose to remove MIPS quality measures that do not meet
case minimum and reporting volumes required for benchmarking after
being in
[[Page 40746]]
the program for 2 consecutive CY performance periods;
Propose to remove quality measures from the program in
instances where the measure steward or owner refuses to enter into a
user agreement with CMS; and
Request information on a Potential Opioid Overuse Measure.
(b) Contribution to Final Score
Under Sec. 414.1330(b)(2), we state that performance in the
quality performance category will comprise 50 percent of a MIPS
eligible clinician's final score for the 2020 MIPS payment year, and
under Sec. 414.1330(b)(3), we state that performance in the quality
performance category will comprise 45 percent of a MIPS eligible
clinician's final score for MIPS payment year 2021. Section
1848(q)(5)(E)(i)(I) of the Act, as amended by section 51003(a)(1)(C)(i)
of the Bipartisan Budget Act of 2018, provides that 30 percent of the
final score shall be based on performance for the quality performance
category, but that for each of the 1st through 5th years for which MIPS
applies to payments, the quality performance category performance
percentage shall be increased so that the total percentage points of
the increase equals the total number of percentage points that is based
on the cost performance category performance is less than 30 percent
for the respective year. As discussed in section III.K.3.c.(2) of this
proposed rule, we propose to weight the cost performance category at 20
percent for the 2022 MIPS payment year, 25 percent for the 2023 MIPS
payment year, and 30 percent for the 2024 MIPS payment year and each
subsequent MIPS payment year. Accordingly, we are proposing to add
Sec. 414.1330(b)(4) to provide that performance in the quality
performance category will comprise 40 percent of a MIPS eligible
clinician's final score for the 2022 MIPS payment year. In addition, we
are proposing at Sec. 414.1330(b)(5) to state that the quality
performance category comprises 35 percent of a MIPS eligible
clinician's final score for the 2023 MIPS payment year. Lastly, we are
proposing to add Sec. 414.1330(b)(6) to state that the quality
performance category comprises 30 percent of a MIPS eligible
clinician's final score for the 2024 MIPS payment year and future
years. We believe that being transparent in how both the quality and
cost performance category weights will be modified over the next few
years of the program will allow stakeholders to better plan and
anticipate how eligible clinicians and group scores will be calculated
in future years as we incrementally make changes to the final score
weights. We seek comment on our proposals to incrementally reduce the
weight of the quality performance category as we gradually increase the
weight of the cost performance category. Specifically, the quality
performance category will comprise 40 percent of a MIPS eligible
clinician's final score for the 2022 MIPS payment year, 35 percent for
the 2023 MIPS payment year, and 30 percent for the 2024 MIPS payment
year and future years.
(c) Quality Data Submission Criteria
(i) Submission Criteria for Groups Electing To Report the Consumer
Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey
We are not proposing any changes to the established submission
criteria for the CAHPS for MIPS Survey. We refer readers to the CY 2019
PFS final rule (83 FR 59756) for previously finalized policies
regarding the CAHPS for MIPS survey.
Although we are not making any proposals in regard to the CAHPS for
MIPS survey this year, we are interested in feedback to add to the
survey, in future years, specific to a solicitation of comments we
previously requested to expand the survey to add narratives in the CY
2018 Quality Payment Program final rule (82 FR 53630). Currently, the
CAHPS for MIPS survey is available for only groups to report under the
MIPS. The patient experience survey data that is available on Physician
Compare is highly valued by patients and their caregivers as they
evaluate their health care options. However, in user testing with
patients and caregivers over the last several years, the users
regularly request more information from patients like them in their own
words, and to publicly report narrative reviews of individual
clinicians and groups. User testing further indicates that patients
want patient-generated information when selecting a clinician. Since
the CAHPS for MIPS survey is only at the group level, we are also
interested in feedback related to collection of data on patient
experiences from individual clinicians, which would be new data for CMS
and consequently new data to publicly report to patients and
caregivers. Including data at the individual level is of interest to
CMS as we have heard this is valuable to patients and caregivers in
making decisions related to their health care. See section III.K.3.h.
of this proposed rule where we are seeking comment on public reporting
considerations on the Physician Compare website for adding patient
narratives in future rulemaking.
Through efforts such as the Patients Over Paperwork initiative and
MyHealthEData initiative (https://www.cms.gov/newsroom/press-releases/trump-administration-announces-myhealthedata-initiative-put-patients-center-us-healthcare-system), we are dedicated to putting patients
first and empowering patients to have the information they need to be
engaged and active decision-makers in their care. We are also mindful
that a patient is a health care consumer for whom aspects of the health
care delivery experience, such as wait times or how a clinician
interacts with patients, may factor into a patient's decision to select
a clinician. We believe that measuring patient experience can help
inform patient decision-making and considered previous government
efforts to measure experience, such as the President's Management
Agenda--OMB Circular No. A-11 section 280--Managing Customer Experience
and Improving Service Delivery (https://www.whitehouse.gov/wp-content/uploads/2018/06/s280.pdf). Specifically, the OMB Circular No. A-11
section 280.7 references how should customer experience be measured in
the federal government. At a minimum, the federal government customer
experience should be measured in seven domains: \113\
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\113\ President's Management Agenda (2018)--OMB Circular No. A-
11 section 280--Managing Customer Experience and Improving Service
Delivery (https://www.whitehouse.gov/wp-content/uploads/2018/06/s280.pdf).
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Overall: (1) Satisfaction; (2) Confidence/Trust.
Service: (3) Quality.
Process: (4) Ease/Simplicity; (5) Efficiency/Speed; (6)
Equity/Transparency.
People: (7) Employee Helpfulness.
While the CAHPS for MIPS survey is an assessment of clinicians
within a group, we are looking at ways to enhance that feedback to
ensure the customer (patient) experience is being measured in such a
way that data from the CAHPS for MIPS survey can be used in healthcare
decision making. We are seeking comments on the above referenced seven
domains and if additional elements, questions, or context should be
added to the current CAHPS for MIPS survey (available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/459/2019%20CAHPS%20for%20MIPS%20Survey_Sample%20Copy.pdf), or if these
domains should be used to measure individual clinicians if a new
instrument was developed to gather that data and share the feedback
with
[[Page 40747]]
patients to make decisions about their healthcare.
For considerations as we prepare for future policies and
rulemaking, we are also seeking comment on:
Measures that would expand the information collected in
the CAHPS for MIPS survey, including a question regarding the patients'
overall experience and satisfaction rating with a recent health care
encounter. Patients value the ``voice'' of other patients and want
information that helps to choose their clinicians, and whether they
would recommend the clinician, group, office or facility to their
family and friends, as detailed in section III.K.3.a. of this rule.
Several versions of the CAHPS survey, including the CAHPS Clinician &
Group Survey 3.0, do have a question regarding the patients' rating of
a clinician. We refer readers to the Agency for Healthcare Research and
Quality's website on CAHPS Clinician and Group Survey for additional
information at https://www.ahrq.gov/cahps/surveys-guidance/cg/index.html. We currently do not collect and display information from a
single question about the patients' satisfaction or experience. Patient
experience measures provide a more objective assessment of health care
quality, since satisfaction may change frequently based on subjective
expectations. The CAHPS for MIPS survey has traditionally focused on
measures of patient experience.
Method for collecting this type of information from
patients and caregivers and if a web, paper, phone, or email based
survey would be preferred? Currently the CAHPS for MIPS survey is only
administered through paper and phone based methods.
Should a tool be developed to collect information about
individual clinicians? Or should this information be kept at the group
level only? Currently patient experience data is only available through
the CAHPS for MIPS survey, and this survey does not collect information
on individual clinicians.
Should this data be collected at a pilot level first,
provided that such an approach is consistent with our statutory
authority, so that we learn from this data before fully implementing
broader across the program? If so, we seek comments regarding the
framework and implementation criteria of a pilot.
In addition, we are seeking comment on the value of using narrative
questions, inviting patients to respond to a series of questions in
free text responding to open ended questions and describing their
experience with care. Patients can write a response in their own words.
We would build from work done by AHRQ to develop a Narrative
Elicitation Protocol (https://www.ahrq.gov/cahps/surveys-guidance/item-sets/elicitation/index.html), which is a set of open-ended questions
that prompt patients to tell a clear and comprehensive story about
their experience with a clinician. Narratives from patients about their
health care experiences can provide a valuable complement to
standardized survey scores, both to help clinicians understand what
they can do to improve their care and to engage and inform patients
about differences among clinicians. Five questions underwent initial
item development for the Clinician & Group CAHPS Survey, focusing on
the patient's relationship with the clinician, patient expectations,
how the expectations were met, what went well, and what could have been
better. We believe patients will be interested in this information to
make informed decisions about their healthcare. In section
III.K.3.c.(1), we seek comment on how the free text questions might be
scored as part of the Quality Payment Program. We seek comment on the
value of collecting and displaying information from narrative
questions, and whether stakeholders have concerns with the potential
burden involved with drafting narrative responses. We also are
interested in understanding whether clinicians would find this
information useful in improving the care they provide to beneficiaries
As we continue learning about what patient experience data and
format is most usable to patients, caregivers, and clinicians we plan
to conduct additional item development and testing of implementation
processes at CMS. Information gathered from these activities, along
with comments received from this rule will be taken into consideration
as we consider future policies for future rulemaking, using a human-
centered design approach where applicable.
(ii) Data Completeness Criteria
We refer readers to the CY 2019 PFS final rule (83 FR 59756 through
59758) where we discuss and codified at Sec. 414.1340 finalized data
completeness criteria.
As described in the CY 2018 Quality Payment Program final rule (82
FR 53632 through 53634), we anticipated on proposing increases to the
data completeness thresholds for data submitted on quality measures
(QCDR measures, MIPS CQMs, eCQMs, and Medicare Part B Claims measures)
in future years of the program. For MIPS payment years 2019 and 2020,
the data completeness threshold was finalized and retained at 50
percent. We provided an additional year for individual MIPS eligible
clinicians and groups to gain experience with MIPS before increasing
the data completeness threshold for MIPS payment year 2021, for which
the data completeness threshold was finalized at 60 percent.
We continue to believe it is important to incorporate higher data
completeness thresholds over time to ensure a more accurate assessment
of a MIPS eligible clinician's performance on quality measures. We
previously noted concerns raised about the unintended consequences of
accelerating the data completeness thresholds too quickly, which may
jeopardize a MIPS eligible clinicians' ability to participate and
perform well under MIPS. We want to ensure that an appropriate yet
achievable data completeness is applied to all eligible clinicians
participating in MIPS. Based on our analysis of data completeness rates
from data submission for the 2017 performance period of MIPS, as
described in Table 35, we believe that it is feasible for eligible
clinicians and groups to achieve a higher data completeness threshold.
Table 35--CY 2017 Data Completeness Rates for MIPS Individual Eligible
Clinicians, Groups, and Small Practices
------------------------------------------------------------------------
Average data
Average data completeness rate-- Average data completeness
individual eligible clinician completeness rate-- small
rate-- groups practices
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76.14................................... 85.27 74.76
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[[Page 40748]]
With the support of the data in Table 35, we propose to amend Sec.
414.1340 to add paragraph (a)(3) to adopt a higher data completeness
threshold for the 2020 MIPS performance period, such that MIPS eligible
clinicians and groups submitting quality measure data on QCDR measures,
MIPS CQMs, and eCQMS must submit data on at least a 70 percent of the
MIPS eligible clinician or group's patients that meet the measure's
denominator criteria, regardless of payer for the 2020 MIPS performance
period. As we observe increased use of electronic methods of reporting,
such as EHRs and QCDRs, we believe it is important to continue to
increase the data completeness threshold, and are interested in
stakeholder feedback on an appropriate incremental approach, and on how
this incremental increase should be implemented. In crafting our
proposal, we also considered other thresholds, such as a higher
threshold of 80 percent, but have concerns that requiring every
clinician or group to adhere to an increased data completeness
threshold that is increased by such a large amount may be considered
burdensome to clinicians. We are requesting comments on other
considerations or possible thresholds we should consider, such as
whether we should increase the data completeness threshold to 80
percent to provide for more accurate assessments of quality.
We have received inquiries regarding perceived opportunities to
selectively submit MIPS data that are unrepresentative of a clinician
or group's performance, suggesting that certain parties may have
misunderstood the intent of our incremental approach to the data
completeness thresholds, and may not fully appreciate their current
regulatory obligations. As stated in Sec. Sec. 414.1390(b) and
414.1400(a)(5), all MIPS data submitted by or on behalf of a MIPS
eligible clinician, group, or virtual group must be certified as true,
accurate and complete. MIPS data that are inaccurate, incomplete,
unusable, or otherwise compromised can result in improper payment.
Using data selection criteria to misrepresent a clinician or group's
performance for a performance period, commonly referred to as ``cherry-
picking,'' results in data that are not true, accurate, or complete.
Accordingly, we propose to further amend Sec. 414.1340 to add a new
subsection (d) to clarify that if quality data are submitted
selectively such that the data are unrepresentative of a MIPS eligible
clinician or group's performance, any such data would not be true,
accurate, or complete for purposes of Sec. 414.1390(b) or Sec.
414.1400(a)(5). We believe this clarification will emphasize to all
parties that the data submitted on each measure is expected to be
representative of the clinician's or group's performance.
We continue to strongly urge all MIPS eligible clinicians to report
on quality measures where they have performed the quality actions with
respect to all applicable patients.
We would like to note that we are not proposing any changes to
Sec. 414.1340(c), which states that groups submitting quality measures
data using the CMS Web Interface or a CMS-approved survey vendor to
submit the CAHPS for MIPS survey must submit data on the sample of the
Medicare Part B patients CMS provides, as applicable. We refer readers
to the CY 2019 PFS final rule (83 FR 59756 through 59758) for
additional discussion of this requirement. Table 36 describes the data
completeness requirements by collection type.
Table 36--Summary of Data Completeness Requirements and Performance Period by Collection Type for the 2020 MIPS
Performance Period
----------------------------------------------------------------------------------------------------------------
Collection type Performance period Data completeness
----------------------------------------------------------------------------------------------------------------
Medicare Part B claims measures...... Jan 1-Dec 31........... 70 percent sample of individual MIPS eligible
clinician's, or group's Medicare Part B
patients for the performance period.
QCDR measures, MIPS CQMs, and eCQMs.. Jan 1-Dec 31........... 70 percent sample of individual MIPS eligible
clinician's, or group's patients across all
payers for the performance period.
CMS Web Interface measures........... Jan 1-Dec 31........... Sampling requirements for the group's Medicare
Part B patients: populate data fields for the
first 248 consecutively ranked and assigned
Medicare beneficiaries in the order in which
they appear in the group's sample for each
module/measure. If the pool of eligible
assigned beneficiaries is less than 248, then
the group would report on 100 percent of
assigned beneficiaries.
CAHPS for MIPS survey measure........ Jan 1-Dec 31........... Sampling requirements for the group's Medicare
Part B patients.
----------------------------------------------------------------------------------------------------------------
(d) Selection of MIPS Quality Measures
(i) Call for Measures and Measure Selection Process
In the CY 2019 PFS final rule (83 FR 59758 through 59761), we
discuss the importance of classifying measures by meaningful measure
areas, and updates to the definition of a high priority measure. We
refer readers to the CY 2019 PFS final rule for additional details.
Furthermore, in the CY 2018 Quality Payment Program final rule (82
FR 53635 through 53637), we state that quality measure submissions
submitted during the timeframe provided by us through the pre-
rulemaking process of each year will be considered for inclusion in the
annual list of MIPS quality measures for the performance period
beginning 2 years after the measure is submitted. This process is
consistent with the pre-rulemaking process and the annual Call for
Measures, which is further described through the CMS Pre-Rulemaking
website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rulemaking.html. The annual
Call for Measures process allows for eligible clinician organizations
and other relevant stakeholder organizations to identify and submit
quality measures for consideration. Presumably, stakeholders would not
submit measures for consideration unless they believe the measures are
applicable to clinicians and can be reliably and validly measured.
Through the annual convention of the consensus-based entity,
stakeholders are given the opportunity provide input on whether or not
they believe measures are applicable to clinicians, feasible,
scientifically acceptable, reliable, and valid at the clinician level.
We intend to continue to submit future MIPS quality measures to the
consensus-based entity, as appropriate, and consider the
recommendations provided as part of the comprehensive assessment of
each measure considered for inclusion in MIPS. In addition, we must go
through notice and comment rulemaking to consider stakeholder feedback
prior to
[[Page 40749]]
finalizing the annual list of quality measures. Furthermore, as
required by statute, new measures must be submitted to an applicable
specialty-appropriate, peer-reviewed journal. We refer readers to the
CY 2018 Quality Payment Program final rule (82 FR 53636) for additional
details on the peer-reviewed journal requirement.
In the CY 2018 Quality Payment Program final rule (82 FR 53636), we
requested stakeholders apply the following set of considerations when
submitting quality measures for possible inclusion in MIPS:
Measures that are not duplicative of an existing or
proposed measure.
Measures that are beyond the measure concept phase of
development, with a strong preference for measures that have completed
reliability, feasibility, and validity testing.
Measures that are outcomes-based rather than process
measures.
Measures that address patient safety and adverse events.
Measures that identify appropriate use of diagnoses and
therapeutics.
Measures that address the domain of care coordination.
Measures that address of patient and caregiver experience.
Measures that address efficiency, cost, and resource use.
Measures that address significant variation in performance
and are not considered topped out.
Measures that are specified as a collection type other
than Medicare Part B Claims. We strongly encourage measure stewards to
keep this in mind as they develop and submit measures for
consideration.
We also encourage stakeholders to consider electronically
specifying their quality measures, as eCQMs, in order to encourage
clinicians and groups to move towards the utilization of electronic
reporting, as we believe electronic reporting will increase timeliness
and efficiency of reporting by replacing manual data entry. In addition
to the aforementioned considerations, when considering quality measures
for possible inclusion in MIPS, we are proposing that beginning with
the 2020 Call for Measures process, MIPS quality measure stewards would
be required to link their MIPS quality measures to existing and related
cost measures and improvement activities, as applicable and feasible.
MIPS quality measure stewards will be required to provide a rationale
as to how they believe their measure correlates to other performance
category measures and activities as a part of the Call for Measures
process. We recognize there are instances where costs measures are not
available for all clinician specialties or that improvement activities
may not be associated with a given quality measure. However, we believe
that when possible, it is important to establish a strong linkage
between quality, cost, and improvement activities. We seek comments on
this proposal.
Furthermore, previously finalized MIPS quality measures can be
found in the CY 2019 PFS final rule (83 FR 60097 through 60285); CY
2018 Quality Payment Program final rule (82 FR 53966 through 54174);
and in the CY 2017 Quality Payment Program final rule (81 FR 77558
through 77816). The new MIPS quality measures proposed for inclusion in
MIPS for the 2020 performance period and future years are found in
Table Group A of Appendix 1 of this proposed rule.
In addition to the individual MIPS quality measures, we also
develop and maintain specialty measure sets to assist MIPS eligible
clinicians with choosing quality measures that are most relevant to
their scope of practice. The following specialty measure sets have been
excluded from this proposed rule because we did not propose any changes
to these specialty measure sets: Pathology, Electro-Physiology Cardiac
Specialist, and Interventional Radiology. Therefore, for the finalized
Pathology specialty measure set, we refer readers to the CY 2019 PFS
final rule corrections notice (84 FR 566). In addition, we refer
readers to the CY 2018 Quality Payment Program final rule for the
finalized Electro-Physiology Cardiac Specialist specialty measure set
(82 FR 53990) and the finalized Interventional Radiology specialty
measure set (82 FR 54098 through 54099). Our proposals for
modifications to existing specialty sets and new specialty sets can be
found in Table Group B of Appendix 1 of this proposed rule. Specialty
sets may include: New measures, previously finalized measures with
modifications, previously finalized measures with no modifications, the
removal of certain previously finalized quality measures, or the
addition of existing MIPS quality measures. Please note that the
proposed specialty and subspecialty sets are not inclusive of every
specialty or subspecialty.
On January 18, 2019,\114\ we announced that we would be accepting
recommendations for potential new specialty measure sets or revisions
to existing specialty measure sets for Year 4 of MIPS under the Quality
Payment Program. These recommendations were based on the MIPS quality
measures finalized in the CY 2019 PFS final rule, the 2019 Measures
Under Consideration list, and provides recommendations to add or remove
the current MIPS quality measures from existing specialty sets, or
provides recommendations for the creation of new specialty sets. All
specialty set recommendations submitted for consideration were assessed
and vetted, and those recommendations that we agree with are being
proposed within this proposed rule.
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\114\ Listserv messaging was distributed through the Quality
Payment Program listserv on January 18th, 2019, titled: ``CMS is
Soliciting Stakeholder Recommendations for Potential Consideration
of New Specialty Measure Sets for the Quality Performance Category
and/or Revisions to the Existing Specialty Measure Sets for the
Quality Performance Category for the 2020 Program Year of Merit-
based Incentive Payment System (MIPS).''
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In addition, MIPS quality measures with proposed substantive
changes can be found in Table Groups D and DD of Appendix 1 of this
proposed rule. As discussed in Table DD of this proposed rule, we have
determined based on extensive stakeholder feedback that the 2018 CMS
Web Interface measure numerator guidance for the Preventive Care and
Screening: Tobacco Use: Screening and Cessation Intervention measure is
inconsistent with the intent of the CMS Web Interface version of this
measure as modified in the CY 2018 Quality Payment Program final rule
(82 FR 54164) and is unduly burdensome on clinicians. Moreover, due to
the current guidance, we are unable to rely on historical data to
benchmark the measure. Therefore, for the 2018 MIPS performance period
and 2020 MIPS payment year, we are excluding the Web Interface version
of this measure from MIPS eligible clinicians' quality scores in
accordance with Sec. 414.1380(b)(1)(i)(A)(2). Beginning with reporting
for the 2019 MIPS performance period and 2021 MIPS payment adjustment,
we are proposing in Table DD of this proposed rule to update the CMS
Web Interface measure numerator guidance. To the extent that this
proposed change constitutes a change to the MIPS scoring or payment
methodology for the 2021 MIPS payment adjustment after the start of the
2019 MIPS performance period, we believe that, consistent with section
1871(e)(1)(A)(ii) of the Act, it would be contrary to the public
interest not to modify the measure as proposed in Table DD of this
proposed rule because the current guidance is inconsistent with the
intent of the CMS Web Interface version of this measure, as modified in
the CY 2018 QPP final rule, and unduly burdensome on clinicians. If
this modification is finalized as proposed, we expect that we would be
[[Page 40750]]
able to benchmark and score the CMS Web Interface version of this
measure for the 2019 MIPS performance period and 2021 MIPS payment
adjustment.
As discussed in section III.E.1.b of this proposed rule, changes to
the CMS Web Interface measures for MIPS that are proposed and finalized
through rulemaking would also be applicable to ACO quality reporting
under the Medicare Shared Savings Program. As discussed in Table Group
A of Appendix 1 of this proposed rule, we propose to add 1 new measure
to the CMS Web Interface in MIPS. Furthermore, as discussed in Table
Group C of Appendix 1 of this proposed rule, we are proposing to remove
1 measure from the CMS Web Interface in MIPS. If finalized, groups
reporting CMS Web Interface measures for MIPS would be responsible for
reporting the finalized measure set, inclusive of any finalized measure
removals and/or additions. We refer readers to the Appendix 1 of this
proposed rule for additional details on the proposals related to
changes in CMS Web Interface measures.
On an annual basis, we review the established MIPS quality measure
inventory to consider updates to the measures. Possible updates to
measures may be minor or substantive as described above. We note that
the current cycle of measure updates to MIPS quality measures is
separate from the eCQM annual update process. An overarching timeline
of milestones related to eCQMs available at https://ecqi.healthit.gov/ecqm-annual-timeline. We seek stakeholder comment as to whether we
should consider realigning the measure update cycle with that of the
eCQM annual update process. We note if the update cycles were to align,
quality measure specifications updates would be gathered earlier in the
year, which may pose an issue when considerations need to be given, but
not limited to: Updates to clinical guidelines and changes in NQF
endorsement status.
In addition, we refer readers to the CY 2019 PFS final rule (83 FR
59759) for additional details on reporting requirements of eCQM
measures. Furthermore, in section III.D. of this proposed rule, we
propose to generally align the CY 2020 eCQM reporting requirements for
the eligible professionals participating in the Medicaid Promoting
Interoperability Program with the MIPS eCQM reporting requirements. We
refer readers to section III.D. of this proposed rule for additional
details and criteria on the Medicaid Promoting Interoperability Program
proposals.
(ii) Global and Population-Based Measures
Section 1848(q)(2)(C)(iii) of the Act provides that the Secretary
may use global measures, such as global outcome measures, and
population-based measures for purposes of the quality performance
category. We believe the purpose of global and population-based
measures is to encourage systemic health care improvement for the
populations being served by MIPS eligible clinicians. In addition, as
described in the CY 2017 Quality Payment Program final rule (81 FR
77130 through 77136), we believe that all MIPS eligible clinicians,
including specialists and subspecialists, have a meaningful
responsibility to their communities, which is why we chose to focus on
population health and prevention measures for all MIPS eligible
clinicians. It is important to note that an individual's health relates
directly to population and community health, which is an important
consideration for quality measurement in MIPS and in general.
Furthermore, we have heard from stakeholders that we should drive
quality measurement towards a set of population-based outcome measures
to publicly report on quality of care.
In addition, we believe including additional administrative claims
based measures in the program will reduce the burden associated with
quality reporting. Quality measures that are specified through the
administrative claims collection type do not require separate data
submission to CMS. Administrative claims measures are calculated based
on data available from MIPS eligible clinicians' billings on Medicare
Part B claims. For these reasons, in Table Group AA of Appendix 1 of
this proposed rule, we are proposing the inclusion of a population
health based quality measure (The All-Cause Unplanned Admission for
Patients with Multiple Chronic Conditions measure) beginning with the
2021 MIPS performance period. We are proposing this measure with a
delayed implementation until the 2021 performance period of MIPS, to
allow for time to work through operational factors of implementing the
measure. Factors include allowing for time for the All-Cause Unplanned
Admission for Patients with Multiple Chronic Conditions measure to go
through the Measures Under Consideration and Measures Application
Partnership (MAP) process that is typically applied for all MIPS
quality measures. We refer readers to section III.K.3.a.(4) of this
proposed rule for additional information on our interest to include
other global and population-based measures in future years of MIPS,
which we envision would include the modification of the submission
requirements under the quality performance category.
(iii) Topped Out Measures
We refer readers to the CY 2018 Quality Payment Program final rule
(82 FR 53637 through 53640), where we finalized the 4-year timeline to
identify topped out measures, after which we may propose to remove the
measures through future rulemaking. We also refer readers to the 2019
MIPS Quality Benchmarks' file that is located on the Quality Payment
Program resource library (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html) to determine which
measure benchmarks are topped out for 2019 and would be subject to the
scoring cap if they are also identified as topped out in the 2020 MIPS
Quality Benchmarks' file. We note that the final determination of which
measure benchmarks are subject to the topped out cap would not be
available until the 2020 MIPS Quality Benchmarks' file is released in
late 2019.
In the CY 2019 PFS final rule (83 FR 59761 through 59763), we
finalized that once a measure has reached extremely topped out status
(for example, a measure with an average mean performance within the
98th to 100th percentile range), we may propose the measure for removal
in the next rulemaking cycle, regardless of whether or not it is in the
midst of the topped out measure lifecycle. However, we would also
consider retaining the measure if there are compelling reasons as to
why it should not be removed (for example, if the removal would impact
the number of measures available to a specialist type or if the measure
addressed an area of importance to the Agency).
As an example, four of the five quality measures within the
pathology specialty set have been identified as extremely topped out in
the 2019 benchmarking file. However, we believe that it is important to
retain these pathology specific measures in the MIPS quality measure
set to ensure that pathologists have a sufficient number of quality
measures to report. Quality measures identified as extremely topped out
are considered to have high, unvarying performance where no meaningful
room for improvement can be identified, and are only identified as such
through data received during the submission period. We have heard from
stakeholders that
[[Page 40751]]
some measures tend to appear topped out or extremely topped out due to
clinicians' ability to select measures they expect to perform well on,
and because of this, the data we receive is not actually representative
of how clinicians perform across the country on these metrics. For this
reason, we seek comment on whether we should increase the data
completeness threshold for quality measures that are identified as
extremely topped out, but are retained in the program due to the
limited availability of quality measures for a specific specialty. In
addition, we seek comment on potential alternative solutions in
addressing extremely topped out measures.
We encourage stakeholders to continue their measure development
efforts in creating new pathology specific quality measures that can
demonstrate a meaningful performance gap, thereby offering
opportunities for quality improvement. We also encourage pathologists
to consider reporting on pathology specific QCDR measures through a
CMS-approved QCDR available for the 2020 performance period. A list of
CMS-approved QCDRs for the 2020 performance period will be made
available on or prior to January 1, 2020, and will be posted on the
Quality Payment Program resource library at https://qpp.cms.gov/about/resource-library.
In addition, in the CY 2019 PFS final rule (83 FR 59761 through
59763), we also finalized our policy to exclude QCDR measures from the
topped out measure timeline. When a QCDR measure reaches topped out
status, as determined during the QCDR measure approval process, it may
not be approved as a QCDR measure for the applicable performance
period.
(iv) Removal of Quality Measures
In the CY 2017 Quality Payment Program final rule (81 FR 77136
through 77137), we discussed removal criteria for quality measures,
including that a quality measure may be considered for removal if the
Secretary determines that the measure is no longer meaningful, such as
measures that are topped out. Furthermore, if a measure steward is no
longer able to maintain the quality measure, it would also be
considered for removal. In addition, in the CY 2019 PFS final rule (83
FR 59763 through 59765), we communicated to stakeholders our desire to
reduce the number of process measures within the MIPS quality measure
set, we believe incrementally removing non-high priority process
measures through notice and comment rulemaking is appropriate. We refer
readers to the CY 2019 PFS final rule (83 FR 59763 through 59765) for
details on the previously established criteria to remove measures.
In addition to previously established measure removal criteria, we
have observed instances where MIPS quality measures have had low
reporting rates year over year, and have made it difficult for some
MIPS quality measures to achieve a benchmark. As a result, these
measures have resulted in clinicians receiving no more than 3 points
for each measure that is unable to meet benchmarking criteria. For
these reasons, we are proposing to remove MIPS quality measures that do
not meet case minimum and reporting volumes required for benchmarking
after being in the program for 2 consecutive CY performance periods. We
believe that a time period of 2 consecutive CY performance periods is
appropriate, as we anticipate that any newly finalized measure would
need more than 1 CY performance period in order to observe measure
reporting trends, and believe that 2 consecutive CY performance periods
allows for sufficient time to monitor reporting volumes. We will factor
in other considerations (such as, but not limited to: The robustness of
the measure; whether it addresses a measurement gap; if the measure is
a patient-reported outcome) prior to determining whether to remove the
measure. Removing measures with this methodology ensures that the MIPS
quality measures available in the program are truly meaningful and
measureable areas, where quality improvement is sought and that
measures that are low reported for 2 consecutive CY performance periods
are removed from the program. We believe low reported measures can
point to that the measure concept does not provide meaningful
measurement to most clinicians. If the measure has too few reporting
clinicians and does not meet the case minimum and reporting volumes,
but other considerations favor retaining the measure, we may consider
keeping the MIPS quality measure, with the caveat that the measure
steward should have a plan in place (prior to approval of the measure)
to encourage reporting of the measure, such as education and
communication or potentially measure specification changes. We seek
comments on this proposal. In addition, we refer readers to Table Group
C of Appendix 1 of this proposed rule for a list of quality measures
and rationales for removal. We have continuously communicated to
stakeholders our desire to reduce the number of process measures within
the MIPS quality measure set. We believe our proposal to remove the
quality measures outlined in Table Group C will lead to a more
parsimonious inventory of meaningful, robust measures in the program,
and that our approach to remove measures should occur through an
iterative process that will include an annual review of the quality
measures to determine whether they meet our removal criteria.
We have heard from stakeholders concerns on removing measures and
the need for more notice before a measure is removed. Therefore, we are
interested in what factors should be considered in delaying the removal
of measures. For example, we have not heard concerns from stakeholders
that selection bias may be impacting low reporting rates, we are
interested if this is something we should consider, and how we could
determine when low-reporting is due to selection bias versus instances
where the measure is not a meaningful metric to the majority of
clinicians who would have reported on the measure otherwise. We seek
comment on whether we should delay the removal of a specific quality
measure by a year, for any of the MIPS quality measures identified for
removal. We also request feedback on which quality measure's removal
should be delayed for a year, and why.
Furthermore, when we finalize measures to be a part of the MIPS
quality measure inventory for a given MIPS payment year, we generally
intend that the measures will be available for reporting by or on
behalf of all MIPS eligible clinicians since MIPS is a government
quality reporting program. It has come to our attention that certain
MIPS measure stewards have limited or prohibited the use of their
measures by third party intermediaries such as QCDRs and qualified
registries. To the extent that MIPS measure stewards limit the
availability of previously finalized measures for MIPS quality
reporting, including reporting by third party intermediaries on behalf
of MIPS eligible clinicians, these limitations may lead to inadvertent
increases in burden both for the MIPS eligible clinicians who rely on
third party intermediaries and for third party intermediaries
themselves. In addition, these limitations may adversely affect our
ability to benchmark the measure or the robustness of the benchmark.
For these reasons, we propose to adopt an additional removal criterion,
specifically, that we may consider a MIPS quality measure for removal
if we determine it is not available for MIPS quality reporting by or on
behalf of all
[[Page 40752]]
MIPS eligible clinicians. We seek comments on this proposal.
(v) Request for Information on Potential Opioid Overuse Measure
To address concerns associated with long-term, high-dose opioids,
we developed an electronic clinical quality measure (eCQM) titled:
Potential Opioid Overuse. The Potential Opioid Overuse measure captures
the proportion of patients aged 18 years or older who receive opioid
therapy for 90 days or more with no more than a 7-day gap between
prescriptions with a daily dosage of 90 morphine milligram equivalents
(MME) or higher. It is intended to report the extent of long-term,
high-dose opioid prescribing with the goal of improving patient safety
by reducing the potential for opioid-related harms and encouraging the
use of alternative pain management. The measure was field tested in
2017. The testing population included 3 test sites, consisting of 19
practices representing 87 clinicians, for CY 2016. Initial results from
measure testing indicated that this measure is important, feasible,
reliable, valid, and usable. Stakeholders supported the measure
concept's importance in addressing a quality improvement opportunity in
a priority population.
Through interviews primarily with EHR vendors, we have identified
potential challenges for implementing the Potential Opioid Overuse
measure. The human readable CQL-based specification is more than 200
pages long in order to accommodate a library providing more information
on opioid medications than is currently available to export for the
Value Set Authority Center (VSAC). Vendors expressed concerns about the
feasibility of accurately capturing some of the medication-specific
data elements within the measure, such as medication start and end
dates and times, because these are not consistently captured during
typical workflows.
We seek to mitigate the usability and feasibility issues for the
measure by gathering information from a wider audience of technical
implementers to strengthen the potential for measure adoption. We
invite public comment on the Potential Opioid Overuse CQL-based
specifications in this section. Specifically, we seek comment on the
following questions:
Would you select this measure to support your quality
measure initiatives? Why?
Would you implement this measure in its current state?
Why?
How can we improve the usability of this measure?
This measure performs medication calculations, to
calculate MME, which helps compare different opioids and opioid
dosages. Are there any workflow, mapping, or other implementation
factors to consider related to the required medication related data
elements needed to perform the MME calculations in this measure?
Specifically related to: Use of the opioid data library, which clearly
lists the required medication information directly in the measure
specification; Use of medication end dates, to calculate medication
durations; Use of coded medication frequencies, such as ``3 times
daily'' or ``every 6 hours,'' required to calculate daily medication
dosages.
Are there any other foreseeable challenges to implementing
this measure?
(2) Cost Performance Category
For a description of the statutory basis and our existing policies
for the cost performance category, we refer readers to the CY 2017 and
CY 2018 Quality Payment Program final rules, and the CY 2019 PFS final
rule (81 FR 77162 through 77177, 82 FR 53641 through 53648, and 83 FR
59765 through 59776, respectively).
In this year's rule, we are proposing to:
Weight the cost performance category at 20 percent for
MIPS payment year 2022, 25 percent for MIPS payment year 2023, and 30
percent for MIPS payment year 2024 and all subsequent MIPS payment
years;
Change our approach to proposing attribution methodologies
for cost measures by including the methodology in the measure
specifications;
Add 10 episode-based measures;
Modify the total per capita cost and Medicare Spending Per
Beneficiary (MSPB) measures; and
Seek comments on the future inclusion of an additional
episode-based measure.
These proposals are discussed in more detail in the following
sections of this proposed rule.
(a) Weight in the Final Score
In the CY 2019 PFS final rule, we established at Sec.
414.1350(d)(3) that the weight of the cost performance category is 15
percent of the final score for the 2021 MIPS payment year (83 FR 59765
through 59766). Section 51003(a)(1)(C) of the Bipartisan Budget Act of
2018 (Pub. L. 115-123, February 9, 2018) (BBA of 2018) amended section
1848(q)(5)(E)(i)(II)(bb) of the Act such that for each of the second,
third, fourth, and fifth years for which the MIPS applies to payments,
not less than 10 percent and not more than 30 percent of the MIPS final
score shall be based on the cost performance category score.
Additionally, section 1848(q)(5)(E)(i)(II)(bb) of the Act as amended
states that it shall not be construed as preventing the Secretary from
adopting a 30 percent weight if the Secretary determines, based on
information posted under section 1848(r)(2)(I) of the Act, that
sufficient cost measures are ready for adoption for use under the cost
performance category for the relevant performance period.
In the CY 2019 PFS proposed rule, we solicited comments on how we
should weight the cost performance category for the 2022 and 2023 MIPS
payment years given the changes within the BBA of 2018 (83 FR 35901).
Several commenters noted that the increased flexibility provided by the
BBA of 2018 should be used to maintain the weight at 10 percent for
MIPS payment year 2021 and in future years. A few commenters were
concerned about increasing the weight of the cost performance category
because of the challenges with the existing attribution and risk-
adjustment methodologies. Some commenters recommended that the cost
performance category weight should be increased to 30 percent as soon
as possible. We considered these comments when we developed our
proposals for setting the weight of the cost performance category in
this proposed rule.
We are proposing a steady increase in the weight of the cost
performance category from the existing weight of 15 percent for the
2021 MIPS payment year to 30 percent beginning with the 2024 MIPS
payment year as required by section 1848(q)(5)(E)(i)(II)(aa) of the
Act. We believe this gradual and predictable increase would allow
clinicians to adequately prepare for the 30 percent weight while
gaining experience with the new cost measures. We recognize that cost
measures are still being developed and that clinicians may not have the
same level of familiarity or understanding of cost measures that they
do of comparable quality measures. We also recognize that there may be
greater understanding of the measures in the cost performance category
as clinicians gain more experience with them.
We are proposing at Sec. 414.1350(d)(4) that the cost performance
category would make up 20 percent of a MIPS eligible clinician's final
score for the 2022 MIPS payment year. We plan to increase the weight of
the cost performance category at standard increments of 5 percent each
year until
[[Page 40753]]
MIPS payment year 2024. Therefore, we propose at Sec. 414.1350(d)(5)
to weight the cost performance category at 25 percent for the 2023 MIPS
payment year and propose at Sec. 414.1350(d)(6) to weight the cost
performance category at 30 percent for the 2024 MIPS payment year and
each subsequent MIPS payment year. This would allow us to meet the 30
percent cost performance category weight when required by the statute
and give clinicians adequate time to gain experience with the cost
measures while they represent a smaller portion of the final score. We
also believe that a predictable increase in the weight of the cost
performance category each year would allow clinicians to better prepare
for each year going forward. We considered maintaining the weight of
the cost performance category at 15 percent for the 2022 and 2023 MIPS
payment years as we recognize that we are still introducing new
measures for the cost performance category and clinicians are still
gaining familiarity and experience with these new measures. However,
recognizing that we are required by the statute to weight the cost
performance category at 30 percent beginning with the 2024 MIPS payment
year, we are concerned about having to increase the cost performance
category's weight significantly for the 2024 MIPS payment year. We
invite comments on whether we should consider an alternative weight for
the 2022 and/or 2023 MIPS payment years.
In accordance with section 1848(q)(5)(E)(i)(II)(bb) of the Act, we
will continue to evaluate whether sufficient cost measures are included
under the cost performance category as we move towards the required 30
percent weight in the final score. As described in section
III.K.3.c.(2)(b)(iii) of this proposed rule, we are proposing to add 10
episode-based measures to the cost performance category beginning with
the 2020 MIPS performance period. We are continuing our efforts to
develop more robust and clinician-focused cost measures. We will also
be continuing to work on developing additional episode-based measures
that we may consider proposing for the cost performance category in
future years to address additional clinical conditions. Introducing
more measures over time would allow more clinicians to be measured in
this performance category, with an increasing focus on costs associated
with services provided by clinicians for specific episodes of care. In
section III.K.3.c.(2)(b)(v) of this proposed rule, in efforts to ensure
that our existing cost measures hold clinicians appropriately
accountable, we propose modifications to both the total per capita cost
and MSPB measures.
(b) Cost Criteria
(i) Background
Under Sec. 414.1350(a), we specify cost measures for a performance
period to assess the performance of MIPS eligible clinicians on the
cost performance category. We will continue to evaluate cost measures
that are included in MIPS on an ongoing basis and anticipate that
measures could be added, modified, or removed through rulemaking as
measure development continues. Any substantive changes to a measure
would be proposed for adoption in future years through notice and
comment rulemaking, following review by the Measure Applications
Partnership (MAP). We would take all comments and feedback from both
the public comment period and the MAP review process into consideration
as part of the ongoing measure evaluation process. For the CY 2020
performance period and future performance periods, we propose to add 10
newly developed episode-based measures to the cost performance category
in section III.K.3.c.(2)(b)(iii) of the proposed rule and propose
modifications to both the total per capita cost and MSPB measures in
section III.K.3.c.(2)(b)(v) of this proposed rule. In section
III.K.3.c.(2)(b)(viii) of this proposed rule, we summarize all new and
existing measures that would be included in the cost performance
category starting with the CY 2020 performance period. Some
modifications to measures used in the cost performance category may
incorporate changes that would not substantively change the measure.
Examples of such non-substantive changes may include updated diagnosis
or procedure codes or changes to exclusions to the patient population
or definitions. While we address such changes on a case-by-case basis,
we generally believe these types of maintenance changes are distinct
from substantive changes to measures that result in what are considered
new or different measures. However, as described in section 3 of the
Blueprint for the CMS Measures Management System Version 14.1 (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf), if substantive changes to
these measures that are owned and developed by CMS become necessary, we
expect to follow the pre-rulemaking process for new measures, including
resubmission to the Measures Under Consideration (MUC) list and
consideration by the MAP. The MAP provides an additional opportunity
for an interdisciplinary group of stakeholders to provide feedback on
whether they believe the measures under consideration are applicable to
clinicians and complement program-specific statutory and regulatory
requirements. Through its Measure Selection Criteria, the MAP focuses
on selecting high-quality measures that address the NQF's three aims of
better care, healthy people/communities, and affordable care, as well
as fill critical measure gaps and increase alignment among programs.
In section III.K.3.c.(2)(b)(v)(A) of this proposed rule, we have
summarized the timeline for measure development, including stakeholder
engagement activities that are undertaken by the measure development
contractor, which include a technical expert panel (TEP), clinical
subcommittees, field testing, and education and outreach activities.
(ii) Attribution
In this section of the proposed rule, we discuss our approach to
the attribution methodology for cost measures along with revisions to
our existing cost measures. In the CY 2017 Quality Payment Program
final rule (81 FR 77168 through 77169), we adopted an attribution
methodology for the total per capita cost measure under which
beneficiaries are attributed using a method generally consistent with
the method of assignment of beneficiaries used in the Shared Savings
Program. We codified this policy under Sec. 414.1350(b)(2) in the CY
2019 PFS final rule (83 FR 59774). In the CY 2017 Quality Payment
Program final rule (81 FR 77174 through 77176), we also adopted an
attribution methodology for the MSPB measure under which an episode is
attributed to the MIPS eligible clinician who submitted the plurality
of claims (as measured by allowed charges) for Medicare Part B services
rendered during an inpatient hospitalization that is an index admission
for the MSPB measure during the applicable performance period. We
codified this policy under Sec. 414.1350(b)(3) in the CY 2019 PFS
final rule (83 FR 59775).
In the CY 2019 PFS final rule (83 FR 59775), we established at
Sec. 414.1350(b)(6) that for acute inpatient medical condition
episode-based measures, an episode is attributed to each MIPS eligible
clinician who bills inpatient E/M claim lines during a trigger
inpatient hospitalization under a TIN that renders at least 30 percent
of the inpatient E/M claim lines in that
[[Page 40754]]
hospitalization, and at Sec. 414.1350(b)(7) that for procedural
episode-based measures, an episode is attributed to each MIPS eligible
clinician who renders a trigger service as identified by HCPCS/CPT
procedure codes.
As discussed in section III.K.3.c.(2)(b)(v) of this proposed rule,
we have reevaluated the total per capita cost and MSPB measures. In the
process of evaluating these measures, the TEP identified areas for
potential refinement within the attribution methodology, and the
revised measures that we propose include substantial changes to the
attribution methodology. As we explain in section III.K.3.c.(2)(b)(v),
we believe these new attribution methodologies better establish the
relationship between the clinician and the patients. In general, for
the cost performance category, we believe that attribution is a
fundamental element of the measures, and we do not believe that a cost
measure can be separated from its attribution methodology. Although in
prior rulemaking, we have discussed the attribution methodologies for
the cost performance category measures in the preamble and included
those methodologies in the regulation text, we intend to take a
different approach going forward and address attribution as part of the
measure logic and specifications. For this proposed rule and in future
rulemaking, we will include the attribution methodology for each cost
performance category measure in the measure specifications, which are
available for review and public comment at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/macra-feedback.html during the
public comment period for the proposed rule, and will be available in
final form at https://qpp.cms.gov/about/resource-library after the
final rule is published. We believe this approach is preferable because
it would reduce complexity for MIPS eligible clinicians and other
stakeholders by presenting the attribution methodology with the rest of
the cost measure specifications, ensure non-substantive changes could
be implemented without undertaking rulemaking, and align with the
approach taken for measures in the quality performance category.
Therefore, we propose to revise Sec. 414.1350(b)(2), (3), (6), and (7)
to reflect that these previously finalized attribution methods apply
for the 2017 through 2019 performance periods. We also propose to
establish at Sec. 414.1350(b)(8) that beginning with the 2020
performance period, each cost measure would be attributed according to
the measure specifications for the applicable performance period.
In the CY 2017 Quality Payment Program final rule, we established a
final policy to attribute cost measures at the TIN/NPI level,
regardless of whether a clinician's performance for purposes of MIPS is
assessed as an individual (the TIN/NPI level) or as part of a group
(the TIN level) (81 FR 77175 through 77176). We codified this policy
under Sec. 414.1350(b)(1) in the CY 2019 PFS final rule (83 FR 59774
through 59775). Similar to the attribution methodology for cost
measures, we also believe that the level of attribution (TIN/NPI or
TIN) is best addressed as part of the measure specifications, allowing
for different considerations for group and individual attribution based
on the underlying measure specification. For this proposed rule and in
future rulemaking, we will include the level of attribution for each
cost performance category measure in the measure specifications, which
will be publicly available as described in the preceding paragraph. The
measure specification documents will provide the methodology for
assigning attribution to an individual clinician or a group, which will
align with whether the participant is reporting data as an individual
clinician or a group under the MIPS program. Therefore, we propose to
revise Sec. 414.1350(b)(1) to reflect that the current policy of
attributing cost measures at the TIN/NPI level, regardless of whether a
clinician's performance for purposes of MIPS is assessed as an
individual or a group, applies for the 2017 through 2019 performance
periods. We intend for the new regulation text proposed at Sec.
414.1350(b)(8) also to include the level of attribution (individual
clinician or group), so we are not proposing additional regulation
text. We note that in section III.K.3.c.(2)(b)(vi)(B) of this proposed
rule, we propose to limit the assessment of certain cost measures to
MIPS eligible clinicians who report as a group based on our assessment
of the reliability of the measure at the group and individual level.
Although this is not directly related to attribution, it does limit the
assessment of certain measures for MIPS eligible clinicians who report
as individuals.
(iii) Episode-Based Measures for the 2020 and Future Performance
Periods
In this section of the proposed rule, we discuss our proposal to
add 10 newly developed episode-based measures to the cost performance
category beginning with the 2020 performance period. We developed
episode-based measures to represent the cost to Medicare and
beneficiaries for the items and services furnished during an episode of
care (``episode''). Episode-based measures are developed to compare
clinicians on the basis of the cost of the care clinically related to
their initial treatment of a patient and provided during the episode's
timeframe. Specifically, we define cost based on the allowed amounts on
Medicare claims, which include both Medicare payments and beneficiary
deductible and coinsurance amounts. We refer our readers to the CY 2019
PFS final rule for more detail on episode-based measures and how they
are established (83 FR 59767).
Prior to presenting our cost measures to the MAP for consideration,
the measure development contractor has continued to seek extensive
stakeholder feedback on the development of episode-based measures,
building on the processes outlined in the CY 2018 PFS final rule (82 FR
53644). These processes included convening a TEP and clinical
subcommittees to solicit expert and clinical input for measure
development, conducting national field testing on the episode-based
measures developed, and seeking input from clinicians and stakeholders
through engagement activities.
To gather input on the 10 episode-based measures that we are
proposing, the measure development contractor convened 10 clinical
subcommittees composed of more than 260 clinicians affiliated with 120
specialty societies through an open call for nominations between
February 6, 2018 and March 20, 2018. Applicants who submitted materials
after the March 20, 2018 deadline were added to a standing pool of
nominees and considered for membership in the measure-specific
workgroups. The clinical subcommittees met during an in-person meeting
in April 2018 to select episode group(s) for development and provide
input on the composition of measure-specific workgroups. The smaller
measure-specific workgroups were introduced as a refinement to the
measure development process based on feedback from members of the first
set of clinical subcommittees. The small group size was intended to
facilitate more focused discussions. The workgroups--one for each
measure--met through in-person meetings and webinars between June and
December 2018 to provide detailed clinical input on each component of
the episode-based measures. These components include episode triggers
and windows (to limit the timing of services included in the episode),
item and service assignment, exclusions,
[[Page 40755]]
attribution, and risk adjustment variables.
In addition, the 10 episode-based measures we are proposing were
developed with input from the Person and Family Committee, a body of
patients and their family members and caregivers who provide input
iteratively during the measure development process. Discussions
regarding patient and caregiver perspectives on the types of episodes
that should be prioritized informed the clinical subcommittees'
considerations for episode selection. Throughout measure development,
the workgroups engaged in bidirectional conversations with the Person
and Family Committee to inform measure specifications. For example,
patient perspectives on services perceived as aiding recovery or
helping to avoid unnecessary costs and complications helped the
workgroup provide recommendations for service assignment, and in turn,
the workgroup provided questions to the Person and Family Committee,
which helped guide their in-depth interviews. After considering each
round of input, clinicians had multiple opportunities to solicit
additional information and feedback from Person and Family Committee
members. In total, the measure developer conducted 84 interviews with
65-70 Person and Family Committee members via one-on-one interviews
during development of the 10 episode-based measures.
Finally, as with the measures finalized in the CY 2019 PFS final
rule (83 FR 59767), the 10 episode-based measures we are proposing
underwent a measure development process based on high level guidance
provided to the measure development contractor by a standing TEP. This
TEP provided oversight and cross-cutting guidance to the measure
development contractor for development of episode-based measures
through four meetings between August 2016 and August 2017.
Further detail can be found in the Measure Development Process
document at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2018-measure-development-process.pdf, which includes a discussion of the
detailed clinical input obtained at each step, and details about the
components of episode-based measures.
We provided an initial opportunity for clinicians to review their
performance under the new episode-based measures via national field
testing conducted in fall of 2018. During field testing, we sought
feedback from stakeholders on the draft measure specifications,
feedback report format, and supplemental documentation through an
online form, and we received 67 responses, including 25 comment
letters. The measure development contractor shared the feedback on the
draft measure specifications with the measure-specific workgroups, who
considered it in providing input on further refinements after the end
of field testing. A field testing feedback summary report, which
details post-field testing refinements added based on the input from
the measure-workgroups, is publicly available on the MACRA feedback
page (https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/macra-feedback.html).
Similar to previous years, we continued to engage clinicians and
stakeholders, conducting extensive outreach activities. These
activities included general informational email blasts, targeted email
outreach to specialty societies, hosting office hours to gather input
on additional opportunities for participation and outreach, and hosting
the MACRA Cost Measures Field Testing Webinar to provide information
about the measure development process and field test reports and a
forum for stakeholder questions to ask questions.
Following the successful field testing and review through the MAP
process, we propose to add the 10 episode-based measures listed in
Table 37 as cost measures for the 2020 performance period and future
performance periods.
The detailed specifications for these 10 episode-based measures are
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2019-revised-ebcm-measure-specs.zip. These specifications documents consist
of (i) methodology for constructing each measure, and (ii) measure
codes list file with medical codes and clinical logic. First, the
methodology document provides an overview of the measure, including a
description of the measure numerator and denominator, the patient
cohort, and the care settings in which the measure is assessed. In
addition, the document includes two one-page, high-level overviews of
(i) methodology and (ii) clinical logic and service codes, which were
added in response to stakeholder feedback regarding provision of
documentation with varying levels of detail to ensure the information
is accessible to all stakeholders. The methodology document provides
detailed descriptions of each logic step involved in constructing the
episode groups and calculating the cost measure. Second, the measure
codes list file contains the service codes and clinical logic used in
the methodology, including the episode triggers, exclusions, episode
sub-groups, assigned items and services, and risk adjustors. More
information about the attribution methodology for each measure is
available in section A.2 of the methodology documentation. In addition,
measure justification forms containing testing results for these
measures are available at the MACRA Feedback page at https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html.
Table 37--Episode-Based Measures Proposed for the 2020 Performance
Period and Future Performance Periods
------------------------------------------------------------------------
Measure topic Episode measure type
------------------------------------------------------------------------
Acute Kidney Injury Requiring New Inpatient Procedural
Dialysis.
Elective Primary Hip Arthroplasty............ Procedural.
Femoral or Inguinal Hernia Repair............ Procedural.
Hemodialysis Access Creation................. Procedural.
Inpatient Chronic Obstructive Pulmonary Acute inpatient medical
Disease (COPD) Exacerbation. condition.
Lower Gastrointestinal Hemorrhage *.......... Acute inpatient medical
condition.
Lumbar Spine Fusion for Degenerative Disease, Procedural.
1-3 Levels.
Lumpectomy Partial Mastectomy, Simple Procedural.
Mastectomy.
Non-Emergent Coronary Artery Bypass Graft Procedural.
(CABG).
[[Page 40756]]
Renal or Ureteral Stone Surgical Treatment... Procedural.
------------------------------------------------------------------------
* This measure is being proposed only for groups. Please reference
section III.K.3.c.(2)(b)(vi)(B) of the proposed rule.
(iv) Proposed Revisions to the Operational List of Care Episode and
Patient Condition Groups and Codes
Section 1848(r) of the Act specifies a series of steps and
activities for the Secretary to undertake to involve the physician,
practitioner, and other stakeholder communities in enhancing the
infrastructure for cost measurement, including for purposes of MIPS and
APMs. Section 1848(r)(2) of the Act requires the development of care
episode and patient condition groups, and classification codes for such
groups, and provides for care episode and patient condition groups to
account for a target of an estimated one-half of expenditures under
Parts A and B (with this target increasing over time as appropriate).
Sections 1848(r)(2)(E) through (G) of the Act require the Secretary to
post on the CMS website a draft list of care episode and patient
condition groups and codes for solicitation of input from stakeholders,
and subsequently, post an operational list of such groups and codes.
Section 1848(r)(2)(H) of the Act requires that not later than November
1 of each year (beginning with 2018), the Secretary shall, through
rulemaking, revise the operational list as the Secretary determines may
be appropriate, and that these revisions may be based on experience,
new information developed under section 1848(n)(9)(A) of the Act, and
input from physician specialty societies and other stakeholders.
In December 2016, we published the Episode-Based Measure
Development for the Quality Payment Program (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Draft-list-of-episode-groups-and-trigger-codes-December-2016.zip) and requested input on a draft list of
care episode and patient condition groups and codes as required by
sections 1848(r)(2)(E) and (F) of the Act. We additionally requested
feedback on our overall approach to cost measure development, including
several pages of specific questions on the proposed approach for
clinicians and stakeholders to provide feedback. We used this feedback
to modify our cost measure development and ensure that our approach is
continually informed by stakeholder feedback. As required by section
1848(r)(2)(G) of the Act, in January 2018, we posted an operational
list of 8 care episode groups and patient condition groups that we
refined with extensive stakeholder input, along with the codes and
logic used to define these episode groups. This operational list is
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2018-Operational-List-of-Care-Episode-and-Patient-Condition-Codes.zip.
Under section 1848(r)(5)(A)(iii) of the Act, to evaluate the
resources used to treat patients with respect to care episode and
patient condition groups, the Secretary shall, as the Secretary
determines appropriate, conduct an analysis of resources use with
respect to care episode and patient condition groups. In accordance
with this section, we used the 8 care episode groups and patient
condition groups included in the operational list as the basis for the
eight episode-based measures that we developed in 2017 through early
2018 and finalized for use in MIPS in the CY 2019 PFS final rule (83 FR
59767-59773). We did not revise this operational list through
rulemaking in 2018 as we did not receive stakeholder feedback
requesting updates to how these episode groups are defined and there
were no new developments requiring revisions. Under section
1848(r)(2)(H) of the Act,we propose to revise the operational list
beginning with CY 2020 to include 10 new care episode and patient
condition groups, based on input from clinician specialty societies and
other stakeholders. The 10 care episode and patient condition groups
were included in the draft list that we posted in December 2016 and
refined based on extensive stakeholder input as described in section
III.K.3.c.(2)(b)(v)(A) of this proposed rule. Our proposed revisions to
the operational list beginning with CY 2020 are available on our MACRA
feedback page at https://www.cms.gov/Medicare/Quality-Initiatives-
Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-
APMs/MACRA-Feedback.html. These care episode and patient condition
groups serve as the basis for the 10 new episode-based measures that we
are proposing in section III.K.3.c.(2)(b)(iii) of this proposed rule
for the cost performance category.
(v) Revised Cost Measures
(A) Re-Evaluation Process for the Total per Capita Cost and Medicare
Spending per Beneficiary Clinician Measures
For the purpose of assessing performance of MIPS eligible
clinicians in the cost performance category, we finalized both the
total per capita cost and MSPB measures to be included in the MIPS
program in CY 2017 Quality Payment Program final rule (81 FR 77166). We
are proposing to modify both of these measures based on stakeholder
input from prior public comment periods and recommendations from the
TEP. We also propose to modify the measure title from Medicare Spending
Per Beneficiary (MSPB) to Medicare Spending Per Beneficiary clinician
(MSPB clinician) to distinguish it from measures with similar names in
use in other CMS programs and to improve clarity. We propose to change
the name from MSPB to MSPB clinician at Sec. Sec. 414.1350(b)(3) and
414.1350(c)(2).
The measure development contractor convened the TEP for two in-
person meetings in August 2017 and May 2018 to provide input on
potential refinements to both measures and for a webinar in November
2018 to determine additional refinements to the measures based on
feedback received from field testing. The TEP's discussion from the May
2018 meeting can be found in the TEP Summary Report at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/TEP-Current-Panels.html#a0913. In addition, the measure
development contractor convened the MSPB Service Refinement Workgroup,
an expert workgroup that the TEP recommended to provide detailed
clinical input on service assignment rules for the revised MSPB
clinician measure. The MSPB Service Refinement Workgroup convened twice
during summer 2018 to develop the service exclusion list. The service
exclusion list contains the service codes and logic for services that
are
[[Page 40757]]
considered clinically unrelated to the index admission of the revised
MSPB clinician episodes and are removed from the episodes and measure
calculation. The revised measures underwent field testing in fall of
October 2018 during which we sought feedback on the refined measure
specifications and supplemental documentation through an online form.
At the end of field testing, the measure development contractor shared
feedback with the standing TEP, which considered the feedback in
determining further measure refinements for the total per capita cost
measure. The TEP also discussed the MSPB clinician measure after field
testing and had the opportunity to provide input on further refinements
to this measure. A field-testing feedback summary report is publicly
available on the MACRA feedback page (https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/macra-feedback.html).
(B) Total per Capita Cost Measure
We finalized the total per capita cost measure for use in MIPS as
an important measurement of clinician cost performance. Having been
used in the Physician Value Modifier program, it had been tested and
was reliable for Medicare populations and was familiar to the clinician
community. When we finalized this measure for use in MIPS, we noted
that as with all the cost measures, we would maintain this measure and
update its specifications as appropriate (82 FR 53643). We continue to
believe that the existing measure is appropriate to use in MIPS and
continue to be committed to maintaining the cost measures with
consideration of stakeholder input and testing. However, as a part of
our routine measure maintenance, we re-evaluated the total per capita
cost measure. The re-evaluation was informed by feedback received on
this measure through prior public comment periods, as described in the
CY 2017 (81 FR 77017 through 77018) and CY 2018 (82 FR 53577 through
53578) Quality Payment Program final rules, as well as feedback that
arose in the measure development contractor's discussions with the TEP
during the process of re-evaluation. This feedback is summarized below:
The total per capita cost measure's attribution
methodology assigned costs to clinicians over which the clinician has
no influence, such as costs occurring before the start of the
clinician-patient relationship.
The attribution methodology did not effectively identify
primary care relationships between a patient and a clinician and could
potentially attribute beneficiaries to a clinician not responsible for
the beneficiaries' primary care.
The measure did not account for the shared accountability
of clinicians and that attributing costs to a single clinician or
clinician group could cause fragmentation of care.
The beneficiary risk factors were determined one year
prior to the start of the performance period, which would preclude the
risk adjustment methodology from reflecting the more expensive
treatment resulting from comorbidities and/or complications that might
arise during the performance period.
The feedback summarized above informed the four
modifications that we are proposing for the total per capita cost
measure.
First, we are proposing to change the attribution methodology to
more accurately identify a beneficiary's primary care relationships.
This is done by identifying a combination of services that occur within
a short period of time and indicate the beginning of a relationship.
More specifically, a primary care relationship is identified by a
candidate event, defined as the occurrence of an E/M service such as an
established patient assisted living visit or an outpatient visit (that
is, the E/M primary care service), paired with one or more additional
services indicative of general primary care (for example, routine chest
X-ray, electrocardiogram, or a second E/M service provided at a later
date). The candidate event initiates a year-long risk window from the
E/M primary care service. The risk window is the period during which a
clinician or clinician group could reasonably be held responsible for
the beneficiary's treatment costs, and the initiation of the risk
window at the onset of the candidate event ensures that costs are
attributed only after the start of the clinician-patient relationship.
Only the portion of the risk window that overlaps with the performance
period, which is divided into 13 four-week blocks called beneficiary-
months, is attributable to a clinician for a given performance period.
For example, if the risk window were initiated during one MIPS
performance period and ends in the following MIPS performance period,
only the beneficiary-months that occur during the earlier MIPS
performance period would be attributed to the clinician/clinician group
to calculate the measure for that particular MIPS performance period.
Dividing the performance period into beneficiary-months allows costs to
be assigned to clinicians and clinician groups during the parts of the
year they are primarily responsible for the patient's care management.
With this methodology, it is possible for multiple candidate events
to occur between a clinician and beneficiary over time, and an
additional candidate event occurring during an existing risk window
reaffirms and extends the period of the clinician's responsibility. For
example, if 2 candidate events for the same clinician and the same
beneficiary occur 6 months apart, a separate 12-month risk window
initiates from the start of each of these candidate events, and the
clinician may be attributed beneficiary-months spanning 18 months and 2
different performance periods. As we described above, for risk windows
that span multiple performance periods, only the beneficiary-months
contained within a given performance period are used to calculate the
measure for that performance period. Beneficiary-months that overlap
between the 2 risk windows are collapsed to ensure that costs are only
accounted for once. Furthermore, if different clinician groups
initiated these 2 risk windows for the same beneficiary, the risk
windows would occur concurrently and would be attributed to their
respective TINs. Within an attributed TIN, only the clinician with the
TIN/NPI combination performing the highest number of candidate events
is attributed the beneficiary-months, since this TIN/NPI combination is
deemed to have the most substantive relationship with the beneficiary.
Finally, multiple TINs and TIN/NPIs billing under different TINs may be
attributed beneficiary-months for the same beneficiary during the
performance period. This attribution method allows multiple clinicians
to be considered for the provision of ongoing primary care for a
patient, which accounts for changes in primary care relationships (for
example, for beneficiaries who move during the year) and reflects
shared clinical responsibility for a patient's care.
To illustrate how candidate events identify primary care
relationships, we are providing an example of a clinical scenario in
which physicians in the primary care medical practice see a beneficiary
as part of the beneficiary's routine health maintenance. A beneficiary
is feeling unwell and goes to a medical practice. At the practice, the
beneficiary sees a family practice clinician who provides an E/M
service (one that has been identified as related to primary care) for
routine health maintenance. The clinician prescribes a course of
medication as part of the care
[[Page 40758]]
plan. The beneficiary returns to the same practice 2 months later when
she notices new symptoms. At this visit, she sees a different family
practice clinician who examines her, adjusts her care plan, and asks
her to return in 3 months for a follow-up in case diagnostic testing or
a change in medication is required. These two E/M services that occur
within proximity (that is, the initial E/M service and the paired event
2 months later--a second E/M service) constitute the candidate event
and indicate that a primary care relationship has begun from the time
of the first visit to the medical practice. The first E/M service
(identified as related to primary care) opens a one-year period (or
risk window) from the date of the service. This is illustrated
graphically in section 2.0 of the measure specifications available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2019-revised-TPCC-measure-specs.zip. During the risk window, the attributed clinician/
clinician group can be held responsible for the overall costs of care
for that beneficiary. The TIN for the medical practice would be
attributed the beneficiary and the TIN/NPI within this practice that
provides the most primary care E/M services that initiate candidate
events would be attributed the beneficiary. Under the current total per
capita cost measure, the TIN and TIN/NPI would have been attributed
this beneficiary from the beginning of the calendar year and held
accountable for services the beneficiary might have received before her
first visit to the medical practice.
Second, we are proposing to change the attribution methodology to
more accurately identify clinicians who provide primary care services,
by the addition of service category exclusions and specialty
exclusions. Specifically, candidate events are excluded if they are
performed by clinicians who (i) frequently perform non-primary care
services (for example, global surgery, chemotherapy, anesthesia,
radiation therapy) or (ii) are in specialties unlikely to be
responsible for providing primary care to a beneficiary (for example,
podiatry, dermatology, optometry, ophthalmology). As a result of these
exclusions, clinician specialties considered for attribution are only
those primarily responsible for providing primary care, such as primary
care specialties and internal medicine sub-specialties that frequently
manage patients with chronic conditions that are in their area(s) of
expertise. We do not propose to change the adjustment for specialty; as
such, the measure would continue to adjust for specialty to account for
variation in cost across clinician specialties and in clinician groups
with diverse specialty compositions.
Third, we are proposing to change the risk adjustment methodology
to determine a beneficiary's risk score for each beneficiary-month
using diagnostic data from the year prior to that month rather than
calculating one risk score for the entire performance period using
diagnostic data from the previous year. This methodology would better
account for any changes in the health status of the beneficiary for the
duration of a primary care relationship and during the performance
period. In addition, we are proposing to add an institutional risk
model to improve risk adjustment for clinicians treating
institutionalized beneficiaries.
Fourth, we are proposing to change the measure to evaluate
beneficiaries' costs on a monthly basis rather than an annual basis.
Specifically, the performance period during which costs are assessed is
divided into 13 beneficiary-months, mentioned earlier, allowing for the
measure and the risk adjustment model to reflect changes in patient
health characteristics at any point throughout the performance period.
In addition, this refinement would avoid measuring annualized costs for
beneficiaries whose death date occurs during the performance period,
which could potentially disincentivize care for older and sicker
patients.
Further detail about these proposed changes to the measure, as well
as a comparison to the total per capita cost measure as currently
specified, is available in the measure specifications documents
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2019-revised-TPCC-measure-specs.zip.
The revised total per capita cost measure underwent MAP review
during the 2018-2019 cycle. In December 2018, the MAP Clinician
Workgroup gave the preliminary recommendation of `conditional support
for rulemaking,' with the condition of NQF endorsement. In January
2019, the MAP Coordinating Committee reversed the Clinician Workgroup's
preliminary recommendation and provided a final recommendation of ``do
not support for rulemaking with potential for mitigation''. More detail
on the mitigating factors is available in the MAP's final report at
http://www.qualityforum.org/Publications/2019/03/MAP_Clinicians_2019_Considerations_for_Implementing_Measures_Final_Report.aspx. We believe that the revised measure provides a more appropriate
and valid attribution approach. We considered the option of proposing
to remove the current version of the measure from the program and not
proposing to replace it with a revised version. However, because we
have developed and implemented only a handful of episode-based measures
at this time, a substantial proportion of clinicians would be left with
only MSPB clinician measure for the cost performance category. Because
fewer than half of all clinicians in MIPS meet the case minimum for the
MSPB clinician measure, and no other measure addresses the costs of
primary care, we believe it is appropriate to use the best version of
the total per capita cost measure available to us. While we recognize
and value the MAP's expressed concerns regarding the revised measure
specifications, we believe we have adequately addressed the mitigating
factors through the information we have made publicly available
(including testing results in the measure justification forms available
at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/macra-feedback.html), as well as our discussions with stakeholders at the MAP
and through further education and outreach activities. Thus, we are
proposing to include the total per capita cost measure with these
revised specifications in the cost performance category beginning with
the CY 2020 performance period.
(C) Medicare Spending per Beneficiary Clinician Measure
Similar to the total per capita cost measure, we finalized the MSPB
clinician measure for use in MIPS as an important measurement of
clinician cost performance. Having been used in the Physician Value
Modifier program, it had been tested and was reliable for Medicare
populations and was familiar to the clinician community. However, when
we finalized this measure for use in MIPS, we noted that as with all
the cost measures, we would maintain this measure and update its
specifications as appropriate (82 FR 53643). We continue to believe
that the existing measure is appropriate to use in MIPS and continue to
be committed to maintaining this cost measure with consideration of
stakeholder input and testing. Hence, we re-evaluated the MSPB
clinician measure as part of our routine measure maintenance. The re-
evaluation was
[[Page 40759]]
informed by feedback received on this measure through prior public
comment periods, as described in the CY 2017 Quality Payment Program
final rule (81 FR 77017 through 77018) and the CY 2018 Quality Payment
Program final rule (82 FR 53577 through 53578), as well as feedback
that arose in the measure development contractor's discussions with the
standing TEP during the process of re-evaluation. This feedback is
summarized below:
The attribution methodology did not recognize the team-
based nature of inpatient care;
The attribution based on the plurality of Part B service
costs during index admission could potentially attribute episodes to
specialties providing expensive services as opposed to those providing
the overall care management for the patient; and
The measure captured costs for services that are unlikely
to be influenced by the clinician's care decisions.
The feedback summarized above informed the two modifications that
we are proposing as part of the re-evaluation of this measure.
First, we are proposing to change the attribution methodology to
distinguish between medical episodes (where the index admission has a
medical MS-DRG) and surgical episodes (where the index admission has a
surgical MS-DRG). A medical episode is first attributed to the TIN
billing at least 30 percent of the inpatient E/M services on Part B
physician/supplier claims during the inpatient stay. The episode is
then attributed to any clinician in the TIN who billed at least one
inpatient E/M service that was used to determine the episode's
attribution to the TIN. A surgical episode is attributed to the
surgeon(s) who performed any related surgical procedure during the
inpatient stay, as determined by clinical input, as well as to the TIN
under which the surgeon(s) billed for the procedure. The list of
related surgical procedures MS-DRGs may be found in the measure codes
list for the revised measure at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/mspb-clinician-zip-file.zip. This revised attribution
methodology accounts for the team-based nature of care provided when
managing medical conditions during an inpatient stay and allows for
attribution to multiple clinicians to ensure that all clinicians
involved in a beneficiary's care are appropriately attributed.
Second, to account for the more limited influence clinicians'
performance has on costs when compared with hospitals, we are proposing
to add service exclusions to the measure to remove costs that are
unlikely to be influenced by the clinician's care decisions.
Specifically, we are proposing to exclude unrelated services specific
to groups of MS-DRGs aggregated by major diagnostic categories (MDCs).
Some examples of unrelated services include orthopedic procedures for
episodes triggered by MS-DRGs under Disorders of Gastrointestinal
System (MDC 06 and MDC 07) or valvular procedures for episodes
triggered by MS-DRGs under Disorders of the Pulmonary System (MDC 04).
Further detail about these proposed changes to the measure is
included in the measure specifications documents, which are available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/mspb-clinician-zip-file.zip. This includes a comparison of the proposed changes
against the MSPB clinician measure as currently specified. A measure
justification form containing testing results for this measure with the
proposed revisions is available on the MACRA Feedback page at https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html. We are proposing to include the revised MSPB clinician
measure with these specifications in the cost performance category
beginning with the CY 2020 performance period.
(vi) Reliability
(A) Reliability for Episode-Based Measures
In the CY 2017 QPP final rule (81 FR 77169 through 77170), we
finalized a reliability threshold of 0.4 for measures in the cost
performance category. In the CY 2019 PFS final rule, we established at
Sec. 414.1350(c)(4) and (5) a case minimum of 20 episodes for acute
inpatient medical condition episode-based measures and 10 episodes for
procedural episode-based measures (83 FR 59773 through 59774). We
examined the reliability of the proposed 10 episode-based measures
listed in Table 38 at our established case minimums and found that all
of these measures meet the reliability threshold of 0.4 for the
majority of groups at a case minimum of 10 episodes for procedural
episode-based measures and 20 episodes for acute inpatient medical
condition episode-based measures. All of the proposed measures meet
this standard at the individual clinician level as well, with the
exception of the Lower Gastrointestinal Hemorrhage episode-based
measure. In section III.K.3.c.(2)(b)(vi)(B) of this proposed rule, we
discuss a proposal to limit our assessment of certain cost measures to
groups (identified by a TIN) based on the results of our reliability
analysis.
Table 38--Percent of TINs and TIN/NPIs That Meet 0.4 Reliability Threshold
----------------------------------------------------------------------------------------------------------------
% TINs meeting % TIN/NPIs
0.4 Mean meeting 0.4 Mean
Measure name reliability reliability reliability reliability
threshold for TINs threshold for TIN/NPIs
----------------------------------------------------------------------------------------------------------------
Acute Kidney Injury Requiring New Inpatient 100.0 0.58 85.3 0.48
Dialysis.......................................
Elective Primary Hip Arthroplasty............... 100.0 0.85 100.0 0.78
Femoral or Inguinal Hernia Repair............... 100.0 0.86 100.0 0.81
Hemodialysis Access Creation.................... 93.1 0.63 70.1 0.48
Inpatient Chronic Obstructive Pulmonary Disease 100.0 0.69 68.0 0.46
(COPD) Exacerbation............................
Lower Gastrointestinal Hemorrhage *............. 74.6 0.51 0.0 0.20
Lumbar Spine Fusion for Degenerative Disease, 1- 100.0 0.77 100.0 0.69
3 Levels.......................................
Lumpectomy Partial Mastectomy, Simple Mastectomy 100.0 0.64 100.0 0.60
Non-Emergent Coronary Artery Bypass Graft (CABG) 100.0 0.82 100.0 0.74
Renal or Ureteral Stone Surgical Treatment...... 100.0 0.77 100.0 0.65
----------------------------------------------------------------------------------------------------------------
* This measure is being proposed only for groups. Please reference section III.K.3.c.(2)(b)(vi)(B) of the
proposed rule.
[[Page 40760]]
(B) Limiting Assessment of Certain Measures to Groups
We have assessed clinicians and groups on cost measures when they
meet the case minimum for a measure. As part of our efforts to ensure
reliable measurement, we have examined the reliability of cost measures
at the group and individual level, as clinicians are able to
participate in MIPS in either way. However, for clinicians who
participate in MIPS as individuals, we have found the proposed Lower
Gastrointestinal Hemorrhage episode-based measure does not meet the
reliability threshold of 0.4 that we established for measures in the
cost performance category. While we considered not including the
measure in MIPS for this reason, we do find that this measure meets the
reliability threshold for those who participate in MIPS as part of a
group. Therefore, we propose to include the measure in the cost
performance category only for MIPS eligible clinicians who report as a
group or virtual group. We will continue to assess the reliability of
cost measures for group and individual participation as the measures
are introduced or are revised. If we identify measures that are
similarly found to meet our reliability threshold at the group level
but not at the individual level, we would again consider limiting the
assessment of the measure to groups.
(C) Reliability for Revised Cost Measures
In the CY 2017 Quality Payment Program final rule, we finalized a
reliability threshold of 0.4 for measures in the cost performance
category (81 FR 77169 through 77170). Additionally, we established a
case minimum of 35 episodes for the MSPB clinician measure (81 FR
77171) and a case minimum of 20 beneficiaries for the total per capita
cost measure (81 FR 77170). We codified these case minimums at Sec.
414.1350(c)(1) and (2) in the CY 2019 PFS final rule (83 FR 59774). We
based these case minimums on our interest in ensuring that the majority
of clinicians and groups that were measured met the threshold of 0.4
reliability, which we felt best balanced our interest in ensuring
moderate reliability without limiting participation. Given the
significant changes to these measures that we are proposing in section
III.K.3.c.(2)(b)(v), we again examined the reliability of the revised
MSPB clinician and total per capita cost measures at these case
minimums and found that the measures meet the reliability threshold of
0.4 for the majority of clinicians and groups at the existing case
minimums, as shown in Table 39.
TABLE 39--Percent of TINs and TIN/NPIs That Meet 0.4 Reliability Threshold for the Revised MSPB Clinician and
Total per Capita Cost Measures
----------------------------------------------------------------------------------------------------------------
% TINs meeting % TIN/NPIs
0.4 Mean meeting 0.4 Mean
Measure name reliability reliability reliability reliability
threshold for TINs threshold for TIN/NPIs
----------------------------------------------------------------------------------------------------------------
Medicare Spending Per Beneficiary Clinician..... 100.0 0.77 100.0 0.69
Total Per Capita Cost........................... 100.0 0.82 100.0 0.89
----------------------------------------------------------------------------------------------------------------
Based on this analysis, in this proposed rule we are not proposing
any changes to the case minimums, which we previously finalized as 35
for the MSPB clinician measure, and 20 for the total per capita cost
measure.
(vii) Request for Comments on Future Potential Episode-Based Measure
for Mental Health
We plan to continue to develop episode-based measures and propose
to adopt them for the cost performance category in future rulemaking.
As a part of these efforts, we seek to expand the range of procedures
and conditions covered to ensure that more MIPS eligible clinicians
have their cost performance assessed under clinically relevant episode-
based measures. In recognition of the importance of assessing mental
health care, we developed an acute inpatient medical condition episode-
based measure for the treatment of inpatient psychoses and related
conditions through the same process involving extensive expert
clinician input as the measures proposed in section
III.K.3.c.(2)(b)(vii) of this proposed rule. The specifications for the
Psychoses/Related Conditions episode-based measure are available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2019-revised-ebcm-measure-specs.zip. The Psychoses/Related Conditions episode-based
measure represents an opportunity to incentivize improvement in the
field of mental health, a CMS priority area.
The Psychoses/Related Conditions episode-based measure was reviewed
by the MAP Clinician Workgroup in December 2018 as part of a group with
the 10 episode-based measures in Table 40 that we are proposing and
received a preliminary recommendation of ``Conditional support for
rulemaking,'' on the condition of NQF endorsement. In January 2019, The
MAP Coordinating Committee pulled this measure for separate discussion
from the other 10 episode-based measures and voted to finalize a
recommendation of ``Do not support for rulemaking.'' The MAP's concerns
with this measure related to: (i) The attribution model and its
potential to hold clinicians responsible for costs outside of their
influence; (ii) geographic variation in community resource
availability; (iii) effects of physical comorbidities on measure score;
and (iv) the potential to exacerbate access issues in mental health
care. More detail is available in the 2019 MAP Clinician Workgroup
final report at http://www.qualityforum.org/Publications/2019/03/MAP_Clinicians_2019_Considerations_for_Implementing_Measures_Final_Report.aspx.
We appreciate the feedback from the MAP but believe that the
measure already accounts for these concerns. The expert workgroup
convened by the measure development contractor to provide input on the
specifications carefully considered these and other issues unique to
mental health care throughout the development process and field
testing. The expert workgroup, which reconvened to consider the MAP's
concerns, noted that they had addressed each of the MAP's concerns
during development activities and that this measure could be a
significant step towards mental health parity by including psychiatry
with other specialties in a MIPS episode-based measure. In addition,
the measure provides opportunities for innovation in care coordination,
which the Person and Family Committee expressed as an improvement need.
We are now seeking
[[Page 40761]]
comments on the Psychoses/Related Conditions episode-based measure. In
future years, we may propose the use of this measure.
Regarding the MAP's first concern about clinician accountability,
the Psychoses/Related Conditions measure is constructed to only capture
costs within an attributed clinician's influence through judicious
service assignment rules. That is, services are only included in the
cost of an episode when they meet specific conditions defined by
procedure, diagnosis, and timing within the episode window. Members of
the expert workgroup also noted that the measure can incentivize
improved care coordination across care settings by holding clinicians
accountable for certain post-discharge care. This recognition of the
potential for measures to incentivize systems care coordination aligns
with the rationale for quality measures currently available for
reporting in MIPS, which acknowledge the goal of promoting shared
accountability and collaboration with patients, families, and
providers. For example, NQF #0576/Quality #391 Follow-Up After
Hospitalization for Mental Illness (81 FR 77645) holds clinicians
accountable for certain follow-up care.
Regarding the MAP's second concern about geographic variation,
empirical analyses indicate the impact of geographic variation has
limited effect on measure score and is similar across episode-based
measures. The measure development contractor conducted empirical
analyses to examine the effect of adding variables to the current risk
adjustment model to account for state differences to assess the impact
of geographic variation. The analyses indicated that there is a high
correlation between the measure using the current risk adjustment model
and the model accounting for state differences. At the TIN level, the
correlation between the Psychoses/Related Conditions base measure and
state-augmented measure is 0.838. At the TIN-NPI level, the correlation
between the Psychoses/Related Conditions base measure and state-
augmented measure is 0.835.
Regarding the MAP's third concern about physical comorbidities, the
measure's risk adjustment model includes variables to account for
patient comorbidities, including variables for patient history of other
physical or mental health issues that might affect outcomes for
patients captured under this measure.
Regarding the MAP's fourth concern about mental healthcare access,
the large number of beneficiaries covered by this measure mitigates the
potential for clinicians to limit access for Medicare patients. The
potential coverage of beneficiaries is high, as there are approximately
102,000 beneficiaries with at least one episode (for episodes ending
between January 1, 2017 and December 31, 2017). Additionally, the
measure is designed to account for complex case mix to preserve access
to care: The patient cohort is divided into sub-groups to ensure
meaningful clinical comparisons between homogenous patient populations.
We believe that this measure has the potential to incentivize improved
care coordination and team-based care, and encourage the use of use
community resources, which would improve access to care.
The Psychoses/Related Conditions episode-based measure would bridge
the measurement gap in the MIPS cost performance category by providing
mental health clinicians an episode-based measure as a complement to
the two broader, population cost measures currently in MIPS. Based on
episodes ending between January 1, 2017 and December 31, 2017,
approximately 97 percent of MIPS eligible TINs and 36 percent of MIPS
eligible TIN/NPIs meeting the 20 episode-case minimum for the
Psychoses/Related Conditions measure also meet the case minimum for the
revised MSPB clinician measure. Similarly, approximately, 98 percent of
MIPS eligible TINs and 23 percent of MIPS eligible TIN/NPIs meeting the
case minimum for the Psychoses/Related Conditions measure also meet the
case minimum for the revised total per capita cost measure. We believe
that this measure accurately reflects cost associated with inpatient
psychiatrists' care and can provide information about cost performance
that is actionable for mental health clinical practice as they provide
clinicians with feedback on the cost of services within their
reasonable influence.
A key goal for cost measures is to assess provider variation due to
practice differences rather than chance, which can be determined by the
measure's reliability. The Psychoses/Related Conditions measure tests
well for reliability. The measure has a mean reliability over 0.7,
generally considered the threshold for high reliability, at both TIN
and TIN-NPI levels at the 10, 20, and 30-episode case minima. At the
20-epsiode case minimum imposed for acute inpatient medical condition
episode-based measures, mean reliability is 0.83 for TIN and 0.88 for
TIN-NPI level reporting, with 100.0 percent of TINs and 100.0 percent
of TIN-NPIs meeting or exceeding the 0.4 threshold for moderate
reliability. A measure justification form with additional testing
results for this measure is available at the MACRA Feedback page at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-
Feedback.html.
We are seeking comments on the potential use of this new Psychoses/
Related Conditions episode-based measure in the cost performance
category in a future MIPS performance period.
(viii) Summary of Previously Established and Proposed Measures for the
Cost Performance Category for the 2020 and Future Performance Periods
Table 40--Summary Table of Cost Measures for the 2020 Performance Period
and Future Performance Periods
------------------------------------------------------------------------
Measure topic Measure type Measure Status
------------------------------------------------------------------------
Total Per Capita Cost....... Population-Based.... Revised and proposed
for 2020
performance period
and beyond.
Medicare Spending Per Population-Based.... Revised and proposed
Beneficiary Clinician. for 2020
performance period
and beyond.
Elective Outpatient Procedural episode- Currently in use for
Percutaneous Coronary based. 2019 Performance
Intervention (PCI). Period and Beyond.
Knee Arthroplasty........... Procedural episode- Currently in use for
based. 2019 Performance
Period and Beyond.
Revascularization for Lower Procedural episode- Currently in use for
Extremity Chronic Critical based. 2019 Performance
Limb Ischemia. Period and Beyond.
[[Page 40762]]
Routine Cataract Removal Procedural episode- Currently in use for
with Intraocular Lens (IOL) based. 2019 Performance
Implantation. Period and Beyond.
Screening/Surveillance Procedural episode- Currently in use for
Colonoscopy. based. 2019 Performance
Period and Beyond.
Intracranial Hemorrhage or Acute inpatient Currently in use for
Cerebral Infarction. medical condition 2019 Performance
episode-based. Period and Beyond.
Simple Pneumonia with Acute inpatient Currently in use for
Hospitalization. medical condition 2019 Performance
episode-based. Period and Beyond.
ST-Elevation Myocardial Acute inpatient Currently in use for
Infarction (STEMI) with medical condition 2019 Performance
Percutaneous Coronary episode-based. Period and Beyond.
Intervention (PCI).
Acute Kidney Injury Procedural episode- Proposed for 2020
Requiring New Inpatient based. Performance Period
Dialysis. and Beyond.
Elective Primary Hip Procedural episode- Proposed for 2020
Arthroplasty. based. Performance Period
and Beyond.
Femoral or Inguinal Hernia Procedural episode- Proposed for 2020
Repair. based. Performance Period
and Beyond.
Hemodialysis Access Creation Procedural episode- Proposed for 2020
based. Performance Period
and Beyond.
Inpatient Chronic Acute inpatient Proposed for 2020
Obstructive Pulmonary medical condition Performance Period
Disease (COPD) Exacerbation. episode-based. and Beyond.
Lower Gastrointestinal Acute inpatient Proposed for 2020
Hemorrhage (at group level medical condition Performance Period
only). episode-based. and Beyond.
Lumbar Spine Fusion for Procedural episode- Proposed for 2020
Degenerative Disease, 1-3 based. Performance Period
Levels. and Beyond.
Lumpectomy, Partial Procedural episode- Proposed for 2020
Mastectomy, Simple based. Performance Period
Mastectomy. and Beyond.
Non-Emergent Coronary Artery Procedural episode- Proposed for 2020
Bypass Graft (CABG). based. Performance Period
and Beyond.
Renal or Ureteral Stone Procedural episode- Proposed for 2020
Surgical Treatment. based. Performance Period
and Beyond.
------------------------------------------------------------------------
(3) Improvement Activities Performance Category
(a) Background
For previous discussions on the background of the improvement
activities performance category, we refer readers to the CY 2017
Quality Payment Program final rule (81 FR 77177 through 77178), the CY
2018 Quality Payment Program final rule (82 FR 53648 through 53661),
and the CY 2019 PFS final rule (83 FR 59776 through 59777).
In this proposed rule, we are proposing to: (1) Modify the
definition of rural area; (2) update Sec. 414.1380(b)(3)(ii)(A) and
(C) to remove the reference to the four listed accreditation
organizations in order to be recognized as patient-centered medical
homes and to remove the reference to the specific accrediting
organization for comparable specialty practices; (3) increase the group
reporting threshold to 50 percent; (4) establish factors to consider
for removal of improvement activities from the Inventory; (5) remove
15, modify seven, and add two new improvement activities for the 2020
performance period and future years; and (6) conclude and remove the
CMS Study on Factors Associated with Reporting Quality Measures. These
proposals are discussed in more detail in this proposed rule.
(b) Small, Rural, or Health Professional Shortage Areas Practices
For our previously established policies regarding small, rural, or
Health Professional Shortage Areas Practices, we refer readers to the
CY 2017 Quality Payment Program final rule (81 FR 77188), CY 2018
Quality Payment Program final rule (82 FR 53581), and Sec. 414.1305.
In the CY 2018 Quality Payment Program final rule (82 FR 53581 through
53582), we changed the definition of rural area at Sec. 414.1305 to
mean ZIP codes designated as rural, using the most recent Health
Resources and Services Administration (HRSA) Area Health Resource File
data set available.
It has come to our attention that the rural area definition at
Sec. 414.1305 includes the incorrect file name for the rural
designation. While we used the correct file, we just referenced it
incorrectly. Therefore, we are proposing to update the MIPS rural area
definition by correcting the file name. In the CY 2017 Quality Payment
Program final rule (81 FR 77188), we incorrectly referenced the file we
used for rural designation as ``the most recent Health Resources and
Services Administration (HRSA) Area Health Resource File data set
available'' instead of the correct file entitled ``Federal Office of
Rural Health Policy (FORHP) eligible ZIP codes'' which may currently be
found at https://www.hrsa.gov/rural-health/about-us/definition/datafiles.html. The HRSA Area Health Resources Files (AHRF) include
data on Health Care Professions, Health Facilities, Population
Characteristics, Economics, Health Professions Training, Hospital
Utilization, Hospital Expenditures, and Environment at the county,
state and national levels, from over 50 data sources \115\ but does not
contain specific data on rurality developed by HRSA's FORHP. To be
clear, we have been using the more appropriate FORHP eligible ZIP code
file in all previous 3 years of MIPS; we simply inadvertently listed
the incorrect file name in the definition. Furthermore, the definition
of rural in MIPS is based on the rural definition developed by HRSA's
FORHP which may be found at https://www.hrsa.gov/rural-health/about-us/definition/index.html. The FORHP defines all non-Metro counties as
rural and uses an additional method of determining rurality called the
Rural-Urban
[[Page 40763]]
Commuting Area (RUCA) codes. The FORHP eligible ZIP codes are available
in a file located at https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/aboutus/definition/forhp-eligible-zips.xlsx. Therefore, we
are proposing to modify the definition of rural area at Sec. 414.1305
to mean a ZIP code designated as rural by the Federal Office of Rural
Health Policy (FORHP), using the most recent FORHP Eligible ZIP Code
file available. We invite public comment on our proposal as discussed
in this proposed rule.
---------------------------------------------------------------------------
\115\ https://data.hrsa.gov/topics/health-workforce/ahrf.
---------------------------------------------------------------------------
(c) Patient-Centered Medical Home and Comparable Specialty Practice
Accreditation Organizations
In the CY 2017 Quality Payment Program final rule (81 FR 77179
through 77180), we finalized at Sec. 414.1380(b)(3)(ii) an expanded
definition of what is acceptable for recognition as a certified-
patient-centered medical home or comparable specialty practice.
Specifically, we finalized that one of the criteria, as stated at Sec.
414.1380(b)(3)(ii)(A), is whether the practice has received
accreditation from one of four accreditation organizations that are
nationally recognized; (A)(1) through (A)(4) lists the four
organizations with nationally recognized patient-centered medical home
accreditation programs: (1) The Accreditation Association for
Ambulatory Health Care; (2) the National Committee for Quality
Assurance (NCQA) Patient-Centered Medical Home; (3) The Joint
Commission Designation; or (4) the Utilization Review Accreditation
Commission (URAC) (81 FR 77180). In addition, we finalized another
criteria at Sec. 414.1380(b)(3)(ii)(C), which states that the practice
is a comparable specialty practice that has received the NCQA Patient-
Centered Specialty Recognition (81 FR 77180). Further, we finalized
that the criteria for being a nationally recognized accredited patient-
centered medical home are that it must be national in scope and must
have evidence of being used by a large number of medical organizations
as the model for their patient-centered medical home (81 FR 77180).
Since finalizing these criteria, it has come to our attention that,
we do not want to exclude other organizations. It was and is not our
intention to limit patient-centered medical home or comparable
specialty practice accreditation organizations to those listed. We
realize that there may be additional accreditation organizations that
have nationally recognized programs for accrediting patient-centered
medical homes and comparable specialty practices that were not
included. Therefore, we request comments on our proposal to update
Sec. 414.1380(b)(3)(ii)(A) and (C) to remove specific entity names.
(d) Improvement Activities Data Submission
We are proposing changes to the improvement activities data
submission for group reporting requirements, as discussed below.
(i) Submission Mechanisms
For our previously established policies regarding improvement
activities performance category submission mechanisms, we refer readers
to the CY 2018 Quality Payment Program final rule (82 FR 53650 through
53656), the CY 2019 PFS final rule (83 FR 59777), and Sec.
414.1360(a)(1). We are not proposing any changes to these policies.
(ii) Submission Criteria
For our previously established policies regarding improvement
activities performance category submission criteria, we refer readers
to the CY 2017 Quality Payment Program final rule (81 FR 77185), the CY
2018 Quality Payment Program final rule (82 FR 53651 through 53652),
the CY 2019 PFS final rule (83 FR 59777 through 59778), and Sec.
414.1380. We are not proposing any changes to these policies.
(iii) Group Reporting
In this proposed rule, we are making two proposals with respect to
group reporting: (a) Increasing the group reporting threshold from at
least one clinician to at least 50 percent of the group beginning with
the 2020 performance year, and (b) at least 50 percent of a group's
National Provider Identifiers (NPIs) must perform the same activity for
the same continuous 90 days in the performance period beginning with
the 2020 performance year. These are discussed in more detail below.
As discussed in the CY 2017 Quality Payment Program final rule (81
FR 77181), in response to a public comment, we stated that if at least
one clinician within the group is performing the activity for a
continuous 90 days in the performance period, the group may report on
that activity. In addition, we specified that all MIPS eligible
clinicians reporting as a group would receive the same score for the
improvement activities performance category if at least one clinician
within the group is performing the activity for a continuous 90 days in
the performance period (81 FR 77181).
In the CY 2018 Quality Payment Program proposed rule (82 FR 30053),
we requested comment for future consideration on issues related to
whether we should establish a minimum threshold (for example, 50
percent) of the clinicians (NPIs) that must complete an improvement
activity in order for the entire group (Taxpayer Identification Number
(TIN)) to receive credit in the improvement activities performance
category in future years. Some commenters expressed concerns that
setting a minimum threshold would add complexity or burden for
clinicians. Other commenters supported the establishment of a minimum
participation threshold in future years, noting that a minimum
threshold will ensure scoring is reflective of care delivered by the
group as a whole rather than one or a few high-performing clinicians.
We believe that by Year 4 (2020 performance year) of the Quality
Payment Program, clinicians should be familiar with the improvement
activities performance category. We believe that increasing the minimum
threshold for a group to receive credit for the improvement activities
performance category will not present additional complexity and burden
for a group. With over 100 improvement activities available for
eligible clinicians to choose from in the Improvement Activities
Inventory, which may be found at the Quality Payment Program website
https://qpp.cms.gov/, that provide a range of options for clinicians
seeking to improve clinical practice that are not specific to practice
size or specialty or practice setting, we believe that a group should
be able to find applicable and meaningful activities to complete that
would apply to at least 50 percent of individual MIPS eligible
clinicians in a group.
Therefore, we are proposing to increase the minimum number of
clinicians in a group or virtual group who are required to perform an
improvement activity to 50 percent for the improvement activities
performance category beginning with the 2020 performance year and
future years. We would like to note that if finalized the proposed
changes to the group threshold would have no impact on the previously
finalized policy that eligible clinicians participating in an APM will
receive full points for the improvement activities performance category
as discussed in the CY 2017 Quality Payment Program final rule (81 FR
77258 through 77260). This is an increase to the previously established
requirement finalized in the CY 2017 Quality Payment Program final rule
(81
[[Page 40764]]
FR 77181) that only one clinician within a TIN needs to attest to the
completion of an improvement activity to get credit towards the MIPS
final score. We believe a 50 percent threshold is achievable and
appropriate because, if a group or virtual group has implemented an
improvement activity, the activity should be recognized and adopted
throughout much of the practice in order to improve clinical practice,
care delivery, and outcomes. This aligns with our definition of an
improvement activity at Sec. 414.1305. In crafting our proposal, we
also considered other thresholds, such as a lower threshold of 25
percent. However, we believe that improvement activities should be
adopted throughout much of the practice to achieve improved outcomes.
We do not believe that 25 percent group participation would reflect
improved outcomes. We also considered a higher threshold of 100
percent, but have concerns that requiring every clinician within a
group to perform improvement activities may be premature at this time
because increasing the threshold by such a large amount may be
considered burdensome to clinicians. However, we believe that 50
percent provides an appropriate balance between requiring at least half
of the NPIs reporting as part of a group to participate in the
improvement activities performance category and acknowledging the
challenges to requiring every NPI in a group to perform the improvement
activity for a group to receive credit. We also believe our proposal
aligns with the 50 percent threshold for the number of practice sites
that must be recognized for a TIN to receive full credit as a patient-
centered medical home (82 FR 53655) and is both achievable and
appropriate at this time.
Furthermore, we believe that requiring at least 50 percent of a
group practice or TIN to perform an improvement activity for the same
continuous 90-day performance period would facilitate improvement in
clinical practice within a TIN. As discussed in the CY 2017 Quality
Payment Program final rule (81 FR 77186), we considered setting the
threshold for the minimum time required for performing an activity to
longer periods up to a full calendar year. However, after researching
several organizations we stated that we believed a minimum of 90 days
is a reasonable amount of time (81 FR 77186). In addition, in response
to comments we stated that we believed that each activity can be
performed for a full 90 consecutive days by some, if not all, MIPS
eligible clinicians, and that there are a sufficient number of
activities included that any eligible clinician may select and perform
for a continuous 90 days that will allow them to successfully report
under this performance category (81 FR 77186).
Therefore, we are requesting comments on our proposal to revise
Sec. 414.1360(a)(2) to state that beginning with the 2020 performance
year, each improvement activity for which groups and virtual groups
submit a yes response in accordance with paragraph (a)(1) of this
section must be performed by at least 50 percent of the NPIs billing
under the group's TIN or virtual group's TINs, as applicable; and these
NPIs must perform the same activity for the same continuous 90 days in
the performance period. To be clear, other submission requirements
would remain the same. In other words, each TIN would need to submit an
attestation for each improvement activity selected that at least 50
percent of its NPIs performed the same activity for the same continuous
90 days in the performance period. For example, TIN 1234 attests that
at least 50 percent of its NPIs performed the improvement activity
entitled: ``Participation in a QCDR that promotes use of patient
engagement tools'' (IA_BE_7) for the same continuous 90-day period.
Because IA_BE_7 is medium-weighted, the example TIN would receive 10
points toward the total possible improvement activities score. TIN 1234
also attests that at least 50 percent of its NPIs performed the
improvement activity entitled: ``Implementation of formal quality
improvement methods, practice changes, or other practice improvement
processes'' (IA_PSPA_19) for the same continuous 90-day period. Because
IA_PSPA_19 is medium-weighted, the example TIN would receive another 10
points toward the total possible improvement activities score. We refer
readers to the CY 2019 Quality Payment Program final rule (83 FR 59753
through 59754) where we discuss the data submission deadline which was
finalized at Sec. 414.1325(e)(1) as follows: For the direct, login and
upload, login and attest, and CMS Web Interface submission types, March
31 following the close of the applicable performance period or a later
date as specified by CMS.
We invite public comments on our proposal as discussed above, as
well as the alternatives considered.
(e) Improvement Activities Inventory
We are proposing changes to the Improvement Activities Inventory
to: (1) Establish removal factors to consider when proposing to remove
improvement activities from the Inventory; (2) remove 15 improvement
activities for the 2020 performance period and future years contingent
on our proposed removal factors being finalized; (3) modify seven
existing improvement activities for the 2020 performance period and
future years; and (4) add two new improvement activities for the 2020
performance period and future years. These proposals are discussed in
more detail in this proposed rule.
(i) Proposed Factors for Consideration in Removing Improvement
Activities
In the CY 2017 Quality Payment Program final rule (82 FR 53660
through 53661), we discussed that in future years, we anticipated
developing a process and establishing factors for identifying
activities for removal from the Improvement Activities Inventory
through the Annual Call for Activities process. In the CY 2018 Quality
Payment Program proposed rule (82 FR 30056), we invited public comments
on what criteria should be used to identify improvement activities for
removal from the Inventory. A few commenters did not support the idea
of establishing removal factors for improvement activities, believing
that many practices have made financial investments to perform these
activities and that no activities should be removed. Some commenters
suggested that we should remove activities that: Have become obsolete,
are topped out, do not show demonstrated improvements over time, or are
not attested to for three consecutive years. The commenters recommended
that their removal should be conducted using an approach similar to
what is used for the removal of quality measures. In our responses, we
stated that we appreciate the commenters input. In addition, we
understand that many practices may have made financial investments to
perform these activities, but believe that over time, certain
improvement activities should be considered for removal to ensure the
list is robust and relevant. We will fully examine each activity prior
to removal. In addition, we stated that commenters would have an
opportunity to provide their input during notice-and-comment
rulemaking. We agreed with commenters that we should remove activities
as needed and should consider the removal criteria already established
for quality measures. We continue to believe that having factors to
consider in removing improvement activities would provide transparency
and alignment with the removal of quality measures. Therefore, we are
proposing to adopt the following factors for our consideration when
[[Page 40765]]
proposing the removal of an improvement activity:
Factor 1: Activity is duplicative of another activity;
Factor 2: There is an alternative activity with a stronger
relationship to quality care or improvements in clinical practice;
Factor 3: Activity does not align with current clinical
guidelines or practice;
Factor 4: Activity does not align with at least one
meaningful measures area;
Factor 5: Activity does not align with the quality, cost,
or Promoting Interoperability performance categories;
Factor 6: There have been no attestations of the activity
for 3 consecutive years; or
Factor 7: Activity is obsolete.
These factors directly reflect those already finalized for quality
measures found in the CY 2019 PFS final rule (83 FR 59765). The removal
of improvement activities from the Inventory, including discussion of
the removal factor(s) considered, would occur through notice-and-
comment rulemaking. We note that these removal factors are
considerations taken into account when deciding whether or not to
remove improvement activities; but they are not firm requirements.
Therefore, we invite public comments on our proposal to implement
factors to consider in removing improvement activities from the
Inventory. In conjunction with this proposal, we are proposing a number
of improvement activity removals as discussed in the next section and
in Appendix 2 of this proposed rule. Those removals are contingent upon
finalization of these removal factors.
(ii) New Improvement Activities and Modifications to and Removal of
Existing Improvement Activities
In the CY 2018 Quality Payment Program final rule (82 FR 53660), we
finalized that we would add new improvement activities or modifications
to existing improvement activities to the Improvement Activities
Inventory through notice-and-comment rulemaking. We refer readers to
Table H in the Appendix of the CY 2017 Quality Payment Program final
rule (81 FR 77177 through 77199), Tables F and G in the Appendix of the
CY 2018 Quality Payment Program final rule (82 FR 54175 through 54229),
and Tables X and G in the Appendix 2 of the CY 2019 PFS final rule (83
FR 60286 through 60303) for our previously finalized Improvement
Activities Inventory. We also refer readers to the Quality Payment
Program website at https://qpp.cms.gov/ for a complete list of the most
current list of improvement activities. In this proposed rule, we
invite comments on our proposals to: (1) Remove 15 improvement
activities from the Inventory beginning with the 2020 performance
period, (2) modify seven existing improvement activities for 2020
performance period and future years, and (3) add two new improvement
activities for 2020 performance period and future years. We refer
readers to Appendix 2 of this proposed rule for further details. Our
proposals to remove improvement activities are being made in
conjunction with our proposal to adopt removal factors and are
contingent upon finalization of that proposal.
(f) CMS Study on Factors Associated With Reporting Quality Measures
In this proposed rule, we are proposing to end this study and
concurrently, remove the incentive under the improvement activity
performance category that this study provided for study participants.
(i) Background
In the CY 2017 Quality Payment Program final rule (81 FR 77195), we
created the Study on Improvement Activities and Measurement. In our
quest to create a culture of improvement using evidence-based medicine
on a consistent basis, we believe fully understanding the strengths and
limitations of the current processes of collecting and submitting
quality measurement data is crucial to better understand and improve
these current processes. We proposed to conduct a study on clinical
improvement activities and measurement to examine clinical quality
workflows and data capture using a simpler approach to quality measures
(81 FR 77195). In the CY 2018 Quality Payment Program final rule (82 FR
53662) and CY 2019 PFS final rule (83 FR 59783), we finalized updates
to the study.
Starting in CY 2017, this annual study was slated for a minimum
period of 3 years, as stated in CY 2019 PFS final rule (83 FR 59776).
Study participants were recruited every study year. The study
population started in CY 2017 with a minimum of 42 individuals (81 FR
77195), grew to a minimum of 102 individuals for CY 2018 (82 FR 53662)
and 200 individuals for CY 2019 (83 FR 59783). Each years' study
population is comprised of the following categories: Urban versus non-
urban, groups and individual clinicians; clinicians reporting quality
measures in groups or reporting individually, different practice sizes;
and different specialty groups (81 FR 77195). These changes to the
study sample size over the years provided data for the study's
analysis. The goals of the study are to see whether there will be
improved outcomes, reduced burden in reporting, and enhancements in
clinical care by selected MIPS eligible clinicians desiring: A more
data driven approach to quality measurement, measure selection
unconstrained by a CEHRT program or system, improving data quality
submitted to CMS, enabling CMS get data more frequently and provide
feedback more often (81 FR 77195). To encourage participation by
clinicians and counterbalance clinician burden for anticipation of
study, participating clinicians were incentivized with full improvement
activity credit as finalized in the CY 2017 Quality Payment Program
final rule (81 FR 77195 through 77197).
(ii) Proposal To End and Remove Study
We believe by the end of 2020 we will have reached the minimum
sample size and have accrued the minimum data needed for the analysis
to achieve the study goals. Therefore, we request comments on our
proposal to conclude this study at the end of the CY 2019 performance
period. In conjunction with our proposal to end the study, we are also
proposing to remove the study and the incentive provided towards the
improvement activity performance category beginning with the 2020
performance period. If the study is ended as proposed above, we are
proposing to remove this activity because it would be obsolete
(proposed removal factor 7). As a result, the full improvement activity
credit given to participants as finalized in the CY 2017 Quality
Payment Program final rule (81 FR 77195-77197), would no longer be
available starting with the 2020 performance period.
(iii) Future Steps
After completing this data collection phase, we next plan to
analyze the data gathered (which include lessons learned) and to make
recommendations to improve outcomes, reduce burden, and enhance
clinical care. We plan to finish the final data analysis by Spring
2020. This analysis would contain all the study years. It would show
the trends and associations of all the factors we examined. It would
also show the lessons learnt by study participants over the 3 years of
the study. At the conclusion of this study and after analysis of the
results, we plan to shift our focus to implementation of
recommendations. We intend for this to include feedback to clinicians
and stakeholders and educational and
[[Page 40766]]
outreach work. We plan to undertake education and outreach to the
public. We would also include the results in other Quality Payment
Program educational materials such as webinars.
(4) Promoting Interoperability
(a) Background
Section 1848(q)(2)(A) of the Act includes the meaningful use of
Certified Electronic Health Record Technology (CEHRT) as a performance
category under the MIPS. In prior rulemaking, we referred to this
performance category as the Advancing Care Information performance
category, and it was reported by MIPS eligible clinicians as part of
the overall MIPS program. In 2018, we renamed the Advancing Care
Information performance category as the Promoting Interoperability
performance category (83 FR 35912). As required by sections 1848(q)(2)
and (5) of the Act, the four performance categories of the MIPS shall
be used in determining the MIPS final score for each MIPS eligible
clinician. In general, MIPS eligible clinicians will be evaluated under
all four of the MIPS performance categories, including the Promoting
Interoperability performance category.
For the Promoting Interoperability performance category, our
proposals include: (1) For the 2023 MIPS payment year, establishing a
performance period of a minimum of a continuous 90-day period within CY
2021, up to and including the full calendar year; (2) making the Query
of Prescription Drug Monitoring Program (PDMP) measure optional in CY
2020, and in the event we finalize this proposal, making the e-
Prescribing measure worth up to 10 points in CY 2020; (3) removing the
numerator and denominator for the Query of PDMP measure and instead
requiring a ``yes/no'' response beginning in CY 2019; (4) removing the
Verify Opioid Treatment Agreement measure beginning in CY 2020; (5)
redistributing the points for the Support Electronic Referral Loops by
Sending Health Information measure to the Provide Patients Access to
Their Health Information measure if an exclusion is claimed, beginning
in CY 2019; (6) revising the description of the Support Electronic
Referral Loops by Receiving and Incorporating Health Information
measure exclusion to more clearly and precisely capture our intended
policy, beginning in CY 2019; (7) continuing the existing policy of
reweighting the Promoting Interoperability performance category for
certain types of non-physician practitioner MIPS eligible clinicians
for the performance period in 2020; and (8) proposals related to
hospital-based MIPS eligible clinicians and non-patient facing MIPS
eligible clinicians in groups.
These proposals are discussed in more detail in this proposed rule.
We are also seeking input through Requests for Information as
follows: (1) Potential Opioid Measures for Future Inclusion in the
Promoting Interoperability performance category, (2) NQF and CDC Opioid
Quality Measures, (3) a Metric to Improve Efficiency of Providers
within EHRs, (4) the Provider to Patient Exchange Objective, (5)
Integration of Patient-Generated Health Data into EHRs Using CEHRT, and
(6) Engaging in Activities that Promote the Safety of the EHR.
(b) Goals of Proposed Changes to the Promoting Interoperability
Performance Category
As we look toward the future of the Promoting Interoperability
performance category, the general goals of our proposals in this
proposed rule center on: (1) A priority of stability within the
performance category after the recent changes made in the CY 2019 PFS
final rule (83 FR 59785 through 59820) while continuing to further
interoperability through the use of CEHRT; (2) reducing administrative
burden; (3) continued use of the 2015 Edition CEHRT; (4) improving
patient access to their EHRs so they can make fully informed health
care decisions; and (5) continued alignment with the Medicare Promoting
Interoperability Program for eligible hospitals and CAHs, where
appropriate.
(c) Promoting Interoperability Performance Category Performance Period
As finalized in the CY 2019 PFS final rule at Sec. 414.1320(e)(1)
(83 FR 59745 through 59747), for purposes of the 2022 MIPS payment
year, the performance period for the Promoting Interoperability
performance category is a minimum of a continuous 90-day period within
the calendar year that occurs 2 years prior to the applicable MIPS
payment year, up to and including the full calendar year. Thus, for the
2022 MIPS payment year, the performance period for the Promoting
Interoperability performance category is a minimum of a continuous 90-
day period within CY 2020, up to and including the full CY 2020
(January 1, 2020 through December 31, 2020).
For the 2023 MIPS payment year, we are proposing to add Sec.
414.1320(f)(1), which would establish a performance period for the
Promoting Interoperability performance category of a minimum of a
continuous 90-day period within the calendar year that occurs 2 years
prior to the applicable MIPS payment year, up to and including the full
calendar year (CY 2021). This proposal aligns with the proposed EHR
reporting period in CY 2021 for the Medicare Promoting Interoperability
Program for eligible hospitals and CAHs (84 FR 19554). We believe this
would be an appropriate performance period because of the maturation
needed within the performance category, including the changes to
measures and other changes being proposed in this rule. In addition, it
would offer stability and continuity for the Promoting Interoperability
performance category after the performance category overhaul that was
finalized in the CY 2019 PFS final rule (83 FR 59785 through 59820).
We are requesting comments on this proposal.
(d) Promoting Interoperability Performance Category Measures for MIPS
Eligible Clinicians
(i) Proposed Changes to Measures for the e-Prescribing Objective
(A) Background
Beginning with the MIPS performance period in 2019, we adopted two
new measures for the e-Prescribing objective that are based on
electronic prescriptions for controlled substances: (1) Query of
Prescription Drug Monitoring Program (PDMP) (83 FR 59800 through
59803); and (2) Verify Opioid Treatment Agreement (83 FR 59803 through
59806). These measures built upon the meaningful use of CEHRT, as well
as the security of electronic prescribing of Schedule II controlled
substances while preventing diversion. For both measures, we defined
opioids as Schedule II controlled substances under 21 CFR 1308.12, as
they are recognized as having a high potential for abuse with potential
for severe psychological or physical dependence. Additionally, we noted
the intent of the new measures was not to dissuade the prescribing or
use of opioids for patients with medical diagnoses or conditions that
benefit from their use, such as patients diagnosed with cancer or those
receiving hospice.
During the comment period for the CY 2019 PFS proposed rule (83 FR
35921 through 35925), and subsequently through public forums and
correspondence, we received extensive comments from stakeholders
regarding the Query of PDMP measure and the Verify Opioid Treatment
Agreement measure. While this feedback is the main catalyst for our
proposals, there have also been significant legislative changes that
have the potential to
[[Page 40767]]
positively impact the Promoting Interoperability performance category,
specifically the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act (SUPPORT Act)
(Pub. L. 115-271, enacted October 24, 2018). This legislation was
enacted to address the opioid crisis and affects a wide range of HHS
programs and policies. While this legislation is not the main reason
for our proposals, we believe it may significantly affect the
maturation, requirements, and use of PDMPs and State networks upon
which the Query of PDMP measure is dependent.
In this proposed rule, we are aiming to be responsive to the
comments that we have received from stakeholders since the CY 2019 PFS
final rule was published and to take into account certain aspects of
the SUPPORT Act that may have implications for the policy goals of the
Promoting Interoperability performance category.
As explained in further detail below, we are proposing to make the
Query of PDMP measure optional in CY 2020, remove the numerator and
denominator that we established for the Query of PDMP measure and
instead require a ``yes/no'' response beginning in CY 2019, and remove
the Verify Opioid Treatment Agreement measure beginning in CY 2020. In
section III.K.3.c.(4)(d)(i) of this proposed rule, we are also
requesting information on potential new opioid use disorder (OUD)
prevention and treatment-related measures. We believe the requests for
information will help to inform future rulemaking and not only help
prevent and treat substance use disorder, but allow us to adopt
measures that enable flexibility without added burden for clinicians.
We value stakeholders' continued interest in and support for combating
the nation's opioid epidemic.
(B) Query of Prescription Drug Monitoring Program (PDMP) Measure
(aa) Query of PDMP Measure
As we stated in the CY 2019 PFS final rule (83 FR 59800 through
59803), the Query of PDMP measure is optional and available for bonus
points for the 2019 performance period, and we will propose our policy
for the Query of a PDMP measure for the 2020 performance period in
future rulemaking. We afforded MIPS eligible clinicians' flexibility
for implementing this measure, including the flexibility to query the
PDMP in any manner allowed under their State law.
However, we have received substantial feedback from health IT
vendors and specialty societies that this flexibility presents
unintended challenges, such as the significant burden associated with
IT system design and development needed to accommodate the measure and
any future changes to it. During the CY 2019 PFS proposed rule comment
period (83 FR 35922 through 35925) and after the final rule was
published, these stakeholders stated that it is premature to require
the Query of PDMP measure in the 2020 performance period especially
given the maturation needed in PDMP development.
We agree with stakeholders that PDMPs are still maturing in their
development and use. In addition there is considerable variation among
state PDMP programs as many only operate within a state and are not
linked to larger systems. For more information, we refer readers to the
following: The National Alliance of Model State Drug Laws (https://namsdl.org/topics/pdmp/) and PDMP Training and Technical Assistance
Center (https://www.pdmpassist.org/content/pdmp-maps-and-tables).
Stakeholders also mentioned the challenge posed by the current lack
of integration of PDMPs into the EHR workflow. Historically, health
care providers have had to go outside of the EHR workflow in order to
separately log in to and access the State PDMP. In addition,
stakeholders noted the wide variation in whether PDMP data can be
stored in the EHR. By integrating PDMP data into the health record,
health care providers can improve clinical decision making by utilizing
this information to identify potential opioid use disorders, inform the
development of care plans, and develop effective interventions. ONC is
currently engaged in an assessment to better understand the current
state of policy and technical factors impacting PDMP integration across
States. This assessment is exploring factors like PDMP data
integration, standards and hubs used to facilitate interstate PMDP data
exchange, access permissions, and laws and regulations governing PDMP
data storage.
In October 2018, the SUPPORT Act became law, signifying an
important investment and approach for our nation in combating the
opioid epidemic. The provisions of this law aim to provide for opioid
use disorder prevention, recovery, and treatment and aim to increase
access to evidence-based treatment and follow-up care included through
legislative changes specific to the Medicare and Medicaid programs.
Specifically, with respect to PDMPs, the SUPPORT Act includes new
requirements and federal funding for PDMP enhancement, integration, and
interoperability, and establishes mandatory use of PDMPs by certain
Medicaid providers, in an effort to help reduce opioid misuse and
overprescribing, and in an effort to help promote the overall effective
prevention and treatment of opioid use disorder.
Section 5042(a) of the SUPPORT Act added section 1944 to the Act,
titled ``Requirements relating to qualified prescription drug
monitoring programs and prescribing certain controlled substances.''
This section increases federal Medicaid matching rates during FY 2019
and 2020 for certain state expenditures relating to qualified PDMPs
administered by states. Under section 1944(b)(1) of the Act, to be a
qualified PDMP, a PDMP must facilitate access by a covered provider to,
at a minimum, the following information with respect to a covered
individual, in as close to real-time as possible: Information regarding
the prescription drug history of a covered individual with respect to
controlled substances; the number and type of controlled substances
prescribed to and filled for the covered individual during at least the
most recent 12-month period; and the name, location, and contact
information of each covered provider who prescribed a controlled
substance to the covered individual during at the least the most recent
12-month period. Under section 1944(b)(2) of the Act, a qualified PDMP
must also facilitate the integration of the information described in
section 1944(b)(1) of the Act into the workflow of a covered provider,
which may include the electronic system used by the covered provider
for prescribing controlled substances.
Section 1944(f) of the Act establishes, for FY 2019 and FY 2020, a
100 percent federal Medicaid matching rate for state expenditures to
design, develop, or implement a PDMP that meets the requirements
outlined in section 1944(b)(1) and (2) of the Act, and to make
connections to that PDMP. Section 1944(f)(2) of the Act specifies that,
to qualify for the 100 percent federal matching rate, a state must have
in place agreements with all contiguous states that, when combined,
enable covered providers in all the contiguous states to access,
through the PDMP, all information described in 1944(b)(1) of the Act.
Section 5042(b) of the SUPPORT Act requires CMS, in consultation
with the Centers for Disease Control and Prevention (CDC), to issue
guidance not later than October 1, 2019 on best practices on the uses
of PDMPs required of prescribers and on protecting the
[[Page 40768]]
privacy of Medicaid beneficiary information maintained in and accessed
through PDMPs. Furthermore, section 5042(c) of the SUPPORT Act requires
that HHS develop and publish, not later than October 1, 2020, model
practices to assist State Medicaid program operations in identifying
and implementing strategies to utilize data-sharing agreements
described in section 1944(b) of the Act for the following purposes:
Monitoring and preventing fraud, waste, and abuse; and improving health
care for individuals enrolled in Medicaid who transition in and out of
Medicaid coverage, who may have sources of health care coverage in
addition to Medicaid coverage, or who pay for prescription drugs with
cash. We note that section 7162 of the SUPPORT Act also supports PDMP
integration as part of the CDC's grant programs aimed at efficiency and
enhancement by states, including improvement in the intrastate and
interstate interoperability of PDMPs.
In addition, the explanatory statement that accompanied Title II of
Division H of the Consolidated Appropriations Act, 2018 (Pub. L. 115-
141),\116\ encouraged the CDC to work with the ONC to enhance the
integration of PDMPs and EHRs. As part of this effort, the CDC and ONC
are collaborating to expand upon previous and leverage input from
current federal efforts to advance and scale PDMP integration with
health IT systems. This collaboration includes testing and refining
standard-based approaches to enable effective integration into clinical
workflows, exploring emerging technical solutions to enhance access and
use of PDMP data, providing technical resources to a variety of
stakeholders to advance and scale the interoperability of health IT
systems and PDMPs, and incorporating policy considerations, as
relevant, to inform the implementation and success of integration
approaches.
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\116\ https://www.govinfo.gov/content/pkg/CREC-2018-03-22/html/CREC-2018-03-22-pt3-PgH2697.htm.
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We understand that there is wide variation across the country in
how health care providers are implementing and integrating PDMP queries
into health IT and clinical workflows, and that it could be burdensome
for health care providers if we were to narrow the measure to allow
only a single workflow. At the same time, we have heard extensive
feedback from EHR developers that incorporating the ability to count
the number of PDMP queries in CEHRT would require more robust
certification specifications and standards. These stakeholders state
that health IT developers may face significant cost burdens under the
current flexibility allowed for health care providers if they fully
develop numerator and denominator calculations for all the potential
use cases and are required to change the specification at a later date.
Developers have indicated that the costs of additional development will
likely be passed on to health care providers without additional benefit
as this development would be solely for the purpose of calculating the
measure rather than furthering the clinical goal of the measure.
Given the stakeholder concerns discussed above regarding the lack
of integration, the recent enactment of the SUPPORT Act (in particular,
its provisions specific to Medicaid providers and qualified PDMPs), and
the activities funded by the CDC, we believe that additional time is
needed to evaluate the changing PDMP landscape prior to requiring a
Query of PDMP measure, or introducing requirements related to EHR-PDMP
integration.
Therefore, we are proposing to make the Query of PDMP measure
optional and eligible for 5 bonus points for the Electronic Prescribing
objective in CY 2020. Making the measure optional in CY 2020 would
allow time for further integration of PDMPs and EHRs to minimize the
burden on MIPS eligible clinicians reporting this measure while still
giving clinicians an opportunity to report on and earn points for the
measure. We are proposing that, in the event we finalize this proposal
for the Query of PDMP measure, the e-Prescribing measure would be worth
up to 10 points in CY 2020.
In addition, beginning with the 2019 performance period, we are
proposing to remove the numerator and denominator that we established
for the Query of PDMP measure in the CY 2019 PFS final rule (83 FR
59800 through 59803) and instead require a ``yes/no'' response. Under
this proposal, the measure description would remain the same (83 FR
59803), but instead of submitting numerator and denominator information
for the measure, MIPS eligible clinicians would submit a ``yes/no''
response. A ``yes'' response would indicate that for at least one
Schedule II opioid electronically prescribed using CEHRT during the
performance period, the MIPS eligible clinician used data from CEHRT to
conduct a query of a PDMP for prescription drug history, except where
prohibited and in accordance with applicable law. We are proposing this
change to give us more time to restructure the measure and develop a
robust measure that meets the needs of both health care providers and
other stakeholders. Because currently there are not standards-based
interfaces between CEHRT and PDMPs, health care providers must manually
track the number of times that they query a PDMP outside of CEHRT. We
are proposing this change to reduce the burden on health care providers
of having to manually keep track of information related to the measure
and to mitigate the burden on health IT developers who would otherwise
have to develop the measure's numerator and denominator calculations
when we expect to propose changes to the measure in the near future.
Therefore, health care providers and health IT developers have
suggested that, given the current state, there would be a significant
reduction in burden by allowing health care providers to satisfy the
measure by submitting a ``yes/no'' response, rather than reporting a
numerator and denominator. In addition, for the 2019 performance
period, the Query of PDMP measure is not scored based on a clinician's
performance as determined by a numerator and denominator; instead, it
is an optional measure that is eligible for a full five bonus points
regardless of how a clinician performs (83 FR 59794 through 59795).
Thus, because the measure is not scored based on performance, requiring
a ``yes/no'' response instead of a numerator and denominator would not
affect the potential number of points that a clinician could earn by
reporting on the measure.
We do not believe that these changes would result in additional
costs (time or money) for health care providers, and instead would
reduce the burden of manually tracking information needed to report on
this measure in its current form. For CY 2019, we did not provide
exclusions for the Query of PDMP and Verify Opioid Treatment Agreement
measures because they were optional and eligible for bonus points, and
similarly, we do not believe exclusions would be necessary for the
Query of PDMP measure if we finalize our proposal to make the measure
optional and eligible for bonus points in CY 2020.
We also welcome comments on future timing for requiring a measure
that includes EHR-PDMP integration and on the value of the measure for
advancing the effective prevention and treatment of opioid use disorder
especially in relation to the requirements of the SUPPORT Act described
above.
We also note that some stakeholders have requested that we define a
value set for controlled substances for the opioid-related measures,
Query of
[[Page 40769]]
PDMP and Verify Opioid Treatment Agreement. In the CY 2019 PFS final
rule (83 FR 59803), for the Query of PDMP and Verify Opioid Treatment
Agreement measures, we defined opioids as Schedule II controlled
substances under 21 CFR 1308.12. We recognize that some challenges
remain related to electronic prescribing of controlled substances,
including more restrictive state laws and lack of products both for
health care providers and pharmacies that include the necessary
functionalities. We anticipate working closely with the Drug
Enforcement Administration (DEA) on future technical requirements that
can better support measurement of adoption and use of electronic
prescribing of controlled substances, which may include the definition
of a value set related to such measures. As more information on
developing technical requirements becomes available, we will provide
additional information.
As we seek comment and continue to advance this measure, we are
excited about future innovations that may help improve PDMPs and
support the electronic prescribing of controlled substances. We
envision a future state where PDMP data is integrated into the clinical
workflow and where clinicians do not have to access multiple systems to
find and reconcile the information. While we may have a long distance
to go to get to this state, we believe that it is an achievable goal
for the future of the Promoting Interoperability performance category.
We are inviting comments on these proposals.
(C) Verify Opioid Treatment Agreement Measure
In the CY 2019 PFS final rule (83 FR 59803 through 59806), we
finalized the Verify Opioid Treatment Agreement measure as optional in
both CYs 2019 and 2020. Since we proposed this measure, we have
received feedback from stakeholders that this measure has presented
significant implementation challenges and an increase in burden, and
does not further interoperability. Below, we outline some of the
ongoing concerns we heard since the measure was finalized in the CY
2019 PFS final rule (83 FR 59803 through 59806).
(aa) Lack of Certification Standards and Criteria
Stakeholders have continually expressed concern regarding the lack
of defined data elements, structure, standards and criteria for the
electronic exchange of opioid treatment agreements and how this impacts
verifying whether there is an opioid treatment agreement to meet this
measure. We acknowledged these concerns in the CY 2019 PFS final rule
(83 FR 59803 through 59806).
In the CY 2019 PFS final rule (83 FR 59803 through 59806), we
stated that there are a number of ways that certified health IT may be
able to support the electronic exchange of opioid abuse-related
treatment data such as the care plan template within the Consolidated-
Clinical Document Architecture (C-CDA). We stated this information
could be considered as part of an opioid treatment agreement, even
though we did not define the elements of one. However, we understand
that while such standards may include relevant information, the lack of
clarity around a specific standard to support incorporation of an
opioid treatment agreement presents an additional source of burden to
clinicians seeking to report on the measure.
(bb) Calculating 30 Cumulative Day Look-Back Period
Another area where stakeholders have expressed concern is how to
calculate 30 cumulative days of opioid prescriptions in a 6-month
period. One possible solution we offered was to utilize the NCPDP 10.6
Medication History query. In the CY 2019 PFS final rule (83 FR 59803
through 59806), we noted that the Medication History query does not
contain a discrete field for prescription days and relies on third
party data that may not be discrete. Since the CY 2019 PFS final rule
was published, stakeholders have continued to express this concern and
impress upon us that the 30-cumulative day total in a 6-month look-back
period cannot be automatically calculated, requiring health care
providers to engage in a burdensome, manual calculation process if they
wish to report on this measure.
In addition, we have heard concerns over which medications should
be used to determine the 30-cumulative day threshold. For example,
stakeholders were unsure if medications given while a patient is
admitted to the hospital should count towards the 30 cumulative days
and also how as needed, or PRN, medications should be addressed.
Stakeholders have also indicated that this measure could present
timing challenges. For example, it may cause patients being discharged
on opioids to be delayed in their discharge to account for the possible
time-consuming nature of having to search for an opioid treatment
agreement.
(cc) Unintended Burden Caused by Flexibility
In the CY 2019 PFS final rule (83 FR 59803 through 59806), we chose
not to define what constitutes an opioid treatment agreement. While we
believed that this would allow flexibility for health care providers to
determine which elements they believed were most important to an opioid
treatment agreement, we have heard from stakeholders that the lack of
definition and standards around what would constitute an opioid
treatment agreement has created an unintended burden. Specifically,
some stakeholders indicated that we should define an opioid treatment
agreement so that MIPS eligible clinicians would have a standardized
definition of an opioid treatment agreement and the criteria to make up
an opioid treatment agreement. However, other stakeholders indicated
that given the lack of consensus within the industry on what should or
should not be included in an opioid treatment agreement and on the
clinical efficacy of various options for such agreements, that it would
be inappropriate for us to define what should constitute an opioid
treatment agreement at this time.
We have heard from stakeholders that the challenges described above
result in a measure that is vague, burdensome to measure and does not
necessarily offer a clinical value to the health care providers or
support the clinical goal of supporting OUD treatment. Therefore, we
are proposing to remove the Verify Opioid Treatment Agreement measure
from the Promoting Interoperability performance category beginning with
the performance period in CY 2020.
While we are proposing to remove the Verify Opioid Treatment
Agreement measure, we believe there may be other opioid measures that
would be more effective in combatting the opioid epidemic, offer value
for health care providers in measuring the impacts of health IT-enabled
resources on OUD prevention and treatment, and engage patients in care
coordination and planning. We are seeking public comment on a series of
question in requests for information regarding new opioid measures in
section III.K.3.c(4)(d)(i) of this proposed rule.
We invite comments on this proposal.
(ii) Health Information Exchange Objective
There are two measures under the Health Information Exchange
objective: The Support Electronic Referral Loops by Sending Health
Information measure and the Support Electronic Referral Loops by
Receiving and Incorporating
[[Page 40770]]
Health Information Measure. We are proposing minor modifications to
both measures.
(A) Proposed Modification of the Support Electronic Referral Loops by
Sending Health Information Measure
In the CY 2019 PFS final rule (83 FR 59807 through 59808), we
renamed the Send a Summary of Care measure to the Support Electronic
Referral Loops by Sending Health Information measure. Although an
exclusion is available for this measure (83 FR 59808), we acknowledged
that we did not address in the CY 2019 PFS proposed rule how the points
for the measure would be redistributed in the event the exclusion is
claimed, and stated that we intended to propose a redistribution policy
in next year's rulemaking (83 FR 59795). Accordingly, we are proposing
to redistribute the points for the Support Electronic Referral Loops by
Sending Health Information measure to the Provide Patients Access to
Their Health Information measure if an exclusion is claimed. We have
chosen to redistribute the points to the Provide Patients Access to
Their Health Information measure because we believe that many MIPS
eligible clinicians may be eligible to claim exclusions for both
measures under the Health Information Exchange objective. Under our
existing policy (83 FR 59788), if an exclusion is claimed for the
Support Electronic Referral Loops by Receiving and Incorporating Health
Information measure, the 20 points associated with it will be
redistributed to the Support Electronic Referral Loops by Sending
Health Information measure. Under our proposal, if exclusions are
claimed for both the Support Electronic Referral Loops by Receiving and
Incorporating Health Information measure and the Support Electronic
Referral Loops by Sending Health Information measure, the 40 points
associated with these measures would be redistributed to the Provide
Patients Access to Their Health Information measure. We are proposing
that this redistribution policy would be applicable beginning with the
2019 performance period/2021 MIPS payment year.
We invite comments on this proposal.
(B) Modification of the Support Electronic Referral Loops by Receiving
and Incorporating Health Information Measure
In the CY 2019 PFS final rule (83 FR 59808 through 59812), we
replaced the Request/Accept Summary of Care measure and the Clinical
Information Reconciliation measure with a new measure called the
Support Electronic Referral Loops by Receiving and Incorporating Health
Information measure. We established the following exclusion for the new
measure: Any MIPS eligible clinician who receives fewer than 100
transitions of care or referrals or has fewer than 100 encounters with
patients never before encountered during the performance period would
be excluded from this measure (83 FR 59812). We are proposing to revise
this description of the exclusion to more clearly and precisely capture
our intended policy. The Request/Accept Summary of Care measure, which
as noted previously was replaced by the new Support Electronic Referral
Loops by Receiving and Incorporating Health Information measure,
included the following exclusion: Any MIPS eligible clinician who
receives transitions of care or referrals or has patient encounters in
which the MIPS eligible clinician has never before encountered the
patient fewer than 100 times during the performance period (83 FR
59798, 82 FR 53679 through 53680). Our intention was to use that same
exclusion from the Request/Accept Summary of Care measure for the new
Support Electronic Referral Loops by Receiving and Incorporating Health
Information measure. Instead, the description of the exclusion that we
included in the CY 2019 PFS final rule (83 FR 59812) did not precisely
track the description of the Request/Accept Summary of Care measure
exclusion, and could be construed in a way that would make the
exclusion more difficult for a MIPS eligible clinician to meet.
Specifically, it could be read to create two different sets of
exclusion criteria: Receiving fewer than 100 transitions of care or
referrals; or having fewer than 100 encounters with patients never
before encountered. This was not our intention. Rather, as with the
Request/Accept Summary of Care measure exclusion, our intention was
that a combination of the two criteria must occur fewer than 100 times
during the performance period for the exclusion to be applicable to a
MIPS eligible clinician. Thus, we are proposing to revise the
description of the Support Electronic Referral Loops by Receiving and
Incorporating Health Information measure exclusion to track the
description of the Request/Accept Summary of Care measure exclusion (83
FR 59798, 82 FR 53679 through 53680): Any MIPS eligible clinician who
receives transitions of care or referrals or has patient encounters in
which the MIPS eligible clinician has never before encountered the
patient fewer than 100 times during the performance period. For
example, during the performance period, if a MIPS eligible clinician
received 50 transitions of care, 50 referrals, and 50 patient
encounters in which they have never before encountered the patient, the
total sum of 150 would be above the threshold of fewer than 100 times,
and therefore the MIPS eligible clinician would not be eligible for
this exclusion. We are proposing that the revised description of the
exclusion would be applicable beginning with the 2019 performance
period/2021 MIPS payment year.
For ease of reference, Table 41 lists the objectives and measures
for the Promoting Interoperability performance category for the 2020
performance period as revised to reflect the proposals made in this
proposed rule. For more information on the 2015 Edition certification
criteria required to meet the objectives and measures, we refer readers
to Table 43 in the CY 2019 PFS final rule (83 FR 59817).
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(e) Scoring Methodology
(i) Proposed Changes to the Scoring Methodology for the 2020
Performance Period
In the CY 2019 PFS final rule (83 FR 59785 through 59796), we
finalized a new performance-based scoring methodology for the Promoting
Interoperability performance category beginning with the performance
period in 2019. As previously discussed in section III.K.3.c.(4)(d)(i)
of this proposed rule, we are proposing to: (1) Make the Query of PDMP
measure optional and eligible for five bonus points in CY 2020; (2)
make the e-Prescribing measure worth up to 10 points in CY 2020, in the
event we finalize the proposal for the Query of PDMP measure; and (3)
remove the Verify Opioid Treatment Agreement measure beginning in 2020.
Table 42 reflects these proposals, although the maximum points
available do not include points that would be redistributed in the
event that an exclusion is claimed.
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[[Page 40776]]
(f) Additional Considerations
(i) Nurse Practitioners, Physician Assistants, Clinical Nurse
Specialists, and Certified Registered Nurse Anesthetists
In prior rulemaking (83 FR 59818 through 59819), we discussed our
belief that certain types of MIPS eligible clinicians (NPs, PAs, CNSs,
and CRNAs) may lack experience with the adoption and use of CEHRT.
Because many of these non-physician clinicians were or are not eligible
to participate in the Medicare or Medicaid EHR Incentive Program (now
known as the Promoting Interoperability Program), we stated that we
have little evidence as to whether there are sufficient measures
applicable and available to these types of MIPS eligible clinicians
under the advancing care information (now known as Promoting
Interoperability) performance category. We established a policy at
Sec. 414.1380(c)(2)(i)(A)(5) for the performance periods in 2017,
2018, and 2019 under section 1848(q)(5)(F) of the Act to assign a
weight of zero to the Promoting Interoperability performance category
in the MIPS final score if there are not sufficient measures applicable
and available to NPs, PAs, CRNAs, and CNSs. We will assign a weight of
zero only in the event that an NP, PA, CRNA, or CNS does not submit any
data for any of the measures specified for the Promoting
Interoperability performance category, but if they choose to report,
they will be scored on the Promoting Interoperability performance
category like all other MIPS eligible clinicians and the performance
category will be given the weighting prescribed by section
1848(q)(5)(E) of the Act. We stated our intention to use data from the
first performance period (2017) to further evaluate the participation
of these MIPS eligible clinicians in the Promoting Interoperability
performance category and consider for subsequent years whether the
measures specified for this category are applicable and available to
these MIPS eligible clinicians.
We have analyzed the data submitted for the 2017 performance period
for the Promoting Interoperability performance category, and have
discovered that the vast majority of MIPS eligible clinicians submitted
data as part of a group. While we are pleased that MIPS eligible
clinicians utilized the option to submit data as a group, it does limit
our ability to analyze data at the individual NPI level. For example,
when a group of MIPS eligible clinicians chooses to report for MIPS as
a group, the data submitted are representative of that entire group, as
opposed to each individual MIPS eligible clinician in the group
submitting data that exclusively reflect his/her own performance.
Approximately 4 percent of MIPS eligible clinicians who are NPs, PAs,
CRNAs, or CNSs submitted data individually for MIPS, and more than two-
thirds of them did not submit data for the Promoting Interoperability
performance category. Additionally, we are challenged because many of
the measures that were available for submission for the 2017
performance period are now unavailable, due to our discontinuation of
the Promoting Interoperability transition measure set, and the overhaul
of the performance category that further reduced the number of
available measures. For these reasons, we are unable to determine, at
this time, whether the measures currently specified for the Promoting
Interoperability performance category for the 2020 performance period
are applicable and available for NPs, PAs, CRNAs, and CNSs. However, as
more data beyond this first year become available, we plan to
reevaluate the measures and consider how we could ensure that there are
sufficient measures applicable and available for these types of MIPS
eligible clinicians.
Thus, we are proposing to continue the existing policy of
reweighting the Promoting Interoperability performance category for
NPs, PAs, CRNAs, and CNSs for the performance period in 2020, and to
revise Sec. 414.1380(c)(2)(i)(A)(5) to reflect this proposal. We are
requesting public comments on this proposal.
(ii) Physical Therapists, Occupational Therapists, Qualified Speech-
Language Pathologist, Qualified Audiologists, Clinical Psychologists,
and Registered Dieticians or Nutrition Professionals
In the CY 2019 PFS final rule (83 FR 59819 through 59820), we
adopted a policy at Sec. 414.1380(c)(2)(i)(A)(4) to apply the same
policy we adopted for NPs, PAs, CNSs, and CRNAs for the performance
periods in 2017-2019 to these new types of MIPS eligible clinicians
(physical therapists, occupational therapists, qualified speech-
language pathologist, qualified audiologists, clinical psychologists,
and registered dieticians or nutrition professionals) for the
performance period in 2019. Because many of these clinician types were
or are not eligible to participate in the Medicare or Medicaid
Promoting Interoperability Program, we have little evidence as to
whether there are sufficient measures applicable and available to them
under the Promoting Interoperability performance category.
For the reasons discussed in section III.K.3.c.(4)(f)(i), for the
performance period in 2020, we are proposing to continue the existing
policy of reweighting the Promoting Interoperability performance
category for physical therapists, occupational therapists, qualified
speech-language pathologist, qualified audiologists, clinical
psychologists, and registered dieticians or nutrition professionals,
and to revise Sec. 414.1380(c)(2)(i)(A)(4) to reflect this proposal.
We invite comments on this proposal.
(iii) Hospital-Based MIPS Eligible Clinicians in Groups
We define a hospital-based MIPS eligible clinician under Sec.
414.1305 as a MIPS eligible clinician who furnishes 75 percent or more
of his or her covered professional services in sites of services
identified by the Place of Service (POS) codes used in the HIPAA
standard transaction as an inpatient hospital (POS 21), on campus
outpatient hospital (POS 22), off campus outpatient hospital (POS 19),
or emergency room (POS 23) setting, based on claims for the MIPS
determination period (81 FR 77238 through 77240, 82 FR 53686 through
53687, 83 FR 59727 through 59730). We established under Sec.
414.1380(c)(2)(i)(C)(6) that a MIPS eligible clinician who is a
hospital-based MIPS eligible clinician as defined in Sec. 414.1305
will be assigned a zero percent weight for the Promoting
Interoperability performance category, and the points associated with
the Promoting Interoperability performance category will be
redistributed to another performance category or categories (81 FR
77238 through 77240, 82 FR 53684, 83 FR 59871). However, if a hospital-
based MIPS eligible clinician chooses to report on the Promoting
Interoperability performance category measures, they will be scored on
the Promoting Interoperability performance category like all other MIPS
eligible clinicians, and the performance category will be given the
weighting prescribed by section 1848(q)(5)(E) of the Act regardless of
their Promoting Interoperability performance category score. We stated
that this policy includes MIPS eligible clinicians choosing to report
as part of a group or part of a virtual group (82 FR 53687).
Under Sec. 414.1310(e)(2)(ii), individual eligible clinicians that
elect to participate in MIPS as a group must aggregate their
performance data across the group's TIN (81 FR 77058). For groups
reporting on the Promoting Interoperability performance category,
[[Page 40777]]
we stated that group data should be aggregated for all MIPS eligible
clinicians within the group (81 FR 77214 through 77216, 82 FR 53687).
We stated that this includes those MIPS eligible clinicians who may
qualify for a zero percent weighting of the Promoting Interoperability
performance category due to circumstances such as a significant
hardship or other type of exception, hospital-based or ASC-based
status, or certain types of non-physician practitioners (82 FR 53687).
We established at Sec. 414.1380(c)(2)(iii) that for MIPS eligible
clinicians submitting data as a group or virtual group, in order for
the Promoting Interoperability performance category to be reweighted,
all of the MIPS eligible clinicians in the group or virtual group must
qualify for reweighting (82 FR 53687, 83 FR 59871). We have heard from
several stakeholders that our policy for groups that include hospital-
based MIPS eligible clinicians sets a threshold that is too restrictive
for a variety of reasons. Some stated that due to high turnover rates
for hospital medicine groups, many such groups rely on locum tenens
clinicians who may practice in multiple settings. They stated that if a
hospital medicine group includes only one MIPS eligible clinician who
does not meet the definition of a hospital-based MIPS eligible
clinician, it could prevent the group from qualifying for reweighting
because not all of the MIPS eligible clinicians in the group would be
considered hospital-based. A few acknowledged that while hardship
exceptions are available for MIPS eligible clinicians who lack control
over CEHRT because they use the hospital's CEHRT, it is an
administrative burden to have to submit a hardship exception
application, especially if the clinician has a locum tenens
relationship. We agree that hospital medicine groups may face unique
circumstances due to the nature of their practice area and the staffing
practices described by stakeholders. Thus, we are proposing to revise
the definition of a hospital-based MIPS eligible clinician under Sec.
414.1305 to include groups and virtual groups. We are proposing that,
beginning with the 2022 MIPS payment year, a hospital-based MIPS
eligible clinician under Sec. 414.1305 means an individual MIPS
eligible clinician who furnishes 75 percent or more of his or her
covered professional services in sites of service identified by the POS
codes used in the HIPAA standard transaction as an inpatient hospital,
on-campus outpatient hospital, off campus outpatient hospital, or
emergency room setting based on claims for the MIPS determination
period, and a group or virtual group provided that more than 75 percent
of the NPIs billing under the group's TIN or virtual group's TINs, as
applicable, meet the definition of a hospital-based individual MIPS
eligible clinician during the MIPS determination period. We believe a
threshold of more than 75 percent is appropriate because it is
consistent with the thresholds for groups in the definitions of
facility-based MIPS eligible clinician and non-patient facing MIPS
eligible clinician under Sec. 414.1305. We are proposing to revise
Sec. 414.1380(c)(2)(iii) to specify that for the Promoting
Interoperability performance category to be reweighted for a MIPS
eligible clinician who elects to participate in MIPS as part of a group
or virtual group, all of the MIPS eligible clinicians in the group or
virtual group must qualify for reweighting, or the group or virtual
group must meet the proposed revised definition of a hospital-based
MIPS eligible clinician (or the definition of a non-patient facing MIPS
eligible clinician, as proposed in section III.K.3.c.(4)(f)(iv), as
defined in Sec. 414.1305.
(iv) Non-Patient Facing MIPS Eligible Clinicians in Groups
We define a non-patient facing MIPS eligible clinician under Sec.
414.1305 as an individual MIPS eligible clinician who bills 100 or
fewer patient facing encounters (including Medicare telehealth services
defined in section 1834(m) of the Act), as described in paragraph (3)
of this definition, during the MIPS determination period, and a group
or virtual group provided that more than 75 percent of the NPIs billing
under the group's TIN or virtual group's TINs, as applicable, meet the
definition of a non-patient facing individual MIPS eligible clinician.
We established under Sec. 414.1380(c)(2)(i)(C)(5) that a MIPS eligible
clinician who is a non-patient facing MIPS eligible clinician as
defined in Sec. 414.1305 will be assigned a zero percent weight for
the Promoting Interoperability performance category, and the points
associated with the Promoting Interoperability performance category
will be redistributed to another performance category or categories (81
FR 77240 through 77243, 82 FR 53680-53682, 83 FR 59871). However, if a
non-patient facing MIPS eligible clinician chooses to report on the
Promoting Interoperability performance category measures, they will be
scored on the Promoting Interoperability performance category like all
other MIPS eligible clinicians, and the performance category will be
given the weighting prescribed by section 1848(q)(5)(E) of the Act
regardless of their Promoting Interoperability performance category
score. We stated that this policy includes MIPS eligible clinicians
choosing to report as part of a group or part of a virtual group (82 FR
53687).
As noted in section III.K.3.c.(4)(f)(iii) of the proposed rule in
connection with our discussion of hospital-based MIPS eligible
clinicians in groups, under Sec. 414.1380(c)(2)(iii), for MIPS
eligible clinicians submitting data as a group or virtual group, in
order for the Promoting Interoperability performance category to be
reweighted, all of the MIPS eligible clinicians in the group or virtual
group must qualify for reweighting. In that section, we are proposing
to revise Sec. 414.1380(c)(2)(iii) to account for groups and virtual
groups that meet the proposed revised definition of a hospital-based
MIPS eligible clinician under Sec. 414.1305, which would only require
the group or virtual group to meet a threshold of more than 75 percent
instead of a threshold of all of the MIPS eligible clinicians in the
group or virtual group. In an effort to more clearly and concisely
capture our existing policy for non-patient facing MIPS eligible
clinicians, we are proposing to revise Sec. 414.1380(c)(2)(iii) to
also account for a group or virtual group that meets the definition of
a non-patient facing MIPS eligible clinician under Sec. 414.1305, such
that the group or virtual group only has to meet a threshold of more
than 75 percent.
(g) Future Direction of the Promoting Interoperability Performance
Category
(i) Request for Information (RFI) on Potential Opioid Measures for
Future Inclusion in the Promoting Interoperability Performance Category
In the past, the Promoting Interoperability performance category
measures focused on very general process focused actions supported by
health IT. In the Medicare and Medicaid Programs; Electronic Health
Record Incentive Program--Stage 3 and Modifications to Meaningful Use
in 2015 through 2017 final rule (80 FR 62766 through 62768), we sought
to expand the potential for Medicare and Medicaid Promoting
Interoperability Program measures to include more complex measures and
closer relationships to high priority health outcomes.
In this RFI, we are seeking comment on Promoting Interoperability
performance category measures that might be relevant to specific
clinical priorities or goals related to addressing OUD prevention and
treatment. As the Query of PDMP measure matures, we believe it will be
essential in improving
[[Page 40778]]
prescribing practices. As outlined in section III.K.3.c.(4)(d).(i) of
this proposed rule, stakeholders indicated that the Verify Opioid
Treatment Agreement measure presented significant implementation
challenges for MIPS eligible clinicians. Therefore, we are seeking
comment on potential new measures for OUD prevention and treatment that
could be included in future years of the Promoting Interoperability
performance category. We welcome all comments, but we are seeking
comment specifically on possible OUD prevention and treatment measures
that include the following characteristics:
Include evidence of positive impact on outcome-focused
improvement activities, and the opioid crisis overall;
Leverage the capabilities of CEHRT where possible,
including: near-automatic calculation and reporting of numerator,
denominator, exclusions and exceptions to minimize manual documentation
required of the provider; and timing elements to reduce quality
measurement and reporting burdens to the greatest extent possible;
Are based on well-defined clinical concepts, measure logic
and timing elements that can be captured by CEHRT in standard clinical
workflow and/or routine business operations. Well-defined clinical
concepts include those that can be discretely represented by available
clinical and/or claims vocabularies such as SNOMED CT, LOINC, RxNorm,
ICD-10 or CPT;
Align with clinical workflows in such a way that data used
in the calculation of the measure is collected as part of a standard
workflow and does not require any additional steps or actions by the
health care provider;
Are applicable to all clinicians (for example, clinicians
participating as individuals or as a group, or clinicians located in a
rural area, designated health professional shortage area (HPSA),
designated medically-underserved area (MUA), or urban area);
Could potentially align with other MIPS performance
categories; and
Are represented by a measure description, numerator/
denominator or yes/no attestation statement, and possible exclusions.
(ii) Request for Information (RFI) on NQF and CDC Opioid Quality
Measures
We also are specifically seeking public comment on the development
of potential measures for consideration for the Promoting
Interoperability performance category that are based on existing
efforts to measure clinical and process improvements specifically
related to the opioid epidemic, including the opioid quality measures
endorsed by the National Quality Forum (NQF) and the CDC Quality
Improvement (QI) opioid measures discussed below. The NQF measures
represent a reference point for evaluating opioid prescribing behaviors
based on measures that have undergone the rigorous NQF measure
endorsement process. The CDC guidelines ``encourage careful and
selective use of opioid therapy in the context of managing chronic pain
through . . . an evidence-based prescribing guideline.'' \117\ The
guidelines have led to the development of CDC measures on prescribing
practices on which we are seeking comment. We believe these measures
may help participants understand the relationship between the measure
description and the use of health IT to support the actions of the
measures.
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\117\ https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf.
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For example, the measures may describe a clinical concept, such as
the CDC Measure 12: Counsel on Risks and Benefits Annually. The actions
for this activity can be supported by CEHRT through the use of
standards to record key health information for the patient and to
identify which patients should be included in the denominator based on
information in the medication list, information gained through
medication reconciliation of data received through health information
exchange with another health provider of care, and/or information
incorporated after a query of a PDMP is completed. The actions for the
numerator could include leveraging CEHRT to provide patient-specific
education, to capture or record Patient Generated Health Data (PGHD),
to engage in secure messaging with the patient and ensure the patient
is engaging with their record through a patient portal or an
Application Programming Interface (API).
We believe that the clinical actions identified within both the NQF
quality measures and the CDC QI opioid measures, can be supported by
the standards and functionalities of certified health IT and we welcome
public comment on the specific use cases for health IT implementation
for the potential measure actions. We recognize that modifications to
the NQF and CDC measures may be necessary to make the measures as
applicable as possible to all participants of the Promoting
Interoperability performance category, and are seeking comment on any
modifications that would be necessary. In addition, we note that there
is some overlap between some of the NQF quality measures and the CDC QI
opioid measures and are seeking comment on whether there are ways in
which the two sets of measures could be correlated to support potential
new measures of the meaningful use of health IT for the Promoting
Interoperability performance category. Finally, we are seeking comment
on which measures might best advance the implementation and use of
interoperable health IT and encourage information exchange between care
teams and with patients.
(A) NQF Quality Measures
Three NQF-endorsed quality measures that were stewarded by the
Pharmacy Quality Alliance (PQA) evaluate patients with prescriptions
for opioids in combination with benzodiazepines, at high-dosage, or
from multiple prescribers and pharmacies. Each measure was evaluated
and recommended for endorsement by the NQF's Patient Safety Standing
Committee \118\ and endorsed by the Consensus Standards Approval
Committee. These measures, NQF #2940, #2950, and #2951, were
recommended by the NQF Measure Application Partnership for inclusion on
the December 2018 Measures Under Consideration List for the Medicare
Shared Savings Program.
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\118\ https://www.qualityforum.org/News_And_Resources/Press_Releases/2017/NQF_Statement_on_Endorsement_of_Opioid_Patient_Safety_Measures.aspx.
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We are seeking public comment on the development of potential
measures for consideration for the Promoting Interoperability
performance category that are based on existing efforts to measure
clinical and process improvements specifically related to the opioid
epidemic, including the opioid quality measures endorsed by the NQF
above and the CDC QI opioid measures discussed below. The NQF measures
represent a reference point for evaluating opioid prescribing behaviors
based on measures that have undergone the rigorous NQF measure
endorsement process. The CDC guidelines ``encourage careful and
selective use of opioid therapy in the context of managing chronic pain
through . . . an evidence-based prescribing guideline.'' \119\ The
guidelines have led to the development of CDC measures on prescribing
practices on which are seeking comment. We are seeking comment on the
following three NQF measures for possible inclusion in the Promoting
Interoperability performance category and any modifications that may be
[[Page 40779]]
necessary to maximize their use in the Promoting Interoperability
performance category:
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\119\ https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf.
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Use of Opioids at High Dosage in Persons Without Cancer
(NQF #2940).
Use of Opioids from Multiple Providers in Persons Without
Cancer (NQF #2950).
Use of Opioids from Multiple Providers and at High Dosage
in Persons Without Cancer (NQF #2951).
We believe these measures relate to activities that hold promise in
combatting the opioid epidemic and can be supported using CEHRT to
complete the actions of the measures. Therefore, we are seeking comment
on how the Promoting Interoperability performance category can
incorporate the description of the use of technology into measure
guidance if these measures were considered for use by MIPS eligible
clinicians. For example, the actions related to the Use of Opioids from
Multiple Providers in Persons Without Cancer (NQF #2950) measure could
include using health IT to electronically prescribe the medication, to
query a PDMP, to identify other care team members, to conduct
medication reconciliation based on information received through health
information exchange with other providers of care, and recording key
health information in a structured format. Additional information
regarding each measure is available using NQF's Quality Positioning
System at http://www.qualityforum.org/QPS/QPSTool.aspx.
(B) CDC Quality Improvement Opioid Measures
We believe there may be promise in the CDC QI opioid measures based
on the prescribing best practices found in Appendix B in the CDC
document, ``Quality Improvement and Care Coordination: Implementing the
CDC Guideline for Prescribing Opioids for Chronic Pain'' (Implementing
the CDC Prescribing Guideline).\120\ CDC developed the ``Implementing
the CDC Prescribing Guideline'' document to help healthcare providers
and systems integrate the CDC Prescribing Guideline \121\ and the
associated QI opioid measures found in the Implementing the CDC
Prescribing Guideline document into their clinical practices. The CDC
developed 16 QI opioid measures to align with the recommendations in
the CDC Prescribing Guideline and to improve opioid prescribing. These
measures are intended to measure implementation of the recommended
practices.
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\120\ https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf.
\121\ https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.
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Generally, we believe these guidelines and measures are consistent
with the objective and measure concept of the Promoting
Interoperability performance category where the recommendation in the
CDC Prescribing Guideline is the overarching objective and an
associated QI opioid measure is a description of the patient population
focus (denominator) and the desired action (numerator). The
``Implementing the CDC Prescribing Guideline'' document, also, includes
practice-level strategies to help organize and improve the management
and coordination of long-term opioid therapy:
Using an interdisciplinary team approach.
Establishing practice policies and standards.
Using EHR data to develop registries and track QI opioid
measures.
These following measures address treatment guidelines for initial
treatment practices and long-term treatment and outcomes. Examples of
measures related to short term OUD prevention and treatment activities
include:
CDC Measure 2: Check PDMP Before Prescribing Opioids.
CDC Measure 4: Evaluate Within Four Weeks of Starting
Opioids.
Examples of measures related to long term OUD prevention and
treatment activities include:
CDC Measure 11: Check PDMP Quarterly.
CDC Measure 12: Counsel On Risks and Benefits Annually.
The data sources from these measures include State PDMP data or the
practice EHR data field.
The CDC and the Agency for Healthcare Research and Quality (AHRQ)
are also developing electronic clinical decision support tools that can
provide real-time clinical decision support for some of the best
practices included in the Implementing the CDC Prescribing Guideline
document based on well-defined clinical concepts.\122\ Well-defined
clinical concepts are those that can be discretely represented by
available content standards or vocabularies such as SNOMED CT or LOINC.
In the context of QI measures, these well-defined clinical concepts
that are part of the clinical decision support artifacts, including the
clinical conditions or prescribed medications that trigger the decision
support, could also be used to develop measures for the Promoting
Interoperability performance category related to OUD prevention and
treatment. This can create a tight linkage between the guidelines, the
recommended clinical actions based on the guidelines, and the improved
outcomes based on the recommended clinical actions.
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\122\ https://cds.ahrq.gov/cdsconnect/topic/opioids-and-pain-management.
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Therefore, we are seeking comment on which of the 16 CDC QI opioid
measures have value for potential consideration for the Promoting
Interoperability performance category. We are further seeking comment
on whether we should consider a different type of measurement concept
for OUD prevention and treatment, such as reporting on a set of cross-
cutting activities and measures to earn credit in the Promoting
Interoperability performance category (for example, a set of one
clinical decision support, the related CDC QI opioid measure, and a
potentially relevant clinical quality measure). While the CDC quality
measures could be implemented for the Quality category, they are
highlighted as under consideration for the PI category as they have
been linked in the CDC work to the use of CDS artifacts through health
IT, as discussed.
We refer readers to the ``Implementing the CDC Prescribing
Guideline'' document, and the related measures, in Appendix B of that
document, which is available at https://www.cdc.gov/drugoverdose/pdf/prescribing/CDC-DUIP-QualityImprovementAndCareCoordination-508.pdf.
(iii) Request for Information (RFI) on a Metric To Improve Efficiency
of Providers Within EHRs
One of the benefits of adopting EHRs is increasing the efficiency
of health care processes and generating cost savings by eliminating
time-consuming paper-based processes. Through the use of EHRs, health
care providers are able to automate administrative aspects of delivery
system management, such as coding and scheduling, easily locate patient
information in electronic charts, and streamline communications with
other health care providers through electronic means.
However, research, also, points to variable results from the
implementation of health IT across practice settings, suggesting that
health IT adoption is not a universal remedy for inefficient practice.
Stakeholders continue to describe ways in which the potential benefits
of EHRs have not been fully realized, and are pointing to non-optimized
electronic workflows and poor system design that can increase, rather
than reduce, administrative burden, which contributes to physician
[[Page 40780]]
burnout.\123\ For instance, in many systems, stakeholders have
identified EHR functionality associated with clinical documentation,
order entry, and messaging as cumbersome. It is our understanding that
in order to achieve true EHR efficiency gains in today's healthcare
environment, the way forward must include reductions in the persistent
sources of technology-related burden, an increased allowance for
ancillary medical staff to assist in medical documentation, and through
the more effective use of technology.
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\123\ https://www.ahrq.gov/professionals/clinicians-providers/ahrq-works/burnout/index.html.
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In November 2018, the Office of the National Coordinator for Health
Information Technology (ONC) released the draft report ``Strategy on
Reducing Regulatory and Administrative Burden Relating to the Use of
Health IT and EHRs,'' \124\ as required by section 4001 of the 21st
Century Cures Act (Pub. L. 114-255, enacted December 13, 2016). In the
draft report, ONC described a variety of factors that may contribute to
EHR-related burden, and provided draft recommendations for how HHS, as
well as other stakeholders may be able to address these factors.
Specifically, the draft report discussed processes where adoption of
improved electronic processes could reduce the EHR-related burden, such
as processes related to prior authorization requests. The draft report,
also, discussed EHR usability and design challenges which may
contribute to EHR-related burden, and identified best practices for
design, as well as a variety of emerging system features which may
improve efficiency in health IT usage. We believe further adoption of
more efficient workflows and technologies, such as those identified in
the draft report, will help health care providers with overall
improvements in patient care and interoperability, and we are seeking
comment on how such implementation of such processes can be effectively
measured and encouraged as part of the Promoting Interoperability
performance category.
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\124\ https://www.healthit.gov/sites/default/files/page/2018-11/Draft%20Strategy%20on%20Reducing%20Regulatory%20and%20Administrative%20Burden%20Relating.pdf.
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We also are interested in how to measure and incentivize efficiency
as it relates to the meaningful use of CEHRT and the furthering of
interoperability. In 2017, the NQF released, ``A Measurement Framework
to Assess Nationwide Progress Related to Interoperable Health
Information Exchange to Support the National Quality Strategy,'' \125\
which included discussion of measure concepts of productivity and
efficiency that can result from the use of health IT, specifically the
health information exchange. For instance, the NQF report identifies a
measure concept for the ``percentage of reduction of duplicate labs and
imaging over time,'' which can capture the impact of electronic
availability of imaging studies on duplicative studies that are often
conducted when health care providers do not have the ability to locate
an existing study. However, we recognize that there are challenges
associated with tying such measures of economic efficiency to a single
factor, such as electronic workflow improvements.\126\
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\125\ https://www.qualityforum.org/Publications/2017/09/Interoperability_2016-2017_Final _Report.aspx.
\126\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699907/.
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Consistent with our commitment to reducing administrative burden,
increasing efficiencies, and improving beneficiary experience via the
``Patients over Paperwork initiative,'' \127\ we are seeking
stakeholder feedback on a potential metric to evaluate health care
provider efficiency using EHRs. Specifically, we are requesting
information on the following questions:
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\127\ https://www.cms.gov/About-CMS/story-page/patients-over-paperwork.html.
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What do stakeholders believe would be useful ways to
measure the efficiency of health care processes due to the use of
health IT? What are measurable outcomes demonstrating greater
efficiency in costs or resource use that can be linked to the use of
health IT-enabled processes? This includes measure description,
numerator/denominator or yes/no reporting, and exclusions.
What do stakeholders believe may be hindering their
ability to achieve greater efficiency (for example, product, measures,
CMS regulations)? Please, provide examples.
What are specific technologies, capabilities, or system
features (beyond those currently addressed in the Promoting
Interoperability performance category) that can increase the efficiency
of provider interactions with technology systems; for instance,
alternate authentication technologies that can simplify provider logon?
How could we reward providers for adoption and use of these
technologies?
What are key administrative processes that can benefit
from more efficient electronic workflows; for instance, conducting
prior authorization requests? How can we measure and reward providers
for their uptake of more efficient electronic workflows?
Could CMS successfully incentivize efficiency? What role
should CMS play in improving efficiency in the practice of medicine?
The underlying goal is to move to a more streamlined, efficient, easier
user experience, whereby providers can input and access a patient's
data in a reliable, timely manner. Having not yet reached this point,
we are seeking feedback on the best way(s) to get there.
(iv) Request for Information (RFI) on the Provider to Patient Exchange
Objective
In March 2018, the White House Office of American Innovation and
the CMS Administrator announced the launch of MyHealthEData and CMS'
role in improving patient access and advancing interoperability. As
part of the MyHealthEData initiative, we are taking a patient-centered
approach to health information access and moving to a system in which
patients have immediate access to their computable health information
and can be assured that their health information will follow them as
they move throughout the health care system from provider to provider,
payer to payer. To accomplish this, we have launched several
initiatives related to data sharing and interoperability to empower
patients and encourage plan and provider competition. One example is
our overhaul of the Advancing Care Information performance category
under MIPS to transform it into the new Promoting Interoperability
performance category, which put a heavy emphasis on patient access to
their health information through the Provide Patients Electronic Access
to Their Health Information measure.
Through the Provide Patients Electronic Access to Their Health
Information measure, we are ensuring that patients have access to their
information through any application of their choice that is configured
to meet the technical specifications of the API in the MIPS eligible
clinician's CEHRT. To make these APIs fully useful to patients, they
should provide immediate access to updated information whenever the
patient needs that information, should be always available, configured
using standardized technology and contain the information a patient
needs to make informed decisions about their care.
In the CY 2019 PFS proposed rule (83 FR 35932), we introduced a
potential future Promoting Interoperability performance category
concept that explored creating a set of priority health IT activities
that would serve as alternatives to the traditional Promoting
[[Page 40781]]
Interoperability performance category measures. We requested public
comment on whether MIPS eligible clinicians should earn credit in the
Promoting Interoperability performance category by attesting to health
IT or interoperability activities in lieu of reporting on specific
measures. We identified specific health IT activities and sought public
comment on those and additional activities that would add value for
patients and health care providers, are relevant to patient care and
clinical workflows, support alignment with existing objectives, promote
flexibility, are feasible for implementation, are innovative in the use
of health IT, and promote interoperability. We received feedback in
support of this future concept.
One such activity that we specifically requested comment on was a
health IT activity in which MIPS eligible clinicians may obtain credit
in the Promoting Interoperability performance category if they maintain
an ``open API,'' or standards-based API, which allows patients to
access their health information through a preferred third-party
application. An API can be thought of as a set of commands, functions,
protocols, or tools published by one software developer (``Developer
A'') that enables other software developers to create programs
(applications or ``apps'') that can interact with developer A's
software without needing to know the internal workings of developer A's
software, all while maintaining consumer privacy data standards. This
is how API technology creates a seamless user experience that is,
typically, associated with other applications that are used in more
common aspects of consumers' daily lives, such as travel and personal
finance. Standardized, transparent, and pro-competitive API technology
can enable similar benefits to consumers of health care services.\128\
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\128\ ONC has made available a succinct, non-technical overview
of APIs in context of consumers' access to their own medical
information across multiple providers' EHR systems, which is
available at the HealthIT.gov website at https://www.healthit.gov/api-education-module/story_html5.html.
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We received feedback from several commenters regarding concerns
that an ``open'' API may open the door to patient data without
security, leaving MIPS eligible clinicians' EHR systems open for cyber-
attacks. However, we wish to note that the term ``open API'' does not
imply that any and all applications or application developers would
have unfettered access to individuals' personal or sensitive
information nor would it allow for any reduction in the required
protections for privacy and security of patient health information.
Additionally, with respect to patient access, a patient will need to
authenticate him/herself to a health care organization that is the
steward of their data (for example, username and password) and the
access provided to an app will be for that one patient. The overall
HIPAA Security Rule, HIPAA Privacy Rule, and other cybersecurity
obligations that apply to HIPAA covered entities remain the same and
would need to be applied to an API in the same way they are currently
applied to any and all other interfaces a health care organization
deploys in production.
ONC's 21st Century Cures Act proposed rule (84 FR 7424 through
7610) includes new proposals that focus on how certified health IT can
use APIs to allow health information to be accessed, exchanged, and
used without special effort through the use of APIs or successor
technology or standards, as provided for under applicable law. For
instance, ONC has proposed to adopt a new criterion for a standards-
based API at Sec. 170.315(g)(10). This standards-based API criterion
would replace the existing API criterion with one that requires the use
of the HL7 Fast Healthcare Interoperability Resources (FHIR[supreg])
standard. ONC has also proposed a series of requirements for the
standards-based API that would improve interoperability by focusing on
standardized, transparent, and pro-competitive API practices.
ONC has proposed to make the standards-based API criterion part of
the 2015 Edition base EHR definition (84 FR 7427), which would ensure
that this functionality is ultimately included in the CEHRT definition
required for participation in the Promoting Interoperability
performance category. If finalized, health IT developers would have 24
months from the publication of the final rule to implement these
changes to certified health IT products.
(A) Immediate Access
The existing Provide Patients Electronic Access to Their Health
Information measure specifies that the MIPS eligible clinicians provide
the patient timely access to view online, download, and transmit his or
her health information, and further specifies that patient health
information must be made available to the patient within 4 business
days of its availability to the MIPS eligible clinicians. We believe it
is critical for patients to have access to their health information
when making decisions about their care. In the recently published
proposed rule titled, ``Medicare and Medicaid Programs; Patient
Protection and Affordable Care Act; Interoperability and Patient Access
for Medicare Advantage Organization and Medicaid Managed Care Plans,
State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities,
Issuers of Qualified Health Plans in the Federally-facilitated
Exchanges and Health Care Providers proposed rule'' (84 FR 7610 through
7680) (hereinafter referred to as the ``CMS Interoperability and
Patient Access proposed rule''), we proposed that certain health plans
and payers be required to make patient health information available
through an open, standards-based API no later than one business day
after it is received by the health plan or payer.
Recognizing the importance of patients having access to their
complete health information, including clinical information from the
MIPS eligible clinicians' CEHRT, and appreciating the new technical
flexibility a standards-based API would provide, we are seeking comment
on whether MIPS eligible clinicians should make patient health
information available immediately through an open, standards-based API,
no later than one business day after it is available to the MIPS
eligible clinicians in their CEHRT. We seek comment on the barriers to
more immediate access to patient information. Additionally, we seek
comment on whether there are specific data elements that may be more or
less feasible to share no later than one business day. We also seek
comment as to when implementation of such a requirement is feasible.
(B) Persistent Access and Standards-Based APIs
As discussed above, the ONC 21st Century Cures Act proposed rule
(84 FR 7479) includes a proposal for adoption of API conditions of
certification that ensure a standards-based API is implemented in a
manner that provides unimpeded access to technical documentation, is
non-discriminatory, preserves rights of access, and minimizes costs or
other burdens that could result in special effort. The ONC 21st Century
Cures Act proposed rule (84 FR 7575), also, includes requirements for
the standardized API related to privacy and security to ensure that
patient health information is protected.
The existing Provide Patients Electronic Access to Their Health
Information measure does not specify the overall operational
expectations associated with enabling patients' access to their health
information. For instance, the measure only specifies that
[[Page 40782]]
access must be ``timely.'' As a result, we request public comment on
whether we should revise the measure to be more specific with respect
to the experience patients should have regarding their access. For
instance, in the ONC 21st Century Cures Act proposed rule (84 FR 7481
through 7484), there is a proposal regarding requirements around
persistent access to APIs, which would accommodate a patient's routine
access to their health information without needing to reauthorize their
application and re-authenticate themselves. We seek comment on whether
the Promoting Interoperability performance category measure should be
updated to accommodate this proposed technical requirement for
persistent access.
As we work to advance interoperability and empower patients through
access to their health information, we continue to explore the role of
APIs. We support the ONC 21st Century Cures Act proposed rule (84 FR
7424) proposal to move to an HL7 FHIR[supreg]-based API under 2015
Edition certification (84 FR 7479). Health care providers committed to
a standards-based API could benefit from joining in on the industry's
new FHIR standards framework to reduce burden in, and improve on,
quality measurement through automation and simplification. Use of FHIR-
based APIs could help push forward interoperability regardless of EHR
systems used providing standardized way to share information.
Understanding this, we are, specifically, seeking public comments
on the following question:
If ONC's proposed FHIR-based API certification criteria is
finalized, would stakeholders support a possible bonus under the
Promoting Interoperability performance category for early adoption of a
certified FHIR-based API in the intermediate time before ONC's final
rule's compliance date for implementation of a FHIR standard for
certified APIs?
(C) Available Data
Recognizing the overall burden that switching EHR systems places on
health care providers, ONC has introduced a new proposal that seeks to
minimize that burden. In the ONC 21st Century Cures Act proposed rule,
ONC proposed to adopt a new 2015 Edition certification criterion for
the EHI export at 45 CFR 170.315(b)(10). The purpose of this criterion
is to provide patients and health IT users the ability to securely
export the entire EHR for a single patient, or all patients, in a
computable, electronic format, and facilitate receiving the health IT
system's interpretation, and use of the EHI, to the extent that is
reasonably practicable using the existing technology of developers.
This patient-focused export capability complements other provisions of
the proposed rule that support patients' access to their EHI, including
information that may eventually be accessible via the proposed
standardized API in 45 CFR 170.215. It is also complementary to the
proposals in the CMS Interoperability and Patient Access proposed rule,
which proposed to require certain health plans and issuers to provide
patients access to their health data through a standardized API.
Building on these proposals, we are seeking comment on an
alternative measure under the Provider to Patient Exchange objective
that would require clinicians to use technology certified to the EHI
criterion to provide the patient(s) their complete electronic health
data contained within an EHR.
Specifically, we are seeking comment on the following questions:
Do stakeholders believe that incorporating this
alternative measure into the Provider to Patient Exchange objective
will be effective in encouraging the availability of all data stored in
health IT systems?
In relation to the Provider to Patient Exchange objective,
as a whole, how should a required measure focused on using the proposed
total EHI export function in CEHRT be scored?
If this certification criterion is finalized and
implemented, should a measure based on the criterion be established as
a bonus measure? Should this measure be established as an attestation
measure?
In the long term, how do stakeholders believe such an
alternative measure would impact burden?
If stakeholders do not believe this will have a positive
impact on burden, in what other way(s) might an alternative measure be
implemented that may result in burden reduction? Please, be specific.
Which data elements do stakeholders believe are of
greatest clinical value or would be of most use to health care
providers to share in a standardized electronic format if the complete
record was not immediately available?
In addition to the above questions, we have some general questions
that are related to health IT activities, for which we are, also,
seeking public comment:
Do stakeholders believe that we should consider including
a health IT activity that promotes engagement in the health information
exchange across the care continuum that would encourage bi-directional
exchange of health information with community partners, such as post-
acute care, long-term care, behavioral health, and home and community
based services to promote better care coordination for patients with
chronic conditions and complex care needs? If so, what criteria should
we consider when implementing a health information exchange across the
care continuum health IT activity in the Promoting Interoperability
performance category?
What criteria should we employ, such as specific goals or
areas of focus, to identify high priority health IT activities for the
future of the performance category?
Are there additional health IT activities we should
consider recognizing in lieu of reporting on existing measures and
objectives that would most effectively advance priorities for
nationwide interoperability and spur innovation?
(D) Patient Matching
ONC has stated that patient matching is critically important to
interoperability and the nation's health IT infrastructure as health
care providers must be able to share patient health information and
accurately match a patient to his or her data from a different health
care provider in order for many anticipated interoperability benefits
to be realized. We continue to support ONC's work promoting the
development of patient matching initiatives. Per Congress' guidance,
ONC is looking at innovative ways to provide technical assistance to
private sector-led initiatives to further develop accurate patient
matching solutions in order to promote interoperability without
requiring a unique patient identifier (UPI). We understand the
significant health information privacy and security concerns raised
around the development of a UPI standard and the current prohibition
against using HHS funds to adopt a UPI standard (84 FR 7656).
Recognizing Congress' statement regarding patient matching and
stakeholder comments stating that a patient matching solution would
accomplish the goals of a UPI, we are seeking comment for future
consideration on ways for ONC and CMS to continue to facilitate private
sector efforts on a workable and scalable patient matching strategy so
that the lack of a specific UPI does not impede the free flow of
information. We are also seeking comment on how we may leverage our
authority to provide support to those working to improve patient
matching. We note that we intend to use comments we receive for
[[Page 40783]]
the development of policy and future rulemaking.
Do stakeholders believe that CMS and ONC patient matching
efforts impact burden? Please, explain.
If stakeholders believe that patient matching is leading
to increased burden, what suggestions might stakeholders have to
promote interoperability securely and accurately, without the
requirement of a UPI, that may result in burden reduction? Please, be
specific.
(v) Request for Information (RFI) on Integration of Patient-Generated
Health Data Into EHRs Using CEHRT
The Promoting Interoperability performance category is continuously
seeking ways to prioritize the advanced use of CEHRT functionalities,
encourage movement away from paper-based processes that increase health
care provider burden, and empower individual beneficiaries to take a
more impactful role in managing their health to achieve their goals.
Increased availability of patient-generated health data (PGHD) \129\
offers providers an opportunity to monitor and track a patient's
health-related data from information that is provided by the patient
and not the provider. Increasingly affordable wearable devices,
sensors, and other technologies capture PGHD, providing new ways to
monitor and track a patient's healthcare experience. Capturing
important health information through devices and other tools between
medical visits could help improve care management and patient outcomes,
potentially resulting in increased cost savings. Although many types of
PGHD are being used in clinical settings today, the continuous
collection and integration of patients' health-data into EHRs to inform
clinical care has not been widely achieved across the health care
system.
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\129\ For more information, we refer readers to https://www.healthit.gov/topic/scientific-initiatives/patient-generated-health-data.
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In the 2015 Edition Health IT Certification Criteria final rule (80
FR 62661; 45 CFR 170.315(e)(3)), ONC finalized a criterion for patient
health information capture functionality within certified health IT
that allows a user to identify, record, and access information directly
and electronically shared by a patient. We finalized a PGHD measure
requiring health care providers to incorporate PGHD or data from a
nonclinical setting into CEHRT (80 FR 62851). However, we removed this
measure in the CY 2019 PFS final rule (83 FR 59813), due to concerns
that the measure was not fully health IT-based and could include paper-
based actions, an approach which did not align with program priorities
to advance the use of CEHRT. Stakeholder comments regarding this
measure also noted that manual processes to conduct actions associated
with the measure could increase health care provider reporting burden
and that there was confusion over which types of data would be
applicable and the situations in which the patient data would apply. At
the same time, there was ample support from the public for ONC and CMS
to continue to advance certified health IT capabilities to capture
PGHD.
However, we continue to believe that it is important for the
Promoting Interoperability performance category to explore new ways to
incentivize health care providers who take proactive steps to advance
the emerging use of PGHD. As relevant technologies and standards
continue to evolve, there may be new approaches through which we can
address challenges related to emerging standards for PGHD capture,
appropriate clinical workflows for receiving and reviewing PGHD, and
advance the technical architecture needed to support PGHD use.
In 2018, ONC released the white paper, ``Conceptualizing a Data
Infrastructure for the Capture, Use, and Sharing of Patient-Generated
Health Data in Care Delivery and Research through 2024,'' \130\ which
described key challenges, opportunities and enabling actions for
different stakeholders, including clinicians, to advance the use of
PGHD. For instance, the report identified an enabling action around
supporting ``clinicians to work within and across organizations to
incorporate prioritized PGHD use cases into their workflows.'' This
action urges clinicians and care teams to identify priority use cases
and relevant PGHD types that would be valuable to improving care
delivery for patient populations. It, also, highlights the importance
of developing clinical workflows that avoid overwhelming the care team
with extraneous data by encouraging care teams to develop management
strategies for shared responsibilities around collecting, verifying,
and analyzing PGHD. A second enabling action the white paper identifies
for clinicians is, ``collaboration between clinicians and developers to
advance technologies supporting PGHD interpretation and use.'' This
enabling action highlights feedback for developers about prioritized
use cases and application features as critical to ensuring that the
necessary refinements are made to technology solutions to effectively
support the capture and use of PGHD. Finally, the report encourages
``clinicians in providing patient education to encourage PGHD capture
and use in ways that maximize data quality,'' recognizing the important
role that clinicians can play in helping patients understand how to
share PGHD, the differences between solicited and unsolicited PGHD, and
how PGHD are relevant for the patient's care.
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\130\ https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper.pdf.
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Considering the enabling actions for clinicians identified in the
white paper, we are interested in ways that the Promoting
Interoperability performance category could adopt new elements related
to PGHD that: (1) Represent clearly defined uses of health IT; (2) are
linked to positive outcomes for patients; and (3) advance the capture,
use, and sharing of PGHD. In considering how the Promoting
Interoperability performance category could continue to advance the use
of PGHD, we also note that a future element related to PGHD would not
necessarily need to be implemented as a traditional measure requiring
reporting of a numerator and denominator. For instance, in the CY 2019
PFS proposed rule (83 FR 35932), we requested comment on the concept of
``health IT'' or ``interoperability'' activities to which a health care
provider could attest, potentially in lieu of reporting on measures
associated with certain objectives. By addressing the use of PGHD
through such a concept, rather than traditional measure reporting, we
could potentially reduce the reporting burden associated with a new
PGHD-related element.
We are inviting stakeholder comment on these concepts, and the
specific questions below:
What specific use cases for capture of PGHD as part of
treatment and care coordination across clinical conditions and care
settings are most promising for improving patient outcomes? For
instance, use of PGHD for capturing advanced directives and pre/post-
operation instructions in surgery units.
Should the Promoting Interoperability performance category
explore ways to reward providers for engaging in activities that pilot
promising technical solutions or approaches for capturing PGHD and
incorporating it into CEHRT using standards-based approaches?
Should health care providers be expected to collect
information from their patients outside of scheduled appointments or
procedures? What are the benefits and concerns about doing so?
Should the Promoting Interoperability performance category
[[Page 40784]]
explore ways to reward health care providers for implementing best
practices associated with optimizing clinical workflows for obtaining,
reviewing, and analyzing PGHD?
We believe the bi-directional availability of data, meaning that
both patients and their health care providers have real-time access to
the patient's electronic health record, is critical. This includes
patients being able to import their health data into their medical
record and have it be available to health care providers. We welcome
input on how we can encourage, enable, and reward health care providers
to advance capture, exchange, and use of PGHD.
(vi) Request for Information (RFI) on Engaging in Activities That
Promote the Safety of the EHR
The widespread adoption of EHRs has transformed the way health care
is delivered, offering improved availability of patient health
information, supporting more informed clinical decision making, and
reduce medical errors.\131\ However, many stakeholders have identified
risks to patient safety as one of the unintended consequences that may
result from the implementation of EHRs. By disrupting established
workflows and presenting clinicians with new challenges, EHR
implementation may increase the incidence of certain errors, resulting
in harm to patients.
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\131\ https://www.healthit.gov/topic/health-it-basics/improved-patient-care-using-ehrs.
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As we continue to advance the use of CEHRT in health care, we are
seeking comment on how to further mitigate the specific safety risks
that may arise from technology implementation. Specifically, we are
seeking comment on ways that the Promoting Interoperability performance
category may reward MIPS eligible clinicians for engaging in activities
that can help to reduce the errors associated with EHR implementation.
For instance, we are requesting comment on a potential future
change to the performance category under which MIPS eligible clinicians
would receive points towards their Promoting Interoperability
performance category score for attesting to performance of an
assessment based on one of the ONC SAFER Guides. The SAFER Guides
(available at https://www.healthit.gov/topic/safety/safer-guides) are
designed to help healthcare organizations conduct self-assessments to
optimize the safety and safe use of EHRs in nine different areas: High
Priority Practices, Organizational Responsibilities, Contingency
Planning, System Configuration, System Interfaces, Patient
Identification, Computerized Provider Order Entry, Test Results
Reporting and Follow-Up, and Clinician Communication.
Each of the SAFER Guides is based on the best evidence available,
including a literature review, expert opinion, and field testing at a
wide range of healthcare organizations, from small ambulatory practices
to large health systems. A number of EHR developers currently utilize
the SAFER Guides as part of their health care provider training
modules.
Specifically, we might consider offering points towards the
Promoting Interoperability performance category score to MIPS eligible
clinicians that attest to conducting an assessment based on the High
Priority Practices \132\ and/or the Organizational Responsibilities
\133\ SAFER Guides which cover many foundational concepts from across
the guides. Alternatively we might consider awarding points for review
of all nine of the SAFER Guides. We are also inviting comments on
alternatives to the SAFER Guides, including appropriate assessments
related to patient safety, which should also be considered as part of
any future bonus option.
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\132\ https://www.healthit.gov/sites/default/files/safer/guides/safer_high_priority_practices.pdf.
\133\ https://www.healthit.gov/sites/default/files/safer/guides/safer_organizational_responsibilities.pdf.
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We are requesting comment on the ideas above, as well as inviting
stakeholders to suggest other approaches we may take to rewarding
activities that promote reduction of safety risks associated with EHR
implementation as part of the Promoting Interoperability performance
category.
(5) APM Scoring Standard for MIPS Eligible Clinicians Participating in
MIPS APMs
(a) Overview
As codified at Sec. 414.1370(a), the APM scoring standard is the
MIPS scoring methodology applicable for MIPS eligible clinicians
identified on the Participation List for the of an APM Entity
participating in a MIPS APM for the applicable MIPS performance period.
As discussed in the CY 2017 Quality Payment Program final rule (81
FR 77246), the APM scoring standard is designed to reduce reporting
burden for such clinicians by reducing the need for duplicative data
submission to MIPS and their respective APMs, and to avoid potentially
conflicting incentives between those APMs and MIPS.
We established at Sec. 414.1370(c) that the MIPS performance
period under Sec. 414.1320 applies for the APM scoring standard. We
finalized under Sec. 414.1370(f) that the MIPS final score calculated
for the APM Entity is applied to each MIPS eligible clinician in the
APM Entity, and the MIPS payment adjustment is applied at the TIN/NPI
level for each MIPS eligible clinician in the APM Entity group. Under
Sec. 414.1370(f)(2), if the APM Entity group is excluded from MIPS,
all eligible clinicians within that APM Entity group are also excluded
from MIPS.
As finalized at Sec. 414.1370(h)(1) through (4), the performance
category weights used to calculate the MIPS final score for an APM
Entity group for the APM scoring standard performance period are:
Quality at 50 percent; cost at 0 percent; improvement activities at 20
percent; and Promoting Interoperability at 30 percent.
(b) MIPS APM Criteria
We established at Sec. 414.1370(b) that for an APM to be
considered a MIPS APM, it must satisfy the following criteria: (1) APM
Entities must participate in the APM under an agreement with CMS or by
law or regulation; (2) the APM must require that APM Entities include
at least one MIPS eligible clinician on a Participation List; (3) the
APM must base payment on quality measures and cost/utilization; and (4)
the APM must be neither a new APM for which the first performance
period begins after the first day of the MIPS performance year nor an
APM in the final year of operation for which the APM scoring standard
is impracticable. In the CY 2019 PFS final rule (59820 through 59821),
we clarified that we consider whether each distinct track of an APM
meets the criteria to be a MIPS APM and that it is possible for an APM
to have tracks that are MIPS APMs and tracks that are not MIPS APMs. We
also clarified that we consider the first performance year for an APM
to begin as of the first date for which eligible clinicians and APM
entities participating in the model must report on quality measures
under the terms of the APM.
Based on the MIPS APM criteria, we expect that the following 10
APMs will satisfy the requirements to be MIPS APMs for the 2020 MIPS
performance period:
Comprehensive ESRD Care Model (all Tracks).
Comprehensive Primary Care Plus Model (all Tracks).
Next Generation ACO Model.
Oncology Care Model (all Tracks).
[[Page 40785]]
Medicare Shared Savings Program (all Tracks).
Medicare ACO Track 1+ Model.
Bundled Payments for Care Improvement Advanced.
Maryland Total Cost of Care Model (Maryland Primary Care
Program).
Vermont All-Payer ACO Model (Vermont Medicare ACO
Initiative).
Primary Care First (All Tracks).
Final CMS determinations of MIPS APMs for the 2020 MIPS performance
period will be announced via the Quality Payment Program website at
https://qpp.cms.gov/. Further, we make these determinations based on
the established MIPS APM criteria as specified in Sec. 414.1370(b).
(c) Calculating MIPS APM Performance Category Scores
(i) Quality Performance Category
As noted, the APM scoring standard is designed to reduce reporting
burden for MIPS eligible clinicians participating in MIPS APMs by
reducing the need for duplicative data submission to MIPS and their
respective APMs, and to avoid potentially conflicting incentives
between those APMs and MIPS. As discussed in the CY 2017 Quality
Payment Program final rule (81 FR 77246), due to operational
constraints, we did not require MIPS eligible clinicians participating
in MIPS APMs other than the Shared Savings Program and the Next
Generation ACO Model to submit data on quality measures for purposes of
MIPS for the 2017 MIPS performance period. As discussed in the CY 2018
Quality Payment Program final rule (82 FR 53695), we designed a means
of overcoming these operational constraints and required MIPS eligible
clinicians participating in such MIPS APMs to submit data on APM
quality measures for purposes of MIPS beginning with the 2018 MIPS
performance period. We also finalized a policy to reweight the quality
performance category to zero percent in cases where an APM has no
measures available to score for the quality performance category for a
MIPS performance period, such as where none of the APM's measures would
be available for calculating a quality performance category score by
the close of the MIPS submission period because measures were removed
from the APM measure set due to changes in clinical practice
guidelines. Although we anticipated different scenarios where quality
would need to be reweighted, we did not anticipate at that time that
the quality performance category would need to be reweighted regularly.
After several years of implementation of the APM scoring standard,
we have found that for participants in certain MIPS APMs (as defined in
Sec. 414.1305), it often is not operationally possible to collect and
score performance data on APM quality measures for purposes of MIPS
because these APMs run on episodic or yearly timelines that do not
always align with the MIPS performance periods and deadlines for data
submission, scoring, and performance feedback. In addition, although we
anticipated different scenarios where quality would need to be
reweighted, we do not believe the quality performance category should
be reweighted regularly.
To achieve the aims of the APM scoring standard, we believe it is
necessary to consider new approaches to quality performance category
scoring.
(A) Allowing MIPS Eligible Clinicians Participating in MIPS APMs To
Report on MIPS Quality Measures
We propose to allow MIPS eligible clinicians participating in MIPS
APMs to report on MIPS quality measures in a manner similar to our
established policy for the Promoting Interoperability performance
category under the APM scoring standard for purposes of the MIPS
quality performance category beginning with the 2020 MIPS performance
period.
Similar to our approach for the Promoting Interoperability
performance category, we would allow MIPS eligible clinicians in MIPS
APMs to receive a score for the quality performance category either
through individual or TIN-level reporting based on the generally
applicable MIPS reporting and scoring rules for the quality performance
category. Under such an approach, we would attribute one quality score
to each MIPS eligible clinician in an APM Entity by looking at both
individual and TIN-level data submitted for the eligible clinician and
using the highest reported score, excepting scores reported by a
virtual group. Thus, we would use the highest individual or TIN-level
score attributable to each MIPS eligible clinician in an APM Entity in
order to determine the APM Entity score based on the average of the
highest scores for each MIPS eligible clinician in the APM Entity.
As with Promoting Interoperability performance category scoring,
each MIPS eligible clinician in the APM Entity group would receive one
score, weighted equally with that of the other MIPS eligible clinicians
in the APM Entity group, and we would calculate one quality performance
category score for the entire APM Entity group. If a MIPS eligible
clinician has no quality performance category score--if the
individual's TIN did not report and the individual did not report--that
MIPS eligible clinician would contribute a score of zero to the
aggregate APM Entity group score.
We would use only scores reported by an individual MIPS eligible
clinician or a TIN reporting as a group; we would not accept virtual
group level reporting because a virtual group level score is too far
removed from the eligible clinician's performance on quality measures
for purposes of the APM scoring standard.
We request comment on this proposal.
(B) APM Quality Reporting Credit
We are also proposing to apply a minimum score of 50 percent, or an
``APM Quality Reporting Credit'' under the MIPS quality performance
category for certain APM entities participating in MIPS, where APM
quality data cannot be used for MIPS purposes as outlined below.
Several provisions of the statute address the possibility of
considerable overlap between the requirements of MIPS and those of an
APM. Most notably, section 1848(q)(1)(C)(ii) of the Act excludes QPs
and partial QPs that do not elect to participate in MIPS from the
definition of a MIPS eligible clinician. In addition, section
1848(q)(5)(C)(ii) of the Act requires that participation by a MIPS
eligible clinician in an APM (as defined in section 1833(z)(3)(C) of
the Act) earn such MIPS eligible clinician a minimum score of one-half
of the highest potential score for the improvement activities
performance category.
In particular, we believe that section 1848(q)(5)(C)(ii) of the Act
reflects an understanding that APM participation requires significant
investment in improving clinical practice, which may be duplicative
with the requirements under the improvement activities performance
category. We believe that MIPS APMs require an equal or greater
investment in quality, which, due to operational constraints, cannot
always be reflected in a MIPS quality performance category score.
Accordingly, we are proposing to apply a similar approach to quality
performance category scoring under the APM scoring standard.
Specifically, we are proposing that APM Entity groups participating in
MIPS APMs receive a minimum score of one-half of the highest potential
score for the quality performance category, beginning with the 2020
MIPS performance period.
To the extent possible, we would calculate the final score by
adding to the credit any additional MIPS quality score received on
behalf of the individual NPI or the TIN. For the purposes of final
[[Page 40786]]
scoring this credit would be added to any MIPS quality measure scores
we receive. All quality category scores would be capped at 100 percent.
For example, if the additional MIPS quality score were 40 percent, that
would be added to the 50 percent credit for a total of 90 percent; if
the quality score were 70 percent, that would be added to the 50
percent credit and because the result is 120 percent, the cap would be
applied for a final score of 100 percent.
We request comment on this proposal.
(i) Exceptions From APM Quality Reporting Credit
Under this proposal, we would not apply the APM Quality Reporting
Credit to the APM Entity group's quality performance score for those
APM Entities reporting only through a MIPS quality reporting mechanism
according to the requirements of their APM, such as the Medicare Shared
Savings Program, which requires participating ACOs to report through
the CMS Web Interface and the CAHPS for ACOs survey measures. In these
cases, no burden of duplicative reporting would exist, and there would
not be any additional unscored quality measures for which to give
credit.
In the case where an APM Entity group is in an APM that requires
reporting through a MIPS quality reporting mechanism under the terms of
participation in the APM, should the APM Entity group fail to report on
required quality measures, the individual eligible clinicians and TINs
that make up that APM Entity group would still have the opportunity to
report quality measures to MIPS for purposes of calculating a MIPS
quality performance category score as finalized in they would in any
Other MIPS APM in accordance with Sec. 414.1370(g)(1)(ii). However, as
in these cases no burden of duplicative reporting would exist, they
would remain ineligible for the APM Quality Reporting credit.
(C) Additional Reporting Option for APM Entities
We recognize that some APM Entities may have a particular interest
in ensuring that MIPS eligible clinicians in the APM Entity group
perform well in MIPS, or in reducing the overall burden of joining the
entity. Likewise, we recognize that some APMs, such as the CMS Web
Interface reporters already require reporting on MIPS quality measures
as part of participation in the APM. Therefore, we are proposing that,
in instances where an APM Entity has reported quality measures to MIPS
through a MIPS submission type and using MIPS collection type on behalf
of the APM Entity group, we would use that quality data to calculate an
APM Entity group level score for the quality performance category. We
believe this approach best ensures that all participants in an APM
Entity group receive the same final MIPS score while reducing reporting
burden to the greatest extent possible.
We request comment on this proposal.
(D) Bonus Points and Caps for the Quality Performance Category
In the 2018 Quality Payment Program final rule (82 FR 53568,
53700), we finalized our policies to include bonus points in the
performance category score calculation when scoring quality at the APM
Entity group level. Because these adjustments would, under the
proposals discussed in section[s] III.J.3.d.(1)(b) of this proposed
rule, already be factored in when calculating an individual or TIN-
level quality performance category score before the quality scores are
rolled-up and averaged to create the APM Entity group level score, we
believe it would be inappropriate to continue to calculate these
adjustments at the APM Entity group level in the case where an APM
Entity group's quality performance score is reported by its composite
individuals or TINs. However, in the case of an APM Entity group that
chooses to or is required by its APM to report on MIPS quality measures
at the APM Entity group level, we would continue to apply any bonuses
or adjustments that are available to MIPS groups for the measures
reported by the APM Entity and to calculate the applicability of these
adjustments at the APM Entity group level.
We request comment on this proposal.
(E) Special Circumstances
In prior rulemaking, with regard to the quality performance
category, we did not include MIPS eligible clinicians who are subject
to the APM scoring standard in the automatic extreme and uncontrollable
circumstances policy or the application-based extreme and
uncontrollable circumstances policy that we established for other MIPS
eligible clinicians (82 FR 53780-53783, 53895-53900; 83 FR 59874-
59875). However, in section III.J.3.c.(5)(c)(i)(c) of this proposed
rule, we are proposing to allow MIPS eligible clinicians participating
in MIPS APMs to report on MIPS quality measures and be scored for the
MIPS quality performance category based on the generally applicable
MIPS reporting and scoring rules for the quality performance category.
In light of this proposal, we believe that the same extreme and
uncontrollable circumstances policies that apply to other MIPS eligible
clinicians with regard to the quality performance category should also
apply to MIPS eligible clinicians participating in MIPS APMs who would
report on MIPS quality measures as proposed. Therefore, beginning with
the 2020 MIPS performance period/2022 MIPS payment year and only with
regard to the quality performance category, we propose to apply the
application-based extreme and uncontrollable circumstances policy (82
FR 53780-53783) and the automatic extreme and uncontrollable
circumstances policy (83 FR 59874-59875) that we previously established
for other MIPS eligible clinicians and codified at Sec.
414.1380(c)(2)(i)(A)(6) and (8), respectively, to MIPS eligible
clinicians participating in MIPS APMs who are subject to the APM
scoring standard and would report on MIPS quality measures as proposed
in section III.J.3.c.(5)(c)(i). We would limit the proposed application
of these policies to the quality performance category because our
proposal in section III.J.3.c.(5)(c)(i) pertains to reporting on MIPS
quality measures.
Under the previously established policies, MIPS eligible clinicians
who are subject to extreme and uncontrollable circumstances may receive
a zero percent weighting for the quality performance category in the
final score (82 FR 53780-53783, 83 FR 59874-59875). Similar to the
policy for MIPS eligible clinicians who qualify for a zero percent
weighting of the Promoting Interoperability performance category (82 FR
53701 through 53702), we propose that if a MIPS eligible clinician who
qualifies for a zero percent weighting of the quality performance
category in the final score is part of a TIN reporting at the TIN level
that includes one or more MIPS eligible clinicians who do not qualify
for a zero percent weighting, we would not apply the zero percent
weighting to the qualifying MIPS eligible clinician. The TIN would
still report on behalf of the entire group, although the TIN would not
need to report data for the qualifying MIPS eligible clinician. All
MIPS eligible clinicians in the TIN who are participants in the MIPS
APM would count towards the TIN's weight when calculating the
aggregated APM Entity score for the quality performance category.
However, in this circumstance, if the MIPS eligible clinician was a
solo practitioner and qualified for a zero percent weighting, if the
MIPS eligible clinician's TIN did not report at the group level and the
MIPS eligible
[[Page 40787]]
clinician was individually eligible for a zero percent weighting, or if
all MIPS eligible clinicians in a TIN qualified for the zero percent
weighting, neither the TIN nor the individual would be required to
report on the quality performance category and would be assigned a
weight of zero when calculating the APM Entity's quality performance
category score.
If quality performance data were reported by or on behalf of one or
more TIN/NPIs in an APM Entity group, a quality performance category
score would be calculated for, and would be applied to, all MIPS
eligible clinicians in the APM Entity group. If all MIPS eligible
clinicians in all TINs of an APM Entity group qualify for a zero
percent weighting of the quality performance category, the quality
performance category would be weighted at zero percent of the MIPS
final score.
We welcome comments from the public in this discussion of how best
to address the technical infeasibility of scoring quality for many of
our MIPS APMs, and whether the above described policy or some other
approach may be an appropriate path forward for the APM entity group
scoring standard in CY 2020.
We request comment on this proposal.
(d) Request for Comment on APM Scoring Beyond 2020
We are also seeking comment on potential policies to be included in
next year's rulemaking to further address the changing incentives for
APM participation under MACRA. We want the design of the APM scoring
standard to continue to encourage appropriate shifts of MIPS eligible
clinicians into MIPS APMs and eventually into Advanced APMs while
ensuring fair treatment for all MIPS eligible clinicians.
We note that the QP threshold will be increasing in future years,
potentially resulting in larger proportions of Advanced APM
participants being subject to MIPS under the APM scoring standard. At
the same time the MIPS performance threshold will be increasing
annually, gradually reducing the impact of the APM scoring standard on
participants' ability to achieve a neutral or positive payment
adjustment under MIPS.
(F) Excluding Virtual Groups From APM Entity Group Scoring
Due to concerns that virtual groups could be used to calculate APM
Entity group scores, we have excluded virtual group MIPS scores when
calculating APM Entity group scores. Previously, we have effectuated
this exclusion through the use and application of terms defined in
Sec. 414.1305, specifically, ``APM Entity,'' ``APM Entity group,''
``group,'' and ``virtual group.'' To improve clarity around the
exclusion of virtual group scores in calculating APM Entity group
scores, we now are proposing to effectuate this exclusion more
explicitly, by amending Sec. 414.1370(e)(2) to state that the score
calculated for an APM Entity group, and subsequently the APM Entity,
for purposes of the APM scoring standard does not include MIPS scores
for virtual groups.
(i) Sunsetting the APM Quality Reporting Credit for APM Entities
One proposal we may consider beginning in the 2021 performance year
would be to apply the APM Quality Reporting Credit described above, if
finalized, to specific APM Entities for a maximum number of MIPS
performance years; this may be set for all APMs or tied to the end of
each APM's initial agreement period.
We believe that this proposal would create an incentive for new APM
Entity groups to continue to form and join new MIPS APMs while
maintaining the incentive for APM Entity groups and MIPS eligible
clinicians to continue to strive to achieve QP status. This proposal
also would complement the shift we are seeing within APMs, such as the
Shared Savings Program, to require APM participants to move into two-
sided risk tracks and Advanced APMs within 2 to 5 years of joining the
model or program.
(ii) Sunsetting the APM Quality Reporting Credit for Non-Advanced APMs
Similar to the first proposal, we may consider an approach whereby
we would implement the above approach to quality scoring and then phase
out the APM Quality Reporting Credit for MIPS APMs that are not also
Advanced APM tracks.
We would have the option to implement this change by removing the
APM Reporting Credit for non-Advanced MIPS APMs entirely at the end of
a set number of years for all non-Advanced APMs (for example, 2 years).
Alternatively we could tie this sunsetting of the APM Quality
Reporting Credit for a non-Advanced APM to the initial agreement period
of each APM, creating a well-timed incentive for movement into Advanced
APM tracks of an APM after the initial agreement period after the start
of the APM.
(iii) Sunsetting the APM Quality Reporting Credit for APM Entities in
One-Sided Risk Tracks
One possible way of acknowledging the uncertainty involved with
joining an APM without extending the APM Reporting Credit to all APM
participants would be to retain the APM Quality Reporting Credit for
all two-sided risk APM tracks but to remove this credit for
participants in all one-sided risk tracks except for those APM Entities
in the first 2 years--or first agreement period--of a MIPS APM.
We believe this approach would help ease the transition from MIPS
to APM participation and ultimately into Advanced APM participation.
However, this proposal would continue to provide the APM Quality
Reporting Credit for participants in two-sided risk APMs who have not
reached the QP threshold. In this way, we could create an incentive for
APM participants to move towards Advanced APMs, even in situations
where it is unlikely the participant would be able to reach the QP
threshold.
(iv) Retain Different APM Quality Reporting Credits for Advanced APMs
and MIPS APMs
Another available option would be to apply an APM Reporting Credit,
as described above to all MIPS APM participants but base the available
credit on the level of risk taken on by the MIPS APM. For example, the
maximum 50 percent credit may continue to be available to APM Entities
in Advanced APM tracks while the value of the credit may be limited to
25 percent for participants in one-sided risk tracks. We are soliciting
comments on how we might best divide these tracks and address the
advent of two-sided risk MIPS APMs that do not meet the nominal amount
and financial risk standards in order to be considered an Advanced APM,
and what an appropriate reporting credit would be for these tracks.
(v) Other Options
We seek comments and suggestions on other ways in which we could
modify the APM scoring standard to continue to encourage MIPS eligible
clinicians to join APMs, with an emphasis on encouraging movement
toward participation in two-sided risk APMs that may qualify as
Advanced APMs.
(e) MIPS APM Performance Feedback
As we discussed in the CY 2017 and 2018 Quality Payment Program
final rules (81 FR 77270, and 82 FR 53704 through 53705, respectively),
MIPS
[[Page 40788]]
eligible clinicians who are scored under the APM scoring standard will
receive performance feedback under section 1848(q)(12) of the Act.
Regarding access to performance feedback, whereas split-TIN APM
Entities and their participants can only access their performance
feedback at the APM Entity group or individual MIPS eligible clinician
level, MIPS eligible clinicians participating in the Shared Savings
Program, which is a full-TIN APM, were able to access their performance
feedback at the ACO participant TIN level for the 2017 performance
period. However, due to confusion caused by the policy in cases, where
not all eligible clinicians in a Shared Savings Program participant TIN
received the APM Entity score, for example eligible clinicians that
terminate before the first snapshot, we intend to better align
treatment of Shared Savings Program ACOs and their participant TINs
with other APM Entities and, where appropriate, with other MIPS groups.
We will continue to allow ACO participant TIN level access to the APM
Entity group level final score and performance feedback, as well as
provide the APM Entity group level final score and performance feedback
to individual MIPS eligible clinicians who bill through the TINs
identified on the ACO's ACO participant list. However, we will also
provide TIN level performance feedback to ACO participant TINs that
will include the information that is available to all TINs
participating in MIPS, including the applicable final scores for MIPS
eligible clinicians billing under the TIN, regardless of their MIPS APM
participation status.
d. MIPS Final Score Methodology
(1) Performance Category Scores
(a) Background
For the 2022 MIPS payment year, we intend to continue to build on
the scoring methodology we finalized for prior years, which allows for
accountability and alignment across the performance categories and
minimizes burden on MIPS eligible clinicians. The rationale for our
scoring methodology continues to be grounded in the understanding that
the MIPS scoring system has many components and various moving parts.
As we transform MIPS through the MIPS Value Pathways (MVP) Framework as
discussed in section III.K.3.a. of this proposed rule, we may propose
modifications to our scoring methodology in future rulemaking as we
continue to develop a methodology that emphasizes simplicity and that
is understandable for MIPS eligible clinicians.
In this proposed rule, we are proposing policies to help eligible
clinicians as they participate in the 2020 performance period/2022 MIPS
payment year, and as we move beyond the transition years of the
program.
(b) Scoring the Quality Performance Category for the Following
Collection Types: Medicare Part B Claims Measures, eCQMs, MIPS CQMs,
QCDR Measures, CMS Web Interface Measures, the CAHPS for MIPS Survey
Measure and Administrative Claims Measures
We refer readers to Sec. 414.1380(b)(1) for our policies regarding
quality measure benchmarks, calculating total measure achievement and
measure bonus points, calculating the quality performance category
percent score, including achievement and improvement points, and the
small practice bonus.
As we move towards the transformation of the program through the
MVP Framework discussed in section III.K.3.a.(2) of this proposed rule,
we anticipate we will revisit and remove many of our scoring policies
such as the 3-point floor, bonus points, and assigning points for
measures that cannot be scored against a benchmark through future
rulemaking. As we propose to transform the MIPS program through MVPs,
our goal is to incorporate ways to address these issues without
developing special scoring policies. We refer readers to section
III.K.3.a.(3)(d) of this proposed rule, for further discussion on
scoring of MVPs.
In section III.K.3.d.(1) of this proposed rule, we discuss the
limited proposals for our scoring policies as we anticipate future
changes as we work to transform MIPS through MVPs. Specifically, we are
proposing to: (1) Maintain the 3-point floor for measures that can be
scored for performance; (2) develop benchmarks based on flat
percentages in specific cases where we determine the measure's
otherwise applicable benchmark could potentially incentivize
inappropriate treatment; (3) continue the scoring policies for measures
that do not meet the case-minimum requirement, do not have a benchmark,
or do not meet the data-completeness criteria; (4) maintain the cap on
measure bonus points for high-priority measures and end-to-end
reporting; and (5) continue the improvement scoring policy. In
addition, we are requesting comment on future approaches to scoring the
CAHPS for MIPS survey measure if new questions are added to the survey.
These proposals are discussed in more detail in this section of the
proposed rule.
(i) Assigning Quality Measure Achievement Points
We refer readers to Sec. 414.1380(b)(1) for more on our policies
for scoring performance on quality measures.
(A) Scoring Measures Based on Achievement
We established at Sec. 414.1380(b)(1)(i) a global 3-point floor
for each scored quality measure, as well as for the hospital
readmission measure (if applicable). MIPS eligible clinicians receive
between 3 and 10 measure achievement points for each submitted measure
that can be reliably scored against a benchmark, which requires meeting
the case minimum and data completeness requirements. In the CY 2017
Quality Payment Program final rule (81 FR 77282), we established that
measures with a benchmark based on the performance period (rather than
on the baseline period) would continue to receive between 3 and 10
measure achievement points for performance periods after the first
transition year. For measures with benchmarks based on the baseline
period, we stated that the 3-point floor was for the transition year
and that we would revisit the 3-point floor in future years.
For the 2022 MIPS payment year, we are proposing to again apply a
3-point floor for each measure that can be reliably scored against a
benchmark based on the baseline period. As we move towards the proposed
MVPs discussed in section III.K.3.a. of this proposed rule, we
anticipate we will revisit and possibly remove the 3-point floor in
future years. As a result, we will wait until there is further policy
development under the proposed framework before proposing to remove the
3-point floor. Accordingly, we are proposing to amend Sec.
414.1380(b)(1)(i) to remove the years 2019, 2020, and 2021 and adding
in its place the years 2019 through 2022 to provide that for the 2019
through 2022 MIPS payment years, MIPS eligible clinicians receive
between 3 and 10 measure achievement points (including partial points)
for each measure required under Sec. 414.1335 on which data is
submitted in accordance with Sec. 414.1325 that has a benchmark at
paragraph (b)(1)(ii) of this section, meets the case minimum
requirement at paragraph (b)(1)(iii) of this section, and meets the
data completeness requirement at Sec. 414.1340. The number of measure
achievement points received for each measure is determined based on the
applicable benchmark decile category and the percentile distribution.
[[Page 40789]]
MIPS eligible clinicians receive zero measure achievement points for
each measure required under Sec. 414.1335 on which no data is
submitted in accordance with Sec. 414.1325. MIPS eligible clinicians
that submit data in accordance with Sec. 414.1325 on a greater number
of measures than required under Sec. 414.1335 are scored only on the
required measures with the greatest number of measure achievement
points. Beginning with the 2021 MIPS payment year, MIPS eligible
clinicians that submit data in accordance with Sec. 414.1325 on a
single measure via multiple collection types are scored only on the
data submission with the greatest number of measure achievement points.
(B) Scoring Measures That Do Not Meet Case Minimum, Data Completeness,
and Benchmark Requirements
We refer readers to Sec. 414.1380(b)(1)(i)(A) and (B) for more on
our scoring policies for a measure that is submitted but is unable to
be scored because it does not meet the required case minimum, does not
have a benchmark, or does not meet the data completeness requirement. A
summary of the proposed policies for the CY 2020 MIPS performance
period is provided in Table 43.
Table 43--Quality Performance Category: Proposed Scoring Policies for the CY 2020 MIPS Performance Period *
----------------------------------------------------------------------------------------------------------------
Measure type Description Scoring rules
----------------------------------------------------------------------------------------------------------------
Class 1............................ For the 2020 MIPS performance period: For the 2020 MIPS
Measures that can be scored based on performance period: 3
performance.. to 10 points based on
Measures that are submitted or calculated that performance compared
meet all the following criteria:. to the benchmark.
(1) Has a benchmark;...........................
(2) Has at least 20 cases; and.................
(3) Meets the data completeness standard
(generally 70 percent for 2020.) **.
** We refer readers to section III.K.3.c.(1)(c)
for our proposal to increase data
completeness..
Class 2............................ For the 2020 MIPS performance period: For the 2020 MIPS
Measures that are submitted and meet data performance period:
completeness, but do not have either of the 3 points.
following:.
(1) A benchmark................................
(2) At least 20 cases..........................
Class 3............................ For the 2020 MIPS performance period: Beginning with the 2020
Measures that are submitted, but do not meet MIPS performance period:
data completeness threshold, even if they have MIPS eligible clinicians
a measure benchmark and/or meet the case other than small
minimum. practices will receive
zero measure achievement
points. Small practices
will continue to receive
3 points.
----------------------------------------------------------------------------------------------------------------
* The Class 2 and 3 measure scoring policies are not applicable to CMS Web Interface measures or administrative
claims-based measures.
For the 2022 MIPS payment year, we are proposing to again apply the
special scoring policies for measures that meet the data completeness
requirement but do not have a benchmark or meet the case minimum
requirement. Accordingly, we are proposing to amend Sec.
414.1380(b)(1)(i)(A)(1) to remove the years 2019, 2020, and 2021 and
adding in its place the years 2019 through 2022 to provide that except
as provided in paragraph (b)(1)(i)(A)(2) (which relates to CMS Web
Interface measures and administrative claims-based measures), for the
2019 through 2022 MIPS payment years, MIPS eligible clinicians receive
3 measure achievement points for each submitted measure that meets the
data completeness requirement, but does not have a benchmark or meet
the case minimum requirement.
(C) Modifying Benchmarks To Avoid the Potential for Inappropriate
Treatment
We established at Sec. 414.1380(b)(1)(ii) that benchmarks will be
based on collection type, from all available sources, including MIPS
eligible clinicians and APMs, to the extent feasible, during the
applicable baseline or performance period. We also established at Sec.
414.1380(b)(1)(i) that the number of measure achievement points
received for each such measure is determined based on the applicable
benchmark decile category and the percentile distribution.
We believe all the measures in the MIPS program are of high
standard as they have undergone extensive review prior to their
inclusion in the program. MIPS measures go through the rulemaking
process, and QCDR measures have an approval process before they are
included in MIPS. We also believe our benchmarking generally provides
an objective way to compare performance differences across different
types of quality measures. However, we have heard concerns from
stakeholders that for a few measures, the benchmark methodology may
incentivize the inappropriate treatment of certain patients, in order
for a clinician to achieve a score in the highest decile. Our scoring
system already provides some protection from inappropriate treatment
because all clinicians in the top 10 percent of the distribution
receive the same 10-point score, thus a clinician with performance in
the 90th percentile has no incentive to go higher. However, for certain
measures with benchmarks set at very high or maximum performance in the
top decile, we are concerned that these levels may not be
representative and may not provide the most appropriate incentives for
clinicians. Specifically, there are some measures that may have the
potential to encourage clinicians to alter the clinical interaction
with patients inappropriately, regardless of the individual patient's
circumstances, in order to achieve that top decile performance level,
for example, intermediate outcome measures that may encourage
clinicians to over treat patients in order to achieve the highest
performance level. Patient safety is our primary concern; therefore, we
are proposing to establish benchmarks based on flat percentages in
specific cases where we determine the measure's
[[Page 40790]]
otherwise applicable benchmark could potentially incentivize treatment
that could be inappropriate for a particular patient type. Rather than
develop benchmarks based on the distribution of scores we would base
them on flat percentages such that any performance rate at or above 90
percent would be in the top decile and any performance rate above 80
percent would be in the second highest decile, and this would continue
for the remaining deciles. We believe the measures that would fall
under this methodology are high-priority or outcome measures for
clinicians to focus on. However, we want to ensure that benchmarks are
set to incentivize the most appropriate behavior, and ensure that our
method for scoring against a benchmark accurately reflects performance
and does not result in clinicians receiving low scores, despite
adherence to the most appropriate treatment.
For the measures identified, we are proposing to use a flat
percentage, similar to how the Shared Savings Program uses flat
percentages to set benchmarks for measures with high performance. We
selected this methodology for the following reasons: First, it is a
straight-forward and simple methodology that currently exists for some
MIPS measures that are collected through the CMS Web Interface. Second,
because we are applying this methodology to measures with very high
performance, we believe this approach is consistent with the Shared
Saving Program approach established at Sec. 425.502(b)(2)(ii) of using
flat percentages to set benchmarks when many reporters demonstrate high
achievement on a measure. The Shared Savings Program uses this method
to avoid penalizing high ACO performance; however, in this case, we
would be applying the flat percentages to ensure that the benchmark
does not result in inappropriate and potentially harmful patient
treatment. We believe this adjustment would provide additional
protection to patients and reduce the potential incentive for
inappropriate treatment of patients.
We propose that to determine whether a measure benchmark may not
provide the most appropriate incentives for treatment, thus creating
the potential for inappropriate treatment based on the patient's
circumstances, CMS medical officers would assess if there are patients
for whom it would be inappropriate to achieve the outcome targeted by
the measure benchmark. This assessment will include reviews of factors
such as whether the measure specifications allow for clinical judgment
to adjust for inappropriate outcomes, if the benchmarks for any of the
impacted measure's collection types could put these patients at risk by
setting a potentially harmful standard for top decile performance, or
whether the measure is topped out. The intent of the assessment is to
have CMS medical officers determine whether certain measure benchmarks
may have unintended consequences that put patients at risk and the
measure benchmark should therefore move to a flat percentage. The
assessment will take into account all available information, including
from the medical literature, published practice guidelines, and
feedback from clinicians, groups, specialty societies, and the measure
steward. Before applying the flat percentage benchmarking methodology
to any recommended measure, we would propose the modified benchmark for
the applicable MIPS payment year through rulemaking. This policy would
be effective beginning with the CY 2020 MIPS performance period (and
thus the 2022 MIPS payment adjustment year). We also seek comment on
future actions we should take to help us in determining which measures
to apply the flat percentage benchmarking to; for example, convening a
technical expert panel.
We have identified two measures for which we believe we need to
apply benchmarks based on flat percentages to avoid potential
inappropriate treatment--MIPS #1 (NQF 0059): Diabetes: Hemoglobin A1c
(HbA1c) Poor Control (9%) and MIPS #236 (NQF 0018): Controlling High
Blood Pressure. Although there are protections built into both of these
measures, such as the use of less stringent requirements than current
clinical guidelines, they lack comprehensive denominator exclusions and
risk-adjustment or risk-stratification, which can lead to the possible
over treatment of patients in order to meet numerator compliance.
Overtreatment could lead to instances where the patient's blood sugar
or blood pressure is lowered to a level that meets the measure standard
but is too low for their optimum health given other coexisting medical
conditions.
Because the factors for determining if a measure benchmark has the
potential to cause inappropriate treatment may include both measure and
benchmark considerations, we are concerned that all the benchmarks
associated with the different collection types of a measure could be
affected. Therefore, we are proposing to use the flat percentage
benchmarks as an alternative to our standard method of calculating
benchmarks by a percentile distribution of measure performance rates
under for all collection types where the top decile for any measure
benchmark is higher than 90 percent under the performance-based
benchmarking methodology at Sec. 414.1380(b)(1)(ii). We are limiting
the application of the flat percentage methodology to all collection
types where the top decile for any measure benchmark is higher than 90
percent so that our flat percentage methodology will actually reduce or
remove the incentive for inappropriate care. If the top decile was
originally below 90 percent, using the flat percentages would actually
raise the level up to 90 percent and therefore provide a stronger
incentive to provide inappropriate care in order to get the top score.
We also seek comment on whether we should use a criteria different than
applying it to collection types where the top decile would be higher
than 90 percent if the benchmark was based on a distribution. For the
two measures we are proposing to modify, we would not know which
benchmarks and their associated collection types are impacted until we
run our analysis; however, based on the benchmarks for the 2019 MIPS
performance period, we would anticipate using the modified benchmarks
for the Medicare Part B claims and the MIPS CQM collection types.
We considered whether we should rerun the benchmarks excluding
those in the top decile but are concerned that the approach would add
complexity to the program overall. We seek comment on whether we should
consider different methodologies for the modified benchmarks such as
excluding the top decile or increasing the required data completeness
for the measure to a very high level (for example, 95 to 100 percent)
and use performance period benchmarks rather than historical
benchmarks.
We are proposing to add paragraph Sec. 414.1380(b)(1)(ii)(C) to
state that beginning with the 2022 MIPS payment year, for each measure
that has a benchmark that CMS determines has the potential to result in
inappropriate treatment, CMS will set benchmarks using a flat
percentage for all collection types where the top decile is higher than
90 percent under the methodology at Sec. 414.1380(b)(1)(ii). We also
propose to revise the text at Sec. 414.1380(b)(1)(ii) to provide
exceptions and to clarify the requirement that benchmarks will be based
on performance by collection type, from all available sources,
including MIPS eligible clinicians and APMs, to the extent feasible,
during the applicable baseline or performance period.
[[Page 40791]]
(ii) Request for Feedback on Additional Policies for Scoring the CAHPS
for MIPS Survey Measure
We refer readers to Sec. 414.1380(b)(1)(vii)(B) for more on our
policy on reducing the total available measure achievement points for
the quality performance category by 10 points for groups that submit 5
or fewer quality measures and register for the CAHPS for MIPS survey,
but do not meet the minimum beneficiary sampling requirements.
In this proposed rule, we are not proposing any changes to the
scoring of the CAHPS for MIPS survey Measure. However, to the extent
consistent with our authority to collect such information under section
1848(q) of the Act, we are considering expanding the information
collected in the CAHPS for MIPS survey measure, described in section
III.K.3.c.(1) of this proposed rule, and seek comment on scoring. One
consideration is adding narrative questions to the CAHPS for MIPS
survey measure, which would invite patients to respond to a series of
questions in free text, such as responding to open ended questions and
describing their experience with care in their own words. We believe
narratives from patients about their health care experiences would be
helpful to other patients when selecting a clinician and can provide a
valuable complement to standardized survey scores, both to help
clinicians understand what they can do to improve care and to engage
and inform patients about differences among their experiences of care.
On the other hand, there may be concerns about the accuracy and
usefulness of narrative information reported by patients. For more
information on the rationale for adding narrative questions, we refer
readers to section III.K.3.c.(1)(c)(i) of this proposed rule. In
addition, we are interested in learning from organizations with
experience scoring narrative information, including methodologies. We
would work with stakeholders on user testing before proposing any such
methodology in future rulemaking. We are also considering adding an
additional CAHPS for MIPS survey question allowing patients to provide
a score for their overall experience and satisfaction rating with a
recent health care encounter, to capture the patient ``voice'' and
provide patients with information useful to making a decision on
clinicians, as detailed in section III.I.3.a.(1) of this proposed rule.
We are interested in feedback regarding how to score this measure. The
new questions could potentially be added to the calculation for a score
for the CAHPS for MIPS survey measure. We would consider any changes
for future notice and comment rulemaking.
(iii) Scoring for MIPS Eligible Clinicians That Do Not Meet Quality
Performance Category Criteria
In the CY 2019 PFS final rule (83 FR 35950), we finalized our
proposal to modify our validation process to provide that it only
applies to MIPS CQMs and the claims collection type, regardless of the
submitter type chosen.
In this proposed rule, we do not propose any changes to this
policy. However, we refer readers to section III.K.3.d.(2)(b)(ii)(A) of
this proposed rule for discussion on the rare circumstances when we are
unable to calculate a quality performance category score for a MIPS
eligible clinician because they do not have applicable or available
quality measures. If we are unable to score the quality performance
category for a MIPS eligible clinician, then we will reweigh the
clinician's quality performance category score according to the
reweighting policies described in sections III.K.3.d.(2)(b)(iii) of
this proposed rule.
(iv) Incentives To Report High-Priority Measures
We refer readers to Sec. 414.1380(b)(1)(v)(A) for more on the cap
on high-priority measure bonus points for the first 3 years of MIPS at
10 percent of the denominator (total possible measure achievement
points the MIPS eligible clinician could receive in the quality
performance category) of the quality performance category.
In the CY 2019 PFS final rule (83 FR 59851), we finalized technical
updates to Sec. 414.1380(b)(1) to more clearly and concisely capture
previously established policies in the section. During this effort we
inadvertently added that a high priority measure must have a benchmark.
This was not intended to be a policy change. We are clarifying that in
order for a measure to qualify for high priority bonus points it must
meet case minimum and data completeness and not have a zero percent
performance. The measure does not need to have a benchmark.
Accordingly, we propose to revise Sec. 414.1380(b)(1)(v)(A)(1)(i) to
provide that each high priority measure must meet the case minimum
requirement at (b)(1)(iii) of this section, meet the data completeness
requirement at Sec. 414.1340, and have a performance rate that is
greater than zero.
We also removed high priority bonus points for CMS Web interface
reporters in the CY 2019 PFS final rule (83 FR 59850 through 59851). We
refer readers to the CY 2019 PFS final rule for further discussion on
this policy.
In this proposed rule, we propose to maintain the cap on measure
points for reporting high priority measures for the 2022 MIPS payment
year. Accordingly, we propose to revise Sec.
414.1380(b)(1)(v)(A)(1)(ii) to remove the years 2019, 2020, and 2021
and adding in its place the years 2019 through 2022 to provide that for
the 2019 through 2022 MIPS payment years, the total measure bonus
points for high priority measures cannot exceed 10 percent of the total
available measure achievement points.
(v) Incentives To Use CEHRT To Support Quality Performance Category
Submissions
We refer readers to Sec. 414.1380(b)(1)(v)(B) for more on our
policy assigning one bonus point for each quality measure submitted
with end-to-end electronic reporting, under certain criteria.
In this proposed rule, we propose to continue to assign and
maintain the cap on measure bonus points for end-to-end electronic
reporting for the 2022 MIPS payment year. We believe with the proposed
framework for transforming MIPS through the MVPs discussed in section
III.K.3.a. of this proposed rule, we can find ways in future years to
incorporate eCQM measures without needing to incentivize end-to-end
reporting with bonus points. As a result, we will wait until there is
further policy development under the proposed framework before
proposing to remove our policy of assigning bonus points for end-to-end
electronic reporting. Accordingly, we propose to revise Sec.
414.1380(b)(1)(v)(B)(1)(i) to remove the years 2019, 2020, and 2021 and
add in its place the years 2019 through 2022 to provide that for the
2019 through 2022 MIPS payment years, the total measure bonus points
for measures submitted with end-to-end electronic reporting cannot
exceed 10 percent of the total available measure achievement points.
(vi) Improvement Scoring for the MIPS Quality Performance Category
Percent Score
We refer readers to Sec. 414.1380(b)(1)(vi)(C)(4) for more on our
policy stating that for the 2020 and 2021 MIPS payment year, we will
assume a quality performance category achievement percent score of 30
percent if a MIPS eligible clinician earned a quality performance
category score less than or equal to 30 percent in the previous year.
In this proposed rule, we propose to continue our previously
established
[[Page 40792]]
policy for the 2022 MIPS payment year and to revise Sec.
414.1380(b)(1)(vi)(C)(4) to remove the phrase ``2020 and 2021 MIPS
payment year'' and adding in its place the phrase ``2019 through 2022
MIPS payment years'' to provide that for the 2020 through 2022 MIPS
payment years, we will assume a quality performance category
achievement percent score of 30 percent if a MIPS eligible clinician
earned a quality performance category score less than or equal to 30
percent in the previous year. Specifically, for the 2022 MIPS payment
year, we will compare the MIPS eligible clinician's quality performance
category achievement percent score for the 2020 MIPS performance period
to an assumed quality performance category achievement percent score of
30 percent if the MIPS eligible clinician earned a quality performance
category score less than or equal to 30 percent for the 2019 MIPS
performance period.
(c) Facility-Based Measurement Scoring Option for the Quality and Cost
Performance Categories for the 2022 MIPS Payment Year
(i) Background
For our previously established policies regarding the facility-
based measurement scoring option, we refer readers to both the CY 2018
Quality Payment Program final rule (82 FR 53752 through 53767) and the
CY 2019 PFS final rule (83 FR 59856 through 59867). In the CY 2019 PFS
proposed rule (83 FR 35962 through 35963), we requested comments on a
number of issues and topics related to whether we should expand the
facility-based scoring option to other facilities and programs in
future years, particularly the use of end-stage renal disease (ESRD)
and post-acute care (PAC) settings as the basis for facility-based
measurement and scoring. We appreciate the many comments we received in
response to this request. We are not proposing an expansion to other
facility types as part of this rule but may consider addressing this
issue in future rulemaking.
(ii) Facility-Based Measurement Eligibility
In the CY 2019 PFS final rule (83 FR 59856 through 59860), we
established the policies that determine eligibility for scoring for
facility-based measurement as an individual and as a group. In the CY
2019 PFS final rule, we established at Sec. 414.1380(e)(2)(i)(C) that
a MIPS eligible clinician is facility-based if the clinician can be
attributed, under the methodology specified in Sec. 414.1380(e)(5), to
a facility with a value-based purchasing score for the applicable
period. While we do not propose any changes to the eligibility of
facility-based measurement for individuals or groups, we are proposing
to amend Sec. 414.1380(e)(2)(i)(C) to improve clarity. Specifically,
we propose to amend Sec. 414.1380(e)(2)(i)(C) to state that a MIPS
eligible clinician is facility-based if the clinician can be assigned,
under the methodology specified in Sec. 414.1380(e)(5), to a facility
with a value-based purchasing score for the applicable period. We hope
to avoid any ambiguity as we have used the term ``attribute'' and
``attribution'' in two ways. We have used the term to refer to the use
of the facility's performance in place of the clinician's own
performance (83 FR 59857). We have also used the term at Sec.
414.1380(e)(2)(i)(C) to reference our method of connecting clinicians
to a facility and indicate that the facility score will be the
clinician's score. We believe these are related but distinct concepts;
therefore, we are proposing to revise Sec. 414.1380(e)(2)(i)(C) to use
the term ``assign'' instead of ``attribute.'' We believe this change in
language more clearly describes how a clinician receives a score under
facility-based measurement while avoiding making any changes to our
methods in determining eligibility for facility-based measurement or
their score. This does not constitute a change in policy.
(iii) Facility-Based Measures for CY 2020 MIPS Performance Period/2022
MIPS Payment Year
For informational purposes, we are providing in Table 44 a list of
the measures included in the FY 2021 Hospital VBP Program measure set
that will be used in determining the quality and cost performance
category scores for the CY 2020 MIPS performance period/2022 MIPS
payment year. The FY 2021 Hospital VBP Program has adopted 12 measures
covering 4 domains (83 FR 20412 through 20413). The performance period
for measures in the Hospital VBP Program varies depending on the
measure, and some measures include multi-year performance periods.
These measures are determined through separate rulemaking; the
applicable rulemaking is usually the Hospital Inpatient Prospective
Payment Systems (IPPS) for Acute Care Hospitals and the Long-Term Care
Hospital (LTCH) Prospective Payment System (PPS) rule. We are using
these measures, benchmarks, and performance periods for the purposes of
facility-based measurement in accordance with Sec. 414.1380(e)(1). The
measures for FY 2021 Hospital VBP Program were summarized in the FY
2019 IPPS/LTCH PPS proposed rule (83 FR 41454 through 41455).
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(d) Scoring the Improvement Activities Performance Category
For our previously established policies regarding scoring the
improvement activities performance category, we refer readers to Sec.
414.1380(b)(3), the CY 2018 Quality Payment Program final rule (82 FR
53767 through 53769), and the CY 2019 PFS final rule (83 FR 59867
through 59868). We also refer readers to Sec. 414.1355 and the CY 2017
Quality Payment Program final rule (81 FR 77177 through 77199), the CY
2018 Quality Payment Program final rule (82 FR 53648 through 53662),
and the CY 2019 PFS final rule (83 FR 59776 through 59785) for our
previously established policies regarding the improvement activities
performance category generally and section III.K.3.c.(3) of this
proposed rule, where we discuss our proposals for the improvement
activities performance category.
(e) Scoring the Promoting Interoperability Performance Category
We refer readers to section III.K.3.c.(4) of this proposed rule,
where we discuss our proposals for the Promoting Interoperability
performance category.
(2) Calculating the Final Score
For a description of the statutory basis and our policies for
calculating the final score for MIPS eligible clinicians, we refer
readers to Sec. 414.1380(c) and the discussion in the CY 2017 Quality
Payment Program final rule (81 FR 77319 through 77329), CY 2018 Quality
Payment Program final rule (82 FR 53769 through 53785), and CY 2019 PFS
final rule (83 FR 59868 through 59878). In this proposed rule, we are
proposing to continue the complex patient bonus for the 2022 MIPS
payment year and to establish performance category reweighting policies
for the 2022, 2023, and 2024 MIPS payment years.
(a) Complex Patient Bonus for the 2022 MIPS Payment Year
In the CY 2019 PFS final rule (83 FR 59869 through 59870), under
the authority in section 1848(q)(1)(G) of the Act, we finalized at
Sec. 414.1380(c)(3) to maintain the complex patient bonus, which we
previously finalized in the CY 2018 Quality Payment Program final rule
(82 FR 53771 through 53776), of up to five points to be added to the
final score for the 2021 MIPS payment year. The complex patient bonus
was developed as a short-term solution to address the impact patient
complexity
[[Page 40794]]
may have on MIPS scoring that we would revisit on an annual basis while
we continue to work with stakeholders on methods to account for patient
risk factors. Our overall goal for the complex patient bonus was
twofold: (1) To protect access to care for complex patients and provide
them with excellent care; and (2) to avoid placing MIPS eligible
clinicians who care for complex patients at a potential disadvantage
while we review the completed studies and research to address the
underlying issues. For a detailed description of the complex patient
bonus finalized for prior MIPS payment years, please refer to the CY
2018 Quality Payment Program final rule (82 FR 53771 through 53776) and
CY 2019 PFS final rule (83 FR 59869 through 59870).
For the 2020 MIPS performance period/2022 MIPS payment year, we
propose to continue the complex patient bonus as finalized for the 2019
MIPS performance period/2021 MIPS payment year and to revise Sec.
414.1380(c)(3) to reflect this policy. Although we intend to maintain
the complex patient bonus as a short-term solution, we do not believe
we have sufficient information available at this time to develop a
long-term solution to account for patient risk factors in MIPS such
that we would be able to include a different approach in this proposed
rule. Section 1848(q)(1)(G) of the Act requires us to consider risk
factors in our scoring methodology for MIPS. Specifically, it provides
that the Secretary, on an ongoing basis, shall, as the Secretary
determines appropriate and based on individuals' health status and
other risk factors, assess appropriate adjustments to quality measures,
cost measures, and other measures used under MIPS and assess and
implement appropriate adjustments to payment adjustments, final scores,
scores for performance categories, or scores for measures or activities
under MIPS. In doing so, the Secretary is required to take into account
the relevant studies conducted by the Office of the Assistant Secretary
for Planning and Evaluation (ASPE) under section 2(d) of the Improving
Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub.
L. 113-185, enacted October 6, 2014) and, as appropriate, other
information, including information collected before completion of such
studies and recommendations. ASPE completed its first report \134\ in
December 2016, which examined the effect of individuals' socioeconomic
status on quality, resource use, and other measures under the Medicare
program, and included analyses of the effects of Medicare's current
value-based payment programs on providers serving socially at-risk
beneficiaries and simulations of potential policy options to address
these issues. The second ASPE report is expected in October 2019 as
required by the IMPACT Act, and will examine additional risk factors
and data. We expect the second report will build on the analyses
included in initial report and may provide additional insight for a
long-term solution to addressing risk factors in MIPS. At this time, we
do not believe additional data sources are available that would be
feasible to use as the basis for a different approach to account for
patient risk factors in MIPS. We plan to continue working with ASPE,
the public, and other key stakeholders on this important issue to
identify policy solutions that achieve the goals of attaining health
equity for all beneficiaries and minimizing unintended consequences.
---------------------------------------------------------------------------
\134\ U.S. Department of Health and Human Services, Office of
the Assistant Secretary for Planning and Evaluation, Report to
Congress: Social Risk Factors and Performance Under Medicare's
Value-Based Purchasing Programs (2016). Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
---------------------------------------------------------------------------
With newly available data from the Quality Payment Program, we
considered whether the data still support the complex patient bonus at
the final score level. We have replicated analyses similar to the ones
presented in Table 27 of the CY 2018 Quality Payment Program final rule
(82 FR 53776). However, our latest analyses use the data submitted for
the Quality Payment Program for the 2017 MIPS performance period and
assess eligibility and final scores based on the proposals we are
making for the 2020 MIPS performance period/2022 MIPS payment year
using the methodology described in the Regulatory Impact Analysis in
section VI. of this proposed rule.
In the CY 2018 Quality Payment Program final rule (82 FR 53771
through 53776), when considering approaches for a complex patient
bonus, we reviewed evidence to identify how indicators of patient
complexity have an impact on performance under MIPS, as well as
availability of data to implement the bonus. Specifically, we
identified two potential indicators for complexity: Medical complexity
as measured through Hierarchical Condition Category (HCC) risk scores;
and social risk as measured through the proportion of patients with
dual eligible status.
We identified these indicators because they are common indicators
of patient complexity in the Medicare program and the data is readily
available. Both of these indicators have been used in CMS programs to
account for risk and both data elements are already publicly available
for individual NPIs in the Medicare Physician and Other Supplier Public
Use File (referred to as the Physician and Other Supplier PUF).
We divided clinicians and groups into quartiles based on average
HCC risk score and percentage of dual eligible patients. To assess
whether there was a difference in MIPS simulated scores by these two
variables, we analyzed the effect of average HCC risk score and dual
eligible ratio separately for groups and individuals. When looking at
individuals, we focused on individuals that reported 6 or more measures
(removing individuals who reported no measures or who reported less
than 6 measures). We restricted our analysis to individuals who
reported 6 or more measures because we wanted to look at differences in
performance for those who reported the 6 measures which are generally
required under MIPS if there are six measures that apply to the MIPS
eligible clinician, rather than differences in scores due to MIPS
eligible clinicians not fully reporting for MIPS.
We also ranked MIPS eligible clinicians by proportion of patients
with dual eligibility as previously done in Table 27 of the CY 2018
Quality Payment Program final rule (82 FR 53776). We have updated the
analysis by using the components of the complex patient bonus and
dividing clinicians into quartiles. The preliminary results are shown
in Table 45.
[[Page 40795]]
Table 45--MIPS Simulated Average Final Score * by HCC Risk Quartile and
Dual Eligible Ratio Quartile
------------------------------------------------------------------------
Estimated 2022 MIPS payment
year final scores using data
submitted for the quality
payment program for the 2017
HCC risk score MIPS performance period
-------------------------------
Individuals
with 6+ Groups
measures *
------------------------------------------------------------------------
Quartile 1--Lowest Average HCC.......... 72.32 70.3
Quartile 2.............................. 72.58 77.59
Quartile 3.............................. 73.2 73.93
Quartile 4--Highest Average HCC......... 72.68 67.66
Dual Eligible Ratio
Quartile 1--Low Proportion of Dual 73.51 73.04
Status.................................
Quartile 2.............................. 72.37 76.28
Quartile 3.............................. 72.16 72.21
Quartile 4--Highest Proportion of Dual 70.7 68.79
Status.................................
------------------------------------------------------------------------
* We restricted our analysis to individuals who reported 6 or more
measures because we wanted to look at differences in performance for
those who reported the 6 measures which are generally required under
MIPS if there are six measures that apply to the MIPS eligible
clinician, rather than differences in scores due to MIPS eligible
clinicians not fully reporting for MIPS.
Table 45 illustrates the average estimated MIPS final scores for
individual MIPS eligible clinicians who submitted at least 6 measures
(generally, those who fully report for MIPS quality) and for group
reporters, stratified by the average HCC risk score and dual eligible
ratio quartiles. For more detail on the original analysis, we refer
readers to the CY 2018 Quality Payment Program final rule (82 FR
53776).\135\
---------------------------------------------------------------------------
\135\ Data submitted for 2017 MIPS performance period was
subject to different policies than later years of MIPS (due to the
``pick-your-pace'' approach in the first year of MIPS and the much
lower performance threshold of 3 points).
---------------------------------------------------------------------------
Overall, the analysis of preliminary data shows a consistent
relationship between the dual eligible ratio quartiles and the average
MIPS final scores only for individuals, where the average MIPS final
score decreases as the quartile increases. We see slight differences in
the average HCC risk score and dual eligible ratio quartiles for
groups, but virtually no difference for average HCC risk score for
individuals. However, we have only 1 year of data and more recent data
may bring different results. In addition, we are awaiting a second
report from ASPE in October 2019 that we expect will provide more
direction for our approach to accounting for risk factors in MIPS. We
are concerned that without the information from ASPE and without
observing a clear trend that would require a change in our methodology,
making any changes beyond our proposal to continue this policy would be
premature at this time.
(b) Final Score Performance Category Weights
(i) General Weights
Section 1848(q)(5)(E)(i) of the Act specifies weights for the
performance categories included in the MIPS final score: In general, 30
percent for the quality performance category; 30 percent for the cost
performance category; 25 percent for the Promoting Interoperability
performance category; and 15 percent for the improvement activities
performance category. For more of the statutory background and
descriptions of our current policies, we refer readers to the CY 2017
and CY 2018 Quality Payment Program final rules (81 FR 77320 through
77329 and 82 FR 53779 through 53785, respectively), as well as the CY
2019 PFS final rule (83 FR 59870 through 59878). Under our proposals in
section III.K.3.c.(2)(a) of this proposed rule, the cost performance
category would make up 20 percent of a MIPS eligible clinician's final
score for the 2022 MIPS payment year, 25 percent for the 2023 MIPS
payment year, and 30 percent for the 2024 MIPS payment year. Under our
proposals in section III.K.3.c.(1)(b) of this proposed rule, the
quality performance category would thus make up 40 percent of a MIPS
eligible clinician's final score the 2022 MIPS payment year, 35 percent
for the 2023 MIPS payment year, and 30 percent for the 2024 MIPS
payment year. Table 46 summarizes the weights proposed for each
performance category.
Table 46--Proposed Weights by MIPS Performance Category for the 2022 Through 2024 MIPS Payment Years
----------------------------------------------------------------------------------------------------------------
2023 MIPS 2024 MIPS
2022 MIPS payment year payment year
Performance category payment year (proposed) (proposed)
(proposed) (percent) (percent)
----------------------------------------------------------------------------------------------------------------
Quality......................................................... 40 35 30
Cost............................................................ 20 25 30
Improvement Activities.......................................... 15 15 15
Promoting Interoperability...................................... 25 25 25
----------------------------------------------------------------------------------------------------------------
[[Page 40796]]
(ii) Flexibility for Weighting Performance Categories
Under section 1848(q)(5)(F) of the Act, if there are not sufficient
measures and activities applicable and available to each type of MIPS
eligible clinician involved, the Secretary shall assign different
scoring weights (including a weight of zero) for each performance
category based on the extent to which the category is applicable to the
type of MIPS eligible clinician involved and for each measure and
activity for each performance category based on the extent to which the
measure or activity is applicable and available to the type of MIPS
eligible clinician involved. Under section 1848(q)(5)(B)(i) of the Act,
in the case of a MIPS eligible clinician who fails to report on an
applicable measure or activity that is required to be reported by the
clinician, the clinician must be treated as achieving the lowest
potential score applicable to such measure or activity. In this
scenario of failing to report, the MIPS eligible clinician would
receive a score of zero for the measure or activity, which would
contribute to the final score for that MIPS eligible clinician.
Assigning a scoring weight of zero percent and redistributing the
weight to the other performance categories differs from the scenario of
a MIPS eligible clinician failing to report on an applicable measure or
activity that is required to be reported. For a description of our
existing policies for reweighting performance categories, please refer
to Sec. 414.1380(c)(2) and the CY 2019 PFS final rule (83 FR 59871
through 59876).
(A) Reweighting Performance Categories Due to Data That Are Inaccurate,
Unusable, or Otherwise Compromised
Under current regulations at Sec. 414.1380(c)(2), we assign
different weights to the performance categories and redistribute weight
from one category to another under specified circumstances where we
have determined reweighting is appropriate. These circumstances do not
currently include cases where a MIPS eligible clinician submits data
that are inaccurate, unusable, or otherwise compromised (referred to in
this section as ``compromised data''). If we determine a MIPS eligible
clinician has submitted compromised data, we assign the clinician a
score of zero for the performance category. Because compromised data is
not currently a basis for reweighting, the determination that data are
inaccurate, unusable or otherwise compromised is likely to reduce the
clinician's final score and therefore may reduce the clinician's
payment adjustments. However, we believe that reweighting of the
applicable performance categories may be appropriate in rare cases.
Specifically, we believe reweighting may be appropriate when a MIPS
eligible clinician's data are inaccurate, unusable or otherwise
compromised due to circumstances that are outside of the control of the
MIPS eligible clinician or its agents.
In the CY 2018 Quality Payment Program final rule, we discussed our
belief that extreme and uncontrollable circumstances, such as natural
disasters, could cause the MIPS measures and activities to be
unavailable to a MIPS eligible clinician (82 FR 53780 through 53783).
For similar reasons, we believe that the measures and activities may
not be available to a MIPS eligible clinician for the quality, cost,
and improvement activities performance categories under section
1848(q)(5)(F) of the Act when data related to the measures and
activities are inaccurate, unusable or otherwise compromised due to
circumstances that are outside of the control of the MIPS eligible
clinician or its agents. In addition, we believe data that are
inaccurate, unusable or otherwise compromised due to circumstances that
are outside of the control of the MIPS eligible clinician or its agents
could constitute a significant hardship for purposes of the Promoting
Interoperability performance category under section 1848(o)(2)(D) of
the Act. Therefore, we are proposing a new policy to allow reweighing
for any performance category if, based on information we learn prior to
the beginning of a MIPS payment year, we determine data for that
performance category are inaccurate, unusable or otherwise compromised
due to circumstances outside of the control of the MIPS eligible
clinician or its agents.
For purposes of this reweighting policy, we propose that
reweighting take into account both what control the clinician had
directly over the circumstances and what control the clinician had
indirectly through its agents. The term agent as used in this proposal
is intended to include any individual or entity, including a third
party intermediary as described in Sec. 414.1400, acting on behalf of
or under the instruction of the MIPS eligible clinician We believe that
reweighting is not appropriate if a clinician could exert influence
over a third party intermediary or another party to prevent or
remediate compromised data and does not do so. However, we believe
reweighting is appropriate in certain circumstances that may be within
the control of the clinician's third party intermediary if the
clinician cannot alter that party's conduct. Such circumstances would
exist if a clinician's third party intermediary could correct the
clinician's compromised data and despite requests from the clinician
the third party intermediary chose not to do so. In this example, the
decision by the third party intermediary not to make the correction
would demonstrate that the third party intermediary was not acting as
an agent of the clinician and the third party intermediary's conduct
would not preclude reweighting. We solicit comments on this approach
and possible alternatives for balancing efforts to allow reweighting in
circumstances in which clinicians are not culpable for compromised data
while maintaining financial incentives for clinicians, third party
intermediaries and other parties to prevent and correct compromised
data.
We propose that our determination of whether reweighing will be
applied under this policy can take into account any information known
to the agency and we will consider the information we obtain on a case-
by-case basis for reweighting. We anticipate considering information
provided to us through routine communication channels for the Quality
Payment Program by any submitter type as defined under Sec. 414.1305,
as well as other relevant information sources of which we are aware. We
request that third party intermediaries, to the extent feasible, inform
MIPS eligible clinicians if the third party intermediary believes their
data may have been compromised. To the extent third party
intermediaries believe that MIPS data may be compromised, we encourage
them to provide us with a list of or other identifying information for
all MIPS eligible clinicians who may have been affected by such issues,
so that we may evaluate the circumstances in a timely manner. We also
encourage MIPS eligible clinicians to contact us and self-identify if
they believe they have compromised data; they should not rely solely on
a third party intermediary to do so. We recognize that there may be
scenarios when a MIPS eligible clinician or one or more of its agents
becomes aware of potential data issues prior to submission of data. We
solicit comment on whether and how our proposed reweighting policy
should apply to these circumstances. We note that compromised data are
not true, accurate or complete for purposes of Sec. 414.1390(b) or
Sec. 414.1400(a)(5) and knowing submission of compromised
[[Page 40797]]
data may result in remedial action against the submitter. A MIPS
eligible clinician should not submit data and should not allow the
submission of his or her data if the MIPS eligible clinician knows that
the data are inaccurate, unusable, or otherwise compromised.
We propose to determine whether the requirements for reweighting
are met by assessing if: (1) The MIPS eligible clinician's data are
inaccurate, unusable, or otherwise compromised; and (2) the data are
compromised due to circumstances outside of the control of the MIPS
eligible clinician or agent. We would make the determination of whether
the clinician's data are inaccurate, unusable or otherwise compromised
based on documentation of the issue and its demonstrated effect on data
of the particular MIPS eligible clinician. As noted above, we propose
to limit this policy to cases where data are compromised outside the
control of the clinician or its agent because we do not want to create
incentives for clinicians or third party intermediaries to knowingly
submit compromised data and want to encourage clinicians and their
agents to take reasonable efforts to correct data that they believe
maybe not compromised. Factors relevant to whether the circumstances
were outside the control of the clinician and its agents include:
Whether the affected MIPS eligible clinician or its agents knew or had
reason to know of the issue; whether the affected MIPS eligible
clinician or its agents attempted to correct the issue; and whether the
issue caused the data submitted to be inaccurate or unusable for MIPS
purposes. We solicit feedback on these factors and whether there are
additional factors we should consider to determine if there should be
reweighing based on compromised data. If we determine that a MIPS
eligible clinician's data were compromised and the conditions for
reweighting are met, we propose to notify the clinician of this
determination through the performance feedback that we provide under
section 1848(q)(12) of the Act if feasible, or through routine
communication channels for the Quality Payment Program. We emphasize
that this proposed reweighting policy is solely intended to mitigate
the potential adverse financial impact of compromised data on the MIPS
eligible clinician; a determination under this proposed policy that
data are compromised due to circumstances outside of the control of the
MIPS eligible clinician and its agent and therefore that reweighting
will occur for that clinician does not indicate and should not be
interpreted to suggest that a third party intermediary or other
individual or entity could not be held liable for the compromised data.
We are proposing to apply reweighting only in cases when we learn
of the compromised data before the beginning of the associated MIPS
payment year because we want to encourage MIPS eligible clinicians and
their agents to inform us of these concerns in a timely basis so we can
update our data sets timely, while minimizing the impacts to other
stakeholders who utilize MIPS data. For example, the Physician compare
website utilizes MIPS data to provide information to patients,
consumers and other stakeholders when selecting a clinician or group.
We are concerned that without the appropriate incentive to notify us in
a timely manner, clinicians and their agents may delay disclosures that
data may be compromised and with these delays the MIPS data could be in
an increased state of flux which will reduce the usefulness of the data
to stakeholders. We are interested in feedback on whether there are
other factors we should consider when adopting a timeline for
reweighting due to compromised data and whether the period should be
broader. We seek comment on whether we should restrict our reweighting
due to compromised data to instances when we learn the relevant
information prior to the beginning of the MIPS payment year and whether
there are other incentives for MIPS eligible clinicians to alert us to
concerns about compromised data. We emphasize that if we determine a
MIPS eligible clinician has submitted compromised data for a
performance category during the associated payment year or at a later
point, the MIPS eligible clinician would not qualify for reweighting
under this proposal, instead for the performance categories with
compromised data the clinician's performance category score would be
zero and the scoring weight for the category would not be
redistributed.
In sum, under the authority in sections 1848(q)(5)(F) and
1848(o)(2)(D) of the Act, we are proposing at Sec.
414.1380(c)(2)(i)(A)(9), and (c)(2)(i)(C)(10), beginning with the 2018
MIPS performance period and 2020 MIPS payment year, to reweight the
performance categories for a MIPS eligible clinician who we determine
has data for a performance category that are inaccurate, unusable or
otherwise compromised due to circumstances outside of the control of
the clinician or its agents if we learn the relevant information prior
to the beginning of the associated MIPS payment year. In addition, we
are proposing to amend Sec. 414.1380(c)(2)(i)(C) to ensure that the
reweighting proposed at Sec. 414.1380(c)(2)(i)(C)(10), would not be
voided by the submission of data for the Promoting Interoperability
performance category as is the case with other significant hardship
exceptions. We solicit comment in this proposal and alternatives to
potentially mitigate the impact on MIPS eligible clinicians who through
no fault of their own have data in a performance category that are
inaccurate, unusable or are otherwise compromised.
We note that we previously finalized at Sec. 414.1380(c) that if a
MIPS eligible clinician is scored on fewer than two performance
categories, he or she will receive a final score equal to the
performance threshold (81 FR 77326 through 77328 and 82 FR 53778
through 53779). Therefore, if a MIPS eligible clinician is scored on
fewer than two performance categories as a result of reweighting due to
compromised data, he or she would receive a final score equal to the
performance threshold.
(iii) Redistributing Performance Category Weights
In the CY 2017 and CY 2018 Quality Payment Program final rules (81
FR 77325 through 77329 and 82 FR 53783 through 53785, 53895 through
53900), in the CY 2019 PFS final rule (83 FR 59876 through 59878), and
at Sec. 414.1380(c)(2)(ii) we established policies for redistributing
the weights of performance categories for the 2019, 2020, and 2021 MIPS
payment years in the event that a scoring weight different from the
generally applicable weight is assigned to a category or categories.
Under these policies, we generally redistribute the weight of a
performance category or categories to the quality performance category
because of the experience MIPS eligible clinicians have had reporting
on quality measures under other CMS programs.
Because the cost performance category was zero percent of a MIPS
eligible clinician's final score for the 2017 MIPS performance period,
we stated in the CY 2019 PFS proposed rule (83 FR 35970) that it is not
appropriate to redistribute weight to the cost performance category for
the 2019 MIPS performance period because MIPS eligible clinicians have
limited experience being scored on cost measures for purposes of MIPS.
In addition, we were concerned that there would be limited measures in
the cost performance category under our proposals for the 2019 MIPS
performance period and stated that it
[[Page 40798]]
may be appropriate to delay shifting additional weight to the cost
performance category until additional measures are developed. However,
we also noted that cost is a critical component of the Quality Payment
Program and believe placing additional emphasis on the cost performance
category in future years may be appropriate. Therefore, we solicited
comment on redistributing weight to the cost performance category in
future years.
Several commenters expressed the belief that the weight of other
performance categories should not be redistributed to the cost
performance category. One commenter stated that the cost performance
category weight should not be increased until additional cost measures
are available and additional results of the episode-based cost measures
are available. Another commenter expressed the belief that the cost
performance category does not yet accurately assess the impact of a
clinician's care on the total cost of care for a patient.
We do not believe it would be appropriate to redistribute weight
from the other performance categories to the cost performance category
for the 2022 MIPS payment year, except in scenarios in which the only
other scored performance category is the improvement activities
performance category. As described in section III.K.3.c.(2)(b)(v) of
this proposed rule, we are proposing substantial changes to the MSPB
and total per capital cost measures, as well as proposing to add 10 new
episode-based measures. We believe it is appropriate to provide MIPS
eligible clinicians additional time to adjust to these changes prior to
redistributing weight to the cost performance category. Under the
proposals we are making in this proposed rule, we would begin to
redistribute more weight to the cost performance category beginning
with the 2023 MIPS payment year, because MIPS eligible clinicians will
have had more experience being scored on cost measures at that point,
and will have had time to adjust to the changes to existing measures
and new episode-based measures that we are proposing.
Under our existing policies, we redistribute weight from the other
performance categories to the improvement activities performance
category in certain scenarios. However, we have generally redistributed
performance category weights more to the quality performance category
to incentivize reporting on quality measures, and because MIPS eligible
clinicians have had more experience with quality measure reporting from
other CMS programs. Beginning with the 2022 MIPS payment year, we
propose to not redistribute performance category weights to the
improvement activities performance category in any scenario. For the
improvement activities performance category, we are only assessing
whether a MIPS eligible clinician completed certain activities (83 FR
59876 through 59878). Because MIPS eligible clinicians will have had
several years of experience reporting under MIPS, we believe it is
important to prioritize performance on measures that show a variation
in performance, rather than the activities under the improvement
activities performance category, which are based on attestation of
completion. Therefore, we believe it is no longer appropriate to
increase the weight of the improvement activities performance category
above 15 percent under our redistribution policies. We note that in
situations where the weights of both the quality and Promoting
Interoperability performance categories are redistributed, cost would
be weighted at 85 percent and improvement activities would be weighted
at 15 percent. We believe this would help to reduce incentives to not
report measures for the quality performance category in circumstances
when a clinician may be able to report but chooses not to do so. For
example, when a clinician may be able to report on quality measures,
but chooses not to report because they are located in an area affected
by extreme and uncontrollable circumstances as identified by CMS and
qualify for reweighting under Sec. 414.1380(c)(2)(i)(A)(8).
For the 2022 MIPS payment year, we propose at Sec.
414.1380(c)(2)(ii)(D) similar redistribution policies to our policies
finalized for the 2021 MIPS payment year (83 FR 59876 through 59878),
with minor modifications, as shown in Table 47. First, we have adjusted
our redistribution policies to account for a cost performance category
weight of 20 percent for the 2022 MIPS payment year. We are also
proposing, in scenarios when the cost performance category weight is
redistributed while the Promoting Interoperability performance category
weight is not, to redistribute a portion of the cost performance
category weight to the Promoting Interoperability performance category
as well as to the quality performance category. We believe this is
appropriate given our current focus on working with the Office of the
National Coordinator for Health IT (ONC) on implementation of the
interoperability provisions of the 21st Century Cures Act (the Cures
Act) (Pub. L. 115-233, enacted December 13, 2016) to ensure seamless
but secure exchange of health information for clinicians and patients.
While we have previously redistributed all of the cost performance
category weight to the quality performance category (83 FR 59876
through 59878), we propose to redistribute 15 percent to the quality
performance category and 5 percent to the Promoting Interoperability
performance category for the 2022 MIPS payment year (see Table 47).
This proposed change would emphasize the importance of interoperability
without overwhelming the contribution of the quality performance
category to the final score. We also propose to weight the improvement
activities performance category at 15 percent and to weight the
Promoting Interoperability performance category at 85 percent for the
2022 MIPS payment year when the quality and cost performance categories
are each weighted at zero percent, to align with our focus on
interoperability and pursuant to our proposal of not redistributing
weight to the improvement activities performance category.
Table 47--Performance Category Redistribution Policies Proposed for the 2022 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
Improvement Promoting
Reweighting scenario Quality Cost (percent) activities interoperability
(percent) (percent) (percent)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
--Scores for all four performance 40 20 15 25
categories...............................
Reweight One Performance Category:
--No Cost................................. 55 0 15 30
--No Promoting Interoperability........... 65 20 15 0
--No Quality.............................. 0 20 15 65
[[Page 40799]]
--No Improvement Activities............... 55 20 0 25
Reweight Two Performance Categories:
--No Cost and no Promoting 85 0 15 0
Interoperability.........................
--No Cost and no Quality.................. 0 0 15 85
--No Cost and no Improvement Activities... 70 0 0 30
--No Promoting Interoperability and no 0 85 15 0
Quality..................................
--No Promoting Interoperability and no 80 20 0 0
Improvement Activities...................
--No Quality and no Improvement Activities 0 20 0 80
----------------------------------------------------------------------------------------------------------------
In section III.K.3.c.(2)(a) of this proposed rule, we have proposed
weights for the cost performance category of 25 and 30 percent for the
2023 and 2024 MIPS payment years, respectively. Because MIPS eligible
clinicians will have had more experience being scored on cost measures,
we believe it would be appropriate to begin redistributing even more of
the performance category weights to the cost performance category
beginning with the 2023 MIPS payment year. While we have proposed to
redistribute weight to the cost performance category for the 2022 MIPS
payment year in scenarios in which only the cost and improvement
activities performance categories are scored, we believe that we should
redistribute weight to the cost performance category in other scenarios
beginning with the 2023 MIPS payment year. In general, we would
redistribute performance category weights so that the quality and cost
performance categories are almost equal. For simplicity, we would
redistribute the weight in 5-point increments. If the redistributed
weight cannot be equally divided between quality and cost in 5-point
increments, we would redistribute slightly more weight to quality than
cost. We believe that redistributing weight equally to quality and cost
is consistent with our goal of greater alignment between the quality
and cost performance categories as described in section III.K.3.c.(2)
of this proposed rule. We would also continue to redistribute weight to
the Promoting Interoperability performance category, but we would
ensure that if the quality and cost performance categories are scored,
they would have a higher weight than the Promoting Interoperability
performance category. For example, beginning with the 2024 MIPS payment
year, if the improvement activities performance category is the only
performance category to be reweighted to zero percent, quality and cost
would be 40 and 35 percent, respectively, and we would not increase the
weight of the Promoting Interoperability performance category (weighted
at 25 percent) so that it would not exceed the weight of the quality or
cost performance categories. Our proposed redistribution polices for
the 2023 and 2024 MIPS payment years, which we propose to codify at
Sec. Sec. 414.1380(c)(2)(ii)(E) and (F), are presented in Tables 47
and 48.
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BILLING CODE 4120-01-C
e. MIPS Payment Adjustments
(1) Background
For our previously established policies regarding the final score
used in MIPS payment adjustment calculations, we refer readers to the
CY 2019 PFS final rule (83 FR 59878 through 59894), CY 2018 Quality
Payment Program final rule (82 FR 53785 through 53799) and CY 2017
Quality Payment Program final rule (81 FR 77329 through 77343).
We are proposing to: (1) Set the performance threshold for the 2022
and 2023 MIPS payment years and (2) set the additional performance
threshold for exceptional performance for the 2022 and 2023 MIPS
payment years.
(2) Establishing the Performance Threshold
Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS,
the Secretary shall compute a performance threshold with respect to
which the final scores of MIPS eligible clinicians are compared for
purposes of determining the MIPS payment adjustment factors under
section 1848(q)(6)(A) of the Act for a year. The performance threshold
for a year must be either the mean or median (as selected by the
Secretary, and which may be reassessed every 3 years) of the final
scores for all MIPS eligible clinicians for a prior period specified by
the Secretary.
Section 1848(q)(6)(D)(iii) of the Act includes a special rule for
the initial 2 years of MIPS, which requires the Secretary, prior to the
performance period for such years, to establish a performance threshold
for purposes of determining the MIPS payment adjustment factors under
section 1848(q)(6)(A) of the Act and an additional performance
threshold for purposes of determining the additional
[[Page 40801]]
MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act,
each of which shall be based on a period prior to the performance
period and take into account data available for performance on measures
and activities that may be used under the performance categories and
other factors determined appropriate by the Secretary. Section
51003(a)(1)(D) of the Bipartisan Budget Act of 2018 amended section
1848(q)(6)(D)(iii) of the Act to extend the special rule to apply for
the initial 5 years of MIPS instead of only the initial 2 years of
MIPS.
In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of
2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which
includes an additional special rule for the third, fourth, and fifth
years of MIPS (the 2021 through 2023 MIPS payment years). This
additional special rule provides, for purposes of determining the MIPS
payment adjustment factors under section 1848(q)(6)(A) of the Act, in
addition to the requirements specified in section 1848(q)(6)(D)(iii) of
the Act, the Secretary shall increase the performance threshold for
each of the third, fourth, and fifth years to ensure a gradual and
incremental transition to the performance threshold described in
section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary)
with respect to the sixth year (the 2024 MIPS payment year) to which
the MIPS applies. The performance thresholds for the first 3 years of
MIPS are presented in Table 50.
Table 50--Performance Thresholds for the 2019 MIPS Payment Year, 2020 MIPS Payment Year, and 2021 MIPS Payment
Year
----------------------------------------------------------------------------------------------------------------
2019 MIPS payment 2020 MIPS payment 2021 MIPS payment
year (points) year (points) year (points)
----------------------------------------------------------------------------------------------------------------
Performance Threshold............................... 3 15 30
----------------------------------------------------------------------------------------------------------------
To determine a performance threshold to propose for the fourth year
of MIPS (2020 MIPS performance period/2022 MIPS payment year) and the
fifth year of MIPS (2021 MIPS performance period/2023 MIPS payment
year), we are again relying upon the special rule in section
1848(q)(6)(D)(iii) of the Act, as amended by 51003(a)(1)(D) of the
Bipartisan Budget Act of 2018.
As required by section 1848(q)(6)(D)(iii) of the Act, we considered
data available from a prior period with respect to performance on
measures and activities that may be used under the MIPS performance
categories. In accordance with clause (iv) of section 1848(q)(6)(D) of
the Act, we also considered which data could be used to estimate the
performance threshold for the 2024 MIPS payment year to ensure a
gradual and incremental transition from the performance threshold we
would establish for the 2022 MIPS payment year. In accordance with
section 1848(q)(6)(D)(i) of the Act, the performance threshold for the
2024 MIPS payment year would be either the mean or median of the final
scores for all MIPS eligible clinicians for a prior period specified by
the Secretary.
To estimate the performance threshold for the 2024 MIPS payment
year, we considered the actual MIPS final scores for MIPS eligible
clinicians for the 2019 MIPS payment year and the estimated MIPS final
scores for the 2020 MIPS payment year and 2021 MIPS payment year. As
referenced in the CY 2019 PFS final rule, we analyzed the actual final
scores for the first year of MIPS (the 2019 MIPS payment year) and
found the mean final score was 74.01 points and the median final score
was 88.97 points (83 FR 59881). In the Regulatory Impact Analysis (RIA)
of the CY 2019 PFS final rule, we used data submitted for the first
year of MIPS (2017 MIPS performance period/2019 MIPS payment year) and
applied the scoring and eligibility policies for the third year of MIPS
(2019 MIPS performance period/2021 MIPS payment year) to estimate the
potential final scores for the 2021 MIPS payment year. The estimated
mean final score for the 2021 MIPS payment year was 69.53 points and
the median final score was 78.72 points (83 FR 60048). We also
estimated mean and median final scores for the 2020 MIPS payment year
of 80.3 points and 90.91 points, respectively, based on information in
the regulatory impact analysis in the CY 2018 Quality Payment Program
final rule (82 FR 53926 through 53950). Specifically, we used 2015 and
2016 PQRS data, 2014 and 2015 CAHPS for PQRS data, 2014 and 2015 VM
data, 2015 and 2016 Medicare and Medicaid EHR Incentive Program data,
the data prepared to support the 2017 performance period initial
determination of clinician and special status eligibility, the initial
QP determination file for the 2019 payment year, the 2017 MIPS measure
benchmarks, and other available data to model the final scores for
clinicians estimated to be MIPS eligible in the 2020 MIPS payment year
(82 FR 53930). We considered using the actual final scores for the 2020
MIPS payment year; however, the data used to calculate the final scores
was submitted through the first quarter of 2019, and final scores for
MIPS eligible clinicians were not available in time for us to use in
our analyses for purposes of this proposed rule (although we intend to
include those results in the final rule if available). We believe the
data points based on actual data from the 2017 MIPS performance period/
2019 MIPS payment year would be appropriate to use in our analysis in
projecting the estimated performance threshold for the 2024 MIPS
payment year. However, after we analyze the actual final scores for the
2020 MIPS payment year, if we see the mean or median final scores
significantly increasing or decreasing, we would consider modifying our
estimation of the performance threshold for the 2024 MIPS payment year
accordingly.
We refer readers to Table 51 for potential values for estimating
the performance threshold for the 2024 MIPS payment year based on the
mean or median final score from prior periods.
[[Page 40802]]
Table 51--Potential Values for Estimated Performance Threshold for the 2024 MIPS Payment Year Based on the Mean
or Median Final Score for the 2019 MIPS Payment Year; 2020 MIPS Payment Year; and 2021 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
2019 MIPS 2020 MIPS 2021 MIPS
payment year * payment year ** payment year ***
(points) (points) (points)
----------------------------------------------------------------------------------------------------------------
Mean Final Score....................................... 74.01 80.30 69.53
Median Final Score..................................... 88.97 90.91 78.72
----------------------------------------------------------------------------------------------------------------
Source: CY 2019 PFS final rule RIA * *** (83 FR 60048); CY 2018 Quality Payment Program final rule RIA ** (82 FR
53926 through 53950).
* Mean and median final scores based on actual final scores for 2019 MIPS payment year.
** Mean and median final scores based on information available in the RIA because actual final scores for the
2020 MIPS payment year were not available in time for this proposed rule.
*** Mean and median final scores based on estimated final scores from 2021 MIPS payment year.
We are choosing the mean final score of 74.01 points for the 2019
MIPS payment year as our estimate of the performance threshold for the
2024 MIPS payment year because it represents a mean based on actual
data; is more representative of clinician performance because all final
scores are considered in the calculation; is more achievable for
clinicians, particularly for those that are new to MIPS; and is a value
that falls generally in the middle of potential values for the
performance threshold referenced in Table 51. In the CY 2019 PFS
proposed rule, we requested comment on our approach to estimating the
performance threshold for the 2024 MIPS payment year, which was based
on the estimated mean final score for the 2019 MIPS payment year, and
whether we should use the median instead of the mean (83 FR 35972). A
few commenters supported the use of the mean rather than the median for
determining the performance threshold because they believed this
approach and the statutory requirement of a gradual and incremental
transition to the performance threshold for the 2024 MIPS payment year
would provide a clear path and certainty and would allow for clinicians
to budget, plan, and develop a long-term strategy for successful
participation in MIPS.
We note that estimating the performance threshold for the 2024 MIPS
payment year based on the mean final score for the 2019 MIPS payment
year is only an estimation that we are providing in accordance with
section 1848(q)(6)(D)(iv) of the Act. We are proposing to use data from
the 2019 MIPS payment year because it is the only MIPS final score data
available and usable in time for the publication of this proposed rule.
We acknowledge that via the 2020 MIPS payment year performance
feedback, we have provided to MIPS eligible clinicians their calculated
final scores. However, the mean and median of final scores for the 2020
MIPS payment year are not yet published. We anticipate that the mean
and median data points for the 2020 MIPS payment year will be available
for consideration prior to publication of the final rule and seek
comment on whether and how we should use this information to update our
estimates. We understand that using final scores from the early years
of MIPS has numerous limitations and may not be similar to the
distribution of final scores for the 2024 MIPS payment year.
Eligibility and scoring policies changed in the initial years of the
program. For example, beginning with the 2020 MIPS payment year, we
increased the low-volume threshold compared to the 2019 MIPS payment
year. We also added incentives for improvement scoring for the quality
performance category and bonuses for complex patients and small
practices, which could increase scores. Starting with the 2021 MIPS
payment year, we modified our eligibility to include new clinician
types and an opt-in policy, revised the small practice bonus,
significantly revised the Promoting Interoperability performance
category scoring methodology, and added a topped-out cap for certain
topped out quality measures. As illustrated in Table 51, we estimated
that the mean and median final scores for the 2020 MIPS payment year
will be higher than for the 2019 MIPS payment year; however, we
anticipate the final scores for the 2021 MIPS payment year will be
lower. Recognizing the limitations of data for the 2019 MIPS payment
year and the 2020 MIPS payment year, we are requesting comments on
whether we should update or modify our estimates. We will propose the
actual performance threshold for the 2024 MIPS payment year in future
rulemaking.
Based on these analyses, we are proposing a performance threshold
of 45 points for the 2022 MIPS payment year and a performance threshold
of 60 points for the 2023 MIPS payment year to be codified at Sec.
414.1405(b)(7) and (8), respectively. A performance threshold of 45
points for the 2022 MIPS payment year and 60 points for the 2023 MIPS
payment year would be an increase that is consistent with the increase
in the performance threshold from the 2020 MIPS payment year (15
points) to the 2021 MIPS payment year (30 points), and we believe it
would allow for a consistent increase over time that provides a gradual
and incremental transition to the performance threshold we will
establish for the 2024 MIPS payment year, which we have estimated to be
74.01 points.
For example, if in future rulemaking we were to set the performance
threshold for the 2024 MIPS payment year at 75 points (which is close
to the mean final score for the 2019 MIPS payment year), this would
represent an increase in the performance threshold of approximately 45
points from the 2021 MIPS payment year (that is, the difference from
the Year 3 performance threshold of 30 points to a Year 6 performance
threshold of 75 points). We believe an increase of approximately 15
points each year, from Year 3 through Year 6 of the MIPS program, would
provide for a gradual and incremental transition toward a performance
threshold that must be set at the mean or median final score for a
prior period in Year 6 of the MIPS program.
We also believe this increase of 15 points per year could
incentivize higher performance by MIPS eligible clinicians and that a
performance threshold of 45 points for the 2022 MIPS payment year, and
a performance threshold of 60 points for the 2023 MIPS payment year,
represent a meaningful increase compared to 30 points for the 2021 MIPS
payment year, while maintaining flexibility for MIPS eligible
clinicians in the pathways available to achieve this performance
threshold. In section III.K.3.e.(4) of this proposed rule, we provide
examples of the ways clinicians can meet or exceed the proposed
performance threshold for the 2022 MIPS payment year.
[[Page 40803]]
We recognize that some MIPS eligible clinicians may not exceed the
proposed performance thresholds either due to poor performance or by
failing to report on an applicable measure or activity that is
required. We also recognize the unique challenges for small practices
and rural clinicians that could prevent them from meeting or exceeding
the proposed performance thresholds and refer readers to sections
III.K.3.a.(3)(b)(i) and III.K.3.a.(3)(b)(i)(A) of this proposed rule
for a discussion of the participation of small and rural practices in
MVPs and a request for feedback on small and rural practices
participation in MVPs, respectively.
We invite public comment on our proposals to set the performance
threshold for the 2022 MIPS payment year at 45 points and to set the
performance threshold for the 2023 MIPS payment year at 60 points. We
also seek comment on whether we should adopt a different performance
threshold in the final rule if we determine that the actual mean or
median final scores for the 2020 MIPS payment year are higher or lower
than our estimated performance threshold for the 2024 MIPS payment year
of 74.01 points. For example, if the actual mean or median final score
for the 2020 MIPS payment year is closer to 85 points, should we
finalize a higher performance threshold than currently proposed? Or if
the mean or median values are lower, should we finalize a lower
performance threshold? We anticipate the data will change over time and
that the distribution of final scores will differ from one year to the
next. We also seek comment on whether the increase should be more
gradual for the 2022 MIPS payment year, which would mean a lower
performance threshold (for example, 35 instead of 45 points), or
whether the increase should be steeper (for example, 50 points). We
also seek comment on alternative numerical values for the performance
threshold for the 2022 MIPS payment year. For the 2023 MIPS payment
year, we alternatively considered whether the performance threshold
should be set at a lower or higher number, for example, 55 points or 65
points, and also seek comment on alternative numerical values for the
performance threshold for the 2023 MIPS payment year.
(3) Additional Performance Threshold for Exceptional Performance
Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to
compute, for each year of the MIPS, an additional performance threshold
for purposes of determining the additional MIPS payment adjustment
factors for exceptional performance under section 1848(q)(6)(C) of the
Act. For each such year, the Secretary shall apply either of the
following methods for computing the additional performance threshold:
(1) The threshold shall be the score that is equal to the 25th
percentile of the range of possible final scores above the performance
threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2)
the threshold shall be the score that is equal to the 25th percentile
of the actual final scores for MIPS eligible clinicians with final
scores at or above the performance threshold for the prior period
described in section 1848(q)(6)(D)(i) of the Act. Under section
1848(q)(6)(C) of the Act, a MIPS eligible clinician with a final score
at or above the additional performance threshold will receive an
additional MIPS payment adjustment factor and may share in the $500
million of funding available for the year under section
1848(q)(6)(F)(iv) of the Act.
As we discussed in section III.K.3.e.(2) of this proposed rule, we
are relying on the special rule under section 1848(q)(6)(D)(iii) of the
Act to propose a performance threshold of 45 points for the 2022 MIPS
payment year and to propose a performance threshold of 60 points for
the 2023 MIPS payment year. As we also discussed in section
III.K.3.e.(2) of this proposed rule, for the initial 5 years of MIPS,
the special rule under section 1848(q)(6)(D)(iii) of the Act also
applies for purposes of establishing an additional performance
threshold for a year. For the 2022 MIPS payment year and the 2023 MIPS
payment year, we are relying on the discretion afforded by the special
rule and proposing to again decouple the additional performance
threshold from the performance threshold.
For illustrative purposes, we considered what the numerical values
would be for the additional performance threshold under one of the
methods described in section 1848(q)(6)(D)(ii) of the Act: The 25th
percentile of the range of possible final scores above the performance
threshold. With a proposed performance threshold of 45 points, the
range of total possible points above the performance threshold is 45.01
to 100 points and the 25th percentile of that range is 58.75, which is
just more than one-half of the possible 100 points in the MIPS final
score. We do not believe it would be appropriate to lower the
additional performance threshold to 58.75 points because it is below
the mean and median final scores for each of the prior performance
periods that are referenced in Table 51. Similarly, with a proposed
performance threshold for the 2023 MIPS payment year of 60 points, the
range of possible points above the performance threshold is 60.01 to
100 points and the 25th percentile of that range is 69.99 points. We do
not believe it would be appropriate to lower the additional performance
threshold to 69.99 points because it is below or close to the mean and
median final scores for each of the prior performance periods that are
referenced in Table 51.
We are relying on the special rule under section 1848(q)(6)(D)(iii)
of the Act to propose at Sec. 414.1405(d)(6) to set the additional
performance threshold for the 2022 MIPS payment year at 80 points and
to propose at Sec. 414.1405(d)(7) to set the additional performance
threshold for the 2023 MIPS payment year at 85 points. These values are
higher than the 25th percentile of the range of the possible final
scores above the proposed performance threshold for the 2022 and 2023
MIPS payment years.
We originally proposed 80 points for the additional performance
threshold for the 2021 MIPS payment year in the CY 2019 PFS proposed
rule (83 FR 35973) although we finalized 75 points in the CY 2019 PFS
final rule (83 FR 59886). In the CY 2019 PFS final rule, we noted the
impact that proposed policy changes for the 2021 MIPS payment year
could have on final scores as clinicians are becoming familiar with
these changes and noted our belief that 75 points was appropriate for
Year 3 of MIPS (83 FR 59883 through 59886). We also signaled our intent
to increase the additional performance threshold in future rulemaking.
(83 FR 59886).
We believe that 80 points and 85 points are minimal and incremental
increases over the additional performance threshold of 75 points for
the 2021 MIPS payment year. We also believe it is appropriate to raise
the bar on what is rewarded as exceptional performance for Year 4 and
for Year 5 of the MIPS program and that increasing the additional
performance threshold each year will encourage clinicians to increase
their focus on value-based care and enhance the delivery of high
quality care for Medicare beneficiaries.
An additional performance threshold of 80 points and 85 points
would each require a MIPS eligible clinician to participate and perform
well in multiple performance categories. Generally, under the proposed
performance category weights for the 2022 MIPS payment year discussed
as section III.K.3.d.(2)(b) of this proposed rule, a MIPS eligible
clinician who is scored on all four performance categories could
receive a maximum of 40 points towards the final score for the quality
[[Page 40804]]
performance category or a maximum score of 65 points for participating
in the quality performance category and Promoting Interoperability
performance category, which are both below the proposed 80-point and
85-point additional performance thresholds. In addition, 80 points and
85 points are at a high enough level that MIPS eligible clinicians must
submit data for the quality performance category to achieve this
target.
For example, if a MIPS eligible clinician gets a perfect score for
the improvement activities (15 percent), cost (20 percent), and
Promoting Interoperability (25 percent) performance categories, but
does not submit quality measures data, then the MIPS eligible clinician
would only receive 60 points (0 points for quality performance category
+ 20 points for the cost performance category + 15 points for
improvement activities performance category + 25 points for Promoting
Interoperability performance category), which is below the proposed
additional performance thresholds. We believe setting the additional
performance threshold at 80 points and 85 points could increase the
incentive for exceptional performance while keeping the focus on
quality performance.
We note that under section 1848(q)(6)(F)(iv) of the Act, funding is
available for additional MIPS payment adjustment factors under section
1848(q)(6)(C) of the Act only through the 2024 MIPS payment year, which
is the sixth year of the MIPS program. We believe it is appropriate to
further incentivize clinicians whose performance meets or exceeds the
additional performance threshold for the fourth and fifth years of the
MIPS program. We recognize that setting a higher additional performance
threshold may result in fewer clinicians receiving additional MIPS
payment adjustments. We also note that a higher additional performance
threshold could increase the maximum additional MIPS payment adjustment
that a MIPS eligible clinician potentially receives if the funds
available (up to $500 million for each year) are distributed over fewer
clinicians that have final scores at or above the higher additional
performance threshold.
We invite public comment on our proposals to set the additional
performance threshold at 80 points for the 2022 MIPS payment year and
at 85 points for the 2023 MIPS payment year. Alternatively, for the
2022 MIPS payment year, we considered whether the additional
performance threshold should remain at 75 points or be set at a higher
number, for example, 85 points, and also seek comment on alternative
numerical values for the additional performance threshold for the 2022
MIPS payment year. We refer readers to sections VI.E.10.c.(3) and
VI.F.2. of the RIA for the estimated maximum payment adjustments when
the additional performance threshold is set at 80 points and at 85
points, respectively, for the 2022 MIPS payment year.
Alternatively, for the 2023 MIPS payment year, we also considered
whether the additional performance threshold should remain at 80 points
as proposed for the 2022 MIPS payment year or whether a different
numerical value should be adopted for the 2023 MIPS payment year, and
also seek comment on alternative numerical values for the additional
performance threshold for the 2023 MIPS payment year. Additionally, in
the event that we adopt different numerical values for the performance
threshold in the final rule than proposed in section III.K.3.e.(2) of
this proposed rule, we seek comment on whether we should adopt
different numerical values for the additional performance threshold and
how we should set those values. We also seek comment on how the
distribution of the additional MIPS payment adjustments across MIPS
eligible clinicians may impact exceptional performance by clinicians
participating in MIPS. For example, the distribution of the additional
MIPS payment adjustments could result in a higher additional MIPS
payment adjustment available to fewer clinicians or could result in a
lower additional MIPS payment adjustment available to a larger number
of clinicians. We also remind readers that we anticipate the data will
change over time and that the distribution of final scores will differ
from one year to the next.
(4) Example of Adjustment Factors
In the CY 2019 PFS proposed rule (83 FR 35978 through 35981) and
the CY 2019 PFS final rule (83 FR 59891 through 59894), we provided a
figure and several tables as illustrative examples of how various final
scores would be converted to a MIPS payment adjustment factor, and
potentially an additional MIPS payment adjustment factor, using the
statutory formula and based on our proposed policies for the 2021 MIPS
payment year. We are updating the figure and tables based on the
policies we are proposing in this proposed rule.
Figure 1 provides an example of how various final scores would be
converted to a MIPS payment adjustment factor, and potentially an
additional MIPS payment adjustment factor, using the statutory formula
and based on the policies proposed for the 2022 MIPS payment year in
this proposed rule. In Figure 1, the performance threshold is 45
points. The applicable percentage is 9 percent for the 2022 MIPS
payment year. The MIPS payment adjustment factor is determined on a
linear sliding scale from zero to 100, with zero being the lowest
possible score which receives the negative applicable percentage
(negative 9 percent for the 2022 MIPS payment year) and resulting in
the lowest payment adjustment, and 100 being the highest possible score
which receives the highest positive applicable percentage and resulting
in the highest payment adjustment. However, there are two modifications
to this linear sliding scale. First, there is an exception for a final
score between zero and one-fourth of the performance threshold (zero
and 11.25 points based on the performance threshold of 45 points for
the 2022 MIPS payment year). All MIPS eligible clinicians with a final
score in this range would receive the lowest negative applicable
percentage (negative 9 percent for the 2022 MIPS payment year). Second,
the linear sliding scale line for the positive MIPS payment adjustment
factor is adjusted by the scaling factor, which cannot be higher than
3.0.
If the scaling factor is greater than zero and less than or equal
to 1.0, then the MIPS payment adjustment factor for a final score of
100 would be less than or equal to 9 percent. If the scaling factor is
above 1.0, but less than or equal to 3.0, then the MIPS payment
adjustment factor for a final score of 100 would be higher than 9
percent.
Only those MIPS eligible clinicians with a final score equal to 45
points (which is the performance threshold in this example) would
receive a neutral MIPS payment adjustment. Because the performance
threshold is 45 points, we anticipate that more clinicians will receive
a positive adjustment than a negative adjustment and that the scaling
factor would be less than 1 and the MIPS payment adjustment factor for
each MIPS eligible clinician with a final score of 100 points would be
less than 9 percent.
Figure 1 illustrates an example of the slope of the line for the
linear adjustments for the 2022 MIPS payment year, but it could change
considerably as new information becomes available. In this example, the
scaling factor for the MIPS payment adjustment factor is 0.203. In this
example, MIPS eligible clinicians with a final score equal to 100 would
have a MIPS payment adjustment factor of 1.823 percent (9 percent x
[[Page 40805]]
0.2026). (Note that this is prior to adding the additional payment
adjustment for exceptional performance, which is explained below.)
The proposed additional performance threshold for the 2022 MIPS
payment year is 80 points. An additional MIPS payment adjustment factor
of 0.5 percent starts at the additional performance threshold and
increases on a linear sliding scale up to 10 percent. This linear
sliding scale line is also multiplied by a scaling factor that is
greater than zero and less than or equal to 1.0. The scaling factor
will be determined so that the estimated aggregate increase in payments
associated with the application of the additional MIPS payment
adjustment factors is equal to $500 million. In Figure 1, the example
scaling factor for the additional MIPS payment adjustment factor is
0.395. Therefore, MIPS eligible clinicians with a final score of 100
would have an additional MIPS payment adjustment factor of 3.95 percent
(10 percent x 0.395). The total adjustment for a MIPS eligible
clinician with a final score equal to 100 would be 1 + 0.0182 + 0.0395
= 0.0578, for a total positive MIPS payment adjustment of 5.78 percent.
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The final MIPS payment adjustments will be determined by the
distribution of final scores across MIPS eligible clinicians and the
performance threshold. More MIPS eligible clinicians above the
performance threshold means the scaling factors would decrease because
more MIPS eligible clinicians receive a positive MIPS payment
adjustment factor. More MIPS eligible clinicians below the performance
threshold means the scaling factors would increase because more MIPS
eligible clinicians would receive a negative MIPS payment adjustment
factor and relatively fewer MIPS eligible clinicians would receive a
positive MIPS payment adjustment factor.
Table 52 illustrates the changes in payment adjustments based on
the final policies for the 2020 and 2021 MIPS payment years, and the
proposed policies for the 2022 and 2023 MIPS payment years discussed in
this proposed rule, as well as the statutorily required increase in the
applicable percent as required by section 1848(q)(6)(B) of the Act.
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We have provided updated examples below with the policies proposed
for the 2022 MIPS payment year to demonstrate scenarios in which MIPS
eligible clinicians can achieve a final score above the proposed
performance threshold of 45 points based on our final policies.
Example 1: MIPS Eligible Clinician in Small Practice Submits 5 Quality
Measures and 1 Improvement Activity
In the example illustrated in Table 53, a MIPS eligible clinician
in a small practice reporting individually exceeds the performance
threshold by performing at the median level for 5 quality measures via
Part B claims collection type and one medium-weight improvement
activity. The practice does not submit data for the Promoting
Interoperability performance category, but does submit a significant
hardship exception application which is approved; therefore, the weight
for the Promoting Interoperability performance
[[Page 40808]]
category is redistributed to the quality performance category under the
proposed reweighting policies discussed in section
III.K.3.d.(2)(b)(iii) of this proposed rule. We also assumed the small
practice has a cost performance category percent score of 50 percent.
Finally, we assumed a complex patient bonus of 3 points which
represents the average HCC risk score for the beneficiaries seen by the
MIPS eligible clinician, as well as the proportion of Medicare
beneficiaries that are dual eligible. There are special scoring rules
for the improvement activities performance category which affect MIPS
eligible clinicians in a small practice.
Six measure achievement points for each of the 5 quality
measures submitted at the median level of performance. We refer readers
to Sec. 414.1380(b)(1)(i) for further discussion of the quality
performance category scoring policy. Because the measures are submitted
via Part B claims, they do not qualify for the end-to-end electronic
reporting bonus, nor do the measures submitted qualify for the high-
priority bonus. The small practice bonus of 6 measure bonus points
apply because at least 1 measure was submitted. Because the MIPS
eligible clinician does not meet full participation requirements, the
MIPS eligible clinician does not qualify for improvement scoring. We
refer readers to Sec. 414.1380(b)(1)(vi) for the full participation
requirements for improvement scoring. Therefore, the quality
performance category is (30 measure achievement points + 6 measure
bonus points)/60 total available measure points + zero improvement
percent score which is 60 percent.
The Promoting Interoperability performance category weight
is redistributed to the quality performance category so that the
quality performance category score is worth 65 percent of the final
score. We refer readers to section III.K.3.d.(2)(b)(iii) of this
proposed rule for a discussion of this policy.
MIPS eligible clinicians in small practices qualify for
special scoring for improvement activities so a medium weighted
activity is worth 20 points out of a total 40 possible points for the
improvement activities performance category. We refer readers to Sec.
414.1380(b)(3) for further detail on scoring policies for small
practices for the improvement activities performance category.
This MIPS eligible clinician exceeds the performance
threshold of 45 points (but does not exceed the additional performance
threshold). This score is summarized in Table 53.
Table 53--Scoring Example 1, MIPS Eligible Clinician in a Small Practice
----------------------------------------------------------------------------------------------------------------
[A] [B] [C] [D]
Performance category Performance score....... Category weight......... Earned points
([B] * [C] * 100)
----------------------------------------------------------------------------------------------------------------
Quality............................... 60%..................... 65%..................... 39
Cost.................................. 50%..................... 20%..................... 10
Improvement Activities................ 20 out of 40 points--50% 15%..................... 7.5
Promoting Interoperability............ N/A..................... 0% (redistributed to 0
quality).
---------------------
Subtotal (Before Bonuses)......... ........................ ........................ 56.5
Complex Patient Bonus............. ........................ ........................ 3
---------------------
Final Score (not to exceed ........................ ........................ 59.5
100).
----------------------------------------------------------------------------------------------------------------
Example 2: Group Submission Not in a Small Practice
In the example illustrated in Table 54, a MIPS eligible clinician
in a medium size practice participating in MIPS as a group receives
performance category scores of 75 percent for the quality performance
category, 50 percent for the cost performance category, and 100 percent
for the Promoting Interoperability and improvement activities
performance categories. There are many paths for a practice to receive
a 75 percent score in the quality performance category, so for
simplicity we are assuming the score has been calculated at this
amount. Again, for simplicity, we assume a complex patient bonus of 3
points. The final score is calculated to be 83 points, and both the
performance threshold of 45 and the additional performance threshold of
80 are exceeded. In this example, the group practice exceeds the
additional performance threshold and will receive the additional MIPS
payment adjustment.
Table 54--Scoring Example 2, MIPS Eligible Clinician in a Medium Practice
----------------------------------------------------------------------------------------------------------------
[A] [B] [C] [D]
Performance category Performance score......... Category weight Earned points
(%) ([B] * [C] * 100)
----------------------------------------------------------------------------------------------------------------
Quality................................. 75%....................... 40 30
Cost.................................... 50%....................... 20 10
Improvement Activities.................. 40 out of 40 points--100%. 15 15
Promoting Interoperability.............. 100%...................... 25 25
---------------------
Subtotal (Before Bonuses)........... .......................... .................... 80
Complex Patient Bonus............... .......................... .................... 3
---------------------
Final Score (not to exceed 100). .......................... .................... 83
----------------------------------------------------------------------------------------------------------------
[[Page 40809]]
Example 3: Non-Patient Facing MIPS Eligible Clinician
In the example illustrated in Table 55, an individual MIPS eligible
clinician that is non-patient facing and not in a small practice
receives performance category scores of 50 percent for the quality
performance category, 50 percent for the cost performance category, and
50 percent for 1 medium-weighted improvement activity. Again, there are
many paths for a practice to receive a 50 percent score in the quality
performance category, so for simplicity we are assuming the score has
been calculated. Because the MIPS eligible clinician is non-patient
facing, they qualify for special scoring for improvement activities and
receive 20 points (out of 40 possible points) for the medium weighted
activity. Also, this individual did not submit Promoting
Interoperability measures and qualifies for the automatic
redistribution of the Promoting Interoperability performance category
weight to the quality performance category. Again, for simplicity, we
assume a complex patient bonus of 3 points.
In this example, the final score is 53 and the performance
threshold of 45 points is exceeded while the additional performance
threshold of 80 points is not.
Table 55--Scoring Example 3, Non-Patient Facing MIPS Eligible Clinician
----------------------------------------------------------------------------------------------------------------
[A] [B] [C] [D]
Performance category Performance score....... Category weight......... Earned points
([B] * [C] * 100)
----------------------------------------------------------------------------------------------------------------
Quality.............................. 50%..................... 65%..................... 32.5
Cost................................. 50%..................... 20%..................... 10
Improvement Activities............... 20 out of 40 points for 15%..................... 7.5
1 medium weight
activity--50%.
Promoting Interoperability........... 0%...................... 0% (redistributed to 0
quality).
Subtotal (Before Bonuses)........ ........................ ........................ 50
Complex Patient Bonus............ ........................ ........................ 3
----------------------
Final Score (not to exceed ........................ ........................ 53
100).
----------------------------------------------------------------------------------------------------------------
We note that these examples are not intended to be exhaustive of
the types of participants in MIPS nor the opportunities for reaching
and exceeding the performance threshold.
f. Targeted Review and Data Validation and Auditing
For previous discussions of our policies for targeted review, we
refer readers to the CY 2017 Quality Payment Program final rule (81 FR
77353 through 77358).
We are proposing to: (1) Identify who is eligible to request a
targeted review; (2) revise the timeline for submitting a targeted
review request; (3) add criteria for denial of a targeted review
request; (4) update requirements for requesting additional information;
(5) state who will be notified of targeted review decisions and require
retention of documentation submitted; and (6) codify the policy on
scoring recalculations. These proposals are discussed in more detail in
this proposed rule.
(1) Targeted Review
(a) Who Is Eligible To Request Targeted Review
In the CY 2017 Quality Payment Program final rule, we established
at Sec. 414.1385(a) that MIPS eligible clinicians and groups may
submit a targeted review request and that these submissions could be
with or without the assistance of a third party intermediary (81 FR
77353). In our efforts to minimize burden on MIPS eligible clinicians
and groups, we believe it is important to allow designated support
staff and third party intermediaries to submit targeted review requests
on their behalf. To expressly acknowledge the role of designated
support staff and third party intermediaries in the targeted review
process, we are proposing to revise Sec. 414.1385(a)(1) to state that
a MIPS eligible clinician or group (including their designated support
staff), or a third party intermediary as defined at Sec. 414.1305, may
submit a request for a targeted review. MIPS eligible clinicians and
groups (including their designated support staff) can request a
targeted review by logging into the QPP website at qpp.cms.gov, and
after reviewing their performance feedback for the relevant performance
period and MIPS payment year, they can submit a request for targeted
review. An authorized third party intermediary as defined at Sec.
414.1305, such as a qualified registry, health IT vendor, or QCDR, that
does not have access to their clients' performance feedback still would
be able to request a targeted review on behalf of their clients. Third
party intermediaries do not have access to the performance feedback of
MIPS eligible clinicians and groups; therefore, we will share an URL
link to the Targeted Review Request Form with these designated
entities. In the CY 2017 Quality Payment Program final rule, we
established at Sec. 414.1385(a)(2) that CMS will respond to each
request for targeted review timely submitted and determine whether a
targeted review is warranted (81 FR 77353). We are proposing to
redesignate this provision as Sec. 414.1385(a)(4).
(b) Timeline for Targeted Review Requests
In the CY 2017 Quality Payment Program final rule (81 FR 77358), we
finalized at Sec. 414.1385(a)(1) that MIPS eligible clinicians and
groups have a 60-day period to submit a request for targeted review,
which begins on the day we make available the MIPS payment adjustment
factor, and if applicable the additional MIPS payment adjustment factor
(collectively referred to as the MIPS payment adjustment factors), for
the MIPS payment year and ends on September 30 of the year prior to the
MIPS payment year or a later date specified by CMS. During the first
year of targeted review for MIPS, we allowed MIPS eligible clinicians
and groups 90 days, with an additional 14-day extension, to submit a
targeted review request. In response to user feedback, in December
2018, we made available revised performance feedback to MIPS eligible
clinicians and groups who had filed a targeted review request. We
believe it is important to ensure MIPS eligible clinicians and groups
have an opportunity to review their revised
[[Page 40810]]
performance feedback prior to the application of the MIPS payment
adjustment factors. We anticipate that by limiting the targeted review
period to 60 days, we would be able to make available the revised
performance feedback during October of the year prior to the MIPS
payment year, which would be approximately 2 months earlier than what
we were able to do for the first year of targeted review. Therefore, we
are proposing to revise Sec. 414.1385(a)(2) to state that all requests
for targeted review must be submitted during the targeted review
request submission period, which is a 60-day period that begins on the
day CMS makes available the MIPS payment adjustment factors for the
MIPS payment year, and to state that the targeted review request
submission period may be extended as specified by CMS. We are proposing
this change would apply beginning with the 2019 performance period.
(c) Denial of Targeted Review Requests
Each targeted review request is carefully reviewed based upon the
information provided at the time the request is submitted. During the
first year of targeted review, CMS received many targeted review
requests that were duplicative. We continue to seek opportunities to
limit burden and improve the efficiency of our processes. Therefore, we
are proposing to revise Sec. 414.1385(a)(3) to state that a request
for a targeted review may be denied if: The request is duplicative of
another request for targeted review; the request is not submitted
during the targeted review request submission period; or the request is
outside of the scope of targeted review, which is limited to the
calculation of the MIPS payment adjustment factors applicable to the
MIPS eligible clinician or group for a year. Notification will be
provided to the individual or entity that submitted the targeted review
request as follows:
If the targeted review request is denied; in this case,
there will be no change to the MIPS final score or associated MIPS
payment adjustment factors for the MIPS eligible clinician or group.
If the targeted review request is approved; in this case,
the MIPS final score and associated MIPS payment adjustment factors may
be revised, if applicable, for the MIPS eligible clinician or group.
(d) Request for Additional Information
In the CY 2017 Quality Payment Program final rule (81 FR 77358), we
finalized at Sec. 414.1385(a)(3) that the MIPS eligible clinician or
group may include additional information in support of their request
for targeted review at the time the request is submitted, and if CMS
requests additional information from the MIPS eligible clinician or
group, it must be provided and received by CMS within 30 days of the
request, and that non-responsiveness to the request for additional
information may result in the closure of the targeted review request,
although the MIPS eligible clinician or group may submit another
request for targeted review before the deadline. Supporting
documentation is a critical component of evaluating and processing a
targeted review request. We may need to request supporting
documentation, as each targeted review request is reviewed individually
and by category. Therefore, we are proposing to add Sec.
414.1385(a)(5) to state that a request for a targeted review may
include additional information in support of the request at the time it
is submitted. If CMS requests additional information from the MIPS
eligible clinician or group that is the subject of a request for a
targeted review, it must be provided and received by CMS within 30 days
of CMS's request. Non-responsiveness to CMS's request for additional
information may result in a final decision based on the information
available, although another request for a targeted review may be
submitted before the end of the targeted review request submission
period. Documentation can include, but is not limited to:
Supporting extracts from the MIPS eligible clinician or
group's EHR.
Copies of performance data provided to a third party
intermediary by the MIPS eligible clinician or group.
Copies of performance data submitted to CMS.
QPP Service Center ticket numbers.
Signed contracts or agreements between a MIPS eligible
clinician/group and a third party intermediary.
(e) Notification of Targeted Review Decisions
In the CY 2017 Quality Payment Program final rule (81 FR 77358), we
finalized at Sec. 414.1385(a)(4) that decisions based on the targeted
review are final, and there is no further review or appeal. We are
proposing to renumber this provision as Sec. 414.1385(a)(7) and to add
text to Sec. 414.1385(a)(7) to state that CMS will notify the
individual or entity that submitted the request for a targeted review
of the final decision. To align with policies finalized at Sec.
414.1400(g) regarding the auditing of entities submitting MIPS data, we
are also proposing to add Sec. 414.1385(a)(8) to state that
documentation submitted for a targeted review must be retained by the
submitter for 6 years from the end of the MIPS performance period.
(f) Scoring Recalculations
In the CY 2017 Quality Payment Program final rule (81 FR 77353), we
stated that if a request for targeted review is approved, the outcome
of such review may vary. We stated, for example, we may determine that
the clinician should have been excluded from MIPS, re-distribute the
weights of certain performance categories within the final score (for
example, if a performance category should have been weighted at zero),
or recalculate a performance category score in accordance with the
scoring methodology for the affected category, if technically feasible
(81 FR 77353). Therefore, we are proposing to add Sec. 414.1385(a)(6)
to state that if a request for a targeted review is approved, CMS may
recalculate, to the extent feasible and applicable, the scores of a
MIPS eligible clinician or group with regard to the measures,
activities, performance categories, and final score, as well as the
MIPS payment adjustment factors.
(2) Data Validation and Auditing
For previous discussions of our policies for data validation and
auditing at Sec. 414.1390, we refer readers to the CY 2017 Quality
Payment Program final rule (81 FR 77358 through 77362). Among other
requirements, Sec. 414.1390(b) establishes that all MIPS eligible
clinicians and groups that submit data and information to CMS for
purposes of MIPS must certify to the best of their knowledge that the
data submitted is true, accurate and complete. MIPS data that are
inaccurate, incomplete, unusable or otherwise compromised can result in
improper payment. Despite these existing obligations, we have received
inquiries regarding perceived opportunities to selectively submit data
that are unrepresentative of the MIPS performance of the clinician or
group. Using data selection criteria to misrepresent a clinician or
group's performance for an applicable performance period, commonly
referred to as ``cherry-picking,'' results in data submissions that are
not true, accurate or complete. A clinician or group cannot certify
that data submitted to CMS are true, accurate and complete to the best
of its knowledge if they know the data submitted is not representative
of the clinician's or group's performance. Accordingly, a clinician or
group that submits a certification under Sec. 414.1390(b) in
connection with the
[[Page 40811]]
submission of data they know is cherry-picked has submitted a false
certification in violation of existing regulatory requirements. If CMS
believes cherry-picking of data may be occurring, we may subject the
MIPS eligible clinician or group to auditing in accordance with Sec.
414.1390(a) and in the case of improper payment a reopening and
revision of the MIPS payment adjustment in accordance with Sec.
414.1390(c).
g. Third Party Intermediaries
We refer readers to Sec. Sec. 414.1305 and 414.1400, the CY 17
Quality Payment Program final rule (81 FR 77362 through 77390), the CY
2018 Quality Payment Program final rule (82 FR 53806 through 53819),
and the CY 2019 PFS final rule (83 FR 59894 through 59910) for our
previously established policies regarding third party intermediaries.
In this proposed rule, we propose to make several changes. We
propose to establish new requirements for MIPS performance categories
that must be supported by QCDRs, qualified registries, and Health IT
vendors. We are proposing to modify the criteria for approval as a
third party intermediary, and establish new requirements to promote
continuity of service to clinicians and groups that use third party
intermediaries for their MIPS submissions. With respect to QCDRs, we
are also proposing requirements to: Engage in activities that will
foster improvement in the quality of care; and enhance performance
feedback requirements. These QCDR proposals would also affect the self-
nomination process. We are also proposing to update considerations for
QCDR measures. With respect to qualified registries, we are also
proposing to require enhanced performance feedback requirements.
Finally, we are clarifying the remedial action and termination
provisions applicable to all third party intermediaries.
Because we believe that third party intermediaries, such as QCDRs,
represent a useful path to fulfilling MIPS requirements while reducing
the reporting burden for clinicians, we believe the proposals discussed
in this section justify the collection of information and regulatory
impact burden estimates discussed in sections IV. and VI. of this
proposed rule, respectively, for additional information on the costs
and benefits.
(1) Proposed Requirements for MIPS Performance Categories That Must Be
Supported by Third Party Intermediaries
We refer readers to Sec. 414.1400(a)(2) and the CY 2017 Quality
Payment Program final rule (81 FR 77363 through 77364) and as further
revised in the CY 2019 PFS final rule at Sec. 414.1400(a)(2) (83 FR
60088) for our current policy regarding the types of MIPS data third-
party intermediaries may submit. In sum, the current policy is that
QCDRs, qualified registries, and health IT vendors may submit data for
any of the following MIPS performance categories: Quality (except for
data on the CAHPS for MIPS survey); improvement activities; and
Promoting Interoperability. Through education and outreach, we have
become aware of stakeholders' desires to have a more cohesive
participation experience across all performance categories under MIPS.
Specifically, we have heard of instances where clinicians would like to
use their QCDR or qualified registry for reporting the improvement
activities and promoting interoperability performance categories, but
their particular third party intermediary does not support all
categories, only quality. Based on this feedback and additional data
regarding QCDRs and qualified registries respectively, which are
discussed further below, we believe it is reasonable to strengthen our
policies at Sec. 414.1400(a)(2), and require QCDRs and qualified
registries to support three performance categories: Quality;
improvement activities; and Promoting Interoperability. Accordingly, we
propose to amend Sec. 414.1400(a)(2) to state that beginning with the
2021 performance period and for all future years, for the MIPS
performance categories identified in the regulation, QCDRs and
qualified registries must be able to submit data for each category, and
Health IT vendors must be able to submit data for at least one
category. We solicit feedback on the benefits and burdens of this
proposal, including whether the requirement to support all three
identified categories of MIPS performance data should extend to health
IT vendors.
However, we recognize the need to create an exception to allow
QCDRs and qualified registries that only represent MIPS eligible
clinicians that are eligible for reweighting under the Promoting
Interoperability performance category. For example, as discussed in the
CY 2019 PFS final rule (83 FR 59819 through 59820), physical therapists
generally are eligible for reweighting of the Promoting
Interoperability performance category to zero percent of the final
score; therefore, under this exception, a QCDR or qualified registry
that represents only physical therapists that reweighted the Promoting
Interoperability performance category to zero percent of the final
score, would not be required to support the Promoting Interoperability
performance category. Therefore, we are proposing to revise Sec.
414.1400(a)(2)(iii) to state that for the Promoting Interoperability
performance category, the requirement applies if the eligible
clinician, group, or virtual group is using CEHRT; however, a third
party could be excepted from this requirement if its MIPS eligible
clinicians, groups or virtual groups fall under the reweighting
policies at Sec. 414.1380(c)(2)(i)(A)(4) or (5) or Sec.
414.1380(c)(2)(i)(C)(1)-(7) or Sec. 414.1380(c)(2)(i)(C)(9). We refer
readers to section III.K.3.c.(4) of this proposed rule for additional
information on the clinician types that are eligible for reweighting
the Promoting Interoperability performance category. We anticipate
using the self-nomination vetting process to assess whether the QCDR or
qualified registry is subject to our proposed requirement to support
reporting the Promoting Interoperability performance category. We
solicit comments on this proposal, including the scope of the proposed
exception from the Promoting Interoperability reporting requirement for
certain types of QCDRs and qualified registries. Specifically, we
solicit comment on whether we should more narrowly tailor, or
conversely broaden, the proposed exceptions for when QCDRS and
qualified registries must support the Promoting Interoperability
performance category.
(2) Approval Criteria for Third Party Intermediaries
We refer readers to Sec. 414.1400(a)(4) and the CY 2019 PFS final
rule (83 FR 59894 through 59895; 60088) for previously finalized
policies related to the approval criteria for third party
intermediaries.
Based on experience with third party intermediaries thus far, in
this proposed rule we are proposing to adopt two additional criteria
for approval at Sec. 414.1400(a)(4) to ensure continuity of services
to MIPS eligible clinicians, groups, and virtual groups that utilize
the services of third party intermediaries. Specifically, we have
experienced instances where a third party intermediary withdraws mid-
performance period, which impacts the clinician or group's ability to
participate in the MIPS program, through no fault of their own. We are
proposing two
[[Page 40812]]
changes to help prevent these disruptions. First, we are proposing at
Sec. 414.1400(a)(4) to add a new paragraph (v) to establish that a
condition of approval for a third party intermediary is for the entity
to agree to provide services for the entire performance period and
applicable data submission period. In addition, we are proposing at
Sec. 414.1400(a)(4) to add a new paragraph (vi) to establish that a
condition of approval is for third party intermediary to agree that
prior to discontinuing services to any MIPS eligible clinician, group
or virtual group during a performance period, the third party
intermediary must support the transition of such MIPS eligible
clinician, group, or virtual group to an alternate data submission
mechanism or third party intermediary according to a CMS approved a
transition plan. We believe it is important to condition the approval
of a third party intermediary on the entity agreeing to follow this
process so that in the case a third-party intermediary fails to meet
its obligation under the proposed new Sec. 414.1400(a)(4)(v) to
provide services for the entire performance period and corresponding
data submission period, the third party intermediary and the
clinicians, groups, and virtual groups it serves have common
expectations of the support the third party intermediary will provide
to its users in connection with its withdrawal. We believe these
proposed conditions of approval will help ensure that entities seeking
to become approved as third party intermediaries are aware of the
expectations to provide continuous service for the duration of the
entire performance period and corresponding data submission period,
will help reduce the extent to which the clinicians, groups, and
virtual groups are inadvertently impacted by a third party intermediary
withdrawing from the program, and will help clinicians, groups, and
virtual groups avoid additional reporting burden that may result from
withdrawals mid-performance period. We note that under this proposal,
if CMS determines that a third party intermediary has ceased to meet
either of these proposed new criteria for approval, CMS may take
remedial action or terminate the third party intermediary in accordance
with Sec. 414.1400(f). We also refer readers to sections III.K.3.g.(3)
and III.K.3.g.(4) where we discuss these proposals for QCDRs and
qualified registries specifically.
(3) Qualified Clinical Data Registries (QCDRs)
In this proposed rule, we propose to update: (a) QCDR approval
criteria; and (b) various policies related to QCDR measures. These
proposals would also affect the QCDR self-nomination process.
(a) QCDR Approval Criteria
We generally refer readers to section 1848(m)(3)(E) of the Act, as
added by section 601(b)(1)(B) of the American Taxpayer Relief Act of
2012, which requires the Secretary to establish requirements for an
entity to be considered a Qualified Clinical Data Registry (QCDR) and a
process to determine whether or not an entity meets such requirements.
We refer readers to section 1848(m)(3)(E)(i), (v) of the Act, the CY
2019 PFS final rule (83 FR 60088), and Sec. 414.1400(a)(4) through (b)
for previously finalized policies about third party intermediaries and
QCDR approval criteria. In this proposed rule, we are proposing to add
to those policies to require QCDRs to: (a) Support all three
performance categories where data submission is required; (b) engage in
activities that will foster improvement in the quality of care; and (c)
enhance performance feedback requirements.
(i) Requirement for QCDRs To Support All Three Performance Categories
Where Data Submission Is Required
We also refer readers to section III.K.3.g.(1) above, where we
propose to require QCDRs and qualified registries to support three
performance categories: Quality, improvement activities, and Promoting
Interoperability. In this section, we discuss QCDRs specifically. As
previously stated in the CY 2017 Quality Payment Program final rule (81
FR 77363 through 77364), section 1848(q)(1)(E) of the Act encourages
the use of QCDRs in carrying out MIPS. Although section
1848(q)(5)(B)(ii)(I) of the Act specifically requires the Secretary to
encourage MIPS eligible clinicians to use QCDRs to report on applicable
measures for the quality performance category, and section
1848(q)(12)(A)(ii) of the Act requires the Secretary to encourage the
provision of performance feedback through QCDRs, the statute does not
specifically address use of QCDRs for the other MIPS performance
categories (81 FR 77363). Although we previously could have limited the
use of QCDRs to assessing only the quality performance category under
MIPS and providing performance feedback, we believed (and still
believe) it would be less burdensome for MIPS eligible clinicians if we
expand QCDRs' capabilities (81 FR 77363). By allowing QCDRs to report
on quality measures, improvement activities, and Promoting
Interoperability measures, we alleviate the need for individual MIPS
eligible clinicians and groups to use a separate mechanism to report
data for these performance categories (81 FR 77363). It is important to
note that QCDRs do not need to submit data for the cost performance
category since these measures are administrative claims-based measures
(81 FR 77363).
As noted above, based on previously finalized policies in the CY
2017 Quality Payment Program final rule (81 FR 77363 through 77364) and
as further revised in the CY 2019 PFS final rule at Sec.
414.1400(a)(2) (83 FR 60088), the current policy is that QCDRs,
qualified registries, and health IT vendors may submit data for any of
the following MIPS performance categories: Quality (except for data on
the CAHPS for MIPS survey); improvement activities; and Promoting
Interoperability.
Through education and outreach, we have become aware of
stakeholders' desires to have a more cohesive participation experience
across all performance categories under MIPS. Specifically, we have
heard of instances where clinicians would like to use their QCDR for
reporting the improvement activities and promoting interoperability
performance categories, but their particular QCDR does not support all
categories, only quality. This results in the clinician needing to
enter into a business relationship with another third party to complete
their MIPS reporting or leverage a different submitter type or
submission type, which can create additional burden to the clinician.
We believe that requiring QCDRs to be able to support these performance
categories will be a step towards addressing stakeholders concerns on
having a more cohesive participation experience across all performance
categories under MIPS. In addition, we believe this proposal will help
to reduce the reporting burden MIPS eligible clinicians and groups face
when having to utilize multiple submission mechanisms to meet the
reporting requirements of the various performance categories.
Furthermore, as we move to a more cohesive participation experience
under the MIPS Value Pathways (MVP), as discussed in section
III.K.3.a., Transforming MIPS: MIPS Value Pathways Framework, we
believe this proposal will assist clinicians in that transition.
Based on our review of existing 2019 QCDRs through the 2019 QCDR
Qualified Posting, approximately 92
[[Page 40813]]
QCDRs, or about 72 percent of the QCDRs currently participating in the
program are supporting all three performance categories. The 2019 QCDR
qualified posting is available in the QPP Resource Library at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/347/2019%20QCDR%20Qualified%20Posting_Final_v3.xlsx. In addition, in our
review of prior data through previous qualified postings for the 2017
and 2018 performance periods, we have observed that a majority of the
QCDRs participating in the program supported the three performance
categories that require data submission. In 2017, 73 percent
(approximately 83 QCDRs) and in 2018, 73 percent (approximately 110
QCDRs) have supported all three performance categories. Based on this
data, we believe it is reasonable to want to continue to strengthen our
policies at Sec. 414.1400(a)(2), to require that QCDRs have the
capacity to support the reporting requirements of the quality,
improvement activities, and promoting interoperability performance
categories.
Therefore, beginning with the 2021 performance period and for
future years, we propose to require QCDRs to support three performance
categories: Quality, improvement activities, and Promoting
Interoperability. Additionally, for reasons, as discussed above, we
propose to amend Sec. 414.1400(a)(2) to state beginning with the 2021
performance period and for all future years, for the following MIPS
performance categories, QCDRs must be able to submit data for all
categories, and Health IT vendors must be able to submit data for at
least one category: Quality (except for data on the CAHPS for MIPS
survey); improvement activities; and Promoting Interoperability with an
exception. As discussed in section III.K.3.g.(1) of this proposed rule,
we are proposing that based on the proposed amendment to Sec.
414.1400(a)(2)(iii), for the Promoting Interoperability performance
category, the requirement applies if the eligible clinician, group, or
virtual group is using CEHRT; however, a third party could be excepted
from this requirement if its MIPS eligible clinicians, groups or
virtual groups fall under the reweighting policies at Sec.
414.1380(c)(2)(i)(A)(4), (c)(2)(i)(A)(5), (c)(2)(i)(C)(1) through
(c)(2)(i)(C)(7), or (c)(2)(i)(C)(9). As part of this proposal, we would
require QCDRs to attest to the ability to submit data for these
performance categories, as applicable, at time of self-nomination.
(ii) Requirement for QCDRs To Engage in Activities That Will Foster
Improvement in the Quality of Care
We generally refer readers to section 1848(m)(3)(E)(i) and (v) of
the Act, which requires the Secretary to establish requirements for an
entity to be considered a qualified clinical data registry and a
process to determine whether or not an entity meets such requirements.
Section 1848(m)(3)(E)(ii)(IV) of the Act provides that in establishing
such requirements, the Secretary must consider whether an entity, among
other things, supports quality improvement initiatives for
participants.
As detailed at Sec. 414.1305(1) a QCDR means: For the 2019, 2020
and 2021 MIPS payment year, a CMS-approved entity that has self-
nominated and successfully completed a qualification process to
determine whether the entity may collect medical or clinical data for
the purpose of patient and disease tracking to foster improvement in
the quality of care provided to patients.
Although ``improvement in the quality of care'' is broadly included
under paragraph (2) of the definition of a QCDR at Sec. 414.1305 in
the 2019 PFS final rule (83 FR 59897), we want to further clarify how a
QCDR can be successful in fostering improvement in the quality of care
provided to patients by clinicians and groups. We understand putting
parameters around exactly what improvement in the quality of care may
be can be difficult due to the varying nature of QCDRs organizational
structures. For example, we have QCDRs that are founded by both large
and small specialty societies, and healthcare systems where the volumes
of services, available resources, and volume of members may vary.
However, we believe QCDRs should enhance education and outreach to
clinicians and groups to improve patient care.
The definition of qualified clinical data registry (QCDR) at Sec.
414.1305(2) currently states that beginning with the 2022 MIPS payment
year, an entity that demonstrates clinical expertise in medicine and
quality measurement development experience and collects medical or
clinical data on behalf of a MIPS eligible clinician for the purpose of
patient and disease tracking to foster improvement in the quality of
care provided to patients. In this proposed rule, we are proposing
policies with regards to ``foster improvement in the quality of care.''
Therefore, we are proposing to add Sec. 414.1400(b)(2)(iii) that
beginning with the 2023 MIPS payment year, the QCDRs must foster
services to clinicians and groups to improve the quality of care
provided to patients by providing educational services in quality
improvement and leading quality improvement initiatives. Quality
improvement services may be broad, and do not necessarily have to be
specific towards an individual clinical process. An example of a broad
quality improvement service would be for the QCDR to provide reports
and educating clinicians on areas of improvement for patient
populations by clinical condition for specific clinical care criteria.
Furthermore, an example of an individual clinical process specific
quality improvement service would be if the QCDR supports a metric that
measures blood pressure management, the QCDR could use that data to
identify best practices used by high performers and broadly educate
other clinicians and groups on how they can improve the quality of care
they provide. We believe educational services in quality improvement
for eligible clinicians and groups would encourage meaningful and
actionable feedback for clinicians to make improvements in patient
care. To be clear, these QCDR quality improvement services would be
separate and apart from any activities that are reported on under the
improvement activities performance category. We believe improvement
activities can be distinguished from quality improvement services,
because they are actions taken by MIPS eligible clinicians under the
improvement activities performance category. Improvement activities
means an activity that relevant MIPS eligible clinician, organizations
and other relevant stakeholders identify as improving clinical practice
or care delivery and that the Secretary determines, when effectively
executed, is likely to result in improved outcomes (Sec. 414.1305).
Quality improvement services, on the other hand, would be actions taken
by the QCDR. While these QCDR quality improvement services could
potentially overlap with an improvement activity, requirements for the
improvement activities performance category would still apply to MIPS
eligible clinicians and groups.
We are proposing to require QCDRs to describe the quality
improvement services they intend to support in their self-nomination
for CMS review and approval. We intend on including the QCDR's approved
quality improvement services in the qualified posting for each approved
QCDR.
[[Page 40814]]
(iii) Enhanced Performance Feedback Requirement
Section 1848(q)(12)(A)(ii) of the Act requires the Secretary to
encourage the provision of performance feedback through QCDRs. In
addition, in establishing the requirements, the Secretary must
consider, among other things, whether an entity provides timely
performance reports to participants at the individual participant level
(section 1848(m)(3)(E)(ii)(III) of the Act). Currently, CMS requires
QCDRs to provide timely performance feedback at least 4 times a year on
all of the MIPS performance categories that the QCDR reports to CMS (82
FR 53812). Based on our experiences thus far under the Quality Payment
Program, we agree that providing feedback at least 4 times a year is
appropriate. However, in the future CMS would like to see, and
therefore encourages QCDRs, to provide timely feedback on a more
frequent basis more than 4 times a year. Receipt of more frequent
feedback will help clinicians and groups make more timely changes to
their practice to ensure the highest quality of care is being provided
to patients. We see value in providing more timely feedback to meet the
objectives \136\ of the Quality Payment Program in improving the care
received by Medicare beneficiaries, lowering the costs to the Medicare
program through improvement of care and health, and advance the use of
healthcare information between allied providers and patients. We also
believe there is value in this performance feedback, and therefore,
encourage QCDRs to work with their clinicians to get the data in
earlier in the reporting period so the QCDR can give meaningful, timely
feedback.
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\136\ Quality Payment Program Overview. https://qpp.cms.gov/about/qpp-overview.
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In the QCDR performance feedback currently being provided to
clinicians and groups, we have heard from stakeholders that that not
all QCDRs provide feedback the same way. We have heard through
stakeholder comments that some QCDR feedback contains information
needed to improve quality, whereas other QCDR feedback does not supply
such information due to the data collection timeline. Additionally, we
believe that clinicians would benefit from feedback on how they compare
to other clinicians who have submitted data on a given measure (MIPS
quality measure or QCDR measure) within the QCDR they are reporting
through, so they can identify areas of measurement in which improvement
is needed, and furthermore, they can see how they compare to their
peers based within a QCDR, since the feedback provided by the QCDR
would be limited to those who reported on a given measure using that
specific QCDR.
Therefore, we are proposing a change so that QCDRs structure
feedback in a similar manner. We propose a new paragraph at Sec.
414.1400(b)(2)(iv), beginning with the 2023 MIPS payment year, to
require that QCDRs provide performance feedback to their clinicians and
groups at least 4 times a year, and provide specific feedback to their
clinicians and groups on how they compare to other clinicians who have
submitted data on a given measure within the QCDR. Exceptions to this
requirement may occur if the QCDR does not receive the data from their
clinician until the end of the performance period. We are also
soliciting comment on other exceptions that may be necessary under this
requirement.
We also understand that QCDRs can only provide feedback on data
they have collected on their clinicians and groups, and realize the
comparison would be limited to that data and not reflect the larger
sample of those that have submitted on the measure for MIPS, which the
QCDR does not have access to. We believe QCDR internal comparisons can
still help MIPS eligible clinicians identify areas where further
improvement is needed. The ability for MIPS eligible clinicians to be
able to know in real time how they are performing against their peers,
within a QCDR, provides immediate actionable feedback. We believe this
provides value gained for clinicians as the majority of QCDRs are
specialty specific or regional based, therefore the clinician can gain
peer comparisons that are specific to their peer cohort, which can be
specialty specific or locality based.
Furthermore, we are also proposing to strengthen the QCDR self-
nomination process at Sec. 414.1400(b)(1) to add that beginning with
the 2023 MIPS payment year, QCDRs are required to attest during the
self-nomination process that they can provide performance feedback at
least 4 times a year (as specified at Sec. 414.1400(b)(2)(iv)).
In addition, the current performance period begins January 1 and
ends on December 31st, and the corresponding data submission deadline
is typically March 31st as described at Sec. 414.1325(e)(1). As
discussed above, we have heard from QCDR stakeholders that in some
instances clinicians wait until the end of the performance period to
submit data to the third party intermediary, who are then unable to
provide meaningful feedback to their clinicians 4 times a year.
Therefore, we are also seeking comment for future notice-and-comment
rulemaking on whether we should require MIPS eligible clinicians,
groups, and virtual groups who utilize a QCDR to submit data throughout
the performance period, and prior to the close of the performance
period (that is, December 31st). We are also seeking comment for future
notice-and-comment rulemaking, on whether clinicians and groups can
start submitting their data starting April 1 to ensure that the QCDR is
providing feedback and the clinician or group during the performance
period. This would allow QCDRs some time to provide enhanced and
actionable feedback to MIPS eligible clinicians prior to the data
submission deadline.
(b) QCDR Measures
We refer readers to Sec. 414.1400(b)(1), the CY 2018 Quality
Payment Program final rule (82 FR 53814) and the CY 2019 PFS final rule
(83 FR 59898 through 59900) for our previously established policies for
the QCDR measure self-nomination process. In this proposed rule, we are
proposing policies related to: (a) Considerations for QCDR measure
approval; (b) requirements for QCDR measure approval; (c)
considerations for QCDR measure rejections; (d) the approval process;
and (e) QCDR measures that have failed to reach benchmarking
thresholds. These are discussed in detail below.
(c) QCDR Measure Requirements
(i) QCDR Measure Considerations and Requirements for Approval or
Rejection
Through education and outreach, we have heard stakeholders'
concerns about the complexity of reporting when there is a large
inventory of QCDR measures to choose from, and believe our proposals
will help to ensure that the measures made available in MIPS are
meaningful to a clinician's scope of practice. In this proposed rule,
we are proposing to codify established QCDR measure considerations and
propose, beginning with the CY 2021 performance period, a number of
QCDR measure specific requirements, that would generally align with
MIPS measure policies, which can be found in the CY 2018 Quality
Payment Program final rule (82 FR 53636), and as described in section
III.K.3.c.(1) of this proposed rule.
[[Page 40815]]
(A) QCDR Measure Considerations
(aa) Previously Finalized QCDR Measure Considerations
We generally refer readers to the Sec. 414.1400(b)(3), CY 2017
Quality Payment Program final rule (81 FR 77374 through 77375) and the
CY 2019 PFS final rule (83 FR 59900 through 59902) for previously
finalized standards and criteria used for selecting and approving QCDR
measures. QCDR measures are reviewed for inclusion on an annual basis
during the QCDR measure review process that occurs once the self-
nomination period closes (82 FR 53810). All previously approved QCDR
measures and new QCDR measures are currently reviewed on an annual
basis to determine whether they are appropriate for the program (82 FR
53811). The QCDR measure review process occurs after the self-
nomination period closes on September 1st. QCDR measures are not
finalized or removed through notice and comment rulemaking; instead,
they are currently approved or not approved through a subregulatory
processes (82 FR 53639).
In the CY 2019 PFS final rule (83 FR 59902), we finalized our
proposal to apply the following criteria beginning with the 2021 MIPS
payment year when considering QCDR measures for possible inclusion in
MIPS:
Measures that are beyond the measure concept phase of
development.
Preference given to measures that are outcome-based rather
than clinical process measures.
Measures that address patient safety and adverse events.
Measures that identify appropriate use of diagnosis and
therapeutics.
Measures that address the domain for care coordination.
Measures that address the domain for patient and caregiver
experience.
Measures that address efficiency, cost and resource use.
Measures that address significant variation in
performance.
In this proposed rule, we propose to codify a number of those
previously finalized QCDR measure considerations (83 FR 59902). We are
proposing to amend Sec. 414.1400 by adding Sec. 414.1400(b)(3)(iv) to
include the following previously finalized QCDR measure considerations
for approval:
Preference for measures that are outcome-based rather than
clinical process measures.
Measures that address patient safety and adverse events.
Measures that identify appropriate use of diagnosis and
therapeutics.
Measures that address the domain of care coordination.
Measures that address the domain for patient and caregiver
experience.
Measures that address efficiency, cost, and resource use.
More information on QCDR measure approval criteria can be found in
the QCDR/Qualified Registry Self-Nomination Tool-Kit in the QPP
Resource Library. We refer readers to section III.K.3.g.(3)(c)(i)(B) of
this rule where we are proposing to change the following previously
finalized considerations into requirements:
Measures that are beyond the measure concept phase of
development.
Measures that address significant variation in
performance.
(bb) New QCDR Measure Considerations for Approval
(AA) QCDR Measure Availability
In the CY 2018 Quality Payment Program final rule (82 FR 53813
through 53814), we finalized a policy beginning with the 2018
performance period, that allowed QCDRs to seek permission from another
QCDR to use an existing and approved QCDR measure. If a QCDR would like
to report on an existing QCDR measure that is owned by another QCDR,
they must have permission from the QCDR that owns the measure that they
can use the measure for the performance period. Permission must be
granted at the time of self-nomination, so that the QCDR that is using
the QCDR measure can include written proof of permission for CMS review
and approval. We also finalized in the CY 2018 Quality Payment Program
final rule (82 FR 53814) that once QCDR measures are approved, we will
assign QCDR measure IDs, and the same measure IDs must be used by the
other QCDRs that have permission to also report on the measure.
We generally encourage QCDR measure owners to permit other QCDRs to
report their measures on behalf of MIPS eligible clinicians for
purposes of MIPS. To the extent that QCDR measure owners limit the
availability of their measures, such limitations may adversely affect a
QCDR's ability to benchmark the measure, the robustness of the
benchmark, or the comparability of MIPS eligible clinicians'
performance results on the measure. For these reasons, we propose to
amend Sec. 414.1400 to add paragraph (b)(3)(iv)(H) to state that CMS
may consider the extent to which a QCDR measure is available to MIPS
eligible clinicians reporting through QCDRs other than the QCDR measure
owner for purposes of MIPS. If CMS determines that a QCDR measure is
not available to MIPS eligible clinicians, groups, and virtual groups
reporting through other QCDRs, CMS may not approve the measure.
(BB) QCDR Measure Addresses a Measurement Gap
As a part of the QCDR measure development process, QCDRs should
conduct an environmental scan of existing QCDR measures; MIPS quality
measures; quality measures retired from the legacy program, PQRS; and
review the most recent CMS Quality Measure Development Plan Annual
Report, which is currently available for 2019 at: https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/2019-Quality-MDP-Annual-Report-and-Appendices.zip and the Blueprint for the CMS Measures
Management System: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf for guidance
in areas where CMS has identified gaps in quality measurement to reduce
the possibility of duplicative measure development. We propose to amend
Sec. 414.1400 to add Sec. 414.1400(b)(3)(iv)(I) to state that we
would give greater consideration to measures for which QCDRs: (a)
Conducted an environmental scan of existing QCDR measures; MIPS quality
measures; quality measures retired from the legacy Physician Quality
Reporting System (PQRS) program; and (b) utilized the CMS Quality
Measure Development Plan Annual Report and the Blueprint for the CMS
Measures Management System to identify measurement gaps prior to
measure development.
(CC) QCDRs Measures Meeting Benchmarking Thresholds
Over the first 2 years of MIPS, we have observed instances where
QCDR measures have been approved for continued use in the program, but
have had low reporting volumes, below the case minimum and reporting
volume thresholds required for a measure to be benchmarked within the
program. As described in the CY 2017 Quality Payment Program final rule
(81 FR 77277 through 77282), for benchmarks to be developed, a measure
must have a minimum of 20 individual clinicians or groups who reported
the measure to meet the data completeness requirement and the minimum
case size criteria. QCDRs should be aware of which measures are
considered low-reported, since measures that do not meet benchmarking
thresholds result in a 3-point floor, as described in the CY 2017
Quality Payment Program final rule (81 FR 77282). QCDR measures are
reviewed and approved on an annual
[[Page 40816]]
basis, and as a part of the review process, we review: The benchmarking
file from the previous year (for example, the 2019 Quality Benchmark
file, found on the QPP Resource Library, which is available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/342/2019%20MIPS%20Quality%20Benchmarks.zip); production submission data
submitted from the previous year's data submission period; and data
provided to us by the QCDRs themselves.
As discussed in our QCDR measure rejection considerations proposal
below, we propose a QCDR measure that does not meet case minimum and
reporting volumes required for benchmarking after being in the program
for 2 consecutive CY performance may not continue to be approved in the
future if our proposal is finalized as proposed. We note that this
factor is parallel to what is being proposed for MIPS quality measures
in section III.K.3.c.(1) of this proposed rule, and is important when
considering the volume of QCDR measures that are currently in the
program that have had low reporting rates year-over-year. We propose to
amend Sec. 414.1400 to add paragraph (b)(3)(iv)(J) to state that
beginning with the 2020 performance period, we place greater preference
on QCDR measures that meet case minimum and reporting volumes required
for benchmarking after being in the program for 2 consecutive CY
performance periods. Those that do not, may not continue to be
approved. We refer readers to section III.K.3.g.(3)(c)(ii) below in
this proposed rule, for discussion on how QCDRs may create
participation plans for existing approved QCDR measures that have
failed to reach benchmarking thresholds, in order to be reconsidered
for future use. We also refer readers to Sec. 414.1330 for additional
information.
(B) QCDR Measure Requirements
(aa) Previously Finalized Requirements Considerations Codified as
Requirements
As mentioned above, in this proposed rule, we propose to change two
previously finalized measure considerations into requirements and
codify those requirements. We previously finalized that we would apply
certain criteria beginning with the 2021 MIPS payment year when
considering QCDR measures for possible inclusion in MIPS (83 FR 59902).
We refer readers to section III.K.3.g.(3)(c)(i)(A) where we are
proposing to codify the majority as measure considerations. However,
for two of those previously finalized consideration, we are proposing
them as requirements:
Measures that are beyond the measure concept phase of
development.
Measures that address significant variation in
performance.
We believe the previously finalized consideration that measures are
beyond the measure concept phase of development should be a requirement
because measures that do not surpass the measure concept phase will not
be able to complete another QCDR measure requirement, measure testing.
In addition, we believe the previously finalized consideration that
measures address significant variation in performance should be a
requirement because QCDR measures that do not demonstrate performance
variation will likely be identified as topped out and will not be
approved.
Therefore, beginning with the 2020 performance period, we are
proposing to change both of those considerations into requirements and
are proposing to amend Sec. 414.1400 by adding Sec. 414.1400(b)(3)(v)
to include the following:
Measures that are beyond the measure concept phase of
development.
Measures that address significant variation in
performance.
(bb) Linking QCDR Measures to Cost Measures, Improvement Activities,
and MIPS Value Pathways (MVP)
To prepare QCDR measures for self-nomination, we believe there
should be consideration of how these QCDR measures relate to similar
topics covered through the other performance categories. We believe (as
noted in the Transforming MIPS: MIPS Value Pathways Framework, see
section III.K.3.a. of this proposed rule) that to transform the MIPS
program to one of value, MIPS measures and QCDR measures, should have
an associated cost measure, improvement activity, and eventually a
corresponding MVP. This would strengthen the QCDR measure's relevance
in the program. We believe that evaluating the strength of these
linkages may decrease the frequency of receiving extraneous QCDR
measures that are not relevant or meaningful within the framework of
the MIPS program.
Therefore, beginning with the 2021 performance period and future
years, we propose that QCDRs must identify a linkage between their QCDR
measures to the following, at the time of self-nomination: (a) Cost
measure (as found in section III.K.3.c.(2) of this proposed rule); (b)
Improvement Activity (as found in Appendix 2: Improvement Activities
Tables); or (c) CMS developed MVPs (as described in Table C-B1 of
section III.K.3.a. of this proposed rule). Under the pathway framework
for example, a surgery specific QCDR should be able to correlate their
surgery-related QCDR measure to an MVP, such as the Major Surgery
pathway.
We understand that not all measures may have a direct link. In
cases where a QCDR measure does not have a clear link to a cost
measure, improvement activity, or an MVP, we would consider exceptions
if the potential QCDR measure otherwise meets the QCDR measure
requirements defined above.
However, we believe that when possible, it is important to
establish a strong linkage between quality, cost, and improvement
activities. Therefore, we also propose to amend Sec. 414.1400 to add
paragraph (b)(3)(iv)(G) to require, beginning with the 2021 performance
period, that QCDRs link their QCDR measures to the following at the
time of self-nomination: (a) Cost measure; (b) improvement activity;
and (c) an MVP. If the potential QCDR measure otherwise meets the QCDR
measure requirements but does not have a clear link to a cost measure,
improvement activity, or an MVP, we would consider exceptions for
measures that otherwise meet the QCDR measure requirements and
considerations as discussed above.
Therefore, we also propose to amend Sec. 414.1400 to add paragraph
(b)(3)(iv)(G) to require, beginning with the 2021 performance period,
that QCDRs link their QCDR measures to the following at the time of
self-nomination: (a) Cost measure; (b) improvement activity; and (c) an
MVP. In cases where a QCDR measure does not have a clear link to a cost
measure, improvement activity, or an MVP, we would consider exceptions
if the potential QCDR measure otherwise meets the QCDR measure
requirements.
(cc) Completion of QCDR Measure Testing
We refer readers to the CY 2019 PFS final rule, where we gave
notice to the public that we were considering proposing to require
reliability and feasibility testing as an added criteria in order for a
QCDR measure to be considered for MIPS in future rulemaking (83 FR
59901 through 59902). After consideration of the public comments
received, and our priority to ensure that all measures available in
MIPS are reliable and valid thereby reducing reporting burden on
eligible clinicians and groups, we are moving forward with a proposal
in this proposed rule.
Beginning with the 2021 performance period and future years, we
propose,
[[Page 40817]]
that for a QCDR measure to be considered for use in the program, all
QCDR measures submitted at the time of self-nomination must be fully
developed with completed testing results at the clinician level, as
defined by the CMS Blueprint for the CMS Measures Management System
(available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf), and as used in the
testing of MIPS quality measures prior to the submission of those
measures to the Call for Measures. We believe that full development and
testing with completed testing results at the clinician level helps to
demonstrate whether the QCDR measure is ready for implementation at the
time of self-nomination. We intend to include only measures that are
valid, reliable, and feasible for use by clinicians and will be
consistent with the criteria that is expected of MIPS quality measures.
As a result, we are also proposing to amend Sec. 414.1400 to add
paragraph (b)(3)(v)(C) to reflect this proposal. At Sec.
414.1400(b)(3)(v)(C), we propose beginning with the 2021 performance
period, all QCDR measures must be fully developed and tested, with
complete testing results at the clinician level, prior to submitting
the QCDR measure at the time of self-nomination.
We note that the testing process for quality measures is dependent
on the measure type (for example, a measure that is specified as an
eCQM measure has additional steps it must undergo when compared to
other measure types). The National Quality Forum (NQF) has developed
guides for measure testing criteria and standards which further
illustrate these differences based on measure type. Additionally, the
costs associated with testing vary based on the complexity of the
measure and the developing organization. The Journal of the American
Medical Association states that the costs associated with quality
measures are generally unknown or unreported.\137\ While we understand
the proposed policy will result in additional costs for QCDRs to
develop measures, given the uncertainty regarding the number and types
of measures that will be proposed in future performance periods coupled
with the lack of available cost data on measure development and
testing, we are unable to determine the financial impact of this
proposal on QCDRs beyond the likelihood of it being more than trivial.
Likewise, we understand that some QCDRs already perform measure testing
prior to submission for approval while others do not. This variability
makes it difficult to estimate the incremental impact of this
regulation. Please refer to section VI the Regulatory Impact Analysis
of this rule for additional details.
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\137\ Schuster, Onorato, and Meltzer. ``Measuring the Cost of
Quality Measurement: A Missing Link in Quality Strategy'', Journal
of the American Medical Association. 2017; 318(13):1219-1220.
https://jamanetwork.com/journals/jama/fullarticle/2653111?resultClick=1.
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(dd) Collection of Data on QCDR Measures
We have observed several instances in which QCDRs have attempted to
use the MIPS Program to ``test'' out measure concepts without concrete
evidence that there is a measurement performance gap. We want to
discourage that and ensure QCDR measures used for the MIPS Program are
valid and reliable. In addition, through reviews of QCDR measure
submissions, where reporting data was provided by the QCDR or through
submission data from the 2017 performance period, we have identified
some current QCDR measures in the program that have continuously low
reporting rates, which affects the ability to meet benchmarking
criteria. The data submitted is insufficient in meeting the case
minimum and volume thresholds required for benchmarking.
Therefore, we are proposing to require QCDRs to collect data on the
potential QCDR measure. For a QCDR measure to be considered for use in
the program, beginning with the 2021 performance period and future
years, we are proposing to amend Sec. 414.1400 to add paragraph
(b)(3)(v)(D) that QCDRs are required to collect data on a QCDR measure,
appropriate to the measure type, prior to submitting the QCDR measure
for CMS consideration during the self-nomination period. The data
collected must demonstrate whether the QCDR measure is valid and
reflects an important clinical concept(s) that clinicians wish to be
measured on. By collecting data on the QCDR measure prior to self-
nomination, QCDRs would be able to demonstrate whether the measure is
implementable and data collection on the metric is possible. In
addition, the data collected on the QCDR measure prior to self-
nomination, could be used to demonstrate that there is a performance
gap and need for measurement. We suggest QCDRs to collect data on as
many months as possible, but strongly encourage QCDRs to collect data
for 12 months prior to submitting the QCDR measure for our
consideration at the time of self-nomination, since quality reporting
requires 12 months of data, as described in Sec. 414.1335, as this
will also likely increase the chance that the measure will be able to
be benchmarked.
(ee) Duplicative QCDR Measures
As first discussed by commenters in the CY 2018 Quality Payment
Program final rule (82 FR 53814), the topic of ``shared'' measures was
discussed and how would CMS intend to harmonize. In the CY 2019 PFS
proposed rule (83 FR 35983), and further discussed in CY 2019 PFS final
rule (83 FR 59901), we shared that we believe duplicative measures are
counterintuitive to the Meaningful Measures initiative that promotes
more focused quality measure development towards outcomes that are
meaningful to patients, families and their providers. Therefore, it is
our intent to move toward measure harmonization, which supports our
efforts to increase measure alignment and eliminate redundancy both
within the MIPS measure set and across our programs (83 FR 59901).
Taking the previous feedback into consideration, we are moving forward
with a proposal in this rule.
Therefore, we propose, beginning with the 2020 performance period,
that after the self-nomination period closes each year, we will review
newly self-nominated and previously approved QCDR measures based on
considerations as described in the CY 2019 PFS final rule (83 FR 59900
through 59902). In instances in which multiple, similar QCDR measures
exist that warrant approval, we may provisionally approve the
individual QCDR measures for 1 year with the condition that QCDRs
address certain areas of duplication with other approved QCDR measures
in order to be considered for the program in subsequent years. The QCDR
could do so by harmonizing its measure with, or significantly
differentiating its measure from, other similar QCDR measures. QCDR
measure harmonization may require two or more QCDRs to work
collaboratively to develop one cohesive QCDR measure that is
representative of their similar yet, individual measures. In other
words, we would not approve duplicative QCDR measures (which will be
identified as a part of our scan of previously approved measures, and
new QCDR measure submissions) if QCDRs choose not to address the areas
of duplication with other approved QCDR measures identified by us
during the previous year's QCDR measure review period. We believe this
policy would help to reduce the number of duplicative QCDR measures
that are submitted as a part of the self-nomination process. Adding a
structured timeframe provides
[[Page 40818]]
transparency to QCDRs who will know what next steps to expect if they
do not address the identified areas of duplication as requested.
Therefore, we propose to amend Sec. 414.1400 to add paragraph
(b)(3)(v)(E) to state beginning with the 2022 MIPS payment year, CMS
may provisionally approve the individual QCDR measures for 1 year with
the condition that QCDRs address certain areas of duplication with
other approved QCDR measures in order to be considered for the program
in subsequent years. If the QCDR measures are not harmonized, CMS may
reject the duplicative QCDR measure(s) as discussed in section
III.K.3.g.(3)(c)(i)(C) below.
(C) QCDR Measure Rejections
We are proposing QCDR measure rejection criteria that generally
aligns with finalized removal criteria for MIPS quality measures in the
CY 2019 PFS final rule (83 FR 59763 through 59765). Utilizing these
considerations would help to ensure that QCDR measures available in the
program are truly meaningful and measurable areas where quality
improvement is sought. As part of this proposal, all previously
approved QCDR measures and new QCDR measures would be reviewed on an
annual basis (as a part of the QCDR measure review process that occurs
after the self-nomination period closes on September 1st) to determine
whether they are appropriate for the program.
We propose to amend Sec. 414.1400 to add paragraph (b)(3)(vii) to
state that beginning with the 2020 performance period, we propose to
reject QCDR measures with consideration of, but not limited to, the
following factors:
QCDR measures that are duplicative or identical to other
QCDR measures or MIPS quality measures that are currently in the
program.
QCDR measures that are duplicative or identical to MIPS
quality measures that have been removed from MIPS through rulemaking.
QCDR measures that are duplicative or identical to quality
measures used under the legacy Physician Quality Reporting System
(PQRS) program, which have been retired.
QCDR measures that meet the ``topped out'' definition as
described at Sec. 414.1305 and in the CY 2017 QPP final rule (81 FR
77282 through 77283). If a QCDR measure is topped out and rejected, it
may be reconsidered for the program in future years if the QCDR can
provide evidence through additional data and/or recent literature that
a performance gap exists and show that the measure is no longer topped
out during the next QCDR measure self-nomination process.
QCDR measures that are process-based, with considerations
to whether the removal of the process measure impacts the number of
measures available for a specific specialty.
Whether the QCDR measure has potential unintended
consequences to a patient's care. For example, the measure disqualifies
a patient from receiving oxygen therapy or other comfort measures.
Considerations and evaluation of the measure's performance
data, to determine whether performance variance exists.
Whether the previously identified areas of duplication
have been addressed as requested. (We refer readers to our proposal
discussed in section III.K.3.g.(3)(c)(i)(B) above.)
QCDR measures that split a single clinical practice or
action into several QCDR measures. For example, splitting a measure
into multiple measures based on a particular body extremity:
Improvement in toe pain--the 5th toe, and a separate measure for the
2nd toe.
QCDR measures that are ``check-box'' with no actionable
quality action. For example, a QCDR measure that measures that a survey
has been distributed to patients.
QCDR measures that do not meet the case minimum and
reporting volumes required for benchmarking after being in the program
for 2 consecutive years (we also refer readers to our proposal in
section III.K.3.g.(3)(c)(ii) below).
Whether the existing approved QCDR measure is no longer
considered robust, in instances where new QCDR measures are considered
to have a more vigorous quality action, where CMS preference is to
include the new QCDR measure rather than requesting QCDR measure
harmonization.
QCDR measures with clinician attribution issues, where the
quality action is not under the direct control of the reporting
clinician (that is, the quality aspect being measured cannot be
attributed to the clinician or is not under the direct control of the
reporting clinician).
QCDR measures that focus on rare events or ``never
events'' in the measurement period. An example of a ``never event''
would be a fire in the operating room.
(ii) QCDR Measure Review Process
(A) Current QCDR Measure Approval Process
We refer readers to the CY 2017 Quality Payment Program final rule
(81 FR 77374 through 77375), the CY 2018 Quality Payment Program final
rule (82 FR 53813 through 53814), and the CY 2019 PFS final rule (83 FR
59900 through 59906), and Sec. 414.1400(b)(3) for our previously
established policies for the QCDR measure self-nomination process. QCDR
measures are reviewed for inclusion on an annual basis during the QCDR
measure review process that occurs once the self-nomination period
closes (82 FR 53810). All previously approved QCDR measures and new
QCDR measures are currently reviewed on an annual basis to determine
whether they are appropriate for the program (82 FR 53811). The QCDR
measure review process occurs after the self-nomination period closes
on September 1st. QCDR measures are not finalized or removed through
notice and comment rulemaking; instead, they are currently approved or
not approved through a subregulatory processes (82 FR 53639). While we
would continue to review measures on an annual basis, in this proposed
rule, we are proposing the addition of a multi-year approval process.
(B) Multi-Year QCDR Measure Approval
Previously in the CY 2018 Quality Payment Program final rule (82 FR
53808), we discussed our concerns with multi-year approval for QCDR
measures and sought comment from stakeholders as to how to mitigate our
concerns. Based on the evolution of public comments in the CY 2019 PFS
final rule (83 FR 59898 through 59901) and ongoing engagement with
QCDRs, we are moving forward with a proposal in this rule.
Currently, our QCDR measure approvals are on a year-to-year basis
(82 FR 53811), from September to December once self-nomination occurs.
In addition to that process, to help reduce yearly self-nomination
burden and address stakeholder feedback (83 FR 59898 through 59901), we
are proposing to amend Sec. 414.1400 to add paragraph (b)(3)(vi) to
implement, beginning with the 2021 performance period, 2-year QCDR
measure approvals (at our discretion) for QCDR measures that attain
approval status by meeting the QCDR measure considerations and
requirements described above.
However, as part of this proposal, upon annual review, we may
revoke the second year's approval if a QCDR measure approved for 2
years is:
Topped out (we refer readers to Sec. 414.1305, in the CY
2017 QPP final rule (81 FR 77282 through 77283));
Duplicative of a more robust measure (this proposal aligns
with our
[[Page 40819]]
proposal at section III.K.3.g.(3)(c) above);
Reflects an outdated clinical guideline;
Requires measure harmonization (this proposal aligns with
our proposal at section III.K.3.g.(3)(c)(i)(B) above); or
The QCDR self-nominating the QCDR measure is no longer in
good standing, as described in the CY 2018 Quality Payment Program
final rule (82 FR 53808).
We believe that this policy should be an incentive for QCDRs who
have remained in good standing in the program. Additionally, for QCDRs
not in good standing, we want to make clear that we would not remove a
measure mid-year; rather, the measure's 2-year approval would be
revoked during annual review after 1 year and the QCDR's measures would
no longer qualify for multi-year approval in the future. For example,
if QCDR ABC is placed on probation in July, all of the QCDR's measures
still would be available for reporting for that performance period
(until December 31st); however, if any of QCDR ABC's QCDR measures were
previously approved for 2 years, the approval would be revoked for the
second year.
(iii) Participation Plan for Existing QCDR Measures That Have Failed To
Reach Benchmarking Thresholds
We refer readers to section III.K.3.g.(3)(c)(i), above in this
proposed rule for discussion of the consideration of QCDR measures that
fail to meet benchmarking thresholds after being in the program for 2
consecutive CY performance may not continue to be approved in the
future.
However, we understand that there are instances where measures that
are low-reported may still be considered important to a respective
specialty. Therefore, beginning with the 2020 performance period, we
propose to amend Sec. 414.1400 to add paragraph (b)(3)(iv)(J)(aa) to
state in instances where a QCDR believes the low-reported QCDR measure
that did not meet benchmarking thresholds is still important and
relevant to a specialist's practice, that the QCDR may develop and
submit a QCDR measure participation plan for our consideration. This
QCDR measure participation plan must include the QCDR's detailed plans
and changes to encourage eligible clinicians and groups to submit data
on the low-reported QCDR measure for purposes of the MIPS program. As
examples, a QCDR measure participation plan could include one or more
of the following:
Development of an education and communication plan.
Update the QCDR measure's specification with changes to
encourage broader participation, which would require review and
approval by us.
Require reporting on the QCDR measure as a condition of
reporting through the QCDR.
To be clear, implementation of a participation plan would not
guarantee that a QCDR measure would be approved for a future
performance period, as we consider many factors in whether to approve
QCDR measures. At the following annual review of QCDR measures, we
would analyze the measure's data submissions to determine whether the
QCDR measure participation plan was effective (meaning, reporting
volume increased, thereby increasing the likelihood of the QCDR measure
being benchmarked). If the data does not show an increase in reporting
volume, we may not approve the QCDR measure for the subsequent year.
(4) Qualified Registries
We refer readers to Sec. Sec. 414.1305 and 414.1400, the CY 2018
Quality Payment Program final rule (82 FR 53815 through 53818) and the
CY 2019 PFS final rule proposed rule (83 FR 59906) for our previously
finalized policies regarding qualified registries. In this proposed
rule, we propose to update qualified registry required services. These
proposals would also affect the qualified registry self-nomination
process.
(a) Qualified Registry Required Services
(i) Requirement for Qualified Registries To Support All Three
Performance Categories Where Data Submission Is Required
We refer readers to section 1848(k)(4) of Act for statutory
authority. We also refer readers to section III.K.3.g.(3) above, where
we propose to require QCDRs and qualified registries to support three
performance categories: Quality, improvement activities, and Promoting
Interoperability. In addition, we refer readers to section
III.K.3.g.(3)(a)(i) where we discuss a parallel requirement for QCDRs.
In this section, we discuss qualified registries specifically. Based on
previously finalized policies the CY 2017 Quality Payment Program final
rule (81 FR 77363 through 77364) and as further revised in the CY 2019
PFS final rule at (83 FR 60088) and Sec. 414.1400(a)(2), the current
policy is that QCDRs, qualified registries, and health IT vendors may
submit data for any of the following MIPS performance categories:
Quality (except for data on the CAHPS for MIPS survey); improvement
activities; and Promoting Interoperability.
We want to continue to strengthen our policies at Sec.
414.1400(a)(2). Based on our review of existing 2019 qualified
registries, approximately 95 qualified registries, or about 70 percent
of the qualified registries currently participating in the program are
supporting all three performance categories. The qualified posting of
approved 2019 qualified registries can be found on the QPP resource
library at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/348/2019%20Qualified%20Registry%20Posting_Final_v1.0.xlsx. We believe it is
reasonable that all qualified registries have the capacity to support
the improvement activities and promoting interoperability performance
categories.
We believe that requiring qualified registries to be able to
support these performance categories will be a step towards addressing
stakeholders concerns on having a more cohesive participation
experience across all performance categories under MIPS. In addition,
we believe this proposal will help to reduce the reporting burden MIPS
eligible clinicians and groups face when having to utilize multiple
submission mechanisms to meet the reporting requirements of the various
performance categories. Furthermore, as we move to a more cohesive
participation experience under the MVPs, as discussed in section
III.K.3.a. of this proposed rule, Transforming MIPS Path to Value, we
believe this proposal will assist clinicians in that transition.
Therefore, as discussed above beginning with the 2021 performance
period and for future years, we propose at Sec. 414.1400(a)(2) to
require qualified registries to support all three performance
categories: Quality (except for data on the CAHPS for MIPS survey);
improvement activities; and Promoting Interoperability with an
exception. As discussed in section III.K.3.g.(1) of this rule, we are
proposing that based on the proposed amendment to Sec.
414.1400(a)(2)(iii), to state that for the Promoting Interoperability
performance category, the requirement applies if the eligible
clinician, group, or virtual group is using CEHRT; however, a third
party could be be excepted from this requirement if its MIPS eligible
clinicians, groups or virtual groups fall under the reweighting
policies at Sec. 414.1380(c)(2)(i)(A)(4), (c)(2)(i)(A)(5),
(c)(2)(i)(C)(1) through (c)(2)(i)(C)(7), or (c)(2)(i)(C)(9). As part of
this proposal, we would require qualified registries to attest to the
ability to submit data for
[[Page 40820]]
these performance categories, as applicable, at time of self-
nomination. We are also proposing this same requirement for QCDRs in
section III.K.3.g.(3) of this proposed rule.
(ii) Enhanced Performance Feedback Requirement
Section 1848(q)(12)(A)(ii) of the Act requires the Secretary to
encourage the provision of performance feedback through qualified
registries. In addition, in establishing the requirements, the
Secretary must consider, among other things, whether an entity
``provides timely performance reports to participants at the individual
participant level''. Currently, CMS requires qualified registries to
provide feedback on all of the MIPS performance categories at least 4
times per year (81 FR 77367 through 77386). While based on our
experiences thus far during the initial years of the Quality Payment
Program, we agree that providing feedback at least 4 times a year is
appropriate. However, in the future CMS would like to see, and
therefore encourages qualified registries, to provide timely feedback
on a more frequent basis more than 4 times a year. Receipt of more
frequent feedback will help clinicians and groups make more timely
changes to their practice to ensure the highest quality of care is
being provided to patients. We see value in providing more timely
feedback to meet the objectives \138\ of the Quality Payment Program in
improving the care received by Medicare beneficiaries, lowering the
costs to the Medicare program through improvement of care and health,
and advance the use of healthcare information between allied providers
and patients. We also believe there is value in this performance
feedback and therefore encourage qualified registries to work with
their clinicians to get the data in earlier in the reporting period so
the qualified registry give that meaningful timely feedback.
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\138\ Quality Payment Program Overview. https://qpp.cms.gov/about/qpp-overview.
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Surrounding the qualified registry performance feedback provided to
clinicians and groups, we have heard from stakeholders that not all
qualified registries provide feedback the same way. We have heard
through stakeholder comments some qualified registries feedback
contains information needed to improve quality, whereas other qualified
registries feedback does not supply such information due to the data
collection timeline. Additionally, we believe that clinicians would
benefit from feedback on how they compare to other clinicians who have
submitted data on a given MIPS quality measure within the qualified
registry they are reporting through, so they can identify areas of
measurement in which improvement is needed, and furthermore they can
see how they compare to their peers based within a qualified registry,
since the feedback provided by the qualified registry would be limited
to those who reported on a given measure using that specific qualified
registry.
As a result, we are proposing to add a new paragraph at Sec.
414.1400(c)(2) to require (i) and (ii). We are simply proposing to
revise the current Sec. 414.1400(c)(2) to reclassify at paragraph
(c)(2)(i) that beginning with the 2022 MIPS payment year, the qualified
registry must have at least 25 participants by January 1 of the year
prior to the applicable performance period. Additionally, we are
proposing to add a new paragraph, Sec. 414.1400(c)(2)(ii), beginning
with the 2023 MIPS payment year, to require that qualifed registries
provide the following as a part of the performance feedback given at
least 4 times a year: Feedback to their clinicians and groups on how
they compare to other clinicians who have submitted data on a given
measure within the qualified registry. We understand that there would
be instances in which the qualified registry cannot meet this
requirement; and therefore, we are also proposing an exception to this
requirement: If the qualified registry does not receive the data from
their clinician until the end of the performance period, this will
preclude the qualified registry from providing feedback 4 times a year,
and the qualified registry could be excepted from this requirement. We
are also soliciting comment on other exceptions that may be necessary
under this requirement.
We also understand that qualified registries can only provide
feedback on data they have collected on their clinicians and groups,
and realize the comparison would be limited to that data and not
reflect the larger sample of those that have submitted on the measure
for MIPS, which the qualified registry does not have access to. We
believe qualified registry internal comparisons can still help MIPS
eligible clinicians identify areas where further improvement is needed.
The ability for MIPS eligible clinicians to be able to know in real
time how they are performing against their peers, within a qualified
registry, provides immediate actionable feedback.
Furthermore, we are also proposing to strengthen the qualified
registry self-nomination process at Sec. 414.1400(c)(1) to add that
beginning with the 2023 MIPS payment year, qualified registries are
required to attest during the self-nomination process that they can
provide performance feedback at least 4 times a year (as specified at
Sec. 414.1400(c)(2)(ii)). We refer readers to section III.K.3.g.(3)(1)
where we are proposing a parallel requirement for QCDRs; we intend to
have the same requirements for both QCDRs and qualifies registries.
In addition, the current performance period begins January 1 and
ends on December 31st, and the corresponding data submission deadline
is typically March 31st as described at Sec. 414.1325(e)(1). As
discussed above, we have heard from qualified registry stakeholders
that in some instances clinicians wait until the end of the performance
period to submit data to the third party intermediary, who are then
unable to provide meaningful feedback to their clinicians 4 times a
year. Therefore, we are also seeking comment for future notice-and-
comment rulemaking on whether we should require MIPS eligible
clinicians, groups, and virtual groups who utilize a qualfied registry
to submit data throughout the performance period, and prior to the
close of the performance period (that is, December 31st). We are also
seeking comment for future notice-and-comment rulemaking, on whether
clinicians and groups can start submitting their data starting April 1
to ensure that the qualified registry is providing feedback and the
clinician or group during the performance period. This would allow
qualified registries some time to provide enhanced and actionable
feedback to MIPS eligible clinicians prior to the data submission
deadline.
(5) Remedial Action and Termination of Third Party Intermediaries
We refer readers to Sec. 414.1400(f), the CY 2017 Quality Payment
Program final rule (81 FR 77548) and the CY 2019 PFS final rule (83 FR
59908 through 59910) for previously finalized policies for remedial
action and termination of third party intermediaries.
Based on experience with third party intermediaries thus far, we
have concerns that certain third party intermediaries may not fully
appreciate their existing compliance obligations or the implications of
non-compliance. Among other provisions, Sec. 414.1400(a)(5)
specifically obligates each third party intermediary to certify that
all data it submits to CMS on behalf of a MIPS eligible clinician,
group or virtual group is true, accurate and complete to the best of
its knowledge.
[[Page 40821]]
Section 414.1400(f)(1) states that, after providing written notice, CMS
may take remedial action or terminate a third party intermediary if CMS
determines that the third party intermediary has ceased to meet one or
more of the applicable criteria for approval or has submitted data that
is inaccurate, unusable or otherwise compromised. Moreover, Sec.
414.1400(f)(3) identifies specific circumstances under which CMS may
determine that data submitted by a third party intermediary meets the
standard for inaccurate, unusable or otherwise compromised data.
Third parties intermediaries have an affirmative obligation to
certify that the data they submit on behalf of a MIPS eligible
clinician, group or virtual group are true, accurate and complete to
the best of its knowledge. MIPS data that are inaccurate, incomplete,
unusable or otherwise compromised can result in improper payment. Using
data selection criteria to misrepresent a clinician or group's
performance for an applicable performance period, commonly referred to
as ``cherry-picking,'' results in data submissions that are not true,
accurate or complete. A third party intermediary cannot certify that
data submitted to CMS by the third party intermediary are true,
accurate and complete to the best of its knowledge if the third party
intermediary knows the data submitted are not representative of the
clinician's or group's performance. As described in section
III.K.3.c.(1) of this proposed rule, we proposed to further amend Sec.
414.1340(a)(3) to clarify that the submitted data should be reflective
of a 70 percent random sample. We believe this clarification will
emphasize to all parties that the data submitted on each measure is
expected to be representative of the clinician's or group's
performance. Accordingly, a third party intermediary that submits a
certification under Sec. 414.1400(a)(5) in connection with the
submission of data it knows are cherry-picked has submitted a false
certification in violation of existing regulatory requirements. If CMS
believes cherry-picking of data may be occurring, we may subject the
third party intermediary and its clients to auditing in accordance with
Sec. 414.1400(g).
Despite these existing obligations, we have received inquiries from
third party intermediaries regarding perceived opportunities to
selectively submit data that are unrepresentative of the MIPS
performance of the clinician or group for which the third party
intermediary is submitting data. These inquires suggest that certain
third party intermediaries may not fully appreciate their current
regulatory obligations or their implications.
The current regulations at Sec. 414.1400(f) clearly establish that
CMS enforcement authority includes the authority to pursue remedial
actions or termination based on its determination that a third party
intermediary was non-compliant with any applicable criteria for
approval in Sec. 414.1400(a) through (e) or if the third party
intermediary submitted data that are inaccurate, unusable or otherwise
compromised. Compliance within Sec. 414.1400(a)(5) is a criteria for
approval. Using data selection criteria to misrepresent a clinician or
group's performance for an applicable performance period results in
data that are inaccurate, unusable and otherwise compromised.
Accordingly, if CMS determined that third party intermediary knowingly
submitted data that are not representative of the clinician's or
group's performance and certified that the submitted data were true,
accurate and complete, CMS would have multiple grounds to impose
remedial action or termination under existing regulations.
In this proposed rule, we propose two changes to more expressly
emphasize CMS enforcement authority. First, we propose to clarify in
this proposed rule that remedial action and termination provisions at
Sec. 414.1400(f)(1) are triggered if we determine that a third party
intermediary submits a false certification under paragraph (a)(5).
Second, as discussed below, we propose to clarify in this proposed rule
that CMS authority to bring remedial actions or terminate a third party
intermediary for submitting data that is inaccurate, unusable or
otherwise compromise extends beyond the specific examples set forth in
Sec. 414.1400(f)(3). With these revisions and a grammatical correction
described below, the proposed Sec. 414.1400(f)(1) would affirm
existing CMS authority to purse remedial actions or termination if we
determine that a third party intermediary has ceased to meet one or
more of the applicable criteria for approval, submits a false
certification under paragraph (a)(5), or has submitted data that are
inaccurate, incomplete, unusable, or otherwise compromised. We
anticipate that these proposed revisions will emphasize to third party
intermediaries the sanctions they may face from CMS if they submit
improper data to CMS. In addition, we note that third party
intermediaries may face liability under the federal False Claims Act if
they submit or cause to submission of false MIPS data.
As noted above, we are proposing revisions to Sec. 414.1400(f)(3)
to clarify the intent of this provision. We refer readers to CY 2019
PFS final rule (83 FR 59908 through 59910) for the discussion of the
evolution of policies regarding remedial actions and termination of a
third party intermediary. The agency's enforcement authority as
codified in Sec. 414.1400(f) broadly extends to include instances of
willful misconduct by the third party intermediary and well as other
instances in which a third party intermediary inadvertently submits
data with deficiencies and errors that render the data ``inaccurate,
unusable or otherwise compromised.'' To facilitate a more fulsome
understanding on when inadvertent conduct could trigger an enforcement
action against a third party intermediary, the current regulatory text
in Sec. 414.1400(f)(3) provides that the threshold for ``inaccurate,
unusable or otherwise compromised'' may be met if the submitted data
includes TIN/NPI mismatches, formatting issues, calculation errors, or
data audit discrepancies that affect more 3 percent of the total number
of MIPS eligible clinicians or groups for which data was submitted by
the third party intermediary. Through this proposed rule, we propose to
add the phrase ``including but not limited to'' to the text of Sec.
414.1400(f)(3) to emphasize that this provision is illustrative of
circumstances that may result in enforcement action and should not be
misinterpreted to limit the agency's ability to impose remedial actions
or terminate a third party intermediary that knowingly submits
inaccurate data.
Lastly, we propose grammatically corrections related to the use of
the plural term ``data.''
h. Public Reporting on Physician Compare
(1) Background
For previous discussions on the background of Physician Compare, we
refer readers to the CY 2016 PFS final rule (80 FR 71116 through
71123), the CY 2017 Quality Payment Program final rule (81 FR 77390
through 77399), the CY 2018 Quality Payment Program final rule (82 FR
53819 through 53832), the CY 2019 PFS final rule (83 FR 59910 through
59915), and the Physician Compare Initiative website at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.
We are proposing to publicly report on Physician Compare: (1)
Aggregate MIPS data, including the minimum and maximum MIPS performance
category and final scores earned by MIPS eligible clinicians, beginning
with Year 2 (CY 2018 data, available starting in late CY
[[Page 40822]]
2019), as technically feasible; and (2) an indicator on the profile
page or in the downloadable database that displays if a MIPS eligible
clinicians is scored using facility-based measurement, as specified
under Sec. 414.1380(e)(6)(vi), as technically feasible. These
proposals are discussed in more detail in this proposed rule.
(2) Regulation Text Changes
Section 1848(q)(9)(A) and (D) of the Act requires that we publicly
report on Physician Compare in an easily understandable format:
The final score for each MIPS eligible clinician;
Performance of each MIPS eligible clinician for each
performance category;
Periodic aggregate information on the MIPS, including the
range of final scores for all MIPS eligible clinicians and the range of
performance of all the MIPS eligible clinicians for each performance
category;
The names of eligible clinicians in advanced APMs and, to
the extent feasible, the names of such advanced APMs and the
performance of such APMs.
Section 1848(q)(9)(B) of the Act requires that the information made
available under section 1848(q)(9) of the Act must indicate, where
appropriate, that publicized information may not be representative of
the eligible clinician's entire patient population, the variety of
services furnished by the eligible clinician, or the health conditions
of individuals treated.
To more completely and accurately reference the data available for
public reporting on Physician Compare, we propose to amend Sec.
414.1395(a) by adding paragraph (1) stating that CMS posts on Physician
Compare, in an easily understandable format: (i) Information regarding
the performance of MIPS eligible clinicians, including, but not limited
to, final scores and performance category scores for each MIPS eligible
clinician; and (ii) the names of eligible clinicians in Advanced APMs
and, to the extent feasible, the names and performance of such Advanced
APMs. As discussed in section III.K.3.h.(3) of this proposed rule, we
are also proposing to amend Sec. 414.1395(a) by adding paragraph (2)
stating that CMS periodically posts on Physician Compare aggregate
information on the MIPS, including the range of final scores for all
MIPS eligible clinicians and the range of the performance of all MIPS
eligible clinicians with respect to each performance category. Finally,
we propose to amend Sec. 414.1395(a) by adding paragraph (3) stating
that the information made available under Sec. 414.1395 will indicate,
where appropriate, that publicized information may not be
representative of an eligible clinician's entire patient population,
the variety of services furnished by the eligible clinician, or the
health conditions of individuals treated.
(3) Final Score, Performance Categories, and Aggregate Information
Section 1848(q)(9)(D) of the Act requires the Secretary to
periodically post on Physician Compare aggregate information on the
MIPS, including the range of composite scores for all MIPS eligible
clinicians and the range of the performance of all MIPS eligible
clinicians with respect to each performance category. We refer readers
to the CY 2018 Quality Payment Program final rule (82 FR 53823), where
we previously finalized policies to publicly report on Physician
Compare, either on profile pages or in the downloadable database, the
final score for each MIPS eligible clinician and the performance of
each MIPS eligible clinician for each performance category, and to
periodically post aggregate information on the MIPS, including the
range of final scores for all MIPS eligible clinicians and the range of
performance of all the MIPS eligible clinicians for each performance
category, as technically feasible, for all future years.
Although we previously finalized a policy to periodically post
aggregate information on the MIPS, as technically feasible, for all
future years, we have not proposed or finalized in rulemaking a
specific timeframe for doing so. As part of our phased approach to
public reporting, we wanted to first gain experience with the MIPS data
prior to publicly reporting it in aggregate, since we had not publicly
reported on Physician Compare aggregate data under legacy programs. For
example, we publicly reported the Physician Quality Reporting System
(PQRS) performance information only at an individual clinician and
group practice level. Now that we have experience with the MIPS data,
including the Year 1 performance information which was not available
for analysis at the time of prior rulemaking, we can now propose a
specific timeframe for publicly reporting aggregate MIPS data on
Physician Compare.
Therefore, in accordance with section 1848(q)(9)(D) of the Act, we
propose to publicly report on Physician Compare aggregate MIPS data,
including the minimum and maximum MIPS performance category and final
scores earned by MIPS eligible clinicians, beginning with Year 2 (CY
2018 data, available starting in late CY 2019), as technically
feasible, and to codify this proposed policy at Sec. 414.1395(a). We
wish to clarify that the aggregate data publicly reported would be
inclusive of all MIPS eligible clinicians. We also note that some
aggregate MIPS data is already publicly available in other places, such
as via the Quality Payment Program Experience Report. We note that the
2017 Quality Payment Program Experience Report is available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/491/2017%20QPP%20Experience%20Report.pdf. As noted in the CY 2018 Quality
Payment Program final rule (82 FR 53823), we will use statistical
testing and user testing, as well as consultation with the Physician
Compare Technical Expert Panel, to determine how and where these data
are best reported on Physician Compare (for example in the Physician
Compare Downloadable Database or on the Physician Compare Initiative
page). In addition to minimum and maximum MIPS performance category and
final scores, we also seek comment on any other aggregate information
that stakeholders would find useful for future public reporting on
Physician Compare.
(4) Quality
For previous discussions on publicly reporting quality performance
category information on the Physician Compare website, we refer readers
to the CY 2018 Quality Payment Program final rule (82 FR 53824) and the
CY 2019 Quality Payment Program final rule (83 FR 59912).
Although we are not making any proposals regarding publicly
reporting quality performance category information, we are seeking
additional comments on adding patient narratives to the Physician
Compare website in future rulemaking, to the extent consistent with our
authority to collect such information under section 1848(q) of the Act
and our authority to include an assessment of patient experience and
patient, caregiver, and family engagement under section 10331(a)(2)(E)
of the Affordable Care Act. Physician Compare website user testing has
repeatedly shown that Medicare patients and caregivers greatly desire
narrative reviews, quotes and testimonials by their peers, and a single
overall ``value indicator,'' reflective for each MIPS eligible
clinician and group, and would expect to find such information on the
Physician Compare website already, based on their experiences with
other consumer-oriented websites. We currently do not
[[Page 40823]]
display any narrative patient satisfaction information on Physician
Compare or any single overall value indicator for MIPS eligible
clinicians and groups (except MIPS performance category and final
scores); currently all performance information on Physician Compare is
publicly reported at the individual measure level. Therefore, we are
seeking comment on the value of and considerations for publicly
reporting such information to assist patients and caregivers with
making healthcare decisions, building upon the feedback received in
response to the CY 2018 Quality Payment Program proposed rule (82 FR
30166 through 30167), in which we specifically sought comment on
publicly reporting responses to five open-ended questions that are part
of the Agency for Healthcare Research and Quality (AHRQ)'s CAHPS
Patient Narrative Elicitation Protocol (https://www.ahrq.gov/cahps/surveys-guidance/item-sets/elicitation/index.html). We refer readers to
section III.K.3.c.(1)(c)(i) of this proposed rule for an additional
solicitation for comments to add narrative reviews into the CAHPS for
MIPS group survey in future rulemaking.
To be publicly reported on Physician Compare, patient narrative
data would have to meet our public reporting standards, described at
Sec. 414.1395(b), and reviewed in consultation with the Physician
Compare Technical Expert Panel, to determine how and where these data
would be best reported on Physician Compare. We seek comment on the
value of collecting and publicly reporting information from narrative
questions and other PROMs, as well as publishing a single ``value
indicator'' reflective of cost, quality and patient experience and
satisfaction with care for each MIPS eligible clinician and group, on
the Physician Compare website and will consider feedback from the
patient, caregiver, and clinician communities before proposing any
policies in future rulemaking. We also note that if we propose to
publicly report patient narratives in future rulemaking, we will
address all related patient privacy safeguards consistent with section
10331(c) of the Affordable Care Act, which requires that information on
physician performance and patient experience is not disclosed in a
manner that violates the Freedom of Information Act (5 U.S.C. 552) or
the Privacy Act of 1974 (5 U.S.C. 552a) with regard to the privacy
individually identifiable health information, and other applicable law.
(5) Promoting Interoperability
We refer readers to the CY 2018 Quality Payment Program final rule
(82 FR 53827) and the CY 2019 Quality Payment Program final rule (83 FR
59913) for previously finalized policies related to the Promoting
Interoperability performance category and Physician Compare.
Although we are not making any proposals regarding publicly
reporting Promoting Interoperability category information, we do want
to refer readers to the ``Medicare and Medicaid Programs; Patient
Protection and Affordable Care Act; Interoperability and Patient Access
for Medicare Advantage Organization and Medicaid Managed Care Plans,
State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities,
Issuers of Qualified Health Plans in the Federally Facilitated
Exchanges and Health Care Providers'' proposed rule (referred to as the
Interoperability and Patient Access proposed rule) published in the
March 4, 2019 Federal Register (84 FR 7646 through 7647), where we
proposed to include an indicator on Physician Compare for the eligible
clinicians and groups that submit a ``no'' response to any of the three
prevention of information blocking attestation statements in Sec.
414.1375(b)(3)(ii)(A) through (C). To report successfully on the
Promoting Interoperability performance category, in addition to
satisfying other requirements, a MIPS eligible clinician must submit an
attestation response of ``yes'' for each of these statements. These
statements contain specific representations about a clinician's
implementation and use of CEHRT and are intended to verify that a MIPS
eligible clinician has not knowingly and willfully taken action (such
as to disable functionality) to limit or restrict the compatibility or
interoperability of certified EHR technology. In the event that these
statements are left blank, that is, a ``yes'' or a ``no'' response is
not submitted, the attestations would be considered incomplete, and we
would not include an indicator on Physician Compare. We also proposed
to post this indicator on Physician Compare, either on the profile
pages or the downloadable database, as feasible and appropriate,
starting with the 2019 performance period data available for public
reporting starting in late 2020. We refer readers to the CY 2017
Quality Payment Program final rule for additional information on these
attestation statements (81 FR 77028 through 77035).
We note that addressing comments on this proposed policy is outside
of the scope of this proposed rule and instead direct readers to review
that proposed rule, available at https://www.federalregister.gov/documents/2019/03/04/2019-02200/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-and, for more
information.
(6) Facility-Based Clinician Indicator
As discussed in the CY 2018 Quality Payment Program final rule (82
FR 53823), we finalized a policy to publicly report the MIPS
performance category and final scores earned by each MIPS eligible
clinician on Physician Compare, either on profile pages or in the
downloadable database. We also finalized that we will make all measures
under the MIPS quality performance category available for public
reporting on Physician Compare, either on profile pages or in the
downloadable database, as technically feasible (82 FR 53824). We will
use statistical testing and user testing to determine how and where
measures are reported on Physician Compare. We established at Sec.
414.1380(e) a facility-based measurement scoring option under the MIPS
quality and cost performance categories for clinicians that meet
certain criteria beginning with the 2019 MIPS performance period/2021
MIPS payment year. Section 414.1380(e)(1)(ii) provides that the scoring
methodology applicable for MIPS eligible clinicians scored with
facility-based measurement is the Total Performance Score methodology
adopted for the Hospital VBP Program, for the fiscal year for which
payment begins during the applicable MIPS performance period.
With this in mind, we have considered how to best display facility-
based MIPS eligible clinician quality and cost information on Physician
Compare, appreciating our obligation to publicly report certain MIPS
data for MIPS eligible clinicians and groups. As those clinicians and
groups scored under the facility-based option are MIPS eligible, we
will publicly report their performance category and MIPS final scores
on Physician Compare and considered two options for publicly reporting
their facility-based measure-level performance information on Physician
Compare: (a) Displaying hospital-based measure-level performance
information on Physician Compare profile pages, including scores for
specific measures and the hospital overall rating; or (b) including an
indicator showing that the clinician or group was scored using the
facility-based scoring option with a link from the clinician's
Physician Compare profile page to the relevant hospital's
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measure-level performance information on Hospital Compare. We believe
that a link from the clinician's Physician Compare profile page to the
relevant hospital's performance information on Hospital Compare is
preferable for several reasons including: Concerns about duplication
with Hospital Compare, interpretability by Physician Compare website
users expecting to find clinician-level, rather than hospital-level,
information and operational feasibility. Additionally, we believe this
approach is consistent with our consumer testing findings that Medicare
patients and caregivers find value in information on the relationships
clinicians and groups may have with facilities where they perform
services. We note that the facility-based scoring indicator would be
separate from the hospital affiliation information for admitting
privileges currently posted on Physician Compare profile pages.
For these reasons, we are proposing to make available for public
reporting an indicator on the Physician Compare profile page or
downloadable database that displays if a MIPS eligible clinician is
scored using facility-based measurement, as specified under Sec.
414.1380(e)(6)(vi), as technically feasible. We are also proposing to
provide a link to facility-based measure-level information, as
specified under Sec. 414.1380(e)(1)(i), for such MIPS eligible
clinicians on Hospital Compare, as technically feasible. In addition,
we are proposing to post this indicator on Physician Compare with the
linkage to Hospital Compare beginning with CY 2019 performance period
data available for public reporting starting in late CY 2020 and for
all future years, as technically feasible. We request comment on this
proposal.
4. Overview of the APM Incentive
a. Overview
Section 1833(z) of the Act requires that an incentive payment be
made in years 2019 through 2024 (or, in years after 2025, a different
PFS update) to Qualifying APM Participants (QPs) for achieving
threshold levels of participation in Advanced APMs. In the CY 2017
Quality Payment Program final rule (81 FR 77399 through 77491), we
finalized the following policies:
Beginning in payment year 2019, if an eligible clinician
participated sufficiently in an Advanced APM during the QP Performance
Period, that eligible clinician may become a QP for the year. Eligible
clinicians who are QPs are excluded from the MIPS reporting
requirements for the performance year and payment adjustment for the
payment year.
For payment years from 2019 through 2024, QPs receive a
lump sum incentive payment equal to 5 percent of their prior year's
estimated aggregate payments for Part B covered professional services.
Beginning in payment year 2026, QPs receive a higher update under the
PFS for the year than non-QPs.
For payment years 2019 and 2020, eligible clinicians may
become QPs only through participation in Medicare Advanced APMs.
For payment years 2021 and later, eligible clinicians may
become QPs through a combination of participation in Medicare Advanced
APMs and Other Payer Advanced APMs (which we refer to as the All-Payer
Combination Option).
In the CY 2018 Quality Payment Program final rule (82 FR 53832
through 53895), we finalized clarifications, modifications, and
additional details pertaining to Advanced APMs, QP and Partial QP
determinations, Other Payer Advanced APMs, Determination of Other Payer
Advanced APMs, Calculation of All-Payer Combination Option Threshold
Scores and QP Determinations, and Physician-Focused Payment Models
(PFPMs).
In the CY 2019 PFS final rule (83 FR 59915 through 59940), we
finalized clarifications, modifications, and additional details
pertaining to use of Certified Electronic Health Record Technology
(CEHRT), MIPS-comparable quality measures, bearing financial risk for
monetary losses, the QP Performance Period, Partial QP election to
report to MIPS, Other Payer Advanced APM criteria, determination of
Other Payer Advanced APMs, calculation of All-Payer Combination Option
Threshold Scores and QP determinations under the All-Payer Combination
Option.
In this proposed rule, we discuss proposals pertaining to Advanced
APMs and the All-Payer Combination Option.
b. Terms and Definitions
As we continue to develop the Quality Payment Program, we have
identified the need to propose new definitions to go along with the
previously defined terms. A list of the previously defined terms is
available in the CY 2017 Quality Payment Program final rule (81 FR
77537 through 77540), the CY 2018 Quality Payment Program final rule
(82 FR 53951 through 53952), and in the CY 2019 PFS final rule (83 FR
60075 through 60076), and reflected in our regulation at Sec.
414.1305.
In the CY 2017 Quality Payment Program final rule, we defined the
term ``Medical Home Model'' and ``Medicaid Medical Home Model.'' Since
defining these terms in the CY 2017 Quality Payment Program final rule,
we have sought comment on whether or not to establish a similar
definition to describe payment arrangements similar to Medical Home
Models and Medicaid Medical Home Models that are operated by other
payers (82 FR 30180).
As discussed in section III.I.4.d.(2)(a) of this proposed rule, we
propose to add the defined term ``Aligned Other Payer Medical Home
Model'' to Sec. 414.1305, to mean a payment arrangement (not including
a Medicaid payment arrangement) operated by an other payer that
formally partners with CMS in a CMS Multi-Payer Model that is a Medical
Home Model through a written expression of alignment and cooperation,
such as a memorandum of understanding (MOU), and is determined by CMS
to have the following characteristics:
The other payer payment arrangement has a primary care
focus with participants that primarily include primary care practices
or multispecialty practices that include primary care physicians and
practitioners and offer primary care services. For the purposes of this
provision, primary care focus means the inclusion of specific design
elements related to eligible clinicians practicing under one or more of
the following Physician Specialty Codes: 01 General Practice; 08 Family
Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37
Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89
Clinical Nurse Specialist; and 97 Physician Assistant;
Empanelment of each patient to a primary clinician; and
At least four of the following: Planned coordination of
chronic and preventive care; Patient access and continuity of care;
Risk-stratified care management; Coordination of care across the
medical neighborhood; Patient and caregiver engagement; Shared
decision-making; and/or Payment arrangements in addition to, or
substituting for, fee-for-service payments (for example, shared savings
or population-based payments).
c. Advanced APMs
(1) Overview
In the CY 2017 Quality Payment Program final rule (81 FR 77408), we
finalized the criteria that define an Advanced APM based on the
requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An
Advanced APM is an APM that:
[[Page 40825]]
Requires its participants to use certified EHR technology
(CEHRT) (81 FR 77409 through 77414);
Provides for payment for covered professional services
based on quality measures comparable to measures under the quality
performance category under MIPS (81 FR 77414 through 77418); and
Either requires its participating APM Entities to bear
financial risk for monetary losses that are in excess of a nominal
amount, or is a Medical Home Model expanded under section 1115A(c) of
the Act (81 FR 77418 through 77431). We refer to this criterion as the
financial risk criterion.
In the CY 2018 Quality Payment Program final rule (82 FR 53832
through 53895), we finalized clarifications, modifications, and
additional details pertaining to the Advanced APM criteria, Qualifying
APM Participant (QP) and Partial QP determinations, the Other Payer
Advanced APM criteria, Determination of Other Payer Advanced APMs,
Calculation of All-Payer Combination Option Threshold Scores and QP
Determinations, and we discussed Physician-Focused Payment Models
(PFPMs).
In the CY 2019 PFS final rule (83 FR 59915 through 59938), we
finalized the following:
Use of CEHRT:
We revised Sec. 414.1415(a)(i) to specify that an
Advanced APM must require at least 75 percent of eligible clinicians in
each APM Entity, or, for APMs in which hospitals are the APM Entities,
each hospital, use CEHRT as defined at Sec. 414.1305 to document and
communicate clinical care with patients and other health care
professionals.
MIPS-Comparable Quality Measures:
We revised Sec. 414.1415(b)(2) to clarify, effective
January 1, 2020, that at least one of the quality measures upon which
an Advanced APM bases payment must either be finalized on the MIPS
final list of measures, as described in Sec. 414.1330; endorsed by a
consensus-based entity; or determined by CMS to be evidenced-based,
reliable, and valid.
We revised Sec. 414.1415(b)(3), effective January 1,
2020, to provide that at least one outcome measure, for which measure
results are included as a factor when determining payment to
participants under the terms of the APM must either be finalized on the
MIPS final list of measures as described in Sec. 414.1330, endorsed by
a consensus-based entity; or determined by CMS to be evidence-based,
reliable, and valid.
Bearing Financial Risk for Monetary Losses:
We revised Sec. 414.1415(c)(3)(i)(A) to maintain the
generally applicable revenue-based nominal amount standard at 8 percent
of the average estimated total Medicare Parts A and B revenue of all
providers and suppliers in participating APM Entities for QP
Performance Periods 2021 through 2024.
In this section of the proposed rule, we address policies regarding
several aspects of the Advanced APM criterion on bearing financial risk
for monetary losses--specifically our proposal to amend the definition
of expected expenditures, and our request for comment on whether
certain items and services should be excluded from the capitation rate
for our definition of full capitation arrangements.
(2) Bearing Financial Risk for Monetary Losses
(a) Overview
In the CY 2017 Quality Payment Program final rule (81 FR 77418), we
divided the discussion of this criterion into two main topics: (1) What
it means for an APM Entity to bear financial risk for monetary losses
under an APM (which we refer to as either the generally applicable
financial risk standard or Medical Home Model financial risk standard);
and (2) what levels of risk we would consider to be in excess of a
nominal amount (which we refer to as either the generally applicable
nominal amount standard or the Medical Home Model nominal amount
standard).
(b) Expected Expenditures
In the CY 2017 Quality Payment Program final rule (81 FR 77550), we
established a definition of expected expenditures at Sec.
414.1415(c)(5) to mean the beneficiary expenditures for which an APM
Entity is responsible under an APM. For episode payment models,
`expected expenditures' means the episode target price. We established
this definition of expected expenditures for the purpose of applying
the Advanced APM financial risk criterion to determine whether an APM
meets the generally applicable nominal amount standard.
In the CY 2017 Quality Payment Program proposed rule (81 FR 28305
through 28309), we proposed to measure three dimensions of risk under
our generally applicable nominal amount standards: (1) Marginal risk,
which refers to the percentage of the amount by which actual
expenditures exceed expected expenditures for which an APM Entity would
be liable under the APM; (2) minimum loss rate (MLR), which is a
percentage by which actual expenditures may exceed expected
expenditures without triggering financial risk; and (3) total potential
risk, which refers to the maximum potential payment for which an APM
Entity could be liable under the APM.
However, based on commenters' concerns regarding technical
complexity, we did not finalize the marginal risk and MLR components of
the generally applicable nominal standard under the Advanced APM
criteria (81 FR 77427), but did finalize those additional elements of
risk under the Other Payer Advanced APM criteria. We stated in the CY
2017 Quality Payment Program final rule (81 FR 77426) that the marginal
risk and MLR components were not necessary to explicitly include in the
generally applicable nominal amount standard for Advanced APMs because
we are committed to creating Advanced APMs with strong financial risk
designs that incorporate risk adjustment, benchmark methodologies,
sufficient stop-loss amounts, and sufficient marginal risk; and that
all APMs involving financial risk that we operate now or in the future
would meet or exceed the proposed marginal risk and MLR requirements.
In the CY 2017 Quality Payment Program proposed rule (81 FR 28306), we
explained that to determine whether an APM satisfies the marginal risk
component of the generally applicable nominal amount standard, we would
examine the payment required under the APM as a percentage of the
amount by which actual expenditures exceeded expected expenditures. We
proposed that we would require that this percentage exceed a required
marginal risk percentage of 30 percent regardless of the amount by
which actual expenditures exceeded expected expenditures. We believed
that any marginal risk below 30 percent could create scenarios in which
the total risk could be very high, but the average or likely risk for
an APM Entity would actually be very low (81 FR 28306).
Our rationale for proposing the marginal risk requirement was that
the inclusion of the marginal risk requirement would contribute to
maintaining a more than nominal level of average or likely risk under
an Advanced APM. We did not finalize the marginal risk requirement
under the Advanced APM criteria because, as noted above, we believed
that all Advanced APMs that we operate now or would potentially operate
in the future would meet or exceed the previously proposed marginal
risk and MLR requirements, and more importantly, we believed the total
risk portion of the nominal amount standard alone was sufficient to
ensure that the level of average or likely risk under an
[[Page 40826]]
Advanced APM would actually be more than nominal for participants.
However, based on our experience to date, we are concerned that the
total risk portion of the benchmark-based nominal amount standard as
currently constructed may not always be sufficient to ensure that the
level of average or likely risk under an Advanced APM is actually more
than nominal for participants. This is because the benchmark-based
nominal amount standard at Sec. 414.1415(c)(3)(i)(B) is dependent upon
the definition of expected expenditures codified at Sec.
414.1415(c)(5), where expected expenditures are defined as the
beneficiary expenditures for which an APM Entity is responsible under
an APM, and for episode payment models, the episode target price.
In our experience implementing the Quality Payment Program and
considering the diversity of model designs, we now believe there is a
need to amend the definition of expected expenditures to ensure there
are more-than-nominal levels of average or likely risk under an
Advanced APM that would meet the generally applicable benchmark-based
nominal amount standard. For instance, an APM could have a sufficient
total risk to meet the benchmark-based nominal amount standard and a
sharing rate that results in adequate marginal risk if actual
expenditures exceed expected expenditures. However, in that same APM,
the level of expected expenditures reflected in the APM's benchmark or
episode target price could be set in a manner that would substantially
reduce the amount of loss the APM Entity would reasonably expect to
incur.
For an APM to meet the generally applicable benchmark-based nominal
amount standard, we believe there should be not only the potential for
financial losses based on expenditures in excess of the benchmark as
provided in Sec. 415.1415(c)(3)(i)(B) of our regulations, but also a
meaningful possibility that an APM Entity might exceed the benchmark.
If the benchmark is set in such a way that it is extremely unlikely
that participants would exceed it, then there is little potential for
participants to incur financial losses, and the amount of risk is
essentially illusory.
Therefore, in Sec. 414.1415(c)(5), we are proposing to amend the
definition of expected expenditures. Specifically, we are proposing to
define expected expenditure as, for the purposes of this section, the
beneficiary expenditures for which an APM Entity is responsible under
an APM. For episode payment models, expected expenditures means the
episode target price. For purposes of assessing financial risk for
Advanced APM determinations, the expected expenditures under the terms
of the APM should not exceed the expected Medicare Parts A and B
expenditures for a participant in the absence of the APM. If expected
expenditures under the APM exceed the Medicare Parts A and B
expenditures that an APM Entity would be expected to incur in the
absence of the APM, such excess expenditures are not considered when
CMS assesses financial risk under the APM for Advanced APM
determinations.
In general, expected expenditures are expressed as a dollar amount,
and may be derived for a particular APM from national, regional, APM
Entity-specific, and/or practice-specific historical expenditures
during a baseline period, or other comparable expenditures. However, we
recognize expected expenditures under an APM often are risk-adjusted
and trended forward, and may be adjusted to account for expenditure
changes that are expected to occur as a result of APM participation.
For the purpose of this proposed definition of expected expenditures,
we would not consider risk adjustments to be excess expenditures when
comparing to the costs that an APM Entity would be expected to incur in
the absence of the APM.
We believe that this proposed amendment would allow us to ensure
that there are more-than-nominal amounts of average or likely risk
under an APM that meets the generally applicable benchmark-based
nominal amount standard. We believe that the proposed amended
definition of expected expenditures, particularly by our not
considering excess expenditures when determining whether an APM meets
the benchmark-based nominal amount standard, would provide a more
definite basis for us to assess whether an APM Entity would bear more
than a nominal amount of financial risk for participants under the
generally applicable benchmark-based nominal amount standard.
We are also proposing a similar amendment to the definition of
expected expenditures applicable to the Other Payer Advanced APM
criteria in section III.I.4.d.(2)(b)(i) of this proposed rule.
We seek comment on this proposal.
(c) Excluded Items and Services Under Full Capitation Arrangements
In the CY 2017 Quality Payment Program final rule (81 FR 74431), we
finalized a capitation standard at Sec. 414.1415(c)(6), which provides
that a full capitation arrangement meets the Advanced APM financial
risk criterion. We defined a capitation arrangement as a payment
arrangement in which a per capita or otherwise predetermined payment is
made under the APM for all items and services for which payment is made
through the APM furnished to a population of beneficiaries, and no
settlement is performed to reconcile or share losses incurred or
savings earned by the APM Entity. We clarified that arrangements
between CMS and Medicare Advantage Organizations under the Medicare
Advantage program are not considered capitation arrangements for
purposes of this definition.
In the CY 2019 PFS final rule (83 FR 59939), we made technical
corrections to the Advanced APM financial risk capitation standard at
Sec. 414.1415(c)(6). These corrections clarified that our financial
risk capitation standard applies only to full capitation arrangements
where a per capita or otherwise predetermined payment is made under the
APM for all items and services furnished to a population of
beneficiaries during a fixed period of time, and no settlement or
reconciliation is performed.
As we have begun to collect information on other payer payment
arrangements for purposes of making Other Payer Advanced APM
determinations, we have noticed that some payment arrangements that are
submitted as capitation arrangements consistent with Sec.
414.1420(d)(7) include a list of services that have been excluded from
the capitation rate, such as hospice care, organ transplants, and out-
of-network emergency services. In reviewing these exclusion lists, we
believe that it may be appropriate for CMS to allow certain capitation
arrangements to be considered ``full'' capitation arrangements even if
they categorically exclude certain items or services from payment
through the capitation rate.
As such, we are seeking comment on what categories of items and
services might be excluded from a capitation arrangement that would
still be considered a full capitation arrangement. Specifically, we
seek comment on whether there are common industry practices to exclude
certain categories of items and services from capitated payment rates
and, if so, whether there are common principles or reasons for
excluding those categories of services. We also seek comment on what
percentage of the total cost of care such exclusions typically account
for under what is intended to be a ``full'' global capitation
arrangement. We also seek
[[Page 40827]]
comment on how non-Medicare payers define or prescribe certain
categories of services that are excluded with regards to global
capitation payment arrangements.
In addition, we are seeking comment on whether a capitation
arrangement should be considered to be a full capitation arrangement
even though it excludes certain categories of services from the
capitation rate under the full capitation standard for Other Payer
Advanced APMs as discussed in section III.I.4.d.(2)(c)(ii) of this
proposed rule.
(3) Summary of Proposals
In this section, we are proposing the following policy:
Expected Expenditures: We are proposing to amend the
definition of expected expenditures codified at Sec. 414.1415(c)(5) to
state, for the purposes of this section, expected expenditures means
the beneficiary expenditures for which an APM Entity is responsible
under an APM. For episode payment models, expected expenditures mean
the episode target price. In addition, for purposes of assessing
financial risk for Advanced APM determinations, the expected
expenditures under the APM should not exceed the expected Medicare
Parts A and B expenditures (including model-specific risk-adjustments
and trend adjustments), for the APM Entity in the absence of the APM.
If expected expenditures under the APM exceed the Medicare Parts A and
B expenditures that the APM Entity would be expected to incur in the
absence of the APM, such excess expenditures would not be considered
when CMS assesses financial risk under the APM for Advanced APM
determinations.
d. Qualifying APM Participant (QP) and Partial QP Determinations
(1) Overview
We finalized policies relating to QP and Partial QP determinations
in the CY 2017 Quality Payment Program final rule (81 FR 77433 through
77450). In the CY 2019 PFS final rule (83 FR 59923 through 59925), we
finalized additional policies relating to QP determinations and Partial
QP election to report to MIPS.
(2) Group Determination
(a) Overview
In the CY 2017 Quality Payment Program final rule (81 FR 77439
through 77440), we finalized that QP determinations would generally be
made at the APM Entity level, but for two exceptions in which we make
the QP determination at the individual level: (1) Individuals
participating in multiple Advanced APM Entities, none of which meet the
QP threshold as a group; and (2) eligible clinicians on an Affiliated
Practitioner List when that list is used for the QP determination
because there are no eligible clinicians on a Participation List for
the APM Entity (81 FR 77439 through 77443). As a result, the QP
determination for the APM Entity would apply to all the individual
eligible clinicians who are identified as part of the APM Entity
participating in an Advanced APM. If that APM Entity's Threshold Score
meets the relevant QP threshold, all individual eligible clinicians in
that APM Entity would receive the same QP determination, applied to
their NPIs, for the relevant year. The QP determination calculations
are aggregated using data for all eligible clinicians participating in
the APM Entity on a determination date during the QP Performance
Period.
(b) Application of Partial QP Status
In the CY 2017 Quality Payment Program final rule (81 FR 77440), we
stated that we would apply QP status at the NPI level instead of at the
TIN/NPI level. We noted that an individual clinician identified by an
NPI may have reassigned billing rights to multiple TINs, resulting in
multiple TIN/NPI combinations being associated with one individual
clinician (NPI). We also stated that if QP status was only applied to
one of an individual clinician's multiple TIN/NPI combinations, an
eligible clinician who is a QP for only one TIN/NPI combination might
still have to report under MIPS for another TIN/NPI combination. Under
that approach, the APM Incentive Payment would be based on only a
fraction of the clinician's covered professional services instead of,
as we believe is the most logical reading of the statute, all those
services furnished by the individual clinician, as represented by an
NPI. Therefore, we expressed our concern with applying QP status only
to a specific TIN/NPI combination as it would not effectuate the goals
of the APM incentive path of the Quality Payment Program to reward
individual clinicians for their commitment to Advanced APM
participation.
For Partial QPs, we currently apply Partial QP status at the NPI
level across all TIN/NPI combinations, as we have for QP status.
However, upon further consideration, and based on our experience
implementing the Quality Payment Program to date, we no longer believe
we should apply Partial QP status at the individual clinician (NPI)
level across all TIN/NPI combinations, as we have and do for QP status.
Partial QPs are excluded from MIPS based on an election made at the APM
Entity or individual eligible clinician level, and this exclusion is
currently applied at the NPI level across all of their TIN/NPI
combinations. When this MIPS exclusion is applied at the NPI level, it
does not always provide a similar net positive outcome across an
individual clinician's TIN/NPI combinations when compared to the APM
Incentive Payment that QPs receive. The MIPS exclusion is different
from QP status as Partial QPs do not receive an APM Incentive Payment,
Partial QPs are only relieved of the MIPS reporting requirements and
not subject to a MIPS payment adjustment. As such, while a Partial QP
might wish to be excluded from the MIPS reporting requirements and
payment adjustment with respect to the TIN/NPI combination that relates
to an APM Entity in an Advanced APM, that same Partial QP might benefit
from reporting to MIPS and receiving a MIPS payment adjustment with
respect to some or all of their other TIN/NPI combinations because they
anticipate receiving an upward MIPS payment adjustment.
So, while the current policy excludes Partial QPs from MIPS
reporting requirements and allows Partial QPs to avoid any potential
downward MIPS payment adjustment, we have heard from stakeholders,
including some clinicians, that this policy has prevented eligible
clinicians from receiving a positive MIPS payment adjustment earned
through a different TIN/NPI combination not associated with the APM
Entity through which they attained Partial QP status. Furthermore, in
many circumstances, the election to be excluded from MIPS for an
eligible clinician is made outside their control at the APM Entity
level. In such scenarios, an eligible clinician may have reported to
MIPS as part of a group or as an individual under a separate TIN/NPI
combination, but would not receive any MIPS payment adjustment based on
that reporting. If eligible clinicians who would have received a
positive MIPS adjustment are excluded from MIPS because of their
Partial QP status, it could potentially discourage eligible clinicians
from participating in Advanced APMs. Additionally, in future years of
the Quality Payment Program, we anticipate that it will become harder
to attain QP and Partial QP status because the QP and Partial QP
payment amount and patient count thresholds will rise, as set forth in
Sec. 414.1430. As a result, a greater number of Advanced APM
participants may attain Partial QP status, which we
[[Page 40828]]
believe increases the importance of removing the potential disincentive
for Advanced APM participation based on the way the MIPS exclusion for
Partial QPs is applied.
Therefore, we are proposing that beginning with the 2020 QP
Performance Period, Partial QP status would apply only to the TIN/NPI
combination(s) through which an individual eligible clinician attains
Partial QP status, and to amend our regulation by adding Sec.
414.1425(d)(5) to reflect this change. This means that any MIPS
election for a Partial QP would only apply to the TIN/NPI combination
through which Partial QP status is attained, so that an eligible
clinician who is a Partial QP for only one TIN/NPI combination may
still be a MIPS eligible clinician and report under MIPS for other TIN/
NPI combinations.
We seek comment on this proposal.
(3) QP Performance Period
(a) Overview
In the CY 2017 Quality Payment Program final rule (81 FR 77446
through 77447), we finalized for the timing of QP determinations that a
QP Performance Period runs from January 1 through August 31 of the
calendar year that is 2 years prior to the payment year. We finalized
that during the QP Performance Period, we will make QP determinations
at three separate snapshot dates (March 31, June 30, and August 31),
each of which will be a final determination for the eligible clinicians
who are determined to be QPs. The QP Performance Period and the three
separate QP determinations apply similarly for both the group of
eligible clinicians on a Participation List and the individual eligible
clinicians on an Affiliated Practitioner List.
(b) APM Entity Termination
In the CY 2017 Quality Payment Program final rule, we finalized at
Sec. 414.1425(c)(5) and Sec. 414.1425(d)(3) that an eligible
clinician is not a QP or Partial QP for a year if the APM Entity group
voluntarily or involuntarily terminates from an Advanced APM before the
end of the QP Performance Period (81 FR 77446 through 77447). We also
finalized at Sec. 414.1425(c)(6) and Sec. 414.1425(d)(4) that an
eligible clinician is not a QP or Partial QP for a year if one or more
of the APM Entities in which the eligible clinician participates
voluntarily or involuntarily terminates from the Advanced APM before
the end of the QP Performance Period, and the eligible clinician does
not individually achieve a Threshold Score that meets or exceeds the QP
or Partial QP payment amount threshold or QP or Partial QP patient
count threshold based on participation in the remaining non-terminating
APM Entities (81 FR 77446 through 77447). We finalized these policies
in part to ensure that APM Entities and eligible clinicians who achieve
QP or Partial QP status during a QP Performance Period actually assume
a more than a nominal amount of financial risk, as is necessary for
Advanced APMs, for at least the full QP performance period from January
1 through August 31, if not the entire performance year under the
Advanced APM.
Currently, under the terms of some Advanced APMs, APM Entities can
terminate their participation in the Advanced APM while bearing no
financial risk after the end of the QP Performance Period for the year
(August 31). Under our current regulation, an APM Entity's termination
after that date would not affect the QP or Partial QP status of all
eligible clinicians in the APM Entity. We acknowledge that it may be
appropriate for an Advanced APM to allow participating APM Entities to
terminate without bearing financial risk for that performance period
under the terms of the Advanced APM itself, including allowing such
terminations to occur after the end of the QP Performance Period
(August 31). However, allowing those eligible clinicians to retain
their QP or Partial QP status without having borne financial risk under
the Advanced APM through which they attained QP or Partial QP status is
not aligned with the structure and principles of the Quality Payment
Program, which is designed to reward those APM Entities and eligible
clinicians for meaningfully assuming more than a nominal amount of
financial risk, as required by the Advanced APM criteria. A critical
aspect of Advanced APMs is that participants must bear more than a
nominal amount of financial risk under the model. If an APM Entity
terminates participation in the Advanced APM without financial
accountability, the APM Entity has not yet borne more than a nominal
amount of financial risk. As such, we do not believe it is appropriate
for eligible clinicians in an APM Entity that terminates after QP
determinations are made, but before bearing more than a nominal amount
of financial risk, to retain any status as QPs or Partial QPs.
Therefore, regarding QP status, we are proposing to revise Sec.
414.1425(c)(5) and add Sec. Sec. 414.1425(c)(5)(i) and
414.1425(c)(5)(ii) which states, beginning in the 2020 QP Performance
Period, an eligible clinician is not a QP for a year if: (1) The APM
Entity voluntarily or involuntarily terminates from an Advanced APM
before the end of the QP Performance Period; (2) or the APM Entity
voluntarily or involuntarily terminates from an Advanced APM at a date
on which the APM Entity would not bear financial risk under the terms
of the Advanced APM for the year in which the QP Performance Period
occurs. In addition, we are proposing to revise Sec. 414.1425(c)(6)
and add Sec. Sec. 414.1425(c)(6)(i) and Sec. 414.1425(c)(6)(ii),
which states, beginning in the 2020 QP Performance Period, an eligible
clinician is not a QP for a year if: (1) One or more of the APM
Entities in which the eligible clinician participates voluntarily or
involuntarily terminates from the Advanced APM before the end of the QP
Performance Period, and the eligible clinician does not individually
achieve a Threshold Score that meets or exceeds the QP payment amount
threshold or QP patient count threshold based on participation in the
remaining non-terminating APM Entities; or (2) one or more of the APM
Entities in which the eligible clinician participates voluntarily or
involuntarily terminates from the Advanced APM at a date on which the
APM Entity would not bear financial risk under the terms of the
Advanced APM for the year in which the QP Performance Period occurs,
and the eligible clinician does not individually achieve a Threshold
Score that meets or exceeds the QP payment amount threshold or QP
patient count threshold based on participation in the remaining non-
terminating APM Entities.
Regarding Partial QP status, we are also proposing to revise Sec.
414.1425(d)(3) and add Sec. Sec. 414.1425(d)(3)(i) and
414.1425(d)(3)(ii), which states, beginning in the 2020 QP Performance
Period, an eligible clinician is not a Partial QP for a year if: (1)
The APM Entity voluntarily or involuntarily terminates from an Advanced
APM before the end of the QP Performance Period; or (2) the APM Entity
voluntarily or involuntarily terminates from an Advanced APM at a date
on which the APM Entity would not bear financial risk under the terms
of the Advanced APM for the year in which the QP Performance Period
occurs. We are also proposing to revise Sec. 414.1425(d)(4) and add
Sec. Sec. 414.1425(d)(4)(i) and 414.1425(d)(4)(ii), which states,
beginning in the 2020 QP Performance Period, an eligible clinician is
not a Partial QP for a year if: (1) One or more of the APM Entities in
which the eligible clinician participates
[[Page 40829]]
voluntarily or involuntarily terminates from the Advanced APM before
the end of the QP Performance Period, and the eligible clinician does
not individually achieve a Threshold Score that meets or exceeds the
Partial QP payment amount threshold or Partial QP patient count
threshold based on participation in the remaining non-terminating APM
Entities; or (2) one or more of the APM Entities in which the eligible
clinician participates voluntarily or involuntarily terminates from the
Advanced APM at a date on which the APM Entity would not bear financial
risk under the terms of the Advanced APM for the year in which the QP
Performance Period occurs, and the eligible clinician does not
individually achieve a Threshold Score that meets or exceeds the
Partial QP payment amount threshold or Partial QP patient count
threshold based on participation in the remaining non-terminating APM
Entities. We believe these additions account for the scenarios in which
an APM Entity terminates from an Advanced APM at a date on which the
APM Entity would not incur any financial accountability under the terms
of the Advanced APM.
We seek comment on this proposal.
(4) Summary of Proposals
In this section, we are proposing the following policies:
Application of Partial QP Status: We propose that
beginning with the 2020 QP Performance Period, Partial QP status will
apply only to the TIN/NPI combination(s) through which an individual
eligible clinician attains Partial QP status. We propose to amend Sec.
414.1425(d)(5) to reflect this change.
APM Entity Termination: We propose to revise Sec. Sec.
414.1425(c)(5), 414.1425(c)(6), 414.1425(d)(3), and 414.1425(d)(4) to
state that an eligible clinician is not a QP or a Partial QP for the
year when an APM Entity terminates from an Advanced APM at a date on
which the APM Entity would not bear financial risk under the terms of
the Advanced APM for the year in which the QP Performance Period
occurs.
e. All-Payer Combination Option
(1) Overview
Section 1833(z)(2)(B)(ii) of the Act requires that beginning in
payment year 2021, in addition to the Medicare Option, eligible
clinicians may become QPs through the Combination All-Payer and
Medicare Payment Threshold Option, which we refer to as the All-Payer
Combination Option. In the CY 2017 Quality Payment Program final rule
(81 FR 77459), we finalized our overall approach to the All-Payer
Combination Option. The Medicare Option focuses on participation in
Advanced APMs, and we make QP determinations under this option based on
Medicare Part B covered professional services attributable to services
furnished through an APM Entity. The All-Payer Combination Option does
not replace or supersede the Medicare Option; instead, it will allow
eligible clinicians to become QPs by meeting the QP thresholds through
a pair of calculations that assess a combination of both Medicare Part
B covered professional services furnished through Advanced APMs and
services furnished through payment arrangements offered by payers other
than Medicare that CMS has determined meet the criteria to be Other
Payer Advanced APMs. We finalized that beginning in payment year 2021,
we will conduct QP determinations sequentially so that the Medicare
Option is applied before the All-Payer Combination Option (81 FR
77438). The All-Payer Combination Option encourages eligible clinicians
to participate in payment arrangements that satisfy the Other Payer
Advanced APM criteria with payers other than Medicare. It also
encourages sustained participation in Advanced APMs across multiple
payers.
We finalized that the QP determinations under the All-Payer
Combination Option are based on payment amounts or patient counts as
illustrated in Tables 36 and 37, and Figures 1 and 2 of the CY 2017
Quality Payment Program final rule (81 FR 77460 through 77461). We also
finalized that, in making QP determinations with respect to an eligible
clinician, we will use the Threshold Score (that is, based on payment
amount or patient count) that is most advantageous to the eligible
clinician toward achieving QP status, or if QP status is not achieved,
Partial QP status, for the year (81 FR 77475).
BILLING CODE 4120-01-P
[[Page 40830]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.091
[[Page 40831]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.092
BILLING CODE 4120-01-C
Unlike the Medicare Option, where we have access to all of the
information necessary to determine whether an APM meets the criteria to
be an Advanced APM, we cannot determine whether payment arrangements
offered by other payers meet the criteria to be an Other Payer Advanced
APM without receiving information about the payment arrangements from
an external source. Similarly, we do not have the necessary payment
amount and patient count information to determine under the All-Payer
Combination Option whether an eligible clinician meets the payment
amount or patient count threshold to be a QP without receiving certain
information from an external source.
In the CY 2018 Quality Payment Program final rule (82 FR 53844
through 53890), we established additional policies to implement the
All-Payer Combination Option and finalized certain modifications to our
previously finalized policies. A detailed summary of those policies can
be found at 82 FR 53874 through 53876 and 53890 through 53891.
In the CY 2019 PFS final rule (83 FR 59926 through 59938), we
finalized the following:
Other Payer Advanced APM Criteria:
We changed the CEHRT use criterion so that in order to
qualify as an Other Payer Advanced APM as of January 1, 2020, the other
payer arrangement must require at least 75 percent of participating
eligible clinicians in each participating APM Entity group, or each
hospital if hospitals are the APM Entities, use CEHRT to document and
communicate clinical care.
[[Page 40832]]
We allowed payers and eligible clinicians to submit
evidence as part of their request for an Other Payer Advanced APM
determination that CEHRT is used by the requisite percentage of
eligible clinicians participating in the payment arrangement (50
percent for 2019, and 75 percent for 2020 and beyond) to document and
communicate clinical care, whether or not CEHRT use is explicitly
required under the terms of the payment arrangement.
We clarified Sec. 414.1420(c)(2), effective January 1,
2020, to provide that at least one of the quality measures used in the
payment arrangement in paragraph (c)(1) of this regulation must be:
++ Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
++ Endorsed by a consensus-based entity; or
++ Determined by CMS to be evidenced-based, reliable, and valid.
We revised Sec. 414.1420(c)(3) to require that, effective
January 1, 2020, unless there is no applicable outcome measure on the
MIPS quality measure list, that to be an Other Payer Advanced APM, an
other payer arrangement must use an outcome measure, that must be:
++ Finalized on the MIPS final list of measures, as described in
Sec. 414.1330;
++ Endorsed by a consensus-based entity; or
++ Determined by CMS to be evidenced-based, reliable, and valid.
We also revised our regulation at Sec. 414.1420(c)(3)(i)
to provide that, for payment arrangements determined to be Other Payer
Advanced APMs for the 2019 performance year that did not include an
outcome measure that is evidence-based, reliable, and valid, and that
are resubmitted for an Other Payer Advanced APM determination for the
2020 performance year (whether for a single year, or for a multi-year
determination as finalized in CY 2019 PFS final rule (83 FR 55931
through 55932), we would continue to apply the previous requirements
for purposes of those determinations. This revision also applies to
payment arrangements in existence prior to the 2020 performance year
that are submitted for determination to be Other Payer Advanced APMs
for the 2020 performance year and later.
We revised Sec. 414.1420(d)(3)(i) to maintain the
generally applicable revenue-based nominal amount standard at 8 percent
of the total combined revenues from the payer of providers and
suppliers in participating APM Entities for QP Performance Periods 2021
through 2024.
Determination of Other Payer Advanced APMs:
We finalized details regarding the Payer Initiated Process
for Remaining Other Payers. To the extent possible, we aligned the
Payer Initiated Process for Remaining Other Payers with the previously
finalized Payer Initiated Process for Medicaid, Medicare Health Plans,
and CMS Multi-Payer Models.
We eliminated the Payer Initiated Process that is
specifically for CMS Multi-Payer Models. These payers will be able to
submit their arrangements through the Payer Initiated Process for
Remaining Other Payers as finalized in the CY 2019 PFS final rule (82
FR 59933 through 59935), or through the Medicaid or Medicare Health
Plan payment arrangement submission processes, and no longer need a
special pathway.
Calculation of All-Payer Combination Option Threshold Scores and QP
Determinations:
We added a third alternative to allow requests for QP
determinations at the TIN level in instances where all clinicians who
reassigned billing rights under the TIN participate in a single APM
Entity. We modified our regulation at Sec. 414.1440(d) by adding a
third alternative to allow QP determinations at the TIN level in
instances where all clinicians who have reassigned billing under the
TIN participate in a single APM Entity, as well as to assess QP status
at the most advantageous level for each eligible clinician.
We clarified that, in making QP determinations using the
All-Payer Combination Option, eligible clinicians may meet the minimum
Medicare threshold using one method, and the All-Payer threshold using
the same or a different method. We codified this clarification by
amending Sec. 414.1440(d)(1).
We extended the weighting methodology that is used to
ensure that an eligible clinician does not receive a lower score on the
Medicare portion of their all-payer calculation under the All-Payer
Combination Option than the Medicare Threshold Score they received at
the APM Entity level in order to apply a similar policy to the proposed
TIN level Medicare Threshold Scores.
In this section of the proposed rule, we address our proposal to
define the term Aligned Other Payer Medical Home Model, and our
proposals regarding bearing financial risk for monetary losses,
specifically the Medicaid Medical Home Model financial risk standard
and the definition of expected expenditures. We also discuss our
request for comment on whether certain items and services should be
excluded from the capitation rate for our definition of full capitation
arrangements.
(2) Aligned Other Payer Medical Home Models
(a) Definition
As we explained when finalizing the definitions of Medical Home
Model and Medicaid Medical Home Model in the CY 2017 Quality Payment
Program final rule, MACRA does not define `medical homes,' but sections
1848(q)(5)(C)(i), 1833(z)(2)(B)(iii)(II)(cc)(BB),
1833(z)(2)(C)(iii)(II)(cc)(BB), and 1833(z)(3)(D)(ii)(II) of the Act
make medical homes an instrumental piece of the law (81 FR 77403). The
terms Medical Home Model and Medicaid Medical Home Model are limited to
Medicare and Medicaid payment arrangements, respectively, and do not
include other payer payment arrangements.
As we discuss in section III.I.4.b. of this proposed rule, we are
proposing to add the defined term ``Aligned Other Payer Medical Home
Model'' to Sec. 414.1305, which would mean an aligned other payer
payment arrangement (not including a Medicaid payment arrangement)
operated by an other payer formally partnering in a CMS Multi-Payer
Model that is a Medical Home Model through a written expression of
alignment and cooperation with CMS, such as a memorandum of
understanding (MOU), and is determined by CMS to have the following
characteristics:
The other payer payment arrangement has a primary care
focus with participants that primarily include primary care practices
or multispecialty practices that include primary care physicians and
practitioners and offer primary care services. For the purposes of this
provision, primary care focus means the inclusion of specific design
elements related to eligible clinicians practicing under one or more of
the following Physician Specialty Codes: 01 General Practice; 08 Family
Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37
Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89
Clinical Nurse Specialist; and 97 Physician Assistant;
Empanelment of each patient to a primary clinician; and
At least four of the following: Planned coordination of
chronic and preventive care; Patient access and continuity of care;
risk-stratified care management; coordination of care across the
medical neighborhood; patient and caregiver engagement; shared
decision-making; and/or
[[Page 40833]]
payment arrangements in addition to, or substituting for, fee-for-
service payments (for example, shared savings or population-based
payments).
The proposed definition of Aligned Other Payer Medical Home Model
includes the same characteristics as the definitions of Medical Home
Model and Medicaid Medical Home Model, but it applies to other payer
payment arrangements. We believe that structuring this proposed
definition in this manner is appropriate because we recognize that
there may be medical homes that are operated by other payers that may
be appropriately considered medical home models under the All-Payer
Combination Option.
We are proposing to exclude Medicaid payment arrangements from this
proposed definition of Aligned Other Payer Medical Home Model because
we have previously defined the term Medicaid Medical Home Model at
Sec. 414.1305 and we believe it is important to distinguish Medicaid
payment arrangements from other payment arrangements, given the
requirements in sections 1833(z)(2)(B)(ii)(I)(bb) and
1833(z)(3)(B)(ii)(I)(bb) of the Act requiring us to consider whether
there is a medical home or alternative payment model under the Title
XIX state plan in each state when making QP determinations using the
All-Payer Combination Option.
For purposes of the Aligned Other Payer Medical Home Model
definition, for an arrangement to be aligned, we mean through a written
expression of alignment and cooperation with CMS, such as an MOU. CMS
Multi-Payer Models require alignment across the different payers and a
written expression reflects the fact that each arrangement has been
reviewed by CMS and CMS has determined that the other payer payment
arrangement is aligned with a CMS Multi-Payer Model that is a Medical
Home Model. We are proposing to limit this Aligned Other Payer Medical
Home Model definition to other payer payment arrangements that are
aligned with CMS Multi-Payer Models that are Medical Home Models
because we can be assured that the structure of these arrangements is
similar to the Medical Home Models and Medicaid Medical Home Models for
which we have already made a similar determination. Based on our
experience to date, we anticipate that participants in these
arrangements may generally be more limited in their ability to bear
financial risk than other entities because they may be smaller and
predominantly include primary care practitioners, whose revenues are a
smaller fraction of the patients' total cost of care than those of
other eligible clinicians. At the same time, we do not believe that
participants in all medical homes, regardless of payer, face the same
limitations on their ability to bear financial risk. We believe that
some participants may have different organizational or financial
circumstances that allow them to bear greater such risk. We believe
that applying the proposed Aligned Other Payer Medical Home Model
definition to all other payer payment arrangements would create
potential new opportunities for gaming in commercial settings where we
do not have control over the design of such models. However, we believe
that payment arrangements that have been aligned and are similar to a
Medicaid Home Model, where we have already put in place policies to
control against gaming, would be similarly constrained.
In addition, we have acquired additional understanding of some
other payer payment arrangements after one year of experience with the
Payer Initiated Process, which included some arrangements that are
aligned with CMS Multi-Payer Models that are Medical Home Models.
We seek comment on this proposal.
(b) Other Payer Advanced APM Criteria for Aligned Other Payer Medical
Home Models
As defined in Sec. 414.1305, an Other Payer Advanced APM is an
other payer arrangement that meets the Other Payer Advanced APM
criteria set forth in Sec. 414.1420. Accordingly, we propose that the
CEHRT criterion codified in Sec. 414.1420(b) and the use of quality
measures criterion codified in Sec. 414.1420(c) would apply to any
Aligned Other Payer Medical Home Model for which we would make an Other
Payer Advanced APM determination. Further, we propose to revise Sec.
414.1420(d)(8) to require Aligned Other Payer Medical Home Models to
comply with the 50 eligible clinician limit to align with the
requirements that apply to Medical Home Models and Medicaid Medical
Home Models.
Regarding the applicable financial risk and nominal amount
standards, consistent with the financial risk and nominal amount
standards applicable to Medical Home Models and Medicaid Medical Home
Models, we propose that the Aligned Other Payer Medical Home Model
financial risk and nominal amount standards would be the same as the
Medicaid Medical Home Model financial risk and nominal amount
standards. We are proposing corresponding amendments to Sec.
414.1420(d)(2) and (4) so that those sections note, Medicaid Medical
Home Model and Aligned Other Payer Medical Home Model financial risk
standard and Medicaid Medical Home Model and Aligned Other Payer
Medical Home Model nominal amount standard, respectively. We believe
that this proposal, as described in section III.I.3.b. of this proposed
rule, is appropriate because the same expectation of ability to bear a
more than nominal amount of financial risk applies to participants in
these models as Medical Home Models and Medicaid Medical Home Models
because the arrangements are already aligned and the participants are
the same.
(c) Determination of Aligned Other Payer Medical Home Model and Other
Payer Advanced APM Status
We propose that payers may submit other payer arrangements for CMS
determination as Aligned Other Payer Medical Home Models and Other
Payer Advanced APMs, as applicable, through the Payer Initiated
Process. This proposal would be effective January 1, 2020 for the 2021
performance year. In the CY 2019 PFS final rule, we finalized a process
for Remaining Other Payers to submit other payer arrangements for CMS
determination of Other Payer Advanced APM status (83 FR 59934 through
59935). Other payers would be required to submit their other payer
arrangements for CMS determination as Aligned Other Payer Medical Home
Models and Other Payer Advanced APMs, as applicable, using this
Remaining Other Payer process.
We propose that APM Entities and eligible clinicians can submit
other payer arrangements for CMS to determine whether they are Aligned
Other Payer Medical Home Models and Other Payer Advanced APMs, as
applicable, through the Eligible Clinician Initiated Process.
We seek comment on these proposals.
(3) Bearing Financial Risk for Monetary Losses
(a) Overview
In the CY 2017 Quality Payment Program final rule (81 FR 77466), we
divided the discussion of this criterion into two main topics: (1) What
it means for an APM Entity to bear financial risk if actual aggregate
expenditures exceed expected aggregate expenditures under a payment
arrangement (which we refer to as either the generally applicable
financial risk standard or Medicaid Medical Home Model financial risk
standard); and (2) what levels of risk we would consider to be in
excess of a
[[Page 40834]]
nominal amount (which we refer to as either the generally applicable
nominal amount standard or the Medicaid Medical Home Model nominal
amount standard).
In the CY 2017 Quality Payment Program final rule, we finalized
that for a Medicaid Medical Home Model to be an Other Payer Advanced
APM, if the APM Entity's actual aggregate expenditures exceed expected
aggregate expenditures, the Medicaid Medical Home Model must:
Withhold payment for services in the APM Entity and/or the
APM Entity's eligible clinicians;
Reduce payment rates to the APM Entity and/or the APM
Entity's eligible clinicians;
Require direct payment by the APM Entity to the Medicaid
program; or
Require the APM Entity to lose the right to all or part of
an otherwise guaranteed payment or payments.
We based this standard on our belief that Medicaid Medical Home
Models are unique types of Medicaid APMs because they are identified
and treated differently under the statute. We believe it is appropriate
to establish a unique standard for bearing financial risk that reflects
these statutory differences and remains consistent with the statutory
scheme, which is to provide incentives for participation by eligible
clinicians in Advanced APMs (81 FR 77467 through 77468).
In addition, to be an Other Payer Advanced APM, a Medicaid Medical
Home Model must require that the total annual amount that an APM Entity
potentially owes or foregoes under the Medicaid Medical Home Model must
be at least:
For QP Performance Period 2019, 3 percent of the APM
Entity's total revenue under the payer.
For QP Performance Period 2020, 4 percent of the APM
Entity's total revenue under the payer.
For QP Performance Period 2021 and later, 5 percent of the
APM Entity's total revenue under the payer.
(b) Aligned Other Payer Medical Home Model Financial Risk and Nominal
Amount Standards
Neither the current Medical Home Model financial risk and nominal
amount standards nor the Medicaid Medical Home Model financial risk and
nominal amount standards do not apply to similar arrangements with
other payers for purposes of Other Payer Advanced APM determinations.
Consistent with our proposal to define the term Aligned Other Payer
Medical Home Model, we are proposing to amend Sec. 414.1420(d)(2) and
(d)(4) of our regulations to also include that conform the financial
risk and nominal amount standards for Aligned Other Payer Medical Home
Models with the existing Medicaid Medical Home Model financial risk and
nominal amount standards for Medicaid Medical Home Models. Consistent
with recognizing the similar characteristics of these payment
arrangements and the same participants, we believe that the same
financial risk and nominal amount standards should be applied to
Aligned Other Payer Medical Home Models.
Further, we are proposing a corresponding amendment to Sec.
414.1420(d)(2)(ii) to state that an Aligned Other Payer Medical Home
Model or Medicaid Medical Home Model require the direct payment by the
APM Entity to the payer, which meaning either the other payer or the
Medicaid agency.
We believe that if we applied the Medicaid Medical Home Model
financial risk and nominal amount standards to all other payer
arrangements that would meet the Aligned Other Payer Medical Home Model
definition but for not being aligned with a CMS Multi-Payer Model that
is a Medical Home Model, we might create gaming opportunities amongst
other payers where medical homes are developed solely to take advantage
of the unique nominal amount standard, particularly because we would
have less insight into the nature of arrangements not aligned with CMS
Multi-Payer Models.
In addition, as the 50 eligible clinician limit as codified in
Sec. Sec. 414.1415(c)(7) and 414.1420(d)(8) currently applies to
Medical Home Models and Medicaid Medical Home Models, respectively, we
correspondingly propose that the 50 eligible clinician limit apply to
Aligned Other Payer Medical Home Models by amending Sec.
414.1420(d)(8).
We seek comment on these proposals.
(b) Generally Applicable Other Payer Advanced APM Nominal Amount
Standard
(i) Overview
In the CY 2017 Quality Payment Program final rule (81 FR 77471), we
finalized at Sec. 414.1420(d)(3)(ii) that except for risk arrangements
described under the Medicaid Medical Home Model Standard, for a payment
arrangement to meet the nominal amount standard the specific level of
marginal risk must be at least 30 percent of losses in excess of the
expected expenditures and total potential risk must be at least 4
percent of the expected expenditures. Furthermore, we finalized that a
payment arrangement must require APM Entities to bear financial risk
for at least 3 percent of the expected expenditures for which an APM
Entity is responsible under the payment arrangement. Section
414.1420(d)(6) provides for the purposes of this section, expected
expenditures is defined as the Other Payer Advanced APM benchmark,
except for episode payment models, for which it is defined as the
episode target price.
(ii) Marginal Risk
As we stated in the 2017 Quality Payment Program final rule (81 FR
77470), to determine that a payment arrangement satisfies the marginal
risk portion of the nominal amount standard, we would examine the
payment required under the payment arrangement as a percentage of the
amount by which actual expenditures exceeded expected expenditures.
Specifically for marginal risk, we finalized that for a payment
arrangement to meet the nominal amount standard, the specific level of
marginal risk must be at least 30 percent of losses in excess of the
expected expenditures. We also stated that the rate of marginal risk
could vary with the amount of losses.
To date, we have applied the marginal risk requirement as requiring
that a payment arrangement must exceed the marginal risk rate of 30
percent at all levels of total losses even as the marginal risk rate
varies depending on the amount by which actual expenditures exceed
expected expenditures, consistent with Sec. 414.1420(d)(5)(i). For
example, certain other payer arrangements where the marginal risk met
or exceeded 30 percent at lower levels of losses in excess of expected
expenditures, but fell below 30 percent at higher levels of losses,
would not meet the marginal risk requirement of the generally
applicable nominal amount standard.
In general, this approach has worked well and served its intended
purpose of ensuring only other payer arrangements with strong financial
risk components are determined to be Other Payer Advanced APMs. At the
same time, this policy has necessitated that we determine that certain
other payer arrangements are not Other Payer Advanced APMs even though
they include strong financial risk components and well exceed the 30
percent marginal risk requirement at the most common levels of losses
in excess of expected expenditures, and employ marginal risk rates
below 30 percent only at much higher levels of losses. We
[[Page 40835]]
do not believe these other payer arrangements include marginal risk
rates below 30 percent to avoid subjecting participants to more than
nominal amounts of risk. Rather, we believe that these other payer
arrangements employ the lower marginal risk rates at higher levels of
losses in order to protect participants from potentially catastrophic
losses and undue financial burden that might arise because of market
factors likely outside their control.
Therefore, we propose to amend Sec. 414.1420(d)(5) by amending
paragraph (d)(5)(i) to provide that in event that the marginal risk
rate varies depending on the amount by which actual expenditures exceed
expected expenditures, the average marginal risk rate across all
possible levels of actual expenditures would be used for comparison to
the marginal risk rate specified in paragraph (d)(3)(ii) of this
section, with exceptions for large losses and small losses as described
in paragraphs (d)(5)(ii) and (d)(5)(iii) of this section.
We would calculate the average marginal risk rate in two steps. An
example of such a calculation is presented in Table 58. This example
uses a model relying on a Total Cost of Care (TCOC) benchmark. This
methodology can also be applied to other types of other payer payment
arrangements. In this example, first, take the sum of the marginal risk
for each percent above the Total Cost of Care (TCOC) benchmark to
determine the participant losses. For example, at 3 percent add 50
percent (amount for 1 percent above benchmark) plus 50 percent (amount
for 2 percent above benchmark) plus 50 percent (amount for 3 percent
above benchmark) equals 1.50 percent. Second, divide the participant
losses by the percentage above the benchmark (in our example, 1.50
percent divided by 3) to get average marginal risk. The average
marginal risk rate remains above 30 percent at all levels of potential
losses up to point where the participant would be responsible for
losses equal to the total potential risk requirement of 3 percent. We
note that this example presents the calculation only up to the point
where the total potential risk requirement is met.
Table 58--Example Average Marginal Risk Calculation
----------------------------------------------------------------------------------------------------------------
Performance (% above TCOC
benchmark) Marginal risk (%) Participant losses (%) Average marginal risk (%)
----------------------------------------------------------------------------------------------------------------
1 50 0.50 50
2 50 1.00 50
3 50 1.50 50
4 25 1.75 44
5 25 2.00 40
6 25 2.25 38
7 25 2.50 36
8 25 2.75 34
9 25 3.00 33
----------------------------------------------------------------------------------------------------------------
Through this amendment, significant and meaningful financial risk
would continue to be required for Other Payer Advanced APMs because the
average marginal risk rate would need to be or exceed 30 percent, while
recognizing that such risk can be demonstrated with some variation in
the application of marginal risk rates, allowing for continued
innovation in the marketplace. This proposed policy ensures that all
Other Payer Advanced APMs have 30 percent of marginal risk up until the
participant owes 3 percent of losses, which is the intended effect of
the standard without excluding certain payment arrangement that have
strong financial risk designs. When considering average marginal risk
in the context of total risk, as we do for Other Payer Advanced APM
determinations, certain risk arrangements can create meaningful and
significant risk-based incentives for performance and at the same time
ensure that the payment arrangement has strong financial risk
components.
We believe this proposed change is consistent with the statute and
the use of guardrails to maintain financially strong models, and note
that in making this change we are not lowering the standard for the
applicable marginal risk rate but rather allowing for a new
demonstration of how it can be met. We clarify that the proposed
amendment would also continue to maintain the allowance for large
losses provision as described in paragraph (d)(5)(ii) of Sec.
414.1420, so that when calculating the average marginal risk rate we
may disregard the marginal risk rates that apply in cases when actual
expenditures exceed expected expenditures by an amount sufficient to
require the APM Entity to make financial risk payments under the
payment arrangement greater than or equal to the total risk
requirements. We also clarify that the exception for small losses
described in paragraph (d)(5)(iii) would also be maintained.
We seek comment on this proposal.
(iii) Expected Expenditures
In the CY 2017 Quality Payment Program final rule (81 FR 77551), we
established the definition of ``expected expenditures'' at Sec.
414.1420(d)(6) to mean the Other Payer APM benchmark, except for
episode payment models, for which it is defined as the episode target
price. We also finalized at Sec. 414.1420(d)(3)(ii) that, except for
arrangements assessed under the Medicaid Medical Home Model financial
risk and nominal amount standards, in order to meet the Other Payer
Advanced APM nominal amount standard, a payment arrangement's level of
marginal risk must be at least 30 percent of losses in excess of the
expected expenditures and the total potential risk must be at least 4
percent (81 FR 77471).
In the CY 2017 Quality Payment Program proposed rule (81 FR 28332),
we proposed to measure three dimensions of risk under our generally
applicable nominal amount standards: (1) Marginal risk, which refers to
the percentage of the amount by which actual expenditures exceed
expected expenditures for which an APM Entity would be liable under the
APM; (2) minimum loss rate (MLR), which is a percentage by which actual
expenditures may exceed expected expenditures without triggering
financial risk; and (3) total potential risk, which refers to the
maximum potential payment for which an APM Entity could be liable under
the APM. However, based on commenters' concerns regarding technical
complexity, we finalized only the marginal risk and MLR requirements.
[[Page 40836]]
In the CY 2017 Quality Payment Program proposed rule (81 FR 28333),
we explained that to determine whether an APM satisfies the marginal
risk portion of the nominal risk standard, we would examine the payment
required under the APM as a percentage of the amount by which actual
expenditures exceeded expected expenditures. We proposed that we would
require that this percentage exceed a required marginal risk percentage
of 30 percent regardless of the amount by which actual expenditures
exceeded expected expenditures.
Our rationale for proposing the marginal risk requirement was that
the inclusion of a marginal risk requirement would be intended to focus
on maintaining a more than nominal level of likely risk under an
Advanced APM or an Other Payer Advanced APM. However, even with a
marginal risk requirement, as there is under the Other Payer Advanced
APM criteria, we believe there is a need to amend the definition of
expected expenditures to ensure there are more than nominal levels of
average or likely risk under Other Payer Advanced APMs that meets the
generally applicable benchmark-based nominal amount standard. Even with
the current marginal risk requirement, a more rigorous definition of
expected expenditures is needed to avoid situations where the level of
expected expenditures would be set in a manner that reduces the losses
a participant might incur. We also believe it is important that our
definition of expected expenditures is consistent across both the
Advanced APM and Other Payer Advanced APM criteria. We generally try to
align the Advanced APM and Other Payer Advanced APM criteria to the
extent feasible and appropriate.
As discussed in section III.I.4.c.(2)(c) of this proposed rule,
this proposal is intended to account for scenarios where a payment
arrangement could have a sufficient total risk potential to meet our
standard and a sharing rate that results in adequate marginal risk if
actual expenditures exceed expected expenditures; however, the level of
expected expenditures reflected in the payment arrangements benchmark
or episode target price could be set in a manner which substantially
reduces the amount of loss a participant in the payment arrangement
would reasonably expect to incur.
For a payment arrangement to meet the generally applicable
benchmark-based nominal amount standard, we believe there should be not
only the potential for financial losses based on expenditures in excess
of the benchmark as provided in Sec. 414.1420(d)(6), but also some
meaningful likelihood that a participant might exceed the benchmark. If
the benchmark is set in such a way that it is extremely unlikely that
participants would exceed it, then there is little potential for
participants to incur financial losses, and the amount of risk is
essentially illusory.
Therefore, in Sec. 414.1420(d)(6), we are proposing to amend the
definition of expected expenditures. Specifically, we would define
expected expenditures as, for the purposes of this section, as the
Other Payer APM benchmark. For episode payment models, expected
expenditures mean the episode target price. For purposes of assessing
financial risk for Other Payer Advanced APM determinations, the
expected expenditures under the payment arrangement should not exceed
the expenditures for a participant in the absence of the payment
arrangement. If expected expenditures (that is, benchmarks) under the
payment arrangement exceed the expenditures that the participant would
be expected to incur in the absence of the payment arrangement such
excess expenditures are not considered when CMS assesses financial risk
under the payment arrangement for Other Payer Advanced APM
determinations.
We believe that this proposed change would prevent the expected
expenditures under the other payer payment arrangement being set in a
manner which substantially reduces the amount of losses a participant
may face while otherwise satisfying this Other Payer Advanced APM
criterion.
We clarify that, in general, expected expenditures are expressed as
a dollar amount, and may be derived from national, regional, APM
Entity-specific, and/or practice-specific historical expenditures
during a baseline period, or other comparable expenditures. However, we
recognize expected expenditures under a payment arrangement are often
risk-adjusted and trended forward, and may be adjusted to account for
expenditure changes that are expected to occur as a result of payment
arrangement participation. For the purpose of this proposed definition
of expected expenditures, we would not consider risk adjustments to be
excess expenditures when comparing to the costs that an APM Entity
would be expected to incur in the absence of the payment arrangement.
We believe that this proposed amendment would allow us to ensure
that there are more-than-nominal amounts of average or likely risk
under an other payer payment arrangement that meets the generally
applicable benchmark-based nominal amount standard. We believe that the
proposed amended definition of expected expenditures, particularly by
our not considering excess expenditures, would provide a more definite
basis for us to assess whether an APM Entity would bear more than a
nominal amount of financial risk for participants under the generally
applicable benchmark-based nominal amount standard.
We seek comment on this proposal.
(iv) Excluded Items and Services Under Full Capitation Arrangements
In the CY 2017 Quality Payment Program final rule (81 FR 77551), we
finalized a capitation standard at Sec. 414.1420(d)(7) which provides
a capitation arrangement meets the Other Payer Advanced APM financial
risk criterion. For purposes of Sec. 414.1420(d)(3), we defined a
capitation arrangement as a payment arrangement in which a per capita
or otherwise predetermined payment is made under the APM for all items
and services for which payment is made under the APM for all items and
services for which payment is made through the APM furnished to a
population of beneficiaries, and no settlement is performed for the
purpose of reconciling or sharing losses incurred or savings earned by
the APM Entity. We clarified that arrangements made directly between
CMS and Medicare Advantage Organizations under the Medicare Advantage
program are not considered capitation arrangements for purposes of
Sec. 414.1420(d)(7).
In the CY 2019 PFS final rule (83 FR 59939), we made technical
corrections to the Advanced APM financial risk capitation standard at
Sec. 414.1420(d)(7). These corrections clarified that our financial
risk capitation standard applies only to full capitation arrangements
where a per capita or otherwise predetermined payment is made under the
APM for all items and services furnished to a population of
beneficiaries during a fixed period of time, and no settlement or
reconciliation is performed.
As we have begun to collect information on other payer payment
arrangements for purposes of making Other Payer Advanced APM
determinations, we have noticed that some payment arrangements that are
submitted for CMS to determine as capitation arrangements consistent
with Sec. 414.1420(d)(7) include a list of services that have been
excluded from the capitation rate, such as hospice care, organ
transplants, or out-of-network emergency room services. In reviewing
[[Page 40837]]
these exclusion lists, we believe that it may be appropriate for CMS to
allow certain capitation arrangement to be considered ``full''
capitation arrangements even if they categorically exclude certain
services from payment through the capitation rate. Therefore, we are
seeking comment on how other payers define or determine what, if any,
exclusions are reasonable in a given capitation arrangement.
Specifically, we seek comment on whether there are common industry
practices to exclude certain categories of items and services from
capitated payment rates and, if so, whether there are common principles
or reasons for excluding those categories of services. In addition, we
seek comment on why such items or services are excluded.
We also seek comment on how non-Medicare payers define or prescribe
certain categories of services that are excluded with regards to global
capitation payment arrangements. We also seek comment on whether a
capitation arrangement should be considered to be a full capitation
arrangement even though it excludes certain categories of services from
the capitation rate under a full capitation arrangement.
(4) Summary of Proposals
In this section, we are proposing the following policies:
Aligned Other Payer Medical Home Model: We proposed to
define the term Aligned Other Payer Medical Home Model. We also propose
to apply the existing Medicaid Medical Home Model financial risk and
nominal amount standards, including the 50 eligible clinician limit, to
Aligned Other Payer Medical Home Models.
Marginal Risk: We propose that when that the marginal risk
rate varies depending on the amount by which actual expenditures exceed
expected expenditures, the average marginal risk rate across all
possible levels of actual expenditures would be used for comparison to
the marginal risk rate requirement, with exceptions for large losses
and small losses as provided in Sec. 414.1420(d)(5).
Expected Expenditures: We are proposing to amend the
definition of expected expenditures codified at Sec. 414.1420(d)(6) to
define expected expenditures as the Other Payer Advanced APM benchmark,
and, for episode payment models, expected expenditures means the
episode target price.
5. Quality Payment Program Technical Revisions
We are proposing certain technical revisions to our regulations to
correct several technical errors and to reconcile the text of several
of our regulations with the final policies we adopted through notice
and comment rulemaking.
We are proposing a technical revision to Sec. 414.1405(f) of our
regulations to specify that the exception for the application of the
MIPS payment adjustment factors to model-specific payments is
applicable starting in the 2019 MIPS payment year, not just for the
2019 MIPS payment year. This proposed revision would align the
regulation text with our final policy as stated in the preamble of the
CY 2019 PFS final rule with comment period (83 FR 59887 through 59888)
which makes clear that the exception begins with the 2019 MIPS payment
year and continues in subsequent years.
We are also proposing technical revisions to Table 59 of the CY
2019 PFS final rule with comment period (83 FR 59935) to correct two
dates. Specifically we propose to change the date for Medicare Health
Plans: Guidance made available to ECs, then Submission Period Opens; it
is currently listed as September 2020, and we propose to change that
date to August 2020. Similarly, we propose to change the date for
Remaining Other Payers: Guidance made available to ECs, then Submission
Period Opens; it is currently listed as September 2020, and we propose
to change that to August 2020. These changes align with what was
originally finalized in the CY 2018 QPP final rule with comment period
(82 FR 53864) which stated that the dates were to be August 2020, and
which we did not intend to change in the CY 2019 PFS final rule. Table
59 is included as the corrected Table 59 from the CY 2019 PFS final
rule.
BILLING CODE 4120-01-P
[[Page 40838]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.093
BILLING CODE 4120-01-C
We are also proposing technical revisions to Sec. Sec.
414.1415(c)(6) and 414.1420(d)(7) to correct the internal citation. The
current citation, 42 U.S.C. 422, is incorrect. It should instead be 42
CFR part 422. We also are proposing technical revisions to Sec.
414.1420(d)(5). We clarify that ``APM'' in Sec. 414.1420(d)(5) should
be ``other payer payment arrangement.'' In the CY 2019 PFS final rule,
we finalized deleting Sec. 414.1420(d)(3)(ii)(B) and consolidating
Sec. 414.1420(d)(3)(ii)(A) into Sec. 414.1420(d)(3)(ii), but that
change was not applied to the regulation. We are proposing to revise
the regulation accordingly in this proposed rule. Relatedly, we propose
to amend Sec. 414.1420(d)(i), (ii), and (iii) to state in ``paragraph
(d)(3)(ii)'' of this section instead of ``paragraph (d)(3)(ii)(A)'' of
this section. We are also proposing to clarify that ``Other Payer
Advanced APM'' in Sec. 414.1420(d)(5)(ii) should be ``other payer
payment arrangement,'' as the marginal risk rate requirements are
applied to any other payer payment arrangement that CMS assesses
against the Other Payer Advanced APM criteria. These proposed revisions
are technical in nature and do not change any substantive policies for
the Quality Payment Program.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter
35), we are required to publish a 60-day notice in the Federal Register
and solicit public comment before a ``collection of information''
requirement is submitted to the Office of Management and Budget (OMB)
for review and approval. For the purposes of the PRA and this section
of the preamble, collection of information is defined under 5 CFR
1320.3(c) of the PRA's implementing regulations.
To fairly evaluate whether an information collection should be
approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit
comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our burden estimates.
The quality, utility, and clarity of the information to be
collected.
Our effort to minimize the information collection burden
on the affected public, including the use of automated collection
techniques.
We are soliciting public comment on each of the required issues
under section 3506(c)(2)(A) of the PRA for the following information
collection requirements (ICRs).
A. Wage Estimates
To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2018 National Occupational Employment and Wage
Estimates for all salary estimates (http://www.bls.gov/
[[Page 40839]]
oes/current/oes_nat.htm). In this regard, Table 60 presents the mean
hourly wage, the cost of fringe benefits and overhead (calculated at
100 percent of salary), and the adjusted hourly wage.
Table 60--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
Fringe
Occupation Mean hourly benefits and Adjusted
Occupation title code wage ($/hr) overhead ($/ hourly wage ($/
hr) hr)
----------------------------------------------------------------------------------------------------------------
Billing and Posting Clerks...................... 43-3021 19.00 19.00 38.00
Bookkeeping, Accounting, and Auditing Clerks.... 43-3031 22.46 22.46 44.92
Chief Executive................................. 11-1011 96.22 96.22 192.44
Compliance Officer.............................. 13-1041 41.85 41.85 83.70
Computer Systems Analysts....................... 15-1121 45.01 45.01 90.02
Health Diagnosing and Treating Practitioners.... 29-1000 49.02 49.02 98.04
Licensed Practical Nurse (LPN).................. 29-2061 22.62 22.62 45.24
Medical Secretary............................... 43-6013 17.83 17.83 35.66
Physicians...................................... 29-1060 101.43 101.43 202.86
Practice Administrator (Medical and Health 11-9111 54.68 54.68 109.36
Services Managers).............................
----------------------------------------------------------------------------------------------------------------
As indicated, we adjusted our employee hourly wage estimates by a
factor of 100 percent. This is necessarily a rough adjustment, both
because fringe benefits and overhead costs vary significantly from
employer to employer, and because methods of estimating these costs
vary widely from study to study. Nonetheless, we believe that doubling
the hourly wage to estimate total cost is a reasonably accurate
estimation method.
B. Proposed Information Collection Requirements (ICRs)
1. ICRs Regarding Medicare Coverage for Opioid Use Disorder Treatment
Services Furnished by Opioid Treatment Programs (OTPs) (Sec. Sec.
414.800 Through 414.806)
As described in section II.G. of this rule, section 2005 of the
SUPPORT for Patients and Communities Act establishes a new Medicare
Part B benefit for OUD treatment services furnished by OTPs for
episodes of care beginning on or after January 1, 2020. In this rule,
CMS proposes to use the payment methodology in section 1847A of the
Act, which is based on Average Sales Price (ASP), to set the payment
rates for the ``incident to'' drugs and ASP-based payment to set the
payment rates for the oral product categories when we receive
manufacturers' voluntarily-submitted ASP data for these drugs.
The proposed burden consists of the time/cost for manufacturers of
oral opioid agonist or antagonist treatment medications (that are
approved by the Food and Drug Administration under section 505 of the
Federal Food, Drug, and Cosmetic Act for use in the treatment of OUD)
to voluntarily prepare and submit their ASP data to CMS.
The burden for such reporting is currently approved by OMB under
control number 0938-0921 (CMS-10110) and would remain unchanged (13
hours per response, 4 responses per year, 180 respondents, and 9,360
total hours) since our currently approved burden already accounts for
the voluntary reporting of ASP data. We estimate that there are
approximately 15 manufacturers of oral drugs used for treatment of
opioid use disorder (OUD). We believe that approximately 10 of the 15
manufacturers already report ASP data to CMS for other drugs, and thus
up to 5 manufacturers may newly report ASP data to CMS. However, we
note that some of these new respondents may have subsidiary or similar
relationships with manufacturers that already report ASP data and may
be able to submit their data with a current respondent. While this
rule's proposed requirements may slightly increase the number of
respondents, our 180 respondent per quarter estimate historically
fluctuates over time as new Part B drug manufacturers are added while
others leave or consolidate. The annual fluctuation in respondents in
the past has typically been +/- 5 to 10 manufacturers per year; over
the past few years, the annual fluctuation has sometimes been greater,
ranging from -13 to +11, but over that several year period the overall
average of the annual fluctuation is near 0. As a result, the potential
slight increase in respondents associated with voluntary reporting from
oral OUD drug manufacturers is well within the range of recent
fluctuations in the number or respondents, and the net figure, taking
into account voluntary OTP reporting, remains unchanged from the
currently approved burden estimate at 180 respondents. In addition, we
believe that additional voluntary reporting for oral drugs used for
treatment of OUD for those manufacturers that currently report ASP data
to CMS would impose minimal additional burden. Consequently, we are not
making any changes under the aforementioned control number. However, we
will continue to monitor the number of respondents to account for
various factors such as a change in the number of voluntary submissions
from oral OUD drug manufacturers, as well as other issues that may not
be related to the voluntary reporting for oral drugs used in OTPs, such
as manufacturer consolidations, and new Part B drug and biological
manufacturers. We will revise the burden estimate as needed.
2. ICRs Regarding the Ground Ambulance Data Collection System
Section 1834(l)(17)(A) of the Act requires that the Secretary
develop a ground ambulance data collection system that collects cost,
revenue, utilization, and other information determined appropriate by
the Secretary with respect to providers of services and suppliers of
ground ambulance services (ground ambulance organizations). Section
1834(l)(17)(I) of the Act states that the PRA does not apply to the
collection of information required under section 1834(l)(17) of the
Act. Accordingly, we are not setting out the burden of the proposed
collection of information under the data collection system. Please
refer to section VI.F.2. of this proposed rule for a discussion of the
estimated impacts associated with the ground ambulance data collection
system.
[[Page 40840]]
3. ICRs Regarding Intensive Cardiac Rehabilitation (Sec. 410.49)
Section 410.49(b)(1)(vii) and (viii) of this proposed rule would
expand the covered conditions to chronic heart failure and add other
cardiac conditions as specified through the national coverage
determination (NCD) process. The proposed rule would expand covered
conditions, but, due to the breadth of the proposed and existing
covered conditions, we do not anticipate the need to use the NCD
process to add additional covered conditions in the near future. In the
unlikely event an NCD request was submitted, it would be covered by OMB
control number 0938-0776 (CMS-R-290), which will not expire until
February 29, 2020. We are not proposing any changes under that control
number since we are not proposing any changes to the submission process
or burden.
4. ICRs Regarding the Medicare Shared Savings Program (42 CFR part 425)
Section 1899(e) of the Act provides that chapter 35 of title 44 of
the U.S. Code, which includes such provisions as the PRA, shall not
apply to the Shared Savings Program. Accordingly, we are not setting
out burden under the authority of the PRA. Please refer to section
VI.E.6. of this proposed rule for a discussion of the impacts
associated with the proposed changes to the Shared Savings Program
quality reporting requirements included in this proposed rule.
5. ICRs Regarding the Open Payments Program
As described in section III.F. of this rule, we propose to: (1)
Expand the definition of ``covered recipient,'' (2) modify ``nature of
payment'' categories, and (3) standardize data on reported covered
drugs, devices, biologicals, or medical supplies.
Expanding the Definition of ``Covered Recipient'' (Sec. Sec.
403.902, 403.904, and 403.908): In this rule we propose to expand the
definition of a ``covered recipient'' in accordance with the SUPPORT
Act to include physician assistants, nurse practitioners, clinical
nurse specialists, nurse anesthetists, and certified nurse midwifes.
The definition currently includes certain physicians and teaching
hospitals. Section 6111(c) of the SUPPORT Act provides that chapter 35
of title 44 of the U.S. Code, which includes such provisions as the
PRA, shall not apply to the changes to the definition of a covered
recipient included in the SUPPORT Act. In this regard we are not
setting out burden under the authority of the PRA. . We do, however,
provide a brief estimate in section V.8 of this proposed rule.
Modification of the ``Nature of Payment'' Categories (Sec. Sec.
403.902 and 403.904): The following proposed changes will be submitted
to OMB for approval under control number 0938-1237 (CMS-10495). Subject
to renewal, the control number is currently set to expire on March 31,
2021. It was last approved on March 21, 2018, and remains active.
The proposed changes would modify the ``nature of payment''
categories and provide more options for applicable manufacturers and
GPOs to capture the nature of the payment made to the covered
recipient. To accommodate this change, we project that reporting
entities would need to update their system to incorporate the proposed
categories. We estimate, based on the trends in the number of entities
that report every year, that there are 1,600 reporting entities and
estimate, using the number of records that these entities report as a
proxy for size of the entity. While the total number of entities that
report fluctuates year to year, but has been close to 1,600 for the
last two program years. We also estimate that 38 percent (or 611
entities) are small, 29 percent (or 457 entities) are medium, and 33
percent (or 532 entities) are large. We also estimate that 25 percent
of reporting entities (400) would need to make minor, one-time updates
to their data collection processes because they expect to report a
transaction with one of the new categories. Among the 400 entities, we
estimate it would take between 5 and 30 hours per entity depending on
the size of the entity (with large companies requiring more time) at
$44.92/hr for support staff. For all of these entities, we estimate a
subtotal of 5,895 hours [(30 hrs for a large entity x 133 entities) +
(10 hrs for a medium entity x 114 entities) + (5 hrs for a small entity
x 153 entities)] at a cost of $264,804 (5,895 hrs x $44.92/hr).
We also expect that all entities would need to make minor, one-time
adjustments to their submission processes. For each entity we estimate
that this would take 2 to 5 hours at $44.92/hr (with larger entities
requiring more time) for support staff and 1 hour at $83.70/hr for
compliance officers. For all entities, we estimate a subtotal of 7,767
hours [(5 hrs for support staff at a large entity x 532 entities) + (5
hrs for support staff at a medium entity x 457 entities) + (2 hrs for
support staff at a small entity x 611 entities) + (1 hr for compliance
officer at each entity regardless of size x 1600 entities)] at a cost
of $410,941 [(2,660 hrs for support staff at large entities x $44.92/
hr) + (2,285 hrs for support staff at medium entities x $44.92/hr) +
(1,222 hrs for support staff at small entities x $44.92/hr) + (1,600
hrs for compliance officers across all entities x $83.70/hr)].
In aggregate, we estimate a one-time burden of 13,662 hours (5,895
hrs + 7,767 hrs) at a cost of $675,745 ($264,804 + $410,941) to
implement. After these adjustments are made, we do not anticipate any
ongoing added burden beyond what is currently approved under the
aforementioned control number.
Table 61--Burden To Modify Nature of Payment Categories
------------------------------------------------------------------------
Description Hours Cost
------------------------------------------------------------------------
Burden to update collection processes 5,895 $264,804
for entities that expect to report a
transaction with a new Nature of
Payment category.......................
Burden to update submission processes 7,767 410,941
and systems to account for the new
Nature of Payment categories...........
-------------------------------
Total............................... 13,662 675,745
------------------------------------------------------------------------
Standardizing Data Reporting for Covered Drugs, Devices,
Biologicals, or Medical Supplies (Sec. Sec. 403.902 and 403.904): The
following proposed changes will be submitted to OMB for approval under
control number 0938-1237 (CMS-10495). Subject to renewal, the control
number is currently set to expire on March 31, 2021. It was last
approved on March 21, 2018, and remains active.
Applicable manufacturers and GPOs will need to accommodate the
reporting of device identifiers. We have made some estimates below, but
we recognize that these estimates may vary because the information
collection system
[[Page 40841]]
changes that are needed will vary since some entities may already be
capturing this information in their systems while others may not.
Nevertheless, we have made some assumptions below, but we welcome
feedback from stakeholders regarding the potential burden associated
with this proposal and the extent to which device identifiers are
already tracked by reporting entities.
We estimate, based on an analysis of currently available data, that
approximately 850 entities (approximately 53 percent of an assumed
1,600) would need to report at least one record with a device
identifier and that 450 of those entities do not already collect the
device identifier. For this analysis we assumed that 38 percent of the
entities would be small, 29 percent would be medium, and 33 percent
would be large. We differentiate because we assume that larger
companies would incur more burden to make the changes needed to begin
reporting device identifiers because they have more complex systems and
potentially more records to report. The number of records submissions
would not change, but this rule would add a new data element that may
need to be reported along with some or all of an entity's records. The
precise tasks would vary by entity, but may include developing
processes for gathering device identifier information or systems for
collecting the data.
For the 450 entities that would be required to start collecting
device identifiers, we estimate that this task would take between 20
and 100 hours for support staff depending on the size of the company
(with larger companies requiring more time) at $44.92/hr. For all
entities, we estimate a subtotal of 24,840 hours [(100 hrs for a large
entity x 150 entities) + (50 hrs for a medium entity x 128 entities) +
(20 hrs for a small entity x 172 entities)] at a cost of $1,115,813
[(15,000 hrs for support staff at a large entity x $44.92/hr) + (6,400
hrs for support staff at a medium entity x $44.92/hr) + (3,440 hrs for
support staff at a small entity x $44.92/hr)].
For the 850 entities that we expect would be required to begin
reporting a device identifier, we estimate that this would take support
staff between 10 and 40 hours per entity (with larger companies
requiring more time) at $44.92/hr and 2 hours at $83.70/hr for
compliance officers. For all entities, we estimate a subtotal of 21,100
hours [(40 hrs for support staff at a large entity x 282 entities) +
(20 hrs for support staff at a medium entity x 244 entities) + (10 hrs
for support staff at a small entity x 324 entities) + (2 hrs for
compliance officers at every entity regardless of size x 850 entities)]
at a cost of $1,013,740 [(11,280 hrs for support staff at large
entities x $44.92/hr) + (4,880 for support staff at medium entities x
$44.92/hr) + (3,240 for support staff at small entities x $44.92/hr) +
(1,700 hrs for compliance officers across all entities regardless of
size x $83.70/hr)].
We also assume that the remaining 750 entities not planning to
submit a device identifier would have a small amount of burden
associated with updating their submission processes. We estimate that
this would take support staff between 2 and 10 hours per entity (with
larger entities requiring more time) at $44.92/hr and 2 hours for
compliance officers at $83.70/hr. For all entities, we estimate a
subtotal of 5,637 hours [(10 hrs for support staff at a large entity x
249 entities) + (5 hrs for support staff at a medium entity x 215
entities) + (2 hrs for support staff at a small entity x 286 entities)
+ (750 hrs for compliance officers at all entities regardless of size x
2 hrs)] at a cost of $311,384 [(2,490 hrs for support staff at large
entities x $44.92/hr) + (1,075 hrs for support staff at medium entities
x $44.92/hr) + (572 hrs for support staff at small entities x $44.92/
hr) + (1,500 hrs for compliance officers at all entities regardless of
size x $83.70/hr)].
In aggregate, we estimate a one-time burden of 51,577 hours (24,840
hrs + 21,100 hrs + 5,637 hrs) at a cost of $2,440,937 ($1,115,813 +
$1,013,740 + $311,384) to implement. After these adjustments are made,
we do not anticipate there being any ongoing added burden beyond what
is currently approved under the aforementioned control number.
Table 62--Burden for Changes To Standardize Data on Reported Covered
Drugs, Devices, Biologicals, or Medical Supplies
------------------------------------------------------------------------
Description Hours Cost
------------------------------------------------------------------------
First year data collection burden for 24,840 $1,115,813
entities that do not currently collect
a device identifier....................
First year submission burden for all 21,100 1,013,740
entities that would be required to
report a device identifier.............
One time submission process and system 5,637 311,384
updates for entities not reporting a
device identifier......................
-------------------------------
Total............................... 51,577 2,440,937
------------------------------------------------------------------------
6. ICRs Regarding Medicare Enrollment of Opioid Treatment Programs
Except as noted otherwise, the following proposed changes will be
submitted to OMB for approval under control number 0938-0685 (CMS-855B;
``Medicare Enrollment Application: Clinics/Group Practices and Certain
Other Suppliers'').
As discussed previously in this rule, we propose that OTP providers
be required to enroll in Medicare via the paper or internet-based
version of the Form CMS-855B (or its successor application) and any
applicable supplement, pay the application fee, submit fingerprints,
and complete a provider agreement.
Based on SAMHSA statistics and our internal data, we generally
estimate that: (1) There are about 1,700 certified and accredited OTPs
eligible for Medicare enrollment; and (2) 200 OTPs would become
certified by SAMHSA in the next 3 years (or roughly 67 per year),
bringing the total amount of OTPs eligible to enroll to approximately
1,900 over the next 3 years.
Form Completion: We estimate that it would take each OTP an average
of 3 hours to obtain and furnish the information on the Form CMS-855B
and a new supplement thereto designed to capture information unique to
OTPs. Per our experience, we believe that the OTP's medical secretary
would be responsible for securing and reporting data on the Form CMS-
855B and new accompanying OTP supplement. We estimate that this task
would take approximately 2.5 hours; of this amount, roughly 30 minutes
would involve completion of the data on the supplement, though this
timeframe could be higher or lower depending upon the number of
individuals whom the OTP must list. Additionally, the form would be
reviewed and signed by a health diagnosing and treating practitioner of
the OTP, a process we estimate would take 0.5 hours. We thus project a
first-year burden of 5,301 hours (1,767 entities x 3 hr) at a cost of
$732,439 (5,301 hr x ((2.5 hr x $35.66/
[[Page 40842]]
hr) + (0.5 hr x $98.04/hr)), a second-year burden of 201 hours (67
entities x 3 hr) at a cost of $27,772 (201 hr x ((2.5 hr x $35.66/hr) +
(0.5 hr x $98.04/hr)), and a third-year burden of 198 hours (66
entities x 3 hr) at a cost of $27,358 (198 hr x((2.5 hr x $35.66/hr) +
(0.5 hr x $98.04/hr)). In aggregate, we estimate a burden of 5,700
hours (5,301 hr + 201 hr + 198 hr) at a cost of $787,569 ($732,439 +
$27,772 + $27,358). When annualized over the 3-year period, we estimate
an annual burden of 1,900 hours (5,700 hours/3) at a cost of $262,523
($787,569/3).
A copy of the draft OTP supplement will be available on-line, and
we welcome public comment on: (1) Its contents; (2) the usefulness of
the data to be captured thereon; and (3) the anticipated burden of
completion.
Fingerprinting: As we are proposing that OTPs be subject to high
categorical risk level screening under Sec. 424.518, we would require
the submission of a set of fingerprints for a national background check
(via FBI Applicant Fingerprint Card FD-258) from all individuals who
maintain a 5 percent or greater direct or indirect ownership interest
in the OTP. The burden is currently approved by OMB under control
number 1110-0046. An analysis of the impact of this proposed
requirement can be found in the RIA section of this rule.
Application Fee: As already discussed in this rule, each OTP would
be required to pay an application fee at the time of enrollment. The
application fee does not meet the definition of a ``collection of
information'' and, as such, is not subject to the requirements of the
PRA. Although we are not setting out such burden under this section of
the preamble, the cost is scored under the RIA section.
Provider Agreement: As mentioned in the preamble of this proposed
rule, OTPs would have to complete a provider agreement in order to
enroll in Medicare. The burden for reporting and completing the
Provider Agreement--CMS Form 1561 and 1561A (OMB control number 0938-
0832) are based on SAMHSA statistics. We generally estimate that there
are about 1,700 already certified and accredited OTPs eligible for
Medicare enrollment initially; and approximately 200 OTPs would become
certified by SAMHSA in the next 3 years (or roughly 67 per year). We
anticipate would take the OPT 5 minutes at $192.44/hr for a Chief
Executive to review and sign the CMS 1561 or CMS 1561A, and an
additional 5 minutes at $35.66/hr for a Medical Secretary to file the
document when fully executed.
In aggregate, we estimate a burden of 317 hours ([1,767 OPTs for
year 1 + 67 OTPs for year 2 + 67 OTPs for year 3] x 10 min/60) at a
cost of $36,154 ([317 hr/2 respondents x $192.44/hr] + [317 hr/2
respondents x $35.66/hr]). This results, roughly, in a Year 1 burden of
295 hours at $33,623, a Year 2 burden of 11 hours at $1,272, and a Year
3 burden of 11 hours at a cost of $1,254. Annually, over the course of
OMB's typical 3-year approval period, we estimate a burden of 106 hours
317 hr/3 years) at a cost of $12,051 ($36,154/3 years).
Total: Table 63 summarizes our foregoing burden estimates.
Table 63--Combined Burden Related to Enrollment of OTPs
[Completion of CMS-855B and provider agreement]
----------------------------------------------------------------------------------------------------------------
Annualized
Year 1 Year 2 Year 3 Total average over 3-
year period
----------------------------------------------------------------------------------------------------------------
Time (Hours).................... 5,596 212 209 6,017 2,006
Cost ($)........................ 766,062 29,044 28,612 823,718 274,572
----------------------------------------------------------------------------------------------------------------
7. The Quality Payment Program (Part 414 and Section III.K. of This
Proposed Rule)
a. Background
(1) Information Collection Requirements Associated With MIPS and
Advanced APMs
The Quality Payment Program is comprised of a series of ICRs
associated with MIPS and Advanced APMs.
The ICRs reflect this proposed rule's policies, as well as policies
in the CY 2017 and 2018 Quality Payment Program final rules (81 FR
77008 and 82 FR 53568, respectively), and the CY 2019 PFS final rule
(83 FR 59452).
(2) Summary of Quality Payment Program Changes: MIPS
As discussed in more detail in section IV.B.7, the MIPS ICRs
consist of: Registration for virtual groups; qualified registry self-
nomination applications; and QCDR self-nomination applications; CAHPS
survey vendor applications; Quality Payment Program Identity Management
Application Process; quality performance category data submission by
Medicare Part B claims collection type, QCDR and MIPS CQM collection
type, eCQM collection type, and CMS web interface submission type;
CAHPS for MIPS survey beneficiary participation; group registration for
CMS web interface; group registration for CAHPS for MIPS survey; call
for quality measures; reweighting applications for Promoting
Interoperability and other performance categories; Promoting
Interoperability performance category data submission; call for
Promoting Interoperability measures; improvement activities performance
category data submission; nomination of improvement activities; and
opt-out of Physician Compare for voluntary participants.
Two MIPS ICRs show an increase in burden due to proposed changes in
policies: QCDR self-nomination applications and Call for Quality
Measures. For the QCDR self-nomination applications ICR, we have
increased our estimate of the time required to submit a QCDR measure by
1.5 hour due to the proposal to require QCDRs to identify a linkage
between their QCDR measures to related cost measures, Improvement
Activities, and MIPS Value Pathways starting with the 2021 self-
nomination period (+1 hour); and the proposal to require QCDR measure
stewards to submit measure testing data as part of the self-nomination
process for each QCDR measure (+0.5 hours). For this same ICR, we have
increased our estimate of the time required for a QCDR to submit their
self-nomination by 0.25 due to the proposal to require QCDRs to include
a description of the quality improvement services they intend to
support. For the Call for Quality Measures, we have increased our
estimate of the time required to nominate a quality measure for
consideration by 1 hour due to the proposal to require that MIPS
quality measure stewards link their MIPS quality measures to existing
and related cost measures and improvement
[[Page 40843]]
activities and provide rationale for the linkage. The remaining changes
to currently approved burden estimates are adjustments to reflect
better understanding of the impacts of policies finalized in previous
rules, as well as the use of updated data sources available at the time
of publication of this proposed rule. We are not proposing any changes
to the following ICRs: Registration for virtual groups, CAHPS survey
vendor applications, Quality Payment Program Identity Management
Application Process, CAHPS for MIPS survey beneficiary participation,
and group registration for CAHPS for MIPS survey. See section
IV.B.7.(n) of this proposed rule for a summary of the ICRs, the overall
burden estimates, and a summary of the assumption and data changes
affecting each ICR.
The revised requirements and burden estimates for all Quality
Payment Program ICRs (except for CAHPS for MIPS and virtual groups
election) will be submitted to OMB for approval under control number
0938-1314 (CMS-10621). The CAHPS for MIPS Survey is approved under OMB
control number 0938-1222 (CMS-10450). The Virtual Groups Election is
approved under OMB control number 0938-1343 (CMS-10652).
Respondent estimates for the quality, Promoting Interoperability,
and improvement activities performance categories are modeled using
data from the 2017 MIPS performance period with the sole exception of
104 CMS Web Interface respondents, which is based on the number of
groups who submitted data for the quality performance category via the
CMS Web Interface for the 2018 MIPS performance period. Although we are
using data from the 2017 MIPS performance period as we did in the CY
2019 PFS final rule, our respondent estimates have been updated to
reflect revised assumptions regarding QPs and APM participants.
Respondent data from the 2018 MIPS performance period was unavailable
in time for publication for this proposed rule as was the number of
groups and virtual groups registering to submit quality performance
category data using the CMS Web Interface. Assuming updated information
is available, we intend to update these estimates in the final rule.
Our participation estimates are reflected in Tables 69, 70, and 71
for the quality performance category, Table 87 for the Promoting
Interoperability performance category, and Table 92 for the improvement
activities performance category.
The accuracy of our estimates of the total burden for data
submission under the quality, Promoting Interoperability, and
improvement activities performance categories may be impacted due to
two primary reasons. First, we anticipate the number of QPs to increase
because of total expected growth in Advanced APM participation as new
models that are Advanced APMs for which we do not yet have enrollment
data become available for participation. The additional QPs will be
excluded from MIPS and likely not report. Second, it is difficult to
predict what eligible clinicians who may report voluntarily will do in
the 2020 MIPS performance period compared to the 2017 MIPS performance
period, and therefore, the actual number of participants and how they
elect to submit data may be different than our estimates. However, we
believe our estimates are the most appropriate given the available
data.
(3) Summary of Quality Payment Program Changes: Advanced APMs
As discussed in more detail in sections IV.B.7. of this rule, ICRs
for Advanced APMs consist of: Partial Qualifying APM participant (QP)
election; Other Payer Advanced APM identification: Payer Initiated and
Eligible Clinician Initiated Processes; and submission of data for All-
Payer QP determinations under the All-Payer Combination Option.
For these ICRs, the proposed changes to currently approved burden
estimates are adjustments based on updated projections for the 2020
MIPS performance period. We are not proposing any changes to our per-
respondent burden estimates. We are also not proposing any changes to
the Other Payer Advanced APM identification: Eligible Clinician
Initiated Process ICR.
(4) Framework for Understanding the Burden of MIPS Data Submission
Because of the wide range of information collection requirements
under MIPS, Table 64 presents a framework for understanding how the
organizations permitted or required to submit data on behalf of
clinicians vary across the types of data, and whether the clinician is
a MIPS eligible clinician or other eligible clinician voluntarily
submitting data, MIPS APM participant, or an Advanced APM participant.
As shown in the first row of Table 64, MIPS eligible clinicians that
are not in MIPS APMs and other clinicians voluntarily submitting data
will submit data either as individuals, groups, or virtual groups for
the quality, Promoting Interoperability, and improvement activities
performance categories. Note that virtual groups are subject to the
same data submission requirements as groups, and therefore, we will
refer only to groups for the remainder of this section unless otherwise
noted. Because MIPS eligible clinicians are not required to submit any
additional information for assessment under the cost performance
category, the administrative claims data used for the cost performance
category is not represented in Table 64.
For MIPS eligible clinicians participating in MIPS APMs, the
organizations submitting data on behalf of MIPS eligible clinicians
will vary between performance categories and, in some instances,
between MIPS APMs. For the 2020 MIPS performance period, the quality
data submitted by MIPS APM participants reporting through the CMS Web
Interface on behalf of their participant MIPS eligible clinicians will
fulfill any MIPS submission requirements for the quality performance
category. For other MIPS APMs, the quality data submitted by APM
Entities on behalf of their participant MIPS eligible clinicians will
fulfill any MIPS submission requirements for the quality performance
category if that data is available to be scored. However, as proposed
in section III.K.3.c.(5)(c)(i)(A) of this rule, beginning in the 2020
MIPS performance period, MIPS eligible clinicians participating in MIPS
APMs whose APM quality data is not available for MIPS may elect to
report MIPS quality measures at either the APM entity, individual, or
TIN-level in a manner similar to our established policy for the
Promoting Interoperability performance category under the APM scoring
standard for purposes of the MIPS quality performance category. If we
determine there are not sufficient measures applicable and available,
we will assign performance category weights as specified in Sec.
414.1370(h)(5).
For the Promoting Interoperability performance category, group TINs
may submit data on behalf of eligible clinicians in MIPS APMs, or
eligible clinicians in MIPS APMs may submit data individually. For the
improvement activities performance category, we will assume no
reporting burden for MIPS APM participants. In the CY 2017 Quality
Payment Program final rule, we described that for MIPS APMs, we compare
the requirements of the specific MIPS APM with the list of activities
in the Improvement Activities Inventory and score those activities in
the same manner that they are otherwise scored for MIPS eligible
clinicians (81 FR 77185). Although the policy allows for the submission
of additional improvement activities if a MIPS APM receives less than
the maximum
[[Page 40844]]
improvement activities performance category score, to date all MIPS APM
have qualified for the maximum improvement activities score. Therefore,
we assume that no additional submission will be needed.
Advanced APM participants who are determined to be Partial QPs may
incur additional burden if they elect to participate in MIPS, which is
discussed in more detail in the CY 2018 Quality Payment Program final
rule (82 FR 53841 through 53844), but other than the election to
participate in MIPS, we do not have data to estimate that burden.
BILLING CODE 4120-01-P
[[Page 40845]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.094
[[Page 40846]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.095
[[Page 40847]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.096
BILLING CODE 4120-01-C
The policies finalized in the CY 2017 and CY 2018 Quality Payment
Program final rules, and the CY 2019 PFS final rule and continued in
this proposed rule create some additional data collection requirements
not listed in Table 64. These additional data collections, some of
which were previously approved by OMB under the control numbers 0938-
1314 (Quality Payment Program, CMS-10621) and 0938-1222 (CAHPS for
MIPS, CMS-10450), are as follows:
Additional Approved ICRs Related to MIPS Third-Party Intermediaries
Self-nomination of new and returning QCDRs (81 FR 77507
through 77508, 82 FR 53906 through 53908, and 83 FR 59998 through
60000) (OMB 0938-1314).
Self-nomination of new and returning registries (81 FR
77507 through 77508, 82 FR 53906 through 53908, and 83 FR 59997 through
59998) (OMB 0938-1314).
Approval process for new and returning CAHPS for MIPS
survey vendors (82 FR 53908) (OMB 0938-1222).
Additional ICRs Related to the Data Submission and the Quality
Performance Category
CAHPS for MIPS survey completion by beneficiaries (81 FR
77509, 82 FR 53916 through 53917, and 83 FR 60008 through 60009) (OMB
0938-1222).
Quality Payment Program Identity Management Application
Process (82 FR 53914 and 83 FR 60003 through 60004) (OMB 0938-1314).
[[Page 40848]]
Additional ICRs Related to the Promoting Interoperability Performance
Category
Reweighting Applications for Promoting Interoperability
and other performance categories (82 FR 53918 and 83 FR 60011 through
60012) (OMB 0938-1314).
Additional ICRs Related To Call for New MIPS Measures and Activities
Nomination of improvement activities (82 FR 53922 and 83
FR 60017 through 60018) (OMB 0938-1314).
Call for new Promoting Interoperability measures (83 FR
60014 through 60015) (OMB 0938-1314).
Call for new quality measures (83 FR 60010 through 60011)
(OMB 0938-1314).
Additional ICRs Related to MIPS
Opt out of performance data display on Physician Compare
for voluntary reporters under MIPS (82 FR 53924 through 53925 and 83 FR
60022) (OMB 0938-1314).
Additional ICRs Related to APMs
Partial QP Election (81 FR 77512 through 77513, 82 FR
53922 through 53923, and 83 FR 60018 through 60019) (OMB 0938-1314).
Other Payer Advanced APM determinations: Payer Initiated
Process (82 FR 53923 through 53924 and 83 FR 60019 through 60020) (OMB
0938-1314).
Other Payer Advanced APM determinations: Eligible
Clinician Initiated Process (82 FR 53924 and 83 FR 60020) (OMB 0938-
1314).
Submission of Data for All-Payer QP Determinations (83 FR
60021) (OMB 0938-1314).
b. ICRs Regarding the Virtual Group Election (Sec. 414.1315)
This rule does not propose any new or revised collection of
information requirements or burden related to the virtual group
election. The virtual group election requirements and burden are
currently approved by OMB under control number 0938-1343 (CMS-10652).
Consequently, we are not making any virtual group election changes
under that control number.
c. ICRs Regarding Third-Party Intermediaries (Sec. 414.1400)
(1) Background
Under MIPS, the quality, Promoting Interoperability, and
improvement activities performance category data may be submitted via
relevant third-party intermediaries, such as qualified registries,
QCDRs, and health IT vendors. Data on the CAHPS for MIPS survey, which
counts as one quality performance category measure, or can be used for
completion of an improvement activity, can be submitted via CMS-
approved survey vendors. Entities seeking approval to submit data on
behalf of clinicians as a qualified registry, QCDR, or survey vendor
must complete a self-nominate process annually. The processes for self-
nomination for entities seeking approval as qualified registries and
QCDRs are similar with the exception that QCDRs have the option to
submit QCDR measures for the quality performance category. Therefore,
differences between QCDRs and qualified registry self-nomination are
associated with the preparation of QCDR measures for approval.
The burden associated with qualified registry self-nomination, QCDR
self-nomination and measure submission, and the CAHPS for MIPS survey
vendor applications follow: \139\
---------------------------------------------------------------------------
\139\ As stated in the CY 2019 PFS final rule (83 FR 53998),
health IT vendors are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------
(2) Qualified Registry Self-Nomination Applications
The proposed requirements and burden associated with qualified
registries and their self-nomination will be submitted to OMB for
approval under control number 0938-1314 (CMS-10621).
As explained below, this rule would both adjust the number of self-
nomination applications based on current data and revise the number of
self-nomination applications due to policies promulgated in the CY 2019
final rule regarding the definition of a QCDR (83 FR 59895) and minimum
participation requirements (83 FR 59897) which are effective beginning
in the 2020 MIPS performance period. The adjustment would increase our
total burden estimates while keeping our burden per response estimates
unchanged. We are not proposing changes to the self-nomination process.
We refer readers to Sec. 414.1400(a)(2) and (c)(1) which state
that qualified registries interested in submitting MIPS data to us on
behalf of MIPS eligible clinicians, groups, or virtual groups need to
complete a self-nomination process to be considered for approval to do
so.
In the CY 2018 Quality Payment Program final rule and as stated in
Sec. 414.1400(c)(1), previously approved qualified registries in good
standing (that is, that are not on probation or disqualified) may
attest that certain aspects of their previous year's approved self-
nomination have not changed and will be used for the applicable
performance period (82 FR 53815). In the same rule, we stated that
qualified registries in good standing that would like to make minimal
changes to their previously approved self-nomination application from
the previous year, may submit these changes, and attest to no other
changes from their previously approved qualified registry application
for CMS review during the self-nomination period (82 FR 53815). The
self-nomination period is from July 1 to September 1 of the calendar
year prior to the applicable performance period beginning with the 2020
MIPS performance period (83 FR 59906).
For this proposed rule, we have adjusted the number of self-
nominating applicants from 150 to 290 based on more recent data and the
assumption that any entity which self-nominated for approval as a QCDR
in previous years and that no longer qualifies as a result of policies
finalized in the CY 2019 PFS final rule, effective beginning with the
2020 MIPS performance period could elect to self-nominate for approval
as a qualified registry. The policies revised both the definition of a
QCDR (83 FR 59895) and minimum participation requirements for entities
seeking approval as a QCDR (83 FR 59897). Entities which no longer meet
the criteria for approval as QCDRs may seek other options such as
collaborating with another entity to meet the new requirements or to
end their participation in the Quality Payment Program, however, we
believe the assumption that these entities will instead elect to self-
nominate as a qualified registry is both appropriate and conservative.
We were unable to change our estimates in the CY 2019 PFS final rule to
reflect these policies because we had neither the data to support a
change nor any notifications of intent by previously approved QCDRs
indicating they would no longer self-nominate as a QCDR (83 FR 59999).
As a result, we are making the necessary adjustments to our
respondents' estimates in this proposed rule.
For the 2019 MIPS performance period, we received 198 applications
for nomination to be a qualified registry, 135 of which were approved
to submit data, a reduction of 6 from the currently approved estimate
of 141 (83 FR 59997 through 59998). Based on the number of self-
nominations received for the 2019 MIPS performance period, we estimate
200 entities will self-nominate as a qualified registry for the 2020
MIPS performance period, not considering
[[Page 40849]]
nominations from entities which previously qualified as QCDRs. Based on
our analysis of the QCDRs approved for the CY 2019 performance period,
63 of the 127 approved QCDRs (49.6 percent) would not meet the criteria
for approval for the CY 2020 performance period. For the 2019 MIPS
performance period, 181 entities self-nominated for approval as QCDRs,
therefore we assume that 90 (49.6 percent) of these entities will self-
nominate for approval as qualified registries for the 2020 MIPS
performance period. In total, we estimate 290 nomination applications
(200 entities + 90 entities) will be received from entities seeking
approval to report MIPS data as qualified registries, an increase of
140 from the currently approved estimate of 150 (83 FR 59997 through
59998). As previously stated, this increase is comprised of both an
adjustment to due updated data (+50 self-nominations) and a revision
due to policies promulgated in the CY 2019 PFS final rule (+90 self-
nominations). Assuming updated data is available, we will update our
estimates in the final rule to reflect the actual number of nomination
applications received for the 2020 MIPS performance period.
The burden associated with the qualified registry self-nomination
process varies depending on the number of existing qualified registries
that elect to use the simplified self-nomination process in lieu of the
full self-nomination process as described in the CY 2018 Quality
Payment Program final rule (82 FR 53815). The QPP Self-Nomination Form
is submitted electronically using a web-based tool. We will be
submitting a revised version of the form for approval under OMB control
number 0938-1314 (CMS-10621).
As described in the CY 2017 Quality Payment Program final rule, the
full self-nomination process requires the submission of basic
information, a description of the process the qualified registry will
use for completion of a randomized audit of a subset of data prior to
submission, and the provision of a data validation plan along with the
results of the executed data validation plan by May 31 of the year
following the performance period (81 FR 77383 through 77384). As shown
in Table 66, we estimate that the staff involved in the qualified
registry self-nomination process will be mainly computer systems
analysts or their equivalent, who have an adjusted labor rate of
$90.02/hr. Consistent with the CY 2019 PFS final rule (83 FR 59998), we
estimate that the time associated with the self-nomination process
ranges from a minimum of 0.5 hours (for the simplified self-nomination
process) to 3 hours (for the full self-nomination process) per
qualified registry. When considering this rule's adjusted number of
nomination applications (290) we estimate that the annual burden will
range from 532.5 hours ([135 simplified self-nominations x 0.5 hr] +
[155 full self-nominations x 3 hr]) to 870 hours (290 qualified
registries x 3 hr) at a cost ranging from $47,936 (532.5 hr x $90.02/
hr) to $78,317 (870 hr x $90.02/hr), respectively (see Table 66).
As shown in Table 65, compared to the currently approved minimum
estimates of 97.5 hours and $8,777 and the maximum estimates of 450
hours and $40,509, the increase in the number of respondents would
adjust our total burden estimates by 435 hours and $39,159 [(-6
registries x 0.5 hr x $90.02/hr) + (146 registries x 3 hr x $90.02/hr)]
and 420 hours and $37,808 (140 registries x 3 hr x $90.02/hr). While we
are proposing to adjust our total burden estimates based on more
current data, the burden per response would remain unchanged.
Table 65--Change in Estimated Burden for Qualified Registry Self-
Nomination
------------------------------------------------------------------------
Minimum burden Maximum burden
------------------------------------------------------------------------
Total Annual Hours for Qualified 97.5 450
Registries in CY 2019 Final Rule (a)...
Total Annual Hours for Qualified 532.5 870
Registries in CY 2020 Proposed Rule (b)
-------------------------------
Difference Between CY 2020 Proposed 435 870
Rule and CY 2019 Final Rule (c) =
(b)-(a)............................
------------------------------------------------------------------------
Total Annual Cost for Qualified $8,777 $40,509
Registries in CY 2019 Final Rule (d)...
Total Annual Cost for Qualified $47,936 $78,317
Registries in CY 2020 Proposed Rule (e)
-------------------------------
Difference Between CY 2020 Proposed $39,159 $37,808
Rule and CY 2019 Final Rule (f) =
(e)-(d)............................
------------------------------------------------------------------------
As finalized in the CY 2017 Quality Payment Program final rule (81
FR 77363 through 77364) and as further revised in the CY 2019 PFS final
rule at (83 FR 60088) and in Sec. 414.1400(a)(2), qualified registries
may submit data for any of the three MIPS performance categories
quality (except for data on the CAHPS for MIPS survey); improvement
activities; and Promoting Interoperability. In section
III.K.3.g.(4)(a)(i) of this rule, beginning with the 2021 performance
period and for future years, we propose to require that qualified
registries support the reporting of improvement activities and
Promoting Interoperability measures in addition to the quality
performance category. As finalized in the CY 2017 Quality Payment
Program final rule, qualified registries are required to provide
feedback on all of the MIPS performance categories at least 4 times a
year (81 FR 77367 through 77386). In section III.K.3.g.(4)(a)(ii), we
propose, beginning with the 2023 MIPS payment period, to require
qualified registries to provide the following as a part of the
performance feedback given at least 4 times (to the extent feasible) a
year: Feedback to their clinicians and groups on how they compare to
other clinicians who have submitted data on a given measure within the
qualified registry. Further, qualified registries will be required to
attest during the self-nomination process that they can provide
performance feedback at least 4 times a year, and if not, provide
sufficient rationale as to why they do not believe they would be able
to meet this requirement. Because we are not requiring qualified
registries to provide performance feedback to their clinicians and
groups at a greater frequency than what has previously been required
combined with qualified registries only being required to provide
feedback using data they are already collecting, we do not believe the
proposal creates enough additional burden for qualified registries to
elect to discontinue participation in the Quality Payment Program.
Therefore, we are not adjusting our estimates for the number of
qualified registries that will self-nominate in the 2021 performance
[[Page 40850]]
period or future years as a result of this proposal; if reliable
information becomes available indicating this assumption is incorrect,
we will adjust our assumptions and respondent estimates at that time.
As part of the current self-nomination process, qualified registries
are already required to attest to the MIPS quality measures,
performance categories, improvement activities, and/or Promoting
Interoperability measures and objectives supported. In section
III.K.3.g.(4)(a)(i) of this proposed rule, beginning with the 2021
performance period, we are proposing to require qualified registries to
support all three performance categories: Quality, improvement
activities, and Promoting Interoperability with the proviso that based
on the proposed amendment to Sec. 414.1400(a)(2)(iii) the requirement
to support submission of Promoting Interoperability data would be
inapplicable to the third party intermediary if the clinician, group or
virtual group is exempt from this reporting requirement. As part of
this proposal, we would require qualified registries to attest to the
ability to submit data for all three of these performance categories at
time of self-nomination. Because qualified registries will only be
required to provide performance feedback to clinicians and not to CMS,
and because qualified registries are already required to attest to the
performance categories they support, we anticipate minimal changes to
the self-nomination process as a result of these proposals and assume
there will be minimal impact on the time required to complete either
the simplified or full self-nomination process.
Qualified registries must comply with requirements on the
submission of MIPS data to CMS. The burden associated with qualified
registry submission requirements will be the time and effort associated
with calculating quality measure results from the data submitted to the
qualified registry by its participants and submitting these results,
the numerator and denominator data on quality measures, the Promoting
Interoperability performance category, and improvement activities data
to us on behalf of their participants. We expect that the time needed
for a qualified registry to accomplish these tasks will vary along with
the number of MIPS eligible clinicians submitting data to the qualified
registry and the number of applicable measures. However, we believe
that qualified registries already perform many of these activities for
their participants. Therefore, we believe the estimates discussed
earlier and shown in Table 66 represents the upper bound for qualified
registry burden, with the potential for less additional MIPS burden if
the qualified registry already provides similar data submission
services.
Based on these assumptions, we estimate the total annual burden
associated with a qualified registry self-nominating to be considered
for approval.
Table 66--Estimated Burden for Qualified Registry Self-Nomination
------------------------------------------------------------------------
Minimum burden Maximum burden
------------------------------------------------------------------------
# of Qualified Registry Simplified Self- 135 0
Nomination Applications submitted (a)..
# of Qualified Registry Full Self- 155 290
Nomination Applications submitted (b)..
Total Annual Hours Per Qualified 0.5 0.5
Registry for Simplified Process (c)....
Total Annual Hours Per Qualified 3 3
Registry for Full Process (d)..........
-------------------------------
Total Annual Hours for Qualified 532.5 870
Registries (e) = (a) * (c) + (b) *
(d)................................
------------------------------------------------------------------------
Cost Per Simplified Process Per Registry $45.01 $45.01
(@computer systems analyst's labor rate
of $90.02/hr.) (f).....................
Cost Per Full Process Per Registry $270.06 $270.06
(@computer systems analyst's labor rate
of $90.02/hr.) (g).....................
-------------------------------
Total Annual Cost for Qualified $47,936 $78,317
Registries (h) = (a) * (f) + (b) *
(g)................................
------------------------------------------------------------------------
Both the minimum and maximum burdens shown in Table 66 reflect
adjustments to the number of respondents (from 150 to 290) due to
availability of more recent data (+50 respondents) and revisions due to
policies finalized in the CY 2019 PFS final rule regarding the
definition and minimum participation requirements for entities seeking
approval as QCDRs which will be effective beginning with the 2020 MIPS
performance period (+90 respondents). For purposes of calculating total
burden associated with this proposed rule as shown in Table 90, only
the maximum burden is being submitted to OMB for their review and
approval.
(3) QCDR Self-Nomination Applications
(a) Self-Nomination Process
The proposed requirements and burden associated with QCDRs and the
self-nomination process will be submitted to OMB for approval under
control number 0938-1314 (CMS-10621).
As explained below, this rule would both adjust the number of self-
nomination applications based on current data and revise the number of
self-nomination applications due to policies promulgated in the CY 2019
final rule regarding the definition of a QCDR (83 FR 59895) and minimum
participation requirements (83 FR 59897) which are effective beginning
in the 2020 MIPS performance period. These changes result in a decrease
from 200 to 91 self-nomination applications in the 2020 MIPS
performance period. This rule would also adjust the number of QCDR
measures submitted for consideration by each QCDR seeking to self-
nominate (from 9 to 11.5), as well as the time required to submit
information (from 1 hour to 2.5 hours) for each QCDR measure. These
changes would increase our minimum total burden estimate (from 2,025
hours to 2,729.25 hours) and increase our maximum total burden estimate
(from 2,400 hours to 2,889.25 hours). In addition, our per response
estimates for the simplified and full self-nomination processes would
increase from 9.5 hours to 29.25 hours and from 12 hours to 31.75
hours, respectively.
We refer readers to Sec. 414.1400(a)(2) and (b)(1) which states
that QCDRs interested in submitting MIPS data to us on behalf of a MIPS
eligible clinician, group, or virtual group will need to complete a
self-nomination process to be considered for approval to do so.
In the CY 2018 Quality Payment Program final rule and Sec.
414.1400(b)(1), previously approved QCDRs in good standing (that are
not on probation or disqualified) that wish to self-nominate using the
simplified process can attest, in whole or in part, that their
previously
[[Page 40851]]
approved form is still accurate and applicable (82 FR 53808). Existing
QCDRs in good standing that would like to make minimal changes to their
previously approved self-nomination application from the previous year,
may submit these changes, and attest to no other changes from their
previously approved QCDR application, for CMS review during the current
self-nomination period, from September 1 to November 1 (82 FR 53808).
The self-nomination period is from July 1 to September 1 of the
calendar year prior to the applicable performance period beginning in
the 2020 MIPS performance period (83 FR 59898).
The burden associated with QCDR self-nomination will vary depending
on the number of existing QCDRs that will elect to use the simplified
self-nomination process in lieu of the full self-nomination process as
described in the CY 2018 Quality Payment Program final rule (82 FR
53808 through 53813). The OPP Self-Nomination Form is submitted
electronically using a web-based tool. We will be submitting a revised
version of the form for approval under OMB control number 0938-1314
(CMS-10621).
For the 2019 MIPS performance period, we received 181 self-
nomination applications from entities seeking approval as QCDRs, 127 of
which were approved to submit data. Based on our analysis of the QCDRs
approved for the CY 2019 performance period, 63 of the 127 approved
QCDRs (49.6 percent) would not meet the criteria for approval for the
CY 2020 performance period. We project that 90 (49.6 percent) of the
181 entities will not self-nominate for approval as QCDRs for the 2020
MIPS performance period but will instead self-nominate to be qualified
registries. Entities which no longer meet criteria for approval as
QCDRs may seek other options as well, including collaborating with
another entity to meet the new requirements or to end their
participation in the Quality Payment Program; however, we believe the
assumption that these entities will instead elect self-nomination as a
qualified registry is both appropriate and conservative. We also
project the remaining 91 entities will submit nomination applications
for approval to report MIPS data as QCDRs for the MIPS 2020 performance
period, a decrease of 109 from the currently approved estimate of 200.
This decrease of 109 is a result of both an adjustment due to use of
more recent data accounts (decrease of 19 self-nominations) and a
change due to previously finalized policies regarding the definition of
a QCDR (83 FR 59895) and minimum participation requirements (83 FR
59897) (decrease of 90 self-nominations). We were unable to change our
estimates in the CY 2019 PFS final rule to reflect these policies
because we had neither the data to support a change nor any
notifications of intent by previously approved QCDRs indicating they
would no longer self-nominate as a QCDR (83 FR 59999). As a result, we
are making the necessary adjustments to our respondent estimates in
this proposed rule. We further estimate that the 64 QCDRs approved to
submit data in the 2019 MIPS performance period that would also qualify
as QCDRs for the 2020 MIPS performance period will use the simplified
self-nomination process. Assuming updated data is available, we will
update our estimates in the final rule to reflect the actual number of
nomination applications received for the 2020 MIPS performance period.
Based on previously finalized policies in the CY 2017 Quality
Payment Program final rule (81 FR 77363 through 77364) and as further
revised in the CY 2019 PFS final rule at Sec. 414.1400(a)(2) (83 FR
60088), the current policy is that all third party intermediaries may
submit data for any of the three MIPS performance categories quality
(except for data on the CAHPS for MIPS survey); improvement activities;
and Promoting Interoperability. In section III.K.3.g.(3)(a)(i) of this
rule, we are proposing, beginning with the 2021 performance period and
future years, to require that QCDRs support three performance
categories: Quality, improvement activities, and Promoting
Interoperability. We are also proposing in section
III.K.3.g.(3)(a)(ii), beginning with the 2023 MIPS payment year and
future years, QCDRs would be required to provide services to clinicians
and groups to foster improvement in the quality of care provided to
patients, by providing educational services in quality improvement and
leading quality improvement initiatives and to describe the quality
improvement services they intend to support in their self-nomination
for CMS review and approval. As finalized in the CY 2018 Quality
Payment Program final rule, QCDRs are required to provide feedback on
all of the MIPS performance categories that the QCDR reports at least 4
times a year (82 FR 53812). In section III.K.3.g.(3)(a)(iii) we
propose, beginning with the 2023 MIPS payment year, to require that
QCDRs provide the following as a part of the performance feedback given
at least 4 times a year: Feedback to their clinicians and groups on how
they compare to other clinicians who have submitted data on a given
measure (MIPS quality measure and/or QCDR measure) within the QCDR. We
also understand that QCDRs can only provide feedback on data they have
collected on their clinicians and groups, and realize the comparison
would be limited to that data and not reflect the larger sample of
those that have submitted on the measure for MIPS, which the QCDR does
not have access to. Further, we are also proposing, beginning with the
2023 MIPS payment year, to require QCDRs to attest during the self-
nomination process that they can provide performance feedback at least
4 times a year, and if not, provide sufficient rationale as to why they
do not believe they would be able to meet this requirement. We do not
believe these proposals create enough additional burden for QCDRs to
elect to discontinue participation in the Quality Payment Program for
multiple reasons: We are not requiring QCDRs to provide performance
feedback to their clinicians and groups at a greater frequency than
what has previously been required, QCDRs will only being required to
provide feedback using data they are already collecting, and we are
giving QCDRs significant flexibility to provide broad quality
improvement services that are tailorable to the specific QCDR and the
clinicians they support. Therefore, we are not adjusting our estimates
for the number of QCDRs that will self-nominate in the 2021 performance
period or future years as a result of this proposal; if reliable
information becomes available indicating this assumption is incorrect,
we will adjust our assumptions and respondent estimates at that time.
As part of the self-nomination process, QCDRs are already required to
attest to the MIPS quality measures, performance categories,
improvement activities, and Promoting Interoperability measures and
objectives supported and will not be required to provide performance
feedback to CMS. Therefore, we anticipate no additional steps being
added to the self-nomination process as a result of these proposals and
assume there will be no impact on the time required to complete either
the simplified or full self-nomination process. With regard to the
proposal to require QCDRs to describe the quality improvement services
they will provide as part of their self-nomination, we estimate this
will require approximately 15 minutes to complete.
We estimate that the self-nomination process for QCDRs to submit on
behalf of MIPS eligible clinicians or groups for MIPS will involve
approximately 3.25 hours per QCDR to submit information
[[Page 40852]]
required at the time of self-nomination as described in the CY 2017
Quality Payment Program final rule including basic information about
the QCDR, describing the process it will use for completion of a
randomized audit of a subset of data prior to submission, providing a
data validation plan, and providing results of the executed data
validation plan by May 31 of the year following the performance period
(81 FR 77383 through 77384). However, for the simplified self-
nomination process, we estimate 0.5 hours per QCDR to submit this
information.
(b) QCDR Measure Requirements
As promulgated in the CY 2017 and CY 2018 Quality Payment Plan
final rules (81 FR 77366 through 77374 and 82 FR 53812 through 53813),
QCDRs calculate their measure results and also must possess
benchmarking capabilities (for QCDR measures) that compare the quality
of care a MIPS eligible clinician provides with other MIPS eligible
clinicians performing the same quality measures. For QCDR measures, the
QCDR must provide to us, if available, data from years prior (for
example, 2017 data for the 2019 MIPS performance period) before the
start of the performance period. In addition, the QCDR must provide to
us, if available, the entire distribution of the measure's performance
broken down by deciles. As an alternative to supplying this information
to us, the QCDR may post this information on their website prior to the
start of the performance period, to the extent permitted by applicable
privacy laws. The time it takes to perform these functions may vary
depending on the sophistication of the entity, but we estimate that a
QCDR will spend an additional 1 hour performing these activities per
measure.
As discussed in section III.K.3.g.(3)(c)(i)(B)(cc), we are
proposing that in order for a QCDR measure to be considered for use in
the program beginning with the 2021 performance period and future
years, all QCDR measures submitted for self-nomination must be fully
developed with completed testing results at the clinician level, as
defined by the CMS Blueprint for the CMS Measures Management System, as
used in the testing of MIPS quality measures prior to the submission of
those measures to the Call for Measures. Beginning with the 2021
performance period and future years, we are proposing in section
III.K.3.g.(3)(c)(i)(B)(dd) to also require QCDRs to collect data on the
potential QCDR measure, appropriate to the measure type, as defined in
the CMS Blueprint for the CMS Measures Management System, prior to
self-nomination. We estimate the time necessary to submit measure
testing data as part of the self-nomination process will average
approximately 0.5 hours per measure, understanding that this estimate
may be either high or low depending on the type of measure and the
quantity of data being submitted. We discuss additional impacts of this
proposal in section VI.C.10.(f) of this rule's Regulatory Impact
Analysis.
In section III.K.3.g.(3)(c)(i)(A)(bb) of this rule, we are
proposing to amend Sec. 414.1400 to state that CMS may consider the
extent to which a QCDR measure is available to MIPS eligible clinicians
reporting through QCDRs other than the QCDR measure owner for purposes
of MIPS. If CMS determines that a QCDR measure is not available to MIPS
eligible clinicians, groups, and virtual groups reporting through other
QCDRs, CMS may not approve the measure. Because the choice to license a
QCDR measure is an elective business decision made by individual QCDRs
and we lack insight into both the specific terms and frequency of
agreements made between entities, we are not accounting for QCDR
measure licensing costs as part of our burden estimate. However, if
information regarding the number of licensing agreements and the
approximate cost per agreement becomes available, we may adjust our
assumptions and burden estimates at that time.
In section III.K.3.g.(3)(c)(i)(B)(cc) of this rule, we propose,
beginning with the 2020 performance period, that after the self-
nomination period closes each year, we will review newly self-nominated
and previously approved QCDR measures based on considerations as
described in the CY 2019 PFS final rule (83 FR 59900 through 59902). In
instances in which multiple, similar QCDR measures exist that warrant
approval, we may provisionally approve the individual QCDR measures for
1 year with the condition that QCDRs address certain areas of
duplication with other approved QCDR measures in order to be considered
for the program in subsequent years. The QCDR could do so by
harmonizing its measure with, or significantly differentiating its
measure from, other similar QCDR measures. QCDR measure harmonization
may require two or more QCDRs to work collaboratively to develop one
cohesive QCDR measure that is representative of their similar yet,
individual measures. We are unable to account for measure harmonization
costs as part of our burden estimate, as the process and outcomes of
measure harmonization will likely vary substantially depending on a
number of factors, including: Extent of duplication with other
measures, number of QCDRs involved in harmonizing toward a single
measure, and number of measures being harmonized among the same QCDRs.
We intend to identify only those QCDR measures which are duplicative to
such an extent as to assume harmonization will not be overly
burdensome, however, because the harmonization process will occur
between QCDRs without our involvement, we are unable to predict or
quantify the associated effort.
As discussed in section III.K.3.g.(3)(c)(i)(B)(bb) of this proposed
rule, beginning with the 2021 performance period and future years, we
are proposing that QCDRs must identify a linkage between their QCDR
measures to the following, at the time of self-nomination: (a) Cost
measures (as found in section III.K.3.c.(2) of this proposed rule); (b)
Improvement Activities (as found in Appendix 2: Improvement Activities
Tables); or (c) CMS developed MIPS Value Pathways (as described in
section III.K.3.a. of this proposed rule). We estimate that a QCDR will
spend an additional 1 hour performing these activities per measure, on
average.
We are also proposing to formalize factors we would take into
consideration for approving and rejecting QCDR measures for the MIPS
program beginning with the 2020 performance period and future years.
With regard to approving QCDR measures, we are proposing the following:
(a) 2-year QCDR measure approval process, and (b) participation plan
for existing QCDR measures that have failed to reach benchmarking
thresholds. As discussed in section III.K.3.g.(3)(c)(ii)(B) of this
rule, we are proposing to implement, beginning with the 2021
performance period, 2-year QCDR measure approvals (at our discretion)
for QCDR measures that attain approval status by meeting the QCDR
measure considerations and requirements described in section
III.K.3.g.(3)(c). The 2-year approvals would be subject to the
following conditions whereby the multi-year approval will no longer
apply if the QCDR measure is identified as: Topped out; duplicative of
a new, more robust measure; reflects an outdated clinical guideline;
requires measure harmonization, or if the QCDR self-nominating the
measure is no longer in good standing. We believe this could result in
reduced burden for QCDRs as they would not necessarily be required to
submit every measure for approval annually. However, because we are
[[Page 40853]]
unable to predict which previously approved QCDR measures will be
removed or retained in future years, we are likewise unable to predict
the total number of measures that will be submitted for approval and
the resulting impact on future burden. If this policy is finalized, the
number of QCDR measures submitted in the 2021 performance period will
reflect the impact of this policy; at that time we will update our
assumptions and burden estimates accordingly.
We estimate that on average, each QCDR will submit information for
11.5 QCDR measures, for a total burden of 11.5 hours per QCDR (1 hr per
measure x 11.5 measures). The estimated average of 11.5 measures per
QCDR is based on an analysis of the QCDR measures submitted for
consideration and QCDR measures approved for the 2019 MIPS performance
period, as well as the measures for QCDRs approved for the CY 2019
performance period that would not meet criteria for approval for the CY
2020 performance period. For the 2019 MIPS performance period, 1,123
QCDR measures were submitted for consideration and 762 were approved;
an approval rate of 68 percent. Of these approved measures, 264 are for
the 63 QCDRs which would not meet criteria for approval for the 2020
MIPS performance period. Averaging the remaining 498 approved QCDR
measures by the 64 QCDRs that would meet the criteria for approval for
the 2020 MIPS performance period results in approximately 7.8 approved
measures per QCDR (498 approved measures / 64 QCDRs). Assuming an
identical 68 percent QCDR measure approval rate for measures submitted
for consideration for the 2020 MIPS performance period, this results in
approximately 11.5 measures submitted for consideration for each QCDR
(7.8 approved measures / 0.68 approval rate). We believe the proposals
to change requirements for QCDR measure submission and to require QCDRs
to harmonize measures we identify as duplicative discussed earlier in
this section will result in a reduction in the number of QCDR measures
submitted for approval in future years. However, we are unable to
quantify the impact these proposed changes will have on the number of
measures QCDRs will submit for approval. As information becomes
available in future years, we will revisit our assumptions to better
reflect the impact of these proposals on QCDRs and the quantity of
measures being submitted for consideration annually. When combined with
our previously stated assumption regarding our inability to predict
which QCDR measures will maintain approval in future years, we believe
the estimate of 11.5 measures per QCDR to be both conservative and
appropriate, as well as an overall decrease of 76 QCDR measures
compared to the 1,123 QCDR measures submitted for consideration in the
CY2019 performance period (1,123 QCDR measures-[91 QCDRs x 11.5
measures per QCDR]).
Beginning with the 2021 performance period, we are proposing in
section III.K.3.g.(3)(c)(iii) of this proposed rule that in instances
where an existing QCDR measure has been in MIPS for 2 years, and has
failed to reach benchmarking thresholds due to low adoption, where a
QCDR believes the low-reported QCDR measure is still important and
relevant to a specialist's practice, that the QCDR may develop and
submit to a QCDR measure participation plan, to be submitted as part of
their self-nomination. Because we are unable to predict the frequency
with which existing QCDR measures will meet the proposed criteria for
allowing QCDRs to submit a measure participation plan or the likelihood
of QCDRs electing to submit a plan, we are unable to estimate the total
burden associated with this proposal. However, we anticipate the time
involved in developing a measure participation plan is likely to
average between 1 and 2 hours, depending on the QCDR and the level of
detail they choose to include. In future performance periods we may
reassess availability of the number of QCDR measure participation plans
submitted by QCDRs and estimate the associated burden, if possible. In
aggregate, we estimate a QCDR will require 2.5 hours per QCDR measure,
an increase of 1.5 hours from the currently approved estimate of 1 hour
(83 FR 59999). As discussed earlier in this section, we estimate each
QCDR will submit 11.5 QCDR measures for approval, on average.
Therefore, we estimate each QCDR will require 28.75 hours (11.5
measures x 2.5 hr per measure) to submit QCDR measures for approval,
independent of the selection of the simplified or full self-nomination
process.
In the CY 2019 PFS final rule, the burden associated with self-
nomination of a QCDR was estimated to range from a minimum of 9.5 hours
(0.5 hours to submit information for simplified self-nomination process
and 9 hours for submission of QCDR measures) to a maximum of 12 hours
(3 hours for the full self-nomination process and 9 hours for the
submission of QCDR measures) (83 FR 59999). For this rule, we propose
to increase the burden associated with self-nomination to a minimum of
29.25 hours (0.5 hours to submit information for the simplified self-
nomination process and 28.75 hours for the submission of QCDR measures)
to a maximum of 32 hours (3.25 hours to submit information for the full
self-nomination process and 28.75 hours for the submission of QCDR
measures) to account for our revised estimate of the average number of
QCDR measures submitted for consideration per QCDR, as well as the
revised estimate of burden per QCDR measure.
We assume that the staff involved in the QCDR self-nomination
process will continue to be computer systems analysts or their
equivalent, who have an average labor rate of $90.02/hr. Considering
that the time per QCDR associated with the self-nomination process
ranges from a minimum of 29.25 hours to a maximum of 32 hours, we
estimate that the annual burden will range from 2,736 hours ([64 QCDRs
x 29.25 hr] + [27 QCDRs x 32 hr]) to 2,912 hours (91 QCDRs x 32 hr) at
a cost ranging from $246,295 (2,736 hr x $90.02/hr) and $262,138 (2,912
hr x $90.02/hr), respectively (see Table 67).
Based on the assumptions previously discussed, we provide an
estimate of the total annual burden associated with a QCDR self-
nominating to be considered ``qualified'' to submit quality measures
results and numerator and denominator data on MIPS eligible clinicians.
Table 67--Estimated Burden for QCDR Self-Nomination and QCDR Measure
Submission
------------------------------------------------------------------------
Minimum Maximum
------------------------------------------------------------------------
# of QCDR Simplified Self-Nomination 64 0
Applications submitted (a).............
# of QCDR Full Self-Nomination 27 91
Applications submitted (b).............
Total Annual Hours Per QCDR for 29.25 29.25
Simplified Process (c).................
Total Annual Hours Per QCDR for Full 32.00 32.00
Process (d)............................
-------------------------------
[[Page 40854]]
Total Annual Hours for QCDRs (e) = 2,736 2,912
(a) *(c) + (b) * (d)...............
------------------------------------------------------------------------
Cost Per Simplified Process Per QCDR $2,633.09 $2,633.09
(@computer systems analyst's labor rate
of $90.02/hr) (f)......................
Cost Per Full Process Per QCDR $2,880.64 $2,880.64
(@computer systems analyst's labor rate
of $90.02/hr) (g)......................
-------------------------------
Total Annual Cost for QCDRs (h) = $246,295 $262,138
(a) * (f) + (b) * (g)..............
------------------------------------------------------------------------
Both the minimum and maximum burden shown in Table 67 reflect
adjustments to the number of respondents due to availability of more
recent data, as well as changes resulting from policies finalized in
the CY 2019 PFS final rule regarding the definition and minimum
participation requirements for entities seeking approval as QCDRs which
will be effective beginning with the 2020 MIPS performance period. For
purposes of calculating total burden associated with the proposed rule
as shown in Table 90, only the maximum burden is used.
Independent of the change to our per response time estimate, the
decrease in the number of respondents (from 200 to 91) results in an
adjustment of between -1,093 hours [(-86 QCDRs x 9.5 hr) + (-23 QCDRs x
12 hr)] at a cost of -$98,392 (-1,093 hr x $90.02) and -1,308 hours (-
109 QCDRs x 12 hr) at a cost of -$117,746 (-1,308 hr x $90.02/hr).
Accounting for the change in the number of QCDRs, the change in time
per QCDR to self-nominate results in an adjustment of 1,820 hours (91
QCDRs x 20 hr) at a cost of $163,836 (1,820 hr x $90.02/hr). As shown
in Table 68, when these two adjustments are combined, the net impact
ranges between 727 hours (-1,093 hr + 1,820 hr) hours at a cost of
$65,444 (-$98,392 + $163,836) and 512 hours (-1,308 hr + 1,820 hr)
hours at a cost of $46,090 (-$117,746 + $163,836).
Table 68--Change in Estimated Burden for QCDR Self-Nomination and QCDR
Measure Submission
------------------------------------------------------------------------
Minimum burden Maximum burden
------------------------------------------------------------------------
Total Annual Hours for QCDRs in CY 2019 2,025 2,400
Final Rule (a).........................
Total Annual Hours for QCDRs in CY 2020 2,736 2,912
Proposed Rule (b)......................
-------------------------------
Difference Between CY 2020 Proposed 711 512
Rule and CY 2019 Final Rule (c) =
(b)-(a)............................
------------------------------------------------------------------------
Total Annual Cost for QCDRs in CY 2019 $182,291 $216,048
Final Rule (d).........................
Total Annual Cost for QCDRs in CY 2020 $246,295 $262,138
Proposed Rule (e)......................
-------------------------------
Difference Between CY 2020 Proposed $64,004 $46,090
Rule and CY 2019 Final Rule (f) =
(e)-(d)............................
------------------------------------------------------------------------
QCDRs must comply with requirements on the submission of MIPS data
to CMS. The burden associated with the QCDR submission requirements
will be the time and effort associated with calculating quality measure
results from the data submitted to the QCDR by its participants and
submitting these results, the numerator and denominator data on quality
measures, the Promoting Interoperability performance category, and
improvement activities data to us on behalf of their participants. We
expect that the time needed for a QCDR to accomplish these tasks will
vary along with the number of MIPS eligible clinicians submitting data
to the QCDR and the number of applicable measures. However, we believe
that QCDRs already perform many of these activities for their
participants. As stated in section III.K.3.g.(3)(a)(i), based on our
review of existing 2019 QCDRs through the 2019 QCDR Qualified Posting,
approximately 92 QCDRs, or about 72 percent of the QCDRs currently
participating in the program are supporting these three performance
categories. In addition, through our review of previous qualified
postings for the 2018 and 2017 MIPS performance periods, we have
observed that in 2018, 73 percent (approximately 110 QCDRs) and in
2017, 73 percent (approximately 83 QCDRs) have supported all three of
the quality, Promoting Interoperability, and improvement activity
performance categories. Given this, we believe it is reasonable that
all QCDRs have the capacity to support the improvement activities and
Promoting Interoperability performance categories and are not making
any further changes to our burden estimates. Therefore, we believe the
2,912-hour estimate noted in this section represents the upper bound of
QCDR burden, with the potential for less additional MIPS burden if the
QCDR already provides similar data submission services.
(4) CAHPS for MIPS Survey Vendor
This rule does not propose any new or revised collection of
information requirements or burden related to CMS-approved CAHPS for
MIPS survey vendors. The requirements and burden are currently approved
by OMB under control number 0938-1222 (CMS-10450). Consequently, we are
not making any MIPS survey vendor changes under that control number.
d. ICRs Regarding Quality Data Submission (Sec. Sec. 414.1325 and
414.1335)
(1) Background
As explained below, this rule would adjust the number of
respondents based on current data. The adjustment would increase our
total burden estimates while keeping our ``per response'' estimates
unchanged. We are not revising any requirements regarding the number of
measures to be submitted or the manner in which they may be submitted.
Under our current policies, two groups of clinicians must submit
quality data under MIPS: Those who submit as MIPS eligible clinicians
and those who opt to submit data voluntarily but are not be subject to
MIPS payment adjustments.
[[Page 40855]]
Clinicians are ineligible for MIPS if they are newly enrolled to
Medicare; are QPs; are partial QPs who elect to not participate in
MIPS; are not one of the clinician types included in the definition for
MIPS eligible clinician; or do not exceed the low-volume threshold as
an individual or as a group.
To determine which QPs should be excluded from MIPS, we used the QP
List for the 2019 predictive file that contains current participation
in Advanced APMs as of January 15, 2019, that could be connected into
our respondent data and are the best estimate of future expected QPs.
From this data, we calculated the QP determinations as described in the
Qualifying APM Participant definition at Sec. 414.1305 for the 2020 QP
performance period. We assumed that all partial QPs would participate
in MIPS data collections. Due to data limitations, we could not
identify specific clinicians who have not yet enrolled in APMs, but who
may become QPs in the future 2020 Medicare QP Performance Period (and
therefore would no longer need to submit data to MIPS); hence, our
model may under estimate or overestimate the number of respondents.
Using participation data from the 2017 MIPS performance period
combined with the estimate of QPs for the 2020 performance period, we
estimate a total of 833,243 clinicians will submit quality data as
individuals or groups in the 2020 MIPS performance period, a decrease
of 131,003 clinicians when compared to our estimate of 964,246
clinicians in the CY 2019 PFS final rule (83 FR 60002). As previously
stated in section IV.B.7.(a.(2), respondent data from the 2018 MIPS
performance period was unavailable at the time of publication of this
proposed rule. Assuming that updated respondent data becomes available
before the publication of the CMS-1715-F final rule, we will revise our
burden estimates in that rule.
In the CY 2017 Quality Payment Program final rule, we assumed that
any clinician that submits quality data codes to us for the Medicare
Part B claims collection type is intending to do so for the Quality
Payment Program to ensure that we fully accounted for any burden that
may have resulted from our policies (81 FR 77501 through 77504); we
continued using this assumption in both the CY 2018 Quality Payment
Program final rule and the CY 2019 PFS final rule. In the CY 2019 PFS
final rule, we finalized limiting the Medicare Part B claims collection
type to small practices beginning with the 2021 MIPS payment year and
allowing clinicians in small practices to report Medicare Part B claims
as a group or as individuals (83 FR 59752). However, we also elected to
continue using the assumption that all clinicians (except QPs) who
submitted data via the Medicare Part B claims collection type in the
2017 MIPS performance period would continue to do so for MIPS to avoid
overstating the impact of the change as we lacked the data to
accurately estimate both the number of clinicians who would be impacted
by the finalized policies and the potential behavioral response of
those clinicians who would be required to switch to another collection
type (83 FR 60001). For this proposed rule, beginning with the 2020
MIPS performance period, we assume only clinicians in small practices
who submitted quality data via Medicare Part B claims in the 2017 MIPS
performance period will continue to do so for the 2020 MIPS performance
period. Further, we assume that clinicians in other practices (not
small practices) who meet at least one of the following criteria will
not need to find an alternate collection type for submitting quality
performance category data for the Quality Payment Program for the 2020
MIPS performance period: (1) Facility-based; (2) submitted quality data
via Medicare Part B claims and at least one other collection type; or
(3) were previously scored as part of a group. Finally, we assume
clinicians in other practices (not small practices) who meet all of the
following criteria will submit via the MIPS CQM collection type for the
2020 MIPS performance period because the Medicare Part B claims
collection type will no longer be available as an option for collecting
and reporting quality data: (1) Scored as individuals; (2) not
facility-based; and (3) submitted quality data only via the Medicare
Part B claims collection type in the 2017 MIPS performance period.
Because we do not have data to accurately predict what collection type
each affected clinician would use to collect and report quality data,
we assume that the affected clinicians will select the MIPS CQM
collection type because, when compared to Medicare Part B claims, we
believe this is the next most accessible and least burdensome
alternative. Our assumptions result in a 121,858 decrease in the
estimated number of clinicians who will submit quality data via
Medicare Part B claims and a 15,556 increase in the number of
clinicians who will submit via the QCDR/MIPS CQM collection type, as
shown in Table 69.
We assume that 100 percent of APM Entities in MIPS APMs will submit
quality data to CMS as required under their models. Consistent with
assumptions used in the CY 2019 PFS final rule (83 FR 60000 through
60001), we include all quality data voluntarily submitted by MIPS APM
participants made at the individual or TIN-level in our respondent
estimates. Therefore, we are not making any adjustments to our
respondent estimates as a result of the proposal discussed in section
III.K.3.c.(5)(c)(i)(A) of this proposed rule, which allows MIPS
eligible clinicians participating in MIPS APMs to elect to report MIPS
quality measures at either the individual or TIN-level under the APM
scoring standard beginning in the 2020 MIPS performance period. To
estimate who will be a MIPS APM participant in the 2020 MIPS
performance period, we used the latest 2019 predictive file that
contains current participation in MIPS APMs as of January 15, 2019,
using all available data. This file was selected to better reflect the
expected increase in the number of MIPS APMs in future years compared
to previous APM eligibility files. If a MIPS eligible clinician is
determined to not be scored as a MIPS APM, then their reporting
assumption is based on their reporting for the CY 2017 MIPS performance
period. For clinicians who participated in an APM in 2017, were not in
an APM in 2019, and did not report MIPS quality data in 2017, we assume
they will elect to report to MIPS via the MIPS CQM collection type,
similar to our previously stated assumption regarding clinicians who
are required to use an alternate reporting option. In addition, we
assume that the 80 TINs that elect to form 16 virtual groups will
continue to collect and submit MIPS data using the same collection and
submission types as they did during the 2017 MIPS performance period,
but the submission will be at the virtual group, rather than group
level.
Our burden estimates for the quality performance category do not
include the burden for the quality data that APM Entities submit to
fulfill the requirements of their APMs. The burden is excluded as
sections 1899(e) and 1115A(d)(3) of the Act (42 U.S.C. 1395jjj(e) and
1315a(d)(3), respectively) state that the Shared Savings Program and
the testing, evaluation, and expansion of Innovation Center models
tested under section 1115A of the Act (or section 3021 of the
Affordable Care Act) are not subject to the PRA.\140\ Tables 69, 70,
and 71 explain our
[[Page 40856]]
revised estimates of the number of organizations (including groups,
virtual groups, and individual MIPS eligible clinicians) submitting
data on behalf of clinicians segregated by collection type.
---------------------------------------------------------------------------
\140\ Our estimates do reflect the burden on MIPS APM
participants of submitting Promoting Interoperability performance
category data, which is outside the requirements of their APMs.
---------------------------------------------------------------------------
Table 69 provides our estimated counts of clinicians that will
submit quality performance category data as MIPS individual clinicians
or groups in the 2020 MIPS performance period based on data from the
2017 MIPS performance period.
For the 2020 MIPS performance period, respondents will have the
option to submit quality performance category data via Medicare Part B
claims, direct, and log in and upload submission types, and CMS Web
Interface. We estimate the burden for collecting data via collection
type: Claims, QCDR and MIPS CQMs, eCQMs, and the CMS Web Interface. We
believe that, while estimating burden by submission type may be better
aligned with the way clinicians participate with the Quality Payment
Program, it is more important to reduce confusion and enable greater
transparency by maintain consistency with previous rulemaking.
For an individual, group, or third-party to submit MIPS quality,
improvement activities, or Promoting Interoperability performance
category data using either the log in and upload or the log in and
attest submission type or to access feedback reports, the submitter
must have a CMS Enterprise Portal user account. Once the user account
is created using the Identity Management Application Process,
registration is not required again for future years.
Table 69 shows that in the 2020 MIPS performance period, an
estimated 109,951 clinicians will submit data as individuals for the
Medicare Part B claims collection type; 359,621 clinicians will submit
data as individuals or as part of groups for the MIPS CQM or QCDR
collection types; 247,329 clinicians will submit data as individuals or
as part of groups via eCQM collection types; and 116,342 clinicians
will submit as part of groups via the CMS Web Interface.
Table 69 provides estimates of the number of clinicians to collect
quality measures data via each collection type, regardless of whether
they decide to submit as individual clinicians or as part of groups.
Because our burden estimates for quality data submission assume that
burden is reduced when clinicians elect to submit as part of a group,
we also separately estimate the expected number of clinicians to submit
as individuals or part of groups.
Table 69--Estimated Number of Clinicians Submitting Quality Performance Category Data by Collection Type
----------------------------------------------------------------------------------------------------------------
Medicare Part CMS web
B claims QCDR/MIPS CQM eCQM interface Total
----------------------------------------------------------------------------------------------------------------
Number of clinicians to collect 109,951 359,621 247,329 116,342 833,243
data by collection type (as
individual clinicians or
groups) in 2020 MIPS
performance period (excludes
QPs) (a).......................
* Number of clinicians to 257,260 324,693 243,062 139,231 964,246
collect data by collection type
(as individual clinicians or
groups) in 2019 MIPS
performance period (excludes
QPs) (b).......................
Difference between 2020 MIPS -147,309 34,928 4,267 -22,889 -131,003
performance period (CY 2020
Proposed Rule) and 2019 MIPS
performance period (CY 2019
Final Rule) (c) = (a)-(b)......
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).
In the CY 2018 Quality Payment Program final rule (82 FR 53625
through 53626), beginning with the 2019 MIPS performance period, we
allowed MIPS eligible clinicians to submit data for multiple collection
types for a single performance category. Therefore, with the exception
of clinicians not in small practices who previously submitted quality
data via Medicare Part B claims, we captured the burden of any eligible
clinician that may have historically collected via multiple collection
types, as we assume they will continue to collect via multiple
collection types and that our MIPS scoring methodology will take the
highest score where the same measure is submitted via multiple
collection types. Hence, the estimated numbers of individual clinicians
and groups to collect via the various collection types are not mutually
exclusive and reflect the occurrence of individual clinicians or groups
that collected data via multiple collection types during the 2017 MIPS
performance period.
Table 70 uses methods similar to those described to estimate the
number of clinicians that will submit data as individual clinicians via
each collection type in the 2020 MIPS performance period. We estimate
that approximately 109,951 clinicians will submit data as individuals
using the Medicare Part B claims collection type; approximately 106,039
clinicians will submit data as individuals using MIPS CQMs or QCDR
collection types; and approximately 47,455 clinicians will submit data
as individuals using eCQMs collection type.
Table 70--Estimated Number of Clinicians Submitting Quality Performance Category Data as Individuals by
Collection Type
----------------------------------------------------------------------------------------------------------------
Medicare Part CMS web
B claims QCDR/MIPS CQM eCQM interface Total
----------------------------------------------------------------------------------------------------------------
Number of Clinicians to submit 109,951 106,039 47,455 0 263,445
data as individuals in 2020
MIPS Performance Period
(excludes QPs) (a).............
* Number of Clinicians to submit 257,260 71,439 47,557 0 376,256
data as individuals in 2019
MIPS Performance Period
(excludes QPs) (b).............
[[Page 40857]]
Difference between 2020 MIPS -147,309 +34,600 -102 0 -112,811
Performance Period (CY 2020
proposed rule) and 2019 MIPS
performance period (CY 2019
final rule) (c) = (a)-(b)......
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).
Consistent with the policy finalized in the CY 2018 Quality Payment
Program final rule that for MIPS eligible clinicians who collect
measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR collection
types and submit more than the required number of measures (82 FR 53735
through 54736), we will score the clinician on the required measures
with the highest assigned measure achievement points and thus, the same
clinician may be counted as a respondent for more than one collection
type. Therefore, our columns in Table 70 are not mutually exclusive.
Table 71 provides our estimated counts of groups or virtual groups
that will submit quality data on behalf of clinicians for each
collection type in the 2020 MIPS performance period and reflects our
assumption that the formation of virtual groups will reduce burden.
With the previously discussed exceptions regarding groups who
experienced a change in APM participation status between the 2017 and
2019 MIPS performance periods, we assume that groups that submitted
quality data as groups in the 2017 MIPS performance period will
continue to submit quality data either as groups or virtual groups for
the same collection types as they did as a group or TIN within a
virtual group for the 2020 MIPS performance period. First, we estimated
the number of groups or virtual groups that will collect data via each
collection type during the 2020 MIPS performance period using data from
the 2017 MIPS performance period. The second and third steps in Table
71 reflect our currently approved assumption that virtual groups will
reduce the burden for quality data submission by reducing the number of
organizations that will submit quality data on behalf of clinicians. We
assume that 40 groups that previously collected on behalf of clinicians
via QCDR or MIPS CQM collection types will elect to form 8 virtual
groups that will collect via QCDR and MIPS CQM collection types. We
assume that another 40 groups that previously collected on behalf of
clinicians via eCQM collection types will elect to form another 8
virtual groups that will collect via eCQM collection types. Hence, the
second step in Table 71 is to subtract out the estimated number of
groups under each collection type that will elect to form virtual
groups, and the third step in Table 71 is to add in the estimated
number of virtual groups that will submit on behalf of clinicians for
each collection type.
Specifically, we assume that 10,552 groups and virtual groups will
submit data for the QCDR or MIPS CQM collection types on behalf of
253,582 clinicians; 4,332 groups and virtual groups will submit for
eCQM collection types on behalf of 199,874 eligible clinicians; and 104
groups will submit data via the CMS Web Interface on behalf of 116,342
clinicians.
Table 71--Estimated Number of Groups and Virtual Groups Submitting Quality Performance Category Data by
Collection Type on Behalf of Clinicians
----------------------------------------------------------------------------------------------------------------
Medicare Part CMS web
B claims QCDR/MIPS CQM eCQM interface Total
----------------------------------------------------------------------------------------------------------------
Number of groups to collect data 0 10,584 4,364 104 15,052
by collection type (on behalf
of clinicians) in 2020 MIPS
performance period (excludes
QPs) (a).......................
Subtract out: Number of groups 0 40 40 0 80
to collect data by collection
type on behalf of clinicians in
2020 MIPS performance period
that will submit as virtual
groups (b).....................
Add in: Number of virtual groups 0 8 8 0 16
to collect data by collection
type on behalf of clinicians in
2020 MIPS performance period
(c)............................
Number of groups to collect data 0 10,552 4,332 104 14,988
by collection type on behalf of
clinicians in 2020 MIPS
performance period (d) = (a)-
(b) + (c)......................
* Number of groups to collect 0 10,542 4,304 286 15,132
data by collection type on
behalf of clinicians in 2019
MIPS performance period (e)....
Difference between 2020 MIPS 0 10 28 -182 -144
performance period (CY 2020
proposed rule) and 2019 MIPS
performance period (CY 2019
final rule) (f) = (d)-(e)......
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).
The burden associated with the submission of quality performance
category data have some limitations. We believe it is difficult to
quantify the burden accurately because clinicians and groups may have
different processes for integrating quality data submission into their
practices' workflows. Moreover, the time needed for a clinician to
review quality measures and other information, select measures
applicable to their patients and the services they furnish, and
incorporate the use of quality measures into the practice workflows is
expected to vary
[[Page 40858]]
along with the number of measures that are potentially applicable to a
given clinician's practice and by the collection type. For example,
clinicians submitting data via the Medicare Part B claims collection
type need to integrate the capture of quality data codes for each
encounter whereas clinicians submitting via the eCQM collection types
may have quality measures automated as part of their EHR
implementation.
We believe the burden associated with submitting quality measures
data will vary depending on the collection type selected by the
clinician, group, or third-party. As such, we separately estimated the
burden for clinicians, groups, and third parties to submit quality
measures data by the collection type used. For the purposes of our
burden estimates for the Medicare Part B claims, MIPS CQM and QCDR, and
eCQM collection types, we also assume that, on average, each clinician
or group will submit 6 quality measures. In terms of the quality
measures available for clinicians and groups to report for the 2020
MIPS performance period, the total number of quality measures will be
206. The new MIPS quality measures proposed for inclusion in MIPS for
the 2020 MIPS performance period and future years are found in Table
Group A of Appendix 1; MIPS quality measures with proposed substantive
changes can be found in Table Group D of Appendix 1; and MIPS quality
measures proposed for removal can be found in Table Group C of Appendix
1. These measures are stratified by collection type in Table 72, as
well as counts of new, removed, and substantively changed measures.
Table 72--Summary of Quality Measures for the 2020 MIPS Performance Period
----------------------------------------------------------------------------------------------------------------
Number
Number Number measures Number
Collection type measures measures proposed with measures
proposed as proposed for a substantive remaining for
new removal change * CY 2020
----------------------------------------------------------------------------------------------------------------
Medicare Part B Claims Specifications........... 0 17 22 47
MIPS CQMs Specifications........................ 3 52 77 184
eCQM Specifications............................. 1 6 33 45
Survey--CSV..................................... 0 0 0 1
CMS Web Interface Measure Specifications........ 1 1 9 10
Administrative Claims........................... 0 0 0 1
---------------------------------------------------------------
Total **.................................... 4 55 95 206
----------------------------------------------------------------------------------------------------------------
* This column includes all measures that have a requested substantive change from the measure stewards. The
total of 95 substantive changes reflects both measures that will continue and a subset of measures that have
been proposed for removal for PY2020. There are 73 substantive changes that are proposed in Appendix 1 for
measures not being proposed for removal.
** A measure may be specified under multiple collection types but will only be counted once in the total.
For the 2020 MIPS performance period, there is a net reduction of
51 quality measures across all collection types compared to the 257
measures finalized for the 2019 MIPS performance period (83 FR 60003).
We do not anticipate that removing these measures will increase or
decrease the reporting burden on clinicians and groups as respondents
are still required to submit quality data for 6 measures. Likewise, we
do not anticipate a change in reporting burden as a result of the one
proposed administrative claims measure (The All-Cause Unplanned
Admissions for Patients with Multiple Chronic Conditions measure) which
is being proposed for the 2021 MIPS performance period as discussed in
section III.K.3.c.(1)(d)(ii) of this rule.
As discussed in section III.K.3.c.(1)(c)(ii) of this rule, we are
proposing to adopt a higher data completeness threshold (the percentage
of eligible patients the clinician must check to see whether the
measure applies to) for the 2020 MIPS performance period, such that
MIPS eligible clinicians and groups submitting quality measure data on
QCDR measures, MIPS CQMs, and eCQMs must submit data on at least 70
percent of the MIPS eligible clinician or group's patients that meet
the denominator criteria, regardless of payer for the 2020 MIPS
performance period. We believe this proposal may increase
administrative burden for some clinicians as it affects the amount of
data they have to collect, but will have no impact on regulatory burden
as it affects neither the number of quality measures they are required
to report nor the amount of data they must report for each quality
measure once results have been aggregated.
(2) Quality Payment Program Identity Management Application Process
This rule does not propose any new or revised collection of
information requirements or burden related to the identity management
application process. The requirements and burden are currently approved
by OMB under control number 0938-1314 (CMS-10621). Consequently, we are
not making any identity management application process changes under
that control number.
(3) Quality Data Submission by Clinicians: Medicare Part B Claims-Based
Collection Type
This rule does not propose any new or revised collection of
information requirements related to the submission of Medicare Part B
claims data for the quality performance category. However, we are
proposing adjustments to our currently approved burden estimates based
on more recent data. The proposed requirements and burden will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
As noted in Table 69, based on 2017 MIPS performance period data,
we assume that 109,951 individual clinicians will collect and submit
quality data via the Medicare Part B claims collection type. This rule
proposes to adjust the number of Medicare Part B claims respondents
from 257,260 to 109,951 (a decrease of 147,309) based on more recent
data and our updated methodology of accounting only for clinicians in
small practices who submitted such claims data in the 2017 MIPS
performance period rather than all clinicians who submitted quality
data codes to us for the Medicare Part B claims collection type. We
continue to anticipate that the Medicare Part B claims submission
process for MIPS is operationally similar to the way the claims
submission process functioned under the PQRS. Specifically, clinicians
will need to
[[Page 40859]]
gather the required information, select the appropriate QDCs, and
include the appropriate QDCs on the Medicare Part B claims they submit
for payment. Clinicians will collect QDCs as additional (optional) line
items on the CMS-1500 claim form or the electronic equivalent HIPAA
transaction 837-P, approved by OMB under control number 0938-1197. This
proposed rule's provisions do not necessitate the revision of either
form and we are making no changes to the associated estimate of
reporting burden.
As shown in Table 73, consistent with our currently approved per
respondent burden estimates, we estimate that the burden of quality
data submission using Medicare Part B claims will range from 0.15 hours
at a cost of $13.50 (0.15 hr x $90.02/hr) to 7.2 hours at a cost of
$648.14 (7.2 hr x $90.02/hr) per respondent. The burden will involve
becoming familiar with MIPS data submission requirements. We believe
that the start-up cost for a clinician's practice to review measure
specifications is 7 hours, consisting of 3 hours at $109.36/hr for a
practice administrator, 1 hour at $202.86/hr for a clinician, 1 hour at
$45.24/hr for an LPN/medical assistant, 1 hour at $90.02/hr for a
computer systems analyst, and 1 hour at $38.00/hr for a billing clerk.
We are not proposing revisions to our currently approved per response
burden estimates.
The estimate for reviewing and incorporating measure specifications
for the claims collection type is higher than that of QCDRs/Registries
or eCQM collection types due to the more manual, and therefore, more
burdensome nature of Medicare Part B claims measures.
Considering both data submission and start-up requirements, the
estimated time (per clinician) ranges from a minimum of 7.15 hours
(0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this
regard the total annual time ranges from 786,150 hours (7.15 hr x
109,951 clinicians) to 1,561,304 hours (14.2 hr x 109,951 clinicians).
The estimated annual cost (per clinician) ranges from $717.70 [(0.15 hr
x $90.02/hr) + (3 hr x $109.36/hr) + (1 hr x $90.02/hr) + (1 hr x
$45.24/hr) + (1 hr x $38.00/hr + (1 hr x $202.86/hr)] to a maximum of
$1,352.34 [(7.2 hr x $90.02/hr) + (3 hr x $109.36/hr) + (1 hr x $90.02/
hr) + (1 hr x $45.24/hr) + (1 hr x $38.00/hr + (1 hr x $202.86/hr)].
The total annual cost ranges from a minimum of $78,912,163 (109,951
clinicians x $717.70) to a maximum of $148,691,575 (109,951 clinicians
x $1,352.34).
Table 73 summarizes the range of total annual burden associated
with clinicians submitting quality data via Medicare Part B claims.
Table 73--Estimated Burden for Quality Performance Category: Clinicians Using the Medicare Part B Claims
Collection Type
----------------------------------------------------------------------------------------------------------------
Minimum burden Median burden Maximum burden
----------------------------------------------------------------------------------------------------------------
# of Clinicians (a)............................................. 109,951 109,951 109,951
Hours Per Clinician to Submit Quality Data (b).................. 0.15 1.05 7.2
# of Hours Practice Administrator Review Measure Specifications 3 3 3
(c)............................................................
# of Hours Computer Systems Analyst Review Measure 1 1 1
Specifications (d).............................................
# of Hours LPN Review Measure Specifications (e)................ 1 1 1
# of Hours Billing Clerk Review Measure Specifications (f)...... 1 1 1
# of Hours Clinician Review Measure Specifications (g).......... 1 1 1
Annual Hours per Clinician (h) = (b) + (c) + (d) + (e) + (f) + 7.15 8.05 14.2
(g)............................................................
-----------------------------------------------
Total Annual Hours (i) = (a) * (h).......................... 786,150 885,106 1,561,304
-----------------------------------------------
Cost to Submit Quality Data (@computer systems analyst's labor $13.50 $94.52 $648.14
rate of $90.02/hr) (j).........................................
Cost to Review Measure Specifications (@practice administrator's $328.08 $328.08 $328.08
labor rate of $109.36/hr) (k)..................................
Cost to Review Measure Specifications (@computer systems $90.02 $90.02 $90.02
analyst's labor rate of $90.02/hr) (l).........................
Cost to Review Measure Specifications (@LPN's labor rate of $45.24 $45.24 $45.24
$45.24/hr) (m).................................................
Cost to Review Measure Specifications (@billing clerk's labor $38.00 $38.00 $38.00
rate of $38.00/hr) (n).........................................
Cost to Review Measure Specifications (@physician's labor rate $202.86 $202.86 $202.86
of $202.86/hr) (o).............................................
-----------------------------------------------
Total Annual Cost Per Clinician (p) = (j) + (k) + (l) + (m) $717.70 $798.72 $1,352.34
+ (n) + (o)................................................
-----------------------------------------------
Total Annual Cost (q) = (a) * (p)....................... $78,912,163 $87,820,173 $148,691,575
----------------------------------------------------------------------------------------------------------------
As shown in Table 74, using the unchanged currently approved per
respondent burden estimates which range from $717.70 to $1,352.34, the
decrease in number of respondents from 257,260 to 109,951 results in a
total adjustment of between -1,053,259 hours (-147,309 respondents x
7.15 hr/respondent) at a cost of -$105,724,111 (-147,309 respondents x
$717.70/respondent) and -2,091,788 hours (-147,309 respondents x 14.2
hr/respondent) at a cost of -$199,212,442 (-147,309 respondents x
$1,352.34/respondent).
Table 74--Change in Estimated Burden for Quality Performance Category: Clinicians Using the Medicare Part B
Claims Collection Type
----------------------------------------------------------------------------------------------------------------
Minimum burden Median burden Maximum burden
----------------------------------------------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final 1,839,409 2,070,943 3,653,092
Rule (a)..............................................
Total Annual Hours for Respondents in CY 2020 Proposed 786,150 885,106 1,561,304
Rule (b)..............................................
--------------------------------------------------------
[[Page 40860]]
Difference Between CY 2020 Proposed Rule and CY -1,053,259 -1,185,837 -2,091,788
2019 Final Rule (c) = (b)-(a).....................
Total Annual Cost for Respondents in CY 2019 Final Rule $184,636,274 $205,478,964 $347,904,017
(d)...................................................
Total Annual Cost for Respondents in CY 2020 Proposed $78,912,163 $87,820,173 $148,691,575
Rule (e)..............................................
--------------------------------------------------------
Difference Between CY 2020 Proposed Rule and CY -$105,724,111 -$117,658,791 -$199,212,442
2019 Final Rule (f) = (e)-(d).....................
----------------------------------------------------------------------------------------------------------------
(4) Quality Data Submission by Individuals and Groups Using MIPS CQM
and QCDR Collection Types
This rule does not propose any new or revised collection of
information requirements related to the MIPS CQM or QCDR collection
types. However, we are proposing adjustments to our currently approved
burden estimates based on more recent data. The proposed requirements
and burden will be submitted to OMB for approval under control number
0938-1314 (CMS-10621).
As noted in Tables 69, 70, and 71, and based on 2017 MIPS
performance period data, we assume that 359,621 clinicians will submit
quality data as individuals or groups using MIPS CQM or QCDR collection
types. Of these, we expect 106,039 clinicians, as shown in Table 70,
will submit as individuals and 10,552 groups and virtual groups, as
shown in Table 71, are expected to submit on behalf of the remaining
253,582 clinicians. As previously stated, we assume clinicians in other
practices (not small practices) who meet all of the following criteria
will submit via the MIPS CQM collection type for the 2020 MIPS
performance period because the Medicare Part B claims collection type
will no longer be available as an option for collecting and reporting
quality data: (1) Scored as individuals; (2) not facility-based; and
(3) submitted quality data only via the Medicare Part B claims
collection type in the 2017 MIPS performance period. As a result of
this assumption and our use of more recent data, this rule proposes to
adjust the number of QCDR and MIPS CQM respondents from 81,981 to
116,591 (an increase of 34,610). Given that the number of measures
required is the same for clinicians and groups, we expect the burden to
be the same for each respondent collecting data via MIPS CQM or QCDR,
whether the clinician is participating in MIPS as an individual or
group.
Under the MIPS CQM and QCDR collection types, the individual
clinician or group may either submit the quality measures data directly
to us, log in and upload a file, or utilize a third-party intermediary
to submit the data to us on the clinician's or group's behalf.
We estimate that the burden associated with the QCDR collection
type is similar to the burden associated with the MIPS CQM collection
type; therefore, we discuss the burden for both together below. For
MIPS CQM and QCDR collection types, we estimate an additional time for
respondents (individual clinicians and groups) to become familiar with
MIPS collection requirements and, in some cases, specialty measure sets
and QCDR measures. Therefore, we believe that the burden for an
individual clinician or group to review measure specifications and
submit quality data total 9.083 hours at $872.37 per individual
clinician or group. This consists of 3 hours at $90.02/hr for a
computer systems analyst (or their equivalent) to submit quality data
along with 2 hours at $109.36/hr for a practice administrator, 1 hour
at $90.02/hr for a computer systems analyst, 1 hour at $45.24/hr for a
LPN/medical assistant, 1 hour at $38.00/hr for a billing clerk, and 1
hour at $202.86/hr for a clinician to review measure specifications.
Additionally, clinicians and groups who do not submit data directly
will need to authorize or instruct the qualified registry or QCDR to
submit quality measures' results and numerator and denominator data on
quality measures to us on their behalf. We estimate that the time and
effort associated with authorizing or instructing the quality registry
or QCDR to submit this data will be approximately 5 minutes (0.083
hours) per clinician or group (respondent) for a cost of $7.50 (0.083
hr x $90.02/hr for a computer systems analyst).
In aggregate, we estimate an annual burden of 1,058,996 hours
(9.083 hr/response x 116,591 groups plus clinicians submitting as
individuals) at a cost of $101,710,684 (116,591 responses x $872.37/
response). The increase in number of respondents from 81,981 to 116,591
results in a total adjustment of 314,363 hours (34,610 respondents x
9.083 hr/respondent) at a cost of $30,192,783 (34,610 respondents x
$872.37/respondent). Based on these assumptions, we have estimated in
Table 75 the burden for these submissions.
Table 75--Estimated Burden for Quality Performance Category: Clinicians
(Participating Individually or as Part of a Group) Using the MIPS CQM/
QCDR Collection Type
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of clinicians submitting as individuals (a)........... 106,039
# of groups submitting via QCDR or MIPS CQM on behalf of 10,552
individual clinicians (b)..............................
# of Respondents (groups plus clinicians submitting as 116,591
individuals) (c) = (a) + (b)...........................
Hours Per Respondent to Report Quality Data (d)......... 3
# of Hours Practice Administrator Review Measure 2
Specifications (e).....................................
# of Hours Computer Systems Analyst Review Measure 1
Specifications (f).....................................
# of Hours LPN Review Measure Specifications (g)........ 1
# of Hours Billing Clerk Review Measure Specifications 1
(h)....................................................
# of Hours Clinician Review Measure Specifications (i).. 1
[[Page 40861]]
# of Hours Per Respondent to Authorize Qualified 0.083
Registry to Report on Respondent's Behalf (j)..........
Annual Hours Per Respondent (k) = (d) + (e) + (f) + (g) 9.083
+ (h) + (i) + (j)......................................
---------------
Total Annual Hours (l) = (c) * (k).................. 1,058,996
---------------
Cost Per Respondent to Submit Quality Data (@computer $270.06
systems analyst's labor rate of $90.02/hr) (m).........
Cost to Review Measure Specifications (@practice $218.72
administrator's labor rate of $109.36/hr) (n)..........
Cost Computer System's Analyst Review Measure $90.02
Specifications (@computer systems analyst's labor rate
of $90.02/hr) (o)......................................
Cost LPN Review Measure Specifications (@LPN's labor $45.24
rate of $45.24/hr) (p).................................
Cost Billing Clerk Review Measure Specifications $38.00
(@clerk's labor rate of $38.00/hr) (q).................
Cost Clinician Review Measure Specifications $202.86
(@physician's labor rate of $202.86/hr) (r)............
Cost for Respondent to Authorize Qualified Registry/QCDR $7.50
to Report on Respondent's Behalf (@computer systems
analyst's labor rate of $90.02/hr) (s).................
---------------
Total Annual Cost Per Respondent (t) = (m) + (n) + $872.37
(o) + (p) + (q) + (r) + (s)........................
---------------
Total Annual Cost (u) = (c) * (t)................... $101,710,684
------------------------------------------------------------------------
As shown in Table 76, using the unchanged currently approved per
respondent burden estimate, the increase in number of respondents from
81,981 to 116,591 results in a total difference of 314,363 hours
(34,610 respondents x 9.083 hr/respondent) at a cost of $30,192,783
(34,610 respondents x $872.37/respondent).
Table 76--Change in Estimated Burden for Quality Performance Category:
Clinicians (Participating Individually or as Part of a Group) Using the
MIPS CQM/QCDR Collection Type
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 744,633
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 1,058,996
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 314,363
Final Rule (c) = (b)-(a)...........................
------------------------------------------------------------------------
Total Annual Cost for Respondents in CY 2019 Final Rule $71,517,901
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $101,710,684
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 $30,192,783
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
(5) Quality Data Submission by Clinicians and Groups: eCQM Collection
Type
This rule does not propose any new or revised collection of
information requirements related to the eCQM collection type. However,
we are proposing to adjust our currently approved burden estimates
based on more recent data. The proposed requirements and burden will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
As noted in Tables 69, 70, and 71, based on 2017 MIPS performance
period data, we assume that 247,329 clinicians will elect to use the
eCQM collection type; 47,455 clinicians are expected to submit eCQMs as
individuals; and 4,332 groups and virtual groups are expected to submit
eCQMs on behalf of the remaining 199,874 clinicians. This rule proposes
to adjust the number of eCQM respondents from 51,861 to 51,787 (a
decrease of 74) based on more recent data. We expect the burden to be
the same for each respondent using the eCQM collection type, whether
the clinician is participating in MIPS as an individual or group.
Under the eCQM collection type, the individual clinician or group
may either submit the quality measures data directly to us from their
eCQM, log in and upload a file, or utilize a third-party intermediary
to derive data from their CEHRT and submit it to us on the clinician's
or group's behalf.
To prepare for the eCQM collection type, the clinician or group
must review the quality measures on which we will be accepting MIPS
data extracted from eCQMs, select the appropriate quality measures,
extract the necessary clinical data from their CEHRT, and submit the
necessary data to the CMS-designated clinical data warehouse or use a
health IT vendor to submit the data on behalf of the clinician or
group. We assume the burden for collecting quality measures data via
eCQM is similar for clinicians and groups who submit their data
directly to us from their CEHRT and clinicians and groups who use a
health IT vendor to submit the data on their behalf. This includes
extracting the necessary clinical data from their CEHRT and submitting
the necessary data to the CMS-designated clinical data warehouse.
We estimate that it will take no more than 2 hours at $90.02/hr for
a computer systems analyst to submit the actual data file. The burden
will also involve becoming familiar with MIPS submission. In this
regard, we estimate it will take 6 hours for a clinician or group to
review measure specifications. Of that time, we estimate 2 hours at
$109.36/hr for a practice administrator, 1 hour at $202.86/hr for a
clinician, 1 hour at $90.02/hr for a computer systems analyst, 1 hour
at $45.24/hr for
[[Page 40862]]
a LPN/medical assistant, and 1 hour at $38.00/hr for a billing clerk.
In aggregate we estimate an annual burden of 414,296 hours (8 hr x
51,787 groups and clinicians submitting as individuals) at a cost of
$40,128,711 (51,787 responses x $774.88/response). Based on these
assumptions, we have estimated in Table 77 the burden for these
submissions.
Table 77--Estimated Burden for Quality Performance Category: Clinicians
(Submitting Individually or as Part of a Group) Using the eCQM
Collection Type
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of clinicians submitting as individuals (a)........... 47,455
# of Groups submitting via EHR on behalf of individual 4,332
clinicians (b).........................................
# of Respondents (groups and clinicians submitting as 51,787
individuals) (c) = (a) + (b)...........................
Hours Per Respondent to Submit MIPS Quality Data File to 2
CMS (d)................................................
# of Hours Practice Administrator Review Measure 2
Specifications (e).....................................
# of Hours Computer Systems Analyst Review Measure 1
Specifications (f).....................................
# of Hours LPN Review Measure Specifications (g)........ 1
# of Hours Billing Clerk Review Measure Specifications 1
(h)....................................................
# of Hours Clinicians Review Measure Specifications (i). 1
Annual Hours Per Respondent (j) = (d) + (e) + (f) + (g) 8
+ (h) + (i)............................................
---------------
Total Annual Hours (k) = (c) * (j).................. 414,296
---------------
Cost Per Respondent to Submit Quality Data (@computer $180.04
systems analyst's labor rate of $90.02/hr) (l).........
Cost to Review Measure Specifications (@practice $218.72
administrator's labor rate of $109.36/hr) (m)..........
Cost to Review Measure Specifications (@computer systems $90.02
analyst's labor rate of $90.02/hr) (n).................
Cost to Review Measure Specifications (@LPN's labor rate $45.24
of $45.24/hr) (o)......................................
Cost to Review Measure Specifications (@clerk's labor $38.00
rate of $38.00/hr) (p).................................
Cost to D21Review Measure Specifications (@physician's $202.86
labor rate of $202.86/hr) (q)..........................
---------------
Total Cost Per Respondent (r) = (l) + (m) + (n) + $774.88
(o) + (p) + (q)....................................
---------------
Total Annual Cost (s) = (c) * (r)............... $40,128,711
------------------------------------------------------------------------
As shown in Table 78, using the unchanged currently approved per
respondent burden estimate, the decrease in number of respondents from
51,861 to 51,787 results in a total difference of -592 hours (-74
respondents x 8 hr/respondent) at a cost of -$57,341 (-74 respondents x
$774.88/respondent).
Table 78--Change in Estimated Burden for Quality Performance Category:
Clinicians (Participating Individually or as Part of a Group) Using the
eCQM Collection Type
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 414,888
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 414,296
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -592
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $40,186,052
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $40,128,711
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$57,341
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
(6) Quality Data Submission via CMS Web Interface
This rule does not propose any new or revised collection of
information requirements related to submission of quality data via the
CMS Web Interface. However, we are proposing adjustments to our
currently approved burden estimates based on more recent data. The
proposed requirements and burden will be submitted to OMB for approval
under control number 0938-1314 (CMS-10621).
We assume that 104 groups will submit quality data via the CMS Web
Interface based on the number of groups who completed 100 percent of
reporting quality data via the Web Interface in the 2018 MIPS
performance period. This is a decrease of 182 groups from the currently
approved number of 286 groups provided in the CY 2019 PFS final rule
(83 FR 60007) due to receipt of more current data. We estimate that
116,342 clinicians will submit as part of groups via this method, a
decrease of 22,889 from our currently approved estimate of 139,231
clinicians.
The burden associated with the group submission requirements is the
time and effort associated with submitting data on a sample of the
organization's beneficiaries that is prepopulated in the CMS Web
Interface. Our burden estimate for submission includes the time (61.67
hours) needed for each group to populate data fields in the web
interface with information on approximately 248 eligible assigned
Medicare beneficiaries and submit the data (we will partially pre-
populate the CMS Web Interface with claims data from their Medicare
Part A and B beneficiaries). The patient data either can be manually
entered, uploaded into
[[Page 40863]]
the CMS Web Interface via a standard file format, which can be
populated by CEHRT, or submitted directly. Each group must provide data
on 248 eligible assigned Medicare beneficiaries (or all eligible
assigned Medicare beneficiaries if the pool of eligible assigned
beneficiaries is less than 248) for each measure. In aggregate, we
estimate an annual burden of 6,414 hours (104 groups x 61.67 hr) at a
cost of $577,359 (6,414 hr x $90.02/hr). Based on the assumptions
discussed in this section, Table 79 summarizes the burden for groups
submitting to MIPS via the CMS Web Interface.
Table 79--Estimated Burden for Quality Data Submission via the CMS Web
Interface
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Eligible Group Practices (a)....................... 104
Total Annual Hours Per Group to Submit (b).............. 61.67
---------------
Total Annual Hours (c) = (a) * (b).................. 6,414
---------------
Cost Per Group to Report (@computer systems analyst's $5,551.53
labor rate of $90.02/hr.) (d)..........................
---------------
Total Annual Cost (e) = (a) * (d)................... $577,359
------------------------------------------------------------------------
As shown in Table 80, using our unchanged currently approved per
respondent burden estimate, the decrease in number of respondents
results in a total adjustment of -11,224 hours (-182 respondents x
61.67 hr) at -$1,010,379 (-11,224 hr x $90.02/hr).
Table 80--Change in Estimated Burden for Quality Data Submission via the
CMS Web Interface
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 17,637
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 6,413
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -11,224
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $1,587,739
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $577,359
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$1,010,379
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
(7) Beneficiary Responses to CAHPS for MIPS Survey
This rule does not propose any new or revised collection of
information requirements or burden related to the CAHPS for MIPS
survey. The CAHPS for MIPS survey requirements and burden are currently
approved by OMB under control number 0938-1222 (CMS-10450).
Consequently, we are not making any MIPS survey vendor changes under
that control number.
(8) Group Registration for CMS Web Interface
This rule does not propose any new or revised collection of
information requirements related to the group registration for CMS Web
Interface. However, we propose to adjust our currently approved burden
estimates based on more recent data. The adjusted burden will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
Groups interested in participating in MIPS using the CMS Web
Interface for the first time must complete an on-line registration
process. After first time registration, groups will only need to opt
out if they are not going to continue to submit via the CMS Web
Interface. In Table 81, we estimate that the registration process for
groups under MIPS involves approximately 0.25 hours at $90.02/hr for a
computer systems analyst (or their equivalent) to register the group.
In this rule, we propose to adjust the number of respondents from
67 to 51 based on more recent data. We assume that approximately 51
groups will elect to use the CMS Web Interface for the first time
during the 2020 MIPS performance period based on the number of new
registrations received during the CY 2018 registration period; a
decrease of 16 compared to the number of groups currently approved by
OMB. The registration period for the CY 2019 MIPS performance period
ends on June 30, 2019; assuming updated information is available, we
will update our respondent estimates in the final rule. As shown in
Table 81, we estimate a burden of 12.75 hours (51 new registrations x
0.25 hr/registration) at a cost of $1,148 (12.75 hr x $90.02/hr).
Table 81--Estimated Burden for Group Registration for CMS Web Interface
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of New Groups Registering for CMS Web Interface 51
(a)....................................................
Annual Hours Per Group (b).............................. 0.25
---------------
[[Page 40864]]
Total Annual Hours (c) = (a) * (b).................. 12.75
---------------
Labor rate for a computer systems analyst (d)........... $90.02/hr
---------------
Total Annual Cost for CMS Web Interface Group $1,148
Registration (e) = (a) * (d).......................
------------------------------------------------------------------------
As shown in Table 82 using our unchanged currently approved per
respondent burden estimates, the decrease in the number of groups
registering to submit MIPS data via the CMS Web Interface results in an
adjustment to the total time burden of 4 hours at a cost of $360 (-16
groups x 0.25 hr x $90.02/hr).
Table 82--Change in Estimated Burden for Group Registrations for the CMS
Web Interface
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 16.75
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 12.75
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -4
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $1,508
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $1,148
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$360
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
(9) Group Registration for CAHPS for MIPS Survey
This rule does not propose any new or revised collection of
information requirements or burden related to the group registration
for the CAHPS for MIPS Survey. The CAHPS for MIPS survey requirements
and burden are currently approved by OMB under control number 0938-1222
(CMS-10450). Consequently, are not making any MIPS survey vendor
changes under that control number.
e. ICRs Regarding the Nomination of Quality Measures
The proposed requirements and burden associated with this data
submission will be submitted to OMB for approval under control number
0938-1314 (CMS-10621).
Quality measures are selected annually through a call for quality
measures under consideration, with a final list of quality measures
being published in the Federal Register by November 1 of each year.
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit
a ``Call for Quality Measures'' each year. Specifically, the Secretary
must request that eligible clinician organizations and other relevant
stakeholders identify and submit quality measures to be considered for
selection in the annual list of MIPS quality measures, as well as
updates to the measures. Under section 1848(q)(2)(D)(ii) of the Act,
eligible clinician organizations are professional organizations as
defined by nationally recognized specialty boards of certification or
equivalent certification boards.
As we described in the CY 2017 Quality Payment Program final rule
(81 FR 77137), we will accept quality measures submissions at any time,
but only measures submitted during the timeframe provided by us through
the pre-rulemaking process of each year will be considered for
inclusion in the annual list of MIPS quality measures for the
performance period beginning 2 years after the measure is submitted.
This process is consistent with the pre-rulemaking process and the
annual call for measures, which are further described at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rule-Making.html.
To identify and submit a quality measure, eligible clinician
organizations and other relevant stakeholders use a one-page online
form that requests information on background, a gap analysis which
includes evidence for the measure, reliability, validity, endorsement
and a summary which includes how the proposed measure relates to the
Quality Payment Program and the rationale for the measure. In addition,
proposed measures must be accompanied by a completed Peer Review
Journal Article form. As discussed in section III.K.3.c.(1)(d)(i) of
this rule, we are proposing that beginning with the 2020 Call for
Measures process, MIPS quality measure stewards would be required to
link their MIPS quality measures to existing and related cost measures
and improvement activities, as applicable and feasible. MIPS quality
measure stewards would also be required to provide a rationale as to
how they believe their measure correlates to other performance category
measures and activities. We believe this would require approximately
0.6 hours at $109.36/hr for a practice administrator and 0.4 hours at
$202.86 for a clinician to research existing measures or activities and
provide a rationale for the linkage to the new measure. We also
estimate it would require 0.3 hours at $109.36/hr for a practice
administrator to make a strategic decision to nominate and submit a
measure and 0.2 hours at $202.86/hr for clinician review time. We
recognize there is additional burden on respondents associated with
development of a new quality measure beyond the 1.5 hour estimate (0.6
hr + 0.4 hr + 0.3 hr + 0.2 hr) which only accounts for the time
required for recordkeeping, reporting, and third-party disclosures
associated with the policy; but we believe this estimate to be
reasonable to nominate and submit a measure. The 1.5 hour estimate also
assumes that submitters will have the necessary information to complete
the nomination form readily available,
[[Page 40865]]
which we believe is a reasonable assumption. Additionally, some
submitters familiar with the process or who are submitting multiple
measures may require significantly less time, while other submitters
may require more if the opposite is true. Representing an average
across all respondents based on our review of the nomination process,
the information required to complete the nomination form, and the
criteria required to nominate the measure, we believe the total
estimate of 1.5 hours per measure to be reasonable and appropriate.
As shown in Table 83, we estimate that 26 submissions will be
received during the 2019 Call for Quality Measures based on the number
of submissions received during the 2018 Call for Quality Measures
process; a decrease of 114 compared to the number of submissions
currently approved by OMB (140 submissions). The 2019 Call for Quality
Measures process ends on June 3, 2019; assuming updated information is
available, we will update our estimate in the final rule. In keeping
with the focus on clinicians as the primary source for recommending new
quality measures, we are using practice administrators and clinician
time for our burden estimates.
Consistent with the CY 2017 Quality Payment Program final rule, we
also estimate it will take 4 hours at $202.86/hr for a clinician (or
equivalent) to complete the Peer Review Journal Article Form (81 FR
77153 through 77155). This assumes that measure information is
available and testing is complete in order to have the necessary
information to complete the form, which we believe is a reasonable
assumption.
As shown in Table 83, in aggregate we estimate an annual burden of
143 hours (26 submissions x 5.5 hr/submission) at a cost of $26,821 {26
submissions x [(0.9 hr x $109.36/hr) + (4.6 hr x $202.86/hr{time} .
Table 83--Estimated Burden for Call for Quality Measures
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of New Quality Measures Submitted for Consideration 26
(a)....................................................
# of Hours Per Practice Administrator to Identify, 0.9
Propose, and Link Measure (b)..........................
# of Hours Per Clinician to Identify and Link Measure 0.6
(c)....................................................
# of Hours Per Clinician to Complete Peer Review Article 4.00
Form (d)...............................................
---------------
Annual Hours Per Response (e) = (b) + (c) + (d)..... 5.50
---------------
Total Annual Hours (f) = (a) * (e).............. 143
---------------
Cost to Identify and Submit Measure (@practice $98.42
administrator's labor rate of $109.36/hr.) (g).........
Cost to Identify Quality Measure and Complete Peer $933.16
Review Article Form (@physician's labor rate of $202.86/
hr.) (h)...............................................
---------------
Total Annual Cost Per Respondent (i) = (g) + (h).... $1,031.58
---------------
Total Annual Cost (j) = (a) * (i)............... $26,821
------------------------------------------------------------------------
Independent of the decrease in the number of new quality measures
submitted for consideration, the increase in burden per nominated
measure results in a difference of 140 hours at a cost of $20,546 {140
submissions x [(0.6 hr x $109.36/hr) + (0.4 hr x $202.86/hr)]{time} .
The decrease in the number of new quality measures submitted results in
an adjustment of -627 hours at -$117,600 (-114 submissions x [(0.9 hr x
$109.36/hr) + (4.6 hr x $202.86/hr)]). As shown in Table 84, in
aggregate, the combine impact of these changes is -487 hours (140-627)
at a cost of -$97,054 ($20,546-$117,600).
Table 84--Change in Estimated Burden for Call for Quality Measures
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 630
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 143
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -487
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $123,875
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $26,821
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$97,054
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
f. ICRs Regarding Promoting Interoperability Data (Sec. Sec. 414.1375
and 414.1380)
(1) Background
For the 2020 MIPS performance period, clinicians and groups can
submit Promoting Interoperability data through direct, log in and
upload, or log in and attest submission types. We have worked to
further align the Promoting Interoperability performance category with
other MIPS performance categories. With the exception of submitters who
elect to use the log in and attest submission type for the Promoting
Interoperability performance category, which is not available for the
quality performance category, we anticipate that individuals and groups
will use the same data submission type for the both of these
performance categories and that the clinicians, practice managers, and
computer systems analysts involved in supporting
[[Page 40866]]
the quality data submission will also support the Promoting
Interoperability data submission process. In the 2019 and prior MIPS
performance periods, individuals and groups submitting data for the
quality performance category via a qualified registry or QCDR that did
not also support reporting of data for the Promoting Interoperability
or improvement activity performance categories would be required to
submit data for these performance categories using an alternate
submission type. The proposals discussed in sections
III.K.3.g.(3)(a)(i) and III.K.3.g.(4)(a)(i) requiring qualified
registries and QCDRs to support the reporting of quality, improvement
activities, and Promoting Interoperability performance categories would
alleviate this issue. Hence, the following burden estimates show only
incremental hours required above and beyond the time already accounted
for in the quality data submission process. Although this analysis
assesses burden by performance category and submission type, we
emphasize that MIPS is a consolidated program and submission analysis
and decisions are expected to be made for the program as a whole.
(2) Reweighting Applications for Promoting Interoperability and Other
Performance Categories
This rule does not propose any new or revised collection of
information requirements related to the submission of reweighting
applications for Promoting Interoperability and other performance
categories. However, we propose to adjust our currently approved burden
estimates based on an updated analysis of individuals and groups who
submitted reweighting applications for the 2017 MIPS performance period
but likely would not submit such applications for the 2019 MIPS
performance period. The adjusted burden estimates will be submitted to
OMB for approval under control number 0938-1314 (CMS-10621).
As established in the CY 2017 and CY 2018 Quality Payment Program
final rules, MIPS eligible clinicians who meet the criteria for a
significant hardship or other type of exception may submit an
application requesting a zero percent weighting for the Promoting
Interoperability performance category in the following circumstances:
Insufficient internet connectivity, extreme and uncontrollable
circumstances, lack of control over the availability of CEHRT,
clinicians who are in a small practice, and decertified EHR technology
(81 FR 77240 through 77243 and 82 FR 53680 through 53686,
respectively). In addition, in the CY 2018 Quality Payment Program
final rule, we established that MIPS eligible clinicians and groups
citing extreme and uncontrollable circumstances may also apply for a
reweighting of the quality, cost, and/or improvement activities
performance categories (82 FR 53783 through 53785). As discussed in
section III.K.3.d.(2)(b)(ii)(A), we are proposing, beginning with the
2018 MIPS performance period and 2020 MIPS payment year, to reweight
the performance categories for a MIPS eligible clinician who we
determine has data for a performance category that are inaccurate,
unusable or otherwise compromised due to circumstances outside of the
control of the clinician or its agents if we learn the relevant
information prior to the beginning of the associated MIPS payment year.
Because this is a new policy and we believe these occurrences are rare
based on our experience, we are unable to estimate the number of
clinicians, groups, or third party intermediaries that may contact us
regarding a potential data issue. Similarly, the extent and source of
documentation provided to us for each event may vary considerably.
Therefore, we are not proposing any changes to our currently approved
burden estimates as a result of this proposal. Respondents who apply
for a reweighting for any of these performance categories have the
option of applying for reweighting for the Promoting Interoperability
performance category on the same online form. We assume that
respondents applying for a reweighting of the Promoting
Interoperability performance category due to extreme and uncontrollable
circumstances will also request a reweighting of at least one of the
other performance categories simultaneously and not submit multiple
reweighting applications. Data on the number of reweighting
applications submitted for the 2018 MIPS performance period is
unavailable for this proposed rule. Assuming updated information is
available for the final rule, we will assess the utility of using this
information to estimate burden for future performance periods and will
make a determination at that time as to the most appropriate data to
use in estimating future burden.
Table 85 summarizes the burden for clinicians to apply for
reweighting the Promoting Interoperability performance category to zero
percent due to a significant hardship exception (including a
significant hardship exception for small practices) or as a result of a
decertification of an EHR. Based on the number of reweighting
applications received for the 2017 MIPS performance period, we assume
6,025 respondents (eligible clinicians or groups) will submit a request
to reweight the Promoting Interoperability performance category to zero
percent due to a significant hardship (including clinicians in small
practices) or EHR decertification. Of that amount we estimate that
3,365 respondents (eligible clinicians or groups) will submit a request
for reweighting the Promoting Interoperability performance category to
zero percent due to extreme and uncontrollable circumstances,
insufficient internet connectivity, lack of control over the
availability of CEHRT, or as a result of a decertification of an EHR.
An additional 2,660 respondents will submit a request for reweighting
the Promoting Interoperability performance category to zero percent as
a small practice experiencing a significant hardship.
The application to request a reweighting to zero percent only for
the Promoting Interoperability performance category is a short online
form that requires identifying the type of hardship experienced or
whether decertification of an EHR has occurred and a description of how
the circumstances impair the clinician or group's ability to submit
Promoting Interoperability data, as well as some proof of circumstances
beyond the clinician's control. The application for reweighting of the
quality, cost, Promoting Interoperability, and/or improvement
activities performance categories due to extreme and uncontrollable
circumstances requires the same information with the exception of there
being only one option for the type of hardship experienced. We estimate
it would take 0.25 hours at $90.02/hr for a computer system analyst to
complete and submit the application. As shown in Table 85, we estimate
an annual burden of 1,506.25 hours (6,025 applications x 0.25 hr/
application) at a cost of $135,593 (1,506.25 hr x $90.02/hr).
[[Page 40867]]
Table 85--Estimated Burden for Reweighting Applications for Promoting
Interoperability and Other Performance Categories
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Eligible Clinicians or Groups Applying Due to 3,365
Significant Hardship and Other Exceptions (a)..........
# of Eligible Clinicians or Groups Applying Due to 2,660
Significant Hardship for Small Practice (b)............
Total Respondents Due to Hardships, Other Exceptions and 6,025
Hardships for Small Practices (c)......................
Hours Per Applicant per application submission (d)...... 0.25
---------------
Total Annual Hours (e) = (a) * (c).................. 1,506.25
---------------
Labor Rate for a computer systems analyst (f)........... $90.02/hr
---------------
Total Annual Cost (g) = (a) * (f)................... $135,593
------------------------------------------------------------------------
As shown in Table 86, using our unchanged currently approved per
respondent burden estimate, the decreased number of respondents results
in a total adjustment of -4 hours (-16 respondents x 0.25 hr/
respondent) and -$360 (-16 respondents x $22.50/respondent).
Table 86--Change in Estimated Burden for Reweighting Applications for
Promoting Interoperability and Other Performance Categories
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 1,510
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 1,506
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -4
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $135,953
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $135,593
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$360
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
(3) Submitting Promoting Interoperability Data
This rule does not propose any new or revised collection of
information requirements related to the submission of Promoting
Interoperability data. However, we propose to adjust our currently
approved burden estimates based on updated estimates of QPs and MIPS
APMs for 2019 MIPS performance period. The adjusted burden estimates
will be submitted to OMB for approval under control number 0938-1314
(CMS-10621).
A variety of organizations will submit Promoting Interoperability
data on behalf of clinicians. Clinicians not participating in a MIPS
APM may submit data as individuals or as part of a group. In the CY
2017 Quality Payment Program final rule (81 FR 77258 through 77260,
77262 through 77264) and CY 2019 PFS final rule (83 FR 59822-59823), we
established that eligible clinicians in MIPS APMs (including the Shared
Savings Program) may report for the Promoting Interoperability
performance category as an APM Entity group, individuals, or a group.
As shown in Table 87, based on data from the 2017 MIPS performance
period, we estimate that a total of 93,863 respondents consisting of
81,358 individual MIPS eligible clinicians and 12,505 groups and
virtual groups will submit Promoting Interoperability data. Similar to
the process shown in Table 71 for groups reporting via QCDR/MIPS CQM
and eCQM collection types, we have adjusted the group reporting data
from the 2017 MIPS performance period to account for virtual groups, as
the option to submit data as a virtual group was not available until
the 2018 MIPS performance period.
Because our respondent estimates are based on the number of actual
submissions received for the Promoting Interoperability performance
category, it is not necessary to account for policies adopted in the CY
2017 Quality Payment Program final rule regarding reweighting, which
state that if a clinician submits Promoting Interoperability data, they
will be scored and the performance category will not be reweighted (81
FR 77238-77245). This approach is identical to the approach we used in
the CY 2019 PFS final rule (83 FR 60013 through 60014), however we
failed to state the distinction in that final rule that we no longer
need to make modifications to our estimates due to the use of actual
MIPS submission data. As established in the CY 2017 and CY 2018 Quality
Payment Program final rules and the CY 2019 PFS final rule, certain
MIPS eligible clinicians will be eligible for automatic reweighting of
the Promoting Interoperability performance category to zero percent,
including MIPS eligible clinicians that are hospital-based, ambulatory
surgical center-based, non-patient facing clinicians, physician
assistants, nurse practitioners, clinician nurse specialists, certified
registered nurse anesthetists, physical therapists; occupational
therapists; qualified speech-language pathologists or qualified
audiologist; clinical psychologists; and registered dieticians or
nutrition professionals (81 FR 77238 through 77245, 82 FR 53680 through
53687, and 83 FR 59819 through 59820, respectively). For the same
reasons discussed above regarding our use of data reflecting the actual
number of Promoting Interoperability data submissions received, these
estimates already account for the reweighting policies in the CY 2017
and CY 2018 Quality Payment Program final rules,
[[Page 40868]]
including exceptions for MIPS eligible clinicians who have experienced
a significant hardship (including clinicians who are in small
practices), as well as exceptions due to decertification of an EHR (81
FR 77240 through 77243 and 82 FR 53680 through 53686).
In section III.K.3.c.(4)(f)(iii), we propose to revise the
definition of a hospital-based MIPS eligible clinician under Sec.
414.1305 to include groups and virtual groups. We propose that,
beginning with the 2022 MIPS payment year, a hospital-based MIPS
eligible clinician under Sec. 414.1305 means an individual MIPS
eligible clinician who furnishes 75 percent or more of his or her
covered professional services in an inpatient hospital, on-campus
outpatient hospital, off campus outpatient hospital, or emergency room
setting based on claims for the MIPS determination period, and a group
or virtual group provided that more than 75 percent of the NPIs billing
under the group's TIN or virtual group's TINs, as applicable, meet the
definition of a hospital-based individual MIPS eligible clinician
during the MIPS determination period. We also propose to revise Sec.
414.1380(c)(2)(iii) to specify that for the Promoting Interoperability
performance category to be reweighted for a MIPS eligible clinician who
elects to participate in MIPS as part of a group or virtual group, all
of the MIPS eligible clinicians in the group or virtual group must
qualify for reweighting, or the group or virtual group must meet the
proposed revised definition of a hospital-based MIPS eligible clinician
or the definition of a non-patient facing MIPS eligible clinician as
defined in Sec. 414.1305. We believe these proposals could result in a
decrease in the number of data submissions for the Promoting
Interoperability performance category, but we do not currently have the
data necessary to determine how many groups would elect to forego
submission. As additional information becomes available in future
years, we will revisit the impact of this policy and adjust our burden
estimates accordingly.
As discussed in section III.K.3.c.(4)(d)(i)(B) of this rule, we
propose to allow clinicians to satisfy the optional bonus Query of PDMP
measure by submitting a ``yes/no'' attestation, rather than reporting a
numerator and denominator. In the CY 2019 PFS final rule, we updated
our burden assumptions from 3 hours to 2.67 hours to reflect the change
from 5 base measures, 9 performance measures, and 4 bonus measures to
the reporting of 4 base measures (83 FR 60013 through 60014). Due to a
lack of data regarding the number of health care providers who would
submit data for bonus Promoting Interoperability measures, we have
consistently been unable to estimate burden related to the reporting of
bonus measures and are therefore unable to account for any change in
burden due to the proposed change to a ``yes/no'' attestation for the
Query of PDMP measure. If we have better data in the future, we may
reassess our burden assumptions and whether we can reasonably quantify
the burden associated with the reporting of bonus measures.
We assume that MIPS eligible clinicians scored under the APM
scoring standard, as described in section III.K.3.c.(5)of this rule,
would continue to submit Promoting Interoperability data the same as in
2017. Each MIPS eligible clinician in an APM Entity reports data for
the Promoting Interoperability performance category through either
their group TIN or individual reporting. In the CY 2019 PFS final rule,
we established that MIPS eligible clinicians who participate in the
Shared Savings Program are no longer limited to reporting for the
Promoting Interoperability performance category through their ACO
participant TIN (83 FR 59822-59823). Burden estimates for this proposed
rule assume group TIN-level reporting as we believe this is the most
reasonable assumption for the Shared Savings Program, which requires
that ACOs include full TIN as ACO participants. As we receive updated
information which reflects the actual number of Promoting
Interoperability data submissions submitted by Shared Savings Program
ACO participants, we will update our burden estimates accordingly.
Table 87--Estimated Number of Respondents To Submit Promoting
Interoperability Performance Data on Behalf of Clinicians
------------------------------------------------------------------------
Number of
respondents
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting 81,358
Interoperability (a)...................................
Number of groups to submit Promoting Interoperability 12,569
(b)....................................................
Subtract: Number of groups to submit Promoting 80
Interoperability on behalf of clinicians in 2020 MIPS
performance period that will submit as virtual groups
(c)....................................................
Add in: Number of virtual groups to submit Promoting 16
Interoperability on behalf of clinicians in 2020 MIPS
performance period (d).................................
Number of groups to submit Promoting Interoperability on 12,505
behalf of clinicians in 2020 MIPS performance period
(e) = (b)-(c) + (d)....................................
---------------
Total Respondents in 2020 MIPS performance period 93,863
(CY 2020 Proposed Rule) (f) = (a) + (e)............
* Total Respondents in 2019 MIPS performance period 93,869
(CY 2019 Final Rule) (g)...........................
---------------
Difference between CY 2020 Proposed Rule and CY -6
2019 Final Rule (h) = (f)-(g)..................
------------------------------------------------------------------------
We estimate the time required for an individual or group to submit
Promoting Interoperability data to be 2.67 hours. As previously
discussed, beginning with the 2021 performance period and for future
years, we propose to require that QCDRs and qualified registries
support three performance categories: Quality, improvement activities,
and Promoting Interoperability. Based on our review of 2019 qualified
registries and QCDRs, we have determined that 70 percent and 72 percent
of these vendors, respectively, already support reporting for these
performance categories. For clinicians who currently utilize qualified
registries or QCDRs that have not previously offered the ability to
report Promoting Interoperability or improvement activity data, we
believe this would result in a reduction of burden as it would simplify
MIPS reporting. In order to estimate the impact on reporting burden, we
would need to correlate the specific individual clinicians and groups
who submitted quality performance category data via the MIPS CQM/QCDR
collection type that are required to report data for both the quality
and Promoting Interoperability performance categories
[[Page 40869]]
with the specific qualified registries or QCDRs that are affected by
this proposal. Currently, we do not have the necessary information to
perform this correlation and are therefore unable to estimate the
resulting impact on burden. If data becomes available in the future
which enables us to perform this analysis, we will update our burden
estimates at that time.
As shown in Table 88, the total burden estimate for submission of
data on the specified Promoting Interoperability objectives and
measures is estimated to be 250,301 hours (93,853 respondents x 2.67
incremental hours for a computer analyst's time above and beyond the
clinician, practice manager, and computer system's analyst time
required to submit quality data) at a cost of $22,532,126 (250,301 hr x
$90.02/hr).
Table 88--Estimated Burden for Promoting Interoperability Performance
Category Data Submission
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting 81,358
Interoperability (a)...................................
Number of groups to submit Promoting Interoperability 12,505
(b)....................................................
Total (c) = (a) + (b)................................... 93,863
Total Annual Hours Per Respondent (b)................... 2.67
---------------
Total Annual Hours (c) = (a) * (b).................. 250,301
---------------
Labor rate for a computer systems analyst to submit $90.02/hr
Promoting Interoperability data (d)....................
---------------
Total Annual Cost (e) = (a) * (d)................... $22,532,126
------------------------------------------------------------------------
As shown in Table 89, using our unchanged currently approved per
respondent burden estimate, the decrease in number of respondents
results in a total adjustment of -16 hours (-6 respondents x 2.67 hr/
respondent) at a cost of -$1,440 (-16 hr x $90.02/hr).
Table 89--Change in Estimated Burden for Promoting Interoperability
Performance Category Data Submission
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 250,317
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 250,301
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -16
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $22,533,566
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $22,532,126
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$1,440
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
g. ICRs Regarding the Nomination of Promoting Interoperability (PI)
Measures
This rule does not propose any new or revised collection of
information requirements related to the nomination of Promoting
Interoperability measures. However, we propose to adjusted our
currently approved burden estimates based on data from the 2018 MIPS
performance period. The adjusted burden estimates will be submitted to
OMB for approval under control number 0938-1314 (CMS-10621).
Consistent with our requests for stakeholder input on quality
measures and improvement activities, we also request potential measures
for the Promoting Interoperability performance category that measure
patient outcomes, emphasize patient safety, support improvement
activities and the quality performance category, and build on the
advanced use of CEHRT using 2015 Edition standards and certification
criteria. Promoting Interoperability measures may be submitted via the
Call for Promoting Interoperability Performance Category Measures
Submission Form that includes the measure description, measure type (if
applicable), reporting requirement, and CEHRT functionality used (if
applicable). This rule does not propose any changes to that form.
We estimate 28 proposals will be submitted for new Promoting
Interoperability measures, based on the number of proposals submitted
during the CY 2018 nomination period. This is a decrease of 19 from the
estimate currently approved by OMB (47 proposals) under the
aforementioned control number. The 2019 Call for Promoting
Interoperability Measures process ends on July 1, 2019; assuming
updated information is available, we will update our estimate in the
final rule. We estimate it will take 0.5 hours per organization to
submit an activity to us, consisting of 0.3 hours at $109.36/hr for a
practice administrator to make a strategic decision to nominate that
activity and submit an activity to us via email and 0.2 hours at
$202.86/hr for a clinician to review the nomination. As shown in Table
90, we estimate an annual burden of 14 hours (28 proposals x 0.5 hr/
response) at a cost of $2,055 (28 x [(0.3 hr x $109.36/hr) + (0.2 hr x
$202.86/hr)].
[[Page 40870]]
Table 90--Estimated Burden for Call for Promoting Interoperability
Measures
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Promoting Interoperability Measure Nominations (a). 28
# of Hours Per Practice Administrator to Identify and 0.30
Propose Measure (b)....................................
# of Hours Per Clinician to Identify Measure (c)........ 0.20
Annual Hours Per Respondent (d) = (b) + (c)............. 0.50
---------------
Total Annual Hours (e) = (a) * (d).................. 14
---------------
Cost to Identify and Submit Measure (@practice $32.81
administrator's labor rate of $109.36/hr) (f)..........
Cost to Identify Improvement Measure (@physician's labor $40.57
rate of $202.86/hr) (g)................................
---------------
Total Annual Cost Per Respondent (h) = (f) + (g).... $73.38
---------------
Total Annual Cost (i) = (a) * (h)............... $2,055
------------------------------------------------------------------------
As shown in Table 91, using our unchanged currently approved per
respondent burden estimate, the decrease in the number of respondents
results in an adjustment of -9.5 hours at a cost of -$1,394 (-19
respondents x 0.5 hr x $73.38 per respondent).
Table 91--Change in Estimated Burden for Call for Promoting
Interoperability Measures
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 23.5
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 14
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -9.5
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $3,449
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $2.055
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$1,394
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
h. ICRs Regarding Improvement Activities Submission (Sec. Sec.
414.1305, 414.1355, 414.1360, and 414.1365)
This rule does not propose any new or revised collection of
information requirements related to the submission of Improvement
Activities data. However, we propose to adjust our currently approved
burden estimates based on more recent data. The adjusted burden will be
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
As discussed in section III.K.3.c.(3)(d)(iii) of this rule, we are
proposing, beginning with the 2020 MIPS performance period and for
future years, to increase the minimum number of clinicians in a group
or virtual group who are required to perform an improvement activity
from at least one clinician to at least 50 percent of the NPIs billing
under the group's TIN or virtual group's TINs, as applicable; and these
NPIs must perform the same activity for the same continuous 90 days in
the performance period. Because eligible clinicians are able to attest
to improvement activity measures at the group level, there is no impact
on reporting burden as a result of this proposal.
As previously discussed, beginning with the 2021 performance period
and for future years, we are proposing to require QCDRs and qualified
registries to support three performance categories: Quality,
improvement activities, and Promoting Interoperability; our discussion
of burden for submitting Promoting Interoperability data in section
IV.B.7.(f).(3) noted our inability to account for the reduction in
burden associated with the proposal. Consistent with our decision not
to change our per respondent burden estimate to submit Promoting
Interoperability data, we are not changing our per respondent burden
estimate to submit improvement activity data as a result of this
proposal.
Furthermore, as discussed in section III.K.3.c.(3)(e)(i) of this
rule, we are proposing to establish removal factors to consider when
proposing to remove improvement activities from the Inventory. However,
we do not believe this would affect reporting burden, because
respondents would still be required submit the same number of
improvement activities and this proposal would not require respondents
to submit any additional information. We are also proposing for the CY
2020 performance period and future years to: Add 2 new improvement
activities, modify 7 existing improvement activities, and remove 15
existing improvement activities. Because MIPS eligible clinicians are
still required to submit the same number of activities, we do not
expect these proposals to affect our currently approved burden
estimates. In addition, in order for an eligible clinician or group to
receive credit for being a patient-centered medical home or comparable
specialty practice, the eligible clinician or group must attest in the
same manner as any other improvement activity.
While our proposals do not add additional reporting burden, we have
adjusted our currently approved burden estimates based on more recent
data. The adjusted burden will be submitted to OMB for approval under
control number 0938-1314 (CMS-10621).
The CY 2018 Quality Payment Program final rule provides: (1) That
for activities that are performed for at least a continuous 90 days
during the performance period, MIPS eligible clinicians must submit a
``yes'' response
[[Page 40871]]
for activities within the Improvement Activities Inventory (82 FR
53651); (2) that the term ``recognized'' is accepted as equivalent to
the term ``certified'' when referring to the requirements for a
patient-centered medical home to receive full credit for the
improvement activities performance category for MIPS (82 FR 53649); and
(3) that for the 2020 MIPS payment year and future years, to receive
full credit as a certified or recognized patient-centered medical home
or comparable specialty practice, at least 50 percent of the practice
sites within the TIN must be recognized as a patient-centered medical
home or comparable specialty practice (82 FR 53655).
In the CY 2017 Quality Payment Program final rule, we described how
we determine MIPS APM scores (81 FR 77185). We compare the requirements
of the specific MIPS APM with the list of activities in the Improvement
Activities Inventory and score those activities in the same manner that
they are otherwise scored for MIPS eligible clinicians (81 FR 77817
through 77831). If, based on our assessment, the MIPS APM does not
receive the maximum improvement activities performance category score,
then the APM Entity can submit additional improvement activities. We
anticipate that MIPS APMs in the 2019 MIPS performance period will not
need to submit additional improvement activities as the models will
already meet the maximum improvement activities performance category
score.
A variety of organizations and in some cases, individual
clinicians, will submit improvement activity performance category data.
For clinicians who are not part of APMs, we assume that clinicians
submitting quality data as part of a group through direct, log in and
upload submission types, and CMS Web Interface will also submit
improvement activities data. In the 2019 and prior MIPS performance
periods, individuals and groups submitting data for the quality
performance category through a MIPS CQM or QCDR that did not also
support reporting of data for the Promoting Interoperability or
improvement activity performance categories would be required to submit
data for these performance categories using an alternate submission
type, the proposals discussed in sections III.K.3.g.(3)(a)(i) and
III.K.3.g.(4)(a)(i) of this rule requiring qualified registries and
QCDRs to support the reporting of quality, improvement activities, and
Promoting Interoperability performance categories would help to
alleviate this issue. As finalized in the CY 2017 Quality Payment
Program final rule (81 FR 77264), APM Entities only need to report
improvement activities data if the CMS-assigned improvement activities
score is below the maximum improvement activities score. Our CY 2018
Quality Payment Program final rule burden estimates assumed that all
APM Entities will receive the maximum CMS-assigned improvement
activities score (82 FR 53921 through 53922).
As represented in Table 92, based on 2017 MIPS performance period
data, we estimate that 102,754 clinicians will submit improvement
activities as individuals during the 2020 MIPS performance period and
15,761 groups will submit improvement activities on behalf of
clinicians. Similar to the process shown in Table 87 for groups
submitting Promoting Interoperability data, we have adjusted the group
reporting data from the 2017 MIPS performance period to account for
virtual groups, as the option to submit data as a virtual group was not
available until the 2018 MIPS performance period. In addition, as
previously discussed regarding our estimate of clinicians and groups
submitting data for the quality and Promoting Interoperability
performance categories, we have updated our estimates for the number of
clinicians and groups that will submit improvement activities data
based on projections of the number of eligible clinicians that were not
QPs or members of an APM in the 2017 MIPS performance period but will
be in the 2019 MIPS performance period, and would therefore not be
required to submit improvement activities data.
Our burden estimates assume there will be no improvement activities
burden for MIPS APM participants. We will assign the improvement
activities performance category score at the APM Entity level. We also
assume that the MIPS APM models for the 2020 MIPS performance period
will qualify for the maximum improvement activities performance
category score and, as such, APM Entities will not submit any
additional improvement activities.
Table 92--Estimated Numbers of Organizations Submitting Improvement
Activities Performance Category Data on Behalf of Clinicians
------------------------------------------------------------------------
Count
------------------------------------------------------------------------
# of clinicians to participate in improvement activities 102,754
data submission as individuals during the 2020 MIPS
performance period (a).................................
# of Groups to submit improvement activities on behalf 15,825
of clinicians during the 2020 MIPS performance period
(b)....................................................
Subtract: # of groups to submit improvement activities 80
on behalf of clinicians in 2020 MIPS performance period
that will submit as virtual groups (c).................
Add in: # of Virtual Groups to submit improvement 16
activities on behalf of clinicians during the 2020 MIPS
performance period (d).................................
# of Groups and Virtual Groups to submit improvement 15,761
activities on behalf of clinicians during the 2020 MIPS
performance period (e).................................
---------------
Total # of Respondents (Groups, Virtual Groups, and 118,515
Individual Clinicians) to submit improvement
activities data on behalf of clinicians during the
2020 MIPS performance period (CY 2020 Proposed
Rule) (f) = (a) + (b) + (e)........................
---------------
* Total # of Respondents (Groups, Virtual Groups, 136,004
and Individual Clinicians) to submit improvement
activities data on behalf of clinicians during the
2019 MIPS performance period (CY 2019 Final Rule)
(g)................................................
---------------
Difference between CY 2020 Proposed Rule and CY -17,489
2019 Final Rule (h) = (g)-(f)..................
------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).
Consistent with the CY 2019 PFS final rule, we estimate that the
per response time required per individual or group is 5 minutes at
$90.02/hr for a computer system analyst to submit by logging in and
manually attesting that certain activities were performed in the form
and manner specified by CMS with a set
[[Page 40872]]
of authenticated credentials (83 FR 60016).
As shown in Table 93, we estimate an annual burden of 9,876 hours
(118,515 responses x 5 minutes/60) at a cost of $889,060 (9,876.25 hr x
$90.02/hr).
Table 93--Estimated Burden for Improvement Activities Submission
------------------------------------------------------------------------
Burden estimate
------------------------------------------------------------------------
Total # of Respondents (Groups, Virtual 118,515.
Groups, and Individual Clinicians) to
submit improvement activities data on
behalf of clinicians during the 2019
MIPS performance period (a).
Total Annual Hours Per Respondent (b).... 5 minutes.
Total Annual Hours (c)................... 9,876.25.
Labor rate for a computer systems analyst $90.02/hr.
to submit improvement activities (d).
------------------------------
Total Annual Cost (e) = (a) * (d).... $889,060.
------------------------------------------------------------------------
As shown in Table 94, using our unchanged currently approved per
respondent burden estimate, the decrease in the number of respondents
results in an adjustment of -1,457 hours (-17,489 responses x 5
minutes/60) at a cost of -$131,197 (-1,457 hr $90.02/hr).
Table 94--Change in Estimated Burden for Improvement Activities
Submission
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 11,334
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 9,876
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -1,457
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $1,020,257
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $889,060
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$131,197
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
i. ICRs Regarding the Nomination of Improvement Activities (Sec.
414.1360)
This rule does not include any new or revised reporting,
recordkeeping, or third-party disclosure requirements related to the
nomination of improvement activities. However, we have adjusted our
currently approved burden estimates based on data from the 2018 MIPS
performance period. The adjusted burden estimates will be submitted to
OMB for approval under control number 0938-1314 (CMS-10621).
In the CY 2018 Quality Payment Program final rule, for the 2018 and
future MIPS performance periods, stakeholders were provided an
opportunity to propose new activities formally via the Annual Call for
Activities nomination form that was posted on the CMS website (82 FR
53657). The 2018 Annual Call for Activities lasted from February 1,
2018 through March 1, 2018, during which we received 128 nominations of
activities which were evaluated for the Improvement Activities Under
Consideration (IAUC) list for possible inclusion in the CY 2019
Improvement Activities Inventory. Based on the number of improvement
activity nominations received in the CY 2018 Annual Call for
Activities, we estimate that we will receive 128 nominations for the
2020 Annual Call for Activities, which is an increase of 3 from the 125
nominations currently approved by OMB. The 2019 Annual Call for
Activities ends on July 1, 2019; assuming updated information is
available, we will update our estimate in the final rule.
We estimate 1.2 hours at $109.36/hr for a practice administrator or
equivalent to make a strategic decision to nominate and submit that
activity and 0.8 hours at $202.86/hr for a clinician's review. As shown
in Table 95, we estimate an annual burden of 256 hours (128 nominations
x 2 hr/nomination) at a cost of $37,571 (128 x [(1.2 hr x $109.36/hr) +
(0.8 hr x $202.86/hr)]).
Table 95--Estimated Burden for Nomination of Improvement Activities
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Nominations of New Improvement Activities (a)...... 128
# of Hours Per Practice Administrator to Identify and 1.2
Propose Activity (b)...................................
# of Hours Per Clinician to Identify Activity (c)....... 0.8
Annual Hours Per Respondent (d) = (b) + (c)............. 2
---------------
Total Annual Hours (e) = (a) * (d).................. 256
---------------
Cost to Identify and Submit Activity (@practice $131.23
administrator's labor rate of $109.36/hr) (f)..........
Cost to Identify Improvement Activity (@physician's $162.29
labor rate of $202.86/hr) (g)..........................
---------------
[[Page 40873]]
Total Annual Cost Per Respondent (h) = (f) + (g).... $293.52
---------------
Total Annual Cost (i) = (a) * (h)............... $37,571
------------------------------------------------------------------------
As shown in Table 96, using our unchanged currently approved per
respondent burden estimate, the increase in the number of nominations
results in an adjustment of 6 hours at a cost of $881 {3 activities x
[(1.2 hr x $109.36/hr) + (0.8 hr x $202.86/hr)]{time} .
Table 96--Change in Estimated Burden for Nomination of Improvement
Activities
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 250
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 256
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 6
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $36,690
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $37,571
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 $881
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
j. ICRs Regarding the Cost Performance Category (Sec. 414.1350)
The cost performance category relies on administrative claims data.
The Medicare Parts A and B claims submission process (OMB control
number 0938-1197; CMS-1500 and CMS-1490S) is used to collect data on
cost measures from MIPS eligible clinicians. MIPS eligible clinicians
are not required to provide any documentation by CD or hardcopy,
including for the 10 episode-based measures we are proposing to include
in the cost performance category as discussed in section
III.K.3.c.(2)(b)(iii) of this rule. Moreover, the provisions of this
proposed rule do not result in the need to add or revise or delete any
claims data fields. Therefore, we are not proposing any new or revised
collection of information requirements or burden for MIPS eligible
clinicians resulting from the cost performance category.
k. Quality Payment Program ICRs Regarding Partial QP Elections
(Sec. Sec. 414.1310(b)(ii) and 414.1430)
This rule does not propose any new or revised collection of
information requirements related to the Partial QP Elections to
participate in MIPS as a MIPS eligible clinician. However, we propose
to adjust our currently approved burden estimates based on updated
projections for the 2020 MIPS performance period. The adjusted burden
will be submitted to OMB for approval under control number 0938-1314
(CMS-10621).
In section III.K.4.d.(2)(b), we propose that, beginning for
eligible clinicians who become Partial QPs in the 2020 MIPS performance
period, Partial QP status will only apply to the TIN/NPI combination
through which Partial QP status is attained. Any Partial QP election
will only apply to TIN/NPI combination through which Partial QP status
is attained so that an eligible clinician who is a Partial QP for only
one TIN/NPI combination may still report under MIPS for other TIN/NPI
combinations. This proposal will potentially increase the total number
of Partial QP elections to participate in MIPS if clinicians achieve
Partial QP status under multiple TIN/NPI combinations.
As shown in Table 97, based on our predictive QP analysis for the
2020 QP performance period, which accounts for the increase in QP and
Partial QP thresholds, we estimate that 12 APM Entities and 2,010
eligible clinicians will make the election to participate as a Partial
QP in MIPS representing approximately 15,500 Partial QPs, an increase
of 1,941 from the 81 elections currently approved by OMB under the
aforementioned control number. We estimate it will take the APM Entity
representative or eligible clinician 15 minutes (0.25 hr) to make this
election. In aggregate, we estimate an annual burden of 505.5 hours
(2,022 respondents x .25 hr/election) at a cost of $45,080 (505.5 hours
x $90.02/hr).
Table 97--Estimated Burden for Partial QP Election
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of respondents making Partial QP election (6 APM 2,022
Entities, 75 eligible clinicians) (a)..................
Total Hours Per Respondent to Elect to Participate as 0.25
Partial QP (b).........................................
Total Annual Hours (c) = (a) * (b)...................... 505.5
Labor rate for computer systems analyst (d)............. $90.02/hr
---------------
Total Annual Cost (d) = (c) * (d)................... $45,505
------------------------------------------------------------------------
[[Page 40874]]
As shown in Table 98, using our unchanged currently approved per
respondent burden estimate, the increase in the number of Partial QP
elections results in an adjustment of 485.25 (1,941 elections x 0.25hr)
at a cost of $43,682 (485.25 hr x $90.02/hr).
Table 98--Change in Estimated Burden for Partial QP Election
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 20.25
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 505.5
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 485.25
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $1,823
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $45,505
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 $43,682
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
l. ICRs Regarding Other Payer Advanced APM Determinations: Payer-
Initiated Process (Sec. 414.1440) and Eligible Clinician Initiated
Process (Sec. 414.1445)
As indicated below, the proposed requirements and burden discussed
under this section will be submitted to OMB for approval under control
number 0938-1314 (CMS-10621).
(1) Payer Initiated Process (Sec. 414.1440)
This rule does not propose any new or revised collection of
information requirements related to the Payer-Initiated Process.
However, we propose to adjust our currently approved burden estimates
based on updated projections for the 2020 MIPS performance period. As
mentioned above, the adjusted burden will be submitted to OMB for
approval.
As shown in Table 99, based on the actual number of requests
received in the 2018 QP performance period, we estimate that in CY 2020
for the 2021 QP performance period 110 payer-initiated requests for
Other Payer Advanced APM determinations will be submitted (10 Medicaid
payers, 50 Medicare Advantage Organizations, and 50 remaining other
payers), a decrease of 105 from the 215 total requests currently
approved by OMB under the aforementioned control number. We estimate it
will take 10 hours at $90.02/hr for a computer system analyst per
arrangement submission. In aggregate, we estimate an annual burden of
1,100 hours (110 submissions x 10 hr/submission) at a cost of $99,022
(1,100 hr x $90.02/hr).
Table 99--Estimated Burden for Other Payer Advanced APM Identification
Determinations: Payer-Initiated Process
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of other payer payment arrangements (15 Medicaid, 100 110
Medicare Advantage Organizations, 100 remaining other
payers) (a)............................................
Total Annual Hours Per other payer payment arrangement 10
(b)....................................................
---------------
Total Annual Hours (c) = (a) * (b).................. 1,100
---------------
Labor rate for a computer systems analyst (d)........... $90.02/hr
---------------
Total Annual Cost for Other Payer Advanced APM $99,022
determinations (e) = (a) * (d).....................
------------------------------------------------------------------------
As shown in Table 100, using our unchanged currently approved per
respondent burden estimate, the decrease in the number of payer-
initiated requests from 215 to 110 results in an adjustment of -1,050
hours (-105 requests x 10 hr) at a cost of -$94,521 (-1,050 hr x
$90.02/hr).
Table 100--Change in Estimated Burden for Other Payer Advanced APM
Identification Determinations: Payer-Initiated Process
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 2,150
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 1,100
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -1,050
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $193,543
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $99,022
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$94,521
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
[[Page 40875]]
(2) Eligible Clinician Initiated Process (Sec. 414.1445)
This rule does not propose any new or revised collection of
information requirements or burden related to the Eligible-Clinician
Initiated Process. The requirements and burden are currently approved
by OMB under control number 0938-1314 (CMS-10621). Consequently, we are
not proposing any changes to under that control number.
(3) Submission of Data for QP Determinations Under the All-Payer
Combination Option (Sec. 414.1440)
This rule does not propose any new or revised collection of
information requirements related to the Submission of Data for QP
Determinations under the All-Payer Combination Option. However, we
propose to adjust our currently approved burden estimates based on
updated projections for the 2020 MIPS performance period. The adjusted
burden will be submitted to OMB for approval under control number 0938-
1314 (CMS-10621).
The CY 2017 Quality Payment Program final rule provided that either
APM Entities or individual eligible clinicians must submit by a date
and in a manner determined by us: (1) Payment arrangement information
necessary to assess whether each other payer arrangement is an Other
Payer Advanced APM, including information on financial risk
arrangements, use of CEHRT, and payment tied to quality measures; (2)
for each payment arrangement, the amounts of payments for services
furnished through the arrangement, the total payments from the payer,
the numbers of patients furnished any service through the arrangement
(that is, patients for whom the eligible clinician is at risk if actual
expenditures exceed expected expenditures), and (3) the total number of
patients furnished any service through the arrangement (81 FR 77480).
The rule also specified that if we do not receive sufficient
information to complete our evaluation of another payer arrangement and
to make QP determinations for an eligible clinician using the All-Payer
Combination Option, we will not assess the eligible clinicians under
the All-Payer Combination Option (81 FR 77480).
In the CY 2018 Quality Payment Program final rule, we explained
that in order for us to make QP determinations under the All-Payer
Combination Option using either the payment amount or patient count
method, we will need to receive all of the payment amount and patient
count information: (1) Attributable to the eligible clinician or APM
Entity through every Other Payer Advanced APM; and (2) for all other
payments or patients, except from excluded payers, made or attributed
to the eligible clinician during the QP performance period (82 FR
53885). We also finalized that eligible clinicians and APM Entities
will not need to submit Medicare payment or patient information for QP
determinations under the All-Payer Combination Option (82 FR 53885).
The CY 2018 Quality Payment Program final rule also noted that we
will need this payment amount and patient count information for the
periods January 1 through March 31, January 1 through June 30, and
January 1 through August 31 (82 FR 53885). We noted that the timing may
be challenging for APM Entities or eligible clinicians to submit
information for the August 31 snapshot date. If we receive information
for either the March 31 or June 30 snapshots, but not the August 31
snapshot, we will use that information to make QP determinations under
the All-Payer Combination Option. This payment amount and patient count
information is to be submitted in a way that allows us to distinguish
information from January 1 through March 31, January 1 through June 30,
and January 1 through August 31 so that we can make QP determinations
based on the two finalized snapshot dates (82 FR 30203 through 30204).
The CY 2018 Quality Payment Program final rule specified that APM
Entities or eligible clinicians must submit all of the required
information about the Other Payer Advanced APMs in which they
participate, including those for which there is a pending request for
an Other Payer Advanced APM determination, as well as the payment
amount and patient count information sufficient for us to make QP
determinations by December 1 of the calendar year that is 2 years to
prior to the payment year, which we refer to as the QP Determination
Submission Deadline (82 FR 53886).
In the CY 2019 PFS final rule, we finalized the addition of a third
alternative to allow QP determinations at the TIN level in instances
where all clinicians who have reassigned billing rights to the TIN
participate in a single (the same) APM Entity (83 FR 59936). This
option will therefore be available to all TINs participating in Full
TIN APMs, such as the Medicare Shared Savings Program. It will also be
available to any other TIN for which all clinicians who have reassigned
billing rights to the TIN are participating in a single APM Entity. To
make QP determinations under the All-Payer Combination Option at the
TIN level as finalized using either the payment amount or patient count
method, we will need to receive, by December 1 of the calendar year
that is 2 years to prior to the payment year, all of the payment amount
and patient count information: (1) Attributable to the eligible
clinician, TIN, or APM Entity through every Other Payer Advanced APM;
and (2) for all other payments or patients, except from excluded
payers, made or attributed to the eligible clinician(s) during the QP
performance period for the periods January 1 through March 31, January
1 through June 30, and January 1 through August 31.
As shown in Table 101, we assume that 20 APM Entities, 448 TINs,
and 83 eligible clinicians will submit data for QP determinations under
the All-Payer Combination Option in 2019, and increase of 242 from the
309 total submissions currently approved by OMB under the
aforementioned control number. We estimate it will take the APM Entity
representative, TIN representative, or eligible clinician 5 hours at
$109.36/hr for a practice administrator to complete this submission. In
aggregate, we estimate an annual burden of 2,755 hours (551 respondents
x 5 hr) at a cost of $301,287 (2,755 hr x $109.36/hr).
Table 101--Estimated Burden for the Submission of Data for All-Payer QP
Determinations
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of APM Entities submitting data for All-Payer QP 20
Determinations (a).....................................
# of TINs submitting data for All-Payer QP 448
Determinations (b).....................................
# of eligible submitting data for All-Payer QP 83
Determinations (c).....................................
Hours Per respondent QP Determinations (d).............. 5
Total Hours (g) = [(a) *(d)] + [(b) * (d)] + [(c) * (d)] 2,755
[[Page 40876]]
Labor rate for a Practice Administrator (h)............. $109.36/hr
---------------
Total Annual Cost for Submission of Data for All- $301,287
Payer QP Determinations (i) = (g) * (h)............
------------------------------------------------------------------------
As shown in Table 102, using our unchanged currently approved per
respondent burden estimate, the increase in the number of data
submissions from 309 to 551 results in an adjustment of 1,210 hours
(242 requests x 5 hr) at a cost of $132,326 (1,210 hr x $109.36/hr).
Table 102--Change in Estimated Burden for the Submission of Data for All-
Payer QP Determinations
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 1,545
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 2,755
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 1,210
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $168,961
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $301,287
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 $132,326
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
m. ICRs Regarding Voluntary Participants Election To Opt-Out of
Performance Data Display on Physician Compare (Sec. 414.1395)
This rule does not propose any new or revised collection of
information requirements related to the election by voluntary
participants to opt-out of public reporting on Physician Compare.
However, we propose to adjust our currently approved burden estimates
based on data from the 2018 MIPS performance period. The adjusted
burden will be submitted to OMB for approval under control number 0938-
1314 (CMS-10621). Subject to renewal, the control number is currently
set to expire on January 31, 2022. It was last approved on January 29,
2019, and remains active.
We estimate that 10 percent of the total clinicians and groups who
will voluntarily participate in MIPS will also elect not to participate
in public reporting. This results in a total of 11,516 (0.10 x 115,163
voluntary MIPS participants) clinicians and groups, a decrease of 101
from the currently approved estimate of 11,617. This decrease is due to
the availability of updated estimates of QPs and APM participation for
the 2020 performance period. Voluntary MIPS participants are clinicians
that are not QPs and are expected to be excluded from MIPS after
applying the eligibility requirements set out in the CY 2019 PFS final
rule but have elected to submit data to MIPS. As discussed in the
Regulatory Impact Analysis section of the CY 2019 PFS final rule, we
estimate that 33 percent of clinicians that exceed one (1) of the low-
volume criteria, but not all three (3), will elect to opt-in to MIPS,
become MIPS eligible, and no longer be considered a voluntary reporter
(83 FR 60050).
In section III.K.3.h.(6) of this rule, we propose to publicly
report (1) an indicator if a MIPS eligible clinician is scored using
facility-based measurement beginning with Year 3 (2019 performance
information available for public reporting in late 2020) and (2)
aggregate MIPS data beginning with Year 2 (2018 performance information
available for public reporting in late 2019). We believe it is possible
that the percentage of voluntary participants electing not to
participate in public reporting may change as a result of this
proposals, we lack the ability to predict the behavior of clinicians'
response to this proposal. Table 103 shows that for these voluntary
participants, we estimate it will take 0.25 hours at $90.02/hr for a
computer system analyst to submit a request to opt-out. In aggregate,
we estimate an annual burden of 2,879 hours (11,516 requests x 0.25 hr/
request) at a cost of $259,168 (2,879 hr x $90.02/hr).
Table 103--Estimated Burden for Voluntary Participants To Elect Opt Out
of Performance Data Display on Physician Compare
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
# of Voluntary Participants Opting Out of Physician 11,516
Compare (a)............................................
Total Annual Hours per Opt-out Requester (b)............ 0.25
---------------
Total Annual Hours for Opt-out Requester (c) = (a) * 2,879
(b)................................................
---------------
Labor rate for a computer systems analyst (d)........... $90.02/hr
---------------
Total Annual Cost for Opt-out Requests (e) = (a) * $259,168
(d)................................................
------------------------------------------------------------------------
[[Page 40877]]
As shown in Table 104, using our unchanged currently approved per
respondent burden estimate, the decrease in the number of opt outs by
voluntary participants from 11,617 to 11,516 results in an adjustment
of 25.25 hours (101 requests x 0.25 hr) at a cost of -$2,273 (25.25 hr
x $90.02/hr).
Table 104--Change in Estimated Burden for Voluntary Participants To
Elect Opt Out of Performance Data Display on Physician Compare
------------------------------------------------------------------------
Burden
estimate
------------------------------------------------------------------------
Total Annual Hours for Respondents in CY 2019 Final Rule 2,904.25
(a)....................................................
Total Annual Hours for Respondents in CY 2020 Proposed 2,879.00
Rule (b)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -25.25
Final Rule (c) = (b)-(a)...........................
---------------
Total Annual Cost for Respondents in CY 2019 Final Rule $261,441
(d)....................................................
Total Annual Cost for Respondents in CY 2020 Proposed $259,168
Rule (e)...............................................
---------------
Difference Between CY 2020 Proposed Rule and CY 2019 -$2,273
Final Rule (f) = (e)-(d)...........................
------------------------------------------------------------------------
n. Summary of Annual Quality Payment Program Burden Estimates
Table 105 summarizes this proposed rule's burden estimates for the
Quality Payment Program. To understand the burden implications of the
policies proposed in this rule, we have also estimated a baseline
burden of continuing the policies and information collections set forth
in the CY 2019 PFS final rule into the 2020 MIPS performance period.
Our estimated baseline burden estimates reflect the availability of
more accurate data to account for all potential respondents and
submissions across all the performance categories, more accurately
reflect the exclusion of QPs from all MIPS performance categories, and
better estimate the number of third-parties likely to self-nominate as
qualified registries and QCDRs, as well as the number of measures
submitted per QCDR. The baseline burden estimate is 3,312,523 hours at
a cost of $315,630,967. This baseline burden estimate is lower than the
burden approved for information collection related to the CY 2019 PFS
final rule due to updated data and assumptions. The difference of 1,619
hours and $147,173 between this baseline estimate and the total burden
shown in Tables 105 and 107 is the burden associated with the proposals
to require QCDRs to submit measure testing data to require proposed
quality measures and QCDR measures to be linked to existing cost
measures, improvement activities, and MIPS Value Pathways, if possible
at the time of self-nomination and to describe the quality improvements
services they intend to support.
[[Page 40878]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.097
Table 106 provides the reasons for changes in the estimated burden
for information collections in the Quality Payment Program segment of
this proposed rule. We have divided the reasons for our change in
burden into those related to new policies and those related to
adjustments in burden from continued Quality Payment Program Year 3
policies that reflect updated data and revised methods.
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C. Summary of Annual Burden Estimates for Proposed Requirements
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D. Submission of Comments
We have submitted a copy of this rule to OMB for its review of the
rule's proposed information collection requirements and burden. The
requirements are not effective until they have been approved by OMB.
To obtain copies of the supporting statement and any related forms
for the proposed collections previously discussed, please visit CMS's
website at https://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html, or call the Reports
Clearance Office at (410) 786-1326.
We invite public comments on the proposed information collection
requirements and burden. If you wish to comment, please submit your
comments electronically as specified in the DATES and ADDRESSES
sections of this proposed rule and identify the rule (CMS-1715-P) and
where applicable the ICR's CFR citation, CMS ID number, and OMB control
number.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
VI. Regulatory Impact Analysis
A. Statement of Need
This proposed rule makes payment and policy changes under the
Medicare PFS and implements required statutory changes under the
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the
Achieving a Better Life Experience Act (ABLE), the Protecting Access to
Medicare Act of 2014 (PAMA), section 603 of the Bipartisan Budget Act
of 2015, the Consolidated Appropriations Act of 2016, the Bipartisan
Budget Act of 2018, and sections 2005 6063, and 6111 of the SUPPORT for
Patients and Communities Act of 2018. This proposed rule also makes
changes to payment policy and other related policies for Medicare Part
B.
This proposed rule is necessary to make policy changes under
Medicare fee-for-service. Therefore, we included a detailed regulatory
impact analysis (RIA) to assess all costs and benefits of available
regulatory alternatives and explained the selection of these regulatory
approaches that we believe adhere to statutory requirements and, to the
extent feasible, maximize net benefits.
B. Overall Impact
We examined the impact of this rule as required by Executive Order
12866 on Regulatory Planning and Review (September 30, 1993), Executive
Order 13563 on Improving Regulation and Regulatory Review (February 2,
2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.
L. 96-354), section 1102(b) of the Social Security Act, section 202 of
the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-
4), Executive Order 13132 on Federalism (August 4, 1999), the
Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771
on Reducing Regulation and Controlling Regulatory Costs (January 30,
2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). An RIA
must be prepared for major rules with economically significant effects
($100 million or more in any 1 year). We estimated, as discussed in
this section, that the PFS provisions included in this proposed rule
would redistribute more than $100 million in 1 year. Therefore, we
estimate that this rulemaking is ``economically significant'' as
measured by the $100 million threshold, and hence also a major rule
under the Congressional Review Act. Accordingly, we prepared an RIA
that, to the best of our ability, presents the costs and benefits of
the rulemaking. The RFA requires agencies to analyze options for
regulatory relief of small entities. For purposes of the RFA, small
entities include small businesses, nonprofit organizations, and small
governmental jurisdictions. Most hospitals, practitioners and most
other
[[Page 40882]]
providers and suppliers are small entities, either by nonprofit status
or by having annual revenues that qualify for small business status
under the Small Business Administration standards. (For details, see
the SBA's website at http://www.sba.gov/content/table-small-business-size-standards (refer to the 620000 series)). Individuals and states
are not included in the definition of a small entity.
The RFA requires that we analyze regulatory options for small
businesses and other entities. We prepare a regulatory flexibility
analysis unless we certify that a rule would not have a significant
economic impact on a substantial number of small entities. The analysis
must include a justification concerning the reason action is being
taken, the kinds and number of small entities the rule affects, and an
explanation of any meaningful options that achieve the objectives with
less significant adverse economic impact on the small entities.
Approximately 95 percent of practitioners, other providers, and
suppliers are considered to be small entities, based upon the SBA
standards. There are over 1 million physicians, other practitioners,
and medical suppliers that receive Medicare payment under the PFS.
Because many of the affected entities are small entities, the analysis
and discussion provided in this section, as well as elsewhere in this
proposed rule is intended to comply with the RFA requirements regarding
significant impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare an
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 603 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area for Medicare
payment regulations and has fewer than 100 beds. The PFS does not
reimburse for services provided by rural hospitals; the PFS pays for
physicians' services, which can be furnished by physicians and non-
physician practitioners in a variety of settings, including rural
hospitals. We did not prepare an analysis for section 1102(b) of the
Act because we determined, and the Secretary certified, that this
proposed rule would not have a significant impact on the operations of
a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits on state,
local, or tribal governments or on the private sector before issuing
any rule whose mandates require spending in any 1 year of $100 million
in 1995 dollars, updated annually for inflation. In 2019, that
threshold is approximately $154 million. This proposed rule will impose
no mandates on state, local, or tribal governments or on the private
sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule (and subsequent final
rule) that imposes substantial direct requirement costs on state and
local governments, preempts state law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on state
or local governments, the requirements of Executive Order 13132 are not
applicable.
Executive Order 13771, entitled ``Reducing Regulation and
Controlling Regulatory Costs,'' was issued on January 30, 2017 and
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.''
This proposed rule, if finalized, is considered an E.O. 13771
regulatory action. We estimate the rule generates $3.46 million in
annualized costs in 2016 dollars, discounted at 7 percent relative to
year 2016 over a perpetual time horizon. Details on the estimated costs
of this rule can be found in the preceding and subsequent analyses.
We prepared the following analysis, which together with the
information provided in the rest of this preamble, meets all assessment
requirements. The analysis explains the rationale for and purposes of
this proposed rule; details the costs and benefits of the rule;
analyzes alternatives; and presents the measures we would use to
minimize the burden on small entities. As indicated elsewhere in this
proposed rule, we are proposing a variety of changes to our
regulations, payments, or payment policies to ensure that our payment
systems reflect changes in medical practice and the relative value of
services, and implementing statutory provisions. We provide information
for each of the policy changes in the relevant sections of this
proposed rule. We are unaware of any relevant federal rules that
duplicate, overlap, or conflict with this proposed rule. The relevant
sections of this proposed rule contain a description of significant
alternatives if applicable.
C. Changes in Relative Value Unit (RVU) Impacts
1. Resource-Based Work, PE, and MP RVUs
Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or
decreases in RVUs may not cause the amount of expenditures for the year
to differ by more than $20 million from what expenditures would have
been in the absence of these changes. If this threshold is exceeded, we
make adjustments to preserve budget neutrality.
Our estimates of changes in Medicare expenditures for PFS services
compared payment rates for CY 2019 with payment rates for CY 2020 using
CY 2018 Medicare utilization. The payment impacts in this proposed rule
reflect averages by specialty based on Medicare utilization. The
payment impact for an individual practitioner could vary from the
average and would depend on the mix of services he or she furnishes.
The average percentage change in total revenues will be less than the
impact displayed here because practitioners and other entities
generally furnish services to both Medicare and non-Medicare patients.
In addition, practitioners and other entities may receive substantial
Medicare revenues for services under other Medicare payment systems.
For instance, independent laboratories receive approximately 83 percent
of their Medicare revenues from clinical laboratory services that are
paid under the Clinical Laboratory Fee Schedule (CLFS).
The annual update to the PFS conversion factor (CF) was previously
calculated based on a statutory formula; for details about this
formula, we refer readers to the CY 2015 PFS final rule with comment
period (79 FR 67741 through 67742). Section 101(a) of the MACRA
repealed the previous statutory update formula and amended section
1848(d) of the Act to specify the update adjustment factors for CY 2015
and beyond. The update adjustment factor for CY 2020, as required by
section 53106 of the Bipartisan Budget Act of 2018, is 0.00 percent
before applying other adjustments.
To calculate the proposed CY 2020 CF, we multiplied the product of
the current year CF and the update adjustment factor by the budget
neutrality adjustment described in the preceding paragraphs. We
estimated the CY 2020 PFS CF to be 36.0896 which reflects the budget
neutrality adjustment under section 1848(c)(2)(B)(ii)(II) of the Act
and the 0.00 percent update adjustment factor specified under
[[Page 40883]]
section 1848(d)(18) of the Act. We estimate the CY 2020 anesthesia CF
to be 22.2774, which reflects the same overall PFS adjustments with the
addition of anesthesia-specific PE and MP adjustments.
Table 108--Calculation of the Proposed CY 2020 PFS Conversion Factor
------------------------------------------------------------------------
------------------------------------------------------------------------
CY 2019 Conversion Factor...... ....................... 36.0391
Statutory Update Factor........ 0.00 percent (1.0000).. ..............
CY 2020 RVU Budget Neutrality 0.14 percent (1.0014).. ..............
Adjustment.
---------------
CY 2020 Conversion Factor.. ....................... 36.0896
------------------------------------------------------------------------
Table 109--Calculation of the Proposed CY 2020 Anesthesia Conversion
Factor
------------------------------------------------------------------------
------------------------------------------------------------------------
CY 2019 National Average ....................... 22.2730
Anesthesia Conversion Factor.
Statutory Update Factor........ 0.00 percent (1.0000).. ..............
CY 2020 RVU Budget Neutrality 0.14 percent (1.0014).. ..............
Adjustment.
CY 2020 Anesthesia Fee Schedule -0.12 percent (0.9988). ..............
Practice Expense and
Malpractice Adjustment.
---------------
CY 2020 Conversion Factor.. ....................... 22.2774
------------------------------------------------------------------------
Table 110 shows the payment impact on PFS services of the policies
contained in this proposed rule. To the extent that there are year-to-
year changes in the volume and mix of services provided by
practitioners, the actual impact on total Medicare revenues would be
different from those shown in Table 110 (CY 2020 PFS Estimated Impact
on Total Allowed Charges by Specialty). The following is an explanation
of the information represented in Table 110.
Column A (Specialty): Identifies the specialty for which
data are shown.
Column B (Allowed Charges): The aggregate estimated PFS
allowed charges for the specialty based on CY 2018 utilization and CY
2019 rates. That is, allowed charges are the PFS amounts for covered
services and include coinsurance and deductibles (which are the
financial responsibility of the beneficiary). These amounts have been
summed across all services furnished by physicians, practitioners, and
suppliers within a specialty to arrive at the total allowed charges for
the specialty.
Column C (Impact of Work RVU Changes): This column shows
the estimated CY 2020 impact on total allowed charges of the changes in
the work RVUs, including the impact of changes due to potentially
misvalued codes.
Column D (Impact of PE RVU Changes): This column shows the
estimated CY 2020 impact on total allowed charges of the changes in the
PE RVUs.
Column E (Impact of MP RVU Changes): This column shows the
estimated CY 2020 impact on total allowed charges of the changes in the
MP RVUs.
Column F (Combined Impact): This column shows the
estimated CY 2020 combined impact on total allowed charges of all the
changes in the previous columns. Column F may not equal the sum of
columns C, D, and E due to rounding.
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2. CY 2020 PFS Impact Discussion
a. Changes in RVUs
The most widespread specialty impacts of the RVU changes are
generally related to the changes to RVUs for specific services
resulting from the misvalued code initiative, including RVUs for new
and revised codes. The estimated impacts for some specialties,
including clinical social workers, neurology, emergency medicine, and
podiatry reflect increases relative to other physician specialties.
These increases can largely be attributed to finalized increases in
value for particular services following the recommendations from the
American Medical Association (AMA)'s Relative Value Scale Update
Committee and CMS review, increased payments as a result of finalized
updates to supply and equipment pricing, and the continuing
implementation of the adjustment to indirect PE allocation for some
office-based services.
The estimated impacts for several specialties, including
ophthalmology and optometry, reflect decreases in payments relative to
payment to other physician specialties as a result of revaluation of
individual procedures reviewed by the AMA's relative value scale update
committee (RUC) and CMS. The estimated impacts for other specialties,
including vascular surgery, reflect decreased payments as a result of
continuing implementation of the previously finalized updates to supply
and equipment pricing. The estimated impacts also reflect decreased
payments due to continued implementation of previously finalized code-
level reductions that are being phased-in over several years. For
independent laboratories, it is important to note that these entities
receive approximately 83 percent of their Medicare revenues from
services that are paid under the CLFS. As a result, the estimated 1
percent increase for CY 2020 is only applicable to approximately 17
percent of the Medicare payment to these entities.
We often receive comments regarding the changes in RVUs displayed
on the specialty impact table (Table 110), including comments received
in response to the proposed rates. We remind stakeholders that although
the estimated impacts are displayed at the specialty level, typically
the changes are driven by the valuation of a relatively small number of
new and/or potentially misvalued codes. The percentages in Table 110
are based upon aggregate estimated PFS allowed charges summed across
all services furnished by physicians, practitioners, and suppliers
within a specialty to arrive at the total allowed charges for the
specialty, and compared to the same summed total from the previous
calendar year. Therefore, they are averages, and may not necessarily be
representative of what is happening to the particular services
furnished by a single practitioner within any given specialty.
b. Impact
Column F of Table 110 displays the estimated CY 2020 impact on
total allowed charges, by specialty, of all the RVU changes. A table
showing the estimated impact of all of the changes on total payments
for selected high volume procedures is available under ``downloads'' on
the CY 2020 PFS proposed rule website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these
procedures for sake of illustration from among the procedures most
commonly furnished by a broad spectrum of specialties. The change in
both facility rates and the nonfacility rates are shown. For an
explanation of facility and nonfacility PE, we refer readers to
Addendum A on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
c. Estimated Impacts Related to Proposed Changes for Office/Outpatient
E/M Services for CY 2021
Although we are not proposing changes to E/M coding and payment for
CY 2020, we are proposing certain changes for CY 2021. We provide the
following impact estimate only for illustrative purposes. We believe
these estimates provide insight into the magnitude of potential changes
for certain physician specialties. Table 111 illustrates the estimated
specialty level impacts associated with implementing the RUC-
recommended work values for the office/outpatient E/M codes, as well as
the revalued HCPCS add-on G-codes for primary care and certain types of
specialty visits in 2020, rather than delaying until CY 2021.
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Overall, those specialties that bill higher level established
patient visits, such as endocrinology or family practice, see the
greatest increases as those codes were revalued higher relative to the
rest of the office/outpatient E/M code set. Those specialties that see
the greatest decreases are those that do not generally bill office/
outpatient E/M visits. Other specialty level impacts are primarily
driven by the extent to which those specialties bill using the office/
outpatient E/M code set and the relative increases to the particular
office/outpatient E/M codes predominantly billed by those specialties.
We note that any potential coding changes and recommendations in
overall valuation for new and existing codes between the CY 2020
proposed rule and the CY 2021 final rule could impact the actual change
in overall RVUs for office/outpatient visits relative to the rest of
the PFS. Given the various factors that will be considered by the
variety of stakeholders involved in the CPT and RUC processes, we do
not believe we can estimate with any degree of certainty what the
impact of potential changes might be. We also, note, however, that any
changes in coding and payment for these services would be subject to
notice and comment rulemaking.
As discussed elsewhere in this section of the proposed rule, we
estimate this approach would lead to burden reduction for
practitioners, while allowing a year of preparatory time and time for
potential refinement over the next year as we take into account any
feedback from stakeholders on these proposed changes.
D. Effect of Proposed Changes Related to Telehealth
As discussed in section II.F. of this proposed rule, we are
proposing to add three new codes, HCPCS codes GYYY1, GYYY2, and GYYY3,
to the list of Medicare telehealth services for CY 2020. Although we
expect these changes to have the potential to increase access to care
in rural areas, based on recent telehealth utilization of services
already on the list, including services similar to the proposed
additions, we estimate there will only be a negligible impact on PFS
expenditures from these additions. For example, for services already on
the list, they are furnished via telehealth, on average, less than 0.1
percent of the time they are reported overall. The restrictions placed
on Medicare telehealth by the statute limit the magnitude of
utilization; however, we believe there is value in allowing physicians
and patients the greatest flexibility when appropriate.
E. Other Provisions of the Proposed Regulation
1. Effect of Medicare Coverage for Opioid Use Disorder Treatment
Services Furnished by Opioid Treatment Programs (OTPs)
As discussed in section II.G of this proposed rule, Section 2005 of
the Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment (SUPPORT) for Patients and Communities Act establishes a new
Medicare Part B benefit for opioid use disorder (OUD) treatment
services furnished by opioid treatment programs (OTPs) for episodes of
care beginning on or after January 1, 2020. The Substance Abuse and
Mental Health Services Administration (SAMHSA) currently performs
regulatory certification of OTPs. Currently, SAMHSA certifies about
1,700 OTPs. They are located predominately in urban areas, tend to be
free-standing facilities, and provide a range of services, including
medication-assisted treatment (MAT). The payor mix for OTPs currently
includes Medicaid, private payors, TRICARE, as well as individual pay
patients. The total estimated Part B net impact, including FFS and
Medicare Advantage, over 10 years is $1,024,000,000. In developing this
estimate, it was assumed that the average treatment length would be 12
months in duration and the average rate per week in CY 2020 was assumed
to be $148, which is a weighted average of the rates we are proposing
for the bundled payments for treatment with methadone, buprenorphine,
and naltrexone. These rates were assumed to be updated annually by the
Medicare Economic Index (MEI). We assumed that the impact in the first
year would be reduced by 50 percent due to potential delays in provider
certification and system modifications. Additionally, any change to
fee-for-service benefits has an associated impact on payments to
Medicare Advantage plans so an adjustment was made to reflect this,
based on the projected distribution of spending in each year. The
estimate also accounts for the impact on the program due to the change
in the Part B premium as a result of this provision. The Part B
enrollment and MEI assumptions were based on the President's Fiscal
Year 2020 Budget baseline that was released in March of 2019. As with
all estimates, and particularly those for new separately billable
services, this outcome is highly uncertain because the available
information on which to base estimates is limited and is not directly
[[Page 40888]]
applicable to a new Medicare payment. The cost and utilization
estimates are based on Medicare and Medicaid claims data for
beneficiaries with OUD, together with statistics about the types of
services typically furnished at OTPs.
It is difficult for us to predict how coverage of OTPs will
specifically affect the market. We anticipate current OTPs may expand
access to care for Medicare beneficiaries since they will be able to
receive payment from Medicare for services furnished to beneficiaries
when they previously were unable to do so. Coverage may also create
financial incentives to establish new OTPs. However, since TRICARE,
Medicaid, and some private payers already pay for OTP services, it is
less clear whether the presence of Medicare payment rates will have any
effect on current rates for OTP services or on new rates should
additional private coverage be established.
2. Changes to the Ambulance Physician Certification Statement
Requirement
This proposed rule would clarify the requirements at Sec. Sec.
410.40 and 410.41 regarding the requirements for physician
certification and non-physician certification statements and expand the
list of staff members who can sign non-physician certification
statements. While we believe that clarification of the regulatory
provisions associated with physician certification and non-physician
certification statements is needed and would be well received by
stakeholders, we do not believe that these clarifications would have
any substantive monetary or impact the amount of time needed to
complete the certification statements. We believe the primary benefit
of the clarification would be for providers and suppliers in preparing
and submitting the original certification statements. It is feasible
the clarification could result in fewer claims being denied. However,
hypothetically, these denials are likely a small subset of the
ambulance claim denials and those denied for technical PCS issues are
likely appealed and overturned.
Moreover, we have examined the impact of expanding the list of
individuals who may sign the non-physician certification statement.
This added flexibility in accessing additional individuals to sign a
non-physician certification statement would be needed only when the
physician was unavailable. Thus, while we anticipate that some
providers would use the increased flexibility, the precise impact is
not calculable.
3. Medicare Ground Ambulance Services Data Collection System
As discussed in section III.B.2. of this proposed rule, section
50203(b) of the BBA of 2018 added a new paragraph (17) to section
1834(l) of the Act, which requires the Secretary to develop a data
collection system to collect cost, revenue, utilization, and other
information determined appropriate with respect to providers and
suppliers of ground ambulance services. In section III.B.4 through
III.B.7. of this proposed rule, we describe our proposals that would
implement this section, including the data that would be collected
through the data collection system, sampling methodology, requirements
for reporting data, payment reductions that would apply to ground
ambulance providers and suppliers that fail to sufficiently report data
and that do not qualify for a hardship exemption, informal review
process that would be available to ground ambulance providers and
suppliers that are subject to a payment reduction, and our policies for
making the data available to the public.
We estimate that ground ambulance providers and suppliers would
need to engage in two primary activities with respect to these
proposals, both of which would require them to incur cost and burden:
Data collection and data reporting. The data collection activity
includes: (1) Reviewing instructions to understand the data required
for reporting; (2) accessing existing data systems and reports to
obtain the required information; (3) obtaining required information
from other entities where appropriate; and (4) if necessary, developing
processes and systems to collect data that are not currently collected,
but that they would be required to report under the data collection
system. The data reporting activity includes entering the collected
information in CMS's proposed web-based data collection system.
To estimate the data collection impact, we assumed that each ground
ambulance organization that is selected to submit data for a year would
take up to 20 hours to collect the required data, which would include 4
hours to review the instructions and 16 hours to collect the required
data. These estimates were informed by our discussions with ambulance
organizations during stakeholder engagements and through more in-depth
interviews with nine ambulance organizations for the purpose of
soliciting feedback on data collection instrument items as described in
section III.B.3. and III.B.4. of this proposed rule. Most participants
indicated that they would be able to provide some of the required
information with an investment of 1-2 hours and complete information
with additional hours to collect the missing data. Many participants
indicated that they would need to reach out to other staff at the
organization, at contracted organizations (such as billing companies),
or at other entities (such as municipal government financial staff for
government ambulance organizations) to collect required information
that was not in the organization's accounting or billing systems. Some
participants indicated that their organization would need to adjust
data collection processes or collect new data over the course of a year
to ensure that required data was available in the appropriate format
prior to submission.
Actual data collection and reporting will vary depending on the mix
of employees at sampled ambulance organizations, the staff with
available time to dedicate to data collection and data reporting
activities at each organization, the staff in different roles that
already perform similar activities in each organization, and whether
billing services are contracted out or conducted internally.
Because we expect that the staff (by category) that will contribute
to data collection and reporting will be highly variable across ground
ambulance organizations, we calculated a blended mean wage for the
purposes of estimating burden. Table 112 lists the Standard
Occupational Classification (SOC) categories contributing to the
blended wage, the mean wage for each SOC specific to North American
Industry Classification System (NAICS) industry code 621910 (Ambulance
Services), and the relative contribution of each SOC to the blended
mean. The source mean wage and employment data is from the Bureau of
Labor Statistics May 2018 Occupational Employment Statistics data
(available from https://download.bls.gov/pub/time.series/oe/) for the
indicated SOC and NAICS codes, which was most recently available wage
and employment data set. We assumed that financial clerks (SOC category
433000) would account for 25 percent of the total data collection and
reporting effort, and that six other SOC categories would contribute to
the remaining 75 percent (see Table 112).
[[Page 40889]]
Table 112--Estimated Mean Hourly Wages for Occupations Involved in Data
Collection
------------------------------------------------------------------------
Mean hourly Weight (%
D-6 wage ($) effort) *
------------------------------------------------------------------------
Top Executives (111000)................. 51.49 17
Other Management Occupations (119000)... 39.23 12
Business and Financial Operations 28.60 15
Occupations (130000)...................
Secretaries and Administrative 18.11 10
Assistants (436010)....................
Other Office and Administrative Support 16.20 10
Workers (439000).......................
Financial Clerks (433000)............... 18.51 25
First-Line Supervisors of Office and 27.92 10
Administrative Support Workers (431011)
-------------------------------
Blended Mean Hourly Wage............ 28.91 100
------------------------------------------------------------------------
* Note: Weights may not sum to 100 percent due to rounding. Source:
Bureau of Labor Statistics Occupational Employment Statistics, May
2018, available from https://download.bls.gov/pub/time.series/oe/.
In addition, we calculated the cost of overhead, including fringe
benefits, at 100 percent of the mean hourly wage. Although we recognize
that fringe benefits and overhead costs may vary significantly by
employer, and that there are different accepted methods for estimating
these costs, doubling the mean blended wage rate to estimate total cost
is an accepted method to provide a reasonably accurate estimate.
Therefore, assuming a mean blended wage of $28.91 for data collection,
and assuming the cost of overhead, including fringe benefits, at 100
percent of the mean hourly wage, we calculated at a wage plus benefits
estimate of $57.82 per hour of data collection. To calculate at the
total data collection cost per sampled ground ambulance organization,
we multiplied the time required for data collection by the burdened
hourly wage (20 hours * $57.82/hour) for a total of $1,156.
We discussed several sampling options in section III.B.5. of this
proposed rule. Our proposed sampling rate of 25 percent would yield an
expected 2,690 respondents in the first sample, resulting in a total
estimated data collection cost of $3,110,684 (2,690 respondents *
$1,156 per respondent).
To estimate the cost of data reporting, we assumed it will require
3 hours to enter, review, and submit information into the proposed web-
based data collection system. The estimate of 3 hours was also informed
by interviews with nine ambulance organizations to solicit feedback on
the data instrument items under consideration. We included time for
staff to review the collected data before entering it into the data
collection system. We also assumed that staff responsible for reporting
the data would have the same blended hourly wage used to estimate data
collection costs above ($28.91) as the staff that collected the data.
Again, assuming the cost of overhead at 100 percent of the mean hourly
wage, we calculated at a wage plus benefits estimate of $57.82.
Therefore, we estimate a per-respondent cost for data submission of
$173.46 (3 hours * $57.82/hour). To calculate the total cost for data
reporting under a 25 percent sampling rate, we multiplied the number of
ground ambulance organizations sampled annually by the time required
for data entry times the total hourly wage estimate, for a total of
$466,603 across all respondents (2,690 respondents * 3 hours * $57.82/
hour).
Adding the total data collection and reporting costs yields a total
annual impact for ground ambulance organizations of $3,577,287
($3,110,684 for data collection [2,690 respondents * 20 hours * $57.82/
hour] + $466,603 total cost for data submission [2,690 respondents * 3
hours * $57.82/hour]) with a 25 percent sampling rate. Our estimate of
total annual impact would be lower at $1,430,649 ($1,244,042 for data
collection [1,076 respondents * 20 hours * $57.82/hour] + $186,606 for
data submission [1,076 respondents * 3 hours * $57.82/hour]) under a 10
percent sampling rate alternative and higher at $7,153,244 ($6,220,212
for data collection [5,379 respondents * 20 hours * $57.82/hour] +
$933,032 for data submission [5,379 respondents * 3 hours * $57.82/
hour]) under a 50 percent sampling rate. In all cases, the estimated
cost of collecting and reporting data is $1,330 per organization
sampled ($1,156 for data collection [20 hours * $57.82/hour] + $173.46
for data submission [3 hours * $57.82/hour]). The per-organization
estimate reflects an average. Based on discussions with ambulance
organizations to provide feedback on instrument items, we do not
anticipate that larger or smaller ambulance organizations in terms of
transport volume, costs, or revenue will face systematically more or
less burden in data collection or reporting. While larger organizations
generally have higher transport volumes, costs, and revenue, and more
complex financial arrangements that may increase reporting burden, they
also tend to have existing data collection and reporting processes and
staff that will reduce the additional effort required to submit the
required data. On the other hand, while smaller organizations have less
data to collect and report, they may not have current processes in
place to begin collecting some required data.
b. Hardship Exemption Process
As discussed in section III.B.7.b. of this proposed rule, we are
proposing a process for ground ambulance organizations to request and
for CMS to grant significant hardship exemptions from the 10 percent
payment reduction. To request a significant hardship exemption, we are
proposing that a ground ambulance organization would be required to
complete and submit a request form that we would make available on the
Ambulances Services Center website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html.
We estimate that 25 percent of the total number of ground ambulance
organizations will be selected each year as the representative sample
to report the required information under the data collection system.
That is, 25 percent out of the total 10,758 NPIs, or 2,690 ambulance
providers and suppliers.
While we expect that few, if any, ground ambulance organizations
will request a hardship exception, we do not have experience in
collecting data from ground ambulance organizations that could be used
to develop an estimate, so we are basing our estimate on the total
number of organizations being surveyed. As a result, we estimate that a
total of 2,690 ground ambulance organizations would apply for a
hardship exemption, and that it would take 15 minutes for each of these
ground ambulance organizations 15 minutes to complete and submit the
request form.
[[Page 40890]]
We assumed for purposes of this estimate that the mix of staff
responsible for completing this form would have the same blended hourly
wage used to estimate the data collection and data reporting costs. We
also calculated the cost of overhead, including fringe benefits, at 100
percent of the mean hourly wage, as we did above. As a result, we
estimated that the total cost burden associated with the completion and
submission of the hardship exemption request form would be
approximately $38,884.
c. Informal Review Process
As discussed in section III.B.7.c. of this proposed rule, we are
proposing a process in which a ground ambulance organization may seek
an informal review of our determination that it is subject to the 10
percent reduction.
We estimate that a collection of information burden of 15 minutes
for a ground ambulance provider or supplier who is requesting an
informal review to gather the requested information and send an email
to our AMBULANCEODF mailbox.
Again, we are using the total number of ambulance organizations
survey each year to develop our estimates. Therefore, a total of 40,350
minutes (15 x 2,690) or 672.5 hours for 2,690 ambulance providers and
suppliers to complete this form. Taking into account the same blended
mean hourly wage and fringe benefits as we did for our other estimates,
we estimate that the total for all sampled ambulance providers and
suppliers to submit the form would be approximately $38,884.
4. Intensive Cardiac Rehabilitation (ICR)
As discussed in section III.C. of this proposed rule, we are adding
stable, chronic heart failure (CHF) (defined as patient with left
ventricular ejection fraction of 35 percent or less and NYHA class II
to IV symptoms despite being on optimal heart failure therapy for at
least 6 weeks) to the list of covered conditions for ICR, as well as,
the ability for use to use the NCD process to add additional covered
conditions for ICR. Heart failure impacts approximately 5.7 million
adults,\141\ and approximately 80 percent of individuals over age 65
have heart failure.\142\ (The majority (86 percent) of Medicare
beneficiaries are over age 65.\143\) We estimate 4,560,000
beneficiaries over age 65 have heart failure.
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\141\ Centers for Disease Control, Heart Failure Fact Sheet,
https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm.
\142\ Vigen, Rebecca et al. ``Aging of the United States
population: impact on heart failure.'' Current heart failure reports
vol. 9,4 (2012): 369-74. doi:10.1007/s11897-012-0114-8.
\143\ CMS, 2019 Fast Facts, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Fast-Facts/index.html.
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The uptake by beneficiaries has historically been low for CR and
ICR. From February 2014 to 2017, after stable CHF was added to the
covered conditions for CR, only 439,888 claims were processed for this
service with a diagnosis code of CHF. Less than 1 percent of
beneficiaries with heart failure utilized CR. Given that the uptake of
ICR has been even lower than CR, we expect the same trend (low uptake)
for intensive cardiac rehabilitation due to the nature of these
programs which entail rehabilitation through lifestyle modification. We
conducted a claims analysis that examined claims prior to and after a
2014 NDC that added stable CHF to the list of covered conditions for
CR. Prior to the implementation of stable CHF as a covered condition
for CR, 1.8 percent of claims for CR included a diagnosis code for CHF.
After implementation, 4.7 percent of claims for CR included a diagnosis
code for CHF. Therefore, for ICR, which has historically been utilized
much less than CR (for example, when all CR and ICR claims are
combined, only 1 percent of the claims are for ICR), we anticipate
there may be a similar slight percentage increase in claims for ICR for
treatment of stable CHF. Assuming a 4.7 percent increase in ICR claims
due to adding stable CHF as a covered condition, we estimate an
increase of 3,378 claims annually. For 2019, the facility and non-
facility prices for CR and ICR are the same, and the average price is
$120.93. Therefore, based on our estimated increase in claims, at an
average price of $120.93, the estimated total cost of adding stable,
chronic heart failure to the list of covered conditions for ICR is
estimated at $408,502 annually. From 2010-2017, the median number of
ICR visits per calendar year was 18 visits per beneficiary. Therefore,
based on our expected increase in the number of claims (3,378), the
estimated number of beneficiaries covered would be 187. Based on these
estimates, we estimate there will only be a negligible impact on
Medicare expenditures from this proposed change.
Additionally, we do not anticipate providers currently offering ICR
would need to obtain any specialized technology and equipment to treat
ICR patients with stable CHF beyond what they would obtain for ICR
patients seeking treatment for the existing six covered conditions.
When this proposed rule is finalized, we will cover the seven
cardiac conditions that constitute the vast majority of cardiac
conditions that CR and ICR can treat. Due to the breadth of the
proposed and existing covered conditions, we do not anticipate the need
to use the NCD process to add additional covered conditions to CR and
ICR in the near future.
Lastly, while CR and ICR have low utilization at this point in
time, an increase in the number of CR and/or ICR providers in
underserved areas could result in an increase in utilization due to
increased availability/proximity to services. However, we are not able
to accurately quantify the number of entities that would seek approval
as CR or ICR programs. Additionally, we acknowledge, that the expansion
of coverage to ICR could generate attention around the importance of
CR/ICR and may increase beneficiary utilization.
5. Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals (EPs)
In the Medicaid Promoting Interoperability Program, to keep
electronic clinical quality measure (eCQM) specifications current and
minimize complexity, we propose to align the eCQMs available for
Medicaid EPs in 2020 with those available for MIPS eligible clinicians
for the CY 2020 performance period. We anticipate that this proposal
would reduce burden for Medicaid EPs by aligning the requirements for
multiple reporting programs, and that the system changes required for
EPs to implement this change would not be significant, as many EPs are
expected to report eCQMs to meet the quality performance category of
MIPS and therefore should be prepared to report on those eCQMs for
2020. Not implementing this alignment could lead to increased burden
because EPs might have to report on different eCQMs for the Medicaid
Promoting Interoperability Program, if they opt to report on newly
added eCQMs for MIPS. We expect that this proposal would have only a
minimal impact on states, by requiring minor adjustments to state
systems for 2020 to maintain current eCQM lists and specifications.
State expenditures to make any systems changes required as a result of
this proposal would be eligible for 90 percent Federal financial
participation.
For 2020, we propose to require that Medicaid EPs report on any six
eCQMs that are relevant to the EP's scope of practice, including at
least one outcome
[[Page 40891]]
measure, or if no applicable outcome measure is available or relevant,
at least one high priority measure, regardless of whether they report
via attestation or electronically. This policy would generally align
with the MIPS data submission requirement for eligible clinicians using
the eCQM collection type for the quality performance category, which is
established in Sec. 414.1335(a)(1). If no outcome or high priority
measure is relevant to a Medicaid EP's scope of practice, he or she
could report on any six eCQMs that are relevant. This proposal would be
a continuation of our policy for 2019 and we believe it would create no
new burden for EPs or states.
We also propose that the 2020 eCQM reporting period for EPs in the
Medicaid Promoting Interoperability Program who have demonstrated
meaningful use in a prior year would be a minimum of any continuous
274-day period within CY 2020. We are proposing to shorten the
reporting period from a full calendar year to enable states to take
attestations for 2020 as early as October 1, 2020. We believe this
would improve states' flexibility as they move toward the end of the
Medicaid Promoting Interoperability Program and the December 31, 2021
statutory deadline to make incentive payments. This should add no
additional burden for EPs or CEHRT vendors, as Certified EHR Technology
(CEHRT) should be able to run eCQM reports for any number of days and
during any time period. The proposed eCQM reporting period would be a
minimum and EPs could continue to report on a full calendar year if
they wish. As in previous years, the 2020 eCQM reporting period for EPs
attesting to meaningful use for the first time would be any continuous
90-day period within the calendar year.
Finally, we are proposing to change Medicaid policy for 2021
related to EP Meaningful Use Objective 1, Measure 1 (Conduct or review
a security risk analysis (SRA)). We are proposing to allow Medicaid EPs
to conduct an SRA at any time during CY 2021, even if the EP conducts
the SRA after attesting to meaningful use of CEHRT to the state. A
Medicaid EP who has not completed an SRA for CY 2021 by the time he or
she attests to meaningful use of CEHRT for CY 2021 would be required to
attest that he or she will complete the required SRA by December 31,
2021. Currently, this measure must be completed in the same calendar
year as the EHR reporting period. This may occur before, during, or
after the EHR reporting period, though if it occurs after the EHR
reporting period it must occur before the provider attests to
meaningful use of CEHRT or before the end of the calendar year,
whichever comes first. In practice, this means that EPs do not attest
to meaningful use of CEHRT before completing this measure. However, due
to the changes we previously made to the EHR and eCQM reporting period
timelines for CY 2021, all Medicaid EPs are expected to attest to
meaningful use of CEHRT on or before October 31, 2021. Accordingly, if
we did not propose to change the deadline for conducting the SRA,
Medicaid EPs would no longer have the option of completing an SRA at
the end of the calendar year, and would likely have to complete one
well before December 2021. If an EP typically conducts the security
risk analysis at the end of each year, this timeline could create
burden for the EP, and may not be optimal for protecting information
security, because it could disrupt the intervals between security risk
analyses. We have also heard feedback from health care providers that
SRAs are generally conducted for a whole clinic and the current
requirement would create burden on non-EP health care providers in
2021. We believe our proposal would prevent additional burden for both
EPs and non-EP health care providers.
This proposal could create burden for states, as they might have to
adjust their pre-payment and post-payment verification plans and
conduct more thorough audits for this meaningful use objective.
However, states are already required to conduct adequate oversight of
the Medicaid Promoting Interoperability Program, including routine
tracking and verification of meaningful use attestations (see 42 CFR
495.318(b), 495.332(c), and 495.368), and we are not proposing to
change that requirement for 2021. We have established at 42 CFR
495.322(b) that 90 percent Federal financial participation will be
available for state administrative expenditures related to Medicaid
Promoting Interoperability Program audits and appeals that are incurred
on or before September 30, 2023.
6. Medicare Shared Savings Program
In section III.F.1.b. of this proposed rule, we summarize certain
modifications to the quality measure set used to assess the quality
performance of ACOs participating in the Shared Savings Program based
on proposed changes made to the CMS Web Interface measures under the
Quality Payment Program in section III.I.3.b.(1). Specifically, we are
proposing: (1) The addition of one CMS Web Interface measure; (2) the
removal of one CMS Web Interface Measure; (3) revisions to the
numerator guidance for ACO-17--Preventive Care and Screening: Tobacco
use: Screening and Cessation Intervention; and (4) reverting ACO-43--
Ambulatory Sensitive Condition Acute Composite (AHRQ Prevention Quality
Indicator (PQI) #91) to pay-for-reporting for 2 years to account for a
substantive change in the measure.
The net result of these proposed modifications to the Shared
Savings Program quality measure set would be a measure set of 23
measures. These proposed changes would have no impact on the number of
measures an ACO is required to report; therefore, there is no expected
change in reporting burden for ACOs.
7. Open Payments
a. Expanding the Definition of ``Covered Recipient'' (Sec. Sec.
403.902, 403.904, and 403.908)
Our initial estimate based on the available information is that
there will be approximately $10 million dollar per year in increased
burden to reporting entities and the new covered recipient groups for
submitting, collecting, retaining, and reviewing data. This estimate is
based on existing burden calculations. It assumes that there will be
734,000 new records (~7 percent increase) reported about 205,000 (~33
percent increase) covered recipients.
We also believe there will be costs to reporting entities for
updating their systems and reporting processes. However, we are unable
to estimate these costs because they will vary depending on the
reporting entity's individual circumstances.
As explained in section IV.5. of this proposed rule, section
6111(c) of the SUPPORT Act states that chapter 35 of title 44 of the
U.S. Code, which includes such provisions as the PRA, shall not apply
to the changes to the definition of a covered recipient. Therefore, a
detailed breakdown is not provided in that section. The above estimates
however, do provide a regulatory impact analysis of this provision.
b. Modification of the ``Nature of Payment'' Categories (Sec. Sec.
403.902 and 403.904)
We anticipate minor additional costs for system updates associated
with our proposed provision to modify the ``nature of payment''
categories. As we indicated in section III.F. of this proposed rule,
said provisions are intended to add clarity. They will not increase the
amount of information to be reported. Data already reported to us may
simply be reported in a different category. We propose these changes
[[Page 40892]]
only to be made prospectively and do not propose to have manufactures
and GPOs to make changes to previously reported data. This provision
would, generally speaking, allow reporting entities to better
characterize the nature of a payment and would not constitute a new
requirement. Hence, the expected impact is minimal.
c. Standardizing Data Reporting (Sec. Sec. 403.902 and 403.904)
Approximately 850 entities (approximately 53 percent), have
reported a transaction that could require the addition of a device
identifier if this proposed rule becomes final. The total cost of the
addition of this new data element cannot be estimated because it would
depend on: (1) Whether the entity already tracks this data element and
(2) the extent to which the entity would need to update their system to
be able to report this data element.
8. Medicare Enrollment of Opioid Treatment Programs
As stated previously in this proposed rule, we propose that OTP
providers be required to not only enroll in Medicare, but also (1) pay
an application fee at the time of enrollment and (2) submit a set of
fingerprints for a national background check (via FBI Applicant
Fingerprint Card FD-258) from all individuals who maintain a 5 percent
or greater direct or indirect ownership interest in the OTP.
a. Application Fee
The application fees for each of the past 3 calendar years (CY)
were or are $560 (CY 2017), $569, (CY 2018), and $586 (CY 2019).
Consistent with Sec. 424.518, the differing fee amounts were
predicated on changes/increases in the Consumer Price Index (CPI) for
all urban consumers (all items; United State city average, CPI-U) for
the 12-month period ending on June 30 of the previous year. While we
cannot predict future changes to the CPI, we note that the fee amounts
between 2017 and 2019 increased by an average of $13 per year. We
believe this is a reasonable barometer with which to establish
estimates (strictly for purposes of this proposed rule) of the fee
amounts in the first 3 CYs of this rule (that is, 2020, 2021, and
2022). We thus project a fee amount of $599 in 2020, $612 for 2021, and
$625 for 2022.
Applying these prospective fee amounts to the number of projected
applicants in the rule's first 3 years, we estimate a cost to enrollees
of $1,058,433 (or 1,767 x $599) in the first year, $41,004 (or 67 x
$612) in the second year, and $41,250 (or 66 x $625) in the third year.
b. Fingerprinting
Based on the experiences of the provider community to date, we
estimate that it would take each owner (BLS: Top Executives)
approximately 2 hours at $123.32/hr to obtain and submit the
fingerprints. (According to the most recent BLS wage data for May 2018,
the mean hourly wage for the general category of ``Top Executives'' is
$61.66 (see http://www.bls.gov/oes/current/oes_nat.htm#43-0000). With
fringe benefits and overhead, the figure is $123.32.)
As mentioned in the preamble of this proposed rule, SAMHSA
statistics indicate that there are currently about 1,677 active OTPs;
of these, approximately 1,585 have full certifications and 92 have
provisional certifications.
Although we do not have specific data on the matter, we project,
for purposes of our proposed burden estimates, a total of 1,500 such
direct or indirect ownership interests in OTP providers that would
require the submission of fingerprints over the first 3 years. This
1,500 figure is less than the 1,900 projected applicants (discussed in
the ICR section of this rule) in the first 3 years following the final
rule's publication because some applicants may have non-profit business
structures and, thus, would not have owners. Furthermore, our
estimation of individual owners who would qualify to submit
fingerprints is based on a sampling of similar provider types,
including DMEPOS suppliers (high risk), MDPP suppliers (high risk),
rural health clinics (limited risk) and others.
Applying this figure to the aforementioned per year breakdown of
applicants, we estimate a first year burden of 2,790 hours at a cost of
$344,063 (2,790 hr x $123.32/hr). We obtained the 2,790 hour estimate
by first dividing 1,767 (the number of first-year applicants) by 1,900,
resulting in a figure of 0.93. We then multiplied 0.93 by 1,500 (the
number of ownership interests over the 3-year period) and thereafter by
2 hours.
Applying this same formula, we project a second-year time estimate
of 106 hours (or 0.0353 x 1,500 applicants x 2 hr) at a cost of $13,072
(106 hr x $123.32/hr), and a third-year estimate of 104 hours (or
0.0347 x 1,500 applicants x 2 hr) at a cost of $12,825 (104 hr x
$123.32/hr). In aggregate, we estimate a burden of 3,000 hours (2,790
hr + 106 hr + 104 hr) at a cost of $369,960 ($344,063 + $13,072 +
$12,825). When annualized over the 3-year period, we estimate an annual
burden of 1,000 hours (3,000 hours/3) at a cost of $123,320 ($369,960/
3).
9. Deferring to State Scope of Practice Requirements
a. Ambulatory Surgery Centers
As of May 2019 there were 5,767 Medicare-participating ASCs. We are
proposing to revise Sec. 416.42 to allow an anesthetist, or a
physician, to perform the required examination before surgery for
anesthesia risk and of the procedure to be performed. We proposed this
revision to reduce ASC compliance burden and provide for patient
assessment and care continuity while maintaining patient safety and
care. At Sec. 416.42(a)(1), we propose to allow an anesthetist, in
addition to a physician, to perform the required pre-surgical risk and
evaluation examination. This change would provide flexibility and allow
either a physician or an anesthetist to perform the pre-surgical
examination. In total, ASCs provided about 6.4 million services in
2016.\144\ We assume that 30 percent of all procedures would utilize
the services of a nurse anesthetist instead of a physician for this
requirement, which would reduce the cost of the examination. We
estimate the pre-surgical evaluation to take 15 minutes to complete. We
are assuming these estimates based on previous experience and
conversations with stakeholders. We acknowledge the uncertainty with
these estimates and invite public comment on our assumptions to
articulate the most accurate information in the final rule
calculations. According to 2018 Bureau of Labor Statistics data, the
hourly cost for a physician (including fringe benefits and overhead
calculated at 100 percent of the mean hourly wage) is approximately
$203 ($51 for 15 minute evaluation), and the hourly cost for a nurse
anesthetist is approximately $168 ($42 for 15 minute evaluation).
Assuming 1.92 million procedures annually, we can predict a savings of
approximately $17.3 million (($51-$42) x 1.92 million). We have used
our best estimate as to the percentage of pre-surgical evaluations by
anesthetists overall, however, we welcome any comments and evidence-
based information that would inform our ability to provide the most
accurate cost savings estimates.
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\144\ MEDPAC, Ambulatory surgical centers services 2017, p. 136.
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b. Hospice
We are proposing to revise Sec. 418.106 to permit hospices to
accept orders for drugs from attending physicians who are physician
assistants. We do not
[[Page 40893]]
believe that are any associated financial impacts for hospices.
10. Changes Due to Updates to the Quality Payment Program
In section III.K. of this proposed rule, we included our proposed
policies for the Quality Payment Program. In this section of the
proposed rule, we present the overall and incremental impacts to the
number of expected QPs and associated APM Incentive Payments. In MIPS,
we estimate the total MIPS eligible population and the payment impacts
by practice size for the 2020 MIPS performance period based on various
proposed policies to modify the MIPS final score and the proposed new
performance threshold and additional performance threshold.
Although the submission period for the second MIPS performance
period ended in early 2019, the final data sets were not available in
time to incorporate into the CY 2020 PFS proposed rule analysis. We
intend to use data from the 2018 MIPS performance period for the final
rule.
a. Estimated APM Incentive Payments to QPs in Advanced APMs and Other
Payer Advanced APMs
From 2019 through 2024, through the Medicare Option, eligible
clinicians receiving a sufficient portion of Medicare Part B payments
for covered professional services or seeing a sufficient number of
Medicare patients through Advanced APMs as required to become QPs, for
the applicable performance period, will receive a lump-sum APM
Incentive Payment equal to 5 percent of their estimated aggregate
payment amounts for Medicare covered professional services furnished
during the calendar year immediately preceding the payment year. In
addition, beginning in payment year 2021, in addition to the Medicare
Option, eligible clinicians may become QPs through the All-Payer
Combination Option. The All-Payer Combination Option will allow
eligible clinicians to become QPs by meeting the QP thresholds through
a pair of calculations that assess a combination of both Medicare Part
B covered professional services furnished through Advanced APMs and
services furnished through Other Payer Advanced APMs.
The APM Incentive Payment is separate from and in addition to the
payment for covered professional services furnished by an eligible
clinician during that year. Eligible clinicians who become QPs for a
year would not need to report to MIPS and would not receive a MIPS
payment adjustment to their Part B PFS payments. Eligible clinicians
who do not become QPs, but meet a lower threshold to become Partial QPs
for the year, may elect to report to MIPS and, if they elect to report,
would then be scored under MIPS and receive a MIPS payment adjustment.
Partial QPs will not receive the APM Incentive Payment. For the 2020 QP
Performance Period, we define Partial QPs to be eligible clinicians in
Advanced APMs who collectively have at least 40 percent, but less than
50 percent, of their payments for Part B covered professional services
through an APM Entity, or collectively furnish Part B covered
professional services to at least 25 percent, but less than 35 percent,
of their Medicare beneficiaries through an APM Entity. If the Partial
QP elects to be scored under MIPS, they would be subject to all MIPS
requirements and would receive a MIPS payment adjustment. This
adjustment may be positive, negative, or neutral. If an eligible
clinician does not attain either QP or Partial QP status, and does not
meet any another exemption category, the eligible clinician would be
subject to MIPS, would report to MIPS, and would receive the
corresponding MIPS payment adjustment.
Beginning in payment year 2026, payment rates for services
furnished by clinicians who achieve QP status for a year would be
increased each year by 0.75 percent for the year, while payment rates
for services furnished by clinicians who do not achieve QP status for
the year would be increased by 0.25 percent. In addition, MIPS eligible
clinicians would receive positive, neutral, or negative MIPS payment
adjustments to payment for their Part B PFS services in a payment year
based on performance during a prior performance period. Although the
statute establishes overall payment rate and procedure parameters until
2026 and beyond, this impact analysis covers only the fourth payment
year (2022 payment year) of the Quality Payment Program in detail.
In section III.K.4.e.(3)(b)(ii) of this proposed rule, we propose
to amend the marginal risk standard finalized in Sec. 414.1420(d)(5)
by amending paragraph (d)(5)(i) to provide that in event that the
marginal risk rate varies depending on the amount by which actual
expenditures exceed expected expenditures, the average marginal risk
rate across all possible levels of actual expenditures would be used
for comparison to the marginal risk rate specified in with exceptions
for large losses and small losses as described in 414.1420(d). We do
not yet have experience with QP and Partial QP Determinations under the
All-Payer Combination Option as it will be operational for the first
time this fall. To date, we have only determined a modest number of
payment arrangements from non-Medicare payers that meet the Other Payer
Advanced APM criteria. However, we expect this added flexibility in the
marketplace may increase the number of arrangements in this category.
Based on our analysis there are 12,000 providers within 5 percent of
performance year 2020 QP thresholds in Advanced APMs, and therefore,
could potentially benefit from participation in Other Payer Advanced
APMs. Assuming a static marketplace, there are between 50-100 eligible
clinicians that would benefit from the change in the marginal risk
requirement at this time (that is, in 2020 QP performance period). This
is because there are likely to be only a small number of eligible
clinicians who both (1) participate in the models we determined were
not Other Payer Advanced APMs, but would become Other Payer Advanced
APMs under the proposed policy, and (2) have QP scores just below the
QP threshold. While this number may grow in the future as payers adopt
payment arrangements designed to reflect the change in the marginal
risk requirement, we anticipate the incremental impact of this proposal
will have a small impact on the number of clinicians that meet the QP
threshold and the total number of payment arrangements that are
determined to be Other Payer Advanced APMs.
Overall, we estimated that between 175,000 and 225,000 eligible
clinicians will become QPs, therefore be excluded from MIPS, and
qualify for the lump sum APM incentive payment based on 5 percent of
their Part B allowable charges for covered professional services in the
preceding year. These allowable charges for QPs are estimated to be
between approximately $9,000 million and $12,000 million in total for
the 2020 performance year. The analysis for this proposed rule used the
APM Participation Lists for the Predictive QP determination file for
2019. We estimate that the total lump sum APM Incentive Payments will
be approximately $500-600 million for the 2022 Quality Payment Program
payment year.
In section VI.E.10., we projected the number of eligible clinicians
that will be QPs, and thus excluded from MIPS, using several sources of
information. First, the projections are anchored in the most recently
available public information on Advanced APMs. The projections reflect
Advanced APMs that will be operating during the 2020 QP Performance
Period, as well as some Advanced APMs anticipated to be operational
during the 2020 QP
[[Page 40894]]
Performance Period. The projections also reflect an estimated number of
eligible clinicians that would attain QP status through the All-Payer
Combination Option. The following APMs are expected to be Advanced APMs
for the 2020 QP Performance Period:
Next Generation ACO Model, Comprehensive Primary Care Plus
(CPC+) Model;
Comprehensive ESRD Care (CEC) Model (Two-Sided Risk
Arrangement);
Vermont All-Payer ACO Model (Vermont Medicare ACO
Initiative);
Comprehensive Care for Joint Replacement Payment Model
(CEHRT Track);
Oncology Care Model (Two-Sided Risk Arrangements);
Medicare ACO Track 1+ Model;
Bundled Payments for Care Improvement Advanced;
Maryland Total Cost of Care Model (Maryland Care Redesign
Program; Maryland Primary Care Program);
Primary Care First; and
Medicare Shared Savings Program (Track 2, Basic Track
Level E, and the ENHANCED Track).
We used the APM Participant Lists and Affiliated Practitioner
Lists, as applicable, (see 81 FR 77444 through 77445 for information on
the APM participant lists and QP determinations) for the Predictive QP
determination file for 2019 to estimate QPs, total Part B allowed
charges for covered professional services, and the aggregate total of
APM incentive payments for the 2020 QP Performance Period. We examine
the extent to which Advanced APM participants would meet the QP
Thresholds of having at least 50 percent of their Part B covered
professional services or at least 35 percent of their Medicare
beneficiaries furnished Part B covered professional services through
the APM Entity.
b. Estimated Number of Clinicians Eligible for MIPS Eligibility
(1) Methodology To Assess MIPS Eligibility
(a) Clinicians Included in the Model Prior To Applying the Low-Volume
Threshold Exclusion
To estimate the number of MIPS eligible clinicians for the 2020
MIPS performance period in this proposed rule, our scoring model used
the first determination period from the 2018 MIPS performance period
eligibility file as described in the CY 2018 Quality Payment Program
final rule (82 FR 53587 through 53592). The first determination period
from the 2018 MIPS performance period eligibility file was selected to
maximize the overlap with the performance period data used in the
model. In addition, since the low-volume threshold was finalized in the
CY 2019 PFS final rule (83 FR 60075) to be based on covered
professional services (services for which payment is made under, or is
based on, the PFS and that are furnished by an eligible clinician),
this eligibility file provided the information to base the low-volume
threshold on covered professional services rather than all items and
services under Part B. We included 1.5 million clinicians (see Table
113) who had PFS claims from September 1, 2016 to August 31, 2017 and
included a 30-day claim run-out. We excluded from our analysis
individual clinicians who were affected by the automatic extreme and
uncontrollable policy finalized for the 2017 MIPS performance period/
2019 MIPS payment year in the CY 2019 PFS final rule (83 FR 59876) as
we are unable to predict how these clinicians would perform in a year
where there was no extreme and uncontrollable event.
Clinicians are ineligible for MIPS (and are excluded from MIPS
payment adjustment) if they are newly enrolled to Medicare; are QPs;
are partial QPs who elect to not participate in MIPS; are not one of
the clinician types included in the definition for MIPS eligible
clinician; or do not exceed the low-volume threshold as an individual
or as a group. Therefore, we excluded these clinicians when calculating
those clinicians eligible for MIPS. We also excluded clinicians
participating in the Medicare Advantage Qualifying Payment Arrangement
Incentive (MAQI) Demonstration for whom the waivers of MIPS reporting
requirements and the associated payment consequences are applicable, as
finalized in the CY 2019 PFS final rule (83 FR 59890).
For the estimated MIPS eligible population for the 2022 MIPS
payment year, we restricted our analysis to clinicians who are a
physician (as defined in section 1861(r) of the Act); a physician
assistant, nurse practitioner, and clinical nurse specialist (as such
terms are defined in section 1861(aa)(5) of the Act); a certified
registered nurse anesthetist (as defined in section 1861(bb)(2) of the
Act); a physical therapist, occupational therapist, speech-language
pathologist, audiologist, clinical psychologist, and registered
dietitian or nutrition professional as finalized in the CY 2019 PFS
final rule (83 FR 60076).
As noted previously, we excluded QPs from our scoring model since
these clinicians are not MIPS eligible clinicians. To determine which
QPs should be excluded, we used the QP List for the 2019 predictive
file that contains current participation in Advanced APMs as of January
15, 2019, using all available data because these data were available by
TIN and NPI, could be merged into our model and are the best estimate
of future expected QPs. From this data, we calculated the QP
determinations as described in the Qualifying APM Participant
definition at Sec. 414.1305 for the 2020 QP performance period. We
assumed that all Partial QPs would elect to participate in MIPS and
included them in our scoring model and eligibility counts. The
projected number of QPs excluded from our model is 124,413 for the 2019
QP performance period due to the expected growth in APM participation.
Due to data limitations, we could not identify specific clinicians who
may become QPs in the 2020 Medicare QP Performance Period; hence, our
model may underestimate or overestimate the fraction of clinicians and
allowed charges for covered professional services that will remain
subject to MIPS after the exclusions.
We also excluded newly enrolled Medicare clinicians from our model.
To identify newly enrolled Medicare clinicians, we used the indicator
that was used for the 2017 MIPS performance period/2019 MIPS payment
year. Finally, we excluded the MAQI participants with a MIPS exclusion
for the 2019 MIPS performance period.
(b) Assumptions Related To Applying the Low-Volume Threshold Exclusion
The low-volume threshold policy may be applied at the individual
(that is, TIN/NPI) or group (that is, TIN or APM entity) levels based
on how data are submitted or at the APM Entity level if the clinician
is part of a MIPS APM Entity scored under the APM scoring standard. To
determine who is a MIPS APM participant, we used the latest 2019
predictive file that contains current participation in MIPS APMs as of
January 15, 2019, using all available data. We identified all
clinicians in our eligible population who are in the 2019 predictive
file and evaluated them as an APM Entity. We also evaluated clinicians
as APM Entities if they are in our eligible population and associated
with an APM Entity for the 2017 performance period but are no longer
billing for Medicare (because they may have changed practices).\145\ If
a MIPS
[[Page 40895]]
eligible clinician is determined to not be scored as a MIPS APM, then
their reporting assumption is based on their reporting for the CY 2017
MIPS performance period. If no data are submitted and the TIN/NPI is
not associated with an APM Entity during the performance period, then
the low-volume threshold is applied at the TIN/NPI level. A clinician
or group that exceeds at least one but not all three low-volume
threshold criteria may become MIPS eligible by electing to opt-in and
subsequently submitting data to MIPS, thereby getting measured on
performance and receiving a MIPS payment adjustment.
---------------------------------------------------------------------------
\145\ A total of approximately 222,000 clinicians were included
in our model and scored using the APM scoring standard. These
clinicians are represented in the individual and group eligibility
rows in Table 113 depending on whether they would have exceeded the
low volume threshold as an individual or because they were part of
an APM entity group submission.
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Table 113 presents the estimated MIPS eligibility status and the
associated PFS allowed charges for the 2020 MIPS performance period
after using Quality Payment Program Year 1 data and applying the
proposed policies for the 2020 MIPS performance period.
For the purposes of modeling, we made assumptions on group
reporting to apply the low-volume threshold. One extreme and unlikely
assumption is that no practices elect group reporting and the low-
volume threshold would always be applied at the individual level.
Although we believe a scenario in which only these clinicians would
participate as individuals is unlikely, this assumption is important
because it quantifies the minimum number of MIPS eligible clinicians.
For this proposed rule model, we estimate there were approximately
221,000 clinicians \146\ who would be MIPS eligible because they exceed
the low volume threshold as individuals and are not otherwise excluded.
In Table 113, we identify clinicians under this assumption as having
``required eligibility.''
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\146\ The count of 220,981 MIPS eligible clinicians for required
eligibility includes those who participated in MIPS (203,027 MIPS
eligible clinicians), as well as those who did not participate
(17,954 MIPS eligible clinicians).
---------------------------------------------------------------------------
We anticipate that groups that submitted to MIPS as a group will
continue to do so for the CY 2020 MIPS performance period. Using this
group assumption and including those identified with MIPS APM entities
in our scoring model, we increased the number of MIPS eligible
clinicians by 566,000 clinicians. In Table 113, we identify these
clinicians who do not meet the low-volume threshold individually but
are anticipated to submit to MIPS as a group or MIPS APM as having
``group eligibility.'' With the availability of CY 2017 Quality Payment
Program Year 1 data, we can identify group reporting through the
submission of improvement activities, Promoting Interoperability, or
quality performance category data.
To model the opt-in policy finalized in the CY 2019 PFS final rule
(83 FR 59735), we assumed that 33 percent of the clinicians who exceed
at least one but not all low-volume threshold criteria and submitted
data to CY 2017 MIPS performance period would elect to opt-in to MIPS.
We selected a random sample of 33 percent of clinicians without
accounting for performance. We believe this assumption of 33 percent
opt-in participation is reasonable because some clinicians may choose
not to submit data due to performance, practice size, or resources or
alternatively, some may submit data, but elect to be a voluntary
reporter and not be subject to a MIPS payment adjustment based on their
performance. This 33 percent participation assumption is identified in
Table 113 as ``Opt-In eligibility''. In this proposed rule analysis, we
estimate an additional 31,000 clinicians would be eligible through this
policy for a total MIPS eligible population of approximately 818,000.
The leads to an associated $68 billion allowed PFS charges estimated to
be included in the 2020 MIPS performance period.
BILLING CODE 4120-01-P
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There are approximately 386,000 clinicians who are not MIPS
eligible, but could be if their practice decides to participate or they
elect to opt-in. We describe this group as ``Potentially MIPS
eligible''. These clinicians would be included as MIPS eligible in the
unlikely scenario in which all group practices elect to submit data as
a group and all clinicians that could elect to opt-into MIPS do elect
to opt-in. This assumption is important because it quantifies the
maximum number of MIPS eligible clinicians. When this unlikely scenario
is modeled, we estimate that the MIPS eligible clinician population
could be as high as 1.2 million clinicians.
Finally, there are some clinicians who would not be MIPS eligible
either
[[Page 40897]]
because they or their group are below the low-volume threshold on all
three criteria (approximately 77,000) or because they are excluded for
other reasons (approximately 203,000).
Since eligibility among many clinicians is contingent on submission
to MIPS as a group, APM participation or election to opt-in, we will
not know the number of MIPS eligible clinicians until the submission
period for the 2020 MIPS performance period is closed. For this impact
analysis, we used the estimated population of 818,391 MIPS eligible
clinicians described above.
c. Estimated Impacts on Payments to MIPS Eligible Clinicians
(1) Summary of Approach
In sections III.K.3.c., III.K.3.d. and III.K.3.e. of this proposed
rule, we present several proposals which impact the measures and
activities that impact the performance category scores, final score
calculation, and the MIPS payment adjustment. We discuss these changes
in more detail in section VI.E.10.c.(2) of this RIA as we describe our
methodology to estimate MIPS payments for the 2022 MIPS payment year.
We note that many of the MIPS policies from the CY 2019 Quality Payment
Program final rule were only defined for the 2019 MIPS performance
period and 2021 MIPS payment year (including the performance threshold,
the additional performance threshold, the policy for redistributing the
weights of the performance categories, and many scoring policies for
the quality performance category) which precludes us from developing a
baseline for the 2020 MIPS performance period and 2022 MIPS payment
year if there was no new regulatory action. Therefore, our impact
analysis looks at the total effect of the proposed MIPS policy changes
on the MIPS final score and payment adjustment for CY 2020 MIPS
performance period/CY 2022 MIPS payment year.
The payment impact for a MIPS eligible clinician is based on the
clinician's final score, which is a value determined by their
performance in the four MIPS performance categories: Quality, cost,
improvement activities, and Promoting Interoperability. As discussed in
section VI.E.10.c.(2) of this proposed rule, we used the most recently
available data from the Quality Payment Program which is generally data
submitted for the 2017 MIPS performance period. We will use 2018 MIPS
performance period data for the impact analysis in the final rule
should that data become available.
The estimated payment impacts presented in this proposed rule
reflect averages by practice size based on Medicare utilization. The
payment impact for a MIPS eligible clinician could vary from the
average and would depend on the combination of services that the MIPS
eligible clinician furnishes. The average percentage change in total
revenues that clinicians earn would be less than the impact displayed
here because MIPS eligible clinicians generally furnish services to
both Medicare and non-Medicare patients; this program does not impact
payment from non-Medicare patients. In addition, MIPS eligible
clinicians may receive Medicare revenues for services under other
Medicare payment systems, such as the Medicare Federally Qualified
Health Center Prospective Payment System, that would not be affected by
MIPS payment adjustment factors.
(2) Methodology To Assess Impact
To estimate participation in MIPS for the CY 2020 Quality Payment
Program for this proposed rule, we used CY 2017 Quality Payment Program
Year 1 performance period data. Our scoring model includes the 818,391
estimated number of MIPS eligible clinicians as described in section
VI.E.10.b.(1)(b) of this RIA.
To estimate the impact of MIPS on eligible clinicians, we generally
used the Quality Payment Program Year 1 submission data, including data
submitted for the quality, improvement activities, and Promoting
Interoperability (which was called advancing care information for the
2017 MIPS performance period) performance categories, CAHPS for MIPS
and CAHPS for ACOs, the total per capita cost measure, Medicare
Spending Per Beneficiary (MSPB) clinician measure and other data
sets.\147\ We calculated a hypothetical final score for the 2020 MIPS
performance period/2022 MIPS payment year for each MIPS eligible
clinician using score estimates described in this section for quality,
cost, Promoting Interoperability, and improvement activities
performance categories.
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\147\ 2016 PQRS and Value Modifier data was used for the
improvement score for the quality performance category. We also
incorporated some additional data sources when available to
represent more current data.
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We did not model virtual groups since we had fewer than 10 virtual
groups register for the 2019 performance period, which was not a
sufficiently large number of virtual groups to model separately for
this RIA. We will revisit modeling virtual groups separately once we
receive virtual group submissions in future years.
(a) Methodology To Estimate the Quality Performance Category Score
We estimated the quality performance category score using a similar
methodology described in the CY 2019 PFS final rule (83 FR 60053
through 60054) with the following modifications that reflect the newly
proposed policies for the 2020 MIPS performance period and improvement
to our modeling methodology. As proposed in section
III.K.3.c.(1)(c)(ii) of this proposed rule, we increased the data
completeness requirement for the CY 2020 performance period from 60
percent to 70 percent.
We also applied modifications that were previously finalized
including the validation process that was finalized in the CY 2017
Quality Payment Program final rule (81 FR 77289 through 77291) and
applying the topped out scoring cap that was finalized (82 FR 53721
through 53727) to the measures subject to the scoring cap for the 2019
MIPS performance period.
Finally, our model applied the APM scoring standard policies
finalized in the CY 2019 PFS final rule (83 FR 59754) as modified by
the proposals in section III.K.3.c.(5)(c)(i)(B) of this proposed rule
to MIPS eligible clinicians identified as being scored as a MIPS APM in
the eligibility section VI.E.10.b.(1)(b) of this proposed rule. As
described in section III.K.3.c.(5)(c)(i)(B) of this proposed rule, we
are proposing to apply a minimum score of 50 percent, or an `APM
Quality Reporting Credit', under the MIPS quality performance category
for certain APM entities participating in MIPS. In our model, this
proposed `APM Quality Reporting Credit' was implemented for APM
Entities that do not use Web Interface. We also propose in sections
III.K.3.c.(5)(c)(i)(A) of this proposed rule to calculate an aggregated
APM Entity quality score from submitted MIPS data by the participants
in an APM Entity if the APM quality data cannot be used.
As described in section VI.E.10.b.(1).(b). of this proposed rule,
we are using the 2019 predictive file that contains current
participation in MIPS APMs as of January 15, 2019, using all available
data to identify who is an APM participant. In the case of MIPS APM
entities that report Web Interface, if the APM Entity existed in 2017,
we calculated a score based on the Web Interface submission from the
2017 performance period. If the APM Entity did submit Web Interface
data for the 2017 performance period, we calculated an aggregate score
based on individual
[[Page 40898]]
submissions similar to how we estimate aggregate scores for MIPS APM
entities that do not utilize Web Interface. If the APM Entity is new
for 2019 (and therefore did not have the ability to submit Web
Interface for the 2017 performance period), we used the average Web
Interface score because we would anticipate the new APM Entities would
report quality using Web Interface in the future. For MIPS APMs that do
not utilize the Web Interface, we estimated the APM Entity quality
performance category score by taking the higher of the group and
individual quality scores for the clinicians in the APM Entity and
calculating the average for the APM Entity. Clinicians were assigned a
score of 0 if they did not submit quality data to MIPS. For the MIPS
APMs that do not utilize Web Interface only, we then applied the
proposed APM Quality Reporting Credit policy to add 50 percent to the
MIPS quality score for APM Entities submitting to MIPS as proposed in
section III.K.3.c.(5)(c)(i)(B) of this proposed rule. All quality
performance category scores would be capped at 100 percent after
receiving the 50 percent APM Quality Reporting Credit.
(b) Methodology To Estimate the Cost Performance Category Score
In section III.K.3.c(2)(b)(iii) of this proposed rule, we propose
to add 10 episode-based measures to the cost performance category
beginning with the 2020 performance period in addition to the 8
episode-based measures finalized in the CY 2019 PFS final rule (83 FR
59767). In section III.K.3.c.(2)(b)(v) of this rule, we propose to
revise the total per capita cost and MSPB clinician measures.
We estimated the cost performance category score using all measures
included in section III.K.3.c.(2)(b)(viii) of this proposed rule. The
total per capita cost measure performance was estimated based on the
proposed revised measure using claims data from October 2016 through
September 2017. The MSPB clinician measure performance was estimated
based on the proposed revised measure using claims data from January
through December of 2017. For the episode-based measures, we used the
specifications for the 8 episode-based measures finalized in the CY
2019 PFS final rule (83 FR 35902 through 35903), the proposed
specifications for the 10 new episode-based measures discussed in
section III.K.3.c.(2)(b)(iii) of this proposed rule and claims data
from January through December of 2017. Cost measures scored if the
clinicians or groups met or exceed the case volume: 20 for the total
per capita cost measure, 35 for MSPB clinician, 10 for procedural
episode-based measures, and 20 for acute inpatient medical condition
episode-based measures. The cost measures are calculated for both the
TIN/NPI and the TIN, except for the lower gastrointestinal hemorrhage
measure, which we propose in section III.K.3.c.(2)(vi)(B) of this
proposed rule to calculate only for groups. For clinicians
participating as individuals, the TIN/NPI level score was used if
available and if the minimum case volume was met. For clinicians
participating as groups, the TIN level score was used, if available,
and if the minimum case volume was met. For clinicians with no measures
meeting the minimum case requirement, we did not estimate a score for
the cost performance category, and the weight for the cost performance
category was reassigned to the quality performance category. The raw
cost measure scores were mapped to scores on the scale of 1-10, using
benchmarks based on all measures that met the case minimum and if the
group or clinician exceeded the low-volume threshold during the
relevant performance period. For the episode-based cost measures,
separate benchmarks were developed for TIN/NPI level scores and TIN
level scores. For each clinician, a cost performance category score was
calculated as the average of the measure scores available for the
clinician.
(c) Methodology To Estimate the Facility-Based Measurement Scoring
As finalized in the CY2019 PFS final rule (83 FR 59856), we
determine the eligible clinician's MIPS cost and quality performance
category score in facility-based measurement based on Hospital VBP
Program Total Performance Score for eligible clinicians or groups who
meet the eligibility criteria, which we designed to identify those who
primarily furnish services within a hospital. We estimate the facility-
based score using the scoring policies finalized in the CY2018 Quality
Payment Program final rule (82 FR 53763). In section III.K.3.d.(1)(c)
of this proposed rule, we are only proposing technical changes for
clarity and those changes do not affect the facility-based policies. In
the CY 2019 PFS final rule (83 FR 60054 through 60055), we were unable
to incorporate the facility-based logic fully into our model. For this
proposed rule, we have new datasets that allow us to more completely
model facility-based measurement.
We used data from the feedback reports for the first determination
period for the 2019 performance period, which is from October 1, 2017
to September 30, 2018 to attribute clinicians and groups to hospitals
and assign the specific Hospital VBP Program Total Performance Score.
Although the time period for facility-based eligibility does not align
with the MIPS eligibility and performance period data, these facility-
based eligibility data were used because we did not have attribution
data available for the matching performance period and the use of
actual attribution data was preferable to using proxy data. If a
Hospital VBP Program Total Performance Score could not be assigned to a
clinician, in instances in which the attributed facility does not
participate in the Hospital VBP program, that clinician was determined
as not eligible for facility-based measurement and assumed to
participate in MIPS via other methods. In some cases, a group or
clinician may have changed practices and would not have an associated
facility-based indicator in the feedback reports (because the feedback
reports used a different time period). In those cases, if the TIN or
TIN-NPI was facility-based in the 2017 MIPS performance period, we
estimated a facility-based score by taking the median MIPS quality and
cost performance score. We are not requiring eligible clinicians to
opt-in to facility-based measurement; it is possible that a MIPS
eligible clinician or a group is automatically eligible for facility-
based measurement, but they participate in MIPS as an individual or a
group. In these cases, we used the higher combined quality and cost
performance category score, as reflected in the final score, from
facility-based scoring compared to the combined quality and cost
performance category score from MIPS submission-based scoring.
(d) Methodology To Estimate the Promoting Interoperability Performance
Category Score
We estimated the Promoting Interoperability performance category
score using the methodology described in the CY 2019 PFS final rule (83
FR 60055) with the following modifications that reflect the newly
proposed policies for the 2020 MIPS performance period.
In section III.K.3.c.(4)(d)(i)(B)(aa) of this proposed rule, we
proposed to modify the Query of PDMP measure to a yes/no response. The
Query of PDMP measure was not modeled because the measure was not
available in the 2017 MIPS performance period submissions data.
In section III.K.3.c.(4)(f)(iii) of this proposed rule, we proposed
to revise the definition of hospital-based MIPS eligible clinician to
include groups and virtual groups. We also proposed that a
[[Page 40899]]
hospital-based MIPS eligible clinician under Sec. 414.1305 means an
individual MIPS eligible clinician who furnishes 75 percent or more of
his or her covered professional services in sites of service identified
by the POS codes used in the HIPAA standard transaction as an inpatient
hospital, on-campus outpatient hospital, off campus outpatient
hospital, or emergency room setting based on claims for the MIPS
determination period, and a group or virtual group provided that more
than 75 percent of the NPIs billing under the group's TIN or virtual
group's TINs, as applicable, meet the definition of a hospital-based
individual MIPS eligible clinician. In section III.K.3.c.(4)(f)(iv) of
this proposed rule, we proposed revisions to also account for a group
or virtual group that meets the definition of a non-patient facing MIPS
eligible clinician such that the group or virtual group only has to
meet a threshold of more than 75 percent. Also, as described in
sections III.K.3.c.(4)(f)(iii) and III.K.3.c.(4)(f)(iv) of this
proposed rule, we proposed to assign a zero percent weight for the
Promoting Interoperability performance category for groups defined as
hospital-based and non-patient facing, and redistribute the points
associated with the Promoting Interoperability performance category to
another performance category or categories. Therefore, in our impact
analysis model, a group was only assigned a zero percent weight for the
Promoting Interoperability performance category and the points for
Promoting Interoperability performance category was redistributed if:
(1) All the TIN/NPIs were eligible for reweighting as established at
Sec. 414.1380(c)(2)(iii) for MIPS eligible clinicians submitting data
as a group or virtual group, or (2) the group met the proposed revised
definition of a hospital-based MIPS eligible clinician as proposed in
section III.K.3.c.(4)(f)(iii) of this proposed rule or the definition
of a non-patient facing MIPS eligible clinician, as proposed in section
III.K.3.c.(4)(f)(iv) of this proposed rule, as defined in Sec.
414.1305. We also incorporated into our model the proposed policy to
continue automatic reweighting for NPs, PAs, CNSs and CRNAs, physical
therapists, occupational therapist, speech-language pathologists,
audiologists, clinical psychologists, and registered dietitians or
nutrition professionals as described in sections III.K.3.c.(4)(f)(i)
and III.K.3.c.(4)(f)(ii) of this proposed rule.
In our model, for the APM participants identified in section
VI.E.10.b.(1).(b).of this proposed rule, we simulated MIPS APM Entity
scores by using submitted Promoting Interoperability data by groups or
individuals that we identified as being in a MIPS APM to calculate an
APM Entity score.
All other proposed policies for the Promoting Interoperability
performance category described in section III.K.3.c.(4) of this
proposed rule did not impact our modeling methodology for this
performance category because either the data were not available in the
2017 MIPS performance period submissions data or the proposed changes
reflect the modeling strategy previously used and described in the CY
2019 PFS final rule (83 FR 60055). For example, since the Verify Opioid
Treatment Agreement measure was not modeled in the CY 2019 PFS final
rule (83 FR 60055) because the measure was not available in the 2017
MIPS performance period submissions data, the proposed removal of this
measure did not impact our impact analysis methodology for this
proposed rule.
(e) Methodology To Estimate the Improvement Activities Performance
Category Score
We modeled the improvement activities performance category score
based on CY 2017 Quality Payment Period Year 1 data and APM
participation in the 2017 MIPS performance period. In section
III.K.3.c.(3)(d)(iii) of this proposed rule, we are proposing to
increase the minimum number of clinicians in a group or virtual group
who are required to perform an improvement activity to 50 percent for
the improvement activities performance category beginning with the CY
2020 performance year and future years. We did not incorporate this
proposed change into our model because we did not have the information
to model this proposal. For the APM participants identified in section
VI.E.10.b.(1)(b) of this proposed rule, we assigned an improvement
activity performance category score of 100 percent.
Clinicians and groups not participating in a MIPS APM were assigned
their CY 2017 Quality Payment Program Year 1 improvement activities
performance category score.
(f) Methodology To Estimate the Complex Patient Bonus
In section III.K.3.d.(2)(a) of this proposed rule, we are proposing
to continue the complex patient bonus. Consistent with the policy to
define complex patients as those with high medical risk or with dual
eligibility, our scoring model used the complex patient bonus
information calculated for the 2018 performance period data, because
this variable was available in time for the publication of this
proposed rule. If the clinician did not have a complex patient bonus
score from the 2018 performance period data (because the bonus was from
a different performance period), we proxied a score using the methods
described in the CY 2019 PFS final rule (83 FR 59869) to supplement the
gap in data.
(g) Methodology To Estimate the Final Score
As proposed in sections III.K.3.c.(1)(b), III.K.3.c.(2)(a), and
summarized in section III.K.3.d.(2)(b) of this proposed rule, our model
assigns a final score for each TIN/NPI by multiplying each performance
category score by the corresponding performance category weight, adding
the products together, multiplying the sum by 100 points, and adding
the complex patient bonus. After adding any applicable bonus for
complex patients, we reset any final scores that exceeded 100 points
equal to 100 points. For MIPS eligible clinicians who were assigned a
weight of zero percent for the Promoting Interoperability due to a
significant hardship or other type of exception, the weight for the
Promoting Interoperability performance category was redistributed to
the quality performance category. For MIPS eligible clinicians who did
not have a cost performance category score, the weight for the cost
performance category was redistributed to the quality and Promoting
Interoperability performance categories.
In our scoring model, we did not address scenarios where a zero
percent weight would be assigned to the quality performance category or
the improvement activities performance category. We applied the
remaining reweighting scenarios described in detail in section
III.K.3.d.(2)(b)(ii) of this proposed rule and in the CY 2019 PFS Final
Rule (83 FR 59871 through 83 FR 59878).
(h) Methodology To Estimate the MIPS Payment Adjustment
As described in the CY 2018 Quality Payment Program final rule (82
FR 53785 through 53787), we applied a hierarchy to determine which
final score should be used for the payment adjustment for each MIPS
eligible clinician when more than one final score is available (for
example if a clinician qualifies for a score for an APM entity and a
group score, we select the APM entity score).
We then calculated the parameters of an exchange function in
accordance
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with the statutory requirements related to the linear sliding scale,
budget neutrality, minimum and maximum adjustment percentages and
additional payment adjustment for exceptional performance (as finalized
under Sec. 414.1405), using a performance threshold of 45 points and
the additional performance threshold of 80 points (as proposed in
sections III.K.3.e.(2) and III.K.3.e.(3) of this proposed rule). We
used these resulting parameters to estimate the positive or negative
MIPS payment adjustment based on the estimated final score and the paid
amount for covered professional services furnished by the MIPS eligible
clinician. We considered other performance thresholds which are
discussed in section VI.F.2. of this RIA.
(3) Impact of Payments by Practice Size
Using the assumptions provided above, our model estimates that $586
million would be redistributed through budget neutrality and that $500
million would be distributed to MIPS eligible clinicians that meet or
exceed the additional performance threshold. The model further
estimates that the maximum positive payment adjustments are 5.8 percent
after considering the MIPS payment adjustment and the additional MIPS
payment adjustment for exceptional performance.
Table 114 shows the impact of the payment adjustments by practice
size and based on whether clinicians are expected to submit data to
MIPS. We estimate that a smaller proportion of clinicians in small
practices (1-15 clinicians) who participate in MIPS will receive a
positive or neutral payment adjustment compared to larger sized
practices. In aggregate, the cohort of clinicians in small practices
participating in MIPS and who submit to MIPS receive a 0.9 percent
increase in total paid amount, which is lower than the comparative
payment increases received by the cohort of MIPS eligible clinicians in
larger-sized practices. Table 114 also shows that 87.3 percent of MIPS
eligible clinicians that participate in MIPS are expected to receive
positive or neutral payment adjustments. We want to highlight that we
are using 2017 performance period submissions data for these
calculations, and it is likely that there will be changes that we
cannot account for at this time. For example, the 2017 performance
period was the first year of the program, and it was considered a
``Pick Your Pace'' year of participation. With ``Pick Your Pace'',
clinicians could begin slowly participating in MIPS at their own pace
by determining how much data to submit and their level of
participation. Specifically, the performance threshold was set at 3
points, and submission of one quality measure or attesting to one
improvement activity would allow a clinician to meet or exceed the
performance threshold. In the second and third years of the program,
the performance thresholds increased, along with the data submission
requirements to avoid a negative payment adjustment. At this time, we
are not able to estimate the impact of these policy changes using Year
1 performance period data, but we anticipate having additional
information based on 2018 (year 2) data submissions when conducting the
impact analysis for the final rule.
The combined impact of negative and positive adjustments and the
additional positive adjustments for exceptional performance as a
percent of paid amount among those that do not submit data to MIPS was
not the maximum negative payment adjustment of 9 percent possible
because these clinicians do not all receive a final score of zero.
Indeed, some MIPS eligible clinicians that do not submit data to MIPS
may receive final scores above zero through performance on the cost
performance category, which utilizes administrative claims data and
does not require separate data submission to MIPS. Among those who we
estimate would not submit data to MIPS, 90 percent are in small
practices (16,116 out of 17,954 clinicians who do not submit data). To
address participation concerns, we have policies targeted towards small
practices including technical assistance and special scoring policies
to minimize burden and facilitate small practice participation in MIPS
or APMs. We also note this participation data is generally based off
participation for the 2017 performance period and that participation
may change for the 2020 performance period. As stated above, the 2017
performance period was the first year of MIPS, which was a ``Pick Your
Pace'' year, and we believe that the level of participation and amount
of data submitted will likely change in ensuing years. For example, we
note in section III.K.1.a. of this proposed rule that we have published
participation rates for the 2018 performance period and those rates
differ from the 2017 performance period participation rates, where a
slight increase in participation was observed. We did not have the
submission data in time for this analysis, but we intend to update our
data for the final rule.
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e. Potential Costs of Compliance With the Promoting Interoperability
and Improvement Activities Performance Categories for Eligible
Clinicians
(1) Potential Costs of Compliance With Promoting Interoperability
Performance Category
In section III.K.3.c.(4)(d)(i)(B)(aa) of this proposed rule, we
propose to allow clinicians and groups to satisfy the optional bonus
Query of PDMP measure by submitting a ``yes/no'' attestation, rather
than reporting a numerator and denominator. As discussed in the
Collection of Information section of this proposed rule, we are not
changing our burden assumptions to account for this proposal due to a
lack of information regarding the number of clinicians reporting bonus
measures combined with our currently approved burden estimates being
based only on the reporting of required measures. However, we do
believe that for clinicians or groups who report this measure, there
will be a reduction in reporting burden compared to what would have
been required to submit the measure without this proposed change
related to the elimination of the need to perform calculations prior to
submitting a numerator and denominator. As data availability allows, we
will reassess the inclusion of this burden in the Collection of
Information in the future.
In sections III.K.3.g.(3)(a)(i) and III.K.3.g.(4)(a)(i) of this
rule, beginning with the 2021 performance period and for future years,
we are proposing to require QCDRs and qualified registries to support
three performance categories: Quality, improvement activities, and
Promoting Interoperability. In the Collection of Information section,
we discussed the potential burden reduction associated with simplifying
MIPS reporting for clinicians who currently utilize qualified
registries or QCDRs that have not previously offered the ability to
report Promoting Interoperability or improvement activity data. We
believe it is also possible that some MIPS eligible clinicians may
elect to begin utilizing qualified registries or QCDRs as a result this
proposed policy and its potential for simplifying their MIPS reporting
combined with the benefits of improving the quality of care provided to
their patients. We do not have information with which to estimate the
number of clinicians who may pursue this option, therefore we cannot
quantify the associated costs, cost savings, and benefits consistent
with the CY 2018 Quality Payment Program final rule (82 FR 53946).
(2) Potential Costs of Compliance With Improvement Activities
Performance Category
In section III.K.3.c.(3)(d)(iii) of this proposed rule, we are
proposing, beginning with the 2020 MIPS performance period and for
future years, to increase the minimum number of clinicians in a group
or virtual group who are required to perform an improvement activity
from at least one clinician to at least 50 percent of the NPIs billing
under the group's TIN or virtual group's TINs, as applicable; and these
NPIs must perform the same activity for the same continuous 90 days in
the performance period. In addition, we are proposing changes to the
[[Page 40902]]
Improvement Activities Inventory to: (1) Establish removal factors to
consider when proposing to remove improvement activities from the
Inventory; (2) remove 15 improvement activities for the CY 2020
performance period and future years contingent on our proposed removal
factors being finalized; (3) modify 7 existing improvement activities
for the CY 2020 performance period and future years; and (4) add two
new improvement activities for the CY 2020 performance period and
future years.
Given groups' familiarity with the improvement activities in the
Improvement Activities Inventory, we assume that a group would find
applicable and meaningful activities to complete that are not specific
to practice size, specialty, or practice setting and would apply to at
least 50 percent of individual MIPS eligible clinicians in the group.
Therefore, an increase in the minimum threshold for a group to receive
credit for the improvement activities performance category should not
present additional complexity or burden. We also anticipate that the
vast majority of clinicians performing improvement activities, to
comply with existing MIPS policies, would continue to perform the same
activities under the policies established in this proposed rule because
previously finalized improvement activities continue to apply for the
current and future years unless otherwise modified per rule-making (82
FR 54175). Most of the improvement activities in Improvement Activities
Inventory remain unchanged for the 2020 MIPS performance period and
most clinicians are likely to have selected improvement activities that
were unaffected by the changes. Of the activities that were removed,
modified, or added, many were duplicative which means many clinicians
or groups would be able to continue the activity, but it would be
reported under a different activity in the Improvement Activities
Inventory.
Our proposal to establish removal factors when proposing to remove
improvement activities from the Improvement Activities Inventory would
provide guidance for clinicians or groups on the considerations for the
removal of improvement activities and would not present additional
burden. The proposed changes to the Improvement Activities Inventory
that include the modification, removal, and addition of improvement
activities provide clarity, avoid duplication, and provide more options
for clinicians to select improvement activities that are appropriate
for their clinical practice and would not present additional burden.
Furthermore, in this proposed rule, we are proposing to end and remove
the Study on Factors Associated with Reporting Quality Measures
beginning with the 2020 MIPS performance period. In the CY 2019 PFS
final rule, we finalized a sample size of 200 clinicians, each of which
completed a 15-minute survey both prior to and after submitting MIPS
data (83 FR 60058). As a result of ending the study, we estimate a
reduction in burden of 100 hours and $20,286 (200 clinicians x 0.5
hours x $202.86).
f. Potential Costs of Compliance for Third Party Intermediaries
Based on previously finalized policies in the CY 2017 Quality
Payment Program final rule (81 FR 77363 through 77364) and as further
revised in the CY 2019 PFS final rule at Sec. 414.1400(a)(2) (83 FR
60088), the current policy is that all third party intermediaries may
submit data for any of the three MIPS performance categories quality
(except for data on the CAHPS for MIPS survey); improvement activities;
and Promoting Interoperability. As previously discussed in section
III.K.3.g.(3)(a)(i) and III.K.3.g.(4)(a)(i) of this proposed rule,
beginning with the 2021 performance period and for future years, we are
proposing to require QCDRs and qualified registries to support three
performance categories: Quality, improvement activities, and Promoting
Interoperability. In section III.K.3.g.(1), we further state that we
anticipate using the QCDR and qualified registry self-nomination
vetting process to assess which of these entities will be subject to
the proposed requirement to support reporting the Promoting
Interoperability performance category and which entities would be
subject to an exception based on which clinician types they serve and
whether those clinician types are eligible for reweighting of the
Promoting Interoperability performance category as discussed in section
III.K.3.c.(4). Based on our review of qualified registries and QCDRs
approved to submit data for the 2019 MIPS performance period, 70
percent of qualified registries and 72 percent of QCDRs already offer
support for the quality, improvement activities, and Promoting
Interoperability performance categories. We believe this proposal could
result in the remaining qualified registries and QCDRs incurring
additional costs to upgrade information technology systems in order to
make this ability available to clinicians, with less cost incurred by
entities who would be subject to an exception for the Promoting
Interoperability performance category. However, given that each of
these entities and their information technology systems are unique, and
there is no method of determining which entities may have already begun
the process of developing this ability, we are unable to determine the
impact of transitioning from allowing this ability as an option to
requiring it. Also, given that the majority of these entities have
already begun offering the ability to submit data on behalf of the
improvement activities and Promoting Interoperability performance
categories, we assume they have done so because they believe the
benefits outweigh the costs and is therefore, in their best financial
interests to do so.
We are also proposing in section III.K.3.g.(3)(a)(ii) of this
proposed rule, beginning with the 2021 performance period, to require
qualified registries and QCDRs to provide the following as part of the
performance feedback given at least 4 times a year: Feedback to their
clinicians and groups on how they compare to other clinicians who have
submitted data on a given measure (MIPS quality measure and/or QCDR
measure) within the QCDR. We understand that QCDRs can only provide
feedback on data they have collected on their clinicians and groups,
and realize the comparison would be limited to that data and not
reflect the larger sample of those that have submitted on the measure
for MIPS, which the QCDR does not have access to. As finalized in the
CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77367
through 77386 and 82 FR 53812), qualified registries and QCDRs are
required to provide feedback on all of the MIPS performance categories
that the qualified registry or QCDR reports at least 4 times a year.
Given that we are not proposing a significant change but are instead
proposing to modify and strengthen the existing policy, we do not
anticipate a significant increase in cost or effort for Third Party
Intermediaries to comply with this proposal. In alignment with our
proposal above, we are also proposing to require QCDRs to provide
services to clinicians and groups to foster improvement in the quality
of care provided to patients, by providing educational services in
quality improvement and leading quality improvement initiatives.
Similar to the requirement to support submission of Promoting
Interoperability and improvement activity data, we believe this
proposal could result in QCDRs incurring additional costs. We are
unable to create a baseline of current service offerings for each QCDR,
which would be needed in order to determine
[[Page 40903]]
the incremental costs associated with providing any additional services
required by this proposal. We believe that by offering these services,
additional MIPS eligible clinicians may be encouraged to utilize these
entities, thereby increasing membership and potentially offsetting some
of the costs the QCDR would have to incur.
In section III.K.3.g.(3)(c)(i)(B)(cc), we are proposing that in
order for a QCDR measure to be considered for use in the program
beginning with the 2021 performance period and future years, all QCDR
measures submitted for self-nomination must be fully developed with
completed testing results at the clinician level, as defined by the CMS
Blueprint for the CMS Measures Management System, as used in the
testing of MIPS quality measures prior to the submission of those
measures to the Call for Measures. Beginning with the 2021 performance
period and future years, we are proposing in section
III.K.3.g.(3)(c)(i)(B)(dd) to also require QCDRs to collect data on the
potential QCDR measure, appropriate to the measure type, as defined in
the CMS Blueprint for the CMS Measures Management System, prior to
self-nomination. The testing process for quality measures is dependent
on the measure type (for example, a measure that is specified as an
eCQM measure has additional steps it must undergo when compared to
other measure types). The National Quality Forum (NQF) has developed
guides for measure testing criteria and standards which further
illustrate these differences based on measure type.\148\ Additionally,
the costs associated with testing vary based on the complexity of the
measure and the developing organization. The Journal of the American
Medical Association states that the costs associated with quality
measures are generally unknown or unreported.\149\ While we understand
the proposed policy will result in additional costs for QCDRs to
develop measures, given the uncertainty regarding the number and types
of measures that will be proposed in future performance periods coupled
with the lack of available cost data on measure development and
testing, we are unable to determine the financial impact of this
proposal on QCDRs beyond the likelihood of it being more than trivial.
Likewise, we understand that some QCDRs already perform measure testing
prior to submission for approval while others do not. This variability
makes it difficult to estimate the incremental impact of this
regulation.
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\148\ http://www.qualityforum.org/Measuring_Performance/Submitting_Standards.aspx.
\149\ Schuster, Onorato, and Meltzer. ``Measuring the Cost of
Quality Measurement: A Missing Link in Quality Strategy'', Journal
of the American Medical Association. 2017; 318(13):1219-1220.
https://jamanetwork.com/journals/jama/fullarticle/2653111?resultClick=1.
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In section III.K.3.g.(3)(c)(i)(A)(bb) of this rule, we are
proposing to amend Sec. 414.1400 to state that CMS may consider the
extent to which a QCDR measure is available to MIPS eligible clinicians
reporting through QCDRs other than the QCDR measure owner for purposes
of MIPS. If CMS determines that a QCDR measure is not available to MIPS
eligible clinicians, groups, and virtual groups reporting through other
QCDRs, CMS may not approve the measure. Because the choice to license a
QCDR measure is an elective business decision made by individual QCDRs
and we have little insight into both the specific terms and frequency
of agreements made between entities, we are unable to account for the
financial impact of licensing QCDR measures for each QCDR. In aggregate
across all QCDRs, the financial impact would be zero as fees paid by
one QCDR will be collected by another QCDR.
In section III.K.3.g.(3)(c)(i)(B)(ee) of this rule, we propose,
beginning with the 2020 performance period, that after the self-
nomination period closes each year, we will review newly self-nominated
and previously approved QCDR measures based on considerations as
described in the CY 2019 PFS final rule (83 FR 59900 through 59902). In
instances in which multiple, similar QCDR measures exist that warrant
approval, we may provisionally approve the individual QCDR measures for
1 year with the condition that QCDRs address certain areas of
duplication with other approved QCDR measures in order to be considered
for the program in subsequent years. The QCDR could do so by
harmonizing its measure with, or significantly differentiating its
measure from, other similar QCDR measures. QCDR measure harmonization
may require two or more QCDRs to work collaboratively to develop one
cohesive QCDR measure that is representative of their similar yet,
individual measures. We are unable to account for the financial impact
of measure harmonization, as the process and outcomes will likely vary
substantially depending on a number of factors, including: Extent of
duplication with other measures, number of QCDRs involved in
harmonizing toward a single measure, and number of measures being
harmonized among the same QCDRs. We intend to identify only those QCDR
measures which are duplicative to such an extent as to assume
harmonization will not be overly burdensome, however, because the
harmonization process will occur between QCDRs without our involvement,
we are unable to predict or quantify the associated effort.
We understand that some QCDRs may believe the proposals to require
measure harmonization and encourage QCDRs to license their measures to
other QCDRs as a consideration for measure approval may result in a
reduced ability for QCDRs to differentiate themselves in the
marketplace. We note that in addition to the suite of measures offered
by a QCDR and their relevance to individual clinicians and groups, ease
of incorporating a QCDR's measures into existing practice workflows, as
well as integration into broader quality improvement programs are two
examples of distinguishing characteristics for clinicians to consider
when selecting a QCDR. In addition, clinicians may also consider cost
(if any); recommendations, support, or endorsements from specialty
societies; the number of other users submitting data to the QCDR; the
specific educational services and quality improvement initiatives
offered; and the specific performance feedback information provided as
part of the required reports provided at least 4 times a year. We
believe that the impact these proposals may have on the perceived
differentiated value of certain QCDRs is counterbalanced by the need to
promote more focused quality measure development towards outcomes that
are meaningful to patients, families and their providers.
In this proposed rule, we are proposing to formalize a number of
factors we would take into consideration for approving and rejecting
QCDR measures for the MIPS program beginning with the 2020 performance
period and future years. With regard to approving QCDR measures, we are
proposing the following: (1) 2-year QCDR measure approval process, and
(2) participation plan for existing QCDR measures that have failed to
reach benchmarking thresholds.
As discussed in section III.K.3.g.(3)(c)(ii)(B), we are proposing
to implement, beginning with the 2021 performance period, 2-year QCDR
measure approvals (at our discretion) for QCDR measures that attain
approval status by meeting the QCDR measure considerations and
requirements described in section III.K.3.g.(3)(c). The 2-year
approvals would be subject to the following conditions whereby the
multi-year approval will no longer apply if the QCDR measure is
identified as: Topped
[[Page 40904]]
out; duplicative of a new, more robust measure; reflects an outdated
clinical guideline; requires measure harmonization, or if the QCDR
self-nominating the measure is no longer in good standing. We believe
this will result in reduced burden for QCDRs as they will no longer be
required to submit each measure for approval annually. However, because
we are unable to predict which previously approved QCDR measures will
be removed or retained in future years, we are likewise unable to
predict the impact on future burden associated with QCDRs submitting
measures for approval. Beginning with the 2021 performance period, we
are proposing that in instances where an existing QCDR measure has been
in MIPS for 2 years and has failed to reach benchmarking thresholds due
to low adoption, where the QCDR believes the low-reported QCDR measure
is still important and relevant to a specialist's practice, that the
QCDR may submit to CMS a QCDR measure participation plan, to be
submitted as part of their self-nomination. Because we are unable to
predict the frequency with which existing QCDR measures will meet the
proposed criteria for allowing QCDRs to submit a measure participation
plan or the likelihood of QCDRs electing to submit a plan, we are
unable to estimate the impact associated with this proposal.
As discussed in section III.K.3.g.(3)(c)(i)(B)(bb) of this proposed
rule, beginning with the 2021 performance period and future years, we
are proposing that QCDRs must identify a linkage between their QCDR
measures to the following, at the time of self-nomination: (a) Cost
measures (as found in section III.K.3.c.(3) of this proposed rule), (b)
improvement activities (as found in Appendix 2: Improvement Activities
Tables), or (c) CMS developed MIPS Value Pathways (as described in
section III.K.3.a. of this proposed rule). We do not assume any
additional impact beyond the 1 hour per QCDR measure discussed in the
Collection of Information section.
g. Assumptions & Limitations
We note several limitations to our estimates of MIPS eligible
clinicians' eligibility and participation, negative MIPS payment
adjustments, and positive payment adjustments for the 2022 MIPS payment
year. We based our analyses on the data prepared to support the 2018
performance period initial determination of clinician and special
status eligibility (available via the NPI lookup on qpp.cms.gov),\150\
participant lists using the 2019 predictive APM Participation List,
which contains the 2018 fourth snapshot and any additional TIN/NPIs
until January 15, 2019, CY 2017 Quality Payment Program Year 1 data and
CAHPS for ACOs. The scoring model results presented in this proposed
rule assume that CY 2017 Quality Payment Program Year 1 data
submissions and performance are representative of CY 2020 Quality
Payment Program data submissions and performance. The estimated
performance for CY 2020 MIPS performance period using Quality Payment
Program Year 1 data may be underestimated because the performance
threshold to avoid a negative payment adjustment for the 2017 MIPS
performance period/2019 MIPS payment year was significantly lower (3
out of 100 points) than the performance threshold for the 2020 MIPS
performance period/2022 MIPS payment year (45 out of 100). We
anticipate clinicians may submit more performance categories to meet
the higher performance threshold to avoid a negative payment
adjustment.
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\150\ The time period for this eligibility file (September 1,
2016 to August 31, 2017) maximizes the overlap with the performance
data in our model.
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In our MIPS eligible clinician assumptions, we assumed that 33
percent of the opt-in eligible clinicians that participated in the CY
2017 Quality Payment Program Year 1 would elect to opt-in to the MIPS
program. It is difficult to predict whether clinicians will elect to
opt-in to participate in MIPS with the proposed policies.
There are additional limitations to our estimates: (1) Because we
used historic data, we assumed participation in the three performance
categories in MIPS Year 1 would be similar to MIPS Year 4 performance;
and (2) to the extent that there are year-to-year changes in the data
submission, volume and mix of services provided by MIPS eligible
clinicians, the actual impact on total Medicare revenues will be
different from those shown in Table 114. Due to the limitations
described, there is considerable uncertainty around our estimates that
is difficult to quantify in detail.
F. Alternatives Considered
This proposed rule contains a range of policies, including some
provisions related to specific statutory provisions. The preceding
preamble provides descriptions of the statutory provisions that are
addressed, identifies those policies when discretion has been
exercised, presents rationale for our proposed policies and, where
relevant, alternatives that were considered. For purposes of the
payment impact on PFS services of the policies contained in this
proposed rule, we presented the estimated impact on total allowed
charges by specialty. The alternatives we considered, as discussed in
the preceding preamble sections, would result in different payment
rates, and therefore, result in different estimates than those shown in
Table 110 (CY 2020 PFS Estimated Impact on Total Allowed Charges by
Specialty).
1. Alternatives Considered Related to Medicare Coverage for Opioid Use
Disorder Treatment Services Furnished by Opioid Treatment Programs
We considered several possibilities for pricing the oral
medications, namely methadone and buprenorphine (oral), included in the
OTP payment bundles. As described in section II.G. of this proposed
rule, we are proposing to use ASP-based payment for oral OTP drugs;
however, in the event we do not receive manufacturer-submitted ASP
pricing data for these drugs, we are also considering several other
alternative pricing mechanisms to determine the pricing of the drug
components of the bundles that include these medications, including the
methodology under Section 1847A of the Act; Medicare Part D
Prescription Drug Plan Finder data; WAC; and NADAC data. For methadone,
we also consider an alternative using the TRICARE payment rate for
methadone in its OTP bundled payment. In Table 14, we display the
estimated initial drug payment rates for the proposed pricing approach
for the oral drugs and each of the alternatives, based on data files
posted at the time of the drafting of this proposed rule. We used the
TRICARE payment rate for methadone to estimate the payment rates for
the methadone payment bundles and NADAC data to estimate the payment
rates for the buprenorphine (oral) payment bundles, and to derive the
impact estimates.
For methadone, we believe using Medicare Part D Prescription Drug
Plan Finder Data to price the medication would have minimal impact on
the RIA estimate since the rate is very close to the TRICARE payment
rate. Using WAC-based pricing for methadone would likely increase the
impact estimate marginally since WAC-based pricing is slightly higher
than the TRICARE payment rate. Since NADAC pricing for methadone is
significantly less than the TRICARE payment rate, using NADAC pricing
would significantly decrease the impact estimates, especially because
the
[[Page 40905]]
vast majority of patients receiving OUD treatment services at OTPs are
receiving methadone.
For buprenorphine (oral), the Medicare Part D Prescription Drug
Plan Finder data is very similar to NADAC pricing. Therefore we believe
there would be minimal changes in the estimated impacts from using this
alternative data source. Since WAC-based pricing is slightly higher
than NADAC pricing, we note that using WAC-based pricing would increase
the estimated impacts marginally.
We also considered several alternatives for the update factor used
in updating the payment rates for the non-drug component of the bundled
payment for OUD treatment services, including the Bureau of Labor
Statistics Consumer Price Index for All Items for Urban Consumers (CPI-
U) (Bureau of Labor Statistics #CUUR0000SA0 (https://www.bls.gov/cpi/data.htm)) and the IPPS hospital market basket reduced by the
multifactor productivity adjustment. Based on a CMS forecast of
projected rates, we believe that the projected MEI and CPI-U rates are
anticipated to be similar, and thus using the CPI-U as an update factor
would have minimal effect on estimated impacts. Since the projected
IPPS hospital market basket rate is generally higher than the projected
MEI rate, using the IPPS hospital market basket rate would result in
higher estimated impacts.
2. Alternatives Considered Related to Payment for E/M Services
In developing our proposed policies for office/outpatient E/M
visits effective January 1, 2021, we considered a number of
alternatives. For reasons discussed in section II.P. of this proposed
rule, we did not include either the extended office/outpatient E/M
HCPCS code GPR01 or the single blended payment rates for combined visit
levels 2 through 4 that were finalized in the CY 2019 final rule for CY
2021 in our considerations. Our alternatives also did not include the
revaluation of global surgical services, as recommended by the AMA RUC,
which incorporated the revised office/outpatient E/M code values. We
note that in all of the alternatives we considered, the valuation for
all codes in the office/outpatient E/M code set would increase.
Therefore, all specialties for whom the office/outpatient codes
represent a significant portion of their billing would also see payment
increases while those specialties who do not report those codes would
see overall payment decreases. Any variation in the magnitude of the
increases or decreases are a result of a specialties overall billing
patterns.
We did, however, consider proposing to eliminate both add-on codes,
HCPCS code GCG0X and HCPCS code GPC1X, that were finalized in the CY
2019 final rule for CY 2021. Our stated rationale in the CY 2019 final
rule for developing HCPCS code GPC1X (83 FR 59625 through 59653) was to
more accurately account for the type and intensity of E/M work
performed in primary care-focused visits beyond the typical resources
reflected in the single payment rate for the levels 2 through 4 visits.
The reason for finalizing HCPCS code GCG0X, as stated in the CY 2019 FR
(83 FR 59625 through 59653) GCG0X was to reflect additional resource
costs for inherently complex services that are non-procedural. We
considered whether these two add-on codes would still be necessary in
the context of the revised descriptors and valuations for office/
outpatient E/M services. We considered an alternative, therefore, in
which we adopted the RUC's recommended values but excluded the two
HCPCS add-on G-codes. In reviewing the results of this policy option,
we observed that our concerns about capturing the work associated with
visits that are part of ongoing, comprehensive primary care and/or care
management for patients having a single, serious, or complex chronic
condition were still present. The specialty level impacts associated
with this alternative are displayed in Table 115. The specialties that
benefited most from this alternative, such as Endocrinology and
Rheumatology, are those that primarily bill levels 3-5 established
patient office/outpatient E/M visits, as those visit levels had the
greatest increases in valuation among the overall office/outpatient E/M
code set.
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We also considered, as an alternative, proposing CMS refinements to
the RUC recommendations for two of the CPT codes. Consistent with our
generally established policies for reviewing work RVUs recommended by
the RUC, we observed that the increase in work RVU for CPT codes 99212
and 99214 (levels 2 and 4 for established patients) seemed
disproportionate to the increase in total time for these services,
particularly in comparison with the work to time relationships among
the other seven E/M code revaluations. For CPT code 99212, we observed
that the total time for furnishing this service increased by 2 minutes
(13 percent increase), but that the recommended work RVU increased by
nearly 50 percent from 0.48 to 0.70. We reviewed other CPT codes with
similar times as the survey code and identified a potential crosswalk
to CPT code 76536 (Ultrasound, soft tissues of head and neck (eg,
thyroid, parathyroid, parotid), real time with image documentation),
with a work RVU of 0.56. We therefore considered decreasing the work
RVU for CPT code 99212 to 0.56. For CPT code 99214, the total time
increased from 40 to 49 minutes, which is a 23 percent change, while
the work RVU increased from 1.50 to 1.92 (28 percent increase). We
considered a crosswalk to CPT code 73206 (Computed tomographic
angiography, upper extremity, with contrast material(s), including
noncontrast images, if performed, and image postprocessing), with a
work RVU of 1.81 and total time of 50 minutes. The refinements we
considered for the RUC recommendations are shown in Table 116.
Table 116--Current, RUC Recommended and CMS Refined Office/Outpatient E/M Work RVUs
----------------------------------------------------------------------------------------------------------------
Alternative: CMS-refined
CPT/HCPCS Current work RVU (current) RUC-recommended work RVU work RVU
----------------------------------------------------------------------------------------------------------------
99201 0.48 NA NA
99202 0.93 0.93 0.93
99203 1.42 1.6 1.6
99204 2.43 2.6 2.6
99205 3.17 3.5 3.5
99211 0.18 0.18 0.18
99212 0.48 0.7 0.56
99213 0.97 1.3 1.3
99214 1.5 1.92 1.81
99215 2.11 2.8 2.8
99XXX NA 0.61 0.5
GPC1X 0.25 NA 0.33
GCG0X 0.25 NA 0.33
----------------------------------------------------------------------------------------------------------------
Table 117 illustrates the specialty level impacts of refining the
RUC recommendations. Under this alternative those specialties who
frequently bill CPT code 99212 or CPT code 99214, such as dermatology
and family practice, respectively, experience more modest increases
relative to other alternatives.
[[Page 40908]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.109
[[Page 40909]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.110
We also considered an alternative that reflected CMS refinements to
the three CPT codes as described above and also included the
consolidated, redefined and revalued HCPCS add-on G code, GPC1X.
Table 118 illustrates the specialty level impacts associated with
making refinements to the RUC recommended values for the office/
outpatient E/M code set and also making separate payment for HCPCS add-
on code GPC1X. These impacts are similar to what we are proposing, with
slight less positive impacts for those specialties who bill CPT codes
99212 or 99214.
[[Page 40910]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.111
[[Page 40911]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.112
BILLING CODE 4120-01-C
3. Alternatives Considered for the Quality Payment Program
For purposes of the payment impact on the Quality Payment Program,
we view the performance threshold and the additional performance
threshold, as the critical factors affecting the distribution of
payment adjustments. We ran two separate models with performance
thresholds of 35 and 50 respectively (as an alternative to the proposed
performance threshold of 45) to estimate the impact of a more moderate
and a more aggressive increase in the performance threshold. A lower
performance threshold would be a more gradual transition and could
potentially allow more clinicians to meet or exceed the performance
threshold. The lower performance threshold would lower the amount of
budget neutral dollars to redistribute and increase the number of
clinicians with a positive payment adjustment, but the scaling factor
would be lower. In contrast, a more aggressive increase would likely
lead to higher positive payment adjustments for clinicians that exceed
the performance threshold because the budget neutral pool would be
redistributed among fewer clinicians. We ran each of these models using
the proposed additional performance threshold of 80. In the model with
a performance threshold of 35, we estimate that $466 million would be
redistributed through budget neutrality. There would be a maximum
payment adjustment of 5.3 percent after considering the MIPS payment
adjustment and the additional MIPS payment adjustment for exceptional
performance. In addition, 8.2 percent of MIPS eligible clinicians would
receive a negative payment adjustment among those that submit data. In
the model with a performance threshold of 50, we estimate that $644
million would be redistributed through budget neutrality, and that
there would be a maximum payment adjustment of 6.1 percent after
considering the MIPS payment adjustment and the additional MIPS payment
adjustment for exceptional performance. In addition, 15.5 percent of
MIPS eligible clinicians would receive a negative payment adjustment
among those that submit data. We proposed a performance threshold of 45
because we believe increasing the performance threshold to 45 points
was not unreasonable or too steep, but rather a moderate step that
encourages clinicians to gain experience with all MIPS performance
categories. We refer readers to section III.K.3.e.(2) of this proposed
rule for additional rationale on the selection of the performance
threshold.
To evaluate the impact of modifying the additional performance
threshold, we ran two models with additional performance thresholds of
75 and 85 as an alternative to the proposed 80 points. We ran each of
these models using a performance threshold of 45. The benefit of the
model with the additional performance threshold of 75 would maintain
the additional performance threshold that was in year 3. In the model
with the additional performance threshold of 75, we estimate that $586
million would be redistributed through budget neutrality, and there
would be a maximum payment adjustment of 4.8 percent after considering
the MIPS payment adjustment and the additional MIPS payment adjustment
for exceptional performance. In addition, 12.7 percent of MIPS eligible
clinicians would receive a negative payment adjustment among those that
submit data. In the model with an additional performance threshold of
85, we estimate that $586 million would be redistributed through budget
neutrality, and that there would be a maximum payment adjustment of 8.3
percent after considering the MIPS payment adjustment and the
additional MIPS payment adjustment for exceptional performance among
those that submit data. Also, that 12.7 percent of MIPS eligible
clinicians will receive a negative payment adjustment among those that
submit data. We proposed the additional performance threshold at 80
points because we believe raising the additional performance threshold
would incentivize continued improved performance while accounting for
policy changes in the fourth year of the program. We refer readers to
section III.K.3.e.(3) of this proposed rule for additional rationale on
the selection of additional performance threshold.
G. Impact on Beneficiaries
1. Medicare PFS
There are a number of changes in this proposed rule that will have
an effect on beneficiaries. In general, we believe that many of these
changes, including those intended to improve accuracy in payment
through regular updates to the inputs used to calculate payments under
the PFS, will have a positive impact and improve the quality and value
of care provided to Medicare providers and beneficiaries.
2. Quality Payment Program
There are several changes in this rule that would have an effect on
beneficiaries. In general, we believe that many of these changes,
including those intended to improve accuracy in payment through regular
updates to the inputs used to calculate payments under the PFS, would
have a positive impact and improve the quality and value of care
provided to Medicare beneficiaries. For example, several of the new
[[Page 40912]]
proposed measures include patient-reported outcomes, which may be used
to help patients make more informed decisions about treatment options.
Patient-reported outcome measures provide information on a patient's
health status from the patient's point of view and may also provide
valuable insights on factors such as quality of life, functional
status, and overall disease experience, which may not otherwise be
available through routine clinical data collection. Patient-reported
outcomes are factors frequently of interest to patients when making
decisions about treatment. Similarly, our proposals in section
III.K.3.g.(2) of this rule will improve the caliber and value of QCDR
measures.
H. Burden Reduction Estimates
1. Payment for E/M Services
In the CY 2019 PFS final rule, we finalized proposals that we made
in response to comments received from RFIs released to the public under
our Patients Over Paperwork Initiative. Specifically, we finalized
proposals that focused on simplifying the medical documentation payment
framework for office/outpatient E/M services and allowing greater
flexibility on the components practitioners could choose to document
when billing Medicare for office/outpatient E/M visits. In that rule we
discussed the specific changes to documentation requirements and
estimated significant reductions in the amount of time that
practitioners would spend documenting office/outpatient E/M visits,
furthering our goal of allowing practitioners more time spent with
patients. As discussed earlier in section II.P. of this proposed rule,
we are proposing to adopt the revised office/outpatient E/M code set.
Our new proposals reflect our ongoing dialog with the practitioner
community and take into account the significant revisions the AMA/CPT
editorial panel has made to the guidelines for the office/outpatient E/
M code set. We note that as part of its efforts to revise the
guidelines, the AMA has also estimated a reduction in the amount of
time practitioners would spend documenting office/outpatient E/M
visits. The AMA asserts that its revisions to the office/outpatient E/M
code set will accomplish similar, albeit greater burden reduction in
comparison with CMS' approach, as finalized in the CY 2019 PFS final
rule, and is more intuitive and in line with the current practice of
medicine. We reviewed the AMA's estimates and acknowledge that overall
the AMA's approach does result in burden reduction that are consistent
with our broader goals discussed above. In comparison to our estimates
of burden reduction, as discussed in the CY 2019 final rule, the AMA's
estimates show less documentation burden to practitioners, the
difference resulting from CMS' finalized policies that allow use of
add-on codes to reflect additional resource costs inherent in
furnishing some kinds of office/outpatient E/M visits that the current
E/M coding and visit levels do not fully recognize (FR 83 59638). The
AMA estimates reflect assumptions that the time spent documenting
appropriate application of the add-on codes may result in additional
burden to practitioners. We disagree with this assumption. In addition
to proposing to redefine and revalue HCPCS G code add-on GPC1X to be
more understandable and easy to report for purposes of medical
documentation and billing, and proposing to delete HCPCS G-code add-on
GCG0X, we believe that while an initial setup period is expected for
practices to establish workflows that incorporate appropriate use of
the add-on code, practices should be able to automate the appropriate
use of the add-on code in a short period of time. Even so, our proposal
to adopt the AMA's revised office/outpatient E/M code set is consistent
with our goal of burden reduction and aligns with the policy principles
that underlay what we finalized in the CY 2019 PFS final rule. The
AMA's estimates of burden reduction as related to office/outpatient E/M
documentation and other materials pertinent to the AMA/CPT and AMA/RUCs
recent efforts to revise the office/outpatient E/M code set are
available at https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management.
2. Beneficiary Liability
Many proposed policy changes could result in a change in
beneficiary liability as it relates to coinsurance (which is 20 percent
of the fee schedule amount, if applicable for the particular provision
after the beneficiary has met the deductible). To illustrate this
point, as shown in our public use file Impact on Payment for Selected
Procedures available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/, the CY 2019
national payment amount in the nonfacility setting for CPT code 99203
(Office/outpatient visit, new) was $109.92, which means that in CY
2019, a beneficiary would be responsible for 20 percent of this amount,
or $21.98. Based on this proposed rule, using the CY 2020 CF, the CY
2020 national payment amount in the nonfacility setting for CPT code
99203, as shown in the Impact on Payment for Selected Procedures public
use file, is $110.43, which means that, in CY 2020, the final
beneficiary coinsurance for this service would be $22.09.
I. Estimating Regulatory Familiarization Costs
If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this rule, we should
estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that will review the rule, we assume that the total number of unique
commenters on last year's rule will be the number of reviewers of this
rule. We acknowledge that this assumption may understate or overstate
the costs of reviewing this rule. It is possible that not all
commenters reviewed last year's rule in detail, and it is also possible
that some reviewers chose not to comment on the rule. For these reasons
we thought that the number of past commenters would be a fair estimate
of the number of reviewers of this rule. We welcomed any comments on
the approach in estimating the number of entities which will review
this rule.
We also recognize that different types of entities are in many
cases affected by mutually exclusive sections of this rule, and
therefore for the purposes of our estimate we assume that each reviewer
reads approximately 50 percent of the rule. We sought comments on this
assumption.
Using the wage information from the BLS for medical and health
service managers (Code 11-9111), we estimate that the cost of reviewing
this rule is $109.36 per hour, including overhead and fringe benefits
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average
reading speed, we estimate that it would take approximately 8.0 hours
for the staff to review half of this rule. For each facility that
reviews the rule, the estimated cost is $874.88 (8.0 hours x $109.36).
Therefore, we estimated that the total cost of reviewing this
regulation is $13,399,662 ($874.88 x 15,316 reviewers).
J. Accounting Statement
As required by OMB Circular A-4 (available at http://www.whitehouse
.gov/omb/circulars/a004/a-4.pdf), in Tables 119 and 120 (Accounting
Statements), we have prepared an accounting statement. This estimate
includes growth in incurred benefits from CY 2019 to CY 2020 based on
the FY 2020 President's Budget baseline.
[[Page 40913]]
Table 119--Accounting Statement: Classification of Estimated
Expenditures
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
CY 2020 Annualized Monetized Transfers. Estimated increase in
expenditures of $0.3 billion
for PFS CF update.
From Whom To Whom?..................... Federal Government to
physicians, other
practitioners and providers
and suppliers who receive
payment under Medicare.
------------------------------------------------------------------------
Table 120--Accounting Statement: Classification of Estimated Costs,
Transfer, and Savings
------------------------------------------------------------------------
Category Transfer
------------------------------------------------------------------------
CY 2020 Annualized Monetized Transfers $0.1 billion.
of beneficiary cost coinsurance.
From Whom to Whom?..................... Beneficiaries to Federal
Government.
------------------------------------------------------------------------
K. Conclusion
The analysis in the previous sections, together with the remainder
of this preamble, provided an initial Regulatory Flexibility Analysis.
The previous analysis, together with the preceding portion of this
preamble, provides an RIA. In accordance with the provisions of
Executive Order 12866, this regulation was reviewed by the Office of
Management and Budget.
List of Subjects
42 CFR Part 403
Grant programs--health, Health insurance, Hospitals,
Intergovernmental relations, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 410
Health facilities, Health professions, Diseases, Laboratories,
Medicare, Reporting and recordkeeping requirements, Rural areas, X-
rays.
42 CFR Part 411
Diseases, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 414
Administrative practice and procedure, Biologics, Drugs, Health
facilities, Health professions, Diseases, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 415
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 416
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 418
Health facilities, Hospice care, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 424
Emergency medical services, Health facilities, Health professions,
Medicare, Reporting and recordkeeping requirements.
42 CFR Part 425
Administrative practice and procedure, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 403--SPECIAL PROGRAMS AND PROJECTS
0
1. The authority citation for part 403 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Section 403.902 is amended--
0
a. By adding in alphabetical order the definitions of ``Certified nurse
midwife'', ``Certified registered nurse anesthetist'', and ``Clinical
nurse specialist'';
0
b. By revising the definition of ``Covered recipient'';
0
c. By adding in alphabetical order the definitions of ``Device
identifier'', ``Long term medical supply or device loan'', ``Non-
teaching hospital covered recipient'', ``Nurse practitioner'',
``Physician assistant'', ``Short term medical supply or device loan'',
and ``Unique device identifier''.
The additions and revisions read as follows:
Sec. 403.902 Definitions.
* * * * *
Certified nurse midwife means a registered nurse who has
successfully completed a program of study and clinical experience
meeting guidelines prescribed by the Secretary, or has been certified
by an organization recognized by the Secretary.
Certified registered nurse anesthetist means a certified registered
nurse anesthetist licensed by the State who meets such education,
training, and other requirements relating to anesthesia services and
related care as the Secretary may prescribe. In prescribing such
requirements the Secretary may use the same requirements as those
established by a national organization for the certification of nurse
anesthetists. Such term also includes, as prescribed by the Secretary,
an anesthesiologist assistant.
* * * * *
Clinical nurse specialist means, an individual who--
(1) Is a registered nurse and is licensed to practice nursing in
the State in which the clinical nurse specialist services are
performed; and
(2) Holds a master's degree in a defined clinical area of nursing
from an accredited educational institution.
* * * * *
Covered recipient means--
(1) Any physician, physician assistant, nurse practitioner,
clinical nurse specialist, certified registered nurse anesthetist, or
certified nurse-midwife who is not a bona fide employee of the
applicable manufacturer that is reporting the payment; or
Device identifier is the mandatory, fixed portion of a unique
device identifier (UDI) that identifies the specific version or model
of a device and the labeler of that device (as described at 21 CFR
801.3 in paragraph (1) of the definition of ``Unique device
identifier'').
* * * * *
Long term medical supply or device loan means the loan of supplies
or a device for 91 days or longer.
Non-teaching hospital covered recipient means a person who is one
or more of the following: Physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified
[[Page 40914]]
registered nurse anesthetist, or certified nurse-midwife.
* * * * *
Nurse practitioner means a nurse practitioner who performs such
services as such individual is legally authorized to perform (in the
State in which the individual performs such services) in accordance
with State law (or the State regulatory mechanism provided by State
law), and who meets such training, education, and experience
requirements (or any combination thereof) as the Secretary may
prescribe in regulations.
* * * * *
Physician assistant means a physician assistant who performs such
services as such individual is legally authorized to perform (in the
State in which the individual performs such services) in accordance
with State law (or the State regulatory mechanism provided by State
law), and who meets such training, education, and experience
requirements (or any combination thereof) as the Secretary may
prescribe in regulations.
* * * * *
Short term medical supply or device loan means the loan of a
covered device or a device under development, or the provision of a
limited quantity of medical supplies for a short-term trial period, not
to exceed a loan period of 90 days or a quantity of 90 days of average
daily use, to permit evaluation of the device or medical supply by the
covered recipient.
* * * * *
Unique device identifier means an identifier that adequately
identifies a device through its distribution and use by meeting the
requirements of 21 CFR 830.20 (mirrored from 21 CFR 801.3).
0
3. Section 403.904 is amended by:
0
a. Revising paragraphs (c)(1), (c)(3) introductory text, (c)(3)(ii) and
(iii), (c)(8), (e)(2) introductory text, (e)(2)(xiv);
0
b. Adding paragraph (e)(2)(xi);
0
c. Revising paragraph (e)(2)(xv);
0
d. Adding paragraph (e)(2)(xviii); and
0
e. Revising paragraphs (f)(1) introductory text, (f)(1)(i)(A)
introductory text, (f)(1)(i)(A)(1), (f)(1)(i)(A)(3), (f)(1)(i)(A)(5),
(f)(1)(iv), (f)(1)(v), (h)(5), (h)(7), and (h)(13).
The revisions and addition read as follows:
Sec. 403.904 Reports of payments or other transfers of value to
covered recipients.
* * * * *
(c) * * *
(1) Name of the covered recipient. For non-teaching hospital
covered recipients, the name must be as listed in the National Plan &
Provider Enumeration System (NPPES) (if applicable) and include first
and last name, middle initial, and suffix (for all that apply).
* * * * *
(3) Identifiers for non-teaching hospital covered recipients. In
the case of a covered recipient the following identifiers:
* * * * *
(ii) National Provider Identifier (if applicable and as listed in
the NPPES). If a National Provider Identifier cannot be identified for
a non-teaching hospital covered recipient, the field may be left blank,
indicating that the applicable manufacturer could not find one.
(iii) State professional license number(s) (for at least one State
where the non-teaching hospital covered recipient maintains a license),
and the State(s) in which the license is held.
* * * * *
(8) Related covered drug, device, biological or medical supply.
Report the marketed or brand name of the related covered drugs,
devices, biologicals, or medical supplies, and therapeutic area or
product category unless the payment or other transfer of value is not
related to a particular covered drug, device, biological or medical
supply.
(i) For drugs and biologicals--
(A) If the marketed name has not yet been selected, applicable
manufacturers must indicate the name registered on clinicaltrials.gov.
(B) Any regularly used identifiers must be reported, including, but
not limited to, national drug codes.
(ii) For devices, if the device has a unique device identifier
(UDI), then the device identifier (DI) portions of it must be reported,
as applicable.
(iii) Applicable manufacturers may report the marketed name and
therapeutic area or product category for payments or other transfers of
value related to a non-covered drug, device, biological, or medical
supply.
(iv) Applicable manufacturers must indicate if the related drug,
device, biological, or medical supply is covered or non-covered.
(v) Applicable manufacturers must indicate if the payment or other
transfer of value is not related to any covered or non-covered drug,
device, biological or medical supply.
* * * * *
(e) * * *
(2) Rules for categorizing natures of payment. An applicable
manufacturer must categorize each payment or other transfer of value,
or separable part of that payment or transfer of value, with one of the
categories listed in paragraphs (e)(2)(i) through (xviii) of this
section, using the designation that best describes the nature of the
payment or other transfer of value, or separable part of that payment
or other transfer of value. If a payment or other transfer of value
could reasonably be considered as falling within more than one
category, the applicable manufacturer should select one category that
it deems to most accurately describe the nature of the payment or
transfer of value.
* * * * *
(xi) Debt forgiveness.
* * * * *
(xiv) Compensation for serving as faculty or as a speaker for a
medical education program.
(xv) Long term medical supply or device loan.
* * * * *
(xviii) Acquisitions.
* * * * *
(f) * * *
(1) Research-related payments or other transfers of value to
covered recipients, including research-related payments or other
transfers of value made indirectly to a covered recipient through a
third party, must be reported to CMS separately from other payments or
transfers of value, and must include the following information (in lieu
of the information required by Sec. 403.904(c)):
(i) * * *
(A) If paid to a non-teaching hospital covered recipient, all of
the following must be provided:
(1) The non-teaching hospital covered recipient's name as listed in
the NPPES (if applicable).
* * * * *
(3) State professional license number(s) (for at least one State
where the non-teaching hospital covered recipient maintains a license)
and State(s) in which the license is held.
* * * * *
(5) Primary business address of the non-teaching hospital covered
recipient(s).
* * * * *
(iv) Name(s) of any related covered drugs, devices, biologicals, or
medical supplies (subject to the requirements specified in paragraph
(c)(8) of this section); for drugs and biologicals, the relevant
National Drug Code(s), if any; and for devices and medical supplies,
the relevant device identifier, if any, and the therapeutic area or
product category if a marketed name is not available.
(v) Information about each non-teaching hospital covered recipient
principal investigator (if applicable) set forth in paragraph
(f)(1)(i)(A) of this section.
* * * * *
[[Page 40915]]
(h) * * *
(5) Short term medical supply or device loan.
* * * * *
(7) A transfer of anything of value to a non-teaching hospital
covered recipient when the covered recipient is a patient, research
subject or participant in data collection for research, and not acting
in the professional capacity of a covered recipient.
* * * * *
(13) In the case of a non-teaching hospital covered recipient, a
transfer of anything of value to the covered recipient if the transfer
is payment solely for the services of the covered recipient with
respect to an administrative proceeding, legal defense, prosecution, or
settlement or judgment of a civil or criminal action and arbitration.
* * * * *
0
4. Section 403.908 is amended by revising paragraphs (g)(2)(ii)
introductory text to read as follows:
Sec. 403.908 Procedures for electronic submission of reports.
* * * * *
(g) * * *
(2) * * *
(ii) Covered recipients--
* * * * *
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
0
5. The authority citation for part 410 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.
0
6. Section 410.20 is amended by adding paragraph (e) to read as
follows:
Sec. 410.20 Physicians' services.
* * * * *
(e) Medical record documentation. The physician may review and
verify (sign/date), rather than re-document, notes in a patient's
medical record made by physicians, residents, nurses, students, or
other members of the medical team including, as applicable, notes
documenting the physician's presence and participation in the services.
0
7. Section 410.40 is amended--
0
a. By redesignating paragraphs (a) through (f) as paragraphs (b)
through (g), respectively;
0
b. By adding new paragraph (a);
0
c. In newly redesignated paragraph (b)(1) by removing the reference
``paragraphs (d) and (e)'' and adding in its place the reference
``paragraphs (e) and (f)''; and
0
d. By revising newly redesignated paragraphs (e)(2)(i), (e)(3)(i), and
(e)(3)(iii) through (e)(3)(v).
The additions and revision reads as follows:
Sec. 410.40 Coverage of ambulance services.
(a) Definitions. As used in this section, the following definitions
apply:
Non-physician certification statement means a statement signed and
dated by an individual which certifies that the medical necessity
provisions of paragraph (e)(1) of this section are met and who meets
all of the criteria in paragraphs (i) through (iii) of this definition.
The statement need not be a stand-alone document and no specific format
or title is required.
(i) Has personal knowledge of the beneficiary's condition at the
time the ambulance transport is ordered or the service is furnished;
(ii) Who must be employed:
(A) By the beneficiary's attending physician; or
(B) By the hospital or facility where the beneficiary is being
treated and from which the beneficiary is transported;
(iii) Is among the following individuals, with respect to whom all
Medicare regulations and all applicable State licensure laws apply:
(A) Physician assistant (PA).
(B) Nurse practitioner (NP).
(C) Clinical nurse specialist (CNS).
(D) Registered nurse (RN).
(E) Licensed practical nurse (LPN).
(F) Social worker.
(G) Case manager.
(H) Discharge planner.
Physician certification statement means a statement signed and
dated by the beneficiary's attending physician which certifies that the
medical necessity provisions of paragraph (e)(1) of this section are
met. The statement need not be a stand-alone document and no specific
format or title is required.
* * * * *
(e) * * *
(2) * * *
(i) Medicare covers medically necessary nonemergency, scheduled,
repetitive ambulance services if the ambulance provider or supplier,
before furnishing the service to the beneficiary, obtains a physician
certification statement dated no earlier than 60 days before the date
the service is furnished.
* * * * *
(3) * * *
(i) For a resident of a facility who is under the care of a
physician if the ambulance provider or supplier obtains a physician
certification statement within 48 hours after the transport, certifying
that the medical necessity requirements of paragraph (e)(1) of this
section are met.
* * * * *
(iii) If the ambulance provider or supplier is unable to obtain a
signed physician certification statement from the beneficiary's
attending physician, or non-physician certification statement must be
obtained.
(iv) If the ambulance provider or supplier is unable to obtain the
required physician or non-physician certification statement within 21
calendar days following the date of the service, the ambulance supplier
must document its attempts to obtain the requested certification and
may then submit the claim. Acceptable documentation includes a signed
return receipt from the U.S. Postal Service or other similar service
that evidences that the ambulance supplier attempted to obtain the
required signature from the beneficiary's attending physician or other
individual named in paragraph (e)(3)(iii) of this section.
(v) In all cases, the provider or supplier must keep appropriate
documentation on file and, upon request, present it to the contractor.
The presence of the physician or non-physician certification statement
or signed return receipt does not alone demonstrate that the ambulance
transport was medically necessary. All other program criteria must be
met in order for payment to be made.
* * * * *
0
8. Section 410.41 is amended by revising the section heading and
paragraph (c)(1) to read as follows:
Sec. 410.41 Requirements for ambulance providers and suppliers.
* * * * *
(c) * * *
(1) Bill for ambulance services using CMS-designated procedure
codes to describe origin and destination and indicate on claims form
that the physician certification is on file, if required.
* * * * *
0
9. Section 410.49 is amended by revising paragraph (b)(1)(vii) and
adding paragraph (b)(1)(viii) to read as follows:
Sec. 410.49 Cardiac rehabilitation program and intensive cardiac
rehabilitation program: Conditions of coverage.
* * * * *
(b) * * *
(1) * * *
(vii) Stable, chronic heart failure defined as patients with left
ventricular ejection fraction of 35 percent or less and New York Heart
Association (NYHA) class II to IV symptoms despite being on optimal
heart failure therapy
[[Page 40916]]
for at least 6 weeks, on or after February 18, 2014 for cardiac
rehabilitation and on or after February 9, 2018 for intensive cardiac
rehabilitation; or
(viii) Other cardiac conditions as specified through a national
coverage determination (NCD). The NCD process may also be used to
specify non-coverage of a cardiac condition for ICR if coverage is not
supported by clinical evidence.
* * * * *
0
10. Section 410.59 is amended by--
0
a. Adding paragraphs (a)(4) and (e)(1)(v); and
0
b. Revising paragraphs (e)(2) introductory text, (e)(2)(i) and (v), and
(e)(3).
The additions and revisions read as follows:
Sec. 410.59 Outpatient occupational therapy services: Conditions.
(a) * * *
(4) Effective for dates of service on and after January 1, 2020,
for occupational therapy services described in paragraph (a)(3)(i) or
(a)(3)(ii) of this section, as applicable--
(i) Claims for services furnished in whole or in part by an
occupational therapy assistant must include the prescribed modifier;
and
(ii) Effective for dates of service on or after January 1, 2022,
claims for such services that include the modifier and for which
payment is made under sections 1848 or 1834(k) of the Act are paid an
amount equal to 85 percent of the amount of payment otherwise
applicable for the service.
(iii) For purposes of this paragraph, ``furnished in whole or in
part'' means when the occupational therapy assistant either:
(A) Furnishes all the minutes of a service exclusive of the
occupational therapist; or
(B) Furnishes a portion of a service--either concurrently with or
separately from the part furnished by the occupational therapist--such
that the minutes for that portion of a service furnished by the
occupational therapy assistant exceed 10 percent of the total minutes
for that service.
* * * * *
(e) * * *
(1) * * *
(v) Beginning in 2018 and for each successive calendar year, the
amount described in paragraph (e)(1)(ii) of this section is no longer
applied as a limitation on incurred expenses for outpatient
occupational therapy services, but, is instead applied as a threshold
above which claims for occupational therapy services must include the
KX modifier (the KX modifier threshold) to indicate that the service is
medically necessary and justified by appropriate documentation in the
medical record and claims for services above the KX modifier threshold
that do not include the KX modifier are denied.
(2) For purposes of applying the KX modifier threshold, outpatient
occupational therapy includes:
(i) Outpatient occupational therapy services furnished under this
section;
* * * * *
(v) Outpatient occupational therapy services furnished by a CAH
directly or under arrangements, included in the amount of annual
incurred expenses as if such services were furnished under section
1834(k)(1)(B) of the Act.
* * * * *
(3) A process for medical review of claims for outpatient
occupational therapy services applies as follows:
(i) For 2012 through 2017, medical review applies to claims for
services at or in excess of $3,700 of recognized incurred expenses as
described in paragraph (e)(1)(i) of this section.
(A) For 2012, 2013, and 2014 all claims at and above the $3,700
medical review threshold are subject to medical review; and
(B) For 2015, 2016, and 2017 claims at and above the $3,700 medical
review threshold are subject to a targeted medical review process.
(ii) For 2018 and subsequent years, a targeted medical review
process applies when the accrued annual incurred expenses reach the
following medical review threshold amounts:
(A) Beginning with 2018 and before 2028, $3,000;
(B) For 2028 and each year thereafter, the applicable medical
review threshold is determined by increasing the medical review
threshold in effect for the previous year (starting with $3,000 in
2027) by the increase in the Medicare Economic Index for the current
year.
0
11. Section 410.60 is amended by--
0
a. Adding paragraphs (a)(4) and (e)(1)(v); and
0
b. Revising paragraphs (e)(2) introductory text, (e)(2)(i), (ii) and
(vi), and (e)(3).
The additions and revisions read as follows:
Sec. 410.60 Outpatient physical therapy services: Conditions.
(a) * * *
(4) Effective for dates of service on and after January 1, 2020,
for physical therapy services described in paragraph (a)(3)(i) or
(a)(3)(ii) of this section, as applicable--
(i) Claims for services furnished in whole or in part by a physical
therapist assistant must include the prescribed modifier; and
(ii) Effective for dates of service on or after January 1, 2022,
claims for such services that include the modifier and for which
payment is made under sections 1848 or 1834(k) of the Act are paid an
amount equal to 85 percent of the amount of payment otherwise
applicable for the service.
(iii) For purposes of this paragraph, ``furnished in whole or in
part'' means when the physical therapist assistant either:
(A) Furnishes all the minutes of a service exclusive of the
physical therapist; or
(B) Furnishes a portion of a service either concurrently with or
separately from the part furnished by the physical therapist such that
the minutes for that portion of a service furnished by the physical
therapist assistant exceed 10 percent of the total minutes for that
service.
* * * * *
(e) * * *
(1) * * *
(v) Beginning in 2018 and for each successive calendar year, the
amount described in paragraph (e)(1)(ii) of this section is not applied
as a limitation on incurred expenses for outpatient physical therapy
and outpatient speech-language pathology services, but is instead
applied as a threshold above which claims for physical therapy and
speech-language pathology services must include the KX modifier (the KX
modifier threshold) to indicate that the service is medically necessary
and justified by appropriate documentation in the medical record; and
claims for services above the KX modifier threshold that do not include
the KX modifier are denied.
(2) For purposes of applying the KX modifier threshold, outpatient
physical therapy includes:
(i) Outpatient physical therapy services furnished under this
section;
(ii) Outpatient speech-language pathology services furnished under
Sec. 410.62;
* * * * *
(vi) Outpatient physical therapy and speech-language pathology
services furnished by a CAH directly or under arrangements, included in
the amount of annual incurred expenses as if such services were
furnished and paid under section 1834(k)(1)(B) of the Act.
(3) A process for medical review of claims for physical therapy and
speech-language pathology services applies as follows:
(i) For 2012 through 2017, medical review applies to claims for
services at
[[Page 40917]]
or in excess of $3,700 of recognized incurred expenses as described in
paragraph (e)(1)(i) of this section.
(A) For 2012, 2013, and 2014 all claims at and above the $3,700
medical review threshold are subject to medical review; and
(B) For 2015, 2016, and 2017 claims at and above the $3,700 medical
review threshold are subject to a targeted medical review process.
(ii) For 2018 and subsequent years, a targeted medical review
process when the accrued annual incurred expenses reach the following
medical review threshold amounts:
(A) Beginning with 2018 and before 2028, $3,000;
(B) For 2028 and each year thereafter, the applicable medical
review threshold is determined by increasing the medical review
threshold in effect for the previous year (starting with $3,000 for
2017) by the increase in the Medicare Economic Index for the current
year.
0
12. Section 410.67 is added to read as follows:
Sec. 410.67 Medicare coverage and payment of Opioid use disorder
treatment services furnished by Opioid treatment programs.
(a) Basis and scope--(1) Basis. This section implements sections
1861(jjj), 1861(s)(2)(HH), 1833(a)(1)(CC) and 1834(w) of the Act which
provide for coverage of opioid use disorder treatment services
furnished by an opioid treatment program and the payment of a bundled
payment under part B to an opioid treatment program for opioid use
disorder treatment services that are furnished to a beneficiary during
an episode of care beginning on or after January 1, 2020.
(2) Scope. This section sets forth the criteria for an opioid
treatment program, the scope of opioid use disorder treatment services,
and the methodology for determining the bundled payments to opioid
treatment programs for furnishing opioid use disorder treatment
services.
(b) Definitions. For purposes of this section, the following
definitions apply:
Episode of care means a one week (contiguous 7-day) period.
Opioid treatment program means an entity that is an opioid
treatment program (as defined in Sec. 8.2 of this title, or any
successor regulation) that meets the requirements described in
paragraph (c) of this section.
Opioid use disorder treatment service means one of the following
items or services for the treatment of opioid use disorder that is
furnished by an opioid treatment program that meets the requirements
described in paragraph (c) of this section.
(1) Opioid agonist and antagonist treatment medications (including
oral, injected, or implanted versions) that are approved by the Food
and Drug Administration under section 505 of the Federal, Food, Drug,
and Cosmetic Act for use in treatment of opioid use disorder.
(2) Dispensing and administration of opioid agonist and antagonist
treatment medications, if applicable.
(3) Substance use counseling by a professional to the extent
authorized under State law to furnish such services including services
furnished via two-way interactive audio-video communication technology,
as clinically appropriate, and in compliance with all applicable
requirements.
(4) Individual and group therapy with a physician or psychologist
(or other mental health professional to the extent authorized under
State law), including services furnished via two-way interactive audio-
video communication technology, as clinically appropriate, and in
compliance with all applicable requirements.
(5) Toxicology testing.
Partial episode of care means an episode of care in which at least
one opioid use disorder treatment service, but less than a majority of
the opioid use disorder treatment services identified in the patient's
current treatment plan (including any changes noted in the patient's
medical record), is furnished.
(c) Requirements for opioid treatment programs. To participate in
the Medicare program and receive payment, an opioid treatment program
must meet all of the following:
(1) Be enrolled in the Medicare program.
(2) Have in effect a certification by the Substance Abuse and
Mental Health Services Administration (SAMHSA) for the opioid treatment
program.
(3) Be accredited by an accrediting body approved by the SAMHSA.
(4) Have in effect a provider agreement under part 489 of this
title.
(d) Bundled payments for opioid use disorder treatment services
furnished by opioid treatment programs.
(1) CMS will establish categories of bundled payments for opioid
treatment programs as follows:
(i) Categories for each type of opioid agonist and antagonist
treatment medication;
(ii) A category for medication not otherwise specified, which must
be used for new FDA-approved opioid agonist or antagonist treatment
medications for which CMS has not established a category; and
(iii) A category for no medication provided. Each category of
bundled payment must consist of a payment amount for a full episode of
care and a payment amount for a partial episode of care.
(2) The bundled payment for episodes of care in which a medication
is provided must consist of payment for a drug component, reflecting
payment for the applicable FDA-approved opioid agonist or antagonist
medication in the patient's treatment plan, and a non-drug component,
reflecting payment for all other opioid use disorder treatment services
reflected in the patient's treatment plan (including dispensing/
administration of the medication, if applicable). The payments for the
drug component and non-drug component must be added together to create
the bundled payment amount. The bundled payment for episodes of care in
which no medication is provided shall consist of a single payment
amount for all opioid use disorder treatment services reflected in the
patient's treatment plan (not including medication or dispensing/
administration of such medication).
(i) Drug component for full episodes of care. For full episodes of
care, the payment for the drug component will be determined as follows,
using the most recent data available at time of ratesetting for the
applicable calendar year:
(A) For implantable and injectable medications, the payment must be
determined using the methodology set forth in section 1847A of the Act,
except that the payment amount shall be 100 percent of the ASP if ASP
is used.
(B) For oral medications, the payment amount must be 100 percent of
ASP, which will be determined based on ASP data that have been
calculated consistent with the provisions in part 414, subpart 800 of
this chapter and voluntarily submitted by drug manufacturers. If ASP
data are not available, the payment amount must be based on an
alternative methodology as determined by the Secretary.
(C) Exception. For the drug component of bundled payments in the
medication not otherwise specified category under paragraph (d)(1)(B)
of this section, the payment amount must be based on the applicable
methodology under paragraphs (d)(2)(i)(A) and (d)(2)(i)(B) of this
section (applying the most recent available data for such new
medication), or invoice pricing until the necessary data become
available.
(ii) Drug component for partial episodes of care. For partial
episodes of care, the payment for the drug
[[Page 40918]]
component will be determined as follows:
(A) For oral medications, the amount will be half of the payment
amount for the full episode of care.
(B) For injectable and implantable medications, the amount will be
the same as the payment amount for the full episode of care.
(iii) Non-drug component for full episodes of care. For full
episodes of care, the payment for CY 2020 for the non-drug components
of the bundled payments will be based on the CY 2019 TRICARE weekly
bundled rate for items and services furnished when a patient is
prescribed methadone, minus the methadone cost, and adjusted as
follows:
(A) For oral medications, no further adjustment.
(B) For injectable medications, to subtract an amount reflecting
the cost of dispensing methadone and to add an amount reflecting the CY
2019 non-facility Medicare payment rate for the administration of an
injection.
(C) For implantable medications, to subtract an amount reflecting
the cost of dispensing methadone and to add an amount reflecting the CY
2019 non-facility Medicare payment rate for insertion, removal, or
insertion and removal of the implant, as applicable.
(iv) Non-drug component for partial episodes of care. For partial
episodes of care, the payment for CY 2020 for the non-drug components
of the bundled payments will be based on the CY 2019 TRICARE weekly
bundled rate for items and services furnished when a patient is
prescribed methadone, minus the methadone cost, adjusted as follows:
(A) For oral medications, to halve the amount.
(B) For injectable medications, to subtract an amount reflecting
the cost of dispensing methadone and then to halve the remaining
amount. The resulting amount will be added to an amount reflecting the
CY 2019 non-facility Medicare payment rate for the administration of an
injection.
(C) For implantable medications, to subtract an amount reflecting
the cost of dispensing methadone and then to halve the remaining
amount. The resulting amount will be added to an amount reflecting the
CY 2019 non-facility Medicare payment rate for insertion, removal, or
insertion and removal of the implant, as applicable.
(v) No medication provided, full and partial episodes of care. The
bundled payment amount for CY 2020 for a full episode of care in which
no medication is provided will be based on the CY 2019 TRICARE weekly
bundled rate for items and services furnished when a patient is
prescribed methadone, minus the methadone cost, and minus an amount
reflecting the cost of dispensing methadone. The bundled payment amount
for CY 2020 for a partial episode of care in which no medication is
provided will be half the payment amount for a full episode of care in
which no medication is provided.
(3) Adjustments will be made to the bundled payment for the
following:
(i) If the opioid treatment program furnishes counseling or therapy
services in excess of the amount specified in the beneficiary's
treatment plan and for which medical necessity is documented in the
medical record, an adjustment will be made for each additional 30
minutes of counseling or individual therapy furnished during the
episode of care or partial episode of care.
(ii) The payment amount for the non-drug component and the full
bundled payment for an episode of care or partial episode of care in
which no medication is provided will be geographically adjusted using
the Geographic Adjustment Factor described in Sec. 414.26.
(iii) The payment amount for the non-drug component and the full
bundled payment for an episode of care or partial episode of care in
which no medication is provided will be updated annually using the
Medicare Economic Index described in Sec. 405.504(d).
(4) Payment for medications delivered, administered or dispensed to
a beneficiary as part of the bundled payment must be considered a
duplicative payment if delivery, administration or dispensing of the
same medications was also separately paid under Medicare Parts B or D.
CMS will recoup the duplicative payment made to the opioid treatment
program.
(e) Beneficiary cost-sharing. A beneficiary copayment amount of
zero will apply.
0
13. Section 410.74 is amended by revising paragraph (a)(2)(iv), and
adding paragraph (e) to read as follows:
Sec. 410.74 Physician assistants' services.
(a) * * *
(2) * * *
(iv) Performs the services in accordance with State law and State
scope of practice rules for PAs in the State in which the physician
assistant's professional services are furnished, with medical direction
and appropriate supervision as provided by State law in which the
services are performed. In the absence of State law governing physician
supervision of PA services, the physician supervision required by
Medicare for PA services would be evidenced by documentation in the
medical record of the PA's approach to working with physicians in
furnishing their professional services.
* * * * *
(e) Medical record documentation. For physician assistants'
services, the physician assistant may review and verify (sign and
date), rather than re-document, notes in a patient's medical record
made by physicians, residents, nurses, students, or other members of
the medical team, including, as applicable, notes documenting the
physician assistant's presence and participation in the service.
0
14. Section 410.75 is amended by adding paragraph (f) to read as
follows:
Sec. 410.75 Nurse practitioners' services.
* * * * *
(f) Medical record documentation. For nurse practitioners'
services, the nurse practitioner may review and verify (sign and date),
rather than re-document, notes in a patient's medical record made by
physicians, residents, nurses, students, or other members of the
medical team, including, as applicable, notes documenting the nurse
practitioner's presence and participation in the service.
0
15. Section 410.76 is amended by adding paragraph (f) to read as
follows:
Sec. 410.76 Clinical nurse specialists' services.
* * * * *
(f) Medical record documentation. For clinical nurse specialists'
services, the clinical nurse specialist may review and verify (sign and
date), rather than re-document, notes in a patient's medical record
made by physicians, residents, nurses, students, or other members of
the medical team, including, as applicable, notes documenting the
clinical nurse specialist's presence and participation in the service.
0
16. Section 410.77 is amended by adding paragraph (e) to read as
follows:
Sec. 410.77 Certified nurse-midwives' services: Qualifications and
conditions.
* * * * *
(e) Medical record documentation. For certified nurse-midwives'
services, the certified nurse-midwife may review and verify (sign and
date), rather than re-document, notes in a patient's medical record
made by physicians, residents, nurses, students, or other members of
the medical team, including, as applicable, notes documenting the
certified nurse-midwife's presence and participation in the service.
0
17. Section 410.105 is amended by adding paragraph (d) to read as
follows:
[[Page 40919]]
Sec. 410.105 Requirements for coverage of CORF services.
* * * * *
(d) Claims. Effective for dates of service on and after January 1,
2020 physical therapy or occupational therapy services covered as part
of a rehabilitation plan of treatment described in paragraph (c) of
this section, as applicable--
(1) Claims for such services furnished in whole or in part by a
physical therapist assistant or an occupational therapy assistant must
be identified with the inclusion of the respective prescribed modifier;
and
(2) Effective for dates of service on and after January 1, 2022,
such claims are paid an amount equal to 85 percent of the amount of
payment otherwise applicable for the service as defined at section
1834(k) of the Act.
(3) For purposes of this paragraph, ``furnished in whole or in
part'' means when the physical therapist assistant or occupational
therapy assistant either--
(i) Furnishes all the minutes of a service exclusive of the
respective physical therapist or occupational therapist; or
(ii) Furnishes a portion of a service--either concurrently with or
separately from the part furnished by the physical or occupational
therapist such that the minutes for that portion of a service exceed 10
percent of the total time for that service.
PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE
PAYMENT
0
18. The authority citation for part 411 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh,
and 1395nn.
0
19. Section 411.370 is amended--
0
a. In paragraph (b) introductory text, by removing the phrase ``CMS
determines'' and adding in its place the phrase ``CMS will determine'';
and
0
b. By revising paragraphs (b)(1), (c) introductory text, (d), and (e).
The revisions read as follows:
Sec. 411.370 Advisory opinions relating to physician referrals.
* * * * *
(b) * * *
(1) The request must relate to an existing arrangement or one into
which the requestor, in good faith, specifically plans to enter. The
planned arrangement may be contingent upon the party or parties
receiving a favorable advisory opinion. Requests that present a general
question of interpretation, pose a hypothetical situation, or involve
the activities of third parties are not appropriate for an advisory
opinion.
* * * * *
(c) Matters not subject to advisory opinions. CMS will not address
through an advisory opinion--
* * * * *
(d) Facts subject to advisory opinions. The requestor must include
in the advisory opinion request a complete description of the
arrangement that the requestor is undertaking, or plans to undertake,
as described in Sec. 411.372.
(e) Acceptance of requests. (1) CMS does not accept an advisory
opinion request or issue an advisory opinion if --
(i) The request is not related to a named individual or entity;
(ii) The request does not describe the arrangement at issue with a
level of detail sufficient for CMS to issue an opinion, and the
requestor does not timely respond to CMS requests for additional
information;
(iii) CMS is aware, after consultation with OIG and DOJ, that the
same course of action is under investigation, or is or has been the
subject of a proceeding involving the Department of Health and Human
Services or another governmental agency; or
(iv) CMS believes that it cannot make an informed opinion or could
only make an informed opinion after extensive investigation, clinical
study, testing, or collateral inquiry.
(2) CMS may elect not to accept an advisory opinion request if it
determines, after consultation with OIG and DOJ, that the course of
action described is substantially similar to a course of conduct that
is under investigation or is the subject of a proceeding involving the
Department or other law enforcement agencies, and issuing an advisory
opinion could interfere with the investigation or proceeding.
* * * * *
0
20. Section 411.372 is amended by revising paragraphs (b)(4)(i) and
(ii), (5), (6), and (8)(ii) to read as follows:
Sec. 411.372 Procedure for submitting a request.
* * * * *
(b) * * *
(4) * * *
(i) A complete description of the arrangement that the requestor is
undertaking, or plans to undertake, including:
(A) The purpose of the arrangement; the nature of each party's
(including each entity's) contribution to the arrangement; the direct
or indirect relationships between the parties, with an emphasis on the
relationships between physicians involved in the arrangement (or their
immediate family members who are involved); and
(B) Any entities that provide designated health services; the types
of services for which a physician wishes to refer, and whether the
referrals will involve Medicare or Medicaid patients;
(ii) Complete copies of all relevant documents or relevant portions
of documents that affect or could affect the arrangement, such as
personal service or employment contracts, leases, deeds, pension or
insurance plans, or financial statements (or, if these relevant
documents do not yet exist, a complete description, to the best of the
requestor's knowledge, of what these documents are likely to contain);
* * * * *
(5) The identity of all entities involved either directly or
indirectly in the arrangement, including their names, addresses, legal
form, ownership structure, nature of the business (products and
services) and, if relevant, their Medicare and Medicaid provider
numbers. The requestor must also include a brief description of any
other entities that could affect the outcome of the opinion, including
those with which the requestor, the other parties, or the immediate
family members of involved physicians, have any financial relationships
(either direct or indirect, and as defined in section 1877(a)(2) of the
Act and Sec. 411.354), or in which any of the parties holds an
ownership or control interest as defined in section 1124(a)(3) of the
Act.
(6) A discussion of the specific issues or questions to be
addressed by CMS including, if possible, a discussion of why the
requestor believes the referral prohibition in section 1877 of the Act
might or might not be triggered by the arrangement and which, if any,
exceptions the requestor believes might apply. The requestor should
attempt to designate which facts are relevant to each issue or question
raised in the request and should cite the provisions of law under which
each issue or question arises.
* * * * *
(8) * * *
(ii) The chief executive officer, or other authorized officer, of
the requestor, if the requestor is a corporation;
* * * * *
0
21. Section 411.375 is amended by revising paragraphs (a) and (b) to
read as follows:
[[Page 40920]]
Sec. 411.375 Fees for the cost of advisory opinions.
(a) Initial payment. Parties must include with each request for an
advisory opinion a check or money order payable to CMS for $250. This
initial payment is nonrefundable.
(b) How costs are calculated. In addition to the initial payment,
CMS will charge an hourly rate of $220. Parties may request an estimate
from CMS after submitting a complete request. Before issuing the
advisory opinion, CMS calculates the fee for responding to the request.
* * * * *
Sec. 411.379 [Amended]
0
22. Section 411.379(e) is amended by removing the phrase ``The 90-day
period'' and adding in its place the phrase ``The 60-day period''.
Sec. 411.380 [Amended]
0
23. Section 411.380 is amended--
0
a. In paragraph (c)(1), by removing the phrase ``within 90 days'' and
adding in its place the phrase ``within 60 days''.
0
b. In paragraph (c)(2), by removing the phrase ``If the 90th day'' and
adding in its place the phrase ``If the 60th day''.
0
c. In paragraph (c)(3) introductory text, by removing the phrase ``The
90-day period'' and adding in its place the phrase ``The 60-day
period''.
Sec. 411.384 [Amended]
0
24. Section 411.384(b) is amended by removing the phrase ``for public
inspection during its normal hours of operation and''.
0
25. Section 411.387 is revised to read as follows:
Sec. 411.387 Effect of an advisory opinion.
(a) An advisory opinion is binding on the Secretary, and a
favorable advisory opinion shall preclude imposition of sanctions under
section 1877(g) of the Act with respect to:
(1) The individuals or entities requesting the opinion; and
(2) Individuals or entities that are parties to the specific
arrangement with respect to which such advisory opinion has been
issued.
(b) The Secretary will not pursue sanctions under section 1877(g)
of the Act against any party to an arrangement that CMS determines is
indistinguishable in all its material aspects from an arrangement with
respect to which CMS issued a favorable advisory opinion.
(c) Individuals and entities may rely on an advisory opinion as
non-binding guidance that illustrates the application of the self-
referral law and regulations to the specific facts and circumstances
described in the advisory opinion.
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
26. The authority for part 414 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
Sec. 414.601 [Amended]
0
27. Section 41.601 is amended by adding the sentence ``Section
1834(l)(17) of the Act requires the development of a data collection
system to collect cost, revenue, utilization, and other information
determined appropriate from providers of services and suppliers of
ground ambulance services.'' to to the end of the section.
0
28. Section 414.605 is amended by adding the definition of ``ground
ambulance organization'' in alphabetical order to read as follows:
Sec. 414.605 Definitions.
* * * * *
Ground ambulance organization means a Medicare provider or supplier
of ground ambulance services.
* * * * *
0
29. Section 414.610 is amended by adding paragraph (c)(9) to read as
follows:
Sec. 414.610 Basis of payment.
* * * * *
(c) * * *
(9) Payment Reduction for Failure to Report Data. In the case of a
ground ambulance organization (as defined at Sec. 414.605) that is
selected by CMS under Sec. 414.626(c) for a year that does not
sufficiently submit data under Sec. 414.626(b) and is not granted a
hardship exemption under Sec. 414.626(d), the payments made under this
section are reduced by 10 percent for the applicable period. For
purposes of this paragraph, the applicable period is the calendar year
that begins following the date that CMS provided written notification
to the ground ambulance organization under Sec. 414.626(e)(1) that the
ground ambulance did not sufficiently submit the required data.
* * * * *
0
30. Section 414.626 is added to read as follows:
Sec. 414.626 Data reporting by ground ambulance organizations.
(a) Definitions. For purposes of this section, the following
definitions apply:
Data collection period means, with respect to a year, the 12-month
period that reflects the ground ambulance organization's annual
accounting period.
Data reporting period means, with respect to a year, the 5 month
period that begins the day after the last day of the ground ambulance
organization's data collection period.
For a year means one of the calendar years from 2020 through 2024.
(b) Data collection and submission requirement. Except as provided
in paragraph (d) of this section, a ground ambulance organization
selected by CMS under paragraph (c) of this section must do the
following:
(1) Within 30 days of the date that CMS notifies a ground ambulance
organization under paragraph (c)(3) of this section that it has
selected the ground ambulance organization to report data under this
section, the ground ambulance must select a data collection period that
corresponds with its annual accounting period and provide the start
date of that data collection period to the ambulance organization's
Medicare Administrative Contractor in accordance with CMS instructions
on reporting the data collection period.
(2) Collect during its selected data collection period the data
necessary to complete the Medicare Ground Ambulance Data Collection
Instrument.
(3) Submit to CMS a completed Medicare Ground Ambulance Data
Collection Instrument during the data reporting period that corresponds
to the ground ambulance organization's selected data collection period.
(c) Representative sample. (1) Random sample. For purposes of the
data collection described in paragraph (b) of this section, and for a
year, CMS will select a random sample of 25 percent of eligible ground
ambulance organizations that is stratified based on:
(i) Provider versus supplier status, ownership (for-profit, non-
profit, and government);
(ii) Service area population density (transports originating in
primarily urban, rural, and super rural zip codes); and
(iii) Medicare-billed transport volume categories.
(2) Selection eligibility. A ground ambulance organization is
eligible to be selected for data reporting under this section for a
year if it is enrolled in Medicare and has submitted to CMS at least
one Medicare ambulance transport claim during the year prior to the
selection under paragraph (b)(1) of this section.
(3) Notification of selection for a year. CMS will notify an
eligible ground ambulance organization that it has been selected to
report data under this section for a year at least 30 days prior to the
beginning of the calendar year in which the ground ambulance
organization must begin to collect data
[[Page 40921]]
by posting a list of selected organizations on the CMS web page and
providing written notification to each selected ground ambulance
organization via email or U.S. mail.
(4) Limitation. CMS will not select the same ground ambulance
organization under this paragraph (c) in 2 consecutive years, to the
extent practicable.
(d) Hardship exemption. A ground ambulance organization selected
under paragraph (c) of this section may request and CMS may grant an
exception to the reporting requirements under paragraph (b) of this
section in the event of a significant hardship such as, a natural
disaster, bankruptcy, or similar situation that the Secretary
determines interfered with the ability of the ground ambulance
organization to submit such information in a timely manner for the data
collection period selected by the ground ambulance organization.
(1) To request a hardship exemption, the ground ambulance
organization must submit a request form (accessed on the Ambulances
Services Center website (https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html) to CMS within 90 calendar days of the
date that CMS notified the ground ambulance organization that it would
receive a 10 percent payment reduction as a result of not submitting
sufficient information under the data collection system. The request
form must include all of the following:
(i) Ground ambulance organization name.
(ii) NPI number.
(iii) Ground ambulance organization address.
(iv) Chief executive officer and any other designated personnel
contact information, including name, email address, telephone number
and mailing address (must include a physical address, a post office box
address is not acceptable).
(v) Reason for requesting a hardship exemption.
(vi) Evidence of the impact of the hardship (such as photographs,
newspaper or other media articles, financial data, bankruptcy filing,
etc.).
(vii) Date when the ground ambulance organization would be able to
begin collecting data under paragraph (b) of this section.
(viii) Date and signature of the chief executive officer or other
designated personnel of the ground ambulance organization.
(2) CMS will provide a written response to the hardship exemption
request within 30 days of its receipt of the hardship exemption form.
(e) Notification of non-compliance and informal review. (1)
Notification of non-compliance. A ground ambulance organization
selected under paragraph (c) of this section for a year that does not
sufficiently report data under paragraph (b) of this section, and that
is not granted a hardship exemption under paragraph (d) of this
section, will receive written notification from CMS that it will
receive a payment reduction under Sec. 414.610(c)(9).
(2) Informal review. A ground ambulance organization that receives
a written notification under paragraph (e)(1) of a payment reduction
under Sec. 414.610(c)(9) may submit a request for an informal review
within 90 days of the date it received the notification by submitting
all of the following information:
(i) Ground ambulance organization name.
(ii) NPI number.
(iii) Chief executive officer and any other designated personnel
contact information, including name, email address, telephone number
and mailing address with the street location of the ground ambulance
organization.
(iv) Ground ambulance organization's selected data collection
period and data reporting period.
(v) A statement of the reasons why the ground ambulance
organization does not agree with CMS's determination and any supporting
documentation.
(f) Public availability of data. Beginning in 2022, and at least
once every 2 years thereafter, CMS will post on its website data that
it collected under this section, including but not limited to summary
statistics and ground ambulance organization characteristics.
(g) Limitations on review. There is no administrative or judicial
review under section 1869 or section 1878 of the Act, or otherwise of
the data required for submission under paragraph (b) of this section or
the selection of ground ambulance organizations under paragraph (c) of
this section.
0
31. Section 414.1305 is amended by--
0
a. Adding the definition of ``Aligned Other Payer Medical Home Model''
in alphabetical order;
0
b. Revising the definition of ``Hospital-based MIPS eligible
clinician'';
0
c. Adding the definition of ``MIPS Value Pathway'' in alphabetical
order; and
0
d. Revising the definition of ``Rural area''.
The additions and revision read as follows:
Sec. 414.1305 Definitions.
* * * * *
Aligned Other Payer Medical Home Model means an aligned other payer
payment arrangement (not including a Medicaid payment arrangement)
operated by a payer formally partnering in a CMS Multi-Payer Model that
is a Medical Home Model through a written expression of alignment and
cooperation, such as a memorandum of understanding (MOU) with CMS, and
is determined by CMS to have the following characteristics:
(1) The other payer payment arrangement has a primary care focus
with participants that primarily include primary care practices or
multispecialty practices that include primary care physicians and
practitioners and offer primary care services. For the purposes of this
provision, primary care focus means the inclusion of specific design
elements related to eligible clinicians practicing under one or more of
the following Physician Specialty Codes: 01 General Practice; 08 Family
Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37
Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89
Clinical Nurse Specialist; and 97 Physician Assistant;
(2) Empanelment of each patient to a primary clinician; and
(3) At least four of the following:
(i) Planned coordination of chronic and preventive care.
(ii) Patient access and continuity of care.
(iii) Risk-stratified care management.
(iv) Coordination of care across the medical neighborhood.
(v) Patient and caregiver engagement.
(vi) Shared decision-making.
(vii) Payment arrangements in addition to, or substituting for,
fee-for-service payments (for example, shared savings or population-
based payments).
* * * * *
Hospital-based MIPS eligible clinician means:
(1) For the 2019 and 2020 MIPS payment years, a MIPS eligible
clinician who furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the Place of
Service (POS) codes used in the HIPAA standard transaction as an
inpatient hospital, on-campus outpatient hospital, off campus-
outpatient hospital, or emergency room setting based on claims for a
period prior to the performance period as specified by CMS; and
(2) For the 2021 MIPS payment year, a MIPS eligible clinician who
furnishes 75 percent or more of his or her covered professional
services in sites of service identified by the POS codes used in the
HIPAA standard transaction as an inpatient hospital, on-campus
[[Page 40922]]
outpatient hospital, off campus outpatient hospital, or emergency room
setting based on claims for the MIPS determination period; and
(3) Beginning with the 2022 MIPS payment year, an individual MIPS
eligible clinician who furnishes 75 percent or more of his or her
covered professional services in sites of service identified by the POS
codes used in the HIPAA standard transaction as an inpatient hospital,
on-campus outpatient hospital, off campus outpatient hospital, or
emergency room setting based on claims for the MIPS determination
period, and a group or virtual group provided that more than 75 percent
of the NPIs billing under the group's TIN or virtual group's TINs, as
applicable, meet the definition of a hospital-based individual MIPS
eligible clinician during the MIPS determination period.
* * * * *
MIPS Value Pathway means a subset of measures and activities
specified by CMS.
* * * * *
Rural area means a ZIP code designated as rural by the Federal
Office of Rural Health Policy (FORHP), using the most recent FORHP
Eligible ZIP Code file available.
* * * * *
0
32. Section 414.1310 is amended by--
0
a. Revising paragraph (e)(2)(ii); and
0
b. Removing paragraphs (e)(3) through (5);
The revision reads as follows:
Sec. 414.1310 Applicability.
* * * * *
(e) * * *
(2) * * *
(ii) Individual eligible clinicians that elect to participate in
MIPS as a group must aggregate their performance data across the
group's TIN, and for the Promoting Interoperability performance
category, must aggregate the performance data of all of the MIPS
eligible clinicians in the group's TIN for whom the group has data in
CEHRT.
* * * * *
0
33. Section 414.1315 is amended by revising paragraph (d)(2) to read as
follows:
Sec. 414.1315 Virtual groups.
* * * * *
(d) * * *
(2) Solo practitioners and groups of 10 or fewer eligible
clinicians that elect to participate in MIPS as a virtual group must
aggregate their performance data across the virtual group's TINs, and
for the Promoting Interoperability performance category, must aggregate
the performance data of all of the MIPS eligible clinicians in the
virtual group's TINs for whom the virtual group has data in CEHRT.
* * * * *
0
34. Section 414.1320 is amended by adding paragraph (f) to read as
follows:
Sec. 414.1320 MIPS performance period.
* * * * *
(f) For purposes of the 2023 MIPS payment year, the performance
period for:
(1) The Promoting Interoperability performance category is a
minimum of a continuous 90-day period within the calendar year that
occurs 2 years prior to the applicable MIPS payment year, up to and
including the full calendar year.
(2) [Reserved]
0
35. Section 414.1330 is amended by adding paragraphs (b)(4), (5), and
(6) to read as follows:
Sec. 414.1330 Quality performance category.
* * * * *
(b) * * *
(4) 40 percent of a MIPS eligible clinician's final score for MIPS
payment year 2022.
(5) 35 percent of a MIPS eligible clinician's final score for MIPS
payment year 2023.
(6) 30 percent of a MIPS eligible clinician's final score for MIPS
payment year 2024 and future years.
0
36. Section 414.1335 is amended by revising paragraph (a)(3)(i) to read
as follows:
Sec. 414.1335 Data submission criteria for the quality performance
category.
(a) * * *
(3) * * *
(i) For the 12-month performance period, a group that participates
in the CAHPS for MIPS survey must use a survey vendor that is approved
by CMS for the applicable performance period to transmit survey
measures data to CMS.
* * * * *
0
37. Section 414.1340 is amended by adding paragraph (d) to read as
follows:
Sec. 414.1340 Data completeness criteria for the quality performance
category.
* * * * *
(d) If quality data are submitted selectively such that the
submitted data are unrepresentative of a MIPS eligible clinician or
group's performance, any such data would not be true, accurate, or
complete for purposes of Sec. 414.1390(b) or Sec. 414.1400(a)(5).
0
38. Section 414.1350 is amended by--
0
a. Revising paragraphs (b) and (c)(2); and
0
b. Adding paragraphs (d)(4), (5), and (6).
The revisions and additions read as follows:
Sec. 414.1350 Cost performance category.
* * * * *
(b) Attribution. (1) Cost measures are attributed at the TIN/NPI
level for the 2017 thorough 2019 performance periods.
(2) For the total per capita cost measure specified for the 2017
through 2019 performance periods, beneficiaries are attributed using a
method generally consistent with the method of assignment of
beneficiaries under Sec. 425.402 of this chapter.
(3) For the Medicare Spending per Beneficiary clinician (MSPB
clinician) measure specified for the 2017 through 2019 performance
periods, an episode is attributed to the MIPS eligible clinician who
submitted the plurality of claims (as measured by allowed charges) for
Medicare Part B services rendered during an inpatient hospitalization
that is an index admission for the MSPB clinician measure during the
applicable performance period.
(4) For the acute condition episode-based measures specified for
the 2017 performance period, an episode is attributed to each MIPS
eligible clinician who bills at least 30 percent of inpatient
evaluation and management (E&M) visits during the trigger event for the
episode.
(5) For the procedural episode-based measures specified for the
2017 performance period, an episode is attributed to each MIPS eligible
clinician who bills a Medicare Part B claim with a trigger code during
the trigger event for the episode.
(6) For the acute inpatient medical condition episode-based
measures specified for the 2019 performance period, an episode is
attributed to each MIPS eligible clinician who bills inpatient E&M
claim lines during a trigger inpatient hospitalization under a TIN that
renders at least 30 percent of the inpatient E&M claim lines in that
hospitalization.
(7) For the procedural episode-based measures specified for the
2019 performance period, an episode is attributed to each MIPS eligible
clinician who renders a trigger service as identified by HCPCS/CPT
procedure codes.
(8) Beginning with the 2020 performance period, each cost measure
is attributed according to the measure specifications for the
applicable performance period.
* * * * *
(c) * * *
[[Page 40923]]
(2) For the Medicare spending per beneficiary clinician measure,
the case minimum is 35.
* * * * *
(d) * * *
(4) 20 percent of a MIPS eligible clinician's final score for MIPS
payment year 2022.
(5) 25 percent of a MIPS eligible clinician's final score for MIPS
payment year 2023.
(6) 30 percent of a MIPS eligible clinician's final score for MIPS
payment year 2024 and each subsequent MIPS payment year.
0
39. Section 414.1360 is amended by adding paragraph (a)(2) to read as
follows:
Sec. 414.1360 Data submission criteria for the improvement activities
performance category.
(a) * * *
(2) Groups and virtual groups. Beginning with the 2020 performance
year, each improvement activity for which groups and virtual groups
submit a yes response in accordance with paragraph (a)(1) of this
section must be performed by at least 50 percent of the NPIs billing
under the group's TIN or virtual group's TINs, as applicable, and the
NPIs must perform the same activity for the same continuous 90 days in
the performance period.
* * * * *
0
40. Section 414.1370 is amended by amending paragraph (e)(2) to read as
follows:
Sec. 414.1370 APM scoring standard under MIPS.
* * * * *
(e) * * *
(2) For purposes of calculating the APM Entity group score under
the APM scoring standard, MIPS scores submitted by virtual groups will
not be included.
* * * * *
0
41. Section 414.1380 is amended--
0
a. In paragraph (b)(1)(i) introductory text by removing the years
``2019, 2020, and 2021'' and adding in its place the years ``2019
through 2022'';
0
b. In paragraph (b)(1)(i)(A)(1) by removing the years ``2019, 2020, and
2021'' and adding in its place the years ``2019 through 2022'';
0
c. By revising paragraph (b)(1)(ii) introductory text;
0
d. By adding paragraph (b)(1)(ii)(C);
0
e. By revising paragraph (b)(1)(v)(A)(1)(i);
0
f. In paragraph (b)(1)(v)(A)(1)(ii) by removing the years ``2019, 2020,
and 2021'' and adding in its place the years ``2019 through 2022'';
0
g. In paragraph (b)(1)(v)(B)(1)(i) by removing the years ``2019, 2020,
and 2021'' and adding in its place the years ``2019 through 2022'';
0
h. In paragraph (b)(1)(vi)(C)(4) by removing the phrase ``2020 and 2021
MIPS payment year'' and adding in its place the phrase ``2020 through
2022 MIPS payment years'';
0
i. By revising paragraph (b)(3)(ii)(A) and (C);
0
j. In paragraph (c)(2)(i)(A)(4) by removing the phrase ``beginning with
the 2021 MIPS payment year'' and adding in its place the phrase ``for
the 2021 and 2022 MIPS payment years'';
0
k. In paragraph (c)(2)(i)(A)(5) by removing the years ``2019, 2020, and
2021'' and adding in its place the years ``2019, 2020, 2021, and
2022'';
0
l. By adding paragraph (c)(2)(i)(A)(9);
0
m. By revising paragraph (c)(2)(i)(C) introductory text;
0
n. By adding paragraphs (c)(2)(i)(C)(10) and (c)(2)(ii)(D), (E), and
(F);
0
o. By revising paragraph (c)(2)(iii) and (c)(3) introductory text; and
0
p. In paragraph (e)(2)(i)(C) by removing the phrase ``Can be
attributed'' and adding in its place the phrase ``Can be assigned''.
The revisions and additions read as follows:
Sec. 414.1380 Scoring.
* * * * *
(b) * * *
(1) * * *
(ii) Benchmarks. Except as provided in paragraphs (b)(1)(ii)(B) and
(C) of this section, benchmarks will be based on performance by
collection type, from all available sources, including MIPS eligible
clinicians and APMs, to the extent feasible, during the applicable
baseline or performance period.
* * * * *
(C) Beginning with the 2022 MIPS payment year, for each measure
that has a benchmark that CMS determines may have the potential to
result in inappropriate treatment, CMS will set benchmarks using a flat
percentage for all collection types where the top decile is higher than
90 percent under the methodology at paragraph (b)(1)(ii) of this
section.
* * * * *
(v) * * *
(A) * * *
(1) * * *
(i) Each high priority measure must meet the case minimum
requirement at paragraph (b)(1)(iii) of this section, meet the data
completeness requirement at Sec. 414.1340, and have a performance rate
that is greater than zero.
* * * * *
(3) * * *
(ii) * * *
(A) The practice has received accreditation from an accreditation
organization that is nationally recognized.
* * * * *
(C) The practice is a comparable specialty practice that has
received recognition through a specialty recognition program offered
through a nationally recognized accreditation organization; or
* * * * *
(c) * * *
(2) * * *
(i) * * *
(A) * * *
(9) Beginning with the 2020 MIPS payment year, for the quality,
cost, and improvement activities performance categories, CMS
determines, based on information known to the agency prior to the
beginning of the relevant MIPS payment year, that data for a MIPS
eligible clinician are inaccurate, unusable or otherwise compromised
due to circumstances outside of the control of the clinician and its
agents.
* * * * *
(C) Under section 1848(o)(2)(D) of the Act, a significant hardship
exception or other type of exception is granted to a MIPS eligible
clinician based on the following circumstances for the Promoting
Interoperability performance category. Except as provided in paragraph
(c)(2)(i)(C)(10) of this section, in the event that a MIPS eligible
clinician submits data for the Promoting Interoperability performance
category, the scoring weight specified in paragraph (c)(1) of this
section will be applied and its weight will not be redistributed.
* * * * *
(10) Beginning with the 2020 MIPS payment year, CMS determines,
based on information known to the agency prior to the beginning of the
relevant MIPS payment year, that data for a MIPS eligible clinician are
inaccurate, unusable or otherwise compromised due to circumstances
outside of the control of the clinician and its agents.
* * * * *
(ii) * * *
(D) For the 2022 MIPS payment year:
BILLING CODE 4120-01-P
[[Page 40924]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.113
(E) For the 2023 MIPS payment year:
[GRAPHIC] [TIFF OMITTED] TP14AU19.114
(F) For the 2024 MIPS payment year:
[[Page 40925]]
[GRAPHIC] [TIFF OMITTED] TP14AU19.115
BILLING CODE 4120-01-C
(iii) For the Promoting Interoperability performance category to be
reweighted in accordance with paragraph (c)(2)(ii) of this section for
a MIPS eligible clinician who elects to participate in MIPS as part of
a group or virtual group, all of the MIPS eligible clinicians in the
group or virtual group must qualify for reweighting based on the
circumstances described in paragraph (c)(2)(i) of this section, or the
group or virtual group must meet the definition of a hospital-based
MIPS eligible clinician or a non-patient facing MIPS eligible clinician
as defined in Sec. 414.1305.
(3) Complex patient bonus. For the 2020, 2021 and 2022 MIPS payment
years, provided that a MIPS eligible clinician, group, virtual group or
APM entity submits data for at least one MIPS performance category for
the applicable performance period for the MIPS payment year, a complex
patient bonus will be added to the final score for the MIPS payment
year, as follows:
* * * * *
0
42. Section 414.1385 is amended by revising paragraph (a) to read as
follows:
Sec. 414.1385 Targeted review and review limitations.
(a) Targeted review. A MIPS eligible clinician or group may request
a targeted review of the calculation of the MIPS payment adjustment
factor under section 1848(q)(6)(A) of the Act and, as applicable, the
calculation of the additional MIPS payment adjustment factor under
section 1848(q)(6)(C) of the Act (collectively referred to as the MIPS
payment adjustment factors) applicable to such MIPS eligible clinician
or group for a year. The process for targeted review is as follows:
(1) A MIPS eligible clinician or group (including their designated
support staff), or a third party intermediary as defined at Sec.
414.1305, may submit a request for a targeted review.
(2) All requests for targeted review must be submitted during the
targeted review request submission period, which is a 60-day period
that begins on the day CMS makes available the MIPS payment adjustment
factors for the MIPS payment year. The targeted review request
submission period may be extended as specified by CMS.
(3) A request for a targeted review may be denied if the request is
duplicative of another request for a targeted review; the request is
not submitted during the targeted review request submission period; or
the request is outside of the scope of the targeted review, which is
limited to the calculation of the MIPS payment adjustment factors
applicable to the MIPS eligible clinician or group for a year. If the
targeted review request is denied, there will be no change to the MIPS
final score or associated MIPS payment adjustment factors for the MIPS
eligible clinician or group. If the targeted review request is
approved, the MIPS final score and associated MIPS payment adjustment
factors may be revised, if applicable, for the MIPS eligible clinician
or group.
(4) CMS will respond to each request for a targeted review timely
submitted and determine whether a targeted review is warranted.
(5) A request for a targeted review may include additional
information in support of the request at the time it is submitted. If
CMS requests additional information from the MIPS eligible clinician or
group that is the subject of a request for a targeted review, it must
be provided and received by CMS within 30 days of CMS's request. Non-
responsiveness to CMS's request for additional information may result
in a final decision based on the information available, although
another request for a targeted review may be submitted before the end
of the targeted review request submission period.
(6) If a request for a targeted review is approved, CMS may
recalculate, to the extent feasible and applicable, the scores of a
MIPS eligible clinician or group with regard to measures, activities,
performance categories, and the final score, as well as the MIPS
payment adjustment factors.
(7) Decisions based on the targeted review are final, and there is
no further review or appeal. CMS will notify the individual or entity
that submitted the request for a targeted review of the final decision.
(8) Documentation submitted for a targeted review must be retained
by the submitter for 6 years from the end of the MIPS performance
period.
* * * * *
0
43. Section 414.1395 is amended by revising paragraph (a) to read as
follows:
Sec. 414.1395 Public reporting.
(a) General. (1) CMS posts on Physician Compare, in an easily
understandable format, the following:
(i) Information regarding the performance of MIPS eligible
clinicians, including, but not limited to, final scores and performance
category scores for each MIPS eligible clinician; and
(ii) The names of eligible clinicians in Advanced APMs and, to the
extent feasible, the names and performance of such Advanced APMs.
(2) CMS periodically posts on Physician Compare aggregate
[[Page 40926]]
information on the MIPS, including the range of final scores for all
MIPS eligible clinicians and the range of the performance of all MIPS
eligible clinicians with respect to each performance category.
(3) The information made available under this section will
indicate, where appropriate, that publicized information may not be
representative of an eligible clinician's entire patient population,
the variety of services furnished by the eligible clinician, or the
health conditions of individuals treated.
* * * * *
0
44. Section 414.1400 is amended by--
0
a. Revising paragraphs (a)(2) introductory text and (a)(2)(iii);
0
b. Adding paragraphs (a)(4)(v) and (vi),
0
c. Revising paragraph (b)(1),
0
d. Adding paragraphs (b)(2)(iii) and (iv), (b)(3)(iv) through (vii), ;
0
e. Revising paragraph (c)(1);
0
f. Adding paragraphs (c)(2)(i) and (ii); and
0
g. Revising paragraphs (f)(1) introductory text and (f)(3) introductory
text.
The revision and addition reads as follows:
Sec. 414.1400 Third party intermediaries.
(a) * * *
(2) Beginning with the 2021 performance period and all future
years, for the following MIPS performance categories, QCDRs and
qualified registries must be able to submit data for all categories,
and Health IT vendors must be able to submit data for at least one
category:
* * * * *
(iii) Promoting Interoperability, if the eligible clinician, group,
or virtual group is using CEHRT; however, a third party could be
excepted from this requirement if its MIPS eligible clinicians, groups
or virtual groups fall under the reweighting policies at Sec.
414.1380(c)(2)(i)(A)(4) or (5) or Sec. 414.1380(c)(2)(i)(C)(1) through
(7) or Sec. 414.1380(c)(2)(i)(C)(9)).
* * * * *
(4) * * *
(v) The third party intermediary must provide services throughout
the entire performance period and applicable data submission period.
(vi) Prior to discontinuing services to any MIPS eligible
clinician, group, or virtual group during a performance period, the
third party intermediary must support the transition of such MIPS
eligible clinician, group, or virtual group to an alternate data
submission mechanism or third party intermediary according to a CMS
approved a transition plan.
* * * * *
(b) * * *
(1) QCDR self-nomination. For the 2020 and 2021 MIPS payment years,
entities seeking to qualify as a QCDR must self-nominate September 1
until November 1 of the CY preceding the applicable performance period.
For the 2022 MIPS payment year and future years, entities seeking to
qualify as a QCDR must self-nominate during a 60-day period during the
CY preceding the applicable performance period (beginning no earlier
than July 1 and ending no later than September 1). Entities seeking to
qualify as a QCDR for a performance period must provide all information
required by CMS at the time of self-nomination and must provide any
additional information requested by CMS during the review process. For
the 2021 MIPS payment year and future years, existing QCDRs that are in
good standing may attest that certain aspects of their previous year's
approved self-nomination have not changed and will be used for the
applicable performance period. Beginning with the 2023 payment year,
QCDRs are required to attest during the self-nomination process that
they can provide performance feedback at least 4 times a year (as
specified at paragraph (b)(2)(iv) of this section), and if not, provide
sufficient rationale as to why they do not believe they would be able
to meet this requirement. Each QCDR would still be required to submit
notification to CMS within the reporting period promptly within the
month of realization of the impending deficiency in order to be
considered for this exception, as discussed at paragraph (b)(2)(iv) of
this section.
(2) * * *
(iii) Beginning with the 2023 MIPS payment year, the QCDR must
foster services to clinicians and groups to improve the quality of care
provided to patients by providing educational services in quality
improvement and leading quality improvement initiatives.
(iv) Beginning with the 2023 MIPS payment year, require QCDRs to
provide performance feedback to their clinicians and groups at least 4
times a year, and provide specific feedback to their clinicians and
groups on how they compare to other clinicians who have submitted data
on a given measure within the QCDR. Exceptions to this requirement may
occur if the QCDR does not receive the data from their clinician until
the end of the performance period.
* * * * *
(3) * * *
(iv) QCDR measure considerations for approval include:
(A) Preference for measures that are outcome-based rather than
clinical process measures.
(B) Measures that address patient safety and adverse events.
(C) Measures that identify appropriate use of diagnosis and
therapeutics.
(D) Measures that address the domain of care coordination.
(E) Measures that address the domain for patient and caregiver
experience.
(F) Measures that address efficiency, cost, and resource use.
(G) Beginning with the 2021 performance period--
(1) That QCDRs link their QCDR measures to the following at the
time of self-nomination:
(i) Cost measure,
(ii) Improvement activity,
(iii) An MVP.
(2) In cases where a QCDR measure does not have a clear link to a
cost measure, improvement activity, or an MVP, we would consider
exceptions if the potential QCDR measure otherwise meets the QCDR
measure requirements and considerations.
(H) Beginning with the 2020 performance period CMS may consider the
extent to which a QCDR measure is available to MIPS eligible clinicians
reporting through QCDRs other than the QCDR measure owner for purposes
of MIPS. If CMS determines that a QCDR measure is not available to MIPS
eligible clinicians, groups, and virtual groups reporting through other
QCDRs, CMS may not approve the measure.
(I) QCDRs should conduct an environmental scan of existing QCDR
measures; MIPS quality measures; quality measures retired from the
legacy Physician Quality Reporting System (PQRS) program; and utilize
the CMS Quality Measure Development Plan Annual Report and the
Blueprint for the CMS Measures Management System to identify
measurement gaps prior to measure development.
(J) Beginning with the 2020 performance period, we place greater
preference on QCDR measures that meet case minimum and reporting
volumes required for benchmarking after being in the program for 2
consecutive CY performance periods. Those that do not, may not continue
to be approved.
(1) Beginning with the 2020 performance period, in instances where
a QCDR believes the low-reported QCDR measure that did not meet
benchmarking thresholds is still important and relevant to a
specialist's practice, that the QCDR may develop and submit a QCDR
measure
[[Page 40927]]
participation plan for our consideration. This QCDR measure
participation plan must include the QCDR's detailed plans and changes
to encourage eligible clinicians and groups to submit data on the low-
reported QCDR measure for purposes of the MIPS program.
(2) [Reserved]
(v) QCDR measure requirements for approval include:
(A) QCDR Measures that are beyond the measure concept phase of
development.
(B) QCDR Measures that address significant variation in
performance.
(C) Beginning with the 2021 performance period, all QCDR measures
must be fully developed and tested, with complete testing results at
the clinician level, prior to submitting the QCDR measure at the time
of self-nomination.
(D) Beginning with the 2021 performance period, QCDRs are required
to collect data on a QCDR measure, appropriate to the measure type,
prior to submitting the QCDR measure for CMS consideration during the
self-nomination period.
(E) Beginning with the 2020 performance period, areas of
duplication identified by CMS should be addressed within a year of the
request. If the QCDR measures are not harmonized, CMS may reject the
duplicative QCDR measure.
(vi) Beginning with the 2021 performance period, QCDR measures may
be approved for 2 years, at CMS discretion, by attaining approval
status by meeting QCDR measure considerations and requirements, Upon
annual review, CMS may revoke QCDR measure second year approval, if the
QCDR measure is found to be: Topped out; duplicative of a more robust
measure; reflects an outdated clinical guideline; requires QCDR measure
harmonization; or if the QCDR self-nominating the QCDR measure is no
longer in good standing.
(vii) Beginning with the 2020 performance period, QCDR measure
rejection criteria considerations, that include, but are not limited
to, the following factors:
(A) QCDR measures that are duplicative, or identical to other QCDR
measures or MIPS quality measures that are currently in the program.
(B) QCDR measures that are duplicative or identical to MIPS quality
measures that have been removed from MIPS through rulemaking.
(C) QCDR measures that are duplicative or identical to quality
measures used under the legacy Physician Quality Reporting System
(PQRS) program, which have been retired.
(D) QCDR measures that meet the topped out definition.
(E) QCDR measures that are process-based, with consideration to
whether the removal of the process measure impacts the number of
measures available for a specific specialty.
(F) Whether the QCDR measure has potential unintended consequences
to a patient's care.
(G) Considerations and evaluation of the measure's performance
data, to determine whether performance variance exists.
(H) Whether the previously identified areas of duplication have
been addressed as requested.
(I) QCDR measures that split a single clinical practice or action
into several QCDR measures.
(J) QCDR measures that are ``check-box'' with no actionable quality
action.
(K) QCDR measures that do not meet the case minimum and reporting
volumes required for benchmarking after being in the program for 2
consecutive years.
(L) Whether the existing approved QCDR measure is no longer
considered robust, in instances where new QCDR measures are considered
to have a more vigorous quality actions, where CMS preference is to
include the new QCDR measure rather than requesting QCDR measure
harmonization.
(M) QCDR measures with clinician attribution issues, where the
quality action is not under the direct control of the reporting
clinician.
(N) QCDR measures that focus on rare events or ``never events'' in
the measurement period.
(c) * * *
(1) Qualified registry self-nomination. For the 2020 and 2021 MIPS
payment years, entities seeking to qualify as a qualified registry must
self-nominate from September 1 until November 1 of the CY preceding the
applicable performance period. For the 2022 MIPS payment year and
future years, entities seeking to qualify as a qualified registry must
self-nominate during a 60-day period during the CY preceding the
applicable performance period (beginning no earlier than July 1 and
ending no later than September 1). Entities seeking to qualify as a
qualified registry for a performance period must provide all
information required by CMS at the time of self-nomination and must
provide any additional information requested by CMS during the review
process. For the 2021 MIPS payment year and future years, existing
qualified registries that are in good standing may attest that certain
aspects of their previous year's approved self-nomination have not
changed and will be used for the applicable performance period.
Beginning with the 2023 payment year, qualified registries are required
to attest during the self-nomination process that they can provide
performance feedback at least 4 times a year (as specified at Sec.
414.1400(c)(2)(ii)), and if not, provide sufficient rationale as to why
they do not believe they would be able to meet this requirement. Each
qualified registry would still be required to submit notification to
CMS within the reporting period promptly within the month of
realization of the impending deficiency in order to be considered for
this exception, as discussed at Sec. 414.1400(c)(2)(ii).
(2) * * *
(i) Beginning with the 2022 MIPS Payment Year, the qualified
registry must have at least 25 participants by January 1 of the year
prior to the applicable performance period.
(ii) Beginning with the 2023 MIPS payment year, require qualified
registries to provide performance feedback to their clinicians and
groups at least 4 times a year, and provide specific feedback to their
clinicians and groups on how they compare to other clinicians who have
submitted data on a given measure within the qualified registries.
Exceptions to this requirement may occur if the qualified registries
does not receive the data from their clinician until the end of the
performance period
* * * * *
(f) * * *
(1) If CMS determines that a third party intermediary has ceased to
meet one or more of the applicable criteria for approval, has submitted
a false certification under paragraph (a)(5) of this section, or has
submitted data that are inaccurate, unusable, or otherwise compromised,
CMS may take one or more of the following remedial actions after
providing written notice to the third party intermediary:
* * * * *
(3) For purposes of paragraph (f) of this section, CMS may
determine that submitted data are inaccurate, unusable, or otherwise
compromised, including but not limited to, if the submitted data:
* * * * *
0
45. Section 414.1405 is amended by--
0
a. Adding paragraphs (b)(7) and (8);
0
b. Adding paragraph, (d)(6) and (7); and
0
c. Revising paragraph (f) introductory text.
The additions and revisions read as follows:
[[Page 40928]]
Sec. 414.1405 Payment.
* * * * *
(b) * * *
(7) The performance threshold for the 2022 MIPS payment year is 45
points.
(8) The performance threshold for the 2023 MIPS payment year is 60
points.
* * * * *
(d) * * *
(6) The additional performance threshold for the 2022 MIPS payment
year is 80 points.
(7) The additional performance threshold for the 2023 MIPS payment
year is 85 points.
* * * * *
(f) Exception to application of MIPS payment adjustment factors to
model-specific payments under section 1115A APMs. Beginning with the
2019 MIPS payment year, the payment adjustment factors specified under
paragraph (e) of this section are not applicable to payments that meet
all of the following conditions:
* * * * *
0
46. Section 414.1415 is amended by revising paragraph (c)(5) and (6) to
read as follows:
Sec. 414.1415 Advanced APM criteria.
* * * * *
(c) * * *
(5) For the purposes of this section, expected expenditures means
the beneficiary expenditures for which an APM Entity is responsible
under an APM. For episode payment models, expected expenditures means
the episode target price. For purposes of assessing financial risk for
Advanced APM determinations, the expected expenditures under the terms
of the APM should not exceed the Medicare Part A and B expenditures for
a participant in the absence of the APM. If the expected expenditures
under the APM exceed the Medicare Part A and B expenditures that an APM
Entity would be expected to incur in the absence of the APM, such
excess expenditures are not considered when CMS assesses financial risk
under the APM for purposes of Advanced APM determinations.
(6) Capitation. A full capitation arrangement meets this Advanced
APM criterion. For purposes of this part, a full capitation arrangement
means a payment arrangement in which a per capita or otherwise
predetermined payment is made under the APM for all items and services
furnished to a population of beneficiaries during a fixed period of
time, and no settlement is performed to reconcile or share losses
incurred or savings earned by the APM Entity. Arrangements between CMS
and Medicare Advantage Organizations under the Medicare Advantage
program (42 CFR part 422) are not considered capitation arrangements
for purposes of this paragraph (c)(6).
* * * * *
0
47. Section 414.1420 is amended by revising paragraph (d)(2)
introductory text, (d)(2)(ii), (d)(3)(ii)), (d)(4) introductory text,
(d)(5), (6), (7) and (8) to read as follows:
Sec. 414.1420 Other payer advanced APM criteria.
* * * * *
(d) * * *
(2) Medicaid Medical Home Model and Aligned Other Payer Medical
Home Model financial risk standard. The APM Entity participates in a
Medicaid Medical Home Model or an Aligned Other Payer Medical Home
Model that, based on the APM Entity's failure to meet or exceed one or
more specified performance standards, does one or more of the
following:
* * * * *
(ii) Require direct payment by the APM Entity to the payer;
* * * * *
(3) * * *
(ii) Except for risk arrangements described under paragraph (d)(2)
of this section, the risk arrangement must have a marginal risk rate of
at least 30 percent.
* * * * *
(4) Medicaid Medical Home Model and Aligned Other Payer Medical
Home Model nominal amount standard. For a Medicaid Medical Home Model
or an Aligned Other Payer Medical Home Model to meet the Medicaid
Medical Home Model nominal amount standard, the total annual amount
that an APM Entity potentially owes a payer or forgoes must be at least
the following amounts:
* * * * *
(5) Marginal risk rate. For purposes of this section, the marginal
risk rate is defined as the percentage of actual expenditures that
exceed expected expenditures for which an APM Entity is responsible
under an other payer payment arrangement.
(i) In the event that the marginal risk rate varies depending on
the amount by which actual expenditures exceed expected expenditures,
the average marginal risk rate across all possible levels of actual
expenditures would be used for comparison to the marginal risk rate
specified in paragraph (d)(3)(ii) of this section, with exceptions for
large losses as described in paragraph (d)(5)(ii) of this section and
small losses as described in paragraph (d)(5)(iii) of this section.
(ii) Allowance for large losses. The determination in paragraph
(d)(3)(ii) of this section may disregard the marginal risk rates that
apply in cases when actual expenditures exceed expected expenditures by
an amount sufficient to require the APM Entity to make financial risk
payments under the other payer payment arrangement greater than or
equal to the total risk requirement under paragraph (d)(3)(i) of this
section.
(iii) Allowance for minimum loss rate. The determination in
paragraph (d)(3)(ii) of this section may disregard the marginal risk
rates that apply in cases when actual expenditures exceed expected
expenditures by less than 4 percent of expected expenditures.
(6) Expected expenditures. For the purposes of this section,
expected expenditures is defined as the Other Payer APM benchmark. For
episode payment models, expected expenditures means the episode target
price. For purposes of assessing financial risk for Other Payer
Advanced APM determinations, the expected expenditures under the
payment arrangement should not exceed the expenditures for a
participant in the absence of the payment arrangement. If expected
expenditures (that is, benchmarks) under the payment arrangement exceed
the expenditures that the participant would be expected to incur in the
absence of the payment arrangement, such excess expenditures are not
considered when assessing financial risk under the payment arrangement
for Other Payer Advanced APM determinations.
(7) Capitation. A full capitation arrangement meets this Other
Payer Advanced APM criterion. For purposes of paragraph (d)(3) of this
section, a full capitation arrangement means a payment arrangement in
which a per capita or otherwise predetermined payment is made under the
payment arrangement for all items and services furnished to a
population of beneficiaries during a fixed period of time, and no
settlement is performed for the purposes of reconciling or sharing
losses incurred or savings earned by the participant. Arrangements made
directly between CMS and Medicare Advantage Organizations under the
Medicare Advantage program (42 CFR part 422) are not considered
capitation arrangements for purposes of this paragraph.
(8) Aligned Other Payer Medical Home Model and Medicaid Medical
Home Model 50 eligible clinician limit. Notwithstanding paragraphs
(d)(2) and (4) of this section, if an APM Entity
[[Page 40929]]
participating in an Aligned Other Payer Medical Home Model or Medicaid
Medical Home Model is owned and operated by an organization with 50 or
more eligible clinicians whose Medicare billing rights have been
reassigned to the TIN(s) of the organization(s) or any of the
organization's subsidiary entities, the requirements of paragraphs
(d)(1) and (3) of this section apply.
* * * * *
0
48. Section 414.1425 is amended by--
0
a. Revising paragraph (c)(5) and (6), (d)(3) and (4); and
0
b. Adding paragraph (d)(5).
The revision and addition reads as follows:
Sec. 414.1425 Qualifying APM participant determination: In general.
* * * * *
(c) * * *
(5) Beginning in the 2020 QP Performance Period, an eligible
clinician is not a QP for a year if:
(i) The APM Entity voluntarily or involuntarily terminates from an
Advanced APM before the end of the QP Performance Period; or
(ii) The APM Entity voluntarily or involuntarily terminates from an
Advanced APM at a date on which the APM Entity would not bear financial
risk for that performance period under the terms of the Advanced APM.
(6) Beginning in the 2020 QP Performance Period, an eligible
clinician is not a QP for a year if:
(i) One or more of the APM Entities in which the eligible clinician
participates voluntarily or involuntarily terminates from the Advanced
APM before the end of the QP Performance Period, and the eligible
clinician does not individually achieve a Threshold Score that meets or
exceeds the QP payment amount threshold or QP patient count threshold
based on participation in the remaining non-terminating APM Entities;
or
(ii) One or more of the APM Entities in which the eligible
clinician participates voluntarily or involuntarily terminates from the
Advanced APM at a date on which the APM Entity would not bear financial
risk under the terms of the Advanced APM, and the eligible clinician
does not individually achieve a Threshold Score that meets or exceeds
the QP payment amount threshold or QP patient count threshold based on
participation in the remaining non-terminating APM Entities.
* * * * *
(d) * * *
(3) Beginning in the 2020 QP Performance Period, an eligible
clinician is not a Partial QP for a year if:
(i) The APM Entity voluntarily or involuntarily terminates from an
Advanced APM before the end of the QP Performance Period; or
(ii) The APM Entity voluntarily or involuntarily terminates from an
Advanced APM at a date on which the APM Entity would not bear financial
risk for that performance period under the terms of the Advanced APM.
(4) Beginning in the 2020 QP Performance Period, an eligible
clinician is not a Partial QP for a year if:
(i) One or more of the APM Entities in which the eligible clinician
participates voluntarily or involuntarily terminates from the Advanced
APM before the end of the QP Performance Period, and the eligible
clinician does not individually achieve a Threshold Score that meets or
exceeds the Partial QP payment amount threshold or Partial QP patient
count threshold based on participation in the remaining non-terminating
APM Entities; or
(ii) One or more of the APM Entities in which the eligible
clinician participates voluntarily or involuntarily terminates from the
Advanced APM at a date on which the APM Entity would not bear financial
risk under the terms of the Advanced APM, and the eligible clinician
does not individually achieve a Threshold Score that meets or exceeds
the Partial QP payment amount threshold or Partial QP patient count
threshold based on participation in the remaining non-terminating APM
Entities.
(5) Beginning in the 2020 QP Performance Period, Partial QP status
applies only to the TIN/NPI combination(s) through which Partial QP
status is attained.
* * * * *
PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS,
SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN
CERTAIN SETTING
0
49. The authority citation for part 415 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
50. Section 415.172 is amended by revising the section heading and
paragraph (b) to read as follows:
Sec. 415.172 Physician fee schedule payment for services of teaching
physicians.
* * * * *
(b) Documentation. Except for services furnished as set forth in
Sec. Sec. 415.174 (concerning an exception for services furnished in
hospital outpatient and certain other ambulatory settings), 415.176
(concerning renal dialysis services), and 415.184 (concerning
psychiatric services), the medical records must document the teaching
physician was present at the time the service is furnished. The
presence of the teaching physician during procedures and evaluation and
management services may be demonstrated by the notes in the medical
records made by the physician or as provided in Sec. 410.20(e) of this
chapter.
* * * * *
0
51. Section 415.174 is amended by--
0
a. Revising paragraph (a)(6); and
0
b. Removing and reserving paragraph (b).
The revision reads as follows:
Sec. 415.174 Exception: Evaluation and management services furnished
in certain centers.
(a) * * *
(6) The medical records must document the extent of the teaching
physician's participation in the review and direction of services
furnished to each beneficiary. The extent of the teaching physician's
participation may be demonstrated by the notes in the medical records
made by the physician or as provided in Sec. 410.20(e) of this chapter
to each beneficiary in accordance with the documentation requirements
at Sec. 415.172(b).
(b) [Reserved]
PART 416--AMBULATORY SURGICAL CENTERS
0
52. The authority citation for part 416 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
Sec. 416.42 [Amended]
0
53. Section 416.42 is amended in paragraph (a)(1), by removing the
phrase ``A physician must'' and by adding in its place the phrase ``A
physician or an anesthetist as defined at Sec. 410.69(b) of this
chapter must''.
PART 418--HOSPICE CARE
0
54. The authority citation for part 418 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
55. Section 418.106 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 418.106 Condition of participation: Drugs and biologicals,
medical supplies, and durable medical equipment.
* * * * *
(b) * * *
(1) Drugs may be ordered by any of the following practitioners:
(i) A physician as defined by section 1861(r)(1) of the Act.
[[Page 40930]]
(ii) A nurse practitioner in accordance with state scope of
practice requirements.
(iii) A physician assistant in accordance with state scope of
practice requirements and hospice policy who is:
(A) The patient's attending physician, and
(B) Not an employee of or under arrangement with the hospice.
* * * * *
PART 424--CONDITIONS FOR MEDICARE PAYMENT
0
56. The authority citation for part 424 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
57. Section 424.67 is added to subpart E to read as follows:
Sec. 424.67 Enrollment requirements for opioid treatment programs
(OTP).
(a) General enrollment requirement. In order for a program or
eligible professional (as that term is defined in 1848(k)(3)(B) of the
Act) to receive Medicare payment for the provision of opioid use
disorder treatment services, the provider must qualify as an OTP (as
that term is defined in Sec. 8.2 of this title) and enroll in the
Medicare program under the provisions of subpart P of this part and
this section.
(b) Specific requirements and standards for enrollment. To enroll
in the Medicare program, an OTP must meet all of the following
requirements and standards:
(1) Fully complete and submit the Form CMS-855B application (or its
successor application) and any applicable supplement or attachment
thereto to its applicable Medicare contractor. This includes, but is
not limited to, the following:
(i) Maintain and submit to CMS (via the applicable supplement or
attachment) a list of all physicians and eligible professionals who are
legally authorized to prescribe, order, or dispense controlled
substances on behalf of the OTP. The list must include the physician's
or eligible professional's:
(A) First and last name and middle initial.
(B) Social Security Number.
(C) National Provider Identifier.
(D) License number (if applicable).
(ii) Certifying via the CMS-855B and/or the applicable supplement
or attachment thereto that the OTP meets and will continue to meet the
specific requirements and standards for enrollment described in
paragraphs (b) and (d) of this section. application) and any applicable
supplement thereto to its applicable Medicare contractor.
(2) Comply with the application fee requirements in Sec. 424.514.
(3) Successfully complete the high categorical risk level screening
required under Sec. 424.518(c).
(4)(i) Have a current, valid certification by SAMHSA for an opioid
treatment program consistent with the provisions and requirements Sec.
8.11 of this title.
(ii) A provisional certification under Sec. 8.11(e) of this title
does not meet the requirements of the paragraph (b)(4)(i) of this
section.
(5) Report on the Form CMS-855 and/or any applicable supplement all
OTP staff that meet the definition of ``managing employee'' in Sec.
424.502. Such individuals include, but are not limited to, the
following:
(i) Medical director (as described in Sec. 8.2 of this title).
(ii) Program sponsor (as described in Sec. 8.2 of this title).
(6)(i)(A) Must not employ or contract with a prescribing or
ordering physician or eligible professional or with any individual
legally authorized to dispense narcotics who, within the preceding 10
years, has been convicted (as that term is defined in 42 CFR 1001.2) of
a federal or state felony that CMS deems detrimental to the best
interests of the Medicare program and its beneficiaries based on the
same categories of detrimental felonies, as well as case by case
detrimental determinations, found at Sec. 424.535(a)(3).
(B) Paragraph (b)(6)(i)(A) of this section applies regardless of
whether the individual in question is:
(1) Currently dispensing narcotics at or on behalf of the OTP; or
(2) A W-2 employee of the OTP.
(ii) Must not employ or contract with any personnel (regardless of
whether the individual is a W-2 employee of the OTP) who is revoked
from Medicare under Sec. 424.535 or any other applicable section in
Title 42, or who is on the preclusion list under Sec. 422.222 or Sec.
423.120(c)(6) of this chapter.
(iii) Must not employ or contract with any personnel (regardless of
whether the individual is a W-2 employee of the OTP) who has a prior
adverse action by a state oversight board, including, but not limited
to, a reprimand, fine, or restriction, for a case or situation
involving patient harm that CMS deems detrimental to the best interests
of the Medicare program and its beneficiaries. CMS will consider the
factors enumerated at Sec. 424.535(a)(22) in each case of patient harm
that potentially applies to this paragraph.
(7)(i) Sign (and adhere to the term of) a provider agreement in
accordance with the provisions of 42 CFR part 489.
(ii) An OTP's appeals under 498 of a Medicare revocation (under
Sec. 424.535) and a provider agreement termination (under Sec.
489.53(a)(1)) must be filed jointly and, as applicable, considered
jointly by CMS under part 498 of this chapter.
(8) Comply with all other applicable requirements for enrollment
specified in this section and in subpart P of this part.
(c) Denial of enrollment. CMS may deny an OTP's enrollment
application on any of the following grounds:
(1) The provider does not have a current, valid certification by
SAMHSA as required under paragraph (b)(4)(i) of this section or fails
to meet any other applicable requirement in this section.
(2) Any of the denial reasons in Sec. 424.530 applies.
(3) An OTP may appeal the denial of its enrollment application
under part 498 of this chapter.
(d) Continued compliance, standards, and reasons for revocation.
(1) Upon and after enrollment, an OTP--
(i) Must remain validly certified by SAMHSA as required under Sec.
8.11 of this title.
(ii) Remains subject to, and must remain in full compliance with,
the provisions of subpart P of this Part and of this section. This
includes, but is not limited to, the provisions of paragraph (b)(6) of
this section, the revalidation provisions in Sec. 424.515, and the
deactivation and reactivation provisions in Sec. 424.540.
(iii) Upon revalidation, successfully complete the moderate
categorical risk level screening required under Sec. 424.518(b).
(2) CMS may revoke an OTP's enrollment on any of the following
grounds:
(i) The provider does not have a current, valid certification by
SAMSHA as required under paragraph (b)(4)(i) or fails to meet any other
applicable requirement or standard in this section, including, but not
limited to, the OTP standards in paragraph (b)(6) and (d)(1) of this
section.
(ii) Any of the revocation reasons in Sec. 424.535 applies.
(3) An OTP may appeal the revocation of its enrollment under part
498 of this title.
(e) Claim payment. For an OTP to receive payment for furnished
drugs:
(1) The prescribing or medication ordering physician's or other
eligible professional's National Provider Identifier must be listed on
Field 17 of the Form CMS-1500; and
(2) All other applicable requirements of this section, this part,
and part 8 of this title must be met.
[[Page 40931]]
(f) Relation to part 8 of this title. Nothing in this section shall
be construed as:
(1) Supplanting any of the provisions in part 8 of this title; or
(2) Eliminating an OTP's obligation to maintain compliance with all
applicable provisions in part 8 of this title.
0
58. Section 424.502 is amended by adding the definition of ``State
oversight board'' in alphabetical order to read as follows:
Sec. 424.502 Definitions.
* * * * *
State oversight board means, for purposes of Sec. Sec.
424.530(a)(15) and 424.535(a)(22) only, any state administrative body
or organization, such as (but not limited to) a medical board,
licensing agency, or accreditation body, that directly or indirectly
oversees or regulates the provision of health care within the State.
* * * * *
0
59. Section 424.518 is amended by adding paragraphs (b)(1)(xii) and
(c)(1)(iv) to read as follows:
Sec. 424.518 Screening levels for Medicare providers and suppliers.
* * * * *
(b) * * *
(1) * * *
(xii) Revalidating opioid treatment programs.
* * * * *
(c) * * *
(1) * * *
(iv) Prospective (newly enrolling) opioid treatment programs.
* * * * *
0
60. Section 424.520 is amended by revising paragraph (d) introductory
text to read as follows:
Sec. 424.520 Effective date of Medicare billing privileges.
* * * * *
(d) Physicians, non-physician practitioners, physician and non-
physician practitioner organizations, ambulance suppliers, and opioid
treatment programs. The effective date for billing privileges for
physicians, non-physician practitioners, physician and non-physician
practitioner organizations, ambulance suppliers, and opioid treatment
programs is the later of--
* * * * *
0
61. Section 424.521 is amended by revising the section heading and
paragraph (a) introductory text to read as follows:
Sec. 424.521 Request for payment by physicians, non-physician
practitioners, physician and non-physician organizations, ambulance
suppliers, and opioid treatment programs.
(a) Physicians, non-physician practitioners, physician and non-
physician practitioner organizations, ambulance suppliers, and opioid
treatment programs may retrospectively bill for services when the
physician, non-physician practitioner, physician or non-physician
organization, ambulance supplier, or opioid treatment program has met
all program requirements, including State licensure requirements, and
services were provided at the enrolled practice location for up to --
* * * * *
0
62. Section 424.530 is amended by reserving paragraphs (a)(12),(13) and
(14) and adding paragraph (a)(15) to read as follows:
Sec. 424.530 Denial of enrollment in the Medicare program.
* * * * *
(a) * * *
(15) Patient Harm. The physician or eligible professional (as that
term is defined in 1848(k)(3)(B) of the Act) has been subject to prior
action from State oversight board, Federal or State health care
program, Independent Review Organization (IRO) determination(s), or any
other equivalent governmental body or program that oversees, regulates,
or administers the provision of health care with underlying facts
reflecting improper physician or eligible professional conduct that led
to patient harm. In determining whether a denial is appropriate, CMS
considers the following factors:
(i) The nature of the patient harm.
(ii) The nature of the physician's or eligible professional's
conduct.
(iii) The number and type(s) of sanctions or disciplinary actions
that have been imposed against the physician or eligible professional
by the State oversight board, IRO, Federal or State health care
program, or any other equivalent governmental body or program that
oversees, regulates, or administers the provision of health care. Such
actions include, but are not limited to in scope or degree:
(A) License restriction(s) pertaining to certain procedures or
practices.
(B) Required compliance appearances before State oversight board
members.
(C) Required participation in rehabilitation or mental/behavioral
health programs.
(D) Required abstinence from drugs or alcohol and random drug
testing.
(E) License restriction(s) regarding the ability to treat certain
types of patients (for example, cannot be alone with members of a
different gender after a sexual offense charge).
(F) Administrative/monetary penalties.
(G) Formal reprimand(s).
(iv) If applicable, the nature of the IRO determination(s).
(v) The number of patients impacted by the physician's or eligible
professional's conduct and the degree of harm thereto or impact upon.
(vi) Any other information that CMS deems relevant to its
determination.
* * * * *
0
63. Section 424.535 is amended by--
0
a. In paragraph (a)(14) introductory text, by removing the phrase
``prescribing Part D drugs'' and adding in its place the phrase
``prescribing Part B or D drugs''; and
0
b. Reserving paragraphs (a)(15) through (21).
0
c. Adding paragraph (a)(22).
The addition reads as follows:
Sec. 424.535 Revocation of enrollment in the Medicare programs.
(a) * * *
(22) Patient Harm. The physician or eligible professional (as that
term is defined in 1848(k)(3)(B) of the Act) has been subject to prior
action from a State oversight board, Federal or State health care
program, Independent Review Organization (IRO) determination(s), or any
other equivalent governmental body or program that oversees, regulates,
or administers the provision of health care with underlying facts
reflecting improper physician or eligible professional conduct that led
to patient harm. In determining whether a revocation is appropriate,
CMS considers the following factors:
(i) The nature of the patient harm.
(ii) The nature of the physician's or eligible professional's
conduct.
(iii) The number and type(s) of sanctions or disciplinary actions
that have been imposed against the physician or eligible professional
by the State oversight board, IRO, federal or state health care
program, or any other equivalent governmental body or program that
oversees, regulates, or administers the provision of health care. Such
actions include, but are not limited to in scope or degree:
(A) License restriction(s) pertaining to certain procedures or
practices.
(B) Required compliance appearances before State medical board
members.
(C) Required participation in rehabilitation or mental/behavioral
health programs.
(D) Required abstinence from drugs or alcohol and random drug
testing.
(E) License restriction(s) regarding the ability to treat certain
types of patients
[[Page 40932]]
(for example, cannot be alone with members of a different gender after
a sexual offense charge).
(F) Administrative or monetary penalties.
(G) Formal reprimand(s).
(iv) If applicable, the nature of the IRO determination(s).
(v) The number of patients impacted by the physician's or eligible
professional's conduct and the degree of harm thereto or impact upon.
PART 425--MEDICARE SHARED SAVINGS PROGRAM
0
64. The authority citation for part 425 continues to read as follows:
Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.
Sec. 425.612 [Amended]
0
65. Section 425.612 is amended in paragraph (a)(1)(v)(E) introductory
text by removing the phrase ``paragraph (a)(1)(v)(B)'' and adding in
its place the phrase ``paragraph (a)(1)(v)(D)''.
PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
0
66. The authority citation for part 489 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1395i-3, 1395x, 1395aa(m), 1395cc,
1395ff, and 1395(hh).
0
67. Section 489.2 is amended by adding paragraphs (b)(10) and (c)(3) to
read as follows:
Sec. 489.2 Scope of part.
* * * * *
(b) * * *
(10) Opioid treatment programs (OTPs).
(c) * * *
(3) OTPs may enter into provider agreements only to furnish opioid
use disorder treatment services.
0
68. Section 489.10 is amended by revising paragraph (a) to read as
follows:
Sec. 489.10 Basic requirements.
(a) Any of the providers specified in Sec. 489.2 may request
participation in Medicare. In order to be accepted, it must meet the
conditions of participation or requirements (for SNFs) set forth in
this section and elsewhere in this chapter. The RNHCIs must meet the
conditions for coverage, conditions for participation and the
requirements set forth in this section and elsewhere in this chapter.
The OTPs must meet the requirements set forth in this section and
elsewhere in this chapter.
* * * * *
0
69. Section 489.13 is amended by revising paragraph (a)(2)(i) to read
as follows:
Sec. 489.13 Effective date of agreement or approval.
(a) * * *
(2) * * *
(i) For an agreement with a community mental health center (CMHC),
opioid treatment program (OTP), or a federally qualified health center
(FQHC), the effective date is the date on which CMS accepts a signed
agreement which assures that the CMHC, OTP or FQHC meets all Federal
requirements.
* * * * *
0
70. Section 489.53 is amended by revising paragraph (a)(3) to read as
follows:
Sec. 489.53 Termination by CMS.
(a) * * *
(3) It no longer meets the appropriate conditions of participation
or requirements (for SNFs and NFs) set forth elsewhere in this chapter.
In the case of an RNHCI, it no longer meets the conditions for
coverage, conditions of participation and requirements set forth
elsewhere in this chapter. In the case of an OTP, it no longer meets
the requirements set forth in this section and elsewhere in this
chapter.
* * * * *
PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT
AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE
MEDICAID PROGRAM
0
71. The authority citation for part 498 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7j, and 1395hh.
0
72. Section 498.2 is amended in the definition of ``Provider'' by
revising the introductory text and adding paragraph (3) to read as
follows:
Sec. 498.2 Definitions.
Provider means any of the following:
* * * * *
(3) An entity that has in effect an agreement to participate in
Medicare but only to furnish opioid use disorder treatment services.
* * * * *
Dated: June 21, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: July 18, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
BILLING CODE 4120-01-P
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[FR Doc. 2019-16041 Filed 7-29-19; 4:15 pm]
BILLING CODE 4120-01-C
