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 Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine Interim Final Rule

 
CONTENT
Federal Register, Volume 84 Issue 221 (Friday, November 15, 2019)
[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Rules and Regulations]
[Pages 62568-63563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24086]
[[Page 62567]]
Vol. 84
Friday,
No. 221
November 15, 2019
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 403, 409, 410, 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 Final Rule; and Coding
and Payment for Evaluation and Management, Observation and Provision of
Self-Administered Esketamine; Final and Interim Final Rules
Federal Register / Vol. 84 , No. 221 / Friday, November 15, 2019 /
Rules and Regulations
[[Page 62568]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 409, 410, 411, 414, 415, 416, 418, 424, 425, 489,
and 498
[CMS-1715-F and IFC]
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 Final Rule; and Coding
and Payment for Evaluation and Management, Observation and Provision of
Self-Administered Esketamine Interim Final Rule
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule and interim final rule.
-----------------------------------------------------------------------
SUMMARY: This major final 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.
In addition, we are issuing an interim final rule with comment period
(IFC) to establish coding and payment for evaluation and management,
observation and the provision of self-administered Esketamine to
facilitate beneficiary access to care for treatment-resistant
depression as efficiently as possible.
DATES:
    Effective date: These regulations are effective on January 1, 2020.
    Comment date: Comments will be accepted/considered ONLY on the
Interim Rule ``Coding and Payment for Evaluation and Management,
Observation and Provision of Self-Administered Esketamine'' contained
in section V. of the preamble of this document. To be assured
consideration, comments must be received at one of the addresses
provided below, no later than 5 p.m. on December 31, 2019.
ADDRESSES: In commenting, please refer to file code CMS-1715-IFC.
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-IFC, 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-IFC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR 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 indices (GPCIs).
    Larry Chan, (410) 786-6864, or Geri Mondowney, (410) 786-1172, for
issues related to potentially misvalued services under the PFS.
    Lindsey Baldwin, (410) 786-1694, Emily Yoder, (410) 786-1804, or
Patrick Sartini, (410) 786-9252, 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.
    Terry Simananda, (410) 786-8144, for issues related to interim
final rule with comment period (payment for self-administered
esketamine).
    Kathy Bryant, (410) 786-3448, for issues related to coinsurance for
colorectal cancer screening tests and global surgery data collection.
    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.
    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 and the requirements
related to the Medicare ground ambulance 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.
[[Page 62569]]
    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).
    Brittany LaCouture, (410) 786-0481, for inquiries related to
Alternative Payment Models (APMs).
    Patricia Taft, (410) 786-4561, for issues related to Physician
Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes Annual
Update.
SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that website to view
public comments.
    Addenda Available Only Through the Internet on the CMS Website: The
PFS Addenda along with other supporting documents and tables referenced
in this final rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.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 final rule, refer to item CMS-1715-F. Readers with questions
related to accessing any of the Addenda or other supporting documents
referenced in this final 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 final 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 final rule revises payment polices under the Medicare
PFS and makes other policy changes, including provisions 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 final
rule includes provisions related to other payment policy changes that
are addressed in section III. of this final rule.
    To facilitate beneficiary access to treatment for treatment-
resistant depression (TRD) as using esketamine, we are creating two new
HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an interim
final basis. For 2020, we are establishing RVUs for these services that
reflect the relative resource costs associated with the evaluation and
management (E/M), observation and provision of the self-administered
esketamine product.
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 final rule, we are establishing 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 final rule also includes discussions and
provisions 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 a ground 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.
Specifically, this final 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 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.)
[[Page 62570]]
 Updates to the Quality Payment Program (section III.K.)
 Physician Self-Referral Law: Annual Update to the List of CPT/
HCPCS Codes (section IV.)
 Interim Final Rule with Comment Period: Coding and Payment for
Evaluation and Management, Observation and Provision of Self-
Administered Esketamine (HCPCS codes G2082 and G2083) (section V.)
 Collection of Information Requirements (section VI.)
 Regulatory Impact Analysis (section VII.)
2. Summary of Costs and Benefits
    We have determined that this final rule is economically
significant. For a detailed discussion of the economic impacts, see
section VII. of this final rule.
II. Provisions of the Final 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 final 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
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
[[Page 62571]]
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 final 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.
    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 VII. of this final 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), and to the GPCI section of this current rule for the CY 2020
update.
    RVUs are converted to dollar amounts through the application of a
CF, which is calculated based on a statutory formula by CMS' 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 PE
[[Page 62572]]
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
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 proposed 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 Final Rule PE/HR''
file available on the CMS website under the supporting data files for
the CY 2020 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    We did not receive any public comments on the use of the proposed
PE/HR proxy values for Medical Toxicology and Hematopoietic Cell
Transplantation and Cellular Therapy. Therefore, we are finalizing our
PE/HR crosswalks as proposed.
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
[[Page 62573]]
(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.
     Then, 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 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.
[[Page 62574]]
    For CY 2020, we proposed 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
proposed 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.
BILLING CODE 4120-01-P
[[Page 62575]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.000
BILLING CODE 4120-01-C
    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
[[Page 62576]]
identical MP risk factors for MP valuation. As a result, we noted that
we did not anticipate the proposal having a discernible effect on the
valuation of the codes listed above. 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 final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    We received public comments on the proposed updates to the expected
specialty list. The following is a summary of the comments we received
and our responses.
    Comment: Several commenters stated that CMS had indicated that the
expected specialty would be updated to include a column specifying if a
service was identified as a low volume service for CY 2020, indicating
if the service-level override was being applied for CY 2020. However,
commenters noted that this additional column did not appear in the
download version and asked for additional information.
    Response: We thank the commenters for identifying this missing
information and we apologize for the technical oversight that caused
this information not to be displayed for the proposed rule. We will
include this additional column in the public use files released with
the final rule.
    Comment: Several commenters disagreed with the CMS proposal to
update the expected specialty list to accurately reflect the previously
finalized crosswalk to thoracic surgery for these services. Commenters
stated that when the expected specialty list was developed, the
affected specialties specifically selected the cardiac surgery
specialty for these codes. Commenters also stated that, for nearly all
of the applicable codes, cardiac surgery was the dominant provider in
the 2018 Medicare claims data. Commenters acknowledged that the MP risk
factor for both cardiac surgery and thoracic surgery is naturally very
similar, but still asked that CMS assign the codes listed in Table 1 to
the cardiac surgery specialty.
    Response: As we stated in the proposed rule, we did not propose to
assign the codes listed in Table 1 to the cardiac surgery specialty.
Instead, we proposed to update the incorrect documentation in our
expected specialty list to accurately reflect the previously finalized
crosswalk to thoracic surgery for these services. The previously
finalized assignment of the cardiac specialty to these services has
been in place since the CY 2012 rule cycle, and we believe that the
expected specialty list should be updated to reflect the correct
specialty assignment.
    Comment: Several commenters disagreed with the CMS methodology used
to determine low volume service status; that is, codes that have fewer
than 100 allowed services in the non-modified 3-year average of
Medicare claims data. Commenters stated that utilization frequencies
are adjusted in the RUC database for certain codes based on the CPT
modifiers that were appended to the code to ensure that certain
services are not over- or underweighted, such as changes made for
bilateral modifier 50, post-op only modifier 55 and anesthesia
modifiers QK, QX and QY. Commenters stated that CMS does not discount
the utilization when determining what constitutes a low volume service
and instead uses the non-modified 3-year service count for this
criterion. Commenters stated that this could lead to double-counting
and overestimating utilization for the purposes of determining low
volume status, and requested that CMS use discounted utilization for
this purpose.
    Response: We disagree that it would be more accurate to use a
discounted form of utilization to determine low volume status. We
finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through
59283) to use claims data to determine which codes are low volume for
the coming year, defining ``low volume'' as those that had fewer than
100 allowed services in the Medicare claims data. We did not finalize a
policy to discount this utilization and we do not believe that it would
be more accurate to do so, as a service is still performed even if a
payment discount is applied to its billing. More importantly, we did
not make any proposals concerning the methodology to determine what
constitute a low volume service in the proposed rule, and therefore, we
are not finalizing any changes to this methodology.
    Comment: One commenter provided a list of 112 additional codes that
the commenter stated were low volume procedures, with an expected
specialty for each code. The commenter recommended that CMS append this
list to the anticipated specialty assignment for low volume services.
Another commenter stated that gastroenterologists do not perform CPT
code 96571 on a current basis, and recommended that CMS remove
gastroenterology as the expected specialty for this code.
    Response: We appreciate the list of additional services identified
by the commenter. As we have stated in previous rulemaking (82 FR
52982), we consider recommendations from the RUC and other stakeholders
on changes to this list on an annual basis. In reviewing the submitted
list of 112 additional codes, we noted that they generally fell into
two categories--codes with a restricted coverage status code (``R'') or
codes that exceed 100 services in the claims data, and therefore, did
not meet our criteria for low volume status. We are finalizing the
addition of these 112 codes to the low volume services list with the
recommended expected specialty; however, we caution that many of these
codes will continue to have utilization too high to meet the criteria
for expected specialty assignment. We are adding these codes to the
list in the interest of maintaining payment stability, such that, if
they were to fall below 100 annual services at a future date, then an
expected specialty would be assigned. We do not have indirect PE data
for two of the specialties on the recommended list, and as a result we
are substituting the established PE/HR crosswalk for these specialties.
(The full list of all established PE/HR crosswalks is available on our
website under downloads for the CY 2020 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.) The two
affected specialties are Interventional Cardiology (crosswalked to
Cardiology) and Surgical Oncology (crosswalked to General Surgery). We
are also finalizing a change to the expected specialty for CPT code
96571 in response to the information supplied by the commenter, which
we are changing to Pulmonary Disease to match the dominant specialty in
the claims data. The complete list of additional updates to the low
volume services list is detailed in Table 2.
BILLING CODE 4120-01-P
[[Page 62577]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.001
[[Page 62578]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.002
BILLING CODE 4120-01-C
    Comment: Several commenters stated that the non-facility PE RVUs
for CPT code 55874 (Transperineal placement of biodegradable material,
peri-prostatic, single or multiple injection(s), including image
guidance, when performed) are projected to decrease 13 percent for CY
2020, which the commenter believed to be attributed to the current
specialty mix utilizing the code. The commenters stated that the
projected decrease for CY 2020 was due to CMS using the first year of
actual claims data, which had a different ratio of the urology and
radiation oncology specialties than in the previously projected
utilization crosswalk. The commenters requested that CMS address the
proposed decreases for CPT code 55874 in the final rule.
    Response: We agree with the commenters that the proposed decreases
for CPT code 55874 were due to changes in the specialty mix, as the
code shifted from projected utilization to reported claims data.
However, we do not agree with the commenters that there is a need to
address the valuation of this code, as we believe that it is important
to use actual claims data as opposed to utilization projections once
the data for new codes has become available. The specialty mix on
reported claims will necessarily be more accurate than the utilization
projections created in advance before claims data exists. We also note
that the specialty mix associated with CPT code 55874 in the claims
data is unrelated to the low volume list or the assignment of an
expected specialty.
    Comment: A commenter stated that CPT codes 33271 (Insertion of
subcutaneous implantable defibrillator electrode) and 33273
(Repositioning of previously implanted subcutaneous implantable
defibrillator electrode) are low volume service codes that are proposed
to have a service-level override to the anticipated specialty of
cardiology. The commenter supported this expected specialty assignment.
    Response: We appreciate the support for our proposals from the
commenter.
    After consideration of the public comments, we are finalizing our
proposal to update the expected specialty list to accurately reflect
the previously finalized crosswalk to thoracic surgery for these
services. We are also finalizing the updates to the expected specialty
list detailed above in Table 2; we reiterate again that we do not
anticipate this finalized proposal having a discernible effect on the
valuation of the codes in the table due to the similarity between the
cardiac surgery and thoracic surgery specialties.
    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
[[Page 62579]]
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 final 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 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.
[[Page 62580]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.003
     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).
     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
[[Page 62581]]
accordingly. Table 4 details the manner in which the modifiers are
applied.
[GRAPHIC] [TIFF OMITTED] TR15NO19.004
    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
final 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) [caret] 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 final 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 final 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.
    Comment: A commenter stated that they disagreed with the 90 percent
utilization metric for CT and MRI equipment, as the commenter did not
believe it to be realistic in a typical outpatient imaging setting, but
the commenter recognized that the percentage is dictated by statute.
The commenter stated that the 90 percent equipment usage assumption for
CT and MRI is inconsistent with actual imaging center practice and
ignores scheduling in the ``real world,'' such as lunch and other
mandated breaks, complicated patients, and downtime for maintenance and
quality control. The commenter stated that to achieve a 90 percent
utilization rate under ideal conditions would require two employees per
unit; one doing pre-service tasks while the other is setting up the
machine as opposed to assumptions of one CT or MRI technologist per
scanner.
    Response: We disagree with the commenters regarding the equipment
time assigned to highly technical equipment such as CT or MRI machines.
We continue to believe that certain highly technical pieces of
equipment
[[Page 62582]]
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 and are typically available for other patients
even when one member of clinical staff may be occupied with a
preservice or postservice task related to the procedure. For a more
detailed description of this topic, we refer readers to the CY 2015 PFS
final rule with comment period (79 FR 67639 through 67640).
    Comment: One commenter stated that most ophthalmology diagnostic
equipment is in use far less than 50 percent of the time. The commenter
indicated that they had developed a survey instrument that asked
ophthalmic technicians to provide time usage estimates for the 16 most-
utilized pieces of diagnostic testing equipment. The commenter stated
that their preliminary survey results produced a utilization rate of 22
percent, much lower than the 50 percent assumption currently used by
CMS. The commenter suggested that CMS should work with the RUC to do a
robust survey to help determine a more valid utilization rate,
including the possibility of specialty-specific equipment utilization
rates. The commenter also requested a meeting to discuss what options
CMS would find acceptable in undertaking their own survey for
ophthalmology services.
    Response: We are always looking for more accurate information to
improve our PE methodology. We appreciate and share stakeholders'
interest in using the most accurate assumption regarding the equipment
utilization rate for particular equipment items, and we will review any
information that the RUC's PE subcommittee or other stakeholders are
willing to submit through the public comment process. We concur with
the commenter that a wide-ranging survey or similar study designed to
address the subject of equipment utilization rates would be an
appropriate tool to investigate this subject in further detail. At the
moment, 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 further
submission of data that illustrates an alternative rate.
    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 did not propose a variable maintenance
factor for equipment cost per minute pricing as we noted that we did
not believe that we have sufficient information at present to do so. We
continue to investigate potential avenues for determining equipment
maintenance costs across a broad range of equipment items.
    Comment: A commenter stated that they continue to believe that
maintenance costs for imaging equipment are much higher than the
current 5 percent assumption. The commenter stated that the maintenance
costs for an MRI unit include servicing the scanner itself plus
replacing cryogens for a cost well in excess of 5 percent even using
CMS' low assumptions of MRI and CT room cost.
    Response: As detailed above, we continue to believe that the
current 5 percent maintenance factor likely understates the true cost
of maintaining some equipment and overstates the maintenance costs for
other equipment. We continue at this time to lack publicly available
datasets regarding equipment maintenance costs or another systematic
data collection methodology for determining maintenance factor. We
remind readers that 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.
    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
did not propose any changes to these interest rates for CY 2020. The
Interest rates are listed in Table 5.
[GRAPHIC] [TIFF OMITTED] TR15NO19.005
    Comment: A commenter stated that they did not support the continued
use of the 2012 SBA maximum interest rates, which the commenter stated
are significantly lower than the 2019 rates. The commenter stated that
CMS should also update the interest rates used to calculate PE RVUs for
such items based on current SBA data.
    Response: We appreciate the additional information regarding SBA
[[Page 62583]]
maximum interest rates from the commenter. However, we did not propose
any changes to these interest rates for CY 2020; we will consider
potential changes to the interest rates used in the equipment cost per
minute calculation for possible future rulemaking.
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 final
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.
    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 and 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
[[Page 62584]]
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 final rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Comment: A commenter wrote to express their concerns with the
manner in which data was displayed in the Proposed CY 2020 Direct PE
Refinements table in the proposed rule (84 FR 40623-40666),
specifically the common refinements to equipment time. The commenter
stated that nearly 64 percent of the total PE refinements were related
to equipment, and 59 percent of these refinements were listed as ``E15:
Refined equipment time to conform to changes in clinical labor time.''
The commenter stated that they did not agree that these are separate
refinements; rather, they are the formulaic result of the applying
refinements to the clinical labor time. The commenter stated that
including these instances as refinements adds a large quantity of rows
to the PE refinement table and gives the impression that there are
major inaccuracies in the RUC PE recommendations. The commenter
provided an example of a single clinical labor refinement to a code
family creating 32 rows of subsequent equipment refinements, and
contended that articulating these edits was not necessary as they do
not reflect either an error or a policy discrepancy with the RUC. The
commenter requested that CMS no longer include refinements based on
``E15: Refined equipment time to conform to changes in clinical labor
time'' in the refinement table of the proposed rule.
    Response: We agree with the commenter that these equipment time
refinements generated in response to clinical labor time refinements
are indeed the result of applying standard equipment time formulas, and
they do not reflect errors in the equipment recommendations or policy
discrepancies with the RUC. We also agree that these refinements add a
significant number of rows to the table of direct PE refinements.
However, we disagree with the commenter on the subject of whether these
constitute separate refinements, and we believe that it is important to
publish the specific equipment times that we are proposing (or
finalizing in the case of the final rule) when they differ from the
recommended values. We include the direct cost change in dollars
resulting from our PE refinements on the aforementioned table, and if
we were to avoid including these equipment refinements, it would not
always be clear what effect they were having on the direct costs for
the procedure. For example, a modest reduction of a few minutes in
clinical labor time can result in a substantial decrease in direct
costs for procedures that employ highly expensive equipment. We believe
that it is more important to provide additional transparency regarding
the changes in direct costs resulting from our equipment time
refinements so that the public can better comment on our proposals, as
opposed to limiting the total number of printed equipment refinements.
    However, we agree with the commenter that the information displayed
in the table of direct PE refinements can be confusing and
overwhelming, and we believe that it could potentially be provided to
the public in a more useful fashion. For this CY PFS 2020 final rule,
we will separate out the ``E15: Refined equipment time to conform to
changes in clinical labor time'' direct PE refinements and print them
in a separate table of refinements. We believe that this will help to
address the issues raised by the commenter while also retaining all of
the data included in previous rules. We refer readers to Table 28 in
section II.N. of this final rule, the Valuation of Specific Codes
section, for additional details.
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
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
[[Page 62585]]
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 noted 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 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
proposed to establish 23 new scope equipment codes as detailed in Table
6.
[[Page 62586]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.006
    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 proposed 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 proposed to
consider these items separately. We proposed to use the initial five
invoices to establish a proposed price of $3,966.08 for the rigid
scope, laryngoscopy (ES075) equipment item. We noted 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. We also noted that 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 stated that 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
did not propose to update the price of the ES065 equipment. We also
noted that we were 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 received submitted
invoices for pricing, we proposed to replace the existing scopes with
the new scope equipment. We noted that we received recommendations from
the RUC's scope workgroup regarding which HCPCS codes make use of the
new scope equipment items, and we proposed to make this scope
replacement for approximately 100 HCPCS codes in total (see Table 7).
[[Page 62587]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.007
[[Page 62588]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.008
[[Page 62589]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.009
[[Page 62590]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.010
    In all but three cases (as identified with an asterisk (*) in Table
7), we proposed 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), we noted the current scopes in use are the
FEES video system
[[Page 62591]]
(ES027) and the FEESST video system (ES028). Since we proposed the use
of a non-channeled flexible digital scope that requires a corresponding
scope video system, we also proposed to add the ES080 equipment at the
same equipment time to these three procedures rather than replacing the
ES027 and ES028 equipment. In all other cases, we proposed to replace
the current scope equipment listed in Table 7 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 did not propose to add one of the new scope
equipment items to these procedures.
    We noted that we did not receive pricing information along with the
workgroup recommendations for the other 15 new scope equipment items.
Therefore, we proposed to establish new equipment codes for these
scopes as detailed in Table 6. However, we noted that due to a lack of
pricing information, we did not propose 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 welcomed additional feedback
from stakeholders regarding the pricing of these scope equipment items,
especially the submission of detailed invoices with pricing data. We
proposed to transition the scopes for which we did have pricing
information over to the new equipment items for CY 2020, and we noted
that we looked forward to engaging with stakeholders to assist in
pricing and then transitioning the remaining scopes in future
rulemaking.
    We received public comments on our scope equipment proposals. The
following is a summary of the comments we received and our responses.
    Comment: Several commenters stated that they appreciated the
proposal of the recommended 23 new scope equipment codes and the
proposed pricing of 8 of those new scope equipment codes. Commenters
also stated that they appreciated the proposal of scope replacements
for 100 CPT codes as recommended by the RUC utilizing the 8 scopes that
CMS was able to price. One commenter encouraged CMS to continue to work
with the RUC workgroup and other stakeholders to obtain detailed
invoices for the scopes for which it did not have pricing data to
assist in the correct pricing and transition of these equipment items.
    Response: We appreciate the support for our proposals from the
commenters. We welcome the submission of additional pricing data from
the RUC scope workgroup and other stakeholders regarding the pricing of
the remaining scope equipment items.
    Comment: One commenter stated that they appreciated the recognition
of the existing specialized equipment that is required in addition to
the proposed scope equipment, and they supported the proposal to add
ES080 and retain ES027 or ES028 at the same equipment time for CPT
codes 92612, 92614, and 92616.
    Response: We appreciate the support for our proposals from the
commenter.
    Comment: Several commenters stated it was their understanding that
additional scope pricing information submitted now would be considered
for the CY 2021 PFS proposed rule. These commenters asked for
clarification that the CPT codes impacted by any scope proposals for CY
2021 will be outlined in a table just as the impacted codes for CY 2020
were outlined in Table 7, so that they will be subject to stakeholder
review and comment prior to implementation.
    Response: As we stated in the proposed rule, we welcome additional
feedback from stakeholders regarding the pricing of these remaining
scope equipment items, especially the submission of detailed invoices
with pricing data. Any future proposals that we make regarding scope
equipment will be subject to notice and comment rulemaking, including
displaying information in a table similar Table 7, if it would be
appropriate to do so.
    Comment: A commenter stated that they had identified
inconsistencies with the scope workgroup recommendations for a small
number of HCPCS codes. The commenter stated that CPT code 45350
(Sigmoidoscopy, flexible; with band ligation(s) (e.g., hemorrhoids))
was recommended by the workgroup to include a multi-channeled flexible
digital scope, flexible sigmoidoscopy (ES085); however, CMS noted in
the proposed rule that this CPT code does not include any scopes among
its current direct PE inputs. The commenter stated that all codes in
the flexible sigmoidoscopy family require a flexible sigmoidoscope in
order to perform the procedure, and therefore, the commenter requested
that CMS add the ES085 scope equipment to CPT code 45350.
    Response: We appreciate the feedback from the commenter in pointing
out this inconsistency in the direct PE inputs for CPT code 45350.
Based on the information supplied by the commenter, we are finalizing
the addition of the ES085 scope equipment to CPT code 45350. We are
finalizing an equipment time of 59 minutes based on the use of our
standard equipment time formula for scopes.
    Comment: A commenter requested that the ``rigid scope,
hysteroscopy'' (ES071) equipment be updated to read ``rigid scope,
channeled, hysteroscopy'' and that the hysteroscopy codes (that is, CPT
codes 58555, 58562, 58565) be valued with ES071. The commenter
submitted an invoice with pricing information associated with the ES071
scope equipment.
    Response: We appreciate the submission of an invoice from the
commenter for use in pricing the ES071 scope. Based on the information
provided by the commenter, we are finalizing a change in the name of
the ES071 scope from ``rigid scope, hysteroscopy'' to ``rigid scope,
channeled, hysteroscopy.'' We are also finalizing a price of $6,795 for
the ES071 scope based on the pricing data supplied by the commenter,
and we are finalizing the replacement of the existing ``endoscope,
rigid, hysteroscopy'' (ES009) scope with the new ES071 scope equipment.
The CPT codes affected by this replacement are CPT codes 58555, 58562,
and 58565 as identified by the commenter, as well as CPT code 58563
which is the only other code that previously employed the ES009 scope.
These scope replacements are summarized below in Table 9.
    Comment: One commenter provided a series of invoices for different
types of rigid scopes in response to the comment solicitation.
    Response: We appreciate the submission of additional invoices from
the commenter. Based on the
[[Page 62592]]
information included in these invoices, we are finalizing prices for
three scopes that did not previously have pricing data. We are
finalizing a price of $2,333.98 for the ``rigid scope, otoscopy''
(ES072) equipment, a price of $3,004.75 for the ``rigid scope, nasal/
sinus endoscopy'' (ES073) equipment, and a price of $21,923.425 for the
``non-channeled flexible digital scope, nasopharyngoscopy'' (ES078)
equipment. We are not finalizing the replacement of any of the old
scope equipment codes with these three new scope equipment items for CY
2020, as the commenter did not identify the HCPCS codes in which this
replacement would take place. We will consider additional scope pricing
information for these three scope equipment codes, including the HCPCS
codes in which they would typically be employed, as part of the CY 2021
PFS proposed rule.
    The commenter also provided five new invoices for the pricing of
the ``non-video flexible scope, laryngoscopy'' (ES092) equipment. These
five invoices had an average price of $5,105.97, which was nearly
identical to our proposed price of $5,078.04 for the ES092 scope. We
believe that these invoices reinforce the accuracy of the proposed
pricing. We are finalizing an increase in the price of the ES092 scope
to $5,105.97, which will slightly increase the direct costs for the 14
HCPCS codes containing this scope listed above in Table 7.
    Comment: Several commenters sent a series of additional invoices,
and recommended crosswalks from existing equipment codes to the
proposed equipment codes to ensure that the equipment currently listed
for GI endoscopy procedures was appropriately attributed to the correct
new scopes. Although the commenters did not provide information to
update any of the proposed scope equipment prices, the commenters did
clarify that several of the new scope equipment items which lacked
proposed prices in fact shared the same current scope equipment codes
as other new scope equipment items that did have proposed pricing. For
example, CMS proposed to replace the ``videoscope, gastroscopy''
(ES034) scope equipment with the new ``multi-channeled flexible digital
scope, esophagoscopy'' (ES088) scope equipment. The commenters
clarified that this same ES034 equipment, when used in additional CPT
codes, would be replaced by either the ``multi-channeled flexible
digital scope, esophagoscopy gastroscopy duodenoscopy'' (ES087) or the
``multi-channeled flexible digital scope, ileoscopy'' (ES089) equipment
items, all of which should share the same proposed price of $34,585.35.
The commenter also explained that the same ``Video Sigmoidoscope''
(ES043) equipment which CMS proposed to replace with the ``multi-
channeled flexible digital scope, pouchoscopy'' (ES090) new scope
equipment would, in additional CPT codes, be replaced by the new
``multi-channeled flexible digital scope, flexible sigmoidoscopy''
(ES085) scope equipment, and that both ES085 and ES090 should share the
same proposed price of $19,308.56. Finally, the commenter also stated
that the new ``ultrasound digital scope, endoscopic ultrasound''
(ES091) equipment item would only be used in the facility setting, and
that none of the HCPCS codes that included this scope contained direct
PE inputs.
    Response: We appreciate the submission of additional invoices and
the clarification of the relationship between the former scope
equipment codes and the newly created scope equipment codes. After
considering this additional information supplied by the commenters, we
are updating Table 8 of CY 2020 new scope equipment codes.
[[Page 62593]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.011
    We note again that we are not finalizing changes to the pricing of
the group of new scope equipment codes with previously proposed prices,
aside from the minor increase in the price of the ES092 equipment, only
newly pricing several scopes that previously lacked pricing, and
extending proposed pricing such that the ES087 and ES089 scopes share
the same price with the ES088 scope, and the ES090 scope shares the
same price with the ES085 scope. The new scope equipment codes ES087,
ES088, and ES089 all share the same price because they are replacing
the same current scope equipment code (ES034), and similarly the new
ES085 and ES090 scope equipment codes share the same price because they
are both replacing the same current scope equipment code (ES043). There
are 21 HCPCS codes which are affected by the new scope replacements;
these codes are detailed in Table 9.
BILLING CODE 4120-01-P
[[Page 62594]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.012
[[Page 62595]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.013
BILLING CODE 4120-01-C
    Although we are updating the scope equipment pricing for CY 2020
such that the ES087 and ES089 scopes share the same price with the
ES088 scope, and the ES090 scope shares the same price with the ES085
scope, we do not mean to suggest that these scopes that share pricing
are identical with one another. We are assigning the same price to
these scopes because they are replacing the same current scope
equipment codes, and because we do not have individual pricing
information for them at the moment. We are open to the submission of
additional invoices in future rule cycles to establish individual
pricing for these scopes, and we continue to welcome more data to help
identify pricing for the remaining 7 scope equipment codes that still
lack invoices.
    After consideration of the public comments, we are finalizing
pricing for the new scope equipment as detailed above in Table 8. We
are also finalizing the scope equipment replacements as detailed in
Tables 7 and 9.
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 proposed 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 proposed 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 agreed with the workgroup's
recommendation, and we proposed 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
proposed to apply the special rule for multiple endoscopic procedures
to this family of codes beginning in CY 2020. We noted 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 proposed 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 the proposal are
detailed in Table 10.
[[Page 62596]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.014
    Special rules for multiple endoscopic procedures would apply if any
of the procedures listed in Table 10 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
Public Law 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).
    We received public comments on the proposed technical corrections
to the direct PE input database and supporting files. The following is
a summary of the comments we received and our responses.
    Comment: One commenter agreed with the RUC workgroup's
recommendation and the CMS proposal to remove the non-facility direct
PE inputs from CPT code 43231 and 43232.
    Response: We appreciate the support for our proposals from the
commenter.
    Comment: One commenter stated that the proposed approach for nasal
sinus endoscopy procedure better reflects the work RVU associated with
the different levels of sinus endoscopy procedures and stated their
support for this payment change. The commenter requested clarification
regarding the application of the bilateral adjustment in conjunction
with the special rules for multiple endoscopic procedures. The
commenter stated that it was their understanding that if the CPT code
is reported as a bilateral procedure and is reported with other
procedure codes on the same day, the guidance is to apply the bilateral
adjustment before applying any form of multiple procedure rules.
    Response: The special rule for multiple endoscopic procedures has
been described correctly in general terms by the commenter, although we
encourage readers once again to refer to the CY 1992 PFS final rule
where this policy was established (56 FR 59515) and to Public Law 100-
04, Medicare Claims Processing Manual, Chapter 23. This manual text
states that special rules for multiple endoscopic procedures apply if
the procedure is billed with another endoscopy in the same family
(i.e., another endoscopy that has the same base procedure). The base
procedure for each code with this indicator is identified in the
endoscopic base code field. In these situations, we apply the multiple
endoscopy rules to a 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 with only 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.
    Comment: A commenter requested clarification regarding the proposal
to apply the special rule for multiple endoscopic procedures to the
family of codes listed in Table 10. The commenter stated that it was
their understanding that that the diagnostic endoscopy described by CPT
code 31231 is included in the valuation of all of the surgical
procedure codes on the list (for example, CPT codes 31254, 31256,
31276, etc.), and therefore, CPT Code 31231 would not be billed on the
same side that any nasal endoscopic surgical code(s) are performed.
However, the commenter stated that it was their understanding that CPT
code 31231 could be billed for one side of the nose if it was the only
procedure performed and there was no surgical intervention on that
side. Assuming that this interpretation was correct, the commenter
stated that they supported the application of the special rules for
endoscopy to the nasal endoscopy family.
    Response: We reiterate that the special rule for multiple
endoscopic procedures has been described correctly in general terms by
the commenter, although we encourage readers once again to refer to the
CY 1992 PFS final rule where this policy was established (56 FR 59515)
and to Public Law 100-
[[Page 62597]]
04, Medicare Claims Processing Manual, Chapter 23. We encourage
stakeholders to contact their local Medicare Administrative Contractor
(MAC) for information regarding proper billing instructions for CPT
code 31231.
    Comment: One commenter stated that they were troubled by the
proposal to apply the multiple endoscopy payment methodology to the CPT
codes included in Table 10 without further clarification in the
regulatory language or the Medicare Carriers Manual about the number of
multiple procedure modifiers CMS can append to one claim. The commenter
questioned whether these 27 codes will be assigned a multiple procedure
indicator of ``3'' and if that would override the prior multiple
procedure indicator of ``4''. The commenter stated that they did not
support the application of multiple endoscopy payment rules if CMS
intended to assign reductions for both multiple endoscopy and multiple
procedures, as application of both payment rules would result in
inappropriate reductions to this set of services.
    Response: In response to the commenter's question, only one
multiple procedure indicator can be applied to each HCPCS code. We also
clarify that our proposal would assign a multiple procedure indicator
of ``3'' to all of the codes listed in Table 10 aside from CPT code
31231, which would be the endoscopic ``base code'' and would be
assigned a multiple procedure indicator of ``2''. We also note that
none of these codes previously contained a multiple procedure indicator
of ``4'', which is associated with certain diagnostic imaging services.
We encourage readers once again to refer 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.
    Comment: One commenter stated that although they recognized that by
including the nasal endoscopy family among the codes using the special
rule for multiple endoscopies, CMS may be trying to harmonize
endoscopic procedures, and they stated that the unique situation
surrounding the nasal endoscopy code family should prohibit the
application of this special rule. The commenter stated that the nasal
endoscopy code family differed significantly from colonoscopy
procedures in that there is not uniformity across the sites of service
where these sinus procedures are performed, since these services could
be performed in both the facility and non-facility settings. The
commenter stated that applying the special rules for multiple
endoscopic procedures to this group would result in a significant
inappropriate reduction in the value of the secondary and subsequent
nasal surgical codes performed on the same patient on the same day when
performed in the office setting, and the commenter stated that they
opposed the application of the special rules for multiple endoscopies
to the nasal endoscopy family in the non-facility setting.
    Response: We disagree that this nasal endoscopy code family differs
significantly from other colonoscopy families where the special rule
for multiple endoscopic procedures has long been in place. Although the
commenter stated that the nasal endoscopy codes were unique in the
sense that they could be performed in both the facility and non-
facility settings, and that the base code for the family, CPT code
31231, is typically an office-based procedure with significant PE built
into the code, we note in response that there are many other groups of
codes which utilize the special rule for multiple endoscopic procedures
and are also performed in both the facility and non-facility settings.
These include CPT codes 31573-31579 (base CPT code 31575), CPT codes
43220-43229 (base CPT code 43220), CPT codes 44389-44394 (base CPT code
44388), and CPT codes 45303-45320 (base CPT code 45300). There are
dozens of these codes which can be performed in both the facility and
non-facility settings, many of them with significant PE inputs built
into their non-facility valuation. In light of this evidence, we
disagree with the commenter that there is a unique situation regarding
the nasal endoscopy family of codes.
    Comment: Several commenters requested that CMS utilize the RUC-
recommended direct PE inputs to publish PE relative value units for CPT
code 90460, which was reviewed by the RUC in October 2009. Rather than
finalize the RUC recommendations, CMS crosswalked CPT code 90460 from
CPT code 90471, which is crosswalked from CPT code 96372 (formerly CPT
code 90772 and then 90782). Commenters stated that the recent measles
crisis spotlights the importance of immunization administration being
appropriately valued, and that the crosswalk from CPT code 96372 to
codes CPT codes 90471/90460 has brought about a 60 percent reduction in
PE RVUs. Commenters stated that CMS typically only uses a crosswalk for
work values, not PE values, and requested that CMS disconnect the codes
after the initial crosswalk so that changes to the source code no
longer affect the crosswalked code. One commenter stated that CMS was
proposing to reduce the non-facility PE RVUs for CPT code 90471 from
0.29 in 2019 to 0.22 in 2020, and while this may appear to be a
relatively small change in RVUs, if finalized it would reduce the
national unadjusted payment for CPT code 90471 (and consequently the
payment rates for HCPCS codes G0008 and G0009) by 15 percent.
    Response: We appreciate the feedback from the commenters and note
that we finalized the crosswalks associated with CPT code 90460 in the
CY 2011 final rule (75 FR 73306). However, we note that we are
separately addressing the valuation of HCPCS codes G0008, G0009, and
G0010 in the codes valuation section of this rule.
    We also received comments regarding a variety of subjects about
which we did not make proposals for CY 2020. These included comments
regarding the proper specialty employed to determine indirect cost
factors for home PT/INR monitoring services and the application of the
multiple procedure payment reduction to physical therapist services. We
will take the feedback from the commenters on these subjects into
consideration for future rulemaking.
    After consideration of the public comments, we are finalizing the
proposal to remove the non-facility direct PE inputs from CPT code
43231 and 43232. We are also finalizing the proposal to apply the
special rule for multiple endoscopic procedures to the family of codes
listed in Table 10 without refinement.
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 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 proposed the following price updates for existing direct PE inputs.
    We proposed 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
proposed that the new pricing take effect for CY 2020 for these items
instead of being phased in over 4 years.
    We also proposed to update the name of the EP001 equipment item
from ``DNA/digital image analyzer (ACIS)'' to ``DNA/Digital Image
Analyzer'' due to
[[Page 62598]]
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 1,300 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-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
[[Page 62599]]
fully implemented for CY 2022. An example of the transition from the
current to the fully-implemented new pricing is provided in Table 11.
[GRAPHIC] [TIFF OMITTED] TR15NO19.015
    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 timeframe 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 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
[[Page 62600]]
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 proposed to
update the prices of the supply and equipment items listed in Table 9
of the CY 2020 PFS proposed rule.
    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) (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 proposed 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 proposed 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 proposed to update the price of the EM visit pack to $5.47 to
match the sum of the prices of the component supplies, and proposed 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 11. 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. Table 12 contains the list of proposed CY
2020 market-based supply and equipment pricing updates:
BILLING CODE 4120-01-P
[[Page 62601]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.016
[[Page 62602]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.017
BILLING CODE 4120-01-C
(2) Invoice Submission
    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.
    We received public comments on updates to prices for existing
direct PE inputs. The following is a summary of the comments we
received and our responses.
    Comment: Many commenters were supportive of the proposed update to
supply and equipment pricing based on the submission of additional
invoices as detailed in Table 12. One commenter thanked CMS for
gathering additional pertinent information and proposing a more
accurate price for the balloon sinus surgery kit (SA106) supply for CY
2020. Several commenters urged CMS to finalize the proposed updates to
the direct PE supplies and equipment prices as listed in the table. One
commenter encouraged CMS to continue to carefully consider all pricing
data including invoices and other supporting evidence that they receive
from the specialty societies throughout this comment period and the
entirety of the 4-year transition period.
    Response: We will continue to carefully consider all pricing data
submitted from commenters throughout the 4-year transition period.
    Comment: Several commenters stated that they were concerned that
supply and equipment pricing will quickly become outdated once the
transition to updated prices is complete in CY 2022. The commenters
encouraged CMS to move to an ongoing update process for supplies and
equipment, as well as for clinical labor staff costs, one that is open
for public comment through the rulemaking process.
    Response: We share the concerns from the commenters that the supply
and equipment pricing will eventually become outdated again after the
pricing transition is complete. We welcome additional feedback from
stakeholders on potential solutions to this issue, and we will consider
the possibility of different approaches to supply and equipment pricing
for use in future rulemaking.
    Comment: One commenter stated that they appreciated and supported
recognition by CMS that the supplies and equipment associated with
physician services were past due for review, but noted that there
remains large numbers of supplies and equipment that are overdue for
updates. The commenter stated that they supported a gradual transition
of the pricing given the widespread impact on the PE values; however,
doing so creates a situation in which items that have seen dramatic
increases over a short time are not being adequately compensated for
several years. The commenter asked CMS to consider shortening the
transition period from 4 years to 3 years for the supply and equipment
pricing.
    Response: Although we appreciate the feedback from the commenter,
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 (83 FR 59479-59480). We did not propose any changes
to this transition period, and therefore, we decline to adopt a
different approach.
    Comment: One commenter stated that they supported the CMS proposal
to update the price of the EM visit pack (SA047) supply to $5.47 to
match the sum of the prices of the component supplies. The commenter
also stated that they had concerns over the pricing of the other
bundled supply items (such as kits, trays, and packs) that may have
been similarly mispriced by StrategyGen. The commenter stated that they
could not assist CMS in correcting supply codes that may have been
incorrectly priced without details about the pricing for individual
component supplies.
    Response: We appreciate the support for our proposed pricing of the
EM visit pack (SA047) supply by the commenter. We encourage
stakeholders to comment
[[Page 62603]]
upon and submit pricing information for any supply items that they
believe may have been mispriced by StrategyGen. In the absence of
alternative pricing information, we continue to believe that our
proposed prices are the most accurate source of data.
    Comment: One commenter recommended CMS consider only the best
available evidence and market research data in proposing any changes to
the pricing approach of the balloon sinus surgery kit (SA106). The
commenter stated that the use of navigation instruments has increased
for this supply kit, particularly in the lower cost office setting,
which enhances the ability to navigate the complex sinus anatomy,
resulting in improved safety and reliability of the procedure, which
benefits the patient.
    Response: We note that the commenter did not make any specific
recommendations regarding the pricing of this supply or submit invoices
with additional pricing information. In the absence of alternative
pricing information, we continue to believe that our proposed prices
are the most accurate source of data.
    Comment: Several commenters stated that they supported and urged
CMS to finalize the proposed prices for the general ultrasound room
(EL015) and vascular ultrasound room (EL016) equipment. Commenters
stated that the proposed prices more accurately reflected the costs
faced by vascular ultrasound practitioners and would reduce health care
costs by ensuring ultrasound services are readily available to the most
vulnerable Medicare beneficiaries.
    Response: We appreciate the support for our proposed pricing by the
commenters.
    Comment: One commenter disagreed with the proposed pricing of the
general ultrasound room (EL015) equipment. The commenter stated that
the proposed pricing would drastically reduce the general ultrasound
room price by 65 percent, which would have a downstream impact on the
vascular ultrasound room, resulting in a 57 percent reduction. The
commenter stated that a 40 percent reduction in payment as a result of
this pricing would significantly reduce patient access to ultrasound
services across the board.
    Response: We clarify for the commenter that we did not propose a
reduction in the price of the general ultrasound room (EL015)
equipment. We proposed to update the price of the general ultrasound
room to $410,303.32 and proposed to continue to transition towards this
price over the remaining years of the phase-in period, with a CY 2020
price of $383,397.77. We note that this is a slight increase over the
finalized CY 2019 price of $369,945.00; we encourage readers to consult
the full list of supply and equipment pricing as detailed in the public
use files.
    Comment: Several commenters disagreed with the proposed pricing of
the ``HDR Afterload System, Nucletron--Oldelft'' (ER003) equipment, the
``treatment planning system, IMRT (Corvus w-Peregrine 3D Monte Carlo)''
(ED033) equipment, and the ``SRS system, SBRT, six systems, average''
(ER083) equipment. The commenters stated that all of these equipment
items have proposed prices that are below industry standards, and that
given the high cost of these items and their substantial utilization in
certain radiation oncology delivery codes, it was imperative that the
CMS inputs accurately reflect the marketplace pricing. The commenters
recommended that CMS conduct additional research regarding fair and
accurate market pricing for equipment items ER003, ED033 and ER083.
Another commenter also disagreed with the proposed pricing of the ER003
equipment, and stated that StrategyGen may have included updated
pricing for a less costly electronic brachytherapy system used to treat
non-melanoma skin cancer, or alternatively the proposed price for ER003
may represent an equipment upgrade or refurbished equipment.
    Response: We share the concerns of the commenters on the importance
to ensure fair and accurate market-based pricing for supplies and
equipment. However, the commenters did not submit invoices or other
pricing data for the ER003, ED033, and ER083 equipment items, and, as
previously stated, in the absence of alternative pricing information,
we continue to believe that our proposed prices are the most accurate
source of data. We continue to welcome feedback from stakeholders on
the proposed updated supply and equipment pricing over the ongoing 4-
year transition period, including the submission of additional invoices
for consideration.
    Comment: Several commenters stated that they supported the efforts
by CMS to ensure accurate pricing for direct PE inputs and supported
the updated valuation of the ultrasound room and vascular ultrasound
room. However, the commenters stated that there was an inconsistency
with the pricing for the CT room (EL007), PET room (EL009), and PET-CT
room (EL010) equipment. The commenters stated that it did not follow
logically that the EL009 equipment is increasing from $1,328,996 to
$2,410,677 and the EL007 equipment is increasing from $1,284,000 to
$1,429,967 while a room that is a combination of these two, EL010, is
decreasing from $2,136,283 to $206,326. The commenters asked that CMS
investigate this issue further while delaying any price change for this
one item.
    Response: With regards to the pricing of the PET-CT room (EL010)
equipment, we share the desire of the commenters to ensure fair and
accurate market-based pricing for this equipment item. However, as we
noted in the previous comment response, the commenters did not submit
invoices or other pricing data for the EL010 equipment, and, as
previously stated, in the absence of alternative pricing information,
we continue to believe that our proposed prices are the most accurate
source of data. We remind stakeholders that the proposed pricing was
based on market research carried out by the StrategyGen contractor
during the prior rule cycle. We continue to welcome feedback from
stakeholders on the proposed updated supply and equipment pricing over
the ongoing 4-year transition period, and we are willing to revisit the
subject of pricing for this equipment if provided with market-based
pricing data.
    Comment: Several commenters disagreed with the proposed price of
the ``stent, vascular, deployment system, Cordis SMART'' (SA103) and
``stent, balloon, implantable'' (SD299) supplies. Commenters stated
that the Cordis SMART stent (SA103) supply is not FDA approved to stent
iliac veins in CPT codes 37238-37239 due to the markedly undersized
diameters of the available stents, and that this supply is essentially
never used in iliac veins due to its much smaller size. The commenter
stated that they believe the proposed pricing of the SA103 supply to be
inaccurate, and stated that they were submitting 10 invoices in the
hopes of pricing a new supply code at $2,537 which would replace the
SA103 supply in these CPT codes. The commenters also stated a desire to
work with CMS to reconsider pricing of the SD299 supply given the
likely non-viability by CY 2022 of the services represented by CPT
codes 37236 and 37237 in the office setting, and to resolve the lack of
clarity surrounding the implantable stent balloon.
    Response: We appreciate the desire on the part of the commenters to
submit invoices with additional pricing data. However, despite an
exhaustive search of the comments, we were unable to find the 10
invoices mentioned in the letters from the commenters, which
[[Page 62604]]
were not included along with the rest of the submitted text. Although
we are willing to consider these invoices if they were to be submitted,
as previously stated, in the absence of alternative pricing
information, we continue to believe that our proposed prices are the
most accurate source of data. We urge commenters submitting invoices to
include them as part of their comment letter to avoid any potential for
miscommunication. We also note for the commenters that we did not make
any proposals regarding CPT codes 37238-37239 or CPT codes 37236-37237,
and therefore, we decline to make changes to the supplies for these
codes at this time.
    Comment: Several commenters disagreed with the proposed price of
the percutaneous neuro test stimulation kit (SA022) supply. The
commenters stated that the proposed price of $114.52 was insufficient
to reflect the cost associated with the SA022 supply, and that there
may have been some misunderstanding about what items comprise the
sacral nerve test kit. The commenters stated that it appears that the
line item reflecting the device that generates the neurostimulation,
which is the most expensive component of the test kit, was not included
in the proposed pricing for this supply, which instead reflects the
costs of the test kit leads only. The commenters stated that they
reviewed all of the paid invoices for kits sold during January and
February 2019, which resulted in pricing that was more in line with the
CY 2018 pricing of $420 for the kit. One commenter submitted a random
sample of 120 paid invoices (out of the 481 paid invoices that the
commenter accumulated in total) for consideration by CMS.
    Response: We appreciate the submission of a large quantity of
additional invoices with pricing data from the commenter. After further
review, we agree with the commenters that the proposed price failed to
incorporate all of the components of the test kit. Based on the data
submitted by the commenters, we are finalizing an update in the price
of the percutaneous neuro test stimulation kit (SA022) supply to
$413.24, and we will continue to transition towards this price over the
remaining years of the phase-in period.
    Comment: One commenter stated that the proposed price of $752.40
for the ``plasma LDL adsorption column (Liposorber)'' (SD186) supply
did not accurately reflect the actual average prices paid by their
provider customers. The commenter submitted copies of all U.S. customer
invoices for purchases of the SD186 supply for the most recent three-
month period from June 1 through August 30, 2019 and requested that the
price should be updated to reflect the average market pricing.
    Response: We appreciate the submission of a large quantity of
additional invoices with pricing data from the commenter. Based on the
data submitted by the commenter, we are finalizing an update in the
price of the ``plasma LDL adsorption column (Liposorber)'' (SD186)
supply to $1118.06, and we will continue to transition towards this
price over the remaining years of the phase-in period.
    Comment: The same commenter stated that the ``plasma antibody
adsorption column (Prosorba)'' (SD185) supply was withdrawn from the
market by its manufacturer more than 10 years ago, and the associated
procedure code (CPT code 36515) has been deleted. The commenter also
stated that the blood warmer tubing set (SC084) supply is not utilized
to perform LDL apheresis with a Liposorber System, and therefore,
recommended that this supply should be delisted as a direct PE input
for CPT code 36516.
    Response: We appreciate the additional information provided by the
commenter regarding these supply items. After conducting our own
review, we agree with the commenter that there is no longer any need
for the ``plasma antibody adsorption column (Prosorba)'' (SD185)
supply, which is not utilized by any HCPCS codes and has been withdrawn
from the market. Therefore, we are finalizing the deletion of the SD185
supply code. We are not finalizing the removal of the blood warmer
tubing set (SC084) supply at this time, as it is currently utilized in
two codes (CPT codes 36514 and 36516), and we did not make any
proposals on this issue. We welcome additional feedback from
stakeholders regarding the use of the SC084 supply for potential future
rulemaking.
    Comment: One commenter stated that they appreciated recent efforts
by CMS to update the price of supply and equipment inputs to better
reflect current market rates. The commenter requested that CMS update
the price inputs for three inputs: The Biodegradable Material Kit--
PeriProstatic (SA126) supply, the Rezum delivery device kit (SA128)
supply, and the water thermotherapy procedure generator (EQ389)
equipment. The commenter submitted invoices with updated pricing data
for consideration by CMS.
    Response: Based on the data submitted by the commenters, we are
finalizing an update in the price of all three of these direct PE
inputs. We are finalizing an increase in the price of the Biodegradable
Material Kit--PeriProstatic (SA126) supply from $2,850 to $2,965 based
on averaging the submission of eight invoices. We are finalizing an
increase in the price of the Rezum delivery device kit (SA128) supply
from $1,150 to $1,220 based on averaging the submission of ten
invoices. Finally, we are finalizing an increase in the price of the
water thermotherapy procedure generator (EQ389) equipment from $27,538
to $33,950 based on averaging the submission of two invoices.
    Comment: One commenter disagreed with the proposed pricing for the
``fluorescein inj (5ml uou)'' (SH033) supply. The commenter stated that
the proposed price for injectable fluorescein was concerning as it did
not reflect the most recent price increase of nearly 60 percent. The
commenter stated that for several months practices have been paying
$38.02 per vial and submitted four invoices to this effect.
    Response: After reviewing the submitted invoices, we are finalizing
an increase of the price of the SH033 supply to $38.02 to match the
information detailed by the commenter.
    Comment: One commenter disagreed with the proposed pricing for
HCPCS code G0166 (External counterpulsation, per treatment session) and
stated that the reductions in the proposed pricing would decrease the
availability of this service and have already impacted their ability to
provide external counterpulsation (ECP) therapy. The commenter stated
that the prior review of HCPCS code G0166 in the CY 2019 rule cycle
contained major errors, including omissions that artificially deflated
the cost of the equipment associated with ECP therapy, inappropriate
valuation of the ECP therapy equipment, and a failure to reflect the
clinical guidelines and requirements for delivering ECP therapy. The
commenter requested that CMS reverse the CY 2019 RVU reductions such
that ECP therapy would return to the CY 2018 payment rates, or
alternately pause any future reductions until CMS considered and acted
upon forthcoming RUC recommendations for HCPCS code G0166. The
commenter also submitted a series of invoices for the EECP external
counterpulsation system (EQ012) equipment and a number of additional
equipment items that previously lacked pricing.
    Response: We remind commenters that we nominated HCPCS code G0166
as potentially misvalued in the CY 2020 PFS proposed rule (84 FR 40516)
due to concerns that the RVUs for this code did not fully reflect the
total resources required to deliver the service. Aside from nominating
HCPCS code G0166 as
[[Page 62605]]
potentially misvalued, we did not make any other proposals concerning
this code. We are aware that the RUC plans to review HCPCS code G0166
for the CY 2021 PFS rule cycle, and we look forward to considering
their recommendations for next year's rulemaking.
    However, although we are not reviewing the work RVU or direct PE
inputs for HCPCS code G0166 for CY 2020, we were able to consider the
submission of invoices from the commenter as part of our market-based
supply and equipment pricing transition. Based on the information
provided by the commenters, we are finalizing an increase in the price
of the EECP external counterpulsation system (EQ012) equipment from
$61,490.75 to $117,495.00. For the additional equipment items submitted
by the commenter, which are not currently included in the direct PE
inputs for HCPCS code G0166, we are finalizing the use of a proxy item
for equipment pricing. We are finalizing the addition of a medium
instrument pack (EQ138) priced at $1,500.00 at the same equipment time
of 73 minutes used by the EECP external counterpulsation system as a
proxy to represent the cost of these additional items. Although the
medium instrument pack is a collection of surgical instruments and not
table accessories, it contains 20 different small items which
individually fall under our $500 threshold for equipment pricing, much
as the additional equipment items on the submitted invoices also failed
to meet the typical $500 threshold. We will further consider pricing
for both the EECP external counterpulsation as part of the review
process for this code along with the RUC recommendations when they
arrive for CY 2021.
    Comment: One commenter disagreed with the proposed pricing of the
INR analysis and reporting system w-software (EQ312) equipment. The
commenter stated that the finalized price for the INR analysis and
reporting system during the CY 2019 rule cycle was orders of magnitude
lower than the amount submitted by the home INR manufacturers and
suppliers, and the commenter was under the belief that the pricing for
this equipment was not reviewed and/or updated. The commenter urged CMS
to review and update the price for the PT/INR analysis and reporting
system based on current market invoices; the commenter also submitted
additional invoices from the same vendor with their letter.
    Response: We clarify for the commenter that we did review the
invoices that they submitted during the previous rule cycle in CY 2019.
Those invoices, along with the additional invoices submitted for the
current CY 2020 rule cycle from the same vendor, did not contain
pricing information for the purchase of an INR analysis and reporting
system (EQ312) equipment item. These invoices instead constituted a
monthly service fee for ``customization and management of provided
applications'' as detailed on the billing form. Under our PE
methodology, monthly service fees are a form of administrative expense,
and payment for these costs is included as part of our indirect PE
allocation. We did not use these invoices for pricing in CY 2019 and we
are not using them for pricing in CY 2020, as they detail a form of
indirect PE under our methodology. We also note that the equipment per-
minute cost formula includes maintenance costs, interest costs, and a
useful life assumption; this formula already incorporates equipment
costs that extend across multiple years. Taking a monthly service fee
and multiplying it across 12 months and then again across 5 years, as
the commenters suggested should take place for these invoices, would
result in equipment costs that are inappropriately excessive, such as
the $6 million equipment price detailed on these invoices. We will
continue to price the INR analysis and reporting system at $19,325 and
continue to transition towards this price over the remaining years of
the phase-in period.
    After consideration of the public comments, we are finalizing the
market-based supply and equipment pricing updates listed in Table 12,
along with the additional finalized pricing changes detailed in the
preceding paragraphs. 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 final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    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 proposed to continue with the third year of
the transition of this adjustment to the standard process for
allocating indirect PE.
    We did not receive any public comments on the proposed adjustments
to allocation of indirect PE for some office-based services. Therefore,
we are finalizing the continuation of the third year of the transition
as proposed.
e. Technical Evaluation Panel Related to Practice Expense
    The RAND Corporation is currently studying potential improvements
to CMS' PE allocation methodology and the data that underlie it. As
part of this study, RAND will be convening a technical expert panel in
late 2019 or early 2020 to obtain input from stakeholders including
physicians, practice and health system managers, health care
accountants, and health policy experts. The expert panel's
recommendations will be discussed in a
[[Page 62606]]
report to be published by RAND in CY 2020.
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 (79 FR 67591 through 67596), 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
PFS proposed rule (79 FR 40349 through 40355) and final rule with
comment period (79 FR 67591 through 67596). In the CY 2018 PFS 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 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
(RF) 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 GPCIs. Therefore, we
proposed to align the update of MP premium data with the update to the
MP GPCIs, that is, we proposed 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 proposed to implement the fourth
comprehensive review and update of MP RVUs for CY 2020 and are seeking
comment on these proposals.
    We received no specific comment regarding our proposal to align the
update of MP premium data with the update to the MP GPCIs. That is, to
review, and if necessary update the MP RVUs at least every 3 years,
similar to our review and update of the GPCIs; therefore, we are
finalizing as proposed.
2. Methodology for the Proposed Revision of Resource-Based Malpractice
(MP) RVUs
a. General Discussion
    We calculated the proposed MP RVUs using updated MP 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 proposed to incorporate several methodological refinements, which
are described below. 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 (RFs) 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: MP 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 used 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 MP premium data because they represent the
expense incurred by practitioners to obtain MP insurance as reported by
insurers. For CY 2020, the most current MP 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
[[Page 62607]]
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.
    MP 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. MP 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 nonphysician
practitioner (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 the 35 state threshold was not
met. In the CY 2020 PFS proposed rule, we noted that the proposed
methodological improvements discussed below 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 proposed 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.
    We received public comments on the proposed methodological
improvement to download and use 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. The
following is a summary of the comments we received and our responses.
    Comment: Commenters noted appreciation for CMS' efforts to improve
the premium data collection process and the opportunity to provide
comments on the new methodology. Commenters were supportive of our
proposed methodological refinement to download and use 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.
    Response: We thank commenters for their feedback and support; we
are finalizing as proposed.
    (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.
    We received public comments on the proposed methodological
improvement to combine 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
premium data for major surgery were used in developing the surgical
risk factor. The following is a summary of the comments we received and
our responses.
    Comment: Commenters stated they appreciated that CMS considered
methods to calculate surgical risk factors, but noted concerns with the
method CMS used to classify surgeries as either minor or major, stating
it was arbitrary and inconsistent with other CMS policy. Commenters
further noted that the definition of minor surgeries and major
surgeries should be consistent and developed with a consensus
methodology among physician specialties. Commenters recommended that
CMS work with the physician community to more accurately define major
and minor surgeries.
    Response: We thank commenters for their appreciation of our work to
calculate a more representative surgical risk factor. We note that we
did not propose definitions for minor and major surgery and will
continue to work with all interested stakeholders on our proposals.
    Comment: Commenters were not supportive of our proposal to
categorize services between HCPCS 59000 and HCPCS 59899 as OB services
and services between HCPCS 10000 and HCPCS 69999 (excluding the OB
services) as surgical, with a physician work value greater than 5.00 as
``major'' surgery, for the purpose of the analysis. Commenters noted
that in doing so, CMS selected an arbitrary and misguided definition of
``minor'' surgery for any code between the HCPCS 10000 and HCPCS 69999
section of the CPT code book with a physician work value less than
5.00. Commenters noted that if CMS intends to collect data at the minor
vs major level, the data must reflect the different risk factors for
those specialties and specifically be applied to codes defined as minor
vs major surgery, and not broadly applied to an entire specialty.
Commenters noted that the proposal could lead to an unfair valuation
for certain specialties and services. The commenter further noted that
CMS should hold off on moving to differentiating between minor and
major surgeries until CMS is able to work with the RUC and impacted
specialties to establish such definitions.
    Response: We reiterate that we did not propose to define minor
surgery and major surgery. The proposal leveraged an existing policy
(64 FR 59834), that categorized services within the surgical range of
HCPCS codes (and the list of invasive cardiology services outside the
surgical range) as surgical. Building upon that existing policy, we
proposed a methodological improvement to
[[Page 62608]]
combine minor surgery and major surgery premiums when both were
delineated in rate filings for a specialty and to set a threshold of a
physician work RVU greater 5.00 to categorize surgical services as
major surgery, (surgical services under 5.00 would be categorized as
minor surgery) for the purpose of the analysis. The methodological
improvement would have developed a more representative surgical risk
factor by combining minor surgery and major surgery premiums. We
further note that this would have produced more data to use in the
analysis and enabled the analysis to reflect a more representative risk
factor for specialties that could have been applied to the code level
for services categorized as minor surgery or major surgery. We note
that in previous updates only major surgery premium data were used
(when both minor surgery and major surgery are delineated on the rate
filings for a specialty) to develop the surgical risk factors, this was
based on a physician work RVU threshold of greater than 5.0, but was
based on rate filings that delineated major surgery for a specialty.
    In consideration of concerns from commenters, we are not finalizing
our proposed methodological refinement to combine major surgery and
minor surgery premiums when both are delineated on the rate filings for
a specialty nor are we finalizing our proposal to use a physician work
RVU greater than 5.00 as a threshold to categorize surgical services as
major surgery (or to categorize surgical services under 5.00 as minor
surgery), for the purpose of the analysis. Instead we are finalizing to
maintain the current methodology and only use major surgery premium
data when both minor surgery and major surgery are delineated in the
rate filings for a specialty (minor surgery premium data are discarded
in those cases) and to use minor surgery premium data when only minor
surgery premium data are delineated in the rate filings for a
specialty--to develop surgical risk factors. However, we note that the
objective of our proposal was to develop a more representative surgical
risk factor by refining our current methodology to allow for the use of
rate filings data that delineated minor and major surgery. Our work to
establish methods to categorize surgical services as minor and major
surgery is ongoing, we look forward to working with and receiving
feedback from stakeholders for consideration in future rulemaking.
    (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 proposed 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 were no data corresponding to a CMS specialty in the filing, we
proposed to use total imputation to establish premiums.
    For example, if a specialty of Sleep Medicine is listed on some
insurers' rate filings, this rate will be matched to the CMS specialty
Sleep Medicine (C0)--partial imputation. 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)--total
imputation. In this example, we believe (consistent with the
longstanding mappings of the regulatory impact table included in all
PFS Federal Register notices) that the rate for General Practice is
likely to be consistent with the rate that a Sleep Medicine provider
would be charged by that insurer, this principle for mapping is used
for the appropriate type of imputation. We note the proposed
methodological improvement would mean 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 to utilize as
much of the information from the filings as possible.
    We solicited comment on these proposed methodological improvements.
Additional technical details about our proposal 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.
    We received public comments on the proposed methodological
improvement to utilize 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. The following is a summary of the comments we received and our
responses.
    Comment: Several commenters disagreed with some of the proposed
specialty mappings for partial and total imputation. Some of these
commenters recommended that CMS use different mappings other than those
that were proposed. A few commenters recommended that CMS publish
impacts for all CMS specialties and not attempt to bundle or map
specialties to what CMS believes are related specialties or
professions.
    Response: We note that 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.
We reiterate that the proposed mappings for partial imputation parallel
the longstanding mappings of the regulatory impact table included in
all PFS Federal Register notices that group CMS specialties (present on
Medicare claims) into clusters of related specialties (impact
specialties) when CMS examines the potential impact of PFS payment
policies on the distribution of payments by providers. This table is
included in section VII. of this final rule, the Regulatory Impact
Analysis.
    Furthermore, the proposed mappings for total imputation (when a CMS
specialty name is not listed on the insurer's rate filing) reflect the
speciality-specifc relationship of the underlying principle to identify
the premium that an individual in a specialty would have been charged.
The proposed mappings for total imputation, specifically for NPP
specialties, parallel the proposal to crosswalk NPP specialties for
which we do not have sufficient comparable professional liability data,
to the lowest physician specialty, which was found to be allergy/
immunology.
    We note that partial and total imputation are necessary to expand
the specialty specific filings data used to develop the proposed risk
factors, which are used to develop the proposed MP RVUs. This
improvement resulted in the development of a more comprehensive data
set, when CMS specialty names were not distinctly identified in the
insurer filings, which sometimes use unique specialty names; we are
finalizing as proposed.
    Comment: A commenter noted that they joined the RUC in urging CMS
to collect premium data for specialties that are missing data or where
data are not available, and in the meantime, to work
[[Page 62609]]
with the RUC to better identify appropriate crosswalks.
    Response: We reiterate that we have, and will continue to work with
the RUC and all interested stakeholders to improve the premium data
collection. Moreover, we continue to make progress in this area as
evidenced in the CY 2020 PFS proposed rule (84 FR 40506), where 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.
    Comment: Commenters recommended that CMS utilize any and all
premium data available to determine accurate crosswalks for specialties
that cannot be directly matched to one of CMS' specialty names.
    Response: We reiterate that we use all of the premium data
collected to match CMS specialties to the rate that a provider in the
specialty would have been charged under each filing, even though PLI
insurers use their own distinctive specialty names.
    Comment: One commenter recommended that CMS map RFs for cardiac
electrophysiology to the risk factor for cardiology (surgery) and
cardiology (no surgery). The commenter noted that they did not
understand the rationale that CMS applied to determine that the RF
should be set at 1.89 and ask CMS to detail how it arrived at that
recommended RF. One commenter noted that electrophysiology is a
distinct specialty of cardiology, with eligibility for board
certification in clinical cardiac electrophysiology through the
American Board of Internal Medicine, as well as in cardiology. Several
commenters noted that cardiac electrophysiology is a relatively small
specialty that may not clearly show in premium data. These commenters
further noted that it would not make sense for services like pacemaker
implantation that includes placing transvenous wires inside the heart
or catheter ablations to treat cardiac arrhythmias inside the heart to
receive a non-surgical PLI risk factor. Several commenters noted that
cardiac electrophysiology currently has a surgery and non-surgery risk
factor.
    Response: We reiterate that details on the data sources and the
methodological approach used to develop RFs are detailed in the CY 2020
PFS proposed rule (84 FR 40504) and the interim report for the CY 2020
Update of GPCIs and MP RVUs for the Medicare PFS. We also remind
stakeholders that we are using updated premium data as reported in the
SERFF for participating states and downloaded from the state-specific
website for non-SERFF states or obtained directly from the state's
alternate access to filings to develop RFs. We were able to collect
more data, and use those data to develop specialty-specific RFs for
specialties that were previously entirely mapped to a different
specialty out of necessity, because we did not have sufficient data.
Therefore, we create a specialty-specific RF based on the distinct data
of each specialty, as reflected in the rate filings, when sufficient.
Thus, the RFs may be considerably different from the previous update,
as a result of utilizing the specialty's own data and not that of a
crosswalk to another specialty as was the case for cardiac
electrophysiology in the proposed rule. Using these data, as reflected
in the filings, more accurately reflects premiums associated with the
specialty.
    We appreciate the additional information provided by the commenters
as to why cardiac electrophysiology should remain mapped to the RF for
cardiology (surgery) and cardiology (no surgery). Upon additional
review of the additional information provided by commenters, we are not
finalizing our proposal to map cardiac electrophysiology to a RF of
1.89, and instead we are finalizing the mapping of RFs for cardiac
electrophysiology to the risk factor for cardiology (surgery) and
cardiology (no surgery).
    Comment: One commenter stated that while the proposal maintains
CMS' established policy of applying the cardiology surgical risk factor
to the procedures identified in Table 15 of the CY 2015 PFS proposed
rule (79 FR 40353 through 40354), it is inconsistent with the CY 2015
PFS final rule, wherein CMS finalized that the cardiology surgical risk
factor would apply to a list of procedures (classified as injection
procedures used in conjunction with cardiac catheterization) that are
outside the code range that CMS considered surgical. This same
commenter stated they are concerned that the proposal to have fewer
subgroups for cardiac electrophysiology inadvertently undervalues many
cardiology surgical procedures on the basis of subspecialty mix
performing the procedure, rather than valuing the procedure on its
surgical status.
    Response: We believe the commenter may have misinterpreted both the
CY 2015 PFS proposed rule (79 FR 40353) and CY 2015 PFS final rule (79
FR 67595), which led to a subsequently misinterpreting what CMS
proposed to maintain in the CY 2020 PFS proposed rule (84 FR 40504). In
CY 2015, we finalized a policy to classify invasive cardiology services
(cardiac catheterizations and angioplasties) that are outside of the
surgical HCPCS code range as surgery for purposes of assigning
specialty-specific risk factors, and to apply the higher cardiology
surgical risk factor to the list of codes outside of the surgical HCPCS
code range, when those services are performed by providers with a
specialty of cardiology. To that end, this is not to imply that we
apply the higher cardiology surgical risk factor to the cardiology
services that are outside the surgical code range regardless of the
provider specialty performing those services, as indicated by the
commenter. We note that the higher surgical risk factor is applied to
the list of codes outside of the surgical HCPCS code range only when
performed by a provider with a specialty of cardiology.
    We reiterate, we calculate service level risk factors based on the
mix of specialties that furnish a given service as indicated by
Medicare claims data. Medicare claims data reflect the service volume
by Medicare primary specialty designations. For CY 2020, we continue to
classify services that are outside of the surgical HCPCS code range as
surgery for purposes of assigning specialty-specific risk factors, and
when furnished by providers with cardiology as the Medicare primary
specialty code on the Medicare claim, apply the higher cardiology
surgical risk factor.
    Comment: One commenter expressed concern with the statement that
cardiac electrophysiology is not typically associated with the number
and mix of surgical services of other surgical specialties. The
commenter further noted that cardiac electrophysiology accounts for
about 75 percent of the utilization, on average, across the cardiac
ablation codes, with the specialty of cardiology accounting for most of
the remainder.
    Response: We note that the statement ``cardiac electrophysiology is
not typically associated with the number and mix of surgical services
of cardiologists'' was not made to imply that providers with a
specialty of cardiac electrophysiology do not perform surgical
procedures. We acknowledge that providers with the specialty of cardiac
electrophysiology perform surgical procedures, as evidenced by our
classification of codes outside of the surgical HCPCS code range as
surgery for purposes of assigning specialty-specific risk factors,
which are performed by providers with specialty of cardiac
electrophysiology and other specialties.
[[Page 62610]]
    Furthermore, in the case of the list of invasive cardiology
services, classified as surgery for purposes of assigning service level
risk factors, we note that the percentage of allowed services
attributed to cardiology decreased for some of these service codes
while the percentage of allowed services furnished by other specialties
with risk factors lower than cardiology, such as cardiac physiology,
increased.
    Additionally, we received several general comments related to the
proposed methodological refinements.
    Comment: One commenter noted appreciation for CMS' attempt to
improve the premium data collection process, stating that the Agency
was successful in acquiring national premium data for 16 specialties
that were formerly mapped entirely to another specialty, and that there
is no longer a mention of the arbitrary 35 state threshold used in the
previous update that triggered the CMS crosswalk methodology used to
develop PLI RVUs for specialties for which there was not premium data
for at least 35 states.
    Response: We note that implementation of the methodological
refinements noted above, no longer necessitated the 35 state threshold.
    Comment: One commenter noted concerns about the percentage of
market share premium data that was collected for Connecticut and
Massachusetts, noting that only 30 percent of market share data were
collected in that locality, even though Connecticut has relatively high
PLI premiums, when compared to the rest of the country.
    Response: As detailed in the ``Final Report for the CY 2020 Update
of GPCIs and MP RVUs for the Medicare PFS'', which is available on the
CMS website under the downloads section of the CY 2020 PFS final rule
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html medical professional liability insurance
is issued at maximum coverage limits. Premiums were collected for
coverage limits of $1 million per occurrence and $3 million aggregate.
States with Patient Compensation Funds may have different coverage
limits, which we accounted for, as noted in the aforementioned final
report. Although data collection for a state may not have met the
threshold of collecting filings until either cumulative market share
met or exceeded 50 percent or filings had been collected for four
groups or companies, it does not imply that premiums were collected for
coverage limits below $1 million per occurrence and $3 million
aggregate.
    We note that the market share filings for Connecticut met the
threshold, because we collected data for four groups. In the case of
Massachusetts, this is a non-SERFF state, so we were limited to the
amount of data provided by the state in response to our request to the
state for these data; we have revised Table 7.A in the final report to
easily identify non-SERFF states.
    Additionally, in our review of the findings reported in Table 7.A
in the final report, we recognized the need for additional
clarification for two states. We clarify that data collection for New
York State did not meet either threshold, because some of the filings
collected were incomplete and unusable, leaving data for three groups,
accounting for 32 percent remaining for the market share analysis. In
the case of Rhode Island, we identified a typographical error in the
chart, which has been fixed.
    Comment: Several commenters noted concerns with the data displayed
in Table 8.B Volume-weighted Distribution of 2017 Physician Work RVUs
by Service Type by CMS Specialty the final report.
    Response: We thank commenters for noting their concerns. These data
display the share of total work RVUs by service risk group used when
combining or splitting premiums across service risk groups as reported
by specialties on rate filings to match the final set of specialty/
service risk groups used in the analysis. The data displayed in that
table are solely for the purposes of the analysis. In consideration of
the comments we received, we have provided additional details on the
calculations in the ``Final Report for the CY 2020 Update of GPCIs and
MP RVUs for the Medicare PFS'', which is available on the CMS website
under the downloads section of the CY 2020 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. Additionally, the table has been revised
to reflect that we are not finalizing our proposed methodological
refinement to combine minor and major surgery premiums when both are
present in the filings for a specialty.
c. Steps for Calculating Malpractice RVUs
    Calculation of the proposed MP RVUs conceptually follows the
specialty-weighted approach used in the CY 2015 PFS 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. We note that not all of the proposed
methodological refinements are being finalized, and therefore, some of
steps for calculating malpractice RVUs differ from the proposal.
    Step (1): Compute a preliminary national average premium for each
specialty.
    Insurance rating area MP 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 MP claims if they occur. To account for the presence of
different classes in the MP 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
[[Page 62611]]
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 13. 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. We note that we are
not finalizing the proposed methodological change to combine minor
surgery and major surgery premium data when both are delineated the
rate filings for a specialty. For all other specialties (those that are
not listed in Table 13) 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.
[GRAPHIC] [TIFF OMITTED] TR15NO19.018
    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 PFS 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 those data to
calculate the CY 2015 MP RVUs for TC-only services. We declined to
utilize those 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 proposed 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 14 shows the risk factors by specialty type and service risk
group.
BILLING CODE 4120-01-P
[[Page 62612]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.019
[[Page 62613]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.020
BILLING CODE 4120-01-C
    We received public comments on the steps for calculating MP RVUs.
The following is a summary of the comments we received and our
responses.
    Comment: Commenters disagreed with our proposal to assign a risk
factor of 1.00, which is the risk factor of the lowest physician
specialty, to TC-only services because of insufficient comparable
professional liability premium data for the full range of health
professionals that furnish TC-only services. The commenters recommended
retaining the current RF for TC-only services until comprehensive data
is acquired rather
[[Page 62614]]
than assigning the lowest physician specialty-level risk factor to
these services. Commenters noted that we should continue to work with
stakeholders to obtain these data.
    Response: We reiterate that we have, and will continue to work in
collaboration with all interested stakeholders to find sufficient
comparable professional liability data for the full range of clinicians
that furnish TC-only services. In general, we continue to make progress
in acquiring premium data as evidenced by the fact that for the CY 2020
update we collected service-specific premium data for an increasing
number of specialties, as compared to the CY 2015 update. We note that
the current RF for TC-only services is 0.91. Although we were able to
find some data for health professionals that furnish TC-only services,
we were unable to find sufficient comparable professional liability
premium data for the full range of health professionals that furnish
TC-only services. We are finalizing our proposal to assign a RF of
1.00, which is the RF of the lowest physician specialty (allergy/
immunology), to TC-only services.
    Comment: Commenters noted that consistent with the previous update
CMS continued to assign the RF of the lowest physician specialty to
NPPs for which there were insufficient or no premium data. We received
contrasting comments on this proposal. For instance, one commenter was
supportive of our proposal to continue assigning the risk factor of the
lowest physician specialty to NPPs for which CMS was unable to collect
sufficient data. In contrast, a few commenters, including the RUC,
stated that CMS should not crosswalk NPPs to the lowest physician
specialty, which is allergy and immunology, and to continue to
aggressively collect premium data on NPPs.
    Response: Our efforts to improve the premium data collection for
NPPs is ongoing. We have made progress in acquiring premium data as
evidenced by the fact that for the CY 2020 update we collected service-
specific premium data for an increasing number of specialties, as
compared to the CY 2015 update, including some NPP specialties, for
which we previously did not have data that were mapped entirely to
another specialty. Although we were able to find data for several NPPs
for which we previously did not have data, we were unable to find
premium data for the full range of NPPs. Premium data collection for
NPPs is ongoing and will continue ahead of the next MP RVU update. We
are finalizing a policy to maintain the current assignment of a RF of
1.00 for NPP specialties, which corresponds to the lowest physician
specialty RF, allergy and immunology.
    Comment: One commenter stated that an alternate option to
crosswalking NPPs to the lowest physician risk factor of allergy and
immunology would be to assign them the RF of another NPP specialty for
which CMS was able to obtain data, the commenter recommended optometry.
    Response: We reiterate that our proposal was to maintain the
crosswalk of NPPs for which we had insufficient or no premium data to
the lowest physician specialty, not to crosswalk NPPs to the RF of a
NPP for which we were able to collect data. At this time, because we
were unable to find premium data for the full range of NPPs, we do not
believe it is appropriate, as suggested by commenters, to assign all
NPPs for which we had insufficient or no premium data to the RF of
optometry, another NPP specialty for which we were able to find some
data. We reiterate that CMS' efforts to improve the premium data
collection for all NPP specialties is ongoing and will continue ahead
of the next MP RVU update.
    Comment: One commenter suggested that the Agency assign codes
performed predominantly by the select NPPs a 0.00 PLI as their premiums
are so inconsequential that even a 0.01 PLI overcompensate them for
their minimal PLI premiums.
    Response: We disagree that NPPs should be assigned a 0.00 PLI and
moreover, we disagree that even a 0.01 PLI overcompensate them for
their minimal PLI premiums. This incorrectly implies that there is zero
risk for NPPs to provide medical services. We reiterate that although
we were able to find data for several NPP specialties for which we
previously did not have data, we were unable to find premium data for
the full range of NPP specialties. Premium data collection for NPP
specialties is ongoing and will continue ahead of the next update.
    Comment: One commenter noted that they previously referenced an
insurance carrier, Health Providers Service Organization (HPSO)
(www.hpso.com), as a source of potential premium data for most NPPs.
This same commenter provided PLI premium data for several NPPs for a
single state from this source, which ranged from $153 to $1,008.
    Response: We thank the commenter for their feedback and potential
data source, as CMS continues efforts to collect premium data on the
full range of NPP specialties ahead of the next MP RVU update.
    Step (4): Calculate MP 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 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
MP 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 final 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 solicited public comment on the list of expected
specialties. We also noted 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
[[Page 62615]]
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.
    We received public comments on the proposed updates to the expected
specialty list for low volume services. The following is a summary of
the comments we received and our responses.
    Comment: Several commenters stated that CMS had indicated that the
expected specialty list would be updated to include a column specifying
if a service was identified as a low volume service for CY 2020,
indicating if the service-level override was being applied for CY 2020.
However, commenters noted that this additional column did not appear in
the download version and asked for additional information.
    Response: We thank the commenters for identifying this missing
information and we apologize for the technical oversight that caused
this information not to be displayed for the proposed rule. We are
finalizing a policy to include this additional column in the public use
files released with the final rule. Additional comments on the proposed
updates to the expected specialty list have been addressed in section
II.B. of this final rule.
    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 final rule, Determination of Practice Expense Relative Value
Units, we discuss specialties that are excluded from ratesetting for
the purposes of calculating PE RVUs. We proposed 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 proposed to also exclude for the
purpose of calculating MP RVUs is available in section II.B. of this
final rule, Determination of Practice Expense Relative Value Units. The
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 is detailed in section VII. of this final rule, the
Regulatory Impact Analysis.
    We received no specific comments regarding our proposal to treat
excluded specialties in a consistent manner for the purposes of
calculating MP RVUs, we are finalizing as proposed.
    Additional information on our methodology for updating the MP RVUs
is available in the ``Final 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 final
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    After consideration of the comments, we are finalizing the CY 2020
update as proposed with minor modifications, as indicated above. We are
finalizing our proposal to download and use 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. We are not finalizing our proposal to combine minor and major
surgery premiums when both are delineated on rate filings for a
specialty nor are we finalizing our proposal to use a physician work
RVU of greater than 5.00, as a threshold to identify surgical services
as major surgery (or to categorize surgical services under 5.00 as
minor surgery). Instead, we are finalizing a policy to develop RFs by
maintaining the current methodology to only use major surgery premium
data when both minor surgery and major surgery are delineated on rate
filings for a specialty, and to use the minor surgery premium data when
it is the only premium type in the rate filings for a specialty. We are
finalizing a policy to map risk factors for cardiac electrophysiology
to the risk factor for cardiology (surgery) and cardiology (no
surgery). We are finalizing our proposal to assign the RF of the lowest
physician specialty (allergy/immunology) to TC-only services, which is
a RF of 1.00. We are finalizing a policy to maintain assigning the
current RF of the lowest physician specialty (allergy/immunology),
which is a RF of 1.00 to NPP specialties. We are finalizing our
proposal to include an additional column on the anticipated low volume
specialty list which specifies if a service was identified as a low
volume service for CY 2020, indicating if the service-level override
was being applied for CY 2020. We are finalizing our proposal to treat
excluded specialties in a consistent manner for the purposes of
calculating MP RVUs.
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,
[[Page 62616]]
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 proposed
to phase in \1/2\ of the latest GPCI adjustment in CY 2020.
    We have completed a review of the GPCIs and are finalizing new
GPCIs in this final rule. We also calculate a geographic adjustment
factor (GAF) for each PFS locality. The GAFs are a weighted composite
of each PFS locality's 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 final 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 final
rule for the CY 2020 final GPCIs and summarized GAFs available on the
CMS website under the supporting documents section of the CY 2020 PFS
final 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 current 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, also referred to as payment
localities, are defined alternatively by state boundaries (statewide
areas 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 a final report,
``Final Report for the CY 2020 Update of GPCIs and MP RVUs for the
Medicare PFS,'' on our website located under the supporting documents
section for the CY 2020 PFS final 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
[[Page 62617]]
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 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 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 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 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/$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 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 proposed 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 GPCI cost share weights for CY 2020 are displayed in Table 15.
    [GRAPHIC] [TIFF OMITTED] TR15NO19.021

[[Page 62618]]
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
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 final rule. The qualifying
states are: Montana; Wyoming; North Dakota; South Dakota; and Nevada.
In accordance with statute, we will 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 PFS locality structure that was in place prior to
CY 2017. 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 locality structure that was in place
prior to CY 2017, 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 locality structure that was in place
prior to CY 2017. 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 locality structure that was in place
prior to CY 2017. 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 locality structure that was in place prior to CY 2017. 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 localities that were in place
prior to CY 2017 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.
[[Page 62619]]
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).
h. Refinements to the GPCI Methodology
    In the process of calculating GPCIs for the purposes of this final
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 proposed 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 proposed 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
methodological refinements yield improved mathematical precision.
Additional information on the GPCI methodology and the refinements are
available in the final report, ``Final Report for the CY 2020 Update of
GPCIs and MP RVUs for the Medicare PFS'' on our website located under
the supporting documents section of the CY 2020 PFS final 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 in this section,
the periodic review and adjustment of GPCIs is mandated by section
1848(e)(1)(C) of the Act. At each update, the 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
CY 2020 updated GPCIs for the first and second year of the 2-year
phase-in, along with the GAFs, are displayed in Addenda D and E to this
final rule available on our website under the supporting documents
section of the CY 2020 PFS final rule web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    The following is a summary of the comments we received on the GPCI
proposals and our responses.
    Comment: A few commenters expressed concern over the expiring work
GPCI floor of 1.0. Some of the commenters stated an objection to any
proposals that could have a negative impact on rural areas such as the
expiration of the work GPCI floor and stated that the GPCIs needs to
account for the unique practice needs of rural providers.
    Response: The 1.0 work GPCI floor is established by statute and
expires on December 31, 2019. We do not have the authority to extend
the 1.0 work GPCI floor beyond December 31, 2019. We note that 34
states have a statewide payment locality, which means that physicians,
whether in urban or rural areas, receive the same geographic adjustment
thus reducing rural/urban payment differentials within a state.
    Comment: A few commenters expressed support for the elimination of
all GAFs under the PFS, except those designed to achieve a specific
public policy goal, such as to encourage physicians to practice in
underserved areas. The commenters stated that GPCIs tend to favor urban
localities over their rural counterparts and works at cross purposes to
the health professional shortage area (HPSA) bonus and other incentives
intended to encourage and support rural physicians. The commenters also
stated that rural beneficiaries would be better served if the GPCIs
were eliminated from the PFS so that the HPSA bonus and other
incentives are not undermined in their efforts to sustain the rural
physician workforce needed to care for those beneficiaries.
    Response: As previously discussed, section 1848(e)(1)(A) of the Act
requires us to develop separate GPCIs to measure resource cost
differences among localities compared to the national average for each
of the three GPCI components, and section 1848(e)(1)(C) of the Act
requires us to review and, if necessary, adjust the GPCIs at least
every 3 years; and based on new data GPCI values may increase or
decrease. Additionally, as noted above, 34 states have a statewide
locality, thus reducing rural/urban payment differentials within a
state.
    Comment: One commenter stated that CMS uses salary data for
individuals with 5 or more years of college, and should instead
evaluate the feasibility of using salary data only from individuals
with graduate degrees in the work GPCI calculations. The commenter also
stated that CMS should also consider that physicians invest a portion
of their compensation in the practice and that portion should not be
counted as salary.
    Response: We note that physicians are not one of the seven
occupation groups used in the work GPCI calculation; therefore, we are
unclear about the commenter's assertion that investments of a portion
of a physician's salary back into the practice should not be counted as
salary. As described above, and consistent with our longstanding
practice, a set of occupation groups representing a variety of
professionals are used in the calculation. We note that the proxy
occupations currently used represent highly educated professional
occupation categories, and therefore, we believe we are already
including salary data for individuals with advanced degrees.
    Comment: One commenter stated concern that the work GPCI does not
utilize actual physician wage data, and states that CMS' statement that
including physician wage data in calculating the work GPCI would
potentially introduce some circularity to the adjustment since Medicare
payments typically contribute to physician wages is flawed. The
commenter stated that in the era of increasing physician employment,
more physicians receive a salary dependent upon local market conditions
and not the portion of their patient panel on Medicare. The commenter
also stated that two of the proxy professional wage categories--
pharmacists, and registered nurses--are professions whose wages are
also comprised, in part, of income gained from participation in the
Medicare program.
    Response: We note that we have long maintained that including
physicians' wages in the physician work GPCI would, in effect make the
physician work GPCI to some extent dependent upon Medicare payments
which in turn are impacted by the indices. We do not dispute the
assertion that local market conditions may also play a role in
determination of a physician's salary; however, we do not believe that
mitigates the potential for circularity and maintain that, still,
Medicare payment is a significant determinant of physician's earnings.
We also recognize that the seven proxy professional wage
[[Page 62620]]
categories span several different industries, including pharmacists,
and registered nurses which demonstrates that the healthcare industry
is represented in those proxy wage categories; however, physicians in
particular are not included in those categories as previously
described. We continue to believe in the majority of instances, the
earnings of physicians will vary among areas to the same degree that
the earnings of other professionals across an array of industries vary.
We reiterate that the work GPCI is not an absolute measure of physician
earnings, rather it is a measure of the relative wage differences for
each locality as compared to the national average. Additionally, the
work GPCI reflects only one quarter of those relative wage differences
consistent with the statutory requirement as discussed previously in
this section.
    Comment: A few commenters stated that CMS should re-evaluate
existing databases to find or develop a nationwide measure of
commercial office rents for use in calculating PE GPCIs. One commenter
stated that CMS should either collect true medical office expense data
or alternatively use data sources available to federal agencies such as
office expense data from the Federally Qualified Health Center Network.
    Response: We appreciate the commenter's feedback. We note that our
efforts are ongoing to identify a publicly-available, robust,
nationally representative commercial rent data source that could be
made available to CMS for this purpose. Further, we welcome
opportunities to discuss such data sources with stakeholders and to
incorporate such data, as appropriate in the GPCI calculation process,
through our standard annual rulemaking process.
    Comment: One commenter expressed support for the proposed
methodological refinements and stated that it could yield improvements
that would be beneficial to all fields of medicine.
    Response: We thank the commenter for the support of our proposed
methodological refinements.
    Comment: A few commenters stated that the proposed refinement to
the weighting of the physician work, employee wage, and purchased
services indices results in inconsistent comparisons of occupational
wages from one county to the next, because industry wages within an
occupational group will vary from one county to the next based on
employment. The commenters recommended using the previous methodology
and also stated that for counties with zero inputs that we use inputs
from MSAs as is done for the rent index or use the national average as
used in the previous update.
    Response: The use of employment weights better captures variation
in median wages themselves, which is exactly what the indices are meant
to reflect. As the commenter indicated, the unweighted approach
captures variation in wages reported by category in an index-like
manner. This is undesirable both substantively and mathematically,
since it makes the GPCIs an index based on an index rather than on the
underlying data of interest. We have reviewed the process for
developing county-level median wages as described in the proposed rule,
and continue to believe that the use of employment weights, as we
proposed, is an improvement over the use of unweighted values as
requested by the commenter. We intend to continue considering how
measures are weighted and summarized throughout the GPCI development
process and will invite public comment on any additional potential
improvements we identify through future rulemaking.
    Comment: A few commenters stated that they find it challenging to
extract and collate the publicly-available BLS OES data (available from
the BLS website), that are used for the work and PE GPCIs in a manner
that enables them to reproduce the data sets used in the work GPCI and
the employee wages, and purchased services components of the PE GPCI;
the commenters stated that CMS should provide more detailed information
in the interest of transparency.
    Response: We note that we provide web links to the publicly-
available data sources used in this GPCI update, the methodological
parameters, as well as an overview of how we develop each GPCI
component in the final report for the CY 2020 Update of GPCIs and MP
RVUs for the Medicare PFS. This practice is consistent with previous
updates. However, in consideration of the commenters' concerns that
navigating the publicly-available BLS OES data on the BLS website is
cumbersome, we have included more detailed steps in the aforementioned
report to further assist interested parties in navigating these data.
    Comment: One commenter stated that the GPCIs in Hawaii do not
account for the unique costs of providing medical services in Hawaii
and that this will lead to an accelerating shortage of health care
providers across the state of Hawaii. The commenter stated that
Hawaii's unique geography makes providing care more expensive and that
the cost of living ranks amongst the highest in the nation, and the
data used by CMS do not reflect the cost of living. The commenter
stated that it disputes the assertion that the equipment, supplies, and
miscellaneous expenses component of the PE GPCI do not vary by
geographic area, and therefore, do not require updating. The commenter
stated that the high cost of shipping equipment plays a major part in
the high cost of healthcare in Hawaii and the PEs should reflect that
additional cost that exists in Hawaii and not in the mainland United
States. The commenter stated that the 1.5 work GPCI floor for Alaska,
and the 1.0 PE GPCI floor for the frontier states should serve as a
basis for reevaluating the cost of providing medical services in
Hawaii. The commenter stated that the GPCIs should be adjusted to
reflect a factor at least equal to Alaska's work GPCI.
    Response: We reiterate that the GPCIs, in particular the work GPCI
and the PE GPCI to which the commenter refers, are based on nationally-
representative and publicly-available wage data from the BLS OES for
the work GPCI and employee wage and purchased services components of
the PE GPCI, and the Census Bureau's ACS data for the rent index
component of the PE GPCI. The GPCIs are a measure of relative resource
cost differences among localities compared to the national average as
informed by the data (not a measure of absolute costs). With regards to
the supplies, equipment, and miscellaneous expense cost index component
of the PE GPCIs, we have stated that we believe there is a national
market for these items and there is not significant geographic
variation in those costs, and as such we assign a value of 1.00 for
this component for each locality, consistent with the national average.
Stakeholders have previously indicated that shipping and transportation
expenses increase the cost of acquiring medical equipment and supplies
in islands relative to the mainland. We have previously attempted to
locate data sources specific to geographic variation in shipping costs,
and we found no comprehensive national data source for this
information, and therefore, we have not been able to quantify variation
in costs specific to islands as indicated by the commenter (we refer
readers to 78 FR 74387 through 74388 for a detailed discussion of this
issue). The commenter did not provide any data to quantify the
variation. We would encourage the commenter and other stakeholders to
submit data supporting this assertion for consideration in future
rulemaking; specifically, we would be
[[Page 62621]]
interested in information regarding potential data sources for shipping
costs for medical equipment and supplies that are accessible to the
public, available on a national basis for both urban and rural areas,
and updated regularly. We remind commenters that the work GPCI value
for Alaska is not based on the data for that state, instead section
1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for
Alaska. Similarly, section 1848(e)(1) of the Act sets a permanent PE
GPCI floor of 1.0 for the frontier states. Additionally, we note that
the GAF in Hawaii, displayed in Addendum D, which represents the
weighted composite of each PFS localities GPCIs, is increasing in the
GPCI update from CY 2019 to years 1 and 2 of the update (CY 2020 and CY
2021).
    Comment: One commenter noted that the MP GPCIs changed more
significantly than other GPCIs, but also acknowledged that MP accounts
for a small share of average total payments so these swings generally
translate into modest payment changes. The commenter urged CMS to give
consideration to comments from state medical associations and other
organizations representing physicians who practice in localities facing
reductions to ensure that the data driving reductions are accurate.
    Response: We note that larger changes in MP GPCI values in an
update year are not unprecedented, and the commenter has correctly
characterized that changes in MP will equate to minimal changes in
payment because MP represents a small share of average total payments.
As discussed in section II.C of this final rule, there were several
proposed methodological refinements in the development of the MP
premium data which underlies the MP risk factors used in determining
both MP RVUs and MP GPCIs which has also contributed to some of the
changes; we note that not all of those proposed methodological
refinements were finalized for CY 2020, and the final MP GPCIs in
Addendum E of this final rule are reflective of that.
    We emphasize that we do give consideration to the public comments
that we receive. We note that only a few comments were received with
regards to the GPCI proposals, though during the process of developing
the CY 2020 final rule GPCIs, which includes reviewing the underlying
data (which are obtained from publicly-available sources as previously
discussed) and reviewing our programming, we did observe the following
issue. The work, PE, and MP GPCIs are based on the 2017 utilization
data as described in the final report for the CY 2020 Update of GPCIs
and MP RVUs for the Medicare PFS. These data became available after the
CY 2020 PFS proposed rule analytic programs had been written for these
measures, but for the purposes of developing the analytic programs the
CY 2016 utilization data were used as a placeholder. During the final
rule development we realized an oversight whereby the 2016 utilization
data had not been replaced with the 2017 utilization data for the work
and PE GPCIs, though we note that for the MP GPCI, the 2017 utilization
data were being used. We have resolved this issue for the final rule
and all 3 GPCI components reflect the updated 2017 utilization data as
described in the aforementioned report. We note that utilization data
are highly correlated year to year so the effect of this change on
final GPCI values was quite modest; specifically, the updated
utilization data had virtually no effect on the resulting work, PE, and
MP GPCIs and the GAFs. Outside of California (see below for a
discussion regarding California), the correlation coefficient between
each of the three GPCIs and the GAF in the proposed rule, and their
corresponding values in the final rule is 0.999.
    Comment: A few commenters expressed concern with regards to the
county rent indices delineated in the county-level data public use file
whereby they noted consistent discrepancies in New England states as
compared to the rest of the country. The commenters stated that before
finalizing the PE GPCIs, CMS should review the indices to ensure that
the relative differences in the indices accurately reflect the relative
differences in rents from the source data file. One of the commenters
indicated that this issue is not observed in any areas outside of New
England.
    Response: We note that during the review of the underlying data and
analytic programs for the final rule, we identified an issue with the
data in New England (Maine, New Hampshire, Vermont, Massachusetts,
Rhode Island, and Connecticut) where the raw data values were defined
at sub-county areas in New England, but were not summarized to the
county-level in the development of the proposed CY 2020 GPCI values.
This led to distorted office rent index values for the six states in
New England, which in turn affected the proposed PE GPCIs in those
states. The CY 2020 PFS final rule office rent index that underlies the
PE GPCI has been corrected so that the input data element is now
summarized at the county-level before being used to develop the index.
Similar to the aforementioned update to the utilization data, the
corrected mapping of raw data values in New England as described above
had virtually no effect on the resulting work, PE, and MP GPCIs and the
GAFs. Outside of California (see below for a discussion regarding
California), the correlation coefficient between each of the three
GPCIs and the GAF in the proposed rule, and their corresponding values
in the final rule is 0.999.
    Comment: One commenter expressed concern with the implementation of
the GPCI requirements in California consistent with section 1848(e)(6)
of the Act which was implemented in the CY 2017 PFS final rule (81 FR
80261 through 80270). The commenter requested that CMS remedy any
errors in the GPCI values. Specifically, the commenter indicated that
CMS did not accurately implement the California MSA-based structure in
the CY 2020 PFS proposed rule consistent with the methodology finalized
in CY 2017 based on the requirements of the statute. The commenter
specifically highlighted issues with the GPCIs for the San Francisco-
Oakland-Hayward localities (localities 05, 06, 07, and 53); the San
Jose-Sunnyvale-Santa Clara localities (localities 09, and 65); and the
Los Angeles-Long Beach-Anaheim localities (localities 26, and 18). The
commenter provided their analysis with their commenter letter, and
stated that based on their findings, the proposed GPCIs for the nine
counties contained in the eight aforementioned localities are
inaccurate. The commenter also requested that CMS provide the
traditional source data for the PE rent and wage indices or the
relative value units (RVUs) by county that have been published in the
past. Aside from the issues with these eight localities as described
above, the commenter indicated that for the remaining California
localities, they support and agree with the proposed GPCIs and commend
CMS for accurately completing the difficult calculations as required by
statute.
    Response: We appreciate the analysis provided by the commenter with
regards to the eight aforementioned localities and thank the commenter
for bringing this to our attention. We agree with the commenter that
there were issues with the calculation of the GPCI values reflected in
the CY 2020 PFS proposed rule for California. In the programming, we
inadvertently used the 32 MSA-based localities for which current GPCIs
are defined to account for different treatment of some counties within
MSAs when creating the new GPCIs, as opposed to using the 27 MSA-based
localities to determine the new MSA-based payment area GPCI amounts.
Additionally, we identified a
[[Page 62622]]
sequencing issue in our programming that led to issues in establishing
the transition values and applying the hold harmless provision. We
apologize for the confusion caused by these issues and have resolved
these programming issues and recalculated the California GPCIs. The
final CY 2020 GPCI values in California reflect the transition and hold
harmless provisions executed in the proper order based on the
requirements of the law. In summary, in California the issue was the
level of aggregation used to create the proposed rule values, which
erroneously resulted in different proposed rule values for counties
within payment localities where there should not be any differences.
Correcting this, along with other changes in the final rule relative to
the proposed rule, led to GAFs that are higher in all but three of the
32 payment localities in California. In those three, the GAF is lower
because it is now correctly equal among non-transition counties within
the new MSA-based payment areas; these three counties had higher values
when erroneously calculated as individual payment localities in the
proposed rule than they have when correctly averaged within the MSA for
the final rule GPCIs. The final rule GAFs for these three areas are
lower than those published in the proposed rule by 0.1 percent in
locality 26 (Los Angeles-Long Beach-Anaheim (Orange cty)), 1.4 percent
in locality 05 (San Francisco-Oakland-Hayward (San Francisco cty)), and
1.8 percent in locality 06 (San Francisco-Oakland-Hayward (San Mateo
cty)), but all three localities have CY 2020 PFS final rule GAFs that
are higher than their current CY 2019 values. In the other 29
California payment localities, the increase in final rule GAFs relative
to the proposed rule values ranges from 0.5 percent to 6.2 percent,
with 13 areas experiencing an increase of 1.2 percent.
    Additionally, we note that we have provided a county-level GPCI
data file as one of the GPCI public use files in the downloads section
of the CY 2020 PFS final rule on the CMS website, that delineates the
requested source data, as well as the RVUs by county, consistent with
what has been published in the past. We reiterate that the county-level
data file also reflects the correction to the oversight in the proposed
rule whereby we inadvertently used the 2016 utilization data for the
work and PE GPCIs (though we correctly used the 2017 utilization data
for the MP GPCIs) as previously discussed.
    Comment: One commenter stated that for CY 2020 in California there
should be 29 distinct fee schedule areas and not 32 fee schedule areas
as finalized when this provision was implemented in CY 2017. The
commenter stated that some of the distinct fee schedule areas that were
used during the period between CY 2017 and CY 2018 are no longer
necessary. The commenter stated that Orange and Los Angeles counties,
which are both in the Los-Angeles-Long Beach-Anaheim MSA, should have
the same GPCI values and be one locality number instead of two.
Similarly, Alameda, Contra Cosa, San Francisco and San Mateo counties
(all in the San Francisco-Oakland-Hayward MSA) should be identified by
one locality number instead of three, and the San Francisco-Oakland-
Hayward (Marin cnty) locality would remain its own distinct locality
number.
    Response: There are 27 MSAs in California, and when CMS implemented
the MSA-based locality structure for California as discussed above, for
operational considerations, we finalized 32 unique MSA-based locality
numbers. We did not propose to make changes to the number of unique
locality numbers for California for CY 2020. Since two of the MSAs that
required multiple unique locality numbers (San Francisco-Oakland-
Hayward, and San Jose-Sunnyvale-Santa Clara) to address operational
considerations as described in the CY 2017 PFS final rule (81 FR 80265
through 80268) contain both transition and non-transition counties, we
would still need to maintain some unique locality numbers. We remind
the commenter that though starting in CY 2022, the applicable GPCIs for
counties in transition areas will be calculated solely under the MSA-
based locality structure as described above, the statutorily-required
hold-harmless provision for counties in transition areas is permanent.
    With regards to the Los Angeles-Long Beach-Anaheim MSA, which
contains 2 counties (across two unique locality numbers: 18 and 26)
that are not transition areas, we acknowledge that the Los Angeles-Long
Beach-Anaheim MSA only needed separate unique locality numbers, for
payment purposes, in year 1 (CY 2017) of the implementation of the MSA-
based structure as neither of the counties in the MSA (Orange nor Los
Angeles counties) are transition counties (and therefore, are not
subject to aforementioned the one-sixth incremental phase-in nor hold-
harmless provision). We will consider the feasibility of assigning one
locality number for that MSA in future rulemaking since there will be
no difference in the GPCI values, for payment purposes, for those
localities going forward. Similarly, the San Francisco-Oakland-Hayward
MSA contains four counties (across three unique locality numbers: 05,
06, and 07) that are not transition areas and will receive the same
GPCI values, for payment purposes, going forward (San Francisco, San
Mateo, Alameda, and Contra Costa counties). As such, we will consider
the feasibility of collapsing those three unique locality numbers and
assigning one unique locality number in future rulemaking. If we
determine that to be operationally feasible, we would propose any
changes in future rulemaking. We note that it would ultimately change
the number of distinct fee schedule areas needed, for payment purposes,
in California from 32 to 29 as suggested by the commenter.
    Additionally, during the development of the CY 2020 PFS final rule
GPCIs, we identified typographical errors in the naming conventions of
four of the California MSA-based localities in Addendum D and Addendum
E: Locality 05-San Francisco-Oakland-Hayward (San Francisco cnty) was
listed as San Francisco; locality 06-San Francisco-Oakland-Hayward (San
Mateo cnty) was listed as San Mateo; locality 07-San Francisco-Oakland-
Hayward (Alameda/Contra Costa cnty) was listed as Oakland/Berkeley; and
San Jose-Sunnyvale-Santa Clara (Santa Clara cnty) was listed as Santa
Clara. This display issue has been corrected in Addendum D and Addendum
E for the final rule.
    Comment: One commenter stated that it believes large cuts to rural
and rest-of-state areas should be avoided or minimized, but locality
boundaries with large payment differences should not be in the middle
of urban areas, because they create payment cliffs where payment can
change if an office is moved across a street or down a block. The
commenter stated that CMS should create locality definitions that are
not constrained by county boundaries, and advocated implementing
locality definitions based on Metropolitan Statistical Areas.
    Response: We appreciate the suggestions for revisions to the PFS
locality structure; however, we did not propose any changes to the PFS
locality structure and decline to do so at this time. Further, we
clarify that just as the localities under the locality structure used
in the PFS are comprised of one or more constituent counties, so are
Metropolitan Statistical Areas. Therefore, the concept of a payment
cliff between neighboring counties as described by the commenter would
not necessarily be mitigated by a change from PFS fee schedule areas to
Metropolitan Fee Schedule Areas.
[[Page 62623]]
    After consideration of the comments, we are finalizing the CY 2020
GPCI update, and the methodological refinements as proposed. The final
GPCIs and summarized GAFs in Addenda D and E to this final rule also
reflect the correction of the underlying programming issues described
above.
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 final 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 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
[[Page 62624]]
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 over 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 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
[[Page 62625]]
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 stated we would 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 have received and reviewed all public comments to all these
codes that were nominated as potentially misvalued. Below, we present
the summarizations of all these public comments.
    Comment: One commenter provided information to CMS in which they
stated that the work involved in furnishing services represented by the
office/outpatient 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 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.
    Response: We acknowledge the points made by the commenter regarding
the valuation of E/M codes for office and outpatient visits. We agreed,
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).
    As we stated in the proposed rule, concurrently, the CPT Editorial
Panel, under similar policy objectives, convened a workgroup and
proposed to refine the existing E/M office/outpatient code set. Shortly
thereafter, the AMA RUC revalued these services and submitted
recommendations to CMS for review. In the CY 2020 PFS proposed rule, we
considered the RUC-recommended values for office/outpatient E/M codes
in proposing new values for CY 2021. For more detail on our review and
consideration of the revalued office/outpatient E/M services please
refer to section II.P of this final rule.
    Table 16 lists the HCPCS and CPT codes that we proposed as
potentially misvalued.
[[Page 62626]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.022
    We received public comments on the HCPCS and CPT codes that we
proposed as potentially misvalued. The following is a summary of the
comments we received and our responses.
    Comment: Several commenters submitted comments about HCPCS code
G0166 and claimed that in the CY 2019 PFS final rule, CMS did not have
the complete list of inputs for this ``Practice Expense only'' code,
which resulted in an under-valuation of its payment.
    Response: We note that the AMA RUC in its comment letter to the
proposed rule informed CMS that it would review this service and
forward any recommendations to CMS for review. We will review the AMA
RUC's forthcoming recommendations and will consider any refinements to
the valuation for this code through our standard rulemaking process for
CY 2021.
    Comment: Several commenters highlighted the payment reduction to
code G0166 in CY 2019 relative to CY 2018 and requested that CMS revert
back to the CY 2018 payment. Commenters also noted that the current and
reduced payment may endanger continued offering of this service,
particularly to beneficiaries with coronary artery disease with angina
for whom surgical intervention may not be appropriate and where
medications have proved to be ineffective.
    Response: We acknowledge the receipt of all comments related to
HCPCS code G0166 outlining that it may be inaccurately valued. We have
reviewed the information included in the comments received, and look
forward to reviewing the AMA RUC recommendations for this service. We
will review the AMA RUC's forthcoming recommendations and will consider
any refinements to the valuation for this code through our standard
rulemaking process for CY 2021.
    We refer readers to section II.B of this final rule for details on
the limited updates to the supply and equipment pricing for HCPCS code
G0166.
    Comment: Several commenters responded to the inclusion of CPT codes
10005 and 10021 on the potentially misvalued codes list, with the
majority urging CMS to revise the CY 2019 finalized RVUs by adopting
the higher RUC recommended RVUs.
    Response: We appreciate commenters' perspective on the valuation of
CPT codes 10005 and 10021 but refer the commenters to our CY 2019 PFS
final rule for our review of the relevant inputs and RUC
recommendations for these codes. We have reviewed the comments
received, including any additional information in response to our
discussion of these codes under the potentially misvalued code
initiative. We believe our refinements to the valuations for these
services continue to be valid, as no new compelling information has
been presented.
    Comment: Commenters disagreed with using the crosswalked CPT code
36440 as the reference code for valuing CPT code 10021, even though the
physician work times for both codes are very similar. One commenter
stated that the previous values for work time (1995) were also based on
a crosswalk (CPT codes 88170 and 88171) and not a survey, and
therefore, the decrease in work time did not warrant a proportional
change in work RVU as the previous times were inaccurate. Also, as
discussed in the CY 2019 PFS final rule with comment period (83 FR
59517), commenters stated that the work intensity for both codes are
unequal as well their incongruous procedure descriptors, pointing out
the fact that CPT codes 36440, 88170, and 88171 are clinically very
different to CPT code 10021.
    Response: As we have discussed in previous rules, we agree that it
is important to use the most recent data available regarding time, and
we note that when many years have passed between when time is measured,
significant discrepancies can occur. However, we continue to believe
that our operating assumption regarding the validity of the existing
values as a point of comparison is critical to the integrity of the
relative value system as currently constructed. The times currently
associated with codes play a very important role in PFS ratesetting,
both as points of comparison in establishing work RVUs and in the
allocation of indirect PE RVUs by specialty. If we were to operate
under the assumption that previously recommended work times had
routinely been overestimated, this would undermine the relativity of
the work RVUs on the PFS in general, given the process under which
codes are often valued by comparisons to codes with similar times, and
it also would undermine the validity of the allocation of indirect PE
RVUs to physician specialties across the PFS. Instead, we believe that
it is crucial that the code valuation process take place with the
understanding that the existing work times used in the PFS ratesetting
processes are accurate. 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. We continue to disagree
with commenters' distinction of different types of physician work times
as being better or worse in their measure of validity in comparison to
each other, and believe that CPT code 36440 is a good comparable code
to CPT code 10021 in physician work and physician work times.
    Comment: For CPT code 10021, one commenter disagreed with CMS
maintaining the code's global indicator of ``XXX'' (global concept does
not apply) and recommended a change to ``000'' (minor surgery/zero day
global).
    Response: We did change the multiple procedure indicator for CPT
code 10021 from a ``0'' (payment rules do not apply) to a ``2''
(standard payment adjustments do apply), but as we stated in CY 2019
PFS final rule (83 FR 59520), we do not agree that it would have been
more accurate to use codes with a 0-day global period as references for
the codes in this family, and the multiple procedure policy continues
to apply for CPT code 10021.
    In concluding our review of all the comments submitted for the
nominated potentially misvalued CPT codes of 10005 and 10021, we do not
believe we have received any additional
[[Page 62627]]
information to consider in the context of our previous review of these
services. Therefore, we are not including CPT codes 10005 and 10021 on
our final list of potentially misvalued codes for CY 2020.
    Comment: One commenter noted on the CMS nominated CPT code 76377
(which we found to be very similar to CPT code 76376 that was AMA RUC
reviewed for CY 2020), that although both code descriptors are similar,
they have different clinical indications, different patients, different
complexity in the work and require different resources and equipment,
and that CPT code 76377 was not identified on any of the normal
screens.
    Response: CMS' nominated CPT code 76377 as potentially misvalued
due to its similarity to 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), which is reviewed and
finalized for 2020. Due to the refinements made to CPT code 76376, CPT
code 76377 should be similarly reviewed to resolve the two codes'
likely discrepancies. We will consider the valuation of this code in
future rulemaking. During this review, we will determine if the
clinical indications, the complexity of the work, and the resources
that are required, are similar or different for both of these codes.
    Comment: We received several comments regarding the AMA RUC's
survey and recommended values for the E/M office/outpatient evaluation
and management codes (99201-99015) for CY 2021.
    Response: We refer readers to section II. P. of this final rule
where we discuss these codes in detail.
    After consideration of the comments received, in summary, we are
including CPT code 76377 and HCPCS code G0166 on our final list of
potentially misvalued codes for CY 2020. However, we are not including
CPT codes 10005 and 10021 on our final list of potentially misvalued
codes for CY 2020.
4. Insertion, Removal, and Removal and Insertion of Implantable
Interstitial Glucose Sensor System (Category III CPT codes 0446T,
0447T, and 0448T)
    Category III CPT codes 0446T, 0447T, and 0448T describe the
services related to the insertion, removal, and removal and insertion
of an implantable interstitial glucose sensor from subcutaneous pocket,
in a subcutaneous pocket via incision. The implantable interstitial
glucose sensors are part of systems that can allow real-time glucose
monitoring, provides glucose trend information, and signal alerts for
detection and prediction of episodes of low blood glucose
(hypoglycemia) and high blood glucose (hyperglycemia).
    Diabetes is the sixth leading cause of death in the United States,
and approximately 20 million Americans have diabetes with an estimated
20.9 percent of the senior population age 60 and older being affected.
Millions of people have diabetes and do not know it. Left undiagnosed,
diabetes can lead to severe complications such as heart disease,
stroke, blindness, kidney failure, leg and foot amputations, and death
related to pneumonia and flu. Scientific evidence now shows that early
detection and treatment of diabetes with diet, physical activity, and
new medicines can prevent or delay much of the illness and
complications associated with diabetes. As with management of other
chronic conditions, we believe innovative technologies that provide
improved data to physicians and patients can be important tools in
promoting patient-centered care.
    The codes that describe the implantation, removal, and removal and
implantation of implantable interstitial glucose sensors are currently
contractor-priced. Since the publication of the CY 2020 PFS proposed
rule, we have become aware that the contractor pricing for these
services has contributed to significant confusion in the community with
regards to Medicare payment rules for these kinds of monitoring
systems. We understand that this confusion has led to inhibited access
to these services for Medicare beneficiaries.
    Given the immediate needs of Medicare beneficiaries with diabetes,
including some who could benefit from these innovative technologies, we
are seeking information from stakeholders to ensure proper payment for
this important physician's service by establishing national payment
rates in future rulemaking.
    We are seeking information from stakeholders on the resources
involved in furnishing the services described by Category III CPT codes
0446T (Creation of subcutaneous pocket with insertion of implantable
interstitial glucose sensor, including system activation and patient
training), 0447T (Removal of implantable interstitial glucose sensor
from subcutaneous pocket via incision), and 0448T (Removal of
implantable interstitial glucose sensor with creation of subcutaneous
pocket at different anatomic site and insertion of new implantable
sensor, including system activation). We are specifically seeking
recommendations, including the work RVUs, work time, and direct PE
inputs, associated with the resources involved in inserting and
removing the device, as well as the resource costs of the implantable
device and disposable supplies (that is, the supply costs of the
implantable device ``implantable interstitial glucose sensor'', and the
smart transmitter).
    Under our existing policies, we welcome recommendations on
appropriate valuation for these services and any recommendations
submitted by February 10, 2020 would be considered for CY 2021 PFS
rulemaking.
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
[[Page 62628]]
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 additions described
later in this section, can be located on the CMS website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.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, 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, we proposed adding three new HCPCS G codes describing new
bundled services for treatment of opioid use disorders in section II.H.
of the CY 2020 PFS proposed rule which we noted are sufficiently
similar to services currently on the telehealth list to be added on a
Category 1 basis. Therefore, we proposed 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 G2086: 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 G2087: 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 G2088: 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).
    We note that in the CY 2020 PFS proposed rule (84 FR 40518), we
referred to these services using placeholder codes, HCPCS codes GYYY1,
GYYY2, and GYYY3, which are being replaced with the final G codes
above. 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 G2086, G2087, and G2088 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 list.
We note that like certain other non-face-to-face PFS services, the
other components of HCPCS codes G2086-G2088 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 G2086-
G2088 are similar to other telehealth services. Were these components
of HCPCS codes G2086-G2088 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. We also note that by considering the face-to-face portion
of these services to be eligible for telehealth services, the
originating site facility fee could be reported, consistent with all
other rules, when these services are furnished via telehealth.
    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
[[Page 62629]]
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 G2086, G2087, and G2088 to the Medicare telehealth list will
complement the existing policies related to flexibilities in treating
SUDs.
    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.
    We received public comments on the proposed HCPCS codes for
addition to the telehealth list on a Category 1 basis. The following is
a summary of the comments we received and our responses.
    Comment: The majority of commenters supported our proposal to add
HCPCS codes G2086, G2087, and G2088 to the Medicare telehealth list,
although a few disagreed, stating that these services should only be
furnished in person.
    Response: We thank the commenters for their support and feedback.
We note that the psychotherapy services that are included in this
bundled payment are already on the list of Medicare telehealth
services. After consideration of the comments received, we are
finalizing our proposal to add HCPCS codes G2086, G2087, and G2088 to
the Medicare telehealth list beginning in CY 2020.
    Comment: Several commenters disagreed with CMS' statement that most
eligible services had been added to the Medicare telehealth list and
suggested that CMS should continue to engage with stakeholders to
identify other services that could be furnished via Medicare telehealth
or communication technology-based services. A few commenters also
provided recommendations for additional services that could be added to
the Medicare telehealth list, as well as suggestions for how CMS could
improve the process of requesting that services be added. Commenters
reiterated as they have for many years that the statutory restrictions
under section 1834(m) of the Act limit availability of telehealth
services, and many encouraged CMS to utilize its demonstration
authority to waive restrictions.
    Response: We will continue to engage with stakeholders to identify
services to add to the Medicare telehealth list and other ways to
leverage technology in furnishing services under the PFS within the
scope of the statute. We note that the deadline for submitting requests
for additions to the Medicare Telehealth list is February 10 of the
year prior to the year in which the codes could be added to the
Medicare telehealth list, and any requests that are received after that
time will be considered in the following year's rulemaking.
    Comment: A few commenters requested that CMS allow visits with the
prescribing physician for medications that require medical visits for
monitoring (for example, buprenorphine) to also be furnished via
telehealth.
    Response: We note that the majority of the E/M visit codes are
already on the Medicare telehealth list and can be furnished in
addition to HCPCS codes G2086, G2087, and G2088. Specific requests for
consideration of additional codes for the Medicare telehealth list
should be submitted through the process outlined above. We also note
that there are existing rules related to telemedicine and prescribing
buprenorphine for the treatment of OUD (https://www.hhs.gov/opioids/sites/default/files/2018-09/hhs-telemedicine-hhs-statement-final-508compliant.pdf).
3. Telehealth Originating Site Facility Fee Payment Amount Update
    Section 1834(m)(2)(B) of the Act established the Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002, at $20.00.
For telehealth services furnished on or after January 1 of each
subsequent calendar year, the telehealth originating site facility fee
is increased by the percentage increase in the Medicare Economic Index
(MEI) as defined in section 1842(i)(3) of the Act. The originating site
facility fee for telehealth services furnished in CY 2019 is $26.15.
The MEI increase for 2020 is 1.9 percent and is based on the most
recent historical update of the MEI through 2019Q2 (2.4 percent), and
the most recent historical multifactor productivity adjustment (MFP)
through calendar year 2018 (0.5 percent). Therefore, for CY 2020, the
payment amount for HCPCS code Q3014 (Telehealth originating site
facility fee) is 80 percent of the lesser of the actual charge or
$26.65. The Medicare telehealth originating site facility fee and the
MEI increase by the applicable time period is shown in Table 17.
[[Page 62630]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.023
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, April 19, 2019, July 17,
2019, and most recently, October 16, 2019.\3\
---------------------------------------------------------------------------
    \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-16oct2019.aspx.
---------------------------------------------------------------------------
    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 (SUD), including OUD (Sec.  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.
---------------------------------------------------------------------------
    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
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 Food and Drug Administration (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
[[Page 62631]]
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) of the Act) 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
Sec.  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\
---------------------------------------------------------------------------
    \5\ https://dpt2.samhsa.gov/treatment/directory.aspx.
    \6\ https://wwwdasis.samhsa.gov/dasis2/nssats.htm.
---------------------------------------------------------------------------
    Many payers currently cover MAT services for treatment of OUD.
Medicaid \7\ is one of the largest payers of medications for 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'' final
rule, many qualified health plans covered MAT medications for plan year
2018 (84 FR 17536).
---------------------------------------------------------------------------
    \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 proposed to
establish rules to govern Medicare coverage of and payment for OUD
treatment services furnished in OTPs. We proposed to establish
definitions of OUD treatment services and OTP for purposes of the
Medicare Program. We also proposed a methodology for determining
Medicare payment for such services provided by OTPs. We proposed to
codify these policies in a new section of the regulations at Sec.
410.67. For a discussion about Medicare enrollment requirements and the
program integrity approach for OTPs, we refer readers to section III.H.
in this final rule, Medicare Enrollment of Opioid Treatment Programs.
2. 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, injected, and implanted
opioid agonist and antagonist medications approved by the 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.
---------------------------------------------------------------------------
    \9\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
    \10\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
---------------------------------------------------------------------------
    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 tablets, oral buprenorphine with
[[Page 62632]]
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 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).
---------------------------------------------------------------------------
    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 mg did not suppress opioid abstinence, with
clinical stability generally achieved at doses between 80 to 120 mg/
day.\25\ By law, methadone used for treatment of OUD can only be
dispensed through an OTP certified by SAMHSA except in certain, very
limited circumstances.\26\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    Naltrexone is FDA-approved to treat alcohol dependence in addition
to OUD.\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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    We proposed 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 proposed 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 proposed to codify this definition of OUD treatment
services furnished by OTPs at Sec.  410.67(b). As part of this
definition, we also proposed 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 solicited 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 noted we were 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
noted 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 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 solicited 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 solicited 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.
    We received a number of public comments on the proposed definition
of ``opioid use disorder treatment services.'' The following is a
summary of the comments we received and our responses.
    Comment: Commenters were generally supportive of including the five
statutorily-required items and services in the definition of OUD
treatment services: (1) Opioid agonist and antagonist treatment
medications approved by the FDA for treatment of OUD; (2) dispensing
and administration
[[Page 62633]]
of such medications; (3) substance use counseling; (4) individual and
group therapy; and (5) toxicology testing. Commenters were also
generally supportive of the use of telecommunications for substance use
counseling and individual and group therapy services.
    Response: We thank commenters for their support of including the
five statutorily-required items and services and the use of
telecommunications for certain services in the definition of OUD
treatment services. We are finalizing a definition of OUD treatment
services that includes these items and services at Sec.  410.67(b).
    Comment: Many commenters expressed support for allowing licensed
mental health professionals to directly bill Medicare for counseling
and therapy services provided in an OTP. Some commenters requested
clarification on whether OUD treatment services would only include
substance use counseling and individual and group therapy services
furnished by physicians, psychologists, and practitioners that can bill
Medicare directly and not services furnished by other types of mental
health professionals that are licensed by the state, such as licensed
professional counselors, licensed mental health counselors, and
licensed clinical professional counselors. These commenters raised
concerns that only allowing physicians and psychologists to furnish
these services and not including other mental health professionals
authorized by the state to furnish counseling and therapy services
would limit access to care due to workforce shortages. Some commenters
requested that we clarify the distinction between substance use
counseling and individual and group therapy services or allow these
terms to be generally used interchangeably.
    Response: Under sections 1861(jjj)(1)(C) and (D) of the Act,
substance use counseling for OUD treatment can be provided by ``a
professional to the extent authorized under State law to furnish such
services,'' while individual and group therapy can be ``with a
physician or psychologist (or other mental health professional to the
extent authorized under State law).'' Consistent with the statute, in
the proposed rule we did not propose to limit the professionals that
can provide these services to physicians, psychologists, or other
practitioners who can bill Medicare directly. Instead, we noted that
the professionals that could provide such services 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 provided by these
professionals would not be covered as OUD treatment services. Regarding
the commenters' request for clarification of the distinction between
substance use counseling and therapy services, we are not specifying
the differences between these two types of services, but would note
that different types of professionals may be authorized to furnish
substance use counseling versus therapy services under state law.
Regarding the comments that supported allowing licensed mental health
professionals to directly bill Medicare for counseling and therapy
services provided in an OTP, we note that only OTPs can bill for the
bundled payment for furnishing OUD treatment services.
    Comment: Several commenters opined on the types of toxicology
testing that should be included in the definition of OUD treatment
services. One commenter recommended that we clarify the language
regarding ``toxicology testing'' in the definition of OUD treatment
services to include ``presumptive and definitive drug testing in line
with clinical best practice'' to better de-stigmatize the use of these
services. Other commenters suggested that only presumptive toxicology
testing be included in the definition and that definitive testing be
billed separately under the Medicare Clinical Laboratory Fee Schedule
(CLFS). Alternatively, if definitive testing were to be included,
commenters suggested that the bundled payment rate should be updated to
reflect the cost of this type of toxicology testing by increasing the
bundled payment rate or establishing add-on payments for definitive
testing. Commenters raised the differences in complexities and costs
between presumptive and definitive toxicology testing. These commenters
explained that presumptive testing is an initial test that is conducted
through point of care rapid result cup testing, which has testing and
accuracy limitations. OTPs typically perform presumptive toxicology
testing for drugs of abuse on-site using cups and dipsticks that
indicate the presence or absence of drug classes as long as the test
systems that are used are classified as waived test systems under the
regulations implementing the Clinical Laboratory Improvement Amendments
(CLIA) (Pub. L. 100-578, enacted October 31, 1988), as amended, 42 CFR
part 493, and the OTP has a valid certificate of waiver that authorizes
it to perform CLIA waived tests.
    Due to limitations of presumptive testing, OTPs may also send urine
samples to reference labs for definitive drug testing to make sure they
know exactly which drugs have been ingested. Definitive drug testing
uses liquid or gas chromatography coupled with mass spectrometry to
identify hundreds of specific drugs and their metabolites. Definitive
drug testing identifies and precisely quantifies specific drugs and/or
metabolites that are positive in a sample. A treating physician may
order a confirmatory test despite the outcome of the presumptive
testing to obtain more information on the drugs that a patient is
taking. Commenters raised the cost differences under the CY 2019
Medicare CLFS between the two types of tests ranging from $12.60-$64.65
for presumptive testing to $114.43-$246.92 for definitive testing. Some
commenters requested clarification of the distinction between the
toxicology testing that would be included in the definition of OUD
treatment services and would be paid under the bundle and medically-
necessary toxicology testing that is billed and paid under the Medicare
CLFS.
    Response: We noted in the CY 2020 PFS proposed rule that under
SAMHSA 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 are used for diagnosing, monitoring
and evaluating progress in treatment (84 FR 40527). Consistent with the
discussion of the different types of toxicology testing in the proposed
rule, we are clarifying that the reference to toxicology testing in the
definition of OUD treatment services includes both presumptive and
definitive testing. We are also clarifying that all types of toxicology
testing that are used for diagnosing, monitoring and evaluating the
progress in treatment at the OTP are included in the definition of OUD
treatment services and would be paid under the bundled payment.
Toxicology tests that are unrelated to the care and treatment for OUD
at an OTP may be paid separately under the CLFS, if reasonable and
necessary, since toxicology tests for these purposes are not included
in the bundled payments to OTPs. CMS expects that the ordering
[[Page 62634]]
practitioner would document the medical necessity for this additional
testing in the beneficiary's medical record.
    Comment: Many commenters supported the inclusion of intake
activities, such as the initial physician examination, initial
assessment and preparation of a treatment plan, as well as periodic
assessments in the definition of OUD treatment services. One of the
commenters noted these were significant activities performed by the
treatment teams that were not included in the proposed bundle, nor are
they paid for separately in the OTPs, and stated these services should
be included. Another commenter stated that initial assessment and
treatment planning activities are generally the first part of OUD
treatment and that treatment planning cannot always be linear and must,
at times, be revised. The commenter noted that these activities are
typical of any substance abuse treatment program and should be included
in the definition of OUD treatment services.
    Response: We agree with commenters that intake activities, such as
the initial physician examination, initial assessment and preparation
of a treatment plan, should be included in the definition of OUD
treatment services. We also agree with commenters that periodic
assessment should be included in the definition of OUD treatment
services. We note that an initial medical examination and both initial
and periodic assessments are required under the SAMHSA regulations.
Specifically, under the SAMHSA requirements at Sec.  8.12(f)(2), 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. The full medical
examination, including the results of serology and other tests, must be
completed within 14 days following admission.
    Under Sec.  8.12(f)(4), OTPs are required to do initial and
periodic assessments. 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.
The initial assessment must include preparation of a treatment plan
that includes: The patient's short-term goals and the tasks the patient
must perform to complete the short-term goals; the patient's
requirements for education, vocational rehabilitation, and employment;
and the medical, psychosocial, economic, legal, or other supportive
services that a patient needs. The treatment plan also must identify
the frequency with which these services are to be provided. The plan
must be reviewed and updated to reflect that patient's personal
history, his or her current needs for medical, social, and
psychological services, and his or her current needs for education,
vocational rehabilitation, and employment services. We understand that
intake activities and periodic assessments are integral services for
the establishment and maintenance of OUD treatment for a beneficiary at
an OTP. Therefore, we are believe it is reasonable to include these
services in the definition of OUD treatment services. Accordingly, we
are finalizing a revised definition of OUD treatment services in Sec.
410.67(b) that reflects the required intake activities and periodic
assessments. We discuss coding and payment for these services in the
Coding section below.
    Comment: A few commenters requested that CMS publish a detailed
list of the items and services that are covered as OUD treatment
services and would be included in the bundled payment to the OTPs.
    Response: The items and services included in the definition of OUD
treatment services are listed in the preamble of this final rule and in
the regulations at Sec.  410.67(b). We note that the items and services
that are medically-necessary for OUD treatment could in some cases also
be furnished and billed by other Medicare practitioners under another
Medicare benefit category. For example, we anticipate that some
beneficiaries 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. In this scenario, the counseling or therapy provided as
part of a physician's service could be billed separately.
    Comment: One commenter supported a definition of OUD treatment
services that would allow for coverage of innovative therapies in
development that have not yet been approved by the FDA for treatment of
OUD. The commenter suggested changing the proposed regulatory language
in Sec.  410.67(b)(1) to ``Therapies approved by the Food and Drug
Administration under section 505 of the Federal, Food, Drug, and
Cosmetic Act for use in treatment of opioid use disorder.'' A few
commenters recommended that drugs used for opioid detoxification
withdrawal and management maintenance such as naloxone, clonidine, and
lofexidine be included in the definition of OUD treatment services.
    Response: We thank the commenters for their feedback on including
drugs that are not opioid agonist or antagonist medications in the
definition of OUD treatment services. For CY 2020, we are finalizing a
definition of OUD treatment services that reflects the statutory
requirement in section 1861(jjj)(1)(A) of the Act to include opioid
agonist and antagonist treatment medications approved by the FDA in the
definition of OUD treatment services. We will consider these comments
on additional drugs to include in the definition of OUD treatment
services under our discretionary authority in section 1861(jjj)(1)(F)
of the Act as we continue to work on refining this new Medicare benefit
in future rulemaking.
    Comment: In response to the request for comment on adding various
other types of items and services to the definition of OUD treatment
services, several commenters indicated that case management and care
coordination are services furnished by OTPs and should be included in
the definition of OUD treatment services. Some commenters also
requested that peer-to-peer support, crisis management, and non-opioid
alternative treatment be included in the definition of OUD treatment
services. One commenter urged CMS to include Medical Nutrition Therapy
services that are furnished by registered dietician nutritionists as a
core component of OTPs because individuals with OUD suffer from
gastrointestinal issues, eating disorders and malnutrition. The
commenter stated it is essential that CMS build a payment model that
leverages the different expertises of the full health care team,
including registered dietician nutritionists. Another commenter urged
CMS to include physical therapy within the list of OUD treatment
services and recommended adjusting the bundled payment rates to account
for instances in which effective treatment requires physical therapy
and other nonpharmacological treatment services. Some commenters noted
that the proposed bundled payment should include both e-prescribing and
behavioral health information technology consultation and support
services. One commenter urged that the definition of OUD treatment
services include services performed by pharmacists including
psychiatric pharmacists, such as medication adherence, management, and
education or counseling. Some commenters suggested adding other
laboratory tests, including HIV, Hepatitis, liver disease,
[[Page 62635]]
or infectious diseases. Other commenters noted SAMHSA requirements for
treatment for tobacco use disorder, alcohol use disorder, and family
services for OTPs and recommended that these should be included in the
definition of OUD treatment.
    Response: We appreciate the comments recommending additional types
of items and services that could be added to the definition of OUD
treatment services. For CY 2020, we are finalizing a definition of OUD
treatment services that includes those items and services that we
understand are required for all OTPs to furnish as specified in SAMHSA
regulations (part 8). Because this is the first year of the OTP
benefit, we believe it would be premature to include in the definition
additional items and services until we have additional information
regarding their use by OTPs in the treatment of Medicare beneficiaries
with OUD. However, we note that the definition of OUD treatment
services does not prevent an OTP from furnishing the additional items
and services suggested above in accordance with best practices as
clinically appropriate, SAMHSA regulations and guidance, and State law.
We may consider the items and services suggested by commenters further
as we continue to work on refining this new Medicare benefit in future
rulemaking. Accordingly, we are interested in continued feedback and
data on the specific items and services, including their frequency,
furnished to beneficiaries by an OTP.
    After consideration of the public comments, we are finalizing our
proposal to include the five statutorily-required items and services in
the definition of OUD treatment services in Sec.  410.67(b). For the
reasons discussed previously, we will also include intake activities
and periodic assessments required under Sec.  8.14(f)(4) in the
definition of OUD treatment services in Sec.  410.67(b).
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, 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 final rule, Medicare
Enrollment of Opioid Treatment Programs, for further details on our
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 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 Sec.  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, as determined by the medical director or
program physician of the OTP in which the patient is enrolled (Sec.
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
[[Page 62636]]
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-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 part 8, subpart C, and any
regulations regarding the use of opioid agonist treatment medications
in the treatment of OUD that 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, that the person has had an OUD for 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, all physicians, nurses, and other licensed
professional care providers, including addiction counselors, must
comply with the credentialing requirements of their respective
professions.
    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 SUD 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\
---------------------------------------------------------------------------
    \34\ https://store.samhsa.gov/system/files/pep15-fedguideotp.pdf.
---------------------------------------------------------------------------
(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 SUDs with MAT
(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 (Sec.  8.11).
    The SAMHSA regulations establish procedures for an entity to apply
to become a SAMHSA-approved accrediting body (Sec.  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;
[[Page 62637]]
    ++ 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;
     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\
---------------------------------------------------------------------------
    \35\ https://www.samhsa.gov/medication-assisted-treatment/opioid-treatment-accrediting-bodies/approved.
---------------------------------------------------------------------------
(4) Provider Agreement
    Section 2005(d) of the SUPPORT Act amended section 1866(e) of the
Act by adding a new paragraph (3) which includes OTPs (but only with
respect to the furnishing of OUD 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 codified at 42 CFR
part 489. Therefore, we proposed to amend part 489 to include OTPs (but
only for furnishing OUD treatment services) as a provider.
Specifically, we proposed to add OTPs (but only for the furnishing of
OUD treatment services) to the list of providers in Sec.  489.2. This
addition makes clear that the other requirements specified in section
1866 of the Act, and implemented in part 489, which include the limits
on charges to beneficiaries, will apply to OTPs (in connection with the
furnishing of OUD treatment services). We also proposed 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 did not propose any conditions of
participation for OTPs, we proposed 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 proposed 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. As
noted earlier in the preamble to this final rule, OTPs are required to
be certified by SAMHSA and accredited by an accrediting body approved
by SAMHSA. In Sec.  489.53, we proposed 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 proposed 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 proposed to amend the
definition of provider in Sec.  498.2 to include OTPs. We also
indicated that we would continue to review the application of the
provider agreement requirements to OTPs to determine whether any
further amendments to parts 489 and 498 were needed to ensure that the
existing provider agreement regulations are applied to OTPs consistent
with our proposals and section 2005 of the SUPPORT Act.
    Comment: Multiple commenters questioned whether provider
agreements, once executed, will be made retroactive to January 1, 2020.
    Response: We proposed in Sec.  489.13(a)(2)(i) that the effective
date of an OTP provider agreement would be the date on which we accept
a signed agreement that ensures that the OTP meets all federal
requirements. Yet, as discussed in section III.H of the final rule we
also proposed retrospective billing dates in Sec.  424.520(d) and Sec.
424.521(a) if the requirements of those sections were met. To ensure
that the provider agreement and billing effective dates are uniform, we
are not finalizing our proposed change to Sec.  489.13(a)(2)(i).
Instead, we will establish a new Sec.  489.13(a)(2)(iii) stating that
the provider agreement effective date is to be consistent with the
billing effective date established pursuant Sec.  424.520(d) or Sec.
424.521(a), as applicable. In sum, the effective dates of OTP provider
agreements will not automatically be made retroactive to January 1,
2020, but will instead be governed by Sec.  489.13(a)(2)(iii).
    After consideration of comments received, we are making changes to
Sec.  489.13(a)(2)(i) to align with the provider agreement effective
date to the billing effective date under Sec.  424.520(d) or Sec.
424.521(a), as applicable. We did not receive any other comments on the
proposals for the provider agreement requirements in Sec. Sec.  489.2,
489.10, 489.43, and 498.2., and are finalizing these changes as
proposed.
(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, in
the proposed rule, we stated that we believe the existing SAMHSA
certification and accreditation requirements are both
[[Page 62638]]
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 indicated that we
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, we
did not propose any additional conditions for participation in Medicare
by OTPs in the CY 2020 PFS proposed rule. We solicited public comments
on our 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 proposed to define ``opioid treatment program'' at Sec.
410.67(b) as an entity that is an OTP as defined in Sec.  8.2 (or any
successor regulation) and meets the applicable requirements for an OTP.
We proposed to codify this definition at Sec.  410.67(b). In addition,
we proposed 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 also
proposed that an OTP must have a provider agreement as required by
section 1866(a) of the Act. We proposed to codify these requirements at
Sec.  410.67(c). We solicited public comments on the proposed
definition of OTP and the proposed Medicare requirements for OTPs.
    The following is a summary of the comments we received and our
responses.
    Comment: Commenters generally supported the proposed definition of
OTP, including the requirements that OTPs 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.
One commenter stated that these policies represent only the start of an
ongoing effort to address the opioid epidemic.
    Response: We appreciate the support for the proposed definition of
OTPs. We understand the importance of combating the opioid epidemic and
intend to monitor the implementation of this new Medicare benefit and
may propose further refinements in future rulemaking. After
consideration of the comments received, we are finalizing our proposed
definition of ``opioid treatment program'' at Sec.  410.67(b).
    Comment: Commenters supported the proposed Medicare requirements
for OTPs, including the requirement that they have in effect a provider
agreement with the Secretary. One commenter welcomed CMS' reminder to
providers that being a Medicare provider carries with it a limit on
charges to beneficiaries, and stated that in addition to the proposal
for zero cost sharing for OTP services, this policy would help to
protect beneficiary access to care and economic security.
    Response: We appreciate the support for the proposal to require
OTPs to enter into a provider agreement and are finalizing this
requirement at Sec.  410.67(c), along with Sec.  424.67(b).
Additionally, we reiterate that as indicated in the Health Insurance
Benefit Agreement (Form CMS-1561),\36\ the provider agrees to conform
to the provisions of section 1866 of the Social Security Act and the
applicable provisions in Title 42 Code of Federal Regulations (CFR),
which in part establish the requirement that a provider must accept
assignment of Medicare payment.
---------------------------------------------------------------------------
    \36\ https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1561.pdf.
---------------------------------------------------------------------------
    Comment: Many commenters supported CMS' view that the comprehensive
OTP standards for certification of OTPs established by SAMHSA address
the same topics as would be addressed by CMS conditions of
participation, and that 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. Furthermore, commenters agreed with CMS' conclusion
that the existing SAMHSA certification and accreditation requirements
are both appropriate and sufficient to ensure the health and safety of
individuals receiving services from OTPs, as well as the effective and
efficient furnishing of such services. Commenters also noted the
regulations established by the DEA and the regulations established by
states for licensure purposes as additional assurances of patient
health and safety. The commenters agreed 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. Thus, the commenters supported the proposal to
accept the existing SAMHSA requirements for certification and
accreditation as the health and safety standards that must be met in
order for an OTP to participate in Medicare.
    Response: We are finalizing our proposal to adopt the existing
SAMHSA requirements for certification and accreditation as the health
and safety standards that must be met in order for an OTP to
participate in Medicare. This approach will avoid unnecessary
regulatory duplication while assuring Medicare beneficiary safety at
OTPs.
    After consideration of the comments, we are finalizing the proposed
definition of ``opioid treatment program'' at Sec.  410.67(b). We are
also finalizing the proposed Medicare requirements for OTPs at Sec.
410.67(c). Specifically, in order 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 certification by SAMHSA, and
be accredited by an accrediting body approved by SAMHSA. Additionally,
we are finalizing our proposal that an OTP must have a provider
agreement as required by section 1866(a) of the Act.
3. 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
proposed to establish bundled payments for OUD treatment services
which, as discussed above, would include 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. In calculating the bundled payments, we proposed 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 proposed to calculate the full
bundled payment rate by combining the drug component and the non-drug
components. We outlined our proposals for determining the bundled
payments for OUD treatment services addressing payment rates for these
services under the Medicaid and
[[Page 62639]]
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 proposed to
codify the methodology for determining the bundled payment rates for
OUD treatment services at Sec.  410.67(d).
    We received a number of public comments on the proposed approach to
calculating the full bundled payment rate. The following is a summary
of the comments we received and our responses.
    Comment: A few commenters supported the proposal to calculate the
full bundled payment rate by combining the drug component and the non-
drug components. Another commenter stated that clinical services, such
as individual and group counseling, should be billed separately from
the medication.
    Response: Section 1861(jjj) of the Act defines OUD treatment
services to include certain opioid treatment medications furnished by
an OTP, as well as other services such as substance use counseling and
individual and group therapy. Section 1834(w) of the Act instructs the
Secretary to make a bundled payment for the services that are furnished
by an OTP to an individual during an episode of care. We do not believe
the statute supports unbundling the medications from the other OUD
treatment services furnished by OTPs during the same episode of care.
    After consideration of the public comments, we are finalizing our
proposal to calculate the full bundled payment rate for services
furnished by OTPs by combining the drug component and the non-drug
components. We are codifying 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. In the proposed rule, we
acknowledged that many private payers cover services furnished by OTPs,
and welcomed 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 also indicated that we might
consider this information as part of the development of the final
bundled payment rates for OUD treatment services furnished by OTPs.
(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 intake/assessment, drug dispensing and screening and
integrated psychosocial and medical treatment and supportive services),
hereafter referred as the non-drug services. In the proposed rule (84
FR 40524), we noted 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)(2), 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.\37\ Beneficiary cost-sharing
consists of a flat copayment that may be applied to this weekly rate.
---------------------------------------------------------------------------
    \37\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
---------------------------------------------------------------------------
    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 (FFS)
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 FFS 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.\38\ Drugs listed on Medicare's Part B ASP files are paid using
the ASP.\39\ Drugs not appearing on the Medicare ASP file are paid at
the lesser of billed
[[Page 62640]]
charges or 95 percent of the AWP.\40\ 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.\41\
---------------------------------------------------------------------------
    \38\ 81 FR 61080.
    \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\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
    \41\ 81 FR 61080.
---------------------------------------------------------------------------
(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 MAT of OUD under their Medicaid programs.
However, as of 2018, only 42 states covered methadone for MAT for OUD
under their Medicaid programs.\42\ We note that section 1006(b) of the
SUPPORT Act amended sections 1902 and 1905 of the 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.
---------------------------------------------------------------------------
    \42\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport_0.pdf.
---------------------------------------------------------------------------
    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,\43\ while the unit of
payment in Maryland for methadone maintenance is weekly,\44\ and
Vermont uses a monthly unit\45\ of payment of these OUD treatment items
and services.
---------------------------------------------------------------------------
    \43\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
    \44\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
    \45\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
---------------------------------------------------------------------------
    For the other MAT drugs, all states cover buprenorphine and the
buprenorphine-naloxone medications;\46\ however, fewer than 70 percent
cover the implanted or extended-release injectable versions of
buprenorphine.\47\ In addition, all states cover the extended-release
injectable naltrexone. \48\ We also found that many states pay
different rates based on the specific type of drug used for MAT.
---------------------------------------------------------------------------
    \46\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
    \47\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
    \48\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
---------------------------------------------------------------------------
    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,\49\ Texas,\50\ and California \51\) separately
reimburse for individual and group counseling services, while other
states (such as Vermont \52\ and New Mexico \53\) include these
services in the OUD bundled payment.
---------------------------------------------------------------------------
    \49\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
    \50\ 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.
    \51\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
    \52\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
    \53\ 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.
---------------------------------------------------------------------------
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 proposed 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). As noted in the
proposed rule, 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 stated that we
believe a weekly duration for an episode of care would be most familiar
to OTPs, and therefore, the least disruptive to adopt. We proposed to
define an episode of care at Sec.  410.67(b) as a 1-week (contiguous 7-
day) period; however, we also solicited comments on whether we should
consider a daily or monthly bundled payment.
    We also recognized that patients receiving MAT are often on this
treatment regimen for an indefinite amount of time, and therefore, we
did not propose any maximum number of weeks during an overall course of
treatment for OUD.
    We received a number of public comments on the duration of the
bundled payment. The following is a summary of the comments we received
and our responses.
    Comment: Many commenters supported the proposal to define an
episode of care as a 1-week (contiguous 7-day) period, while several
commenters stated that a monthly episode of care may be more
appropriate in some circumstances, such as during the maintenance phase
of treatment, and a few commenters supported daily bundles because that
approach is more consistent with the payment structure under their
state Medicaid program. Many commenters were supportive of our decision
not to propose any maximum number of weeks for a course of treatment
for OUD.
    Response: While we recognize that the clinical needs of patients
may differ depending on their stage of treatment, we are finalizing our
proposal to define an episode of care as a 1-week (contiguous 7-day)
period. OTPs are generally familiar with weekly episodes and we believe
use of a weekly bundle will be less disruptive to the extent that an
OTP already has processes in place to bill for weekly episodes. We
recognize that patients receiving MAT are often on this treatment
regimen for an indefinite amount of time, and therefore, we are not
imposing any limit on the maximum number of weeks
[[Page 62641]]
during an overall course of treatment for OUD.
    After consideration of the public comments, we are finalizing our
proposal to define an episode of care as a 1-week (contiguous 7-day)
period at Sec.  410.67(b). We are not finalizing any limit on the
maximum number of weeks during an overall course of treatment for OUD.
(a) Requirements for an Episode
    In the proposed rule (84 FR 40525), we noted 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 recognized 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 explained that 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 proposed
that it could bill for a full weekly bundle. We proposed 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).
    Comment: Several commenters stated that the frequency of services
listed in the proposed rule for a typical case (we assumed one
substance use counseling session, one individual therapy session, and
one group therapy session per week and one toxicology test per month)
would usually only occur during the initial phase of treatment/
stabilization.
    Response: We reiterate that we understand that the frequency of
services will vary over time, and may be very different for a patient
in the initial phase of treatment compared to a patient in the
maintenance phase of treatment. We note that while we identified a set
of services for purposes of calculating the payment rate for the weekly
bundle, it is not a requirement for billing the bundled payment that
all of those services be furnished in a given episode of care. Rather,
as we discuss in more detail below, we are finalizing a policy under
which the threshold to bill for an episode of care will be that at
least one service was furnished to the patient during the week that
corresponds to the episode of care.
(b) Partial Episode of Care
    As we explained in the proposed rule, 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
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 proposed 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 proposed
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
proposed 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 noted our intent to monitor this issue and to consider the
need to make changes to this policy in future rulemaking to ensure that
the billing for partial episodes is not being abused. We proposed 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
solicited 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 solicited 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 the 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 solicited comment regarding whether any
other payers of OTP services allow for billing of partial bundles and
what thresholds they use.
    We received public comments on our proposal to create separate
coding and payment for partial episodes. The following is a summary of
the comments we received and our responses.
    Comment: Many commenters noted that determining the threshold for
when to bill the partial episode versus the full episode was
impractical, stating it would be cumbersome to implement and would
require far more frequent updating of the treatment plan than is
typical, especially since the frequency of services delivered can vary
significantly from week to week. Commenters also requested
clarification on how various services would count toward the 51 percent
threshold, and urged CMS to eliminate the partial bundled payment to
simplify billing and reduce confusion that could lead to billing
compliance issues. A few commenters stated that the total number of
services associated with a patient's treatment plan is not documented
in a way that would facilitate using the proposed threshold for billing
for a full bundle, and therefore, it would not be feasible for OTPs to
operationalize the proposed approach. Some commenters also noted that
operationalizing this approach would require them to obtain additional
administrative resources to track the services provided to each patient
in relation to their treatment plan in order to determine when the
threshold for billing for a full bundle is met. A few commenters stated
that applying partial episodes to the TRICARE bundled rate is
inconsistent with TRICARE's approach, which already accounts for
differences in treatment intensity in a single unified payment rate.
Others recommended that
[[Page 62642]]
CMS should not apply partial week payments, as the reduced resource
costs for some episodes are already reflected in the payment rate for
the full week bundle. A few commenters supported the concept of partial
episodes, but requested clarification about the billing threshold.
    Response: Based on the concerns raised by the commenters, we are
not finalizing partial episodes at this time. We understand that many
OTPs would need to change their documentation patterns to
operationalize the proposed threshold for determining when to bill a
full episode versus a partial episode and that having to make such
changes in a short amount of time could be burdensome and potentially
create barriers to providing care. In the interest of combating the
opioid crisis and in the best interest of beneficiaries, our goal is to
minimize barriers to OTPs enrolling in Medicare and beginning to
furnish services to Medicare beneficiaries. Accordingly, for CY 2020,
we are finalizing only the proposal to establish full weekly bundled
payments at Sec.  410.67(d)(2). The threshold to bill a full episode
will be that at least one service was furnished (from either the drug
or non-drug component) to the patient during the week that corresponds
to the episode of care. We are finalizing this threshold at Sec.
410.67(d)(3). We note that we will be monitoring for abuse given this
lower threshold for billing for full weekly bundled payment. We also
note that we remain interested in implementing a payment policy for
partial episodes at some point in the future. We would establish the
policies to govern partial episodes through notice and comment
rulemaking, and we are interested in working with OTPs to explore how
such a policy would best be applied.
(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 as described in detail
below), we proposed 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 proposed to codify this non-drug episode of care at Sec.
410.67(d).
    We did not receive any comments on non-drug episodes of care, and
are finalizing the policies governing the use of non-drug episodes of
care in Sec.  410.67(d)(1)(iii).
(2) Drug and Non-Drug Components
    As discussed above, in establishing the bundled payment rates, we
proposed 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, in the proposed rule (84 FR 40526),
we stated our belief that the significant variation in the cost of
these drugs would need 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 proposed to base the OTP bundled payment rates,
in part, on the type of medication used for treatment. Specifically, we
proposed 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 proposed to create a category of bundled payment
describing a drug not otherwise specified to be used for new drugs (as
discussed further below). We also proposed a non-drug bundled payment
to be used when medication is not administered (as discussed further
below) noting that 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 proposed 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).
    We received public comments related to our proposal to establish
categories of OTP bundled payments based on the type of opioid agonist
and antagonist treatment medication used during the episode of care.
The following is a summary of the comments we received and our
responses.
    Comment: Several commenters submitted comments concerning our
proposal to base the OTP bundled payment rates, in part, on the type of
medication (that is, methadone (oral), buprenorphine (oral),
buprenorphine (injection), buprenorphine (implant), naltrexone
(injection)) used for treatment. A few commenters supported our
proposal to use the five medication categories. Another commenter
supported the medication categories but cautioned CMS to monitor and
evaluate drug pricing and availability to ensure the payments are
sufficient to cover the cost of medications. In contrast, another
commenter stated that the medications should not be bundled and that
the bundles, if used, were too broad. This commenter believed such an
approach would inhibit the ability of the health care provider to
choose the best treatment for a patient.
    Response: Section 1861(jjj)(1) of the Act defines OUD treatment
services to include certain opioid treatment medications furnished by
an OTP. Section 1834(w) of the Act instructs the Secretary to make a
bundled payment for these services. We do not believe the statute
supports unbundling the medications from the other OUD treatment
services furnished by OTPs. We defined the five medication categories
to represent the distinct types of covered OTP medications currently on
the market based on primary active ingredient, method of
administration, and cost. We believe these categories of bundled
payments 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 discuss our treatment of new drugs
below.
[[Page 62643]]
    Comment: One commenter urged CMS to clarify whether the naltrexone
bundled payment category referred to injectable or oral naltrexone.
    Response: The naltrexone drug product that is FDA-approved for the
treatment of opioid dependence is an extended-release, intramuscular
injection.\54\ The naltrexone bundled payment category refers to this
injectable product.
---------------------------------------------------------------------------
    \54\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
---------------------------------------------------------------------------
    Comment: A commenter brought to our attention the fact that
buprenorphine-only products are both FDA-approved and marketed for the
treatment of opioid dependence by generic manufacturers, whereas in the
proposed rule, we stated our understanding that all oral buprenorphine
products also contained naloxone as an active ingredient. The commenter
recommended that we clarify the definition of buprenorphine products to
note the inclusion of these products as well.
    Response: Upon further inspection, we have identified marketed
buprenorphine-only products. We have also reviewed the available
pricing for both the buprenorphine-only and the buprenorphine with
naloxone products and found them to be similar. We believe that
including both types of products in the same drug category for payment
purposes would not negatively impact patient access to either of these
two versions of buprenorphine. Therefore, we are clarifying that the
proposed ``Buprenorphine (oral)'' drug category includes both the
buprenorphine-only and buprenorphine-naloxone products that are
currently FDA-approved and marketed for the treatment of opioid
dependence.
    After consideration of the public comments, we are finalizing our
proposal to base the OTP bundled payment rates, in part, on the type of
medication used for treatment. These categories reflect those drugs
currently approved by the FDA under section 505 of the FFDCA for use in
treatment of OUD: that is, methadone (oral), buprenorphine (oral),
buprenorphine (injection), buprenorphine (implant), naltrexone
(injection)). We will 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 proposed that OTPs would
bill for the episode of care using the medication not otherwise
specified (NOS) code (HCPCS code G2075). In such cases, we proposed to
use the typical or average maintenance dose to determine the drug cost
for the new bundle. We also proposed that pricing would be determined
based on the relevant pricing methodology (described in section II.G.3.
of this final 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 proposed 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 proposed to use ASP-based payment
when we receive manufacturer-submitted ASP data for these drugs. In the
event that we do not receive manufacturer-submitted ASP pricing data,
we considered several potential pricing mechanisms (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 did not propose
a specific pricing mechanism for the situation in which we do not
receive manufacturer-submitted ASP pricing data, but solicited public
comment on several potential approaches for estimating the acquisition
cost and payment amounts for these drugs. 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 proposed to use
invoice pricing until either ASP pricing data or the information
necessary to apply the chosen alternate pricing methodology becomes
available to price the medication. We proposed 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 we
have the opportunity to consider through rulemaking establishing a
unique bundled payment for episodes of care during which the new drug
is furnished. We solicited comments on this proposed approach to the
treatment of new drugs used for MAT in OTPs.
    We received public comments on the proposals related to new drugs.
The following is a summary of the comments we received and our
responses.
    Comment: A few commenters generally supported coverage of new FDA-
approved medications for OUD. One commenter noted that a flexible
approach to innovative therapies to treat OUD is critical to ensure
that Medicare beneficiaries have access to all FDA-approved therapies
that best meet their needs.
    Response: We believe that our proposal to allow providers to bill
using a medication NOS code would offer OTPs the flexibility to provide
beneficiaries with quick access to new FDA-approved medications for OUD
until we have the opportunity to consider through rulemaking
establishing a unique bundled payment for episodes of care during which
the new drug is furnished.
    Therefore, we are finalizing our proposal to allow OTPs to bill for
an episode of care using the medication not otherwise specified (NOS)
code (HCPCS code G2075) 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. In
such cases, the typical or average maintenance dose would be used to
determine the drug cost for the new bundle, which contractors would
then add to the non-drug component payment amount that corresponds with
the relevant payment for drug administration (oral, injectable, or
implantable) to determine the total bundled payment for the episode of
care. We are also finalizing our proposal that pricing would be
determined based on the relevant pricing methodology as described in
section II.G.3. of this final rule or through invoice pricing in the
event the information necessary to apply the relevant pricing
methodology is not available. We are codifying this approach for
determining the amount of the bundled payment for episodes of care with
new medications in Sec.  410.67(d)(2)(i)(C).
    As discussed above, we also solicited 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
[[Page 62644]]
context of OUD treatment services provided by OTPs. Additionally, we
solicited 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.
    We did not receive any comments on the pricing of new drugs with a
novel mechanism of action. We intend to monitor for the development of
such new drugs for the treatment of OUD, and may consider this topic
further in future rulemaking.
(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 proposed to
define as the FDA-approved opioid agonist and antagonist treatment
medications, the 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), 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 SAMHSA 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 the SAMHSA 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. We did not receive comments on our proposal to
include counseling, therapy, toxicology testing, and drug
administration in the non-drug component of the bundle.
ii. Other Services
    As discussed in the CY 2020 PFS proposed rule, we proposed 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
solicited 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. We noted that 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 would be necessary. As discussed above,
we received comments that were supportive of creating add-on payment
adjustments for intake activities and periodic assessments, and we are
finalizing including intake activities and periodic assessment in the
definition of OUD treatment services.
(3) Adjustment to Bundled Payment Rate for Additional Counseling or
Therapy Services
    In addition to the items and services that we proposed to include
in the bundles, we recognized 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. In
developing our policies for the proposed rule, we sought to ensure that
patients have access to these needed services. Accordingly, we proposed
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, in the proposed
rule, we assumed that a typical case might include one substance use
counseling session, one individual therapy session, and one group
therapy session per week. As we explained in the proposed rule, we
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 explained
that we expect the medical necessity for billing the add-on code would
be documented in the medical record. The proposed add-on code would
reflect each additional 30 minutes of counseling or group or individual
therapy furnished in a week of MAT, and could be billed in conjunction
with the codes describing the full episode of care. For example,
[[Page 62645]]
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. We acknowledged that an unintended
consequence of using the treatment plan to determine when billing of
the add-on code would be permissible 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 indicated that we expect OTPs will ensure that treatment plans
reflect the full scope of services expected to be furnished during an
episode of care and will update treatment plans regularly to reflect
changes. We noted that we intend to monitor this issue and would
consider making changes to this policy through future rulemaking if
necessary to ensure that this payment adjustment is not being billed
inappropriately. We solicited comments on the add-on code and the
threshold for billing. We proposed to codify this adjustment to the
bundled payment rate for additional counseling or therapy services in
Sec.  410.67(d)(3)(i).
    We received several comments on our proposed adjustment to the
bundled payment rate for additional counseling or therapy services. The
following is a summary of the comments we received and our responses.
    Comment: Many commenters supported our proposal to create an add-on
G-code to adjust the bundled payment rate for additional counseling or
therapy services furnished. Several commenters stated that the number
of therapy and counseling services described in the proposed rule
usually only occurs during the initial stages of treatment and a few
commenters stated that patients with that level of need in a given week
may be referred for more intensive treatment, such as Intensive
Outpatient (IOP) treatment. Some commenters noted the variation in
payment rates for counseling across various state Medicaid programs and
a few commenters suggested that we use HCPCS code G0396 as a reference
code in valuing the payment rate for the counseling add-on code.
    Response: After consideration of the public comments, we are
finalizing our proposal to establish an add-on code to describe an
adjustment to the bundled payment when additional counseling or therapy
services are furnished. This add-on payment is codified in the
regulations at Sec.  410.67(d)(4)(i)(A). The payment rate we are
finalizing for this add-on payment is discussed in more detail later in
this final rule. This add-on code may be billed when counseling or
therapy services are furnished that substantially exceed the amount
specified in the patient's individualized treatment plan. OTPs will be
required to document the medical necessity for these services in the
patient's medical record. Additionally, we note that we understand the
frequency with which counseling and therapy services are furnished will
vary over time for each individual patient and will often decrease over
time as a patient stabilizes. Nevertheless, we believe it is important
to acknowledge that some patients will require more intensive
counseling and therapy services at certain times during their treatment
and to establish a payment methodology under which OTPs may receive
payment for furnishing these medically necessary services.
(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 proposed 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
believed this would be an appropriate approach because, as discussed
previously, we expected 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 federally-designated geographic health professional
shortage areas would be able to facilitate treatment through virtual
care coming from an urban or other external site; however, we noted
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 noted 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, we
indicated that the restrictions of section 1834(m) of the Act would not
apply. Additionally, we noted 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 proposed to include language in Sec.  410.67(b) in the
definition of OUD 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 solicited comment as to
whether the proposal, including the furnishing of these services
through communication technology, would be clinically appropriate. We
also solicited public comment on other components of the bundle that
may be clinically appropriate to be furnished via communication
technology, while considering SAMHSA's guidance that OTPs should pay
exceptional attention to data security and privacy.
    We received public comments on the proposal to include substance
use counseling and individual and group therapy services furnished
using telecommunications technology in the definition of OUD treatment
services. The following is a summary of the comments we received and
our responses.
    Comment: Many commenters supported the proposal to allow OTPs to
use two-way interactive audio-video
[[Page 62646]]
communication technology, as clinically appropriate, in furnishing
substance use counseling and individual and group therapy services,
respectively. Several commenters noted that allowing the use of
communication technology in furnishing these services has the potential
to vastly expand OTPs' reach, particularly in underserved areas. A few
commenters urged CMS to afford OTPs maximum flexibility in how
telemedicine is deployed, such as allowing the provision of such
services regardless of whether or not the counselor or patient is
physically located at an OTP and noted that several states already
support less restrictive telemedicine practices. One commenter
recommended that CMS should also allow OTPs to furnish other important
medical services to beneficiaries via telecommunications, including:
Medication dose assessment and interactions, basic primary care, and
HIV and hepatitis C risk reduction. A few commenters requested
clarification as to whether a patient participating in individual and/
or group counseling could do so from their home or another location of
their choosing as opposed to a designated satellite location.
    Response: We are finalizing our proposal 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. In response to the requests for clarification
regarding where the beneficiary and practitioner can be located at the
time the service is furnished, we note that section 2001 of the SUPPORT
Act 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. Accordingly, consistent with this
policy, we believe it is appropriate to permit beneficiaries to receive
substance use counseling and individual group therapy services
furnished by an OTP using telecommunications technology in their home
or any other telehealth originating site, provided the requirements
that apply to telehealth services payable under the PFS after July 1,
2019, are met. In response to commenters who recommended that CMS
should allow OTPs to furnish other medical services to beneficiaries
via telecommunications, we note that SAMHSA and the DEA have
regulations related to OUD services furnished via telecommunications
that we would need further time to consider, but we may revisit this
recommendation in developing our policies for future rulemaking.
    After consideration of the public comments, we are finalizing our
proposal 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. We
are also finalizing our proposal to include substance use counseling
and individual and group therapy services furnished via two-way
interactive audio-video communication technology in the definition of
opioid use disorder treatment service in Sec.  410.67(b). We note that
as OTP services are not PFS services, no originating site facility fee
(HCPCS code Q3014) applies to OUD treatment services, and OTPs are not
authorized to bill for the originating site facility fee.
(5) Coding
    We proposed to adopt a coding structure for OUD treatment services
that would vary by the medication administered. To operationalize this
approach, we proposed 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 proposed to
establish partial episode G codes to correspond with each of those
bundles, respectively. Additionally, we proposed to create an add-on
code to describe additional counseling that is furnished beyond the
amount specified in the patient's treatment plan. We also noted that
were we to finalize including intake activities and periodic
assessments in the definition of OUD treatment services, we welcomed
feedback on whether we should consider modifying the payment associated
with the bundle or creating add-on codes for services such as the
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 CLFS. For
example, we noted that 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 welcomed 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 noted 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 proposed that the codes describing the
bundled payment for an episode of care or partial episode of care with
a medication not otherwise specified 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 noted 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
[[Page 62647]]
potential for misuse of a medication not otherwise specified code, we
also welcomed comments as to whether this code was needed.
    See Table 18 for a list of the HCPCS codes for the weekly bundles
that we are finalizing (G2067-G2075). We proposed that only an entity
enrolled with Medicare as an OTP could bill these codes. Additionally,
we proposed 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.
    We received many comments related to coding and payment for OTP
services. The following is a summary of the comments we received and
our responses.
    Comment: As described previously, many commenters supported the
inclusion of intake activities, such as the initial physician
examination, initial assessment and preparation of a treatment plan, as
well as periodic assessments in the definition of OUD treatment
services. Many commenters suggested that we create add-on codes to
describe these services, and several commenters specifically suggested
that we use CPT codes 99204 and 99214 as reference codes for pricing
the intake and periodic assessment add-ons, respectively. A few
commenters recommended that CMS work with OTPs and/or SAMHSA to
determine whether an add-on for periodic assessments would sufficiently
cover the needs of pregnant and postpartum women who seek care at OTPs.
    Response: As discussed above, we are finalizing including intake
activities and periodic assessment in the definition of OUD treatment
services. It is our understanding that these services are furnished
much less frequently than the other services included in the weekly
bundled payments; therefore, we are creating add-on G-codes to describe
these services, which will allow us to make more targeted payments for
these services. We note that the add-on code describing intake
activities should only be billed for new patients (that is, patients
starting treatment at the OTP). We agree with the commenters that the
level 4 office/outpatient E/M visits are a good approximation of the
services provided at intake and during periodic assessments at OTPs
based on the expected acuity of patients with OUD receiving services at
OTPs, who are likely to have multiple co-morbidities and present with
problems that are of moderate to high severity and require medical
decision making of moderate complexity. Therefore, we are pricing the
add-on code describing intake activities using CPT code 99204 (Office
or other outpatient visit for the evaluation and management of a new
patient, which requires these 3 key components: A comprehensive
history; A comprehensive examination; Medical decision making of
moderate 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
moderate to high severity. Typically, 45 minutes are spent face-to-face
with the patient and/or family) as a reference code, which is assigned
a CY 2019 non-facility rate of $166.86 under the PFS in addition to
accounting for one toxicology test furnished at intake, using CPT code
80305 (Drug test(s), presumptive, any number of drug classes, any
number of devices or procedures; capable of being read by direct
optical observation only (e.g., utilizing immunoassay [e.g., dipsticks,
cups, cards, or cartridges]), includes sample validation when
performed, per date of service) as a reference code, which is assigned
a rate of $12.60 under the CLFS in CY 2019. Therefore, we summed those
two amounts to calculate the total payment rate for the add-on code
describing intake activities, which is $179.46. Similarly, we are
pricing the add-on code describing periodic assessments using CPT code
99214 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires at least 2 of
these 3 key components: A detailed history; A detailed examination;
Medical decision making of moderate 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 moderate to high severity. Typically, 25
minutes are spent face-to-face with the patient and/or family) as a
reference code, which is assigned a CY 2019 non-facility rate of
$110.28 under the PFS. The medical services described by these add-on
codes could be furnished by a program physician, a primary care
physician or an authorized healthcare professional under the
supervision of a program physician or qualified personnel such as nurse
practitioners and physician assistants. The other assessments,
including psychosocial assessments could be furnished by practitioners
who are eligible to do so under their state law and scope of licensure.
Additionally, we note that the add-on code describing periodic
assessments could be billed for each periodic assessment performed for
patients that require multiple assessments during an episode of care,
such as patients who are pregnant or postpartum. We note that in order
to bill for the add-on code, the services would need to be medically
reasonable and necessary and that OTPs should document the rationale
for billing the add-on code in the patient's medical record. We also
plan to monitor utilization of the periodic assessment add-on code
given program integrity concerns about overutilization, and may
consider further refinements in future rulemaking.
    Comment: Several commenters supported the creation of add-on codes
to account for more frequent presumptive testing, including presumptive
testing using instrumented chemistry analyzers, and for definitive
testing. Several commenters highlighted the differences between
presumptive and definitive tests, stating that CPT code 80305 describes
a presumptive screen test by Dipstick or Point of Care rapid test cup,
and noted that there is a significant difference in the payment rate
for this code compared to the codes describing definitive drug testing.
Several commenters requested that CMS set a rate that encompasses
medically-appropriate testing frequencies, but also addresses the
complexity of testing, noting that that the presumptive screening test
uses limited technology and should not be relied upon by clinicians for
providing true actionable and reliable information and stated that a
bundled rate that includes only a crosswalk to a point-of-care rapid
test will severely impact patient care. A few commenters noted that
most basic drug tests will not detect Fentanyl and that failure to
properly identify Fentanyl may place patients' lives at risk, and
therefore, recommended that CMS consider referencing the current CLFS
rates for codes HCPCS codes G0480-G0483, which describe definitive drug
testing. A few commenters noted that point of care immunoassay testing
is rarely able to detect methadone or buprenorphine and can never
detect naltrexone and, if methadone or buprenorphine is detected, the
immunoassay is unable to determine whether the patient is compliant or
is adulterating the urine sample. In contrast, definitive testing is
appropriate for detecting all of the drugs used for MAT therapy.
    Response: We find the commenters' arguments that both higher level
presumptive tests and definitive tests
[[Page 62648]]
can be clinically appropriate in the treatment of OUD to be compelling.
Further, we want to avoid creating financial disincentives that would
prevent OTPs from furnishing medically-necessary care. Accordingly, we
are building into the bundled payments both presumptive and definitive
testing. We understand from commenters that while SAMHSA requires at
least 8 toxicology screenings per year per patient, toxicology
screening is frequently done more often, including up to weekly in new
patients and that this is most frequently presumptive testing, but in
more rare circumstances definitive testing is also performed. Thus, in
consideration of what we believe might be an average case, we are
assuming that beneficiaries will receive an average of two presumptive
tests and one definitive test per month.
    We priced the presumptive test based on the CLFS rate for CPT code
80305, which is $12.60, and then prorated that amount by dividing that
rate by 2 to reflect the presumption that this type of testing would be
furnished only twice a month. We priced the definitive test based on
the CLFS rate for HCPCS code G0480, which is $114.43 and then prorated
that amount by dividing that rate by 4 to reflect our presumption that
this type of testing would be furnished once a month. Additionally, we
note that we interpret the statute to require that all toxicology
testing furnished by the OTP must be included in the bundled payment or
adjustments to the bundled payment and could not be billed separately
under the CLFS. We have elected to build the payment for these tests
into the weekly bundled rates, rather than creating add-on codes, in
order to avoid creating an incentive to furnish testing more frequently
than needed. However, as OTPs begin to bill Medicare, if we find that
there is an issue with beneficiaries receiving access to medically-
necessary definitive testing, we may consider making changes to how
these tests are paid through future rulemaking.
    Comment: Several commenters stated that OTPs often provide case
management and/or care management services and requested that CMS
consider reimbursing for these services either as part of the standard
bundle or as an adjustment to the bundled payment, as applicable. A few
commenters stated that OTPs serve as a fixed point of responsibility in
the provision of whole person-centered care and improving health
outcomes through collaborative arrangements with health care providers
outside of the OTP and that the goal of care management is to reduce
health care costs, specifically preventable hospital admissions,
readmissions, and avoidable emergency room visits. The commenters also
stated that OTP staff also help patients with accessing food benefits,
housing, and employment searches, which are critical components for
sustained recovery, as part of case management.
    Response: We appreciate the feedback and note that we would like to
work with OTPs to better understand how these services are furnished in
the OTP setting and, as noted previously, we are interested in
continued feedback and data on the specific items and services,
including their frequency, furnished to beneficiaries by an OTP. We may
consider making payment for case management/care management activities
in future rulemaking.
    We note that the definition of OUD treatment services described in
this final rule would need to be revised in future rulemaking to
include any such additional items and services.
    Comment: A few commenters requested that CMS clarify whether the
proposed billing codes could be used when a patient is undergoing
detoxification in an OTP and some commenters requested a separate code
describing a bundled payment for the costs associated with medications
for medically-supervised management of opioid withdrawal, as well as
counseling and toxicology testing. One commenter requested guidance to
clarify how OTPs could bill for a ``naloxone challenge test'' prior to
initiation of treatment with Vivitrol (naltrexone for extended-release
injectable suspension).
    Response: We note that there is no specified dosage required for
billing the bundled payments, so if a patient is tapering off methadone
or buprenorphine while undergoing detoxification, the bundled payments
describing those drugs may be used if the requirements for billing are
satisfied and the non-drug bundle could be billed during any time that
the patient is not being dispensed or administered a covered OUD
treatment medication. We may consider for future rulemaking whether
additional coding or payment changes are needed with respect to
detoxification or the provision of naloxone.
    Comment: Several commenters requested clarification related to how
take-home dosages of medication should be billed. A few commenters
noted that the proposed definition of a partial episode does not
account for patients who have earned take-home dose privileges and as a
result may only attend the OTP once or twice in a month.
    Response: We agree with the commenters that additional coding is
required to accurately account for the costs associated with providing
a patient with take-home doses of medication. Accordingly, we are
finalizing two codes to describe adjustments to the bundled payments,
one for take-home supplies of methadone, which describes up to 7
additional days of medication, and can be billed along with the
respective weekly bundled payment in units of up to 3 (for a total of
up to a one month supply), and one for take-home supplies of oral
buprenorphine, which also describes up to 7 additional days of
medication and can be billed along with the base bundle in units of up
to 3 (for a total of up to a 1 month supply). We note that SAMHSA
allows a maximum take-home supply of one month of medication;
therefore, we do not expect the add-on codes describing take-home doses
of methadone and oral buprenorphine to be billed any more than 3 times
in one month (in addition to the weekly bundled payment). We also note
that the add-on code for take-home doses of methadone can only be used
with the methadone weekly episode of care code (HCPCS code G2067).
Similarly, the add-on code for take-home doses of oral buprenorphine
can only be used with the oral buprenorphine weekly episode of care
code (HCPCS code G2068). We are pricing the add-on code describing
take-home supplies of methadone, HCPCS code G2078, based on the payment
rate for the drug component for the weekly bundle describing treatment
with methadone ($35.28) and we are pricing the add-on code describing
take home supplies of buprenorphine, HCPCS code G2079, based on the
payment rate for the drug component for the weekly bundle describing
treatment with oral buprenorphine ($86.26).
    Comment: Several commenters requested clarification related to how
the bundled payment codes should be billed in a variety of situations.
A few commenters specifically requested clarification on how ``guest
dosing'' should be billed and others inquired as to whether prior
authorization would be required.
    Response: In response to comments seeking clarification about the
threshold to bill the partial vs. the full episodes, as noted above, we
are finalizing only full episodes at this time and will consider
partial episodes for future rulemaking. Additionally, as noted above,
we are finalizing a number of add-on G codes to describe adjustments
[[Page 62649]]
to the bundle. Specifically, we are creating add-on codes for intake
activities, periodic assessments, take-home supplies of methadone, take
home supplies of oral buprenorphine, and additional counseling
furnished. We note that some of the bundled payment codes describe a
drug that is typically only administered once per month, such as the
injectable drugs, or once in a 6-month period, in the case of the
buprenorphine implants. In those cases, the code describing the bundled
payment that includes the cost of the drug would be billed during the
week that the drug is administered, and if at least once service is
furnished in a subsequent week, the non-drug bundle would be billed.
For example, in the case of a patient receiving injectable
buprenorphine, we would expect that HCPCS code G2069 would be billed
for the week during which the injection was administered and that HCPCS
code G2074, which describes a bundle not including the drug, would be
billed during any subsequent weeks that at least one non-drug service
is furnished until the injection is administered again, at which time
HCPCS code G2069 would be billed again for that week. We note that as
HCPCS codes G2067-G2075 cover episodes of care of 7 contiguous days, we
will not permit an OTP to bill any of these codes for the same
beneficiary more than once per 7 contiguous day period. Additionally,
consistent with FDA labelling, we do not generally expect the codes
describing bundled payments including the injectable drugs (HCPCS codes
G2069 and G2073) to be furnished more than once every 4 weeks.
Similarly, consistent with FDA labelling, we do not generally expect
the codes describing bundled payments including insertion of the
buprenorphine implants (HCPCS codes G2070 and G2072) to be furnished
more than once every 6 months.
    However, we do understand there are limited clinical scenarios when
a beneficiary may be appropriately furnished OUD treatment services at
more than one OTP within a 7 contiguous day period, such as for guest
dosing or when a beneficiary transfers care between OTPs. We note that
in these limited circumstances, each of the involved OTPs may bill the
appropriate HCPCS codes that reflect the services furnished to the
beneficiary. We expect that both OTPs involved would provide sufficient
documentation in the patient's medical record to reflect the clinical
situation and services provided. We will be monitoring the claims data
to ensure that this flexibility is not being abused. Additionally, in
instances in which a patient is switching from one drug to another, the
OTP should only bill for one code describing a weekly bundled payment
for that week and should determine which code to bill based on which
drug was furnished for the majority of the week. In response to
commenters who requested clarification regarding prior authorization,
we note that we did not propose, and are not finalizing any prior
authorization requirements for services furnished in OTPs, as our goal
is not to restrict access to necessary care.
    The codes and long descriptors for the OTP bundled services and
add-on services we are finalizing are:
     HCPCS code G2067: 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 G2068: 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 G2069: 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 G2070: 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 G2071: 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 G2072: 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 G2073: 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 G2074: 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 G2075: 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 G2076: Intake activities, including initial
medical examination that is a complete, fully documented physical
evaluation and initial assessment conducted by a program physician or a
primary care physician, or an authorized healthcare professional under
the supervision of a program physician or qualified personnel that
includes preparation of a treatment plan that includes the patient's
short-term goals and the tasks the patient must perform to complete the
short-term goals; the patient's requirements for education, vocational
rehabilitation, and employment; and the medical, psycho-social,
economic, legal, or other supportive services that a patient needs,
conducted by qualified personnel (provision of the services by a
Medicare-enrolled Opioid Treatment Program); List separately in
addition to code for primary procedure.
     HCPCS code G2077: Periodic assessment; assessing
periodically by qualified personnel to determine the most appropriate
combination of services and treatment (provision of the services by a
Medicare-enrolled Opioid Treatment Program); List separately in
addition to code for primary procedure.
     HCPCS code G2078: Take-home supply of methadone; up to 7
additional day supply (provision of the services by a Medicare-enrolled
Opioid Treatment
[[Page 62650]]
Program); List separately in addition to code for primary procedure.
     HCPCS code G2079: Take-home supply of buprenorphine
(oral); up to 7 additional day supply (provision of the services by a
Medicare-enrolled Opioid Treatment Program); List separately in
addition to code for primary procedure.
     HCPCS code G2080: 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.
    Finally, we proposed that only an entity enrolled with Medicare as
an OTP could bill these codes. Additionally, we proposed 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. We did not receive comments on these proposals, and are
finalizing both these proposals.
(6) Payment Rates
    We proposed that the codes describing the OTP bundled services
(HCPCS codes G2067-G2075) would be assigned flat dollar payment
amounts, as listed in Table 18. 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 section 1848 of the Act. Because OUD treatment services are not
considered physicians' services and are paid outside the PFS, we
indicated that 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 proposed 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 the 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 proposed to use the typical or average maintenance dose to
determine the drug costs for each of the 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 proposed
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
solicited 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 solicited
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 noted that the bundled payment
rates were intended to be comprehensive with respect to the drugs
provided; therefore, we did 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 did not anticipate to be significant in the OTP setting.
    We received several comments on our proposal to use typical
maintenance dosage levels to calculate payment rates.
    Comment: One commenter expressed concern over the proposal to use
average maintenance doses to determine the drug cost component of the
bundled payment. This commenter noted that TRICARE explicitly rejected
this approach for buprenorphine and naltrexone due to significant
variation in the dosage and frequency of administration for these
drugs; and, instead, suggested an alternative methodology that would
more appropriately account for variations in the clinical needs of
patients.
    Response: While the TRICARE payment rates for OTP services were
considered in determining the Medicare payment for OTP services, we
note that section 1834(w)(2) of the Act expressly directs the Secretary
to implement the Medicare OTP benefit using one or more payment
bundles. We recognize that there may be some variation in the dosage
and frequency of administration of these medications. Some
beneficiaries may receive a larger than average dose, while other
beneficiaries will receive a smaller than average dose; but payment
based on the typical dose means that, across the Medicare beneficiaries
served by the OTP, the payment amount should be reasonable and
represent the average costs incurred in furnishing the drug component
of the OUD treatment services. We believe the proposal to use the
typical maintenance dosages is a reasonable approach to address the
variable dosing of these medications within the statutory direction to
implement this payment through one or more bundles.
    Comment: Most commenters agreed that the proposed 100 mg daily dose
for methadone was reasonable. A couple of commenters also agreed with
the proposed typical maintenance dosages of 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.
However, several commenters stated that the proposed typical
maintenance dosage for oral buprenorphine of 10 mg is too low. A few
commenters suggested that there is evidence indicating that higher
doses of buprenorphine are associated with better treatment retention.
Other commenters stated that OTP patients respond better to a higher
dosing level of oral buprenorphine, in part, because they tend to have
a longer history of opioid abuse. Commenters suggested potential
alternative dosages ranging from 12-20 mg. Several commenters suggested
setting the typical maintenance dosage for oral buprenorphine at 16 mg
per day. One commenter noted this dosage is supported by SAMHSA's
Treatment Improvement Protocol (TIP) 63 (located at https://store.samhsa.gov/system/files/sma18-5063fulldoc.pdf). In addition,
while a few commenters stated that the 100 mg monthly dose for the
extended-release buprenorphine injection was the appropriate
maintenance dose, some commenters noted it would not adequately account
for the first 2 months of treatment at the higher dose of 300 mg per
month. Another commenter stated that there was
[[Page 62651]]
evidence indicating certain patients would require longer treatment
with the higher dose of the extended-release buprenorphine injection
and that the FDA label instructions allowed consideration of increasing
the maintenance dose to 300 mg monthly for patients in which the
benefits outweigh the risk. One commenter stated that CMS would need to
better define how the average maintenance dose was calculated in order
to allow for comment on the methodology.
    Response: We disagree with the commenter who stated that there was
insufficient detail provided in the proposed rule in order to comment
on the proposed average maintenance doses. As we described in the
proposed rule, we identified the typical maintenance dose for each
medication using the FDA-approved prescribing information or through a
review of the published, preferably peer-reviewed, literature. We also
included a reference in the proposed rule to each of the sources used
to identify the typical maintenance doses.
    We note that, as the HCPCS codes for the extended-release
buprenorphine injection (that is, Q9991: Buprenorphine XR 100 mg or
less and Q9992: Buprenorphine XR over 100 mg) have the same payment
rate; therefore, we do not believe that it is necessary to establish a
second typical maintenance dose to calculate the payment rate for this
drug. However, we agree that the typical maintenance dosage for oral
buprenorphine should be set higher than the proposed 10 mg. The range
offered by commenters was between 12 mg and 20 mg, with a 16 mg per day
dose receiving the most support. We also note that SAMHSA's TIP 63 and
the FDA labeling support a target dosage of 16 mg for maintenance
treatment.\55\
---------------------------------------------------------------------------
    \55\ See https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022410s038lbl.pdf.
---------------------------------------------------------------------------
    After consideration of the public comments, we are finalizing our
proposal to use the typical maintenance dosages to calculate payment
rates for the drug component of the weekly bundles (that is, a 100 mg
daily dose for methadone, 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) except that
the payment rate for the drug component of the oral buprenorphine
bundle will be calculated using a typical maintenance dose of 16 mg
daily, rather than a 10 mg dose.
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
proposed 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 did not believe that a cost-to-charge ratio based on
such reported information could be available for a significant period
of time. Furthermore, we explained that 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,
we proposed 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 another more direct assessment of drug acquisition cost;
however, we also noted that we intended to continue to explore
alternate ways to gather this information. As described in greater
detail below, we proposed that the payment amounts for the drug
component of the bundles be based on CMS pricing mechanisms currently
in place. We solicited 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
proposed to include in the OTP bundled payments and for which we do not
receive manufacturer-submitted ASP data, we explained that we were
considering several potential approaches for determining the payment
amounts for the drug component of the bundles. Although we did not
propose a specific pricing mechanism, we solicited comments on several
different approaches, and stated that we intended 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 began by breaking the
drugs into two categories based on their current coverage and payment
by Medicare. First, we discussed the injectable and implantable drugs,
which are generally covered and paid for under Medicare Part B, and
then discussed the oral medications, which are generally covered and
paid for under Medicare Part D.\56\ Buprenorphine (injection),
buprenorphine (implant), and naltrexone (injection) would fall into the
former category and methadone and buprenorphine (oral) would fall into
the latter category.
---------------------------------------------------------------------------
    \56\ 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
[[Page 62652]]
example, the Hospital Outpatient Prospective Payment System
(OPPS)).\57\
---------------------------------------------------------------------------
    \57\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
---------------------------------------------------------------------------
    In most cases, payment using the methodology in section 1847A of
the Act means payment is determined 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 \58\ 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 for 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.
---------------------------------------------------------------------------
    \58\ 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 \59\ or average manufacturer price (AMP)-based price substitutions
as authorized under section 1847A(d) of the Act \60\. 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.\61\ We
also use current AWP to make payment under the OPPS for very new drugs
without an ASP.\62\ 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.\63\
---------------------------------------------------------------------------
    \59\ See 75 FR 73465-73466, the section titled Partial Quarter
ASP data.
    \60\ See 77 FR 69140.
    \61\ Section 1842(o)(1)(A)(iv) of the Act.
    \62\ 80 FR 70426 and 80 FR 70442-3; Medicare Claims Processing
Manual 100-04, Chapter 17, Section 20.1.3.
    \63\ 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 for
more expensive drugs.\64\ 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.\65\
---------------------------------------------------------------------------
    \64\ See MedPAC Report to the Congress: Medicare and the Health
Care Delivery System June 2015, pages 65-72.
    \65\ Ibid.
---------------------------------------------------------------------------
    We proposed 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 proposed 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 explained our belief that limiting the add-on
would incentivize the use of the most clinically appropriate drug for a
given patient. In addition, we noted that it was our understanding that
many OTPs purchase directly from drug manufacturers, thereby limiting
the markup from distribution channels. We also proposed 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. We noted that the quarterly ASP Drug
Pricing Files include ASP plus 6 percent payment amounts.\66\
Accordingly, we adjusted 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. The proposed payment rates can be found
in Table 15 of the CY 2020 PFS proposed rule (84 FR 40537). We proposed
to codify the ASP payment methodology for the drug component of weekly
bundles that include implantable or injectable medications at Sec.
410.67(d)(2). We solicited public comment on the 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.
---------------------------------------------------------------------------
    \66\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
---------------------------------------------------------------------------
    We received several comments on our proposals regarding pricing of
Part B drugs. The following is a summary of the comments received and
our responses.
    Comment: Several commenters expressed concern regarding the
proposal 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 and to limit the payment amounts to 100 percent of the
volume-weighted ASP for a code instead of 106 percent of the volume-
weighted ASP for a code. (We note that a similar proposal for setting
the payment rates for the oral OTP drugs follows and that several of
the comments we received did not specifically reference which group of
drugs they were addressing; therefore, we have included a discussion of
these comments under both sections.) A few commenters supported the
proposal, reasoning that ASP provides a transparent and public
benchmark that would allow monitoring for unexpected and unnecessary
price changes by manufacturers.
    Several other commenters expressed concerns about the proposal to
price the Part B injectable and implantable drugs used in the bundle
using the ASP without the 6 percent add-on. Commenters noted that the
add-on is a necessary part of the payment to account for items such as
overhead costs and/or additional mark-ups in the traditional drug
distribution channels that are not captured in the manufacturer-
reported ASP. A few commenters stated that the 6 percent
[[Page 62653]]
add-on would allow the OTP to recoup costs associated with rigorous
storage and inventory tracking systems required by the DEA. These
commenters also stated that the large OTPs, hospitals, and physician
systems could skew ASP lower than the prices that smaller or rural OTPs
could negotiate on their own. One commenter expressed concerns that
OTPs might not be able to afford Part B drugs without the add-on to
cover these costs, and suggested a cautious approach to ensure the
success of these programs. A few commenters noted that the proposal to
price Part B drugs using ASP without the 6 percent add-on would provide
a disincentive for an OTP to utilize the most appropriate product for
the patient in order to limit their cost of care. Some commenters
objected to CMS' statement in the proposed rule that limiting the 6
percent add-on would incentivize the use of the most clinically
appropriate drug for a given patient asserting that the 6 percent add-
on does not provide an incentive to choose high-cost treatment
inappropriately because physicians do not profit from administering
Part B drugs under the ASP methodology. Several commenters also
questioned CMS' legal authority to limit the payment amount for these
drugs to 100 percent of the ASP.
    Response: We thank the commenters for their feedback on our
proposal to set the payment amounts for ``incident to'' drugs at 100
percent of the volume-weighted ASP. We agree that use of ASP provides a
transparent and public benchmark for manufacturers' pricing as it
reflects the manufacturers' actual sales prices to all purchasers (with
limited exceptions) and is the only pricing methodology that includes
off-invoice rebates and discounts as described in section 1847A(c)(3)
of the Act. For this reason, we believe the ASP to be the most market-
based approach to set drug prices for the OTP bundled payments.
    As noted above, section 1834(w) of the Act grants the Secretary
significant discretion to establish bundled payment rates for OUD
treatment services. The statute does not dictate the use of any
specific methodology, such as the methodology in section 1847A of the
Act, in setting the payment rate for the drug component of the bundled
payments. Therefore, we do not agree with the comments that indicated
CMS has a legal obligation to include the 6 percent add-on when using
ASP to determine the payment rate for the drug component of the bundled
payments to OTPs for OUD treatment services.
    As noted in the proposed rule, we understand that many OTPs
purchase medications directly from drug manufacturers, thereby limiting
the markup from distribution channels. We received this information
during a routine informational industry call with OTP advocates in
preparation for drafting the proposed rule. We also note that this fact
was not challenged by any of the commenters. Furthermore, we do not
believe the record-keeping or storage requirements noted are unique to
OTPs. In fact, the selection of drugs purchased by most OTPs is quite
limited, which theoretically limits the utility of third-parties, such
as wholesalers, and their associated costs and increases the purchase
volume for OTPs and accompanying manufacturer discounts. We believe
that this situation could lend itself to an OTP drug channel for
purchasing at discounted rates either directly or through the use of
buying groups as is the standard in the pharmacy industry today.
Furthermore, we remain concerned that certain providers will look to
differential drug costs to determine which therapies to offer. As a
result, we believe that our proposed approach of paying for ``incident
to'' drugs based on ASP offers the most appropriate balance between
ensuring OTPs receive appropriate reimbursement for their drug
acquisition costs, while also preserving the incentive to use the most
clinically appropriate drug for the treatment of individual
beneficiaries.
    After consideration of the public comments, we are finalizing our
proposal 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 and to limit the payment amounts for these drugs to 100
percent of the volume-weighted ASP for a drug category or code. We are
codifying this policy in the regulations at Sec.  410.67(d)(2)(i)(A).
However, we continue to be interested in feedback regarding drug
acquisition costs for OTP providers, and in particular any drug
acquisitions that exceed these rates after factoring in discounts,
rebates, etc., and, if necessary, may revisit the payment methodology
for ``incident to'' OTP drugs in future rulemaking to ensure that OTPs'
drug acquisition costs are appropriately reimbursed.
iii. Oral Drugs
    We proposed 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 stated that we believe using the ASP
pricing data for oral OTP drugs currently covered under Part D \67\
would facilitate the computation of the estimated costs of these drugs.
However, we acknowledged that we do not collect ASP pricing information
under section 1927(b) of the Act for these drugs. We solicited 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.
---------------------------------------------------------------------------
    \67\ 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 proposed 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 that HCPCS code. We explained
our belief that limiting the 6 percent add-on would incentivize the use
of the most clinically appropriate drug for a given patient. In
addition, we explained our understanding that many OTPs purchase
directly from drug manufacturers, thereby limiting the markup from
distribution channels. We proposed 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. We noted that the quarterly ASP Drug Pricing Files include
ASP plus 6 percent payment amounts.\68\ 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. The proposed payment rates were provided in Table 15 of the
proposed rule. We proposed to codify the ASP payment methodology for
the drug component of weekly bundles that include an oral medication at
Sec.  410.67(d)(2)(i)(B). We solicited 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.
---------------------------------------------------------------------------
    \68\ 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 also considered several potential alternative 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.
[[Page 62654]]
We did not propose a specific pricing mechanism for these drugs at this
time, but solicited public comment on the following potential
approaches for estimating the acquisition cost and payment amounts for
these drugs and on alternative approaches. We noted that we would
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 payment 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 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.\69\ 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, 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.
---------------------------------------------------------------------------
    \69\ 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, we indicated that 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. We explained that 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 Prescription Drug Plan Finder data available at the drafting
of this CY 2020 PFS final rule. We noted 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,\70\ 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.\71\
---------------------------------------------------------------------------
    \70\ 82 FR 50742 through 50745.
    \71\ 75 FR 49142.
---------------------------------------------------------------------------
    In the proposed rule, we stated that we believe 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.\72\ 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.
---------------------------------------------------------------------------
    \72\ 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 solicited 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
proposed 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
[[Page 62655]]
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
noted that we believe 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. We noted that if we were to
select this option to estimate the cost of certain drugs, we would
develop pricing using the most recent data files available at the time
of drafting this 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
proposed 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 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), we believe 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. In the proposed rule, we explained that 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, we also noted that 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. We noted that if we were to
select this option to estimate the cost of certain drugs, we would
develop pricing using the most recent data files available at the time
of drafting this CY 2020 PFS final rule.
Alternative Methadone Pricing: TRICARE
    We also considered an approach for estimating the cost of methadone
using the amount calculated by TRICARE. As discussed above in this
section of this final rule, the TRICARE rates for medications used in
OTPs to treat OUD are spelled out in the 2016 TRICARE final rule (81 FR
61068); in the regulations at 32 CFR 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.\73\ 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.\74\
---------------------------------------------------------------------------
    \73\ 81 FR 61079.
    \74\ 81 FR 61079.
---------------------------------------------------------------------------
    We noted that this option would only be applicable for methadone
because TRICARE has developed a FFS payment methodology for
buprenorphine and naltrexone.\75\ 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.\76\ 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.\77\
---------------------------------------------------------------------------
    \75\ 81 FR 61080.
    \76\ 81 FR 61080.
    \77\ 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 stated that we believed that pricing methadone consistent with
the TRICARE payment rate could 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.'' \78\
---------------------------------------------------------------------------
    \78\ 81 FR 61080.
---------------------------------------------------------------------------
    We proposed 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)(i)(B). We solicited
[[Page 62656]]
public comment on the potential alternative approaches for estimating
the cost of oral drugs that we proposed 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 were set
forth in Table 14 of the proposed rule. We stated that we would
consider the comments received on these different approaches when
deciding on the approach that we would use to determine the payment
rates for oral drugs in the CY 2020 PFS final rule. We also solicited
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.
    We received several comments on our proposals regarding pricing of
oral drugs. The following is a summary of the comments received and our
responses.
    Comment: Several commenters submitted comments on the proposal to
use ASP-based payment to set the payment rates for the oral product
categories when we receive manufacturer-submitted ASP data for these
drugs and to limit the payment amounts for oral drugs to 100 percent of
the volume-weighted ASP instead of 106 percent of the volume-weighted
ASP. (We note that a similar proposal for the injectable and
implantable Part B drugs is discussed above and that several of the
comments we received did not specifically reference which group of
drugs they were concerning; therefore, we have included a discussion of
these comments under both sections.) A few commenters supported the
proposal, reasoning that ASP provides a transparent and public
benchmark that would allow monitoring for unexpected and unnecessary
price changes by manufacturers; and a couple of commenters encouraged
us to require manufacturers to report these data.
    Several other commenters expressed concerns about the proposal to
price the oral drugs used in the bundle using the ASP without the 6
percent add-on. Commenters stated that the add-on is a necessary part
of the payment to account for things such as overhead costs and/or
additional mark-ups in the traditional drug distribution channels that
are not captured in the manufacturer-reported ASP. A few commenters
stated that the 6 percent add-on would allow the OTP to recoup costs
associated with rigorous storage and inventory tracking systems
required by the DEA. These commenters also stated that large OTPs,
hospitals, and physician systems could skew ASP lower than the prices
that smaller or rural OTPs could negotiate on their own. One commenter
expressed concerns that OTPs might not be able to afford the oral drugs
used in MAT without the add-on to cover these costs, and suggested that
the Administration should be overly cautious to ensure success of these
programs. Some commenters expressed concerns that this proposal would
provide a disincentive for an OTP to utilize the most appropriate
product for the patient to limit their cost of care. Several commenters
also questioned CMS' legal authority to limit the payment amount for
these drugs to 100 percent of the ASP.
    Response: We thank the commenters for their feedback on our
proposal to use ASP-based payment to set the payment rates for the oral
product categories when we receive manufacturer-submitted ASP data for
these drugs and to limit the payment amounts for oral drugs to 100
percent of the volume-weighted ASP instead of 106 percent of the
volume-weighted ASP. We agree that use of ASP provides a transparent
and public benchmark for manufacturers' pricing as it reflects the
manufacturers' actual sales prices to all purchasers (with limited
exceptions) and is the only pricing methodology that includes off-
invoice rebates and discounts as described in section 1847A(c)(3) of
the Act. For this reason, we believe the ASP to be the most market-
based approach to set drug prices for the OTP benefit.
    As noted above, section 1834(w) of the Act grants the Secretary
considerable discretion to establish bundled payment rates for OUD
treatment services. The statute does not dictate use of any specific
methodology, such as the methodology in section 1847A of the Act, in
setting these payments. We used our discretion, granted by the Act, in
proposing to modify the methodology in section 1847A of the Act to set
payments to OTPs for oral drugs for which ASP data are available.
Therefore, we do not agree with the comments that indicated CMS has a
legal obligation to include the 6 percent add--when using ASP to
determine payments to OTPs for oral drugs.
    As noted in the proposed rule, we understand that many OTPs
purchase medications directly from drug manufacturers, thereby limiting
the markup from distribution channels. We received this information
during a routine informational industry call with OTP advocates in
preparation for drafting the proposed rule. We also note that this fact
was not challenged by any of the commenters. Furthermore, we do not
believe the record-keeping or storage requirements noted are unique to
OTPs. In fact, the selection of drugs purchased by most OTPs is quite
limited, which theoretically limits the utility of third-parties, such
as wholesalers, and their associated costs and increases the purchase
volume for OTPs and accompanying manufacturer discounts. We believe
that this situation could lend itself to an OTP drug channel for
purchasing at discounted rates either directly or through the use of
buying groups as is the standard in the pharmacy industry today.
Furthermore, we remain concerned that certain providers will look to
differential drug costs to determine which therapies to offer. As a
result, we believe that our proposed approach of paying for oral drugs
based on ASP, when available, offers an appropriate balance between
ensuring OTPs receive appropriate reimbursement for their drug
acquisition costs, while also preserving the incentive to use the most
clinically appropriate drug for the treatment of individual
beneficiaries.
    After consideration of the public comments, we are finalizing our
proposal to use ASP-based payment to set the payment rates for the oral
drugs and to limit the payment amounts for these drugs to 100 percent
of the volume-weighted ASP when it is available. However, we continue
to be interested in feedback regarding drug acquisition costs for OTP
providers, and in particular any drug acquisitions that exceed these
rates after factoring in discounts, rebates, etc., and if necessary,
may revisit the payment methodology for oral OTP drugs in future
rulemaking to ensure that OTPs' drug acquisition costs are
appropriately reimbursed.
    Comment: A few commenters submitted comments on the potential
pricing mechanisms described in the proposed rule to estimate the
payment amounts for oral OTP drugs in the event that we do not receive
manufacturer-submitted ASP pricing data. Some commenters supported
establishing payments based on current Medicare law and practice, such
as the rates provided under Part D, for other oral drugs. Another
commenter advised against using methods such as AWP and WAC as these
options can be manipulated by the manufacturers. This commenter also
noted that NADAC and the Medicare Plan Finder prices may not be
relevant to all OTP medications as they are retail-based price measures
and OTPs are providers. One commenter suggested use of the methodology
in section 1847A of the
[[Page 62657]]
Act, which would generally default to WAC-based payment if ASP is not
reported. One commenter generally opposed the use of TRICARE rates,
while another specifically stated that the current TRICARE payment rate
for methadone, as presented in the proposed rule, is fair and should be
used as a reference price for Medicare.
    Response: We agree with commenters that using current programmatic
pricing mechanisms where available is preferable to a pricing
methodology that is novel and unproven. As oral buprenorphine used for
OUD is currently dispensed by retail pharmacies, we believe that a
retail-based pricing method may be most relevant to this drug product
and more reflective of actual costs than a list price. As noted above,
the NADAC survey collects acquisition costs for covered outpatient
drugs purchased by retail pharmacies, which include invoice prices from
independent and chain retail community pharmacies. 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. As the NADAC survey data on invoice prices provide the
closest pricing metric to ASP that we are aware of, we believe, at this
time, that NADAC data would be the best pricing benchmark to set the
prices for non-methadone oral drugs (that is, currently only the oral
buprenorphine products) furnished by OTPs for which ASP data are not
available. We further agree that retail pricing benchmarks, such as
NADAC and Part D Plan Finder data, may not be particularly relevant for
methadone, because methadone is not dispensed by retail pharmacies for
this indication and its use for OUD is limited to OTPs. As a result, we
believe that use of the TRICARE rate for methadone, when ASP data are
not available, is currently the most applicable reference price for
Medicare payment of methadone used in the OTP setting.
    After consideration of the public comments, we are finalizing our
proposal to use ASP-based payment to set the payment rates for the oral
product categories when we receive manufacturer-submitted ASP data for
these drugs and to limit the payment amounts for oral drugs to 100
percent of the volume-weighted ASP. We have used the same version of
the quarterly manufacturer-submitted data used for calculating the most
recently posted ASP data files to determine the CY 2020 payment rates
for OTPs. When ASP data are not available for the oral drugs used in
OTPs, we are finalizing a policy under which we will use the TRICARE
rate to set the payment for the drug component of the methadone bundle,
and NADAC data to set the payment for the drug component of the oral
buprenorphine bundle. Payment rates for these drugs are provided in
Table 18. We note that, for purposes of determining payment for CY
2020, we were able to calculate an ASP for methadone using manufacturer
reported data. However, we did not receive ASP data from any of the
buprenorphine oral manufacturers. Therefore, the drug component of the
oral buprenorphine weekly bundle will be priced using NADAC survey
data. We are finalizing this payment methodology for the oral drugs at
Sec.  410.67(d)(2)(i)(B).
(b) Non-Drug Component
    To price the non-drug component of the bundled payments, we
proposed 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 under TRICARE (that is, the Inpatient Prospective
Payment System update factor) (81 FR 61079). The updated amount for CY
2019 is $133.15 (of which $22.19 is the methadone cost and the
remainder, $110.96, is for the non-drug services).\79\ In the proposed
rule, we stated that we believed using the TRICARE weekly bundled rate
would be 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 recognized 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, we noted that 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 bundled payments. We proposed 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 the proposal,
we noted that 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.
---------------------------------------------------------------------------
    \79\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
---------------------------------------------------------------------------
    Because the TRICARE payment rate for the non-drug services included
in its weekly bundled rate for methadone reflects the daily
administration of methadone, as part of our proposed approach we
indicated that 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 proposed 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 stated that
we understood 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 proposed to value 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 proposed 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 would account for the fact that these injectable drugs
are not oral drugs that are dispensed daily; we proposed that we would
then instead add the fee that Medicare pays for the
[[Page 62658]]
administration of an injection (which is currently $16.94 under the CY
2019 non-facility Medicare payment rate for CPT code 96372). We
proposed to update the amount of this adjustment annually using the
same methodology that we were proposing to use to update the non-drug
component of the bundled payments.
    Similarly, we proposed that 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 of the implants 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, 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 the code describing implant insertion, we proposed that 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 the code describing implant removal, we
proposed that 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 the code describing implant
insertion and removal, we proposed that 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)).
We note that in the proposed rule, we inadvertently misstated the
amounts for HCPCS codes G0516, G0517, and G0518. The correct amounts
for HCPCS codes G0516, G0517, and G0518 under the CY 2019 non-facility
Medicare payment rate are $246.15, $265.61, and $465.26, respectively.
    To determine the payment rates for the code describing a non-drug
bundled payment, we proposed 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 proposed that the payment rate for the add-on code for each
additional 30 minutes of counseling or group or individual therapy
would be based on 30 minutes of substance use counseling and valued
based on a crosswalk to the rates set by state Medicaid programs for
similar services.
    We received a number of public comments on our proposed payment
rates for the non-drug component of the bundled payment and the add-on
code for additional counseling or therapy services. The following is a
summary of the comments we received and our responses.
    Comment: Many commenters stated that the proposed rate for the non-
drug component of the bundled payment was insufficient. A few
commenters expressed concern that establishing a Medicare rate that is
lower than the rates set by some state Medicaid programs would
destabilize the market. Some commenters recommended that the single
full week TRICARE payment rate should be the floor used to pay for a
basic Medicare OTP benefit assuming a similar level of service and that
any additional services, such as extra counseling and/or therapy
visits, should be reimbursed outside of the bundle, as CMS proposed for
counseling sessions above the basic benefit and stated that if
additional services are added to the basic benefit, the bundled payment
should increase to reflect the additional services. Some commenters
stated that the proposed rate reflects a market rate that is
significantly discounted, noting that it is benchmarked on an insurance
industry practice rooted in stigma and limited resources and expressed
concern that it may inadvertently limit access to care at a time when
the opioid overdose epidemic continues to cause significant mortality.
Additionally, a few commenters noted that the TRICARE rate reflects the
average cost of care for the typical TRICARE patient, but that they
believed Medicare patients would generally require more services. A few
commenters noted that the only difference between OTPs and office-based
OUD treatment is the means of regulation and medication offered, and
that therefore, the different settings should not be cause to pay
differentially. Some commenters encouraged CMS to adjust the payment
rates to account for severity of illness. Several commenters stated
that the proposed rate for counseling is too low, which would make it
difficult for providers to employ qualified practitioners. Several
commenters urged CMS to use a building block methodology, which sums
the Medicare payment rates for similar services furnished in the non-
facility setting, to calculate the payment rate for the non-drug
component.
    Response: After consideration of the public comments, we are
finalizing a payment rate for the non-drug component that is calculated
based on a building block methodology using the Medicare payment rates
for similar services furnished in the non-facility setting. We note
that we considered a variety of different rates, including TRICARE and
Medicaid, and decided ultimately to use Medicare rates for similar
services. We appreciate commenters' feedback about the TRICARE rate,
including the concern that it reflects an average cost of care for the
TRICARE patient population, and note that by finalizing payment rates
using the established rates for similar services under Medicare, we
believe these rates will be more reflective of the resource costs
involved in furnishing services to the Medicare patient population. We
also acknowledge that establishing a methodology under which Medicare
payments would be less than those made by state Medicaid programs could
create unnecessary barriers to access to care. Additionally, we
recognize that a differential in payment OUD treatment services
furnished by OTPs and OUD treatment furnished in the office setting may
set up a disparity that could disadvantage OTPs.
    The services that are included in the non-drug component of the
weekly bundles are the same services that are included in the TRICARE
rate, which are individual therapy, group therapy, substance use
counseling, and toxicology testing. Therefore, we believe that a
reasonable alternative approach is to finalize payment rates for the
non-drug component of the bundled payments for CY 2020 that are
determined using a building block methodology under which the payment
rate for the same set of non-drug services is based on established
rates for similar services under the Medicare PFS (non-facility rates),
the Medicare CLFS, and state Medicaid programs.
    Specifically, the payment rate we are finalizing for the non-drug
component reflects the Medicare payment rates for the following codes
as reference codes for the services that are included in the TRICARE
rate, (individual therapy, group therapy, substance use counseling, and
toxicology testing): CPT code 90832 (Psychotherapy, 30 minutes with
patient), in CY 2019 is currently assigned a non-facility rate of
$68.47 under the PFS; CPT code 90853 (Group psychotherapy (other than
of a multiple-family group)), which in CY 2019 is assigned a non-
facility rate of $27.39
[[Page 62659]]
under the PFS; HCPCS code G0396 (Alcohol and/or substance (other than
tobacco) abuse structured assessment (e.g., audit, dast), and brief
intervention 15 to 30 minutes), which in CY 2019 is assigned a non-
facility rate of $30.94 under the PFS when furnished by nonphysician
practitioners (NPPs), as we believe this is a more accurate reflection
of the practitioner type who would be furnishing substance use
counseling in an OTP; CPT code 80305 (Drug test(s), presumptive, any
number of drug classes, any number of devices or procedures; capable of
being read by direct optical observation only (e.g., utilizing
immunoassay [e.g., dipsticks, cups, cards, or cartridges]), includes
sample validation when performed, per date of service), which in CY
2019 is assigned a rate of $12.60 under the CLFS, and which we will
prorate to account for two tests per month in the base bundled payment;
and HCPCS code G0480 (Drug test(s), definitive, utilizing (1) drug
identification methods able to identify individual drugs and
distinguish between structural isomers (but not necessarily
stereoisomers), including, but not limited to gc/ms (any type, single
or tandem) and lc/ms (any type, single or tandem and excluding
immunoassays (e.g., ia, eia, elisa, emit, fpia) and enzymatic methods
(e.g., alcohol dehydrogenase)), (2) stable isotope or other universally
recognized internal standards in all samples (e.g., to control for
matrix effects, interferences and variations in signal strength), and
(3) method or drug-specific calibration and matrix-matched quality
control material (e.g., to control for instrument variations and mass
spectral drift); qualitative or quantitative, all sources, includes
specimen validity testing, per day; 1-7 drug class(es), including
metabolite(s) if performed), which in CY 2019 is assigned a rate of
$114.43 under the CLFS, and which we will prorate to account for one
test per month in the base bundled payment, as discussed previously.
The sum of these amounts is $161.71.
    We are also finalizing our proposal to adjust the non-drug
component rate to account for different administration and dispensing
costs of the drug that is used in the episode of care (either oral,
injectable, or implantable). We note that in calculating the proposed
rates, the TRICARE weekly bundled rate included administration of oral
drugs, which we then adjusted accordingly for the other bundled
payments by subtracting the amount for dispensing oral drugs and adding
a different amount to account for administration of the injectable and
implantable drugs. We are finalizing the rate we proposed for
dispensing oral drugs using an approximation of the average dispensing
fees under state Medicaid programs, which is $10.50, since there is no
Medicare Part B rate for oral MAT drugs. For the injectable drugs
(buprenorphine and naltrexone), we proposed 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, and to add the Medicare non-facility rate for
administration of an injection. This adjustment was necessary to
account for the fact that the TRICARE rate includes oral dispensing
fees, whereas these injectable drugs are not oral drugs that are
dispensed daily. However, because we are adopting a building block
methodology in final rule to determine the payment rate for the non-
drug component of the weekly bundles, it is no longer necessary to
subtract the oral dispensing fee; however, as we proposed, we will
include the Medicare non-facility rate for administration of an
injection in our determination of the payment rate for the non-drug
component for weekly bundles that include injectable drugs. We are
finalizing the rate we proposed for administration of an injection,
based on CPT code 96372 (Therapeutic, prophylactic, or diagnostic
injection (specify substance or drug); subcutaneous or intramuscular)
as a reference code, is $16.94.
    For the codes describing the insertion, removal, or insertion and
removal of the buprenorphine implants, we proposed to adjust the non-
drug component payment rate to remove the cost of daily administration
of an oral drug and by adding the Medicare non-facility payment rate
for the insertion, removal, or insertion and removal of the implants,
respectively. Again, removal of the cost of daily administration of an
oral drug is no longer necessary under our building block methodology;
but, we are finalizing our proposal to include the rates for the
insertion, removal, or insertion and removal of the buprenorphine
implants, as applicable. The reference codes, which we proposed and are
finalizing are: HCPCS codes G0516 (Insertion of non-biodegradable drug
delivery implants, 4 or more (services for subdermal rod implant)),
which in CY 2019 is assigned a non-facility rate of $246.15. G0517
(Removal of non-biodegradable drug delivery implants, 4 or more
(services for subdermal implants)), which in CY 2019 is assigned a non-
facility rate of $265.61 under the PFS, and G0518 (Removal with
reinsertion, non-biodegradable drug delivery implants, 4 or more
(services for subdermal implants)), which in CY 2019 is assigned a non-
facility rate of $465.26 under the PFS. Under the building block
methodology we are adopting in this final rule, the total non-drug
component payment for the non-drug bundle is $161.71, the total non-
drug component payment for oral drugs is $172.21, the total non-drug
component payment for the injectable drugs is $178.65, the total non-
drug component payment for the buprenorphine implant insertion is
$407.86, the total non-drug component payment for the buprenorphine
implant removal is $427.32, and the total non-drug component payment
for the buprenorphine implant insertion and removal is $626.97. See
Table 18 for a full listing of the final payment rates that we are
establishing in this final rule, which reflect the sum of the drug
component and non-drug component for each bundled payment. We believe
the rates we are finalizing are reflective of an average case, but we
recognize that the number of services furnished for patients who have
stabilized and are in the maintenance phase of treatment, may be
significantly less. However, we note that while the reference codes
listed above were considered for the purpose of valuation of the non-
drug component of the weekly bundled payments, it is not a requirement
for billing these codes (HCPCS codes G2067-G2075) that all of the
services described by these reference codes would necessarily be
furnished during each week that the bundled payment is billed. Rather,
the threshold to bill for the bundled payment is that at least one
service in the bundle is furnished during that week, which could be
administration of the drug, individual therapy, group therapy,
substance use counseling, or toxicology testing.
    In response to commenters who stated that the proposed rate for the
counseling add-on code was too low, we note that we are finalizing a
rate of $30.94, which is based on the CY 2019 PFS non-facility rate for
HCPCS code G0396 (Alcohol and/or substance (other than tobacco) abuse
structured assessment (e.g., audit, dast), and brief intervention 15 to
30 minutes), when furnished by NPPs, and is higher than the proposed
amount for this add-on code. Additionally, we believe that the
availability of this add-on code will allow OTPs to receive
reimbursement for additional counseling services furnished to patients
with more needs, thereby accounting for varying levels of severity of
illness. We will be
[[Page 62660]]
monitoring the claims data to ensure that use of this add-on code is
not being abused.
i. Medication Not Otherwise Specified
    In the proposed rule, we stated that we would expect the non-drug
component for the medication not otherwise specified bundled payment
(HCPCS code G2075) to be consistent with the pricing methodology for
the other bundled payments and therefore, to 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 similarly stated that we
would adjust the TRICARE payment rate for non-drug services using the
same methodology we proposed for the bundled payments with injectable
medications (to subtract an amount for daily dispensing and add the
non-facility Medicare payment rate for administration of the
injection). For implantable medications, we stated that we would also
use the same methodology we proposed for the bundled payments with
implantable medications, with the same crosswalked non-facility
Medicare payment rates (for insertion, removal, and insertion and
removal). We solicited 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 proposed for determining the payment rate for the non-
drug component of an episode of care 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.
    We did not receive any comments on our proposal relating to pricing
the non-drug component for medication not otherwise specified bundled
payments. Consistent with our original proposal, we intend to determine
the payment for the non-drug component of the medication not otherwise
specified bundle based on whether the drug is oral, injectable, or
implantable. However, this payment would be determined using the
building block payment methodology that we are adopting in this final
rule to determine the non-drug component of the bundled payments for
medications that have the same mode of administration.
(c) Partial Episode of Care
    For the codes describing partial episodes for methadone and oral
buprenorphine, we proposed 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 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 solicited comment on
other methods that could be used to calculate these payment rates. We
proposed 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 the codes describing partial episodes for injectable
buprenorphine and naltrexone, we proposed 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 proposed 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 the codes describing partial episodes for the buprenorphine
implant insertion, removal, and insertion and removal, we proposed that
the payment rates for the drug component would be the same as the
payment rate for the corresponding weekly bundle. For the non-drug
component, we proposed 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 $246.15, $265.61, and $465.26, respectively).
    For the code describing a non-drug partial episode of care, we
proposed that the payment rate would be calculated by taking one half
of the payment rate for the corresponding weekly bundle.
    We proposed that the payment rate for the code describing partial
episodes for a medication not otherwise specified would be calculated
based on whether the medication is oral, injectable or implantable,
following the methodology described above for the corresponding type of
partial episode. We solicited 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.
    We did not receive comments on our proposed methodology for
determining payment rates for partial episodes. However, as discussed
above, after consideration of the public comments, we are not
finalizing our proposal to create partial episodes at this time, and
thus will not be finalizing our proposed methodology for pricing
partial episodes.
BILLING CODE 4120-01-P
[[Page 62661]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.024
[[Page 62662]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.025
BILLING CODE 4120-01-C
(8) Place of Service (POS) Code for Services Furnished at OTPs
    In the proposed rule, we explained that we would be creating a new
POS code specific to OTPs since there are no existing POS codes that
specifically describe OTPs. We indicated that claims for OTP services
would include this place of service code. We also noted that POS codes
are available for use by all payers. We did not propose to make any
differential payment based on the use of this new POS code.
    The following is a summary of the comments we received regarding
the discussion of creating a new POS and our responses.
    Comment: Several commenters supported the plan to create a new POS
code that would specifically describe OTPs. A few commenters stated
that if non-OTP pharmacies were to dispense MAT drugs covered by an OTP
bundle, it is not clear how the OTP POS code will be transmitted to
Part D plans or pharmacies so that they will know whether an enrollee
is also enrolled in an OTP. Another commenter stated that while POS
codes currently distinguish inpatient from outpatient OUD treatment,
they do not distinguish between a Medicare-enrolled OTP and a non-
Medicare-enrolled OTP and recommended that CMS should consider multiple
value sets for POS codes to help retail pharmacies dispense
prescriptions and process claims appropriately.
    Response: We have created a new place of service code, which will
be described as Place of Service code 58 (Non-residential Opioid
Treatment Facility--a location that provides treatment for OUD on an
ambulatory basis. Services include methadone and other forms of MAT).
We expect that POS code 58 will be noted on claims
[[Page 62663]]
submitted for the HCPCS G codes describing OTP services. Additionally,
we note that the G codes describing the OTP bundled payments and add-on
codes can only be billed by OTPs and cannot be billed by other
providers. We note that POS codes are not specific to Medicare use and
may be used by other payers.
    In response to the comments about non-OTP pharmacies dispensing MAT
drugs included in an OTP bundle, we encourage pharmacies and
prescribing OTPs be in close communication in order to ensure proper
billing procedures are followed and to prevent duplicative payments.
The presence of POS code 58 on retail pharmacy claims will not mean
that the pharmacy should process MAT claims any differently than they
do now. We appreciate the suggestion to create multiple value sets for
POS codes, and will take that under consideration.
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. In
the proposed rule, we noted that many of the individual items or
services provided by OTPs that would be included in the bundled payment
rates under the proposed policies may also be appropriately available
to beneficiaries through other Medicare benefits. Although we
recognized the potential for significant program integrity concerns
when similar items or services are payable under separate Medicare
benefits, we also stated that we believe 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, 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, 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 explained that 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 explained our belief 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 proposed 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 proposed to codify this policy at Sec.
410.67(d)(4). We acknowledged that some OTPs may negotiate arrangements
whereby community pharmacies supply MAT-related medications to OTPs.
However, we stated that 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 stated that 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. We also noted that CMS intends to monitor
for duplicative payments, and would take appropriate action as needed
when such duplicative payments are identified. Therefore, we proposed
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
proposed to codify this policy at Sec.  410.67(d)(4). We noted 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.
    We received a few comments on our proposed policy to address
duplicative payments. The following is a summary of the comments we
received and our responses.
    Comment: A few commenters supported the proposal that the OTP
should be accountable for ensuring duplicative payments are not made on
the basis that OTPs are in the best position to know whether a drug
included in the patient's treatment plan is furnished by the OTP.
    Response: We thank the commenters for their feedback and support.
    Comment: One commenter stated that the new Medicare bundled
payments to OTPs should not impact payment for MAT prescriptions
rightfully transmitted to a retail pharmacy unless the prescription is
from an OTP. The commenter stated that having to determine whether a
MAT drug presented to a retail pharmacy should be covered under the new
Part B OTP bundle or Part D could introduce a delay in access to
treatment. The commenter stated that retail pharmacies should continue
to process any MAT prescription under Part D, as they do today. The
commenter also stated that prescribers who administer implantable or
injectable MAT drugs outside of a SAMHSA-certified OTP would continue
to bill these drugs to Part B. Additionally, the commenter questioned
if the Medicare bundled payments to OTPs will include MAT drugs that
are prescribed within an OTP by a licensed prescriber, but dispensed
outside of it.
    Response: With regard to the commenter's question concerning MAT
drugs prescribed within an OTP but dispensed outside of it, there is no
issue of duplicative payment if the OTP has an arrangement with the
pharmacy whereby CMS pays the OTP a bundled payment rate and the OTP
reimburses the pharmacy through an independent arrangement (in which
case the pharmacy would not bill the Part D plan, as it would be
reimbursed by the OTP). However, if such an arrangement does not exist,
and the pharmacy intends to submit a Part D claim, then the OTP should
not bill for an episode of care that includes a drug component but
instead should bill for a non-drug episode of care (HCPCS code G2074).
Similarly, we note that if the drug administration for a Part B MAT
drug occurs outside the OTP and the OTP is not also billing for a
weekly bundle that includes that Part B drug, then the administering
provider can bill Part B.
[[Page 62664]]
    Comment: One commenter stated that while they agree with our
proposal to recoup duplicative payments from OTPs, CMS should monitor
for any unintended impacts to access or other challenges that may
result. The commenter stated that CMS must not create a situation in
which beneficiaries cannot access needed care because they are
receiving OUD treatment through an OTP bundle.
    Response: We have explicitly acknowledged that we do not believe a
beneficiary receiving the same kinds of services from both an OTP and
another provider or supplier would necessarily constitute a duplicative
payment. We reiterate, however, that we do have an expectation 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. For example, OTPs could actively coordinate care and
facilitate information exchange between other prescribers, dispensers
and plans who prescribe, administer, dispense, or pay for medications
for OUD treatment. We also note that OTPs and other health care
providers must comply with all applicable laws and regulations, such as
the Health Insurance Portability and Accountability Act and the
Substance Abuse Confidentiality Regulations (42 CFR part 2). We intend
to conduct monitoring to ensure that our policies regarding duplicative
payment do not have any such unintended consequences as described by
the commenter.
    Comment: A few commenters stated that drugs dispensed outside the
OTP should not be included in the OTP bundle. One commenter stated that
community pharmacies currently face challenges in knowing whether a
prescription is from an inpatient OTP or whether the inpatient OTP is
prescribing outpatient therapy for a patient who is being discharged.
The commenter stated that the best way to avoid duplicate payments from
occurring is to limit the OTP bundled payment to drugs dispensed by an
OTP facility; similarly the commenter stated that if take-home
medications are included in the OTP bundle, they should also be
dispensed by the OTP.
    Response: We disagree that only medications provided at the OTP
should be included in the bundled payment. As indicated above, we are
aware that some OTPs have arrangements with pharmacies whereby the OTP
reimburses the pharmacy through an independent arrangement. In this
case, it is appropriate for the OTP to bill for the weekly bundled
payment that corresponds to the medication provided to the beneficiary.
We also note that if questions arise regarding the purpose of the
prescription, as described by the commenter, the pharmacy should
contact the prescribing OTP for any necessary clarifications.
    Comment: A few commenters stated that more information is needed to
better understand how CMS will monitor and protect against duplicative
billing/payment. The commenters recommended that CMS update the
guidance in the Medicare Program Integrity Manual to better outline the
process through which duplicative payments will be monitored and
corrected.
    Response: We will consider issuing further guidance either through
future rulemaking or subregulatory guidance, as suggested.
    Comment: One commenter disagreed that OTPs should be financially
accountable for duplicative payments. The commenter stated that OTPs
may not have access to prescribing information for every physician or
clinician the beneficiary sees outside of the OTP, nor do reporting
mechanisms exist for this information in order for OTPs to quickly and
efficiently review prior to engaging patients in time-sensitive
deployment of OUD treatment.
    Response: We reiterate that we have explicitly acknowledged that we
do not believe that payments for the same kinds of services from both
an OTP and a separate provider or supplier would necessarily result in
a duplicative payment. We also emphasize that we have narrowly defined
duplicative payment to involve only those circumstances where
medications that are delivered, administered or dispensed to a
beneficiary are paid as part of the OTP bundled payment, and where the
delivery, administration or dispensing of the same medications (that
is, same drug, dosage and formulation) is also separately paid under
Medicare Part B or Part D for the same beneficiary with the same date
of service. As noted earlier, we do not intend to prevent the
appropriate billing under Medicare Part B or Part D for individual
items or services that could be provided by OTPs as part of an episode
of care and included in the bundled payment rate, but that may also be
appropriately available to beneficiaries through other Medicare
benefits.
    Comment: One commenter supported the proposal to hold OTPs
accountable for duplicative payments, but stated that CMS should issue
a non-enforcement or hold harmless grace period for CY 2020 for audits
and other consequences such as Star Ratings related to the new OUD
treatment services benefit.
    Response: We appreciate the feedback and note that section
1834(w)(1) of the Act expressly requires that we take steps to ensure
that no duplicative payments are made. Moreover, as explained above, we
have narrowly defined duplicative payment, so we do not believe that a
grace period would be necessary for CY 2020.
    After consideration of the public comments, we clarifying that our
final policy on duplicative payments refers to payment for the same
medication for the same beneficiary on the same date of service. Thus
we are finalizing our proposal 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 a claim for the same medications for the
same beneficiary on the same date of service was paid under a different
Medicare benefit, CMS will generally recoup the duplicative payment
made to the OTP. We have updated the text at Sec.  410.67(d)(5) to
reflect this clarification.
d. Cost Sharing
    Section 2005(c) of the SUPPORT Act amended 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 proposed 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 would also ensure 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.\80\ We solicited
[[Page 62665]]
public comment 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 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 recognized that setting the copayment
for OUD services at an amount greater than zero could create a barrier
to access to treatment for many beneficiaries. We proposed to codify
the proposed copayment amount of zero at Sec.  410.67(e). We solicited
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.
---------------------------------------------------------------------------
    \80\ 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 Part 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 noted 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.
    We received public comments on the proposals related to cost
sharing for the bundled payments for OUD treatment services. The
following is a summary of the comments we received and our responses.
    Comment: Many commenters supported the proposal to set the
copayment at zero for a time limited duration. A few commenters
encouraged CMS to consider setting the copayment at zero permanently,
noting that individuals who require the services of an OTP will have
difficulty making copayments for a variety of reasons, regardless of
whether there is an opioid epidemic across the nation. One commenter
noted that if a patient received OUD treatment services outside of an
OTP, they would pay 20 percent Part B coinsurance under Medicare at
other health care settings or Part D plan cost sharing for any
pharmacy-dispensed prescription drugs which may disadvantage other
established Medicare provider types. This commenter also noted that
OTPs may not be available to patients in all geographic localities,
which would seem to be unfair.
    Response: We appreciate the support for our proposal. After
consideration of the public comments, we are finalizing our proposal to
set the copayment at zero for a time limited duration, as we believe
this would minimize barriers to patient access to OUD treatment
services. Setting the copayment at zero also ensures OTPs receive the
full Medicare payment amount for Medicare beneficiaries if secondary
payers are not available or do not pay the copayment, especially for
those beneficiaries who are dually eligible for Medicare and Medicaid.
However, as we explained in the proposed rule, we are interested in
setting the copayment at zero for a time limited duration (for example,
until such time as the Secretary does not renew the national public
health emergency declaration for the continued consequence of the
opioid crisis affecting our nation), and intend to address the
copayment in future rulemaking at such a time we deem appropriate.
Although we appreciate the concern that OUD treatment services
furnished in other settings require beneficiary cost sharing, we
believe it is important, especially in light of the opioid epidemic, to
minimize barriers to patient access to OUD treatment services in such
instances that we are able to and note that section 2005 of the SUPPORT
Act does not provide authority to waive cost sharing for OUD treatment
services furnished in other settings.
    Comment: One commenter requested that OTPs be allowed to receive
Medicare bad debt payments for any uncollected Part B deductible
payments, noting that OTP providers are unlikely to be successful in
collecting deductibles for many patients in this population. Another
commenter expressed concern that the application of the Part B
deductible to OUD treatment services furnished by OTPs might
particularly affect dually eligible beneficiaries currently receiving
OTP care as they are likely to visit an OTP provider in January, before
they hit their annual Part B deductible. This could put them in the
position of owing over $100 in January.
    Response: We note that bad debts arising from covered services paid
under a reasonable charge-based methodology or a fee schedule are not
reimbursable under the Medicare program (42 CFR 413.89(i)).
Additionally, we note that the majority of dually eligible individuals
are Qualified Medicare Beneficiaries (QMBs), a program in which
Medicaid covers the Medicare Part A (if any) and Part B premiums and
other Medicare cost-sharing. States may pay for deductibles,
coinsurance, and copayments for Medicare services furnished by Medicare
providers to QMBs to the extent consistent with the Medicaid State
Plan. States have the option to reduce or eliminate the state's
Medicare cost sharing payments by adopting policies that limit payment
to the lesser of (a) the Medicare cost sharing amount, or (b) the
difference between the Medicare payment and the Medicaid rate for the
service, consistent with the methodology identified in the state plan.
When Medicaid rates are lower this can result in the provider receiving
reduced or even no payment for the deductible. Regardless of the amount
paid by the state for the deductible, coinsurance, and copayments,
sections 1848(g)(3) and 1866(a)(1)(A) of the Act prohibit Medicare
providers from billing QMBs for Medicare Parts A and B cost sharing
amounts. States may also choose to cover Medicare cost-sharing for
certain other full-benefit dually eligible individuals.
    As discussed in more detail below, once a provider is enrolled in
Medicare, Medicare will crossover the deductible portion of the claim
to state Medicaid agencies, and the state will adjudicate the claim.
However, as noted above, states often use different HCPCS billing codes
for OTP services than Medicare does; in these cases, we note that the
state's claims processing system may reject the claim and will notify
the provider, who can re-code and resubmit the claim directly to the
state.
    In summary, we are finalizing our proposal to set the copayment for
OUD treatment services furnished by OTPs at zero for a time limited
duration, as we believe this would minimize barriers to patient access
to OUD treatment services. We are codifying this beneficiary cost-
sharing amount at Sec.  410.67(e).
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.
[[Page 62666]]
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 OUD 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. Because we believe OUD treatment services
furnished by OTPs will also be subject to varying cost based upon the
geographic locality where the services are furnished, in the proposed
rule we proposed to apply a geographic locality adjustment to the
bundled payment rate for OUD treatment services. We discussed our
proposed approach with respect to both 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 reflected national pricing, and because there is no
GAF applied to the payment of Part B drugs under the ASP methodology,
we did not believe that it would be necessary to adjust the drug
component of the bundled payment rates for OTP services based upon
geographic locality. Therefore, we proposed not to apply a geographic
locality adjustment to the drug component of the bundled payment rate
for OTP services. We did not receive any comments on this proposal and
are finalizing as proposed not to make any geographic adjustment to the
drug component of the bundled payment rates.
(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
treatment services 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, in the proposed rule we stated that we
believed it would be appropriate to apply a geographic locality
adjustment to the non-drug component of the bundled payments. We
believed that the geographic variation in the cost of the non-drug
services provided by OTPs would 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 proposed 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 three fee schedule components
(work, PE, and malpractice).
    Although we proposed to adjust the non-drug component of the
payments for 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 we proposed the OTP bundled payment as a flat rate payment for all
OUD treatment services furnished during an episode of care, we
explained that 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 proposed to use the
Geographic Adjustment Factor (GAF) at Sec.  414.26. Specifically, we
proposed 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 the 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 non-drug component of OUD treatment services
is comprised of work, PE, and malpractice expenses, we proposed using
the GAF as we believe the weighted composite of all three GPCIs
reflected in the GAF would be the more appropriate GAF to reflect
geographic variations in the cost to OTPs of furnishing OUD treatment
services.
    The GAF, which is determined under Sec.  414.26, is discussed
earlier in section II.D.1. of this final rule and the specific GAF
values for each payment locality are posted in Addendum D to this final
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
proposed using the GAF as we believed 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 proposed 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 solicited public comment on the 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 solicited comments on any factors, other than the GAF,
that could be used to make this payment adjustment.
    Additionally, we noted that the majority of OTPs operate in urban
localities. In light of this fact, we
[[Page 62667]]
explained that we were interested in receiving information on whether
rural areas have appropriate access to treatment for OUD. We were
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 solicited comment for future consideration on this issue and
potential solutions we could consider adopting to address this
potential issue through future rulemaking.
    We received a few comments on the proposed locality adjustment. The
following is a summary of the comments we received and our responses.
    Comment: One commenter supported using the GAF to geographically
adjust the non-drug component of the bundled payment.
    Response: We thank the commenter for their support and feedback.
    Comment: One commenter stated that CMS should create a 17 percent
rural add-on payment to be applied to the bundled payment rate in low-
population density areas where it is difficult to find doctors, nurses,
and counselors to treat OUD patients. The commenter noted that Medicare
provides a 17 percent rural add-on for inpatient psychiatric facilities
which often treat substance abuse cases.
    Response: We appreciate the suggestion and may consider whether to
propose a rural add-on payment in future rulemaking. In the interim, we
note that the current Medicare PFS locality structure contains 34
states with a statewide payment locality, which means that, in these
states, the geographic adjustment is the same in all areas, whether
urban or rural, thus reducing rural/urban payment differentials within
a state. We intend to monitor this issue, and as previously stated, may
revisit the issue of a rural add-on payment in the future.
    After consideration of the public comments, we are finalizing our
proposal to adjust the non-drug component of the OTP bundled payments
using the GAF in Sec.  410.67(d)(4)(ii). Additionally, although we did
not explicitly address the application of a geographic adjustment in
the context of the add-on payment adjustments for non-drug services in
the proposed rule, we believe that the same logic regarding the
differential costs for those services would apply and should be
recognized. As such, we are also finalizing that the add-on payment
adjustments for non-drug services will be geographically adjusted as
described above.
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 proposed 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 proposed 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 proposed 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 proposed 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. For
example, if we were to price the drug component of the bundled payment
rate for episodes of care 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. In the proposed rule, 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 be updated using the most
recently available NADAC data at the time of ratesetting for the
applicable calendar year.
    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 believed that it was important
to apply an annual update to the payment rates that recognizes the
differing rate of growth of drug costs 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 (BLS), which measures the average change over time in the
selling prices received by domestic producers for their output.
Ultimately we decided against proposing to update 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 believed the proposed approach would update the
pricing of the drug component of the OUD treatment services payment
rate in the manner that would be most familiar to stakeholders. We
solicited public comment on the proposed approach to updating the drug
component of the bundled payment rates. We also solicited 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.
    We did not receive any comments on the proposed approach to update
the drug component of the bundled payment rates, and are finalizing our
proposal to use the most recently available data from the applicable
pricing mechanism finalized for drug pricing, as described above, to
annually update the drug component of the bundled payment. We are
codifying this policy at Sec.  410.67(d)(2)(i), which provides that the
payment for the drug component of episodes of care will be determined
using the most recent data available at the time of ratesetting for the
applicable calendar year.
[[Page 62668]]
(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 proposed 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' PEs, with an adjustment for the change in
economy-wide, private nonfarm business multifactor productivity. The
method for calculating 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 also considered other potential update
factors, such as the BLS Consumer Price Index for All Items for Urban
Consumers (CPI-U) (Bureau of Labor Statistics #CUUR0000SA0 (https://www.bls.gov/cpi/data.htm) and the IPPS hospital market basket reduced
by the multifactor productivity adjustment. The 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 believed 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 proposed 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 proposed to codify this
proposal at Sec.  410.67(d)(3)(iii).
    We received one comment on the annual update for the non-drug
component of the bundled payment rate. The following is a summary of
the comment we received and our response.
    Comment: One commenter disagreed with using the MEI to increase the
non-drug component payment and stated that the MEI focuses more
narrowly on physician practices. The commenter stated that an OTP's
cost structures are more similar to hospital outpatient departments
than physician offices. The commenter stated that over time, updating
rates by the MEI, which closely mirrors general inflation, will create
access to care issues as federal and state mandated OTP costs grow
faster than Medicare reimbursements. The commenter also stated that
TRICARE utilizes the IPPS annual update factor and if CMS' goal is to
align payment with the TRICARE model, it should act consistently and
also adopt its annual adjustment policy.
    Response: We clarify that CMS' goal is not to align payment with
the TRICARE model. As indicated above, section 1834(w)(2) of the Act
provides that the Secretary may consider the rates paid to OTPs for
comparable services under Medicaid or under TRICARE. As we discussed in
the CY 2020 PFS proposed rule, we considered payments for those
comparable services in the development of our payment rates. However,
we note that we also solicited comment on the scope of private payer
OTP coverage and the payment rates private payers have established for
OTPs furnishing comparable OUD treatment services for consideration.
    We appreciate the commenter's concern about using the MEI to update
the non-drug component of the OTP bundled payment rate. Ideally, we
would develop a market basket that reflects the detailed cost
structures of OTP facilities; however, these data are not currently
available. Therefore, we have to use a price index that best
approximates the cost of the medical services being provided by the OTP
facilities. Although TRICARE uses the IPPS annual update factor, we
believe the MEI is a more appropriate index to use to update the non-
drug component of the OTP bundled payment rate based on both conceptual
and compositional reasons.
    From a conceptual standpoint, we believe physicians' services
furnished in the office setting more closely align to the OUD treatment
services furnished by OTPs as they both encompass minimally invasive
medical care such as assessment, counseling, and administering of
medications. The MEI measures the market price changes in the inputs
used to furnish physicians' services, and represents both the medical
and non-medical costs associated with providing this care. In contrast,
hospitals engage in complex inpatient and outpatient medical services,
such as surgical procedures and emergency room trauma, which are
significantly different to the services furnished in OTP facilities.
The IPPS market basket reflects these complex services and the non-
medical costs associated with managing these large facilities, such as
non-medical labor-related services (including but not limited to legal,
accounting, financial, and installation and maintenance repair
services), which account for almost 25 percent of the IPPS market
basket.
    From a compositional standpoint, the MEI more closely aligns with
the services associated with the OTP payment system. In particular, the
MEI does not reflect drug costs (which will be updated separately for
OTPs, as discussed previously) as these costs are not reimbursed under
the Medicare PFS, for which the MEI was originally developed. The IPPS
market basket, however, is an operating market basket that reflects
drug costs because these costs are included in the IPPS operating base
payment rate. Additionally, the MEI includes PE associated with all
operations, including any capital or leasing costs. The IPPS market
basket, on the other hand, excludes capital costs because under the
IPPS, capital costs are reimbursed separately and the IPPS capital
payment rates are updated using the IPPS capital market basket, which
reflects the complex capital acquisition and financing methods of IPPS
hospitals. Finally, the MEI reflects an adjustment for expected
productivity improvements associated with the provision of care (the
MEI uses the change in economy-wide private non-farm business
multifactor productivity), which, given the similarity in the nature of
services furnished in the physician office and OTP settings, OTPs would
also be anticipated to be able to achieve. The IPPS market basket does
not include a productivity adjustment as that adjustment is applied
separately as part of the payment rate update. These compositional
differences account for many of the differences between the growth
rates of the MEI and the IPPS market basket that the commenter
identified as a concern. Because the
[[Page 62669]]
differences in growth rates between the IPPS market basket and the MEI
are due to these compositional differences, we disagree with the
commenter that there is a concern with using the MEI to update the non-
drug component of the bundled payment rates. That is, we believe the
MEI is an appropriate price index to serve as a proxy for changes in
market costs associated with providing OTP services, as it reflects
both the medical and non-medical costs of providing noninvasive medical
care in a non-inpatient facility.
    After consideration of the public comments, we are finalizing the
proposal to update the non-drug component of the bundled payment for
OUD treatment services based upon the MEI. These policies are codified
in Sec.  410.67(d)(4)(iii). Additionally, although we did not
explicitly address the application of the annual update to the add-on
payment adjustments for non-drug services in the proposed rule, we
believe that the same logic regarding the potential changing costs of
the services included in the non-drug component of the bundled payment
rates is applicable. As such, we are finalizing that the add-on payment
adjustments for non-drug services will be subject to the annual update
as described above.
    In addition to comments on our proposals and the related issues on
which we specifically requested public input, we received a number of
other public comments related to our implementation of this new
Medicare benefit for OUD treatment services furnished in an OTP.
Several comments focused on various aspects of how the OTP proposals
intersect with Medicaid, those beneficiaries dually eligible for
Medicare and Medicaid, Medicare Advantage, and certain requirements
related to compliance, quality measurement, and Electronic Health
Records. While these issues were not addressed specifically in the
proposed rule, we believe it is important to clarify how the OTP
policies interface with existing policies under these other programs.
The following is a summary of the comments we received and our
responses.
    Comment: Most commenters expressed concerns that in the states that
currently cover OTP services under Medicaid, the transition from
Medicaid to Medicare as primary payer for those OTP services for dually
eligible individuals could result in disruptions to dually eligible
individuals' OTP treatment, as well as for OTP providers. Several
commenters noted the tight timeframes for OTP providers to enroll in
Medicare. For those OTPs currently serving dually eligible individuals
under Medicaid, any enrollment backlog may create cash flow problems
for these providers, as Medicaid is the payer of last resort, which
normally means Medicaid stops paying for a benefit once Medicare starts
to cover it. They also noted that the timing of the final regulation
would result in less than 60 days to implement needed changes to
billing systems. Commenters requested flexibilities during this
transition, including a transition period in which OTP providers could
still bill Medicaid, with well-publicized transition timelines for a
grace period during which improperly submitted claims could be
corrected.
    Response: We appreciate the concerns expressed by commenters. As
discussed in more detail below, Medicaid must pay for OTP services for
dually eligible individuals if the service is covered by the Medicaid
state plan and the OTP provider is enrolled in Medicaid and not yet
enrolled in Medicare.
    We will issue guidance to states on strategies to promote
continuity of care for dually eligible individuals during this
transition period while upholding their responsibilities under Medicaid
as the payer of last resort. We will remind states that Medicaid must
pay for services delivered to these beneficiaries by OTP providers who
are not yet enrolled in Medicare. Recognizing that many OTP providers
may not yet be enrolled in Medicare on January 1, 2020, we will
recommend that states not impose systems edits to automatically reject
claims, (under the assumption that the OTP is Medicare-enrolled and
therefore Medicare is the appropriate primary payer for the dually
eligible individual) for OTP services furnished to dually eligible
individuals at the start of the year. We will encourage states to reach
out to their Medicaid-enrolled OTP providers to advise them to enroll
as quickly as possible in Medicare. To support continuity of care, we
will ask states to offer OTPs options during the interim until Medicare
approves the provider enrollment, including billing Medicaid for
payment (with the understanding that Medicaid will later recoup the
Medicaid payments made, back to the effective date of Medicare provider
enrollment, and the provider will bill Medicare instead for those
claims), or to hold claims and bill Medicare once the OTP provider is
Medicare-enrolled. As requested by the commenters, we will also include
in our outreach to OTP providers information about these transition
options.
    Comment: One commenter who supported a transition period requested
that the transition period be extended in cases where OTP providers
need to be credentialed and contract with a large number of Medicare
Advantage plans, or when Medicaid Managed Care Organizations are
involved in covering the Medicare cost-sharing. Commenters noted that
unlike Medicare, where there is a single provider enrollment process,
it will take significantly longer for OTP providers to become network
providers with multiple Medicare Advantage plans, potentially delaying
their ability to provide services to dually eligible enrollees of those
plans.
    Response: We share the concern around ensuring continuity of care
for dually eligible individuals who are currently obtaining treatment
from an OTP provider through Medicaid and are enrolled in a Medicare
Advantage managed care plan. The factors impacting transition are
different in Medicare Advantage from those discussed below for Original
Medicare. Under section 1852(a) of the Act and 42 CFR 422.100, Medicare
Advantage (MA) plans must cover the Medicare OTP benefit because it is
a Part B benefit. MA plans may meet this obligation by contracting with
OTP providers or making other arrangements with non-contracted OTP
providers. Under current MA program requirements, MA plans may furnish
OTP access for their enrollees either by establishing direct contracts
with OTPs or by arranging access on a non-contract basis. If an MA plan
furnishes access to OTPs by contracting with one or more OTPs the MA
plan is not necessarily required to contract with all OTP providers in
the area, but must ensure that the contracts with OTPs it does have
furnish sufficient access and availability to OTP services for its
enrollees and are also consistent with the community pattern of care
based on the service area where the MA plan is being offered. If an MA
plan allows its enrollees to obtain OTP services on a non-contract
basis the MA plan must ensure that its enrollees are able to access OTP
services that are available within the community pattern of care. (see
Sec.  422.112). If a dually eligible individual enrolled in the plan is
currently in treatment with an OTP provider with which the plan does
not contract, the plan should create a transition process under which
the individual can continue to see their current OTP provider while the
plan works with the individual to transition to a network provider.
Allowing the individual to continue to see their current provider
during this transition will ensure continuity of care for this
vulnerable population.
    Comment: One commenter specifically requested that dually
[[Page 62670]]
eligible individuals receiving services from an OTP provider not
enrolled in Medicare be able to continue to receive treatment from that
provider, and further requested this apply to dually eligible
individuals not yet in treatment but who have no Medicare OTP providers
in their area.
    Response: As noted above, Medicaid must still cover OTP services
for dually eligible individuals whose provider is not yet enrolled in
Medicare. This flexibility promotes continuity of care for dually
eligible individuals already receiving OTP services under Medicaid now,
as well as providing beneficiaries access to Medicaid-enrolled OTP
providers when there are no Medicare-enrolled OTP providers in their
area.
    Comment: Some commenters requested clarification on how OTP
providers would bill for dually eligible individuals once Medicare
starts covering these services on January 1, 2020, including the
process for the Part B deductible to be paid by Medicaid.
    Response: Once Medicare starts covering OTP services, a Medicare-
enrolled OTP provider would bill Medicare for OUD treatment services
furnished to dually eligible individuals under Original Medicare. For
Original Medicare, if the dually eligible beneficiary has not yet met
their annual Medicare Part B deductible, Medicare will automatically
``crossover'' the claim to Medicaid to adjudicate for payment of the
deductible. In addition, please see responses to comments below for a
discussion of the process when a state is using different billing codes
than Medicare, and when an OTP provider is not yet enrolled in
Medicare.
    For OTP providers serving dually eligible individuals enrolled in
Medicare Advantage, there is no automated crossover process. For cost
sharing applicable to the OTP benefit under the MA plan, MA plans are
required by Sec.  422.504(g)(1) to specify in their contracts with
providers that such dually eligible enrollees will not be held liable
for Medicare Part A and Part B cost sharing when the State is
responsible for paying such amounts, and to inform providers of
Medicare and Medicaid benefits, and rules for enrollees eligible for
Medicare and Medicaid. We understand most MA plans have not entered
into coordination of benefit agreements with state Medicaid agencies.
In these instances, the MA plan would not have any means to forward
claims for cost sharing directly to state Medicaid programs for
payment; and so an OTP provider would need to bill Medicaid directly
for the cost sharing that the provider may not collect from the
enrollee; this may also mean that the OTP provider has to re-code the
claim if the state uses different billing codes than the Medicare
Advantage plan uses.
    Comment: One commenter specifically requested that the timeframe
for state Medicaid agencies to update their respective fee schedules
match the Medicare payment methodology to prevent denials when Medicare
sends the crossover claim to Medicaid for the deductible.
    Response: State Medicaid programs often use different codes and pay
differently than Medicare. There is no requirement to match the
Medicare payment methodology, but states do need to be able to process
claims for the beneficiary's cost-sharing liability for most dually
eligible individuals. If the state uses different billing codes, its
claims processing system may initially deny the crossover claim, and
send a remittance advice to the provider notifying the provider of the
denial. The OTP provider should then re-code the claim using the
Medicaid billing codes and resubmit to Medicaid for processing.
    Comment: A few commenters suggested that CMS offer an expedited
process for receiving a Medicare denial, to provide Medicaid with proof
that Medicare will not cover the OTP services. A few other commenters
also suggested CMS make available an up-to-date-listing of Medicare
enrolled OTP providers in each state.
    Response: We agree it is important to support OTP providers and
states by providing the information needed to facilitate the process
for an OTP provider to bill Medicaid for services furnished to a dually
eligible individual, when that is permitted. Medicaid will often accept
a Medicare claims denial as proof that Medicare will not cover the
service, and will process the claim for Medicaid coverage. However,
Medicare can only process a claim from a Medicare-enrolled provider,
and thus can only issue a claims denial to a Medicare-enrolled
provider.
    As we note in our response to a prior comment, Medicaid must pay
for OUD treatment services furnished by an OTP to a dually eligible
individual when the service is covered by the Medicaid state plan and
the OTP provider is enrolled in Medicaid, but is not enrolled in
Medicare. We agree with the suggestion to make publicly-available and
update a list of Medicare-enrolled OTP providers so OTPs and states
have evidence that a given provider is not Medicare-enrolled. We
anticipate this information will also have value for Medicare
beneficiaries seeking OUD treatment services in OTPs. We also note that
states already have access to the CMS Provider Enrollment, Chain, and
Ownership System (PECOS) provider enrollment system, and can confirm
provider enrollment or lack thereof through queries to that system.
    Comment: Several commenters expressed concern about the
intersection of Medicaid's ``Upper Payment Limit'' (UPL) policy with
the proposed Medicare payment rates for OTP services. The commenters
noted that most states that cover OTP services have payment rates that
are higher than the proposed Medicare payment rates, and expressed a
concern that Medicaid's UPL policy requires Medicaid rates to be lower
than Medicare's. Commenters noted that unless Medicare significantly
increases its proposed rates, state Medicaid agencies would be forced
to lower theirs to comply with the UPL. Commenters requested that CMS
increase the Medicare rates for services furnished by OTPs to exceed
the Medicaid rate in every state, or not apply the UPL requirements to
the Medicaid OTP services.
    Response: We appreciate the concern expressed by the commenters.
However, the UPL requirements do not directly impact payment rates for
individual services such as the OUD treatment services furnished by
OTPs in the way commenters describe, and states have policy options to
address UPL-related concerns. As background, state Medicaid agencies
can opt to cover OTP services under the Medicaid clinic benefit or the
Medicaid rehabilitation benefit. The Medicaid clinic benefit is subject
to a UPL based on estimated Medicare payments, but states demonstrate
compliance with this requirement at an aggregate level across the range
of services covered under the clinic benefit as a whole for a given
year. States are not required to set Medicaid payment lower than
Medicare at a service or code-level basis. Within the UPL requirements,
states have significant flexibility in how they may pay for individual
services or codes or make payments to clinics that specialize in
providing certain types of care. As a result, states offering OTP
services under the clinic benefit would not be required to reduce their
payment rates to be less than Medicare for OTP services. We will issue
guidance reminding states that the UPL policy for the clinic benefit
applies at the aggregate level, and will work with states to determine
how to comply with the UPL if they currently cover OTP under the clinic
benefit. For states that offer OTP services under the rehabilitation
benefit, we note there is no UPL for that benefit, so the Medicare
[[Page 62671]]
payment rate for OTP services does not impact Medicaid payment for
those states. As a result, there is no need to adjust the Medicare
payment rates for OUD treatment services furnished by OTPs that we are
adopting in this final rule to address this concern.
    Comment: One commenter suggested CMS provide guidance to states on
what the Medicare OTP benefit does and does not cover, to facilitate
Medicaid covering specific OTP services for dually eligible individuals
that Medicare does not cover.
    Response: We acknowledge that states may have a more expansive
benefit for services provided by OTPs than Medicare's, and that in
those situations, states may continue to cover specific OTP services
that Medicare does not. To support a smooth transition, we will provide
guidance to states to describe the Medicare OTP benefit and remind them
that Medicaid may still cover specific OTP services not covered under
the Medicare OTP benefit.
    Comment: Several commenters suggested that CMS conduct significant
outreach on coordination of benefits; that is, how Medicare will be
primary payer and Medicaid will be secondary payer for dually eligible
individuals. One commenter further suggested that OTP providers should
receive training and technology to facilitate screening patients for
Medicare, as well as Medicaid, eligibility and enrollment.
    Response: We agree with the need for significant outreach to OTP
providers regarding coordination of benefits, and are collaborating
with SAMHSA--which certifies OTP providers--to do so. We will explore
options around providing technical assistance on connecting eligible
clients to Medicare and Medicaid coverage.
    Comment: One commenter suggested that as part of supporting the
transition from Medicaid to Medicare coverage of OTP services, CMS
issue guidance to remind states to continue transportation coverage for
full benefit dually eligible individuals receiving services under the
Medicare OTP benefit.
    Response: As noted elsewhere, Medicare is the primary payer for
services that are payable by both Medicare and Medicaid. However,
Medicare has a limited non-emergency ambulance transportation benefit.
If a full benefit dually eligible individual is obtaining a Medicaid-
coverable benefit for which Medicare is the primary payer, the state
must assure, in certain circumstances, transportation to the medical
service (in the limited instances in which Medicaid does not cover a
service Medicare covers, it is optional for states to cover
transportation). As a result, when states cover OTP services, and when
the applicable criteria are met, Medicaid must assure non-emergency
medical transportation for full benefit dually eligible individuals
obtaining Medicare-covered OTP services.
    Comment: Several commenters supported the proposal to initially set
the copayment for OTP services zero, but requested that this policy be
made permanent for dually eligible individuals.
    Response: We will consider issues on future copayment rates, and on
keeping the zero copayment for dually eligible individuals, as part of
any future rulemaking on the cost-sharing requirements for the benefit
as a whole.
    Comment: A commenter raised concerns regarding the January 1, 2020
implementation date for the OTP benefit due to implementation barriers.
The commenter stated that MAOs need final payment codes, payment
information and clarity regarding any benefit caps or other benefit
limits. The commenter further stated that MAOs need additional time to
finalize contracting systems and to develop operational details for the
benefit.
    Response: Although we understand the concern, we do not plan to
delay the implementation of this benefit due to the acute need for the
OUD treatment services furnished by OTPs. We will work closely with
MAOs to ensure timely implementation of this benefit. Plans must
provide enrollees with a level of access to Medicare-covered OTP
services that is consistent with prevailing community patterns of care
in the areas where the network is being offered (Sec.  422.112(a)(10)).
We note that, for CY 2020, Medicare Advantage plans may contract with
an OTP provider so long as the requirements for such providers (such as
licensure, certification, and other qualifications, etc.) under Titles
XVIII and XI of the Act are met. Allowing the individual to continue to
see their current provider during this transition will ensure
continuity of care for this vulnerable population.
    Comment: One commenter recommended that CMS issue a non-enforcement
or ``hold harmless'' grace period against plans for Part B vs. Part D
determinations for 2020, with respect to audits and other consequences
such as Star Ratings related to the new OUD treatment services benefit.
    Response: We do not believe it is appropriate for CMS to issue a
``hold harmless'' period regarding the implementation of the new OTP
benefit. As we have noted in other responses, we believe there is an
urgency in making this benefit available to people struggling with
opioid use disorder. CMS will work closely with organizations to ensure
a smooth implementation of this benefit. With regard to the Part B
versus Part D determination, we remind Medicare Advantage plans that
Sec.  422.112(b)(7) requires plans that also cover Part D drugs to
coordinate coverage and have a process in place to ensure provision of
the covered drug to an enrollee in a timely fashion. CMS clarifies that
buprenorphine prescribed by DATA 2000 providers outside of OTPs can
continue to be covered under Part D. The DATA 2000 and OTP programs are
designed to meet the needs of those needing opioid dependency treatment
in different ways. Therefore, because buprenorphine is still covered
under Part D when furnished outside an OTP, sponsors should not need to
implement new point of service Part B versus Part D pharmacy edits for
a buprenorphine claim. In addition, any substantive changes to the Star
Ratings measure specifications must be adopted through rulemaking per
Sec. Sec.  422.164 and 423.184.
    Comment: A commenter recommended that CMS delay the implementation
of the OTP benefit until January 1, 2021, because MA plans did not have
an opportunity to account for the new benefit in their 2020 year bids.
    Response: In the CY 2020 Call Letter released April 1, 2019
available at the following web link: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf,
CMS issued guidance to MAOs regarding section 2005 of the SUPPORT Act
and implementing the OTP benefit. In the Call Letter, CMS reminded
plans that opioid use disorder treatment services furnished by OTPs
would be covered as a Medicare Part B benefit beginning January 1,
2020. We also stated that MA organizations should prepare their bids
using available information and reiterated that MA plans must provide
all medically necessary Part A and Part B covered services to enrollees
consistent with section 1852 of the Act and the regulations in part
422. As such, MA plans were given the opportunity to account for the
new benefit in their 2020 bids and did so when bids were submitted on
June 3, 2019.
    Comment: A commenter expressed concerns that there may be
insufficient number of OTPs available in 2020 who are SAMSHA accredited
with a Medicare provider agreement to contract with MA plans.
    Response: We note that MA plans will be required to furnish access
to OTP
[[Page 62672]]
services consistent with what is available to Original Medicare
beneficiaries residing in the same geographic area. (see Sec.  422.112)
While OTPs will currently not be a specialty included in our evaluation
of MA networks, all plan covered services must be furnished consistent
with community patterns of care (see Sec.  422.112(a)(10)). This means
that a plan's enrollees, who are receiving services from an OTP, cannot
be required to travel significantly farther than the distance Original
Medicare beneficiaries are required to travel in order to access
services from the OTP. MA plans are not required to furnish
transportation to the OTP facilities as part of the OTP benefit.
However, MA plans can furnish transportation to health care services as
a supplemental benefit. In addition, as noted elsewhere, Medicaid must
assure, in certain circumstances, non-emergency transportation for a
dually eligible individual to obtain a Medicaid-coverable benefit for
which Medicare is primary payer.
    Comment: A commenter stated that, in order to administer this new
benefit, guidance is needed on which services must be covered by an MA
plan without cost-sharing and the timelines for coverage without cost-
sharing (for example, no more than 12 months of active treatment). The
commenter further stated that since OUD treatment is complex and can
vary from patient to patient, it is important that plans understand
whether there should be no cost-sharing on all components or if there
are specific nuances in how to apply the requirement.
    Response: MA plans can offer the OTP benefit consistent with the
bids which were submitted for CY 2020, including proposed cost-sharing.
We note that MA plans must assure that, in instances in which they
impose cost-sharing for the OTP benefit, providers do not bill a
Qualified Medicare Beneficiary for such cost-sharing. (see Sec.
422.504(g)(1).)
    Comment: A commenter requested clarification as to whether OTPs
will be billing Medicare Part B--that is, the FFS Medicare program--for
services furnished to Medicare Advantage enrollees.
    Response: No. OTPs that furnish Medicare covered medically
necessary services to MA enrollees will be paid by the enrollees' MA
plans. MA plans are required to furnish or cover all benefits that are
covered by Medicare Part A and Part B, excluding hospice, for their
enrollees. As previously noted, MA plans are required to contract with,
or arrange on a non-contract basis for, enrollee access to medically
necessary OTP services consistent with the community pattern of care.
MA plans may have direct contracts with OTPs in which they negotiate
the terms and conditions of payment for the Medicare-covered services
furnished by the OTP. An OTP treating an MA enrollee that does not have
a contract with the enrollee's MA plan should contact the MA plan to
confirm coverage and payment.
    Comment: A commenter requested additional information about CMS'
expectations of how the OTP benefit will be made available to Medicare
Advantage enrollees.
    Response: In the CY 2020 Call Letter released on April 1, 2019, CMS
issued guidance to MA organizations regarding section 2005 of the
SUPPORT Act and implementing the OTP benefit. In the CY 2020 Call
Letter, CMS reminded plans that opioid use disorder treatment services
furnished by OTPs would be covered as a Medicare Part B benefit by
plans beginning January 1, 2020. We also stated that MA organizations
should prepare their bids using available information and reiterated
that MA plans must provide all medically necessary Part A and Part B
covered services to enrollees consistent with section 1852 of the Act
and the regulations in part 422.
    For dually eligible individuals who may already be receiving OTP
services through Medicaid, MA plans should ensure continuity of care
for their enrollees any time there is a transition from a non-
contracted to a contracted provider. In addition, as noted above, MA
plans must assure that in instances in which they impose cost-sharing
on the OTP benefit, providers do not bill a Qualified Medicare
Beneficiary for such cost-sharing.
    Comment: A commenter asks that CMS not allow MA plans to utilize
prior authorization (PA) or step therapy for treatment of opioid
withdrawal symptoms.
    Response: MA plans may use step therapy for Part B drugs when
medically appropriate and consistent with the requirements in Sec.
422.136. We also note that when an MA plan processes a coverage request
that involves prior authorization or other utilization management
requirements, such as step therapy for Part B drugs, the plan's
determination on whether to grant approval of a service or a drug for
an enrollee constitutes an organization determination under part 422,
subpart M, and is subject to appeal. Specifically, as described at
Sec.  422.568, the MA organization must notify the enrollee of its
determination as expeditiously as the enrollee's health condition
requires. CMS is considering strategies we can use to monitor the
implementation of the OTP benefit by MA plans and any issues that may
impede access to medically necessary treatment of opioid use disorder,
including what data might be available to evaluate plan performance.
    Comment: A commenter questioned how MA-PD and Prescription Drug
Plan sponsors will know what beneficiaries are eligible for this
benefit. The commenter proposes that an option would be to provide an
indicator in the CMS Medicare Advantage and Prescription Drug data
System (MARx), with start and end dates, for beneficiary eligibility
for OTP services.
    Response: All beneficiaries needing treatment for opioid addiction
are eligible for this benefit. We appreciate the data suggestion and
will take it into consideration in our on-going implementation of the
OTP benefit.
    Comment: A commenter questioned how Medicare's managed care plan
partners are supposed to reflect the use of this new benefit in their
required data submissions.
    Response: We will furnish guidance to MA organizations and cost
plans on this topic at a later date.
    Comment: A commenter requested that since OTPs are currently
providing OUD services to Medicare beneficiaries, and that the provider
enrollment process would not start until the new Part B benefit is
available (January 1, 2020), will CMS allow for payments to OTPs for
services delivered in the 30 days prior to their successful enrollment.
    Response: As we noted in a previous response, MA plans cannot
contract or furnish the Part B OTP services through any OTP that is
SAMSHA accredited if that OTP has not yet enrolled in Medicare but the
MA plan may cover or furnish services provided by such a provider as a
supplemental benefit (Sec.  422.204(b)(3). Allowing the individual to
continue to see their current provider during this transition will
ensure continuity of care for this vulnerable population. Furthermore,
in some situations, the MA plan may be required by Sec.  422.112(a)(3)
to provide out-of-network access for the OTP benefit and we remind MA
organizations of their obligations under part 422 regulations to
furnish all Part A and Part B benefits, excluding hospice, to their
enrollees.
    Comment: A commenter noted that the Annual Notice of Change and
Evidence of Coverage (ANOC and EOC) documents can play an essential
role in updating beneficiaries as to new benefits, but the timing for
[[Page 62673]]
implementation of the OTP benefit in 2020 makes this impractical, and
instead suggested that CMS undertake a robust public education campaign
aimed directly at beneficiaries.
    Response: The SUPPORT Act became law in October 2018 and CMS issued
guidance to MA organizations in the CY 2020 Draft Call Letter (issued
in January 2019) and the CY 2020 Final Call Letter (issued in April
2019) about the requirement to cover the OTP benefit, so MA
organizations had sufficient time to plan to include the necessary
information in ANOCs and EOCs for 2020. Medicare Advantage plans are
required to include the new OTP benefit in their 2020 ANOC/EOC. We are
also implementing a comprehensive education campaign regarding the new
OTP benefit. Our public education campaign will feature CMS information
channels, education resources and outreach leveraging media/stakeholder
networks to raise awareness and engage Medicare beneficiaries.
Specifically it will include earned media (for example, drop-in article
for local/community newspapers), social media (for example, tweets and
Facebook posts), beneficiary publications, and outreach to beneficiary
partners including State Health Insurance Assistance Programs (SHIPs)
across the country, in addition to information available from 1-800-
MEDICARE and our consumer website, http://www.medicare.gov.
    Comment: One commenter requested more information about the
compliance criteria, quality metrics, and electronic health record
(EHR) requirements that will be used to evaluate OTPs, and whether OTPs
will be subject to the requirements of the Quality Payment Program.
    Response: We did not propose any compliance criteria, quality
metrics, or EHR requirements for OTPs. As OTPs are not one of the
eligible clinician types for the Quality Payment Program, they are not
able to participate in MIPS or to be a Qualifying APM Participant (QP).
However, OTPs may be able to participate in a Center for Medicare and
Medicaid Innovation payment model, depending on the eligible
participants identified for that specific model, and then would be
subject to the requirements of that specific model, which could include
quality or EHR-related requirements.
    After a thorough review of the above policy considerations
reflected in the public comments we received, we are finalizing the
proposed provisions to implement the new OTP benefit under section 2005
of the SUPPORT Act, with modifications as described above, at Sec.
410.67, part 489 and part 498.
H. Bundled Payments Under the PFS for Substance Use Disorders
1. Background and Provision
    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 proposed to establish
bundled payments for the overall treatment of OUD, including
management, care coordination, psychotherapy, and counseling
activities. We noted that, if a patient's treatment involves MAT, this
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 also proposed 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 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. We note that use of these codes is
limited to only beneficiaries diagnosed with OUD; however, we may
consider other potential bundles describing services for other
substance use disorders in future rulemaking.
    To implement this new bundled payment, we proposed 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 implanted
buprenorphine) in the office setting compared to the OTP setting. We
note that these codes should not be billed for beneficiaries who are
receiving treatment at an OTP, as we believe that would be duplicative
since the bundled payments made to OTPs cover similar services for the
treatment of OUD. Based on feedback we received through the comment
solicitation, we proposed 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 solicited comment on
whether we should consider creating a separately billable
[[Page 62674]]
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 proposed 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 nonphysician practitioner (NPP)
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 did not propose to require consultation with a specialist as a
condition of payment for these codes, but we note that consultation
with a specialist could be counted toward the minutes required for
billing HCPCS codes G2086, G2087, and G2088.
    The codes and descriptors for the services are:
     HCPCS code G2086: 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 G2087: 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 G2088: 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 G2086 and G2087, 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 G2086, G2087, and G2088 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 proposed that the add-on code (HCPCS
code G2088) 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
proposed that when the time requirement is met, HCPCS code G2088 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 solicited comment on the proposal.
    We proposed to value HCPCS codes G2086, G2087, and G2088 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 G2086, 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
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 G2086 is also based
on a crosswalk to CPT code 99492. Additionally, for HCPCS code G2086,
we proposed 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 PE described by these crosswalk
codes is analogous to the services described in HCPCS code G2086
because HCPCS code G2086 includes similar care
[[Page 62675]]
coordination activities as described in CPT code 99492 and bundles in
the psychotherapy services described in CPT codes 90832 and 90853.
    We proposed to value HCPCS code G2087 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 G2087 is also based on a crosswalk to CPT codes 99493. For HCPCS
code G2087, we proposed 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 PE described by
these crosswalk codes is analogous to the services described in HCPCS
code G2087 because HCPCS code G2087 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 proposed to value HCPCS code G2088 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 G2087 is also based on a
crosswalk to CPT codes 99493. For HCPCS code G2088, we proposed to use
a crosswalk to the direct PE inputs associated with CPT code 99494. We
believe that the work and PE described by this crosswalk code is
analogous to the services described in HCPCS code G2088 because HCPCS
code G2088 includes similar care coordination activities as described
in CPT code 99494.
    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
proposed 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 G2086, G2087, and
G2088. We solicited comments on the proposal.
    We proposed 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 proposed 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 services described by HCPCS codes G2086-G2088.
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 proposed that these visits could similarly serve
as the initiating visit for OUD services.
    We proposed that the counseling, therapy, and care coordination
described in the 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 also proposed 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, 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 proposed 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 proposed 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 proposed to allow any of the individual therapy, group therapy
and counseling services included in HCPCS codes G2086, G2087, and G2088
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 final rule regarding
[[Page 62676]]
Telehealth Services, like certain other non-face-to-face PFS services,
the components of HCPCS codes G2086 through G2088 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 G2086 through G2088 are similar to other telehealth services. If
the non-face-to-face components of HCPCS codes G2086 through G2088 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 final rule,
Telehealth Services, we proposed to add HCPCS codes G2086, G2087, and
G2088 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 services described above (HCPCS codes G2086, G2087, and
G2088), we solicited 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 final rule, Medicare Coverage
for Certain Services Furnished by Opioid Treatment Programs, we
proposed 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 using any newly 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 solicited 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 solicited feedback from stakeholders and the
public on other potential bundles describing services for other
substance use disorders for our consideration in future rulemaking.
    We received public comments on the proposed bundled payments under
the PFS for substance use disorders. The following is a summary of the
comments we received and our responses.
    Comment: Many commenters expressed support for this proposal and a
few noted that the PFS bundle would provide an opportunity to increase
access to OUD treatment for beneficiaries who live in areas without an
OTP, but also encouraged CMS to seek opportunities to more closely
align the benefit across OTP and PFS settings before it is introduced
and to monitor for any unintended responses to payment incentives,
noting differences in the number of psychotherapy sessions included.
    Response: We agree with the commenters regarding the importance of
alignment in these services when furnished in different settings and
note that we are finalizing several changes to the coding and payment
for services furnished in an OTP (see section II.G of this final rule),
which we believe more closely align the payments made by Medicare for
OUD services across settings. For example, we are finalizing using a
building block methodology to calculate the payment rate for the OTP
bundled payments using Medicare rates, including the rates for CPT
codes 90832 and 90853, which were also used to calculate the payment
rates HCPCS codes G2086, G2087, and G2088. Additionally, we are
finalizing an adjustment to the OTP bundled payments to account for
intake activities, similar to activities included in HCPCS code G2086,
which describes the initial month of treatment. In response to the
comments related to monitoring for unintended responses to payment
incentives, we note that we will be monitoring utilization of HCPCS
codes G2086, G2087, and G2088 and their interaction with other
services, as well as the codes describing bundled payments for services
furnished at OTPs.
    Comment: A few commenters commended CMS on several aspects of this
proposal and urged that the proposed codes and valuations be finalized,
and also recommended that CMS consider establishing bundled payment
amounts that recognize services for different levels of patient need
and different types of practice arrangements, including consultation
with specialists.
    Response: We thank the commenters for their statements of support.
We are finalizing the payment amounts for HCPCS codes G2086, G2087, and
G2088 as proposed. We also appreciate the commenters' views on coding
for these services, and will consider whether it would be appropriate
to create codes describing different levels of patient need and
different practice arrangements for possible future rulemaking.
[[Page 62677]]
    Comment: A few commenters recommended that CMS adjust the payment
methodology for these services to account for patient complexity/
severity using the American Society of Addiction Medicine (ASAM)
Criteria or other equivalent criteria and to account for different
types of practice arrangements and emerging technologies. These
commenters also recommended that we lower the threshold for billing the
add-on code to allow it to be billed when the OUD treatment services
described by the base code exceeds 125-150 percent of the minimum time
required to bill the base code for the month. Additionally, the
commenters recommended that CMS urge health care practitioners to
consult with physician addiction specialists, as appropriate, when
treating patients with moderate to severe OUD.
    Response: After considering public comments, we are finalizing our
proposal without modification that HCPCS code G2088 can 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 continue to 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. Additionally, we agree
with the commenter's recommendation that practitioners furnishing OUD
treatment services should consult with addiction specialists, as
clinically appropriate.
    Comment: Many commenters requested that CMS allow additional
psychotherapy services to be furnished for patients receiving treatment
for OUD or another SUD. A few commenters expressed concern that a
practitioner would not be able to bill separately for psychotherapy
services furnished to beneficiaries with OUD and a co-occurring mental
health condition, noting that in rural areas there may not be enough
behavioral health providers for a patient to be seen by separate
practitioners for SUD and mental health diagnoses.
    Response: It is not our intention to limit access to medically
necessary services through the creation of bundled payment for OUD
treatment services. We clarify that while the psychotherapy services
described by CPT codes 90832 (Psychotherapy, 30 minutes with patient),
90834 (Psychotherapy, 45 minutes with patient), 90837 (Psychotherapy,
60 minutes with patient), and 90853 (Group psychotherapy (other than of
a multiple-family group)) cannot be reported by the same practitioner
for the same beneficiary in the same month as the codes describing this
bundled episode of care, practitioners can bill for additional
psychotherapy furnished for the treatment of OUD using the add-on code
(HCPCS code G2088). In cases where psychotherapy services are furnished
for co-occurring diagnoses, any of the psychotherapy codes could be
billed, as medically reasonable and necessary. We note that
practitioners should determine which of the patient's diagnoses they
are treating is the primary one being treated during that session in
order to decide whether it is appropriate to bill separately for
psychotherapy services furnished for co-occurring diagnoses. After
reflecting on these and other comments, we also believe it is important
to modify our proposal to establish a requirement that at least one
psychotherapy service must be furnished in order to bill for HCPCS
codes G2086 or G2087. Since the new G codes incorporate the resource
costs involved in furnishing psychotherapy services into the payment
rate, we believe it is appropriate that a minimum of at least one
psychotherapy service be furnished in order to bill for HCPCS codes
G2086 or G2087. We note that not all OUD treatment necessarily require
provision of regular psychotherapy services for all patients, for
example for patients receiving MAT over a long period of time. In these
cases, we note that existing coding describing care management services
(CPT codes 99484, 99492, 99493, and 99494) and E/M services can be
billed for treatment of substance use disorders, including OUD, so we
do not believe that this requirement will inhibit access to OUD
services.
    Comment: A few commenters expressed concern that the proposed G
codes will inappropriately limit access to a variety of evidence-based,
non-opioid pain management therapies.
    Response: We note that the proposed bundled payment codes would not
preclude practitioners from furnishing or billing for other non-opioid
pain management treatments.
    In summary, after consideration of the comments, we are finalizing
HCPCS codes G2086, G2087, and G2088 with modifications to establish a
requirement that at least one psychotherapy service must be furnished
in order to bill for HCPCS codes G2086 or G2087. We are clarifying that
practitioners can bill for additional psychotherapy furnished for the
treatment of OUD using the add-on code (HCPCS code G2088) and, in cases
where psychotherapy services furnished are furnished for co-occurring
diagnoses, for any of the psychotherapy codes, as medically reasonable
and necessary.
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.
    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 bundled payment under the PFS for OUD treatment
furnished by physicians, we reviewed the applicability of RHCs and
FQHCs
[[Page 62678]]
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 G2086 and G2087,
beginning on January 1, 2020. The requirements to bill the services
would be similar to the requirements under the PFS for G2086 and G2087,
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 stated that we did not believe
that adding a new and separate code to report a bundle of OUD services
was necessary. Therefore, we did not propose to add a new G code for a
bundle of OUD services.
    We received public comments on our decision not to add a new G code
for a bundle of OUD services furnished by RHCs and FQHCs. The following
is a summary of the comments we received and our responses.
    Comment: Commenters requested that we create a new G code for RHCs
and FQHCs to bill for a bundle of OUD services. None of these comments
were from an RHC or FQHC or a representative of RHCs or FQHCs.
    Response: As we have noted, RHCs and FQHCs that provide OUD
services to their patients can bill for individual psychotherapy
services using a range of CPT codes that are billable visits under the
RHC all-inclusive rate (AIR) and FQHC Prospective Payment System (PPS)
when furnished by an RHC or FQHC practitioner. These codes can be
billed on the same day as a qualified primary care visit, and RHCs and
FQHCs can also bill for care management services and receive a payment
in addition to their AIR or PPS payment. We did not receive any
comments that lead us to conclude that a separate G code for RHCs and
FQHCs to bill for OUD services is necessary, or any comments on how
such a code would not be duplicative of existing billing mechanisms.
    After considering the comments, we are finalizing our proposal not
to establish a separate G code for OUD payments to RHCs and FQHCs. If
we become aware that a separate code would be beneficial to RHCs and
FQHCs that choose to furnish these services, we will again consider
this.
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 (NPPs) 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 in some states for
PAs regarding physician supervision. According to these commenters,
some states have already updated 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 invited 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
[[Page 62679]]
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. Summary of Proposal and Final Provisions
    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 proposed to
revise the regulation at Sec.  410.74 that establishes physician
supervision requirements for PAs. Specifically, we proposed to 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 required 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
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 NPPs as members of the medical team. As we are informed about
transitions in state law and 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 on this issue largely defers to state law and 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.
    We received public comments on the proposed physician supervision
PA services provisions. The following is a summary of the comments we
received and our responses.
    Comment: The majority of commenters supported our proposal overall,
to the extent that it considers state law and scope of practice rules
for the state in which the services are furnished, to largely conform
our interpretation of the statutory physician supervision requirement
for PA services as interpreted under regulations at Sec.  410.74(a)(2)
with the statutory physician collaboration requirement for NP and CNS
services as interpreted under regulations at Sec. Sec.  410.75(c)(3)
and 410.76(c)(3). Commenters indicated that aligning the physician
supervision requirement for PA services with the physician
collaboration requirement for NPs and CNSs would reduce practical
differences in PA and NP/CNS utilization for employers, employees,
States and even Medicare patients. They stated that deferring to state
law and scope of practice rules for supervision of PA services will
enable PAs to practice at the top of their education and expertise, and
therefore, assist the State in which they practice with meeting its
healthcare workforce needs, particularly in states that include remote
rural and underserved areas. These commenters noted that PAs are
authorized to provide medical and surgical care in all 50 States and
the District of Columbia, and are committed to increasing access to
high quality care for all, as well as continuity of care under the
changing landscape of healthcare in the U.S. Commenters from 20 States
provided evidence of changes in their state laws or scope of practice
rules to move away from references to ``physician supervision'' of PAs,
and in some cases replacing it with the term, ``physician
collaboration'' to describe the PA-physician relationship. Commenters
reported such changes in laws and rules for PA supervision in Arizona,
California, Colorado, Connecticut, Florida, Idaho, Illinois,
Massachusetts, Michigan, Missouri, Montana, Nevada, North Dakota,
Oregon, Oklahoma, Rhode Island, South Carolina, Texas, Utah, and
Virginia. PA commenters practicing in Kansas, Vermont and Wisconsin
indicated that their state laws and scope of practice rules are
currently undergoing similar changes that should be effective in 2020
or shortly thereafter. Additionally, these commenters supported CMS'
efforts to reduce practice burdens on PAs and to develop regulations
for the Medicare program that closely align with the transition in
state laws and scope of practice rules for PAs regarding physician
supervision. These commenters also noted that the changes being made to
state laws and scope of practice rules were recommended by the December
2018 Federal government report on healthcare competition entitled,
``Reforming America's Healthcare System Through Choice and
Competition'' available at https://www.hhs.gov/sites/default/files/Reforming-Americas-Healthcare-System-Through-Choice-and-Competition.pdf. The commenters directed our attention to the specific
recommendation in the report that states should consider eliminating
requirements for rigid collaborative practice and supervision
agreements that are not justified by legitimate health and safety
concerns to ensure continuity of care for American healthcare
consumers.
    Response: We appreciate the commenters' recognition of our efforts
to reduce burden on PA practice given the changes in their professional
practice since the inception of the Medicare Part B benefit category
for PAs under Medicare law. We also appreciate the commenters' support
of our proposal to consider state law and scope of practice rules
governing PA supervision as an appropriate measure by which to ensure
that the physician supervision requirement for PA services under
Medicare statute at section 1861(s)(K)(i) of the Act is met. We
particularly appreciate the feedback from commenters citing changes
that have already been made to state laws and scope of practice rules
to address evolution in PA practice. These comments are very helpful to
inform our broader understanding of the current healthcare landscape
for PAs, and to ensure that the statutory PA physician supervision
requirement continues to be met.
    Comment: Many commenters who supported our proposal to the extent
that it relates to state law and scope of practice rules for physician
supervision of PA services disagreed with our proposal to address
situations where states are silent about their scope of practice
requirements for physician supervision of PA services. Specifically,
these commenters urged us to require that, in the absence of state law
governing physician supervision of PA services, PAs should be required
to document at the practice level, rather than in the medical record,
the working relationship that they have with physicians. The commenters
expressed
[[Page 62680]]
concern that requiring PAs to document their approach in the medical
record for every patient that they treat would be a tremendous
administrative burden that would have a significantly adverse impact on
the PA's ability to deliver care. A few commenters suggested that there
should not be a requirement for PAs to document the relationship with
any supervising or collaborating physician in every patient chart
because such documentation is already provided as part of the practice
protocols for PAs that are maintained by the individual State boards of
medicine. Furthermore, some commenters recommended that, in the absence
of state law addressing physician supervision of PA services,
documentation at the practice of the working relationship that PAs have
with physicians should be required to address situations where PAs deal
with issues outside their scope of practice.
    Response: We are clarifying that it is not our intention to create
an overly burdensome and unnecessary administrative documentation
requirement governing PA physician supervision that results in a
hindrance to PA practice. We believe that, in the absence of state law,
if there is documentation at the practice which demonstrates the
working relationship that PAs have with physicians in furnishing their
professional services, then this would be adequate to ensure that the
statutory requirement for PA physician supervision is met. However, we
believe that in the absence of state law and scope of practice rules
governing physician supervision of PAs, the relationship that PAs have
with physicians in their practice should be required and documented at
the practice for all services that PAs furnish, not solely for services
outside their scope of practice.
    Comment: One commenter suggested that the PA physician supervision
requirement and the NP and CNS physician collaboration requirement
should be totally removed so that these health care professionals are
not tethered to a physician in any way. This commenter further
suggested that the removal of a physician supervision requirement would
enable PAs to be able to bill the Medicare program directly for their
services like NPs and CNSs, rather than having their services billed by
their employer as they currently are.
    Response: The Medicare statute sets forth the requirements for
physician supervision of PA services and the requirement for physician
collaboration for NP and CNS services. As such, we do not have
authority to remove those requirements. Additionally, our regulation at
Sec.  410.150(b)(15), which is based on the statutory requirements of
section 1842(b)(6)(C)(i) of the Act governing payment for PA services
requires that a PA's employer or independent contractor must bill the
Medicare program for PA services. Accordingly, we are not making
changes to requirements for Medicare Part B payment for PA professional
services in this final rule.
    Comment: Some commenters opposed the proposal overall, and
particularly the standard CMS proposed to address the PA physician
supervision requirement in the absence of state law and scope of
practice rules. These commenters stressed that by just substituting
``physician supervision'' with ``physician collaboration,'' the
proposal fails to meet the statutory physician supervision requirement
and instead relies on unnecessary variations in standards of care based
on differences in state law that are inappropriate for a federal
program. These commenters stated that the PA educational curricula are
not tailored to developing the responsibilities of PAs to perform all
medical services and procedures such as ordering appropriate diagnostic
tests and performing highly technical radiology procedures without
physician oversight and direction. They believe that physician
involvement, either through the physical presence of a physician or
availability via telecommunications technology, was necessary to ensure
that optimal patient care is not compromised. Additionally, these
commenters alluded to high-profile lawsuits against provider
organizations in the last year involving PA documentation and billing
policy where audits revealed documentation and signature challenges for
electronic medical records (EMR) systems in determining whether
physician supervision had occurred, and in distinguishing work
furnished by a physician, PA or other supplier involved in a patient's
care. They suggested that these same obstacles could potentially apply
to our proposed medical record documentation standard for PAs to
demonstrate, in the absence of state law, the relationship that they
have with physicians when furnishing their services. Overall, these
commenters stated that the current requirement we established in
regulation for a general level of physician supervision to meet the
statutory physician supervision requirement for PA services is
appropriately consistent with state laws, and enables physicians to
maintain the ultimate responsibility for managing patient care without
preempting state law and scope of practice rules or inadvertently
eliminating any physician oversight of PA services. Accordingly, these
commenters urged CMS to maintain the current regulatory standard for
general physician supervision of PA services as a clearer standard for
physician supervision across-the-board for the Medicare program, and
consistent with statutory requirements.
    Response: We appreciate the concerns that these commenters raised
about our proposal and acknowledge that the statutory requirement for
physician supervision of PA services remains in effect. Further, we
believe it is appropriate for the Medicare program to recognize and
consider the role of states in regulating medical practice and their
autonomy to establish, uphold, and enforce their laws and PA scope of
practice requirements that are uniquely appropriate for their
respective states, just as we ensure that there is appropriate
physician supervision of PA services, consistent with the requirement
under Medicare law. Additionally, we believe that the commenters'
concerns about obstacles for EMR systems to determine whether physician
supervision occurred will be mitigated by our decision, as described
above, to require in the absence of state law addressing physician
supervision of PA services that PAs must document at the practice,
rather than in the medical record, their relationship with physicians
when furnishing their professional services.
    Comment: Some of the commenters who opposed our proposal to require
that PAs must document how they handle physician supervision of their
services in the absence of state law recommended that we remove the
documentation standard as proposed and replace it with a standard that
imposes a requirement that PAs work within a health care team led by a
physician, given that they believe no state allows PAs to practice
independently without any physician supervision or collaboration.
    Response: We appreciate this suggestion about how to ensure that
physician supervision of PA services occurs in states that are silent
about this requirement in their laws or scope of practice requirements
for PA professional services. However, we disagree with the commenters'
suggestion that, where state law or scope of practice requirements do
not address physician supervision of PA services, we should not adopt
the proposed requirement that PAs document their approach to working
with physicians. We believe it is
[[Page 62681]]
important to continue to ensure that the statutory requirement for
physician supervision of PA services is met. We also disagree with the
commenters' suggestion that we should impose specific requirements that
PAs must practice as part of a physician-led health care team. Based on
information provided by other commenters, it seems clear that the way
PAs practice is evolving, and that state laws and scope of practice
rules are being modified to embrace that change. We believe our role
and responsibility is to ensure continued compliance with Medicare
statutory requirements without placing undue limitations on changes in
PA medical practice. As such, we will recognize and consider state law
and scope of practice rules principally to ensure that physician
supervision occurs without mandating under our regulations that PAs
work within a health care team led by a physician.
    Comment: Commenters posed various questions about PA services that
are outside the scope the proposals we included in the CY 2020 PFS
proposed rule. These comments pertained to issues such as PA
supervision requirements for both SAMHSA-designated physicians and PAs
when furnishing medically-assisted treatment (MAT) services to patients
with opioid use disorder; physician supervision requirements for PAs
when furnishing services in PA-directed rural health clinics; hospice
physician supervision requirements for PAs and the presence of hospice
Medical Directors; extending the same considerations for PA physician
supervision requirements to pharmacists when furnishing their services
incident to the professional services of physicians; and, the Medicare
payment implications under this proposal for PA services.
    Response: We did not propose changes to the regulations regarding
PA services other than the provision that generally addresses the
statutory requirement for physician supervision of PA services.
Therefore, we are not addressing these other issues in this final rule.
    After considering the public comments, we are finalizing our
proposal on PA physician supervision, with modifications as described
above, to require under Sec.  410.74(a)(2) the following:
     That a PA must furnish their professional services in
accordance with state law and state scope of practice rules for PAs in
the state in which the PA's professional services are furnished. Any
state laws or state scope of practice rules that describe the required
practice relationship between physicians and PAs, including explicit
supervisory or collaborative practice requirements, describe a form of
supervision for purposes of section 1861(s)(2)(K)(i) of the Act.
     For states with no explicit state law or scope of practice
rules regarding physician supervision of PA services, physician
supervision is a process in which a PA has a working relationship with
one or more physicians to supervise the delivery of their health care
services. Such physician supervision is evidenced by documenting at the
practice level the PA's scope of practice and the working relationships
the PA has with the supervising physician/s when furnishing
professional services.
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 Change Request
(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).
    As stated in the CY 2020 PFS proposed rule, we are aware that
nonphysician practitioners (NPPs) 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 NPPs 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
[[Page 62682]]
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 NPP 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
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. Proposed Provisions and Summaries of and Responses to Public
Comments
    After considering the concerns expressed by these stakeholders, we
noted in the CY 2020 PFS proposed rule that 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 proposed 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. We
explained that this principle would apply across the spectrum of all
Medicare-covered services paid under the PFS. We noted that because the
proposal is intended to apply broadly, we proposed 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.
    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 proposed 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.'' We noted that
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 also
noted 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 would 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 also proposed 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 received public comments on the proposed Review and Verification
of Medical Record Documentation provisions. The following is a summary
of the comments we received and our responses.
    Comment: Many commenters supported the premise for this
documentation proposal which they stated almost unanimously would
relieve burdensome documentation requirements for PAs, NP, CNSs, and
CNMs who are authorized providers under Medicare Part B in that it
would minimize ``note bloat'' and clinician burnout, and would allow
clinicians to focus their limited time instead on patient care. The
commenters stated that enabling physicians other than teaching
physicians, PAs and APRNs who furnish and bill 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 is forward-thinking,
reflective of the professional healthcare setting and, it eliminates
disparities in clinical training opportunities so that a student's
experience ranks more than shadowing. The commenters noted that
recognizing PA and APRN preceptors in the same manner as teaching
physicians regarding student medical record documentation would advance
access to quality care for Medicare beneficiaries particularly in rural
and underserved areas by granting clinical training opportunities to PA
and APRN students. Additionally, these commenters expressed support for
this documentation proposal because they believed it would remove the
disparity in burden reduction between physicians and clinicians such as
PAs and APRNs and, instead would lead to parity for all suppliers of
Medicare services paid under the PFS. The commenters also noted that
another advantage of these documentation requirements is that they will
lead to electronic health records (EHRs) being less cluttered with
repetitive notes of little additional clinical use, making more
meaningful
[[Page 62683]]
information easier for physicians and clinicians to identify while
offering greater certainty to medical team members and Medicare
Administrative Contractors (MACs) alike.
    Response: We appreciate the insight provided by commenters about
how the broad flexibility under our proposal would enhance the clinical
training opportunities and experience for other physicians, PAs, APRNs
and their students while still maintaining the integrity of the
information documented in the medical record as it is reviewed and
verified by the billing practitioner.
    Comment: A commenter supported the merit of the broad flexibility
provided under the medical record documentation proposal and suggested
that we could improve our proposal by including certified registered
nurse anesthetists (CRNAs) and their students under this proposal
because CRNAs are also included under the nursing industry's ``APRN''
umbrella. The commenter pointed out that the proposal currently
includes NPs, CNSs and CNMs, which are three out of the four categories
of APRNs. However, this commenter stated that CRNAs should also be
included under this proposal, because not only are CRNAs considered
APRNs, they are also authorized by Medicare to furnish and bill for E/M
services and all medically necessary services within their state scope
of practice. CRNAs regularly complete comprehensive E/M documentation
for patients, which is also well within their scope of practice.
Accordingly, the commenter believed that since this criterion was a
factor in proposing the medical record documentation policy for PAs,
NPs, CNSs and CNMs, CRNAs should be included under this policy.
    Response: We appreciate the commenter bringing to our attention
that CRNAs are another type of clinical nurse that the nursing industry
recognizes as an APRN, and that the commenter believed should be
included under this medical record documentation proposal. The
regulations at Sec.  410.69 interpret the statutory CRNA benefit
category at section 1861(bb)(1) of the Act to authorize Medicare Part B
payment to CRNAs for anesthesia services and related care that CRNAs
are legally authorized to perform by the state in which the services
are furnished. We also acknowledge that some states license CRNAs to
furnish E/M services as part of the ``related care'' services
authorized under their Medicare Part B benefit category. Upon further
reflection, we agree that it is appropriate to include CRNAs and their
students, as well as other members of their health care team, for
purposes of the medical record documentation proposal.
    Comment: Several commenters suggested that CMS specifically name
the types of students that it intends to include as those who are
eligible to make notes in the medical record documentation in order to
avoid unnecessary confusion by obscuring the intended scope of students
as ``other members of the medical team.'' These commenters stated that
explicitly naming the types of clinicians and students for which the
documentation they add can be reviewed and verified by the billing
professional would eliminate misinterpretation on the part of health
systems, care providers, and educators, and would improve both clinical
training opportunities and, ultimately, patient care.
    Response: We acknowledge that uncertainty in the healthcare
industry and for MACs about the specific types of students who were
allowed to make notes in the medical record which teaching physicians
could review and verify without re-documenting was a factor we
considered in proposing to revise the documentation requirements in the
CY 2020 PFS proposed rule. We find the comment to be persuasive
regarding the need for us to be more explicit regarding the flexibility
we intend to establish for other physicians, PAs and APRNs and their
students. Given that the initial impetus for our proposal was to
address potential confusion about our reference in a manual provision
to ``students,'' we would not want to generate any further potential
for confusion with this policy. In making our proposal, we referred not
only to medical students, but more broadly to students in the
disciplines of the clinicians who are authorized to bill the Medicare
program for a broad spectrum of health care services, including all
level E/M services. We agree with the commenters that it is important
to be clear about the scope of this policy and, therefore, we will
modify our proposal to explicitly list the types of students for which
the medical records documentation policy applies rather than using a
generic reference to ``students.'' Therefore, at Sec. Sec.  410.20,
410.69, 410.74, 410.75, 410.76 and 410.77, we will modify our proposed
amendments to the regulation to specify the types of students who may
make notes in the medical record that may then be reviewed and
verified, rather than re-documented, by the billing clinician.
    Comment: Several commenters suggested that CMS specify that
physicians, PAs, and APRNs may sign off on only those notes in the
medical record made by someone of their same provider type or
discipline. For example, a PA may only review and verify information
included in a patient's chart by another PA or PA student. One of these
commenters stated that CMS should withhold any documentation
requirement changes until the agency establishes guidelines in future
rulemaking that clarify the circumstances under which a clinician would
be permitted to review and verify medical record documentation.
Conversely, a few of these same commenters questioned the proposal and
stated that it is unclear whether a PA or APRN can sign off on any
resident or student documentation regardless of their credential level.
For example, a PA would be able to attest and bill for work that was
performed by a senior resident who is training to become a medical
doctor. A few of these commenters warned that scope of practice laws
may impose documentation requirements that lead to physicians and
clinicians only reviewing documentation of their own student types and
not that of other disciplines. Furthermore, the commenters stated that
the teaching physician services requirements do not permit PAs and
APRNs to formally act as teaching physicians.
    Response: We did not propose any limitations that would restrict a
billing professional to only reviewing and verifying documentation in
the medical record entered by health care team members practicing or
training within their same specialty or discipline. We believe that
this type of limitation on our proposal would defeat our intended
purpose to provide broad flexibility, establishing a generalized
principle for medical record documentation for all professional
services paid under the Medicare PFS in all settings. Therefore, we
disagree with the commenters' recommendation, and are not finalizing
restrictions on the scope of medical record documentation entered by
members of the medical team that can be reviewed and verified by the
billing professional. Additionally, our documentation proposal does not
address any applicable billing or payment requirements for the work or
services that others furnish in connection with the professional
services that are billed by teaching physicians, other physicians, PAs
or APRNs. Rather, our proposal is limited to addressing who is
authorized, for purposes of the Medicare program, to review and verify
documentation in the medical record entered by certain individuals,
without having to re-document the information.
[[Page 62684]]
    Comment: Similarly, several commenters representing physicians
supported making the proposed changes to medical record documentation
requirements for physicians only, and not for PAs and APRNs. They
stated that only physicians submitting a claim for services are
responsible and appropriately trained to review and verify
documentation in the medical record provided by physicians, residents,
nurses, students, or other members of the medical team across the
spectrum of all Medicare-covered services paid under the PFS. They
maintained that safeguards must be in place to ensure the medical
record includes accurate documentation of clinical findings,
treatments, and ongoing care plans by all members of the medical team.
    Response: We note that the billing professional, in submitting a
claim to Medicare for services paid under the PFS, is responsible for
the accuracy of the information included on that claim. While we
appreciate the perspective of these commenters, stakeholders and other
commenters have made it clear to us that the role of PAs and APRNs has
changed to the point that our current regulations present an unintended
burden for billing practitioners, unnecessarily requiring them to re-
document information entered into the medical record by physicians,
residents, nurses, students, and other members of the medical team when
it would be sufficient for them to simply review and verify it.
Therefore, we are not establishing a requirement in this final rule
that only a billing physician may review and verify documentation in
the medical record added by physicians, residents, nurses, students,
and other members of the medical team.
    Comment: Commenters requested clarification about whether multiple
students and residents can enter documentation into the medical record
on the same day and during the same office visit. One commenter stated
that, currently, MACs or auditing agencies will deny PA or APRN
services when furnished on the same day as a service billed by a
physician regardless of the physician's specialty.
    Response: We appreciate the information and suggestion provided by
these commenters. We did not propose a limitation on how many members
of the medical team can enter information in the medical record for a
given date of service or patient encounter, and do not believe such a
limitation is warranted. We did not address the scope of services that
can be billed for a patient on the same date of service. Therefore,
this aspect of the comment is outside the scope of the proposed rule
and we will not address it in this final rule.
    Comment: Several commenters encouraged CMS to re-examine the
current requirements regarding documentation of the billing
practitioner's physical presence and participation in certain E/M
services and procedures. The commenters stated that this physical
presence and participation requirement results in significant burden
for teaching physicians and PA and APRN preceptors when their students
are participating in patient care. These commenters stated that while
physical presence and participation of physicians and practitioners in
the clinic is critical for safe patient care, presence in the
examination room during documentation is onerous and unnecessary. The
commenters also noted that this requirement greatly diminishes the
learning experience for students, as they do not develop the ability to
think or operate independently, formulate diagnoses, and generate
treatment plans, producing less experienced graduate clinicians who are
not as prepared as they could be to provide care on their own.
    Response: We did not propose any changes to requirements pertaining
to the documentation of physical presence and participation for certain
E/M services and procedures at Sec. Sec.  415.172 and 415.174, and we
are not addressing these requirements in this final rule.
    Comment: A commenter questioned whether this proposal recognizes
``scribes'' other than a medical assistant or a registered nurse for
purposes of entering notes in a patient's medical record. The commenter
defined a scribe as an independent individual assisting a single care
provider, and expressed concern that utilizing clinical support staff
as a scribe to document services will lead to dissatisfaction of
employees and loss of clinical support staff, which would adversely
affect the shortage in clinical support staff that already exists.
Likewise, a commenter suggested that CMS should explicitly include
dieticians and nutritionists among the other members of the medical
team who are eligible to enter notes in the medical record.
    Response: We proposed broad flexibility for teaching physicians,
other physicians, PAs and APRNs to use their discretion in identifying,
for each particular case, the individuals who are serving as members of
the medical team, potentially including scribes, dieticians,
nutritionists, or other members of their medical team. Although we are
modifying our proposal to clarify the scope of students that may be
considered members of the medical team for purposes of this
documentation policy as explained above, we intentionally did not
propose to specify who can be included as a member of the medical team.
    Comment: One commenter questioned whether their assumption is
correct that this proposal applies to all types of services (that is,
procedures, E/M services, and diagnostic services).
    Response: The commenter's assumption is accurate; our proposed
medical record documentation policy would apply broadly to all services
of physicians, PAs and APRNs, regardless of the type of service (E/M,
procedure, diagnostic test) or the setting in which the service is
furnished.
    Comment: We received a number of comments that were outside the
scope of the CY 2020 PFS proposed rule.
    Response: We appreciate and will consider these comments for other
purposes including possible future rulemaking.
    After considering the comments, we are finalizing our proposal with
a couple of modifications. We are explicitly naming PA and NP, CNS, CNM
and CRNA students as APRN students, along with medical students, as the
types of students who may document notes in a patient's medical record
that may be reviewed and verified rather than re-documented by the
billing professional; and revising Sec. Sec.  410.20, 410.69, 410.74,
410.75, 410.76, 410.77, 415.172 and 415.174 to reflect this change.
Additionally, similar to the revisions we are making to the regulations
at Sec. Sec.  410.20, 410.69, 410.74, 410.75, 410.76, 410.77, 415.172
and 415.174, we are amending our regulation at Sec.  410.69 to add a
new paragraph (5) under the definition of CRNA to include CRNAs as a
category of APRNs for purposes of this policy, and to include CRNA
students under the reference to APRN students.
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
[[Page 62685]]
practitioner, their clinical staff, or both (see Table 19). 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.
[GRAPHIC] [TIFF OMITTED] TR15NO19.026
    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 final rule, we continue our ongoing work in this area through code
set refinement related to TCM services and CCM services, in addition to
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. 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, a recent
analysis of TCM claims data by Bindman and Cox \81\ found that use of
TCM services is low when compared to the number of Medicare
beneficiaries with eligible discharges. 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
medically necessary TCM services could positively affect patient
outcomes.
---------------------------------------------------------------------------
    \81\ 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 the proposal designed to increase utilization of TCM
services, we considered factors that could contribute 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 furnishing these
services.
    We focused initially on the requirements for billing TCM services.
In reviewing 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 could not 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. 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. Additionally, many of the codes
were not separately payable or covered under the PFS so even if they
had been reported for PFS payment, they would not have been paid
separately (see, for example, 77 FR 68985).
[[Page 62686]]
    In response to those initial 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 are either
bundled, noncovered by Medicare, or invalid for Medicare payment
purposes. Table 20 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 CY 2020 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 do
not substantially overlap with TCM services and should be separately
payable alongside medically necessary 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.
    After review of the services described by the 14 HCPCS codes, we
determined that the 14 codes, when medically necessary, may complement
TCM services rather than substantially overlap or duplicate services.
We also believed removing the billing restrictions associated with the
14 codes might increase use of TCM services.
[GRAPHIC] [TIFF OMITTED] TR15NO19.027
    Thus, with the goal of increasing medically appropriate use of TCM
services, we proposed to revise our billing requirements for TCM by
allowing TCM codes to be billed concurrently with any of these 14
codes. In the proposed rule, we solicited comment on four questions
related to current billing policies. They included:
     Does overlap of services exist, and if so, which services
should be
[[Page 62687]]
restricted from being billed concurrently with TCM?
     Does overlap depend upon whether the same or a different
practitioner reports the services; we note that CPT reporting rules
generally apply at the practitioner level?
     Should our policy differ based upon whether the same or
different practitioner reports the services?
     Does 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) overlap with TCM or
should it be reportable and separately payable in the same service
period?
    The second part of our analysis examined how current payment rates
for TCM might negatively affect the appropriate utilization of TCM
services, an idea proposed by Bindman and Cox. Although we sought
comment previously about factors affecting utilization of CCM and TCM
services, we received too few comments related specifically to TCM to
know if payment affected use of the service.
    As part of a regular RUC review of new technologies or services
during 2018, 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. 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 TCM codes, the RUC recommended a slight
increase in work RVUs for both codes. We believe the results from the
new survey better reflect the work involved in furnishing TCM services
as care management services. Thus, also for CY 2020, we proposed 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 did not propose any
PE refinements to the TCM codes.
    We received public comments to our proposed policies and questions.
The following is a summary of the comments we received.
    Comment: With regard to the questions about billing requirements,
most commenters wrote in support of our proposal to remove billing
restrictions associated with the 14 codes that, at present, cannot be
billed concurrently with TCM. A few commenters indicated that overlap,
if it does exist, is minimal. Some commenters cautioned that our
suggested change to billing might cause increased confusion for payers
other than Medicare and suggested that CMS instead work with the CPT
Editorial Panel to review and possibly revise the restrictions. In
response to our questions about overlap in services, commenters
reported that overlap is not dependent upon whether the same or a
different practitioner reports the services. Commenters added that
policy should not be based upon what practitioner reports the services.
Finally, commenters expressed support for allowing CPT code 99491
(Chronic care management services, provided personally by a physician
or other qualified healthcare professional, at least 30 minutes of
professional time per calendar month) to be reportable and separately
payable in the same service period as TCM.
    Response: We thank the many commenters for their comments regarding
ways to increase utilization of TCM services. Our goal in proposing to
remove the current billing restrictions was to increase appropriate
utilization of TCM services, particularly in light of the potential
benefits noted by Bindman and Cox. Since publication of the CY 2020 PFS
proposed rule, we have identified two chronic care management codes,
CPT codes 99490 and 99491 that are not listed in the TCM section of the
CPT manual as being restricted from concurrent billing. However, in the
care management section of the 2019 CPT Manual, prefatory language
indicates that neither CPT code 99495 nor 99496 (see, page 50) can be
billed during the same month as CPT code 99490. Given our proposal to
remove current billing restrictions, we believe that both CPT codes
99490 and the new 99491 should be added to the list of care management
codes that can be billed concurrently with TCM when relevant and
medically necessary.
    We continue to believe that revising the billing requirements and
allowing TCM codes to be billed concurrently with codes currently
restricted will help to achieve our goal and may result in other payers
implementing similar changes. Additionally, this change may lead the
CPT Editorial Panel to consider revising the current prohibitions on
billing TCM with certain codes.
    Comment: Commenters uniformly recommended that CMS finalize the
increased valuations for the two TCM codes. Commenters expressed
support for the agency's goal of increasing utilization of medically
necessary TCM services given the potential benefits the services
provide to patients as noted by Bindman and Cox.
    Response: We believe that adopting the RUC-recommended increase in
valuation of the work RVUs will support our goal of increasing
medically necessary TCM services.
    After considering public comments on our questions and proposals,
and in light of our goal of increasing utilization of TCM services, we
are finalizing our proposal to allow concurrent billing of the care
management codes currently restricted from being billed with TCM. This
includes allowing concurrent billing of TCM with the 14 codes specified
in Table 20, as well as CPT codes 99490 and 99491, which we have
identified as codes that also fit this policy. We are finalizing for
both TCM codes the proposed increases in work RVUs and the RUC-
recommended direct PE inputs. We look forward to working with the
public and other stakeholders to potentially further refine our billing
policies through future notice and comment rulemaking.
3. Chronic Care Management (CCM) Services
    CCM services are comprehensive care coordination services per
calendar month, furnished by a physician or nonphysician practitioner
(NPP) managing overall care and their clinical staff, for patients with
two or more serious chronic conditions. There are currently two general
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). Tables 21 and 22 list the
applicable current codes (abbreviated) and provide a high-level summary
of the CCM service elements. We refer readers to the following website
for more comprehensive information regarding the CCM codes and the
existing requirements for billing them to the PFS, available on our
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
[[Page 62688]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.028
[GRAPHIC] [TIFF OMITTED] TR15NO19.029
    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.\82\ 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 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
[[Page 62689]]
and help ensure that beneficiaries who need CCM services have access to
them. Accordingly, we proposed the following changes to the CCM code
set for CY 2020.
---------------------------------------------------------------------------
    \82\ 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 (QHP). 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 (see below). Some
stakeholders continue to recommend that we should create an add-on code
for non-complex CCM performed by clinical staff, such that these
services would be defined and valued in 20-minute increments of time
with additional payment for each additional 20 minutes of clinical
staff time spent performing care management activities.
    We agreed that coding changes that identify additional time
increments may improve payment accuracy for non-complex CCM.
Accordingly, we proposed 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 have described the initial 20
minutes of clinical staff time, and the second G code would have
described each additional 20 minutes thereafter. We intended 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 said we would consider adopting any CPT
code(s) once the CPT Editorial Panel completes its work. We
acknowledged 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 solicited 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 proposed 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 proposed a work RVU of 0.61 for HCPCS code GCCC1,
which we crosswalked from CPT code 99490. We believed these codes would
have a similar amount of work since they would have the same intra-
service time of 15 minutes.
    We proposed 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 proposed a work RVU of
0.54 for HCPCS code GCCC2 based on a crosswalk to CPT code 11107
(Incisional biopsy of skin (e.g., 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 believed would accurately reflect the work associated with
each additional 20 minutes of CCM services. Both codes would have the
same intraservice time of 15 minutes. We noted 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,
we believed CPT code 11107 shared a similar work intensity to proposed
HCPCS code GCCC2. Furthermore, although HCPCS codes GCCC1 and GCCC2
would share the same intraservice time, add-on codes may have lower
intensity than the base codes because they describe the continuation of
an already initiated service.
    We solicited public comment on whether we should limit the number
of times HCPCS code GCCC2 could be reported in a given service period
for a given beneficiary. It was 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 already be described under
existing coding for complex CCM. We believed 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 noted that complex CCM already describes (in part) 60 or
more minutes of clinical staff time in a service period. We solicited
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.
    Comment: Several commenters supported the proposed add-on HCPCS
code GCCC2, and recommended that there be a limit on its use
(frequency) to keep non-complex CCM distinct from complex CCM. These
commenters stated that patients requiring multiple uses of the add-on
service likely require the moderate to high medical decision making of
complex CCM. Other commenters stated that, while they have patients who
do not require the complex
[[Page 62690]]
medical decision making that is part of complex CCM, care management
for these patients is time-consuming and would require 60 or more
minutes of non-complex CCM clinical staff time within a service period.
These commenters suggested that limiting the frequency of reporting
HCPCS code GCCC2 to twice during a service period allows for accurate
payments, while preventing inappropriate use of the code. The Medicare
Payment Advisory Commission (MedPAC) expressed support for the proposed
add-on code for non-complex CCM because it would better reflect the
resources involved in furnishing care management services and increase
payment accuracy for CCM. Other commenters stated that G codes would
help to facilitate earlier implementation and would ease transition to
any updates made to CPT codes.
    However, a number of commenters were not supportive of the
introduction of temporary G codes within the CCM code set, believing it
would produce administrative burden and cause confusion. These
commenters stated that in September 2019 the CPT Editorial Panel was
considering an application for similar changes to refine the code set.
These commenters urged us to work with the CPT Editorial Panel
regarding changes to the CCM code set and its revaluation. A few
commenters suggested that CMS could achieve its burden reduction goals
by continuing to recognize CPT codes 99490, 99487, and 99489 and also
provide CMS-specific guidance for those codes for purposes of billing
Medicare.
    Response: We are not finalizing our proposal to create HCPCS codes
GCCC1 (or GCCC3 or GCCC4, see below) in consideration of commenters'
concerns that the introduction of temporary G codes replacing most of
the CCM code set would create administrative burden, especially in
light of the CPT Editorial Panel's currently ongoing work in this area.
However we are finalizing GCCC2 (the add-on for non-complex CCM
clinical staff time), henceforth referred to as G2058, because this
code addresses what we believe is an important gap in the current code
set that should be addressed more immediately, and that finalizing only
this single G code rather than the full range of proposed G codes will
allow payment for these services while creating significantly less
administrative burden. Practitioners who choose to use G2058 can report
the initial 20 minutes of non-complex CCM under CPT code 99490 and
receive increased payment for their work under G2058. We are
sympathetic to commenters' concerns that the introduction of temporary
replacement G codes across the CCM code set may introduce substantial
confusion or administrative burden, but we believe a single new G code
to pay more for additional 20-minute increments of non-complex CCM
clinical staff time is important to pursue now. We are finalizing the
work RVU for G2058 as proposed.
    We agree with commenters that there should be a frequency limit on
the reporting of HCPCS code G2058 to maintain the distinction between
complex and non-complex CCM and, in response to comments, we are
finalizing that HCPCS code G2058 will be reportable a maximum of two
times within a given service period for a given beneficiary. We believe
the availability of this G code will further our policy goals to
improve payment accuracy for care management services and allow
practitioners and their teams to spend more time with their patients.
    Comment: A few commenters suggested that CMS should revalue the
work RVUs for the CCM codes given that we proposed to increase the work
RVUs for TCM, and CCM was originally valued based upon the RVUs for
TCM.
    Response: We appreciate these suggestions but, given the ongoing
work of the CPT Editorial Panel regarding these codes, we will consider
potential revaluation of this code set in the context of any future
changes or recommendations that may be made by the CPT Editorial Panel
or the RUC.
b. Complex CCM Services (CPT Codes 99487 and 99489, and HCPCS Codes
GCCC3 and GCCC4)
    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
and establishment or substantial revision of the care plan.
Specifically, the CPT codes for complex CCM include in the code
descriptors a requirement for establishment or substantial revision of
the comprehensive care plan. 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 proposed 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
believed 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 believed it is unnecessary as a means of
distinguishing eligible patients. Instead of CPT code 99487, we
proposed 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 proposed a work RVU
of 1.00 for HCPCS code GCCC3, which is a crosswalk to CPT code 99487.
    Instead of CPT code 99489, we proposed 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
[[Page 62691]]
management services of less than 30 minutes additional to the first 60
minutes of complex chronic care management services during a calendar
month)). We proposed a work RVU of 0.50 for HCPCS code GCCC4, which is
a crosswalk to CPT code 99489.
    We intended 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 stated that we would consider
adopting any new or revised complex CCM CPT code(s) once the CPT
Editorial Panel completes its work. We acknowledged 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 solicited 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.
    Comment: While expressing general support for the proposed changes
to these codes to remove the element of substantial care plan revision,
several commenters expressed concerns that the temporary introduction
of G codes would produce administrative burden and cause confusion.
These commenters stated that in September 2019 the CPT Editorial Panel
was considering an application for similar changes to refine the code
set and clarify care planning. These commenters urged us to work with
the CPT Editorial Panel regarding changes to the CCM code set and its
revaluation. However, other commenters stated that G codes would help
to facilitate earlier implementation and would ease transition to any
updates made to CPT codes. A few commenters suggested that CMS could
achieve its burden reduction goals by continuing to recognize CPT codes
99490, 99487, and 99489 and also provide CMS-specific guidance for
those codes for purposes of billing Medicare.
    Response: We are not finalizing our proposal to create HCPCS codes
GCCC3 and GCCC4 in light of concerns raised by commenters, especially
in light of the CPT Editorial Panel's currently ongoing work in this
area and the concerns expressed by those that we expect would likely
provide these services. Instead, given the support for our proposed
care planning changes, for CY 2020 we will continue to recognize CPT
codes 99487 and 99489, but with a different care planning element for
purposes of billing Medicare. Beginning in CY 2020, for PFS billing
purposes for CPT codes 99487 and 99489, we will interpret the code
descriptor ``establishment or substantial revision of a comprehensive
care plan'' to mean that a comprehensive care plan is established,
implemented, revised, or monitored. This will allow for consistency in
the care planning service element of complex CCM and non-complex CCM
services provided by clinical staff. While we usually create G codes
with alternative code descriptors when our payment policy varies from
what is included in a CPT code descriptor(s), the change we proposed
for the complex CCM care plan code descriptor is a relatively minor
modification to the CPT code descriptor that we believe can be
accomplished without the use of G codes. We look forward to reviewing
any refinements or other recommendations for these services that may
come from the CPT Editorial Panel and the RUC, and will consider such
recommendations through our rulemaking process.
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
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. In our CY 2020 PFS proposed rule, we
noted 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 proposed 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 believed
simpler language could 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
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.
    We proposed new language to 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.
[[Page 62692]]
    We welcomed 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.
    Comment: Commenters largely supported CMS' proposed definition of
the typical care plan, and stated that it was simpler than the current
definition and also comprehensive.
    Response: We thank the commenters for their support and are
finalizing our proposed changes to the typical care plan for all CCM.
We are eliminating 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 inserting the phrase ``interaction and
coordination with outside resources and practitioners and providers.''
The new language will 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 anticipate that this change will reduce burden and simplify the
important work of interacting and coordinating with resources external
to the practice.
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 proposed separate coding and payment
for Principal Care Management (PCM) services, which describe care
management services for one serious chronic condition. A qualifying
condition will typically be expected to last between 3 months and 1
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.
    Although we did not propose any restrictions on the specialties
that could bill for PCM, we expect that most of these services will 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 will 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 will be billed when a single condition is of such complexity
that it cannot 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. Although 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 will still oversee the overall care for the patient
while the practitioner billing for PCM services will 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 will also be able to bill for PCM services.
We proposed 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
will 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 proposed to make separate payment for PCM services
via two new G codes: HCPCS code G2064 (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
G2065 (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
[[Page 62693]]
medication regimen, and/or the management of the condition is unusually
complex due to comorbidities). HCPCS code G2064 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 single high risk disease or complex chronic condition.
HCPCS code G2065 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 G2064, we proposed 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
G2064 and the physician work is of similar intensity. Therefore, we
proposed a work RVU of 1.28 for HCPCS code G2064.
    For HCPCS code G2065, we proposed 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 will be the same. Therefore, we proposed a work RVU of 0.61
for HCPCS code G2065.
    Although we proposed 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 solicited 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 acknowledged that we concurrently proposed revisions for both
complex and non-complex CCM services. Were we not to finalize the
changes for both complex and non-complex CCM services, we stated our
belief 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 solicited
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.
    Comment: Most commenters supported separate payment for PCM
services, noting the gap in payment for care management and
coordination for a patient's single complex or chronic condition. Other
commenters were supportive of the policy goal but expressed concerns
that the work described by PCM is duplicative of work being furnished
as part of CCM and encouraged CMS to work with the CPT editorial panel
to develop coding for this service.
    Response: We appreciate the support for both the policy goal of
appropriate payment for care management services conducted for a
patient's single complex or chronic condition and for separate payment
for PCM services. We look forward to reviewing and considering
recommendations from the CPT Editorial Panel and the RUC, should they
develop and value CPT codes describing this or similar services,
through our rulemaking process.
    Comment: A few commenters stated that HCPCS code G2064 was
undervalued and should have a work RVU of 1.45, which is the same work
RVU as CPT code 99491 (Chronic care management services, provided
personally by a physician or other qualified health care professional,
at least 30 minutes of physician or other qualified health care
professional time, 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). CPT code 99491
describes the work associated with care management performed by the
billing practitioner, in contrast to CPT code 99490, which describes
the work associated with supervision of care management performed by
clinical staff. Commenters pointed out that CPT codes 99491 and 99490
served as the model for HCPCS codes G2064 and G2065. Commenters stated
that CPT code 99491 was a more accurate crosswalk for HCPCS code G2064
because both codes describe the work associated with care management
and coordination performed by the billing practitioner, and G2065
describes the work associated with supervising care management done by
clinical staff and was valued the same as CPT code 99490. Commenters
also pointed out that, although PCM services describe care management
associated with a single condition, the fact that this condition has
most likely experienced an exacerbation or has caused the patient to
recently be hospitalized, results in greater intensity than the work
associated with managing multiple chronic conditions, some of which may
be more stable.
    Response: After considering these comments, we agree that the work
RVU we proposed for code G2064 (1.28 RVUs) should be valued through a
crosswalk to CPT code 99491, and we agree with the points made by
commenters regarding the intensity of care management for a single
condition, especially when that condition has likely experienced an
exacerbation. We also agree that the relativity between CPT codes 99490
and 99491 should be preserved in HCPCS codes G2064 and G2065.
Therefore, we are finalizing an RVU of 1.45 for HCPCS code G2064.
    Comment: A few commenters supported creation of an add-on code for
additional time spent engaged in PCM services beyond the initial 30
minutes, similar to HCPCS code G2060 discussed above.
    Response: We thank commenters for their input. Given that this is a
new service, we believe it would be more appropriate to monitor uptake
and stakeholder response, and we will consider whether to establish a
separate add-on code for additional time spent furnishing PCM services
beyond the initial 30 minutes for possible future rulemaking.
    Although 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
[[Page 62694]]
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. Although we did not propose additional
requirements for the 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
solicited 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.
    We received public comments 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. The following is a summary of the comments we received and
our responses.
    Comment: Many commenters' shared CMS' concerns. Some commenters
recommended that CMS not finalize separate payment for PCM services,
stating that this would move away from patient-specific, continuous,
comprehensive value based care management and coordination toward a
more disease specific care management, resulting in fragmented care and
service duplication. A few commenters with concerns about care
fragmentation suggested that CMS first implement PCM through a
demonstration. Others supported requiring the billing practitioner
document ongoing communication and care coordination with any other
practitioners overseeing care of the patient, such as primary care
practitioners, pharmacists, hospitalists, or social workers, as
applicable. These commenters stated that this would be sufficient to
maintain coordination and continuity of care in the instance where
multiple practitioners are involved in furnishing care to the
beneficiary. A few commenters also suggested that CMS not allow billing
of PCM services by multiple practitioners for the same indication.
Still other commenters stated that it was not necessary to include any
requirements pertaining to care fragmentation or service duplication,
and that such requirements would be a barrier to uptake.
    Response: While we share commenters' concerns regarding care
fragmentation and service duplication, we do not believe they rise to
the level that separate payment should not be adopted for these
services. The type of care management services that we believe are
appropriately described by the PCM codes involve work intensively
focused on managing a single condition and, with very few exceptions,
could not be replaced by a single practitioner billing CCM services for
management of multiple chronic conditions. However, we also believe it
necessary to put in place some requirements so as to avoid a situation
where each of a patient's individual conditions are being managed
separately by different practitioners who all bill for PCM services.
Therefore, we are finalizing a requirement that ongoing communication
and care coordination between all practitioners furnishing care to the
beneficiary must be documented by the practitioner billing for PCM in
the patient's medical record.
    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 proposed that the full CCM scope of service requirements
apply to PCM, including documenting the patient's verbal consent in the
medical record. We solicited 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 23
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 solicited comment on
how best to educate practitioners and beneficiaries on the benefits of
PCM services.
[[Page 62695]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.030
    We received public comments 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. The following is a
summary of the comments we received and our responses.
    Comment: Most commenters supported application of the required
elements of CCM to PCM with a number of refinements, although a few
urged CMS not to add overly burdensome billing requirements. Commenters
requested that CMS clarify that elements of CCM, such as the
``systematic needs assessment,'' ``receipt of preventive services,''
and a ``comprehensive care plan'' must be furnished only for the
specific chronic condition for which the billing practitioner is
treating the patient. Some commenters pointed out that a
``comprehensive care plan'' was not needed when a practitioner is
engaged in care management and coordination of a single complex or
chronic condition, and instead suggested it be changed to ``disease-
specific care plan.'' Other commenters suggest that we remove this
language entirely. Commenters expressed concern with requiring that the
EHR be certified to a particular standard. Commenters generally
recommended that an initiating visit be furnished within a window of
time to demonstrate that a relationship has been established between
the beneficiary and the practitioner furnishing PCM. Commenters
supported the retention of the requirement that there be the capacity
for in-person care management. Commenters also recommended that verbal
and or written consent be documented in the medical record so that the
patient is aware of the service and any applicable cost sharing,
although some stated that this was a burdensome requirement given that
they may not know in advance which beneficiaries will require PCM
services.
    Response: We thank commenters for all their input. We agree with
commenters that a ``disease-specific'' care plan is more appropriate
than a comprehensive care plan, as the practitioner will be providing
care coordination and management for a single condition, and as such,
the care plan may be more limited. We also agree that certain aspects
of CCM, such as ``systematic needs assessment'' and ``receipt of
preventive services'' should only be furnished as applicable to the
condition being treated and should not be a requirement to bill for PCM
services. Table 24 shows the elements of CCM, as revised in response to
comments, that will be required for PCM.
[[Page 62696]]
[GRAPHIC] [TIFF OMITTED] TR15NO19.031
    With regard to the certified EHR, we continue to believe that use
of certified EHR technology is vital to ensure that practitioners are
capable of providing the full scope of PCM services, such as timely
care coordination and continuity of care (see our prior discussion of
this issue at 79 FR 67723). The use of certified EHR technology helps
ensure that members of the care team have timely access to the
patient's most updated health information. Also, we believe that use of
certified EHR technology among physicians and other practitioners will
increase as we move forward to implement the Quality Payment Program,
including MIPS and Advanced Alternative Payment Models, as well as
other value-based payment initiatives. Accordingly, we are not
modifying the proposed use of certified EHR technology as an element of
PCM services.
    We received public comments on how best to educate practitioners
and beneficiaries on the benefits of PCM services. The following is a
summary of the comments we received and our responses.
    Comment: Commenters recommended that CMS issue guidance for billing
and coding criteria, clinical situations in which PCM may be billed,
and what defines a complex condition.
    Response: We look forward to continued engagement with the public
to revise and refine PCM services as they are implemented. We encourage
stakeholders to submit questions and information to CMS so that we
might consider changes or clarification for future rulemaking.
    Additionally, we proposed to add HCPCS code G2065 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).
    Comment: Commenters supported adding HCPCS code G2065 to the list
of designated care management services for which we allow general
supervision.
    Response: We thank commenters for their support and are finalizing
as proposed.
    Due to the potential for duplicative payment, we proposed 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 also proposed that PCM will not be billable by the same
practitioner for the same patient during a surgical global period, as
we believe those resource costs will already be included in the
valuation of the global surgical code.
    We also solicited comment on any potential for duplicative payment
between the 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/
[[Page 62697]]
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).
    Comment: Commenters generally supported restricting the number of
care management services billable by the same practitioner for the same
patient, stating that this was necessary to avoid service duplication.
A few commenters also stated that services such as interprofessional
consultation and chronic care RPM should not be separately billable in
the same month as PCM by the same practitioner for the same
beneficiary. Others disagreed, stating the RPM and interprofessional
consultations describe distinct services not accounted for in the work
of PCM. RPM in particular was described by these commenters as being
complimentary to PCM services, rather than duplicative.
    Commenters requested clarification as to potential overlap between
PCM and CCM and some commenters suggested that PCM could be billed
concurrent with CCM for the same beneficiary, if billed by different
practitioners. Commenters also requested that CMS clarify any potential
overlap between PCM and HCPCS code GPC1X (Visit complexity 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).
    Response: We do not believe there will be a duplication of care
management between PCM and other care management services solely as a
result of separate payment for the new PCM codes, particularly with the
revised list of required elements which better distinguish PCM services
from CCM. However, we also agree with commenters that PCM services
should not be furnished with other care management services by the same
practitioner for the same beneficiary, nor should PCM services be
furnished at the same time as interprofessional consultations for the
same condition by the same practitioner for the same patient. However,
we are convinced by stakeholders who stated that RPM services are
distinct from PCM and could be billed concurrently by the same
practitioner for the same beneficiary provided that the time is not
counted twice. We will also be monitoring billing of these services. We
will appreciate continued input and engagement on these issues with the
public and stakeholder community, and may make refinements to these
policies in future rulemaking.
    With regard to the relationship between PCM services and HCPCS code
GPC1X, we do not believe there is any overlap. We note that PCM
describes ongoing care management services and is billed monthly,
whereas HCPCS code GPC1X is an adjustment to an office/outpatient E/M
visit (which are separately billable alongside PCM) to capture
additional resource costs associated with performing either a primary
care visit or a visit that is part of ongoing care of a patients
single, serious, or complex condition.
    Comment: A commenter requested that RHCs and FQHCs be allowed to
furnish and report PCM services.
    Response: We thank the commenter for the suggestion. While we did
not propose a new mechanism for RHCs and FQHCs to report PCM services
specifically, we recognize that the requirements for the new PCM codes
are similar to the requirements for the services described by HCPCS
code G0511, which is the RHC/FQHC-specific general care management
code, and will consider adding PCM to G0511 in future rulemaking.
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 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 99458 (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 99458, 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 did
not agree with the RUC-recommended work RVU of 0.61 for CPT code 99458.
Instead, we proposed a work RVU of 0.50 for the add-on code, which we
believed was supported by CPT code 88381 (Microdissection (i.e., sample
preparation of microscopically identified target); manual) and 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 proposed the RUC-recommended direct PE inputs for
CPT code 99458.
    Finally, we proposed that RPM services could be furnished under
general supervision. Because care management services include
establishing, implementing, revising, or monitoring treatment plans, as
well as providing support services, and because
[[Page 62698]]
RPM services 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 believed that
CPT codes 99457 and 99458 should be included as designated care
management services. Designated care management services can be
furnished under general 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.
    We received public comments on the proposed valuation of the RPM
add-on CPT code 99458 and our proposal to designate CPT codes 99457 and
99458 as care management services. The following is a summary of the
comments we received in response to our two proposals, as well as our
responses.
    Comment: We received numerous comments regarding our valuation of
the new RPM code, CPT code 99458. Commenters uniformly disagreed with
our proposed work RVU of 0.50 writing that there are no efficiencies to
be gained when continuing the same treatment management service for an
additional 20 minutes. Some commenters questioned our use of CPT code
88381 (Microdissection (i.e., sample preparation of microscopically
identified target); manual) as a reference code, a code that does not
resemble the work and the intensity of the work furnished during a care
management session.
    Response: We thank the many commenters for their insights into the
work required for CPT codes 99457 and 99458.
    Comment: Commenters uniformly agreed with our proposal to designate
CPT codes 99457 and 99458 as care management services so that the
services can be furnished under general supervision.
    Response: We agree with commenters that the add-on code requires
the same work time and intensity as the RPM base code. Therefore, we
are finalizing the RUC-recommended work RVU 0.61 for CPT code 99458. We
are also finalizing the RUC-recommended direct PE. In addition, we are
finalizing our proposal to designate both CPT code 99457 and CPT code
99458 care management codes as defined in Sec.  410.26(b)(5) of our
regulations.
    Comment: Several commenters expressed concerns about the ambiguity
of the code descriptors for the RPM codes. Commenters requested that
CMS define what is meant by ``physiologic parameters'', ``digitally
transmitted data'' (as opposed to patient-reported data), ``medical
device,'' and ``interactive communication''. Several commenters asked
if we could expand the list of practitioners allowed to furnish RPM
services, while others requested that we clarify who can furnish and
bill for the RPM services. One commenter stated that the prefatory
language for the codes should state explicitly that an established
patient-practitioner relationship must exist prior to billing for RPM
services. Another commenter recommended that we provide guidance
related to billing and documentation for RPM. Some commenters
questioned whether the codes could be used for patients that without
chronic conditions.
    Response: We appreciate the many questions raised by commenters
about the set of RPM codes and understand the frustration commenters
expressed with the current code descriptors. Therefore, given the
numerous questions raised by commenters, we plan to consider these and
other questions related to RPM in future rulemaking.
    Comment: We received a few comments asking whether RPM is a
billable service in RHCs and FQHCs.
    Response: RHCs are paid an all-inclusive rate (AIR) when a
medically necessary, face-to-face visit is furnished by an RHC
practitioner. FQHCs are paid the lesser of their charges or the FQHC
PPS rate when a medically-necessary, face-to-face visit is furnished by
an FQHC practitioner. Both the RHC AIR and the FQHC PPS rate include
all services and supplies furnished incident to the visit. Services
such as RPM are not separately billable because they are already
included in the RHC AIR or FQHC PPS payment.
6. Comment Solicitation on Consent for Communication Technology-Based
Services
    In the CY 2019 PFS final rule, we finalized separate payment for a
number of services that could be furnished via telecommunications
technology. Specifically, we 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 through 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
[[Page 62699]]
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 (CTBS), we sought comment in the CY 2020 PFS proposed
rule on whether a single advance beneficiary consent could be obtained
for a number of communication technology-based services. During the
consent process, the practitioner will make sure the beneficiary is
aware that utilization of these services will result in a cost sharing
obligation. We solicited 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 1-year period, or
for a set number of services, after which a new consent will need to be
obtained. We also solicited comment on the potential program integrity
concerns associated with allowing advance consent and how best to
minimize those concerns.
    We received public comments on the appropriate interval of time or
number of services for which consent could be obtained and the
potential program integrity concerns associated with allowing advance
consent and how best to minimize those concerns. The following is a
summary of the comments we received and our responses.
    Comment: Many commenters supported requiring a generalized consent
for multiple communication technology-based services or
interprofessional consultations. Most commenters suggested that a year
was an appropriate interval for which consent should be obtained,
although some commenters suggested other time intervals, such as every
6 months, quarterly, or no requirement at all.
    A few commenters suggested that there should be separate consent
processes for services that involve an interaction with the patient,
such as HCPCS codes G2010 to report the remote evaluation of recorded
video and/or images for an established patient and G2012 to report
brief communication technology-based service for an established
patient, and services that do not involve direct interaction with the
patient, such as CPT codes 99446 through 99449, 99451 and 99452, which
describe services such as electronic assessment and management by a
consultative physician.
    Other commenters raised more general concerns with beneficiary cost
sharing, pointing out that beneficiaries may not be accustomed to being
charged cost sharing for non-face-to-face services. These commenters
urged CMS to eliminate cost sharing for these services.
    Response: We appreciate commenters' support for allowing a single
consent to be obtained for multiple CTBS or interprofessional
consultation services over an interval of time, rather than requiring
consent to be obtained prior to each service. Given the commenters'
support, we are finalizing a policy to permit a single consent to be
obtained for multiple CTBS or interprofessional consultation services.
Based on feedback from commenters, we believe an appropriate interval
for the single consent is one year, and we are finalizing that the
single consent must be obtained at least annually. We will continue to
consider whether a separate consent should be obtained for services
that involve direct interaction between the patient and practitioner,
and those that do not involve interaction such as interprofessional
services; and we may address this issue in potential future rulemaking.
    We also appreciate commenters' continued concerns about the burden
associated with cost sharing for CTBS and interprofessional
consultation services. Although we do not have statutory authority to
eliminate cost sharing for these services, we appreciate the continued
input from the public as to how best to educate both practitioners and
beneficiaries to reduce instances of unexpected bills.
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, CCM furnished by
a physician or other qualified health care professional, or general
behavioral health services, and we are allowing G0511 to also be billed
when the requirements for PCM are met. Payment for this service is set
at the average of the national, non-facility payment rates for CPT
codes 99490, 99487, 99491, and 99484. We proposed 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 were finalized for practitioners billing under the
PFS; as indicated above, these codes were not finalized. We note that
we did not propose any changes in the valuation of these codes.
    Comment: Regarding the use HCPCS codes GCCC1 and GCCC3, commenters
noted they would be supportive of this change if they were finalized
for practitioners billing under the PFS for RHCs and FQHCs.
    Response: Since HCPCS codes GCCC1 and GCCC3 are not being finalized
for use under the PFS, we are not finalizing this change for RHCs and
FQHCs. Therefore, payment for HCPCS G0511 will continue to set based on
the average of the national, non-facility payment rates for CPT codes
99490, 99487, 99491, and 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.
    In addition to screening tests, which typically are furnished to
patients in the absence of signs or symptoms of illness
[[Page 62700]]
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 are available 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. In the CY 2020 PFS
proposed rule (84 FR 40556), we solicited 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.
Specifically, we solicited 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 also solicited 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.
    We received over 1,600 public comments on the requirements for
coinsurance for colorectal cancer screening tests.
    Comment: Many comments were on coverage and statutory issues, such
as coverage for colorectal cancer screening more frequently and not
requiring coinsurance for diagnostic colonoscopy.
    Response: These comments are out of scope.
[[Page 62701]]
    Comment: Many commenters were on professionals providing
information to individuals receiving a screening colonoscopies. Several
commenters noted that Medicare could do a better job of educating
beneficiaries about when screening colonoscopies become diagnostic
colonoscopies, and therefore, coinsurance applies. In addition to not
understanding that when removal of a polyp, lesion or growth is
discovered a screening colonoscopy becomes a diagnostic one, some
commenters misunderstood that a screening colonoscopy can only occur
every 10 years for most individuals, or the appropriate frequency for a
high risk individual. Many commenters were confused that a diagnostic
colonoscopy occurs after a positive Cologuard[supreg] or fetal occult
blood tests rather than a screening colonoscopy.
    Response: As a result of our review of the public comments, we
intend to undertake a comprehensive review of all of our outreach
materials, such as the Medicare & You Handbook and Medicare Preventive
Services, to see if Medicare policies on payment and coverage for
screening colonoscopies can be made clearer. We believe this would be a
service to Medicare beneficiaries.
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. Summary of 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.
In the CY 2020 PFS proposed rule, we proposed 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. Specifically, we
proposed 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 proposed 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 also proposed 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
[[Page 62702]]
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).
    We received public comments on the proposed revisions to regulation
text to codify the changes required by section 50202 of the BBA of
2018. The following is a summary of the comments we received and our
responses.
    Comment: Several commenters appreciated our proposal to clarify and
codify the requirements as outlined in section 50202 of the BBA of
2018.
    Response: We thank commenters for their support.
    After considering the comments, we are finalizing as proposed the
changes in regulation text to reflect the requirements of section 50202
of the BBA of 2018.
2. 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 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
    We interpreted 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.
[[Page 62703]]
    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
proposed 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 proposed 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 proposed 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 proposed 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 proposed to apply the CQ/CO modifier policies to all
services that would be billed with the respective GP or GO therapy
modifier. We believed this was 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.
    For purposes of deciding whether the 10 percent de minimis standard
is exceeded, we offered 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 proposed 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 would be required to be added to the claim for that service.
As noted above, we proposed 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 25 for minutes needed to meet or
exceed using the ``simple'' method with typical times for the total
time of a therapy service.
[GRAPHIC] [TIFF OMITTED] TR15NO19.032
    We also clarified 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.
    We proposed to address more specifically the application of the 10
percent de minimis standard in various clinical scenarios to decide
when the CQ/CO modifiers apply. We acknowledged that application of the
10 percent de minimis standard can work differently depending on the
types of services and scenarios involving both
[[Page 62704]]
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. A summary
of our proposals for applying the CQ/CO modifiers using the 10 percent
de minimis standard, along with applicable billing scenarios, are
outlined below by category. In each of these scenarios, we assumed 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 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 25.
     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
[[Page 62705]]
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 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 regulations at Sec. Sec.
410.59(a)(4) and 410.60(a)(4), we proposed 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
proposed revision to the documentation requirement for the daily
treatment note would extend 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 sought 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 solicited comment 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 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
[[Page 62706]]
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 anticipated that we would add examples
to illustrate when the applicable therapy assistant modifiers must be
applied, similar to the examples provided below.
    In the CY 2020 PFS proposed rule, we provided detailed 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 (84 FR 40562 through 40564).
c. Regulatory Provisions
    In accordance with section 1834(v)(2)(B) of the Act, we proposed 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 proposed 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 noted 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 clarified 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.
    We received almost 9,000 public comments on the proposed payment
provisions for outpatient PT and OT services furnished in whole or in
part by therapy assistants. The following is a summary of the comments
we received and our responses.
    Comment: Many commenters objected to our proposal that the time for
the therapeutic service furnished ``in part'' by the PTA/OTA that
counts towards the 10 percent standard includes both the minutes spent
concurrently with and separately from the therapist. These commenters
also expressed concerns that this unfairly discounts services that are
fully furnished by therapists in which the therapy assistant supports
them while providing a service. Some of these commenters stated that
section 53107 of the BBA of 2018 does not permit the application of the
assistant modifier for a PT or OT service furnished by the respective
physical or occupational therapist and that CMS exceeded its authority
in proposing to do so.
    Many commenters stated that when a therapy assistant and therapist
furnish care to a patient at the same time, it is apparent the patient
requires both professionals; and, that this clinical scenario either
represents a highly skilled procedure or one where such services are
required for safety reasons. Commenters stated their belief that
applying the therapy assistant modifiers to discount payment for these
services is not justified.
    Many commenters stated they objected to the use of the term
``concurrent'' when applying the 10 percent standard for purposes of
outpatient therapy services because it conflicts with the definition of
``concurrent'' as it applies to the SNF Part A patient. The SNF Minimum
Data Set Resident Assessment Instrument (MDS-RAI) manual guidance
defines ``concurrent'' to include the number of minutes of therapy when
the therapist or assistant is treating two residents at the same time.
Some commenters also disagreed with our use of the term ``concurrent''
because that term is not currently defined for outpatient therapy
services in statute, regulation, or in our manuals to ``reflect when
two clinicians (therapist and therapist assistant) are providing care
to a beneficiary at the same time.'' These commenters recommended that
CMS adopt the term ``team'' instead, based on a reference to a document
on the CMS therapy services website titled ``11 Part B Billing
Scenarios,'' because they stated it describes care being delivered to
one patient at the same time by two professionals as ``team-based
therapy.''
    Other commenters suggested that instead of ``concurrent,'' that we
use the term ``in tandem'' to describe the cases where a therapist and
a therapy/therapist assistant are jointly furnishing services to a
patient at the same time. One commenter recommended that CMS reconsider
its definition of ``concurrent'' therapy and align it with the
definition in Part A.
    Some commenters supported our proposal including a few commenters
that agreed there should be a payment differential for the services
furnished by a therapy assistant; and, several stated they fully
supported of all of the proposals. A few commenters shared their
concerns that they have observed therapy assistants practicing outside
their scope of practice and their level of training--such as managing a
patient's plans of care, some without any therapist supervision.
    Many commenters urged CMS to restructure the proposal to recognize
as services furnished in whole or in part by therapy assistants only
those minutes that the therapy assistant spends independently with the
patient when the therapist is absent.
    Response: After a review of commenters' concerns and our current
policies, we are persuaded to reconsider our interpretation of what
time counts as services furnished in whole or in part by therapy
assistants, including for purposes of applying the 10 percent standard.
We agree with commenters that we should not count the time when a
therapist and a therapist assistant furnish services to the same
patient at the same time. We believe this
[[Page 62707]]
interpretation is appropriate because we agree with commenters that
when a therapist and therapist assistant furnish services together, the
therapist is fully furnishing the service. Also, any time that the
therapy assistant furnishes services alone or independent of the
therapist is time that the therapist can be credited for furnishing
services to a different patient. We also note the commenters' incorrect
use of the term ``clinicians'' to refer to the both the therapist and
the therapy assistant. We clarify that the term clinician refers only
the physical or occupational therapist and that a therapy assistant is
considered a qualified professional when furnishing services under the
supervision of a therapist. For purposes of Medicare, therapy
assistants are limited in the services they may furnish and may not
supervise other therapy caregivers (see MBPM, Chapter 15, section 230.1
and 230.2).
    We agree with commenters that using the term ``concurrent'' could
be confusing because it is used for the SNF Part A patient to represent
the number of minutes that a therapist or therapy assistant is treating
two patients at the same time. Given that we are not finalizing the
proposal to count the minutes of service furnished by the assistant
together with the therapist, we no longer have a need to use the
``concurrent'' term. Regarding the suggestion that we use the term
``team'' instead of concurrent, we also do not define in our manuals
the term ``team'' because we believe it is ambiguous. We have only used
the term ``team'' in the ``Team'' billing scenario in one of the ``11
Billing Scenarios'' where it is used in an example in which the
physical therapist and occupational therapist furnish all the minutes
of a 30-minute service together--only the physical therapist or
occupational therapist can bill for each 15 minute unit, but not both.
    We find the commenters' concerns persuasive and are revising our
proposed policy so that the time spent by a PTA/OTA furnishing a
therapeutic service ``concurrently,'' or at the same time, with the
therapist will not count for purposes of assessing whether the 10
percent standard has been met. Instead, we are finalizing a policy that
only the minutes that the PTA/OTA spends independent of the therapist
will count towards the 10 percent de minimis standard. We are revising
our regulation text at Sec. Sec.  410.59 (outpatient occupational
therapy), 410.60 (physical therapy), and 410.105 (for PT and OT CORF
services) accordingly. In the CY 2020 PFS proposed rule, we provided
detailed 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 (84 FR 40562
through 40564). We intend to provide further detail regarding examples
of clinical scenarios to illustrate our final policies regarding the
applicability of the therapy assistant modifiers through information
that we will post on the cms.gov website.
    Comment: Commenters opposed our proposal to apply the 10 percent
time standard, for billing purposes, to all the billed units of a
service defined by a single procedure code, and urged CMS to not
finalize the proposal. These commenters requested that instead CMS
finalize a policy that assesses the 10 percent standard for each 15-
minute unit of each procedure code. Commenters noted that the proposal
was contrary to the response to comments in the CY 2019 PFS final rule
(83 FR 59659) in which we provided an example of how our systems would
allow them to bill for 15-minute units of a timed service on 2 separate
claim lines--one with an assistant modifier and the other without. Some
commenters stated that the proposal would not allow proper payment when
a therapist fully furnishes 30 minutes of a timed service, then hands
off to a therapy assistant who fully performs another 15 minutes of the
same service. Many commenters stated that the proposed policy does not
reflect congressional intent because it would discount the therapists'
services, rather than therapy assistants' services.
    Response: We acknowledge that we provided a hypothetical billing
example in the CY 2019 PFS final rule suggesting that our policy would
allow the number of 15-minute units of a code furnished by the PT/OT
and the PTA/OTA to be listed separately on two different claim lines,
and that the example differed from the proposal we developed for the CY
2020 PFS proposed rule. As the commenters noted, we proposed, for
billing purposes, that each outpatient therapy service that is subject
to the 10 percent de minimis standard would be identified on the claim
by a single procedure code, for both untimed codes and codes described
in 15-minute-unit increments. After consideration of the public
comments on our proposal and further reflection on our manual
requirements to document timed codes, we find the commenters' concerns
persuasive and, for purposes of billing, we are finalizing a revised
definition of a service to which the de minimis standard is applied to
include untimed codes and each 15-minute unit of codes described in 15-
minute increments as a service. Accordingly, we are revising our final
policy in response to comments to allow the separate reporting, on two
different claim lines, of the number of 15-minute units of a code to
which the therapy assistant modifiers do not apply, and the number of
15-minute units of a code to which the therapy assistant modifiers do
apply. In the CY 2020 PFS proposed rule, we provided detailed examples
of clinical scenarios to illustrate how the 10 percent de minimis
standard would be applied under our proposals (84 FR 40562 through
40564). The revised policy we are finalizing here will apply generally
in the same way as illustrated in those examples, except for the
difference in the minutes of time that are counted toward the 10
percent standard (not counting the minutes furnished together by a
therapist and therapy assistant), the application of the 10 percent
standard to each billed unit of a timed code rather than to all billed
units of a timed code, and the billing on two separate claim lines of
the units of a timed code to which the therapy assistant modifiers do
and do not apply. We intend to provide further detail regarding
examples of clinical scenarios to illustrate our final policies
regarding the applicability of the therapy assistant modifiers through
information that we will post on the cms.gov website.
    Comment: Nearly all commenters opposed our proposal to require that
the treatment notes explain, in a short phrase or statement, the
application or non-application of the therapy assistant modifier for
each therapy service furnished. Many of these commenters stated that
the statute does not require documentation to explain why a modifier
was or was not applied for each code. Most commenters stated that the
proposed documentation requirements associated with the de minimis
standard for the therapy assistant modifiers are exceedingly burdensome
and conflict with the Administration's ``Patients over Paperwork
Initiative.'' The commenters stated that it is unreasonable to impose a
new documentation requirement on therapists and therapy providers that
is duplicative of current requirements. Many commenters stated that the
Medicare Benefit Policy Manual (MBPM) already includes extensive
documentation requirements, and that the Medicare Claims Processing
Manual (MCPM) includes extensive detail on how to count minutes for
therapy services.
    Many commenters stated that if a therapist or therapy provider has
a
[[Page 62708]]
mechanism to provide evidence as to whether a specific service was
furnished independently by a therapist or an assistant, or was
furnished ``in part'' by an assistant, in sufficient detail to permit a
medical record reviewer to determine whether the de minimis threshold
was met, they should not also be required to separately document this
information in a narrative note. A few of the commenters opposing the
addition of narrative phrases for each service stated that we should
revise our current subregulatory guidance to include a statement such
as the following: ``The provider should have a mechanism in place to
provide evidence whether a specific service was furnished independently
by a therapist or an assistant, or was furnished ``in part'' by an
assistant in sufficient detail to permit the determination of whether
the ``de minimis'' threshold was met.'' Another commenter stated that
it is expected and appropriate for the documentation in the medical
record to specify whether a certain service was furnished independently
by a therapist or an assistant or was furnished ``in part'' by an
assistant in enough detail to permit a medical record reviewer to
determine whether the de minimis threshold was met.
    Many commenters stated that they believe our proposed documentation
requirement to explain in the medical record the use or non-use of the
modifiers would serve as another tool for medical reviewers to use
against therapy providers to justify a technical denial even though the
medical record may otherwise contain sufficient documentation to
justify the use or non-use of the CQ/CO modifier.
    Many commenters submitted comments that were specific to our
request for comment on documentation of the minutes for services
furnished by the PTA/OTA as a means to avoid possible additional burden
associated with a contractor's medical review process conducted for
these services. Nearly all of the commenters stated they opposed adding
a requirement to include a narrative phrase in the treatment note and
requiring documentation of the minutes as duplicative of existing
documentation requirements. One commenter, also not in favor of
requiring the addition of narrative phrases to the medical record
because they do not believe such phrases provide value to patient care
or providers, stated that the therapy provider should document the
number of minutes provided solely by the assistant and that this should
be adequate to support the use and nonuse of the CO/CQ modifiers--
citing an example that included ``CPT 97110--Assistant provided 8
minutes, Therapist provided 24 minutes'' and ``CPT 97530--Assistant
provided 22 minutes, Therapist provided 0 minutes.''
    Several commenters supported the proposed documentation
requirements. One commenter stated they have already begun taking steps
to support billing compliance via their electronic health record that
creates a selection to attach the appropriate PTA/OTA modifier and
includes the creation of a ``smart phrase'' which the therapist can
document to support compliance of billing and review.
    Response: We appreciate the comments regarding our documentation
proposal. After consideration of the comments and a review of our
manual provisions, we find many of the commenters' suggestions
persuasive. We agree that the addition of narrative phrases for each
service may be duplicative of existing documentation requirements in
the MBPM, chapter 15, section 220 and in Chapter 5, MCPM. Although a
few commenters supported the addition of narratives, we also took note
of the many commenters who told us that therapists and therapy
providers should not be required to include a narrative for each
service explaining the application or non-application of the therapy
assistant modifiers when the medical record contains evidence as to
whether a specific service was furnished independently by a therapist
or an assistant, or was furnished ``in part'' by an assistant, in
sufficient detail to permit a medical record reviewer to determine
whether the de minimis threshold was met.
    As a result, we are not finalizing the proposed documentation
requirement to explain in the treatment note, in a short phrase or
statement, the application or non-application of the therapy assistant
modifier for each therapy service furnished; nor are we finalizing a
requirement that the therapist and therapy assistant minutes be
included in the documentation. Instead, we remind therapists and
therapy providers that correct billing requires sufficient
documentation in the medical record to support the codes and units
reported on the claim, including those reported with and without an
assistant modifier.
    Further, we clarify that we would expect the documentation in the
medical record to be sufficient to know whether a specific service was
furnished independently by a therapist or a therapist assistant, or was
furnished ``in part'' by a therapist assistant, in sufficient detail to
permit the determination of whether the 10 percent standard was
exceeded.
    Comment: Many commenters expressed concern that the application of
the therapy assistant modifiers is likely to result in drastic
underpayments for outpatient therapy services beginning in 2022, which
they believe would severely restrict beneficiary access to vital
therapy services, particularly in rural and underserved areas. Other
commenters specifically requested that CMS exempt rural areas from the
therapy assistant modifier policy.
    Response: While we appreciate the concerns raised about the
potential effects of the therapy assistant modifier policy, we do not
believe that section 1834(v) of the Act permits us to exempt the
application of the PTA/OTA modifier policies in rural and underserved
areas. We intend to monitor the implementation of the therapy assistant
modifiers, including any changes to access to outpatient therapy
services.
    Comment: One commenter stated their concerns about the correct
ordering of modifiers on claims for therapy services to assure correct
payment, but without adding to therapists' or therapy providers'
administrative burden. They based their concerns on a CMS longstanding
FAQ, which states that modifiers that impact payment should be in the
first position, and are seeking clarification as to whether the CQ or
CO modifier would need to be in the first position on claims for PT
services (modifier GP) and OT services (modifier GO) where one of those
new modifiers applies. The commenters stated that if the CQ or CO
modifier is required to be in the first position, that would need to be
done manually because therapists and therapy providers are not able to
program their chargemasters to accommodate every possible modifier
combination to meet Medicare and non-Medicare reporting requirements.
    Response: We appreciate the commenter's comments. We note that we
do not have central standard systems edits in place to reject or return
claims for PT or OT services if the CQ or CO modifier is not in the
first modifier position. However, some CMS contractors processing
professional claims may have systems logic in place that would do so.
We recently issued instructions to our contractors to reorder modifiers
for PT and OT services so that claims with the therapy assistant
modifiers are not returned. This reordering will be effective for
claims containing CQ and CO modifiers with dates of service on and
after January 1, 2020.
[[Page 62709]]
3. Therapy KX Modifier Threshold Amounts
    The KX modifier thresholds, as discussed above in this section,
were established through section 50202 of the Bipartisan Budget Act
(BBA) of 2018. Formerly referred to as therapy caps, these KX modifier
thresholds are a permanent provision of the law, meaning that the
statute does not specify an end date. These per-beneficiary amounts
under section 1833(g) of the Act (as amended by section 4541 of the
Balanced Budget Act of 1997) (Pub. L. 105-33, August 5, 1997) are
updated each year based on the MEI. Specifically, these amounts are
calculated by updating the previous year's amount by the MEI for the
upcoming calendar year and rounding to the nearest $10.00. Increasing
the CY 2019 KX modifier threshold amount of $2,040 by the CY 2020 MEI
of 1.9 percent and rounding to the nearest $10.00 results in a CY 2020
KX threshold amount of $2,080 for PT and SLP services combined and
$2,080 for OT services.
    Section 50202 of the Bipartisan Budget Act of 2018 also added
section 1833(g)(7)(B) of the Act which retains the targeted medical
review process, but at a lower threshold amount of $3,000 (until CY
2028) as detailed above in this section. Accordingly, for CY 2020, the
MR threshold is $3,000 for PT and SLP services combined and $3,000 for
OT services. Some, but not all claims exceeding the MR threshold amount
are subject to review, under the established targeted review process.
For information on the targeted manual medical review process, go to
https://www.cms.gov/ResearchStatistics-Data-and-Systems/MonitoringPrograms/Medicare-FFS-CompliancePrograms/Medical-Review/TherapyCap.html.
    We track each beneficiary's incurred expenses for therapy services
annually and counts them toward the KX modifier and MR thresholds by
applying the PFS rate for each service less any applicable multiple
procedure payment reduction (MPPR) amount for services of CMS-
designated ``always therapy'' services. As explained previously in this
section, we apply the PFS-rate accrual process to outpatient therapy
services furnished by critical access hospitals (CAHs) even though they
may be paid on a cost basis (effective January 1, 2014).
    When the expenses incurred for the beneficiary's outpatient therapy
services for the year have exceeded one or both of the KX modifier
thresholds, therapy suppliers and providers use the KX modifier on
claims for subsequent medically necessary services. By using the KX
modifier, the therapist and therapy provider attest that the services
above the KX modifier thresholds are reasonable and necessary and that
documentation of the medical necessity for the services is in the
beneficiary's medical record. Claims for outpatient therapy services
that exceed the KX modifier thresholds but do not include the KX
modifier are denied.
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 final 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 re-proposed 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 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 proposed
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
[[Page 62710]]
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 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
[[Page 62711]]
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.
    We received several comments regarding our methodologies for work
valuation in response to the CY 2020 PFS proposed rule and those
comments are summarized below.
    Comment: Several commenters disagreed with our reference to older
work time sources, and stated that their use led to the proposal of
work RVUs based on flawed assumptions. Commenters stated that codes
with ``CMS/Other'' or ``Harvard'' work time sources, used in the
original valuation of certain older services, were not surveyed, and
therefore, were not resource-based. Commenters also stated that it was
invalid to draw comparisons between the current work time and work RVUs
of these services to the newly surveyed work time and work RVUs as
recommended by the RUC.
    Response: We agree that it is important to use the recent data
available regarding work times, and we note that when many years have
passed between when time is measured, significant discrepancies can
occur. However, we also believe that our operating assumption regarding
the validity of the existing values as a point of comparison is
critical to the integrity of the relative value system as currently
constructed. The work times currently associated with codes play a very
important element in PFS ratesetting, both as points of comparison in
establishing work RVUs and in the allocation of indirect PE RVUs by
specialty. If we were to operate under the assumption that previously
recommended work times had routinely been overestimated, this would
undermine the relativity of the work RVUs on the PFS in general, given
the process under which codes are often valued by comparisons to codes
with similar times. It also would undermine the validity of the
allocation of indirect PE RVUs to physician specialties across the PFS.
Instead, we believe that it is crucial that the code valuation process
take place with the understanding that the existing work times, used in
the PFS ratesetting processes, are accurate. 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 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 old work time values that were established many
years ago and have not since been reviewed in our methodology, we refer
readers to our discussion of the subject in the CY 2017 PFS final rule
(81 FR 80273 through 80274).
    Comment: Several commenters disagreed with the use of time ratio
methodologies for work valuation. Commenters stated that this use of
time ratios is not a valid methodology for valuation of physician
services. Commenters stated that treating all components of physician
time (preservice, intraservice, postservice and post-operative visits)
as having identical intensity is incorrect, and inconsistently applying
it to only certain services under review creates inherent payment
disparities in a payment system which is based on relative valuation.
Commenters stated that in many scenarios, CMS selects an arbitrary
combination of inputs to apply rather than seeking a valid clinically
relevant relationship that would preserve relativity. Commenters urged
CMS to determine the work valuation for each code based not only on
surveyed work times, but also the intensity and complexity of the
service and relativity to other similar services, rather than basing
the work value entirely on time.
    Response: We disagree and continue to believe that the use of time
ratios is one of several appropriate methods for identifying potential
work RVUs for particular PFS services, particularly when the
alternative values recommended by the RUC and other commenters do not
account for information provided by surveys that suggests the amount of
time involved in furnishing the service has changed significantly. We
reiterate that, consistent with the statute, we are required to value
the work RVU based on the relative resources involved in furnishing the
service, which include time and intensity. When our review of
recommended values reveals that changes in the resource of time have
been unaccounted for in a recommended RVU, then we believe we have the
obligation to account for that change in establishing work RVUs since
[[Page 62712]]
the statute explicitly identifies time as one of the two elements of
the work RVUs.
    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,
but in applying the time ratios, we are using derived intensity
measures based on current work RVUs for individual procedures. We
clarify again that we do not treat all components of physician time as
having identical intensity. If we were 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. For example, among the codes reviewed in this
current CY 2020 PFS final rule, CPT codes 52442 (Cystourethroscopy,
with insertion of permanent adjustable transprostatic implant; each
additional permanent adjustable transprostatic implant) and 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) share the identical work time of 15 minutes
but have very different work RVUs of 1.01 and 0.33 respectively. In
addition, CPT codes 11983 (Removal with reinsertion, non-biodegradable
drug delivery implant), 64446 (Injection(s), anesthetic agent(s) and/or
steroid; sciatic nerve, continuous infusion by catheter (including
catheter placement)), and 78804 (Rp L.T.I.D. w/flow when performed,
wholebody 2 or more days) all share the same intraservice work time of
15 minutes and total work time of 40 minutes but each code has a
different work RVU. These examples demonstrate that we do not value
services purely based on work time; instead, we incorporate time as one
of multiple different factors employed in our review process.
Furthermore, we reiterate that we use time ratios to identify
potentially appropriate work RVUs, and then use other methods
(including estimates of work from CMS medical personnel and crosswalks
to key reference or similar codes) to validate these RVUs. For more
details on our methodology for developing work RVUs, we direct readers
to the discussion CY 2017 PFS final rule (81 FR 80272 through 80277).
    We also want to clarify for the commenters that our review process
is not arbitrary in nature. 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). With regards to the
invocation of clinically relevant relationships by the commenters, we
emphasize that we continue to believe 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, we
do not agree that codes must share the same site of service, patient
population, or utilization level to serve as an appropriate crosswalk.
    Comment: Several commenters discouraged the use of valuation based
on work RVU increments. Commenters stated that this methodology
inaccurately treats all components of the physician time as having
identical intensity and would lead to incorrect work valuations.
Commenters stated that CMS should carefully consider the clinical
information justifying the changes in physician work intensity provided
by the RUC and other stakeholders.
    Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes. We note that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service. We have no evidence to suggest that the use
of an incremental difference between codes conflicts with the statute's
definition of the work component as the resources in time and intensity
required in furnishing the service. We do consider clinical information
associated with physician work intensity provided by the RUC and other
stakeholders as part of our review process, although we remind readers
again that we do not agree that codes must share the same site of
service, patient population, or utilization level to serve as an
appropriate crosswalk.
    In response to comments, in the CY 2019 PFS final rule (83 FR
59515), we clarified 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 also occasionally make use of a
``bracket'' for code valuation. A ``bracket'' refers to when a work RVU
falls between the values of two CPT codes, one at a higher work RVU and
one at a lower 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 valuation
considered for specific codes. Table 26 contains a list of codes and
descriptors for which we are finalizing work RVUs; this includes all
codes for which we received RUC recommendations by February 10, 2019.
The 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 final 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
[[Page 62713]]
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 27 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this final rule, Determination of
Practice Expense Relative Value Units (PE RVUs), we address certain
refinements that would be common across codes. Refinements to
particular codes are addressed in the portions of this section that are
dedicated to particular codes. We note 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 27 result in changes under the $0.35
threshold and are unlikely to result in a change to the RVUs.
    We also note that the 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 final 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 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 final rule, Determination
of Practice Expense Relative Value Units (PE RVUs), for more
information regarding the collaborative work of CMS and the
[[Page 62714]]
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 28 and 29 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this final 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.
    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 28 and 29 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 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 final 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 15769, 15771, 15772, 15773,
and 15774)
    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 proposed the RUC-recommended work RVUs of 6.68 for CPT code
15769 (Grafting of autologous soft tissue, other, harvested by direct
excision (e.g., fat, dermis, fascia)), 6.73 for CPT code 15771
(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 15772 (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 15773 (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 15774 (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 proposed the RUC-recommended direct PE inputs for this code
family without refinement.
    We received public comments on the proposed valuation of the codes
in the Tissue Grafting Procedures family. The following is a summary of
the comments we received and our responses.
[[Page 62715]]
    Comment: A commenter stated that they supported our proposal to use
the RUC-recommended work RVUs for these codes.
    Response: We appreciate the support for our proposal from the
commenter. After consideration of the public comments, we are
finalizing the work RVUs and direct PE inputs for the codes in the
Tissue Grafting Procedures family as proposed.
(2) Drug Delivery Implant Procedures (CPT Codes 11981, 11982, 11983,
20700, 20702, 20704, 20701, 20703, and 20705)
    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 did not propose 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,
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 offered 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 offered 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 proposed a work RVU of
1.14, and accepted the survey-recommended 5 minutes for intraservice
time and 30 minutes of total time. We did not propose 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 offered 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 proposed a work RVU of 1.34, and accepted the RUC-
recommended 10 minutes for intraservice time and 33 minutes of total
time. We did not propose 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
offered 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 proposed a work RVU of 1.91, and accepted the RUC-recommended
15 minutes for intraservice time and 40 minutes of total time. We did
not propose any direct PE refinements to CPT code 11983.
    The new proposed add-on CPT codes 20700-20705 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 20700 (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
[[Page 62716]]
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 proposed for CPT code 20700, a work RVU of
1.32, and accept the RUC-recommended 20 minutes of intraservice time
and 27 minutes of total time.
    The specialty society's survey for CPT code 20702 (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 32
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 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 20702.
    The specialty society's survey for CPT code 20704 (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 37
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
proposed the work RVU of 1.80 with the RUC-recommended 30 minutes of
intraservice time and 37 minutes of total time, for CPT code 20704.
    The specialty society's survey for CPT code 20701 (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 proposed the RUC-
recommended work RVU of 1.13 with 15 minutes of intraservice time and
18 minutes of total time for 20701.
    The specialty society's survey for CPT code 20703 (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 23 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 proposed the RUC-
recommended work RVU of 1.80 with 20 minutes of intraservice time and
23 minutes of total time for 20703.
    The specialty society's survey for CPT code 20705 (Removal of drug
delivery
[[Page 62717]]
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
proposed the RUC-recommended work RVU of 2.15 with 25 minutes of
intraservice time and 28 minutes of total time for 20705.
    We received public comments on the proposed valuation of the codes
in the Drug Delivery Implant Procedures family. The following is a
summary of the comments we received and our responses.
    Comment: In an overall comment to code valuations, but also
pertinent to this section, one commenter stated that they are
increasingly concerned that CMS is eschewing the bedrock principles of
valuation within the RBRVS (namely, magnitude estimation, survey data
and clinical expertise) in favor of arbitrary mathematical formulas and
in their opinion, make a distinction in the different types of
physician time, which are ``CMS/Other'' time source, ``Harvard'' time
source, and ``RUC'' time source (from physician surveys).
    Response: As we have discussed in previous rules, we agree that it
is important to use the most recent data available regarding time, and
we note that when many years have passed between when physician times
are measured, significant discrepancies can occur. However, we also
continue to believe that our operating assumption regarding the
validity of the existing time values as a point of comparison is
critical to the integrity of the current relative value system.
    The physician times and intensities currently associated with
codes, play important roles in PFS ratesetting in their comparativeness
to each other, in establishing work RVUs. If we were to operate under
the assumption that previously recommended work times had routinely
been overestimated, this would undermine the relativity of the work
RVUs on the PFS. Given that the process under which codes are often
valued by comparison to codes with similar times, we acknowledge the
distinction between ``CMS/Other'' times, ``Harvard'' times, and ``RUC''
physician surveyed times, but we cannot apply different validation
weights to any of these labels. They are all physician times data
collected over many years. We understand that some time values may not
have been reviewed or re-surveyed in a number of years, but that alone
is not an indicator of how accurate or inaccurate a time value may be.
We believe that over the years as more codes are being reviewed and
examined, that collectively the entire fee schedule of procedure codes
should all naturally align themselves into a very reliable and more
accurate system reflecting every code's relativity to one another (in
their work RVUs, in their procedure times, and in their work
intensities).
    We believe that it is crucial that the code valuation process with
existing work times and work RVUs in the PFS ratesetting processes are
accurate. We recognize that adjusting work RVUs for changes in
physician times is not always a straightforward process and that the
intensity associated with changes in time is not necessarily always
linear, which is why we always try to apply various methodologies to
identify several potential work values for individual codes. CMS CPT
code review not only examines the relationships between work, time, and
intensity, but we also look at magnitude and rank order anomalies
particularly in families or groups of codes that are closely related,
but may differ slightly in degrees found in their clinical descriptions
and possibly in the typical beneficiary populations that each code
might serve. Among these codes, we try to keep the differences in
times, work, and intensity properly distant between each other. In some
cases, where there are marked improvements in medical techniques and
technological assistance, we may see better efficiencies in physician's
work, and thus decreases in physician's times, but we also recognize
that some improvements may introduce greater complexity and either a
greater intensity and/or increase in physician times.
    We reiterate that we believe it would be irresponsible to ignore or
discount ``CMS/Other'' times or ``Harvard'' times in our data system
and that we need to consider all times and all intensities and all
procedure code's clinically relevant relatedness (or non-relatedness)
to each other, in establishing more refined work RVUs for PFS services.
Also note that ``RUC'' physician times are not always necessarily AMA
RUC surveyed times. CMS may have adjusted AMA RUC surveyed times in our
annual review of all HCPCS codes, as well as times that the AMA labels
as ``Harvard'' or ``CMS/Other'' physician times.
    Comment: One commenter stated the current source of time for CPT
code 11981 is CMS/Other. The commenter also stated the crosswalk or
methodology used in the original valuation of this service is unknown
and not resource-based; therefore, it is invalid to compare the current
time and work to the surveyed time and work. The commenter noted this
code's source of time is CMS/Other, implying that the time was merely
crosswalked or selected by a single CMS staffer some time ago, and CMS
should not compare the valid survey time to the initial CMS/Other time
because the initial CMS/Other source data is flawed and has no validity
for comparison.
    Response: The current physician time for CPT code 11981 is 39
minutes of total time and the current work RVUs is 1.48. The AMA RUC's
new recommended times are 5 minutes intra-service time and 30 minutes
total time (surveyed total time was 31 minutes). We accept the AMA RUC
newly surveyed-recommended times. The AMA RUC selected multiple
reference CPT codes 55876, 57500, 67515, 12013, and 12004 that they
believe to be comparable to CPT code 11981. We selected the reference
CPT code 67500, with 5 minutes intra-time and 33 minutes total time,
which we believe to be a better reference code and is clearly
comparable to the accepted recommended times for CPT code 11981. CPT
code 67500 was last reviewed in 2005 and the time source was from the
``RUC'' who no doubt surveyed this code at that time, so CPT code
67500's time source is not ``CMS/Other'', which we do not believe is
material to selecting a reference code for physician work and time. As
discussed above, we believe there is no comparison flaw in time or work
RVUs, based on the AMA RUC's distinction labeling of ``RUC'' times,
``CMS/Other
[[Page 62718]]
times'', or ``Harvard'' times. We believe that it is crucial that the
code valuation process take place with the understanding that all
existing work times, used in the PFS ratesetting processes, are
accurate. Our reference CPT code 67500's work RVU is 1.18.
    Comment: Some commenters stated that CPT code 11981 is not
clinically related to our reference code of CPT code 67500, as it
relates to both the physician description of work and the typical
patient population treated with this service.
    Response: As part of our review, we look for comparable codes that
are similar in physician service times, work RVUs, work intensity, and
clinical similarity. As discussed above, we believe there is no
comparison flaw in time or work RVUs, based on the AMA RUC's
distinction labeling of ``RUC'' times, ``CMS/Other times'', or
``Harvard'' times. We believe that it is crucial that the code
valuation process take place with the understanding that all existing
work times, used in the PFS ratesetting processes, are accurate. We
continue to believe that CPT code 67500 is the better reference code
for us to use to establish an appropriate valuation for CPT code 11981.
Both codes require 5 minutes intra-service time and CPT code 11981
takes 30 minutes total time while CPT code 67500 takes a similar amount
of 33 minutes of total time.
    While the commenters object to CMS' reference CPT code of 67500 as
being clinically related to CPT code 11981, the commenter's additional
selected CPT reference codes of 67515, 12013, and 12004, are also very
different from CPT code 11981. There appears to be a discrepancy in the
AMA RUC's CPT (referencing) code 67515 (Injection of medication or
other substance into Tenon's capsule, work RVU = 1.40, 5 minutes intra-
service time and 21 minutes total time). CMS' data indicates a
different work RVU and physician times for this code. For CPT code
67515, we have on record for work RVU = 0.75, 3 minutes intra-service
time and 13 minutes total time.
    The AMA RUC CPT (referencing) codes 12013 and 12004 appears to be
at least partially valued on the length of a wound repair (2.6 cm to
5.0 cm or 7.6 cm to 12.5 cm), and assuming that the longer the wound
repair is, the more work and physician time is required to perform the
procedure. CPT code 11981 does not have this ``size length''
characteristic, so we question if CPT codes 12013 or 12004 more or less
are a valid comparison referencing codes to CPT code 11981 where there
is not this ``size length'' characteristic. As we have stated, the
clinical relatedness of codes are not always exact, nor always
available.
    Comment: The RUC survey respondents offered 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 intra-
service time and 59 total minutes)) and 57500 (Biopsy of cervix, single
or multiple, or local excision of lesion, with or without fulguration
(separate procedure) (work RVU = 1.20, 15 minutes intra-service time
and 29 total minutes)) as referencing codes to CPT code 11981.
    The AMA RUC recommendation offered CPT code 67515 (Injection of
medication or other substance into Tenon's capsule (work RVU = 1.40, 5
minutes intra-service time and 21 minutes total time)), MPC codes 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, 15 minutes
intra-service time and 27 total minutes)) and 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 15 minutes intra-service time and 29 total minutes)). The
AMA RUC offer these reference codes to have similar physician work and
total time to CPT code 11981.
    Response: All of the commenter's reference comparison CPT codes
have far more intra-service time than CPT code 11981 intra-service time
of 5 minutes, except for CPT code 67515, but this code appears to only
have 3 minutes of intra-service time and 0.75 work RVUs. CMS' CPT
(reference) code of 67500 appears to have the closest physician times
to CPT code 11981 and their work RVUs should be similar.
    After consideration of the public comments for CPT code 11981, we
are finalizing the proposed work RVU as 1.14.
    Comment: Several commenters stated the current source of time for
CPT code 11982 is CMS/Other. Commenters also stated the crosswalk or
methodology used in the original valuation of this service is unknown
and not resource-based; therefore, it is invalid to compare the current
time and work to the surveyed time and work. Commenters noted this
code's source of time is CMS/Other, implying that the time was merely
crosswalked or selected by a single CMS staffer some time ago. CMS
should not compare the valid survey time to the initial CMS/Other time
because the initial CMS/Other source data is flawed and has no validity
for comparison.
    Response: The current physician times for CPT code 11982 are 44
minutes of total time and the current work RVUs is 1.78. The AMA RUC's
new recommended times are 10 minutes intra-service time and 33 minutes
total time (surveyed total time was 34 minutes). CMS accepts the AMA
RUC newly surveyed recommended times and used CPT reference code 64486,
with 10 minutes intra-service time and 35 minutes total time, which are
clearly comparable to the accepted recommended times for CPT code
11982. CPT code 64486 was introduced by CPT in 2014 and the time source
was from the ``RUC'' who no doubt surveyed this code at that time, so
CPT code 64486's time source is not ``CMS/Other'', which we do not
believe is material to selecting a reference code for physician work
and time. As part of our review, we look for comparable codes that are
similar in physician service times, work RVUs, work intensity, and
clinically relatedness. As discussed above, we believe there is no
comparison flaw in time or work RVUs, based on the AMA RUC's
distinction labeling of ``RUC'' times, ``CMS/Other times'', or
``Harvard'' times. We believe that it is crucial that the code
valuation process take place with the understanding that all existing
work times, used in the PFS ratesetting processes, are accurate and
there is no comparison flaw. Our reference CPT code 64486's work RVU is
1.27.
    Comment: Commenters stated that CPT code 11982 is essentially not
clinically related to our reference code of CPT code 64486, in
physician description of work and the typical patient population that
they treat.
    Response: As part of our review, we look for comparable codes that
are similar in physician service times, work RVUs, work intensity, and
are clinically related. As discussed above, we believe there is no
comparison flaw in time or work RVUs, based on the AMA RUC's
distinction labeling of ``RUC'' times, ``CMS/Other times'', or
``Harvard'' times. We believe that it is crucial that the code
valuation process take place with the understanding that all existing
work times, used in the PFS ratesetting processes, are accurate. CPT
codes 11982 and 64486 are not clinically related, but their work times
and work RVUs are similar. The commenter's selected reference CPT codes
of 54150 and 12004, can also be said to be very similar to CPT code
11982 as well. CPT (referencing) code 54150 appears to apply only to
the male patient population, where CPT code 11982
[[Page 62719]]
applies to both the male and female population. CPT (referencing) code
12004 appears to be at least partially valued on the length of a wound
repair (7.6 cm to 12.5 cm), assuming that the longer the wound repair
is, the more work and physician time is required to perform the
procedure, but CPT code 11982 does not have this ``size length''
characteristic. As previously stated, clinical relatedness between
codes are not always exact, nor always available for exact comparison
and we continue to believe that CMS' reference CPT code 64486 is
equally as valid as the AMA RUC's reference CPT codes.
    Comment: The AMA RUC and the survey respondents offered CPT code
54150 (Circumcision, using clamp or other device with regional dorsal
penile or ring block (work RVU = 1.90, 15 minutes intra-service 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 intra-service time and 29 minutes total time)) as
comparable reference codes to CPT code 11982.
    Response: Both AMA RUC reference codes have more intra-service
times than CPT code 11982, so accordingly, they have more work RVUs. We
believe CPT code 11982 with 10 minutes of intra-service time should
have a work RVU value that is less than the AMA RUC reference codes and
less than their recommended 1.70 RVUs. CPT code 64486 physician times
are very similar to CPT code 11982's physician times and their work
RVUs should be similar.
    After consideration of the public comments for CPT code 11982, we
are finalizing its work RVU, as proposed, to 1.34 RVUs.
    Comment: One commenter stated the current source of time for CPT
code 11983 is CMS/Other and the crosswalk or methodology used in the
original valuation of this service is unknown and not resource-based;
therefore, it is invalid to compare the current time and work to the
surveyed time and work. The commenter further stated this code's source
of time is CMS/Other, implying that the time was merely crosswalked or
selected by a single CMS staffer some time ago. CMS should not compare
the valid survey time to the initial CMS/Other time because the initial
CMS/Other source data is flawed and has no validity for comparison.
    Response: The current physician times for CPT code 11983 are 49
minutes of total time and the current work RVUs is 3.30. The AMA RUC's
new recommended times are 15 minutes intra-service time and 40 minutes
total time (surveyed total time was 41 minutes). We accept the AMA RUC
newly surveyed recommended times and used CPT code 62324, with 15
minutes intra-service time and 43 minutes total time, which are
comparable to the AMA RUC recommended times for CPT code 11983. CPT
code 62324 was introduced by CPT in 2017 and the time source was from
the ``RUC'' who no doubt surveyed this code at that time, so CPT code
62324's time source is not ``CMS/Other'', which we do not believe is
material to selecting a reference code for physician work and time. As
part of our review, we look for comparable codes that are similar in
physician service times, work RVUs, work intensity, and clinically
similarity. As discussed above, we believe there is no comparison flaw
in time or work RVUs, based on the AMA RUC's distinction labeling of
``RUC'' times, ``CMS/Other times'', or ``Harvard'' times. We believe
that it is crucial that the code valuation process take place with the
understanding that all existing work times, used in the PFS ratesetting
processes, are accurate. We continue to believe that CPT code 62324 is
the better reference code to CPT code 11983. Our reference CPT code
62324's work RVU is 1.89.
    Comment: Commenters stated that the intensity of the work required
to perform CPT code 11983 is not comparable to CMS' reference to
injection of anesthetic code 62324 and yet in their original AMA RUC
survey for CPT code 11983, the commenter stated the survey respondents
indicated that CPT code 11983 (originally 15 minutes intra-service
time, 69 minutes total time, and 3.30 work RVUs) overall requires the
same or more intensity and complexity to perform as CPT code 55700 (15
minutes of intra-service time, 35 minutes of total time, and 2.50 work
RVUs). The RUC noted that since CPT code 11983 has such a low intra-
service time and is a 000-day service comparing the intra-service per
unit of time (IWPUT) is not a useful comparison.
    Response: The commenters stated that CPT (CMS reference) code 62324
(15 minutes intra-service time, 43 minutes total time and their work
RVU is 1.89) is less intensive than CPT code 11983 and thus their work
RVUs are not comparable. But, the original selected surveyees'
reference CPT code of 55700 (15 minutes intra-service time, 35 minutes
total time and work RVU is 2.50) has been stated as the same or less
intensive than CPT code 11983. Therefore, we question if that is true.
If CPT code 55700 (2.50 work RVUs) is the same or less intensive than
CPT code 11983, CPT code 11983's proposed work RVU should be 2.50 or
greater. The RUC recommended work RVU for CPT code 11983 is 2.10. This
is less than 2.50. The survey median yielded 2.50. Further, the AMA RUC
asserts that the work RVU for CPT code 11983 should be higher than 1.89
(62324) and also higher than 2.50 (55700) but recommends a proposed
work RVU of 2.10. The AMA RUC noted that since CPT code 11983 has such
a low intra-service time and is a 000-day service, comparing the intra-
service per unit of time (IWPUT) is not a useful comparison. (The AMA
RUC also referenced CPT code 54150 (work RVU is 1.90) and CPT code
52281 (work RVU is 2.75) as potential reference codes.
    As part of our review, we look for comparable codes that are
similar in physician service times, work RVUs, work intensity, and are
clinical related. As discussed above, we believe there is no comparison
flaw in time or work RVUs, based on the AMA RUC's distinction labeling
of ``RUC'' times, ``CMS/Other times'', or ``Harvard'' times. We believe
that it is crucial that the code valuation process take place with the
understanding that all existing work times, used in the PFS ratesetting
processes, are accurate and there is no comparison flaw. As for the
question of our selection of CPT code 62324 being more or less
clinically related to CPT code 11983, as we have previously stated in
this regard, perfect clinical relatedness is not always available in
selecting a reference code. The same is true with the AMA RUC selection
of reference code(s).
    After consideration of the public comments for CPT code 11983, we
are finalizing the work RVU, as proposed, of 1.91 RVUs.
    Comment: One commenter stated that CMS may have a typo in the text
of the proposed rule because the CY 2020 PFS proposed rule Physician
Time file indicated the same time as the RUC recommended with a total
of 27 minutes for CPT code 20700.
    Response: The commenter is correct that there was a typo in the
text concerning CPT code 20700 (206X0) where in one sentence the total
physician time was stated as 27 minutes and then in a subsequent
sentence it was stated as 20 minutes. The typo has been corrected. Upon
further review of the AMA RUC recommendations and CMS own examination,
we believe that our proposed RVU value of 1.32 work RVUs on balance is
not entirely supportable, and we are instead adopting the AMA RUC
recommended
[[Page 62720]]
value of 1.50 work RVUs for CPT code 20700.
    Comment: Concerning the paragraph on CPT code 20702 (206X1),
commenters noted that there were two typos in the proposed rule for the
CMS reference CPT code 11047. The commenter stated that the RUC total
time recommended for CPT code 20702 (206X1) is 32 minutes not 38
minutes and the total time for CMS reference code 11047 is 31 minutes
not 32 minutes, but both are listed correctly in the CY 2020 PFS
proposed rule Physician Time file.
    Response: The commenter is correct that there was a typo in the
text concerning CPT code 20702 (206X1) where in one sentence the total
physician time was stated as 38 minutes when it was actually 32
minutes. The 38 minutes was from the survey total time for this code,
and it was inadvertently used. The typo has been corrected. Upon
further review of the AMA RUC recommendations and CMS' own examination,
we believe that our proposed value of 1.70 work RVUs on balance is not
entirely supportable, and we are instead adopting the AMA RUC
recommended value of 2.50 work RVUs for CPT code 20702.
    Comment: One commenter noted that there is a typo in the text of
the proposed rule for CPT code 20704 (206X2). The commenter stated the
RUC recommended 5 minutes evaluation pre-service time, 30 minutes
intra-service time and 2 minutes post-service time, totaling 37 minutes
for CPT code 20704 (206X2), not 45 minutes. The physician time for CPT
code 20704 (206X2) is listed correctly in the CY 2020 PFS proposed rule
Physician Time file.
    Response: The commenter is correct that there was a typo in the
text concerning CPT code 20704 (206X2) where in one sentence the total
physician time was stated as 45 minutes when it was actually 37
minutes. The 45 minutes was this from this CPT code's surveyed total
time and the actual AMA RUC recommended total time was 37 minutes. The
typo has been corrected. Upon further review of the AMA RUC
recommendations and CMS' own examination, we believe our proposed value
of 1.80 work RVUs on balance is not entirely supportable and we are
instead adopting the AMA RUC recommended value of 2.60 work RVUs for
CPT code 20704.
    After consideration of the public comments, we are accepting the
AMA RUC's surveyed times for CPT codes 11981, 11982, and 11983,
however, we do not agree with the AMA RUC recommended work RVUs, and we
are finalizing our proposed work RVUs of 1.14 for CPT code 11981, 1.34
for CPT code 11982, and 1.91 for CPT code 11983. For CPT codes 20700 to
20705, we agree with and are finalizing the AMA RUC's recommended work
RVUs of 1.50 for CPT code 20700, 1.13 for CPT code 20701, 2.50 for CPT
code 20702, 1.80 for CPT code 20703, 2.60 for CPT code 20704, and 2.15
for CPT code 20705. We recognize that the manual preparation and
insertion of drug delivery device(s) should take more time than their
removal code counterparts, and while we accepted the work RVUs for the
removal codes, on the whole, they did not make as much sense in their
relativity to each other, with our proposed work RVUs for the
insertions. The AMA RUC recommended insertion work RVUs are a better
fit with the removal work RVUs.
(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 proposed 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 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 was 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 proposed 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 did not propose 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
[[Page 62721]]
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
proposed 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 proposed 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 proposed 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.
    We received public comments on the proposed valuation of the codes
in the Bone Biopsy Trocar-Needle family. The following is a summary of
the comments we received and our responses.
    Comment: Several commenters disagreed with the CMS proposed work
RVU of 1.65 for CPT code 20220 and stated that CMS should instead
finalize the RUC-recommended work RVU of 1.93. Commenters stated that a
superficial bone biopsy as described in CPT code 20220 is more intense
to perform than a liver biopsy as described in the CMS crosswalk code
(47000), and that the typical indication for CPT code 20220, a
potentially infectious or malignant lesion, requires a biopsy with an
11-gauge Jamshidi bone biopsy needle. Commenters stated that accurate
placement and increased risk of adjacent structures results in a
greater intensity of physician work relative to CPT code 47000.
    Response: We appreciate the additional information from the
commenters regarding the relative intensity of CPT codes 20220 and
47000. In light of this additional information, we agree with the
commenters that the superficial bone biopsy service described by CPT
code 20220 has a higher intensity than the liver biopsy service
described by CPT code 47000. Although we stated that the crosswalk code
was ``potentially more intense'' in the proposed rule, we ultimately
proposed a higher intensity for CPT code 20220 than CPT code 47000 at
our work RVU of 1.65. Based on the information provided by the survey
respondents, who considered CPT code 47000 to have similar intensity to
CPT code 20220, we continue to disagree with the RUC-recommended work
RVU of 1.93, which would assign a significantly higher intensity to CPT
code 20220. We continue to believe that it was more accurate to propose
a work RVU of 1.65, based on the aforementioned crosswalk to CPT code
47000, which assigns both codes a similar intensity, accounts for the
decrease in the surveyed intraservice work time, and incorporates the
information provided by the survey respondents.
    Comment: Several commenters disagreed with the CMS proposed work
RVU of 2.45 for CPT code 20225 and stated that CMS should instead
finalize the RUC-recommended work RVU of 3.00. Commenters stated that
crosswalking a deep bone biopsy performed on patients with a
destructive malignant lesion to CPT code 30906, a service used for
controlling an established patient's nosebleed, was inappropriate.
Commenters noted that the proposed intensity of CPT code 20225 was
lower than the intensity of the crosswalk code.
    Response: We disagree with the commenters that there is a
meaningful difference in intensity between CPT code 20225 and our
crosswalk CPT code 30906. These two codes share the same intraservice
time of 30 minutes and differ by only 1 minute of total time, 64
minutes as compared to 63 minutes. The intensity of these two codes
differs by less than one half of one percentage point, and it would be
difficult for two procedures to match more closely on intensity (which
is itself a derived number not measured directly) without sharing the
same work times. We also disagree with the commenters that the choice
of CPT code 30906 is an inappropriate crosswalk on clinical grounds.
CPT code 30906 is far from a simple ``nosebleed'', instead describing a
service in which the typical patient requires repeated treatment for
control of nasal hemorrhages using anesthesia and extensive cautery.
Like CPT code 20225, CPT code 30906 is a significant 0-day global
procedure that requires 30 minutes of intraservice work time. We
continue to believe that it was more accurate to propose a work RVU of
2.45 for CPT code 20225, based on the aforementioned crosswalk to CPT
code 30906, which we believe better maintains the relative intensity of
the two codes in the family, and better preserves relativity with the
rest of the codes on the PFS.
    Comment: Several commenters stated the crosswalk or methodology
used in the original valuation of CPT code 20220 is unknown and not
resource-based, and therefore, it was invalid for CMS to compare the
current time and work to the surveyed time and work. Commenters stated
that referencing physician times and derived intensities created almost
30 years ago under the Harvard study as a method to critique RUC
recommendations was not appropriate. Commenters also stated that when
CPT code 20225 was last evaluated in 1995, work times were evaluated
with much less rigor, and that the near zero intensity of CPT code
20225 indicated a severely anomalous relationship between the current
work value and current physician time.
    Response: We disagree with the commenter that it was invalid to
compare the current time and work to the surveyed time and work. We
believe that it is crucial that the code valuation process take place
with the understanding that the existing work times, used in the PFS
ratesetting processes, are accurate. 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
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 old
work time values that were established many years ago and have not
since been reviewed in our methodology, we refer readers to our
discussion of the subject in the Methodology for Establishing Work RVUs
section of this rule (section II.N.2. of this final rule), as well as a
longer discussion in the CY 2017 PFS final rule (81 FR 80273 through
80274).
[[Page 62722]]
    Comment: Several commenters disagreed with the CMS proposal to
replace the bone biopsy device (SF055) supply with the bone biopsy
needle (SC077) in CPT code 20225. Commenters stated that the bone
biopsy device was necessary to perform this procedure and that the
omission of this supply item when this service was last reviewed in
2004 was an oversight. Commenters stated that in the vast majority of
cases, deep bone biopsies are performed percutaneously using a bone
biopsy drill device that allows for access to sclerotic bony lesions in
a manner that a bone biopsy needle cannot, and that failing to
accurately include the devices typically used to perform this service
in a nonfacility setting would likely result in the procedures being
pushed to a more expensive facility setting.
    Response: Although we appreciate the additional information about
the bone biopsy device provided by the commenters, we disagree that its
use would be typical for CPT code 20225. As we stated in the proposed
rule, CPT code 20225 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 believe it unlikely that the lack of a
bone biopsy device in the current direct PE inputs for CPT code 20225
was an accidental omission, given that it has been omitted from the
direct PE inputs for the past 15 years--had this been an oversight, we
would expect that there would have been a previous attempt to address
it. We also note that the clinical description of work for CPT code
20225 makes no mention of a bone biopsy drill, but does repeatedly
mention the use of a needle for the bone biopsy. Based on this
evidence, we continue to believe that the continued use of the bone
biopsy needle supply would be typical for the procedure.
    After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for the codes in the Bone Biopsy Trocar-
Needle family as proposed.
(4) Trigger Point Dry Needling (CPT Codes 20560 and 20561)
    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 20560 (Needle insertion(s) without injection(s), 1 or 2 muscle(s))
and we proposed 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 20560, which makes it an appropriate choice for a
crosswalk. In our review of CPT code 20560, 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 20560, 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
20560 should be valued at a higher rate, and therefore, we proposed 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 20561 (Needle insertion(s) without injection(s), 3 or more
muscle(s)) and we proposed 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 20561, 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 proposed a work RVU of 0.32 for CPT code 20560
with 10 minutes of intraservice work time, and a work RVU of 0.48 for
CPT code 20561 with 15 minutes of intraservice work time. We also
considered crosswalking the work RVU of CPT code 20561 to the 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 20561 was more intense than CPT
code 97140.
    We also proposed to designate CPT codes 20560 and 20561 as ``always
therapy'' procedures, and we solicited comments on this designation. We
proposed the RUC-recommended direct PE inputs for all codes in the
family.
    We received public comments on the proposed valuation of the codes
in the Trigger Point Dry Needling family. The following is a summary of
the comments we received and our responses.
    Comment: Several commenters disagreed with the CMS proposed work
RVU of 0.32 for CPT code 20560 and stated that CMS should instead
finalize the HCPAC-recommended work RVU of 0.45. Commenters stated that
CMS disregarded all factors that go into work valuation apart from
time, as well as minimized the understanding of the service on the part
of the survey respondents. Commenters stated that the survey
respondents recognized that CPT code 20560 is more intense and complex
to perform than the top reference code, CPT code 97140, because it is
an invasive procedure rather than non-invasive manual therapy.
Commenters stated that 70 percent of the survey respondents that
selected this key reference code indicated that CPT code 20560 requires
more mental effort and judgment and 84 percent indicated that more
physiological stress is involved. Commenters stated that noninvasive
techniques do not have the same risks or skill requirement as
procedures described by 20560, and that a higher level of education for
the qualified health care professional is required in addition to a
higher level of skill and focus during and following the procedure when
performing CPT code 20560.
    Response: In response to the first issue raised by the commenters
regarding work valuation based on 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. We clarify again that
we do not treat all components of physician time as having identical
intensity. If we were 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. For more
details on our methodology for developing work RVUs, we refer readers
to our discussion of the subject in the Methodology for Establishing
Work RVUs section of this rule (section II.N.2 of this final rule), as
well as a longer discussion in the CY 2017 PFS final rule (81 FR 80272
through 80277).
    We also disagree with the commenters that CPT code 20560 is more
intense and complex to perform than the top
[[Page 62723]]
reference code, CPT code 97140. Although it is true that a majority of
survey respondents stated that CPT code 20560 requires more mental
effort/judgment and additional physiological stress, 74 percent of the
same survey respondents also stated that CPT code 20560 required less
physical effort than CPT code 97140, which would suggest that the
reviewed code instead has a lower intensity. We do not agree that the
survey responses provide sufficient support for assigning a higher work
RVU to CPT 20560 than CPT code 97140, especially given that this top
reference code has 50 percent more intraservice time. We similarly do
not agree that the intensity of the non-invasive manual therapy
procedure described by CPT code 97140 is inherently lower on clinical
grounds than the invasive procedure described by CPT code 20560. The
manual therapy procedure described by CPT code 97140 has its own
distinct type of skill requirements since there is more extensive
direct contact between the practitioner and the patient than in CPT
code 20560. We continue to believe that CPT code 20560 should not be
valued at a higher rate than CPT code 97140, and therefore, we proposed
a work RVU of 0.32 based on the aforementioned crosswalk to CPT code
36600.
    Comment: Several commenters disagreed with the CMS proposed work
RVU of 0.48 for CPT code 20561 and stated that CMS should instead
finalize the HCPAC-recommended work RVU of 0.60. Commenters stated that
CMS started with the work RVU they assigned to CPT code 20560 and then
selected crosswalk codes that matched the intraservice time ratio
between the codes in the family. Commenters stated that this is an
erroneous methodology and, if finalized, would create a rank order
anomaly between this and other similar services.
    Response: We clarify that we did not use an intraservice time ratio
to determine the work valuation of CPT code 20561. As we stated in the
proposed rule, we proposed a work RVU of 0.48 based on a crosswalk to
CPT codes 97113 and 97542 as both of these codes share the same work
RVU of 0.48 and the same intraservice time of 15 minutes as CPT code
20561, with CPT code 97113 having 2 fewer minutes of total time and CPT
code 97542 having 2 additional minutes of total time. We believe that
the close match between the surveyed work time for CPT code 20561 and
the work times of these two codes indicated that these three services
should be valued similarly, and we disagree that the proposed work RVU
would create a rank order anomaly due to the close relationship between
the work times of these codes. We noted in the proposed rule that the
proposed work RVU of 0.48 for CPT code 20561 is an exact match of the
intraservice time ratio between the two codes in the family; however,
we cited this fact as supporting evidence and not as the primary basis
for valuation. Although we did not use a time ratio for work valuation
in this case, we continue to believe that the use of time ratios is one
of several appropriate methods for identifying potential work RVUs for
particular PFS services. For more details on our methodology for
developing work RVUs, we refer readers to our discussion of the subject
in the Methodology for Establishing Work RVUs section of this rule
(section II.N.2. of this final rule), as well as a longer discussion in
the CY 2017 PFS final rule (81 FR 80272 through 80277).
    Comment: Several commenters provided the same rationale for CPT
code 20561 in relation to the top reference code from the survey, CPT
code 97140, as they had made for CPT code 20560. Commenters stated that
the survey respondents recognized that CPT code 20561 is more intense
and complex to perform than the top reference code, CPT code 97140,
because it is an invasive procedure rather than non-invasive manual
therapy. Commenters stated that 71 percent of the survey respondents
that selected this key reference code indicated that CPT code 20560
requires more mental effort and judgment and 88 percent indicated that
more physiological stress is involved. Commenters stated that
noninvasive techniques do not have the same risks or skill requirement
as procedures described by 20561, and that a higher level of education
for the qualified health care professional is required in addition to a
higher level of skill and focus during and following the procedure when
performing CPT code 20561.
    Response: We continue to disagree with the commenters that CPT code
20561 is more intense and complex to perform than the top reference
code, CPT code 97140, for many of the same reasons that we cited in our
response to the same comments regarding CPT code 20560. As we observed
for the first code in the family, 69 percent of the same survey
respondents also stated that CPT code 20561 required less physical
effort than CPT code 97140, which would again suggest that the reviewed
code instead has a lower intensity. Unlike CPT code 20560, we agree
that CPT code 20561 should have a higher work RVU than CPT code 97140,
which is why we proposed a work RVU of 0.48 for the procedure. To the
extent that the commenters are stating that CPT code 20561 should have
a higher work RVU than CPT code 97140, we agree with the commenters and
we proposed a work RVU accordingly. We do not agree with the commenters
that CPT code 20561 should be valued nearly 50 percent higher than CPT
code 97140 given their nearly identical work times and similar overall
intensity.
    Comment: One commenter agreed with the CMS proposal to designate
CPT codes 20560 and 20561 as ``always therapy'' procedures. The
commenter stated that acupuncturists would also use additional
modalities and procedures in their scope along with these codes, and
that these would not typically be billed independently.
    Response: We appreciate the support for our proposals from the
commenter.
    Comment: Many commenters disagreed with the CMS proposal to
designate CPT codes 20560 and 20561 as ``always therapy'' procedures.
Commenters stated that these services may be performed by a wide range
of professionals and that it may not be appropriate to bill the service
under a therapy plan of care. Commenters also stated that assigning a
designation of ``always therapy'' to these codes would be inconsistent
with CMS' designation of other CPT codes as ``sometimes therapy'' codes
that could be appropriately provided either as therapy services or non-
therapy services. Other commenters objected to the proposal by stating
that dry needling codes should be placed in the surgical section of the
CPT codebook, and that due to the invasive nature of these procedures
using needles, they should only be performed by licensed medical
physicians or licensed acupuncturists. Commenters urged CMS to change
the designation of CPT codes 20560 and 20561 to ``sometimes therapy''
procedures.
    Response: We appreciate the feedback from the commenters in
providing additional information about which providers will bill these
services, and the fact that it may not be appropriate to bill these
service under a therapy plan of care. After consideration of the
comments, we are not finalizing our proposal to designate CPT codes
20560 and 20561 as ``always therapy'' procedures. We believe that a
``sometimes therapy'' designation would be more appropriate if we were
to designate these codes as therapy procedures.
    Comment: One commenter stated that if CPT codes 20560 and 20561 are
covered services under Medicare then
[[Page 62724]]
an acupuncturist should be a qualified health care professional and
should be recognized by Medicare to provide this service. The commenter
described some of the clinical benefits associated with acupuncture and
stated again that acupuncturists should be recognized by Medicare to
provide dry needling.
    Response: We appreciate the feedback from the commenter regarding
the practice of acupuncture. However, we did not make a proposal
regarding the classification of acupuncturists, and therefore, this
comment is out of scope.
    After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for the codes in the Trigger Point Dry
Needling family as proposed. We are not finalizing these codes as
``always'' or ``sometimes'' therapy services because dry needling
services are non-covered unless otherwise specified through a national
coverage determination (NCD). Please refer to the NCD Manual, Section
30.3 at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part1.pdf.
(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
disagreed with the recommended work-RVU of 3.75, stating that we did
not think that this reduction in work RVU from the current value of
3.89 was commensurate with the RUC-recommended 33-minute reduction in
intraservice time and 105-minute reduction in total time. We noted that
while we understand that the RUC considers the current Harvard study
time values for this service to be invalid estimations, we believed
that a further reduction in work RVUs is warranted given the
significance of the RUC-recommended reduction in physician time. We
proposed 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 to more accurately
account for the decrease in the surveyed work time.
    For the direct PE inputs, we proposed to refine the equipment time
for the power table (EF031) to conform to our established policies for
non-highly technical equipment.
    We received public comments on the proposed valuation of the codes
in the Closed Treatment Vertebral Fracture family. The following is a
summary of the comments we received and our responses.
    Comment: A few commenters stated that CMS is inappropriately
comparing accurate survey time to Harvard time, which the commenter
stated holds zero validity for comparison. The commenters further
stated that our proposed value fails to acknowledge that the Harvard
work value was much higher based on the Harvard study physician work
times than the current work value of the service. One commenter noted
that in the June 1991 proposed rule, the work RVU for 22310, based on
the Harvard study, was 6.31, then, in the November 1991 final rule for
the 1992 PFS, the work RVU was reduced to 1.95, and then in 1997,
hospital and office visits were assigned by algorithm for practice
expense (PE) purposes. The commenter stated that the entire history of
value of this code is fraught with misestimations of time and the
current work RVU of 3.89 has nothing to do with the Harvard study.
    Response: We believe that it is crucial that the code valuation
process take place with the understanding that the existing work times,
used in the PFS ratesetting processes, are accurate. 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 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 old work time values that were established many
years ago and have not since been reviewed 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 recognize that this code has undergone revisions and that the
work value has changed significantly from the Harvard value. If we
accept the commenter's contention that the current work RVU is
unrelated to the original Harvard work RVU, and we compare the time
values to the original 1991 Harvard work value of 6.31, our proposed
work RVU continues to appear to be appropriate. A ratio of the change
in intraservice time to the original RVU of 6.31 is 3.50; a ratio of
the change in total time to the original work RVU of 6.31 is 2.38.
These ratios suggest that our proposed RVU of 3.45 is a more accurate
valuation than the RUC's recommended RVU of 3.75. We continue to
believe that a crosswalk to CPT code 21073, which describes
manipulation under general or monitored care under anesthesia with
manipulation of the TMJ, is appropriate. CPT code 22310 involves closed
treatment without manipulation and the application of a brace, while
CPT code 21073 involves anesthesia and manipulation; we believe the
similar work and time of CPT code 21073 validates our work RVU of 3.45
for CPT Code 22310.
    Comment: Several commenters stated that they agreed with our
proposal to refine the equipment time for the power table (EF031) to
conform to our established policies for non-highly technical equipment.
    Response: We appreciate the support for our proposal from the
commenters.
    After consideration of the public comments, we are finalizing our
work RVU of 3.45 as proposed. We are also finalizing the direct PE
inputs as proposed.
(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 proposed 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
[[Page 62725]]
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
proposed 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 proposed 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 proposed 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.
    We received public comments on the proposed valuation of the codes
in the Tendon Sheath Procedures family. The following is a summary of
the comments we received and our responses.
    Comment: A few commenters stated that, for CPT code 26020, our
supporting reference codes, CPT code 28122 and CPT code 28289, are
inappropriate in that they have lower total time values than the
surveyed total time of CPT code 26020, and that this reflects that
these two reference codes typically involve a patient who is discharged
within 23 hours of the procedure and are less intense. The commenter
stated that the RUC's recommendation of the median survey value for CPT
code 26020 is necessary because even at the survey median, the
intraoperative intensity (0.027), is so low that there are no
comparator codes with a lower work RVU. This commenter also stated that
the survey 25th percentile work RVU would vastly underestimate the
physician work, resulting in an intraoperative intensity of 0.006--or
essentially zero.
    Response: For CPT code 26020, we continue to believe that the RUC's
recommended work RVU of 7.79 is disproportionately high, as it
represents a 35 percent increase in work despite a 5 minute increase in
intraservice time and a 30 minute increase in total time. We believe
our proposal to value CPT code 26020 with the survey 25th percentile,
which represents a roughly 26 percent increase is more proportionate.
Further, we note that our proposed value recognizes the work inherent
in this procedure, including the requisite inpatient monitoring, as it
lies within the top quartile of all 90-day global period codes with an
intraservice time of 45 minutes. We recognize that the relatively high
total time value for this code results in a relatively low intensity
value, however we continue to believe that our value appears to be
consistent with other relatively low-intensity procedures of similar
times. The intensity value that results from our proposed work RVU is
extremely close to that which results from the RUC's recommended work
RVU, and therefore, we continue to think that our value adequately
reflects the work inherent in the procedure.
    Comment: One commenter stated that our proposal to maintain the
current work RVU for CPT code 26055 indicates that we inappropriately
noted that the reduction in time should exactly correlate with a
reduction in work RVU. The current times are based on a 2005 survey but
the current work RVU is based on the Harvard study. The commenter
stated that CMS should not compare the old times relative to the work
RVU. The commenter disagreed with use of an incremental methodology to
value CPT code 26055, as it inaccurately treats all components of the
physician time as having identical intensity. In addition, the
commenter stated maintaining the current work RVU for CPT code 26055
results in an inappropriately low intensity of 0.011 which does not
reflect an open surgical procedure typically performed in a facility
under moderate sedation and is not much higher than the assigned value
for pre-service scrub/dress/wait time.
    Response: We do not believe that our proposal assumes that the
reduction in time for this service should exactly correlate with a
reduction in work RVU; a proportionate reduction based solely on time
would result in a lower RVU than that proposed. As discussed elsewhere
in this rule, we believe that our operating assumption regarding the
validity of the existing values as a point of comparison is critical to
the integrity of the relative value system as currently constructed. We
believe the use of an incremental difference between codes is a valid
methodology for setting values, especially in valuing services within a
family of revised codes where it is important to maintain appropriate
intra-family relativity. Historically, we have frequently utilized an
incremental methodology in which we value a code based upon its
incremental difference between another code or another family of codes.
We note that the RUC has also used the same incremental methodology on
occasion when it was unable to produce valid survey data for a service.
We have no evidence to suggest that the use of an incremental
difference between codes conflicts with the statute's definition of the
work component as the resources in time and intensity required in
furnishing the service. For more details on our methodology for
developing work RVUs, we refer readers to our discussion of the subject
in the Methodology for Establishing Work RVUs section of this rule
(section II.N.2. of this final rule), as well as a longer discussion in
the CY 2017 PFS final rule (81 FR 80272 through 80277). We continue to
believe that our proposed work RVU maintains the proportionate
relationship with CPT code 26020.
    We continue to believe that comparisons to similar procedures of
similar time values indicate that our proposed value accurately
reflects the intensity inherent in the procedure.
    Comment: Several commenters disagreed with the CMS proposal to
refine the quantity of the impervious staff gown (SB027) supply from 2
to 1 for CPT codes 26055 and 26160 and stated that this gown was not
duplicative. Commenters stated that two gowns are required in the
procedure room (for the practitioner and a clinical staff member) and a
separate gown is required, typically for a second clinical staff
individual, for the cleaning of instruments in a separate room.
Commenters stated that the US Department of Labor, Occupational Safety
and Health Administration (OSHA) regulations require that all personal
protective equipment must be removed prior to leaving the work area,
which includes removing the impervious staff gown worn during the
procedure, and therefore, necessitating the inclusion of another gown
as a supply input.
    Response: We appreciate the additional information provided by the
commenters regarding the number of impervious staff gowns typically
used in these procedures. As a result of this additional information,
we are not
[[Page 62726]]
finalizing our proposed refinement to reduce the quantity of the
impervious staff gown (SB027) supply from 2 to 1 for CPT codes 26055
and 26160. We are instead finalizing the RUC-recommended direct PE
inputs for all three codes in the family.
    After consideration of the public comments, we are finalizing our
proposed work RVUs of 6.84 for CPT code 26020, 3.11 for CPT code 26055,
and 3.57 for CPT code 26160. We are finalizing the RUC-recommended
direct PE inputs for all three codes in the family as stated
previously.
(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 proposed to refine the equipment time
for the power table (EF031) to conform to our established policies for
non-highly technical equipment.
    We received public comments on the proposed valuation of the Closed
Treatment Fracture--Hip code. The following is a summary of the
comments we received and our responses.
    Comment: A few commenters disagreed with our proposal, stating that
it relies on a comparison of accurate survey time to Harvard time, the
latter of which they stated holds zero validity for comparison.
    Response: We believe that it is crucial that the code valuation
process take place with the understanding that the existing work times,
used in the PFS ratesetting processes, are accurate. 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 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 old work time values that were established many
years ago and have not since been reviewed in our methodology, we refer
readers to our discussion of the subject in the Methodology for
Establishing Work RVUs section of this rule (section II.N.2. of this
final rule), as well as a longer discussion in the CY 2017 PFS final
rule (81 FR 80273 through 80274).
    Comment: One commenter stated that reducing the work RVU of this
service based on a comparison to the current work value does not
adequately take into account that the current value reflects
adjustments made to the original Harvard work RVU in various rule
cycles over many years to account for increases in the E/M services
included in the global period of this service. A downward adjustment to
the work RVU would essentially reverse increases that have been made to
account for this post-operative work.
    Response: We disagree that reducing the work RVU ignores the value
of the E/M services included in the global period; while the Harvard
work values for services such as this one have been adjusted upward in
previous years to account for these services, we nevertheless have
included the surveyed work time in our analysis of this code; and this
surveyed time includes post-operative work. Our proposed work RVU was
not based solely on the reduction in time. We note that our crosswalk
code, CPT code 27267 (Closed treatment of femoral fracture, proximal
end, head; without manipulation) includes a similar amount of
postoperative work, and therefore, we believe that our value adequately
reflects this work.
    Comment: The RUC commented that our proposed work RVU will
inappropriately value this service equally to the work RVU of the
survey key reference service, CPT code 27267, and the latter has
significantly less pre-service time, and is thus not an appropriate
crosswalk. Furthermore, our proposed value does not adequately correct
the negative IWPUT resulting from the current value, stating that the
resulting IWPUT of 0.008 is essentially zero.
    Response: We continue to believe that CPT code 27267 is an
appropriate crosswalk; both procedures involve closed treatment of hip
without manipulation. While the derived intensity value that results
from our proposed value of 5.50 is lower than that which results from
the RUC's value, it is only negligibly so, with a difference of 0.033
in IWPUT.
    Comment: A commenter stated that they agreed with our proposal to
refine the equipment time for the power table (EF031) to conform to our
established policies for non-highly technical equipment.
    Response: We appreciate the support for our proposals from the
commenter.
    After consideration of the public comments, we are finalizing as
proposed a work RVU of 5.50 for CPT code 27220. We are also finalizing
the direct PE inputs as proposed.
(8) Arthrodesis--Sacroiliac 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
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
[[Page 62727]]
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 proposed 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
proposed the RUC-recommended work RVU, we solicited 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 proposed the RUC-recommended direct PE inputs for CPT code
27279.
    We received public comments on the proposed valuation of the
Arthrodesis--Sacroiliac Joint code. The following is a summary of the
comments we received and our responses.
    Comment: A commenter questioned how the most recent stakeholder
comment was obtained, since the RUC recommendations are not public
until after the publication of the proposed rule. The commenter stated
that the recent stakeholder comment could not have been received by CMS
via the formal comment process, and questioned if the comment was
communicated via the passing of verbal comment between individuals at
the RUC meeting or someone gained confidential information
inappropriately. The commenter stated the reason this service was
reviewed in 2019 is because it was nominated by a stakeholder that it
may be undervalued.
    Response: This communication between the agency and a stakeholder
was not inappropriate. When considering potential valuation for
services on the PFS, we may take into account information provided to
us by stakeholders including specialty societies that may have
participated in the RUC process but did not agree with what was
submitted as part of the RUC's recommendations. In any event, we
reiterate that the stakeholder's argument that the service is
undervalued refers to the current valuation of the service.
    Comment: The RUC restated that it had determined that there is not
compelling evidence to revalue this procedure as the intensity required
to perform CPT code 27279 has not changed. With no convincing rationale
that the physician work, intensity or complexity has changed for this
service, the RUC recommended to maintain the work RVU of 9.03 for CPT
code 27279. The RUC did not believe that CPT code CPT code 27279 should
be valued with a direct crosswalk to CPT code 27280, stating that the
latter is vastly different than CPT code 27279 because it is an open
procedure that includes instrumentation, requires double the amount of
intra-service time to perform, and is more intense and complex to
perform.
    Many commenters stated that the work RVU of CPT code 27279 is
undervalued, and stated that the service is complex and intense and
involves significant risk and preoperative work. Commenters presented
study results that demonstrate the advantages of this procedure over
the open procedure, stating that it is minimally invasive and has
vastly improved outcomes. Some commenters cited studies that they noted
demonstrate cost-effectiveness metrics and patient reported outcome
improvements that are better than nearly all orthopaedic and spinal
procedures, and more cost-efficient than ongoing nonoperative care.
Commenters stated that, while the procedure described by CPT code 27279
is less invasive than the open procedure; it nevertheless is similar in
terms of intensity, as it requires significant pre and postoperative
care, image guidance, and monitoring. A commenter cited risk associated
with placement of the guide wires which may result in damage to vital
structures including spinal nerve roots, blood vessels, and viscera.
Similarly, commenters cited risks inherent in spinal procedures such as
bleeding, infection, and pseudoarthrosis. One commenter discussed
insertion of pins and pegs that run the risk of violating the sacral
foraminas creating radiculopathies. In addition, a commenter mentioned
the potential for postoperative hematomas. Other risks cited include
considerable risk of nerve damage, vascular compressions and iatrogenic
fractures caused by misplacement of the guide wires, broaches and large
implants. According to a commenter, the anatomy involved in this
procedure is more complex than for a discectomy or decompression
laminectomy. Commenters stated that the procedure is significantly more
intense than the crosswalk code that its current value was originally
based on, 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). The commenters stated that this procedure
requires special skill given the complexity of the anatomy and
extensive preoperative time.
    Commenters offered various suggestions for a more appropriate
valuation for CPT code 27279; many commenters stated that 27279 is more
appropriately valued with a work RVU of 20.00, as it is comparable in
time and intensity to CPT code 27280. One commenter suggested a work
RVU of 14.23 which resulted from a regression analysis of surveys.
Other suggested crosswalk codes offered by commenters include CPT codes
63030 (Laminotomy (hemilaminectomy), with decompression of nerve
root(s), including partial facetectomy, foraminotomy and/or excision of
herniated intervertebral disc; 1 interspace, lumbar), with a work RVU
of 13.18, 63047 (Laminectomy, facetectomy and foraminotomy (unilateral
or bilateral with decompression of spinal cord, cauda equina and/or
nerve root[s], [e.g., spinal or lateral recess stenosis]), single
vertebral segment; lumbar), with a work RVU of 15.37, 22551
(Arthrodesis, anterior interbody, including disc space preparation,
discectomy, osteophytectomy and decompression of spinal cord and/or
nerve roots; cervical below C2), with a work RVU of 25.00, 27245
(Treatment of intertrochanteric, peritrochanteric, or subtrochanteric
femoral fracture; with intramedullary implant, with or without
interlocking screws and/or cerclage) with a work RVU of 18.18, 27130
(Arthroplasty, acetabular and proximal femoral prosthetic replacement
(total hip arthroplasty), with or without autograft or allograft), with
a work RVU of 20.72, 22612 (Arthrodesis, posterior or posterolateral
technique, single level; lumbar (with lateral transverse technique,
when performed)) with a
[[Page 62728]]
work RVU of 23.53, 63040 (Laminotomy (hemilaminectomy), with
decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc,
reexploration, single interspace; cervical) with an RVU of 20.31, 63042
(Laminotomy (hemilaminectomy), with decompression of nerve root(s),
including partial facetectomy, foraminotomy and/or excision of
herniated intervertebral disc, reexploration, single interspace;
lumbar) with an RVU of 18.76, 63045 (Laminectomy, facetectomy and
foraminotomy (unilateral or bilateral with decompression of spinal
cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral
recess stenosis]), single vertebral segment; cervical) with a work RVU
of 17.95, and 63046 (Laminectomy, facetectomy and foraminotomy
(unilateral or bilateral with decompression of spinal cord, cauda
equina and/or nerve root[s], [e.g., spinal or lateral recess
stenosis]), single vertebral segment; thoracic) with a work RVU of
17.25.
    Response: Commenters have provided extensive evidence that leads us
to believe that the current work RVU understates the inherent intensity
of the procedure. We agree with the RUC's longstanding contention that
survey data is critical in determining appropriate valuation of
services. The fact that this code is valued based on a crosswalk from
2014 rather than on updated survey data raised concerns. The RUC's
survey data, as well as extensive stakeholder comment indicates to us
that this service continues to be undervalued.
    We agree with the RUC that CPT code 27279 would not be accurately
valued identically to the analogous open procedure CPT code 27280, as
the latter is substantially more complex and requires twice the amount
of intraservice time to perform. Therefore, finalizing an equivalent
value for these two services would introduce a rank-order anomaly.
While we are persuaded by extensive public comment that this service as
currently valued does not adequately reflect the work inherent in
performing the procedure, we note that all of the crosswalk codes
recommended by commenters involve significantly more physician time
than that required for CPT code 27279, and values crosswalked to these
codes would not maintain appropriate rank-order between CPT codes 27279
and 27280, and would in many instances result in a valuation that is
higher than that of the open procedure, CPT code 27280. We believe it
is preferable to value this service in close adherence to the surveyed
time values. After consideration of the comments, we are finalizing a
work RVU of 12.13 with a direct crosswalk to CPT code 57288 (Sling
operation for stress incontinence (e.g., fascia or synthetic)), which
describes an open procedure of similar intensity. This procedure has an
identical intraservice time value and similar total time value. We
believe that the description of this service and its work and time
values indicate that it is a strong crosswalk and a work RVU of 12.13
is a more accurate valuation for this service. We believe a value
crosswalked to this service more accurately reflects the work inherent
in performing the procedure while accounting for the surveyed work
time.
    After consideration of the public comments, we are finalizing a
work RVU of 12.13 for this service. We are also finalizing the direct
PE inputs as proposed.
(9) Pericardiocentesis and Pericardial Drainage (CPT Code 33016, 33017,
33018, and 33019)
    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 pericardiocentesis
drainage procedures to differentiate by age and to include imaging
guidance.
    We proposed 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 33016 (Pericardiocentesis, including imaging guidance, when
performed) and proposed 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 33016 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 33016, 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 33016 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 33016 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
33017 (Pericardial drainage with insertion of indwelling catheter,
percutaneous, including fluoroscopy
[[Page 62729]]
and/or ultrasound guidance, when performed; 6 years and older without
congenital cardiac anomaly) and proposed 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 33017 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 33017, we
noted many of the same issues that we had raised with CPT code 33016,
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 33016, 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 33017 based on a crosswalk to CPT code 52234 based
on the same rationale that we detailed with regards to CPT code 33016.
    We disagree with the RUC-recommended work RVU of 6.00 for CPT code
33018 (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 proposed a work RVU of 5.00 based on the survey
25th percentile value. In our review of CPT code 33018, we noted many
of the same issues that we had raised with CPT codes 33016 and 33017,
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