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

 
CONTENT
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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
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\).
---------------------------------------------------------------------------
    \54\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \55\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \66\ See section 1860D-2(e) of the Act.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \67\ 82 FR 50742 through 50745.
    \68\ 75 FR 49142.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \70\ 81 FR 61079.
    \71\ 81 FR 61079.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \75\ 81 FR 61080.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
[[Page 40602]]
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),
[[Page 40603]]
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.
[[Page 40604]]
(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\
---------------------------------------------------------------------------
    \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.
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    \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.
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    \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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    \91\ This report is available at https://www.gao.gov/assets/650/649018.pdf.
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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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    \92\ This report is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/Downloads/Report-To-Congress-September-2015.pdf.
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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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    \93\ Available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/index.html.
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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
[[Page 40691]]
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
[[Page 40692]]
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.
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(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