[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Rules and Regulations]
[Pages 84472-85377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26815]
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Vol. 85
Monday,
No. 248
December 28, 2020
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 400, 410, 414, et al.
Medicare Program; CY 2021 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; Quality Payment
Program; Coverage of Opioid Use Disorder Services Furnished by Opioid
Treatment Programs; Medicare Enrollment of Opioid Treatment Programs;
Electronic Prescribing for Controlled Substances for a Covered Part D
Drug; Payment for Office/Outpatient Evaluation and Management Services;
Hospital IQR Program; Establish New Code Categories; Medicare Diabetes
Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and
Payment for Virtual Check-in; Final Rule
Federal Register / Vol. 85 , No. 248 / Monday, December 28, 2020 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 400, 410, 414, 415, 423, 424, and 425
[CMS-1734-F, CMS-1734-IFC, CMS-1744-F, CMS-5531-F and CMS-3401-IFC]
RIN 0938-AU10, 0938-AU31, 0938-AU32, and 0938-AU33
Medicare Program; CY 2021 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;
Quality Payment Program; Coverage of Opioid Use Disorder Services
Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid
Treatment Programs; Electronic Prescribing for Controlled Substances
for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and
Management Services; Hospital IQR Program; Establish New Code
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model
Emergency Policy; Coding and Payment for Virtual Check-in Services
Interim Final Rule Policy; Coding and Payment for Personal Protective
Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in
Response to the Public Health Emergency (PHE) for COVID-19; and
Finalization of Certain Provisions from the March 31st, May 8th and
September 2nd Interim Final Rules in Response to the PHE for COVID-19
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final rule and interim final rule.
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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 requirements; Medicaid Promoting
Interoperability Program requirements for Eligible Professionals;
updates to the Quality Payment Program; Medicare coverage of opioid use
disorder services furnished by opioid treatment programs; Medicare
enrollment of Opioid Treatment Programs; payment for office/outpatient
evaluation and management services; Requirement for Electronic
Prescribing for Controlled Substances for a Covered Part D drug under a
prescription drug plan or an MA-PD plan and Medicare Diabetes
Prevention Program (MDPP) expanded model Emergency Policy. This final
rule also finalizes certain provisions of the interim final rules with
comment period that CMS issued on March 31, 2020, May 8, 2020\,\ and
September 2, 2020 in response to the Public Health Emergency (PHE) for
the Coronavirus Disease 2019 (COVID-19). This rule also establishes
coding and payment for virtual check-in services and for personal
protective equipment (PPE) on an interim final basis.
DATES: Effective Date: The regulations in the final rule are effective
on January 1, 2021.
Applicability date: The policies in this final rule are applicable
on January 1, 2021, except as follows:
(1) The revisions to 42 CFR 400.200 and 425.611(b)(1)(ii) are
applicable retroactively to the start of the PHE for COVID-19 on
January 27, 2020. (See discussions in sections II.J. and III.G.5.d.(2)
of this final rule, respectively.)
(2) The revisions to 42 CFR 425.400(c)(2) are applicable
retroactively for the performance year starting on January 1, 2020.
(See discussion in section III.G.5.e.(3) of this final rule.)
Comment date: Comments will be accepted/considered ONLY on the
``Interim Final Rule with Comment Period for Coding and Payment of
Virtual Check-in Services'' contained in section II.D. of the preamble
of this document and ``Interim Final Rule with Comment Period for
Coding and Payment for Personal Protective Equipment (PPE)'' contained
in section II.H. 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 February 1, 2021.
ADDRESSES: In commenting, please refer to file code CMS-1734-IFC.
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-1734-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-1734-IFC, Mail Stop C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850.
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, PFS specialty-specific impacts,
and the interim final rule with comment period for coding and payment
for PPE.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Emily Yoder, (410) 786-1804, Donta Henson, (410) 786-1947, and
Patrick Sartini, (410) 786-9252, for issues related to telehealth,
other services involving communications technology, and interim final
rule with comment period for coding and payment of virtual check-in
services.
Liane Grayson, (410) 786-6583, for issues related to care
management services and remote physiologic monitoring services.
Emily Yoder, (410) 786-1804, Christiane LaBonte, (410) 786-7237,
Ann Marshall, (410) 786-3059, and Patrick Sartini, (410) 786-9252, for
issues related to payment for office/outpatient evaluation and
management visits.
Christiane LaBonte, (410) 786-7237, and Cindy Bergin, (401) 786-
1176, for issues related to teaching physician services.
Roberta Epps, (410) 786-4503, and Regina Walker-Wren, (410) 786-
9160, for issues related to supervision of diagnostic tests.
Ann Marshall, (410) 786-3059, for issues related to incident to
pharmacist services.
Gift Tee, (410) 786-9316, for issues related to therapy services.
Sarah Leipnik, (410) 786-3933, for issues related to medical record
documentation.
Lindsey Baldwin, (410) 786-1694 and Terry Simananda, (410) 786-
8144, for issues related to Medicare coverage of opioid use disorder
treatment services furnished by opioid treatment programs.
Laura Ashbaugh, (410) 786-1113, for issues related to Clinical
Laboratory Fee
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Schedule: Revised Data Reporting Period and Phase-in of Payment
Reductions
Joseph Schultz, (410) 786-2656, for issues related to opioid
treatment program provider enrollment regulation updates for
institutional claim submissions.
Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs,
primary care management services, and the FQHC market basket.
Rachel Katonak, (410) 786-8564, or JoAnna Baldwin (410) 786-7205,
for issues related to comprehensive screenings for seniors: Section
2002 of the Substance Use-Disorder Prevention that Promote Opioid
Recovery and Treatment for Patients and Communities Act (SUPPORT Act).
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, or Sabrina Ahmed, (410) 786-7499, for
issues related to the Medicare Shared Savings Program (Shared Savings
Program) Quality performance standard, quality reporting requirements
and finalization of Shared Savings Program provisions from the March
31st COVID-19 IFC.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or [email protected], for issues related to Shared
Savings Program beneficiary assignment, repayment mechanism
requirements, and finalization of Shared Savings Program provisions
from the May 8th COVID-19 IFC.
Cheryl Gilbreath, (410) 786-5919, for issues related to home
infusion therapy benefit.
Heather Hostetler, (410) 786-4515 for issues related to removal of
selected national coverage determinations.
Joella Roland, (410) 786-7638, for issues related to requirement
for electronic prescribing for controlled substances for a covered Part
D drug under a prescription drug plan or an MA-PD plan.
Edmund Kasaitis, (410) 786-0477, for issues related to Part B drug
payment and Food Drug & Cosmetic Act section 505(b)(2) drug products.
Elizabeth Holland, (410) 786-1309, for issues related to updates to
certified electronic health record technology due to the 21st Century
Cures Act.
Julia Venanzi, (410) 786-1471, for issues related to the Hospital
Inpatient Quality Reporting (IQR) Program.
Cynthia Hake, (410) 786-3404, for issues related to HCPCS Level II
codes.
Amanda Rhee, (410) 786-3888, for the Medicare Diabetes Prevention
Program (MDPP) expanded model emergency policy.
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 the Physician
Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes.
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://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other 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
2021 PFS final rule, refer to item CMS-1734-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 to the implementation of
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. In addition,
this final rule includes provisions related to other payment policy
changes that are addressed in sections III. and IV. of this final rule.
We are issuing an interim final rule with comment period (IFC) to
establish coding and payment for virtual check-in services to support
the continuing need for coding and payment to reflect the provision of
lengthier audio-only services outside of the PHE for COVID-19, if not
as substitutes for in-person services, then as a tool to determine
whether an in-person visit is needed, particularly as beneficiaries may
still be cautious about exposure risks associated with in-person
services. We are also issuing an interim final rule with comment period
to establish coding and payment for PPE as a bundled service and
certain supply pricing increases in recognition of the increased
market-based costs for certain types of PPE.
1. Summary of the Major Provisions
The statute requires us to establish payments under the PFS based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: Work;
practice expense (PE); and malpractice (MP) expense. In addition, the
statute requires that we establish by regulation each year's payment
amounts for all physicians' services paid under the PFS, incorporating
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major final rule, we are establishing RVUs for CY 2021 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
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discussions and provisions regarding several other Medicare Part B
payment policies.
Specifically, this final rule addresses:
Practice Expense RVUs (section II.B.)
Potentially Misvalued Services Under the PFS (section II.C.)
Telehealth and Other Services Involving Communications
Technology, and the Interim Final Rule with Comment Period for Coding
and Payment for Virtual Check-in Services (section II.D.)
Care Management Services and Remote Physiologic Monitoring
Services (section II.E.)
Refinements to Values for Certain Services to Reflect
Revisions to Payment for Office/Outpatient Evaluation and Management
(E/M) Visits and Promote Payment Stability during the PHE for COVID-19
(section II.F.)
Scopes of Practice and Related Issues (section II.G.)
Valuation of Specific Codes, and the Interim Final rule with
Comment Period for Coding and Payment for Personal Protective Equipment
(PPE) (section II.H.)
Modifications related to Medicare Coverage for Opioid Use
Disorder (OUD) Services Furnished by Opioid Treatment Programs (OTPs)
(section II.I.)
Technical Correction to the Definition of Public Health
Emergency (section II.J.)
Clinical Laboratory Fee Schedule (section III.A.)
Opioid Treatment Program Provider Enrollment Regulation
Updates for Institutional Claim Submissions (section III.B.)
Payment for Primary Care Management Services in RHCs and FQHCs
(section III.C.)
Changes to the Federally Qualified Health Center Prospective
Payment System (FQHC PPS) for CY 2021: Rebasing and Revising of the
FQHC Market Basket (section III.D.)
Comprehensive Screenings for Seniors: Section 2002 of the
Substance Use-Disorder Prevention that Promote Opioid Recovery and
Treatment for Patients and Communities Act (SUPPORT Act) (section
III.E.)
Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals (EPs) (section III.F.)
Medicare Shared Savings Program (section III.G.)
Notification of Infusion Therapy Options Available Prior to
Furnishing Home Infusion Therapy Services (section III.H.)
Modifications to Quality Reporting Requirements and Comment
Solicitation on Modifications to the Extreme and Uncontrollable
Circumstances Policy for Performance Year 2020 (section III.I.)
Removal of Selected National Coverage Determinations (section
III.J.)
Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D drug under a prescription drug plan or
an MA-PD plan (section III.K.)
Medicare Part B Drug Payment for Drugs Approved Through the
Pathway Established Under Section 505(b)(2) of the Food, Drug, and
Cosmetic Act (section III.L.)
Updates to Certified Electronic Health Record Technology
Requirements in the Promoting Interoperability Program, Quality Payment
Program, and Hospital Inpatient Quality Reporting Program due to the
21st Century Cures Act (section III.M.)
Establishing New Code Categories (section III.N.)
Medicare Diabetes Prevention Program (MDPP) expanded model
emergency policy (section III.O.)
Updates to the Quality Payment Program (section IV.)
Physician Self-Referral Law: Annual Update to the List of CPT/
HCPCS Codes (section V.)
Waiver of Delay in Effective Date for this Final Rule (section
VI.)
Collection of Information Requirements (section VII.)
Regulatory Impact Analysis (section VIII.)
2. Provisions Related to the PHE for COVID-19
The United States is currently responding to an outbreak of
respiratory disease caused by a novel (new) coronavirus. This virus has
been named ``severe acute respiratory syndrome coronavirus 2'' (``SARS-
CoV-2''), and the disease it causes has been named ``coronavirus
disease 2019'' (``COVID-19''). On January 31, 2020, the Secretary
determined that a PHE existed nationwide as a result of the
consequences of the COVID-19 pandemic (hereafter referred to as the PHE
for COVID-19). On March 13, 2020, President Trump declared the COVID-19
pandemic a national emergency. Effective, October 23, 2020, the
Secretary renewed the January 31, 2020 determination that a PHE exists
and has existed since January 27, 2020. (Note: This declaration was
previously renewed on April 21, 2020 and July 25, 2020.)
As the healthcare community continues to establish and implement
recommended infection prevention and control practices, regulatory
agencies operating under appropriate waiver authority during the PHE
for COVID-19 are also working to revise and implement regulations that
support these healthcare community infection prevention and treatment
practices. We addressed some of these regulations in three previous
interim final rules with comment period (IFCs):
The ``Medicare and Medicaid Programs; Policy and
Regulatory Revisions in Response to the COVID-19 Public Health
Emergency'' IFC appeared in the April 6, 2020 Federal Register (85 FR
19230) with an effective date of March 31, 2020 (hereafter referred to
as the ``March 31st COVID-19 IFC'');
The ``Medicare and Medicaid Programs, Basic Health
Program, and Exchanges; Additional Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency and Delay of Certain
Reporting Requirements for the Skilled Nursing Facility Quality
Reporting Program'' IFC appeared in the May 8, 2020 Federal Register
(85 FR 27550) with an effective date of May 8, 2020 (hereafter referred
to as the ``May 8th COVID-19 IFC''); and
The ``Medicare and Medicaid Programs, Clinical Laboratory
Improvement Amendments (CLIA), and Patient Protection and Affordable
Care Act; Additional Policy and Regulatory Revisions in Response to the
COVID-19 Public Health Emergency'' IFC appeared in the September 2,
2020 Federal Register (85 FR 54820) with an effective date of September
2, 2020 (hereinafter referred to as the ``September 2nd COVID-19 IFC).
In this final rule, we are finalizing certain provisions of the
March 31st, May 8th, and September 2nd COVID-19 IFCs.
We indicated in the CY 2021 PFS proposed rule (85 FR 50140 and
50147) our intent that for certain provisions of the March 31st, May
8th, and September 2nd COVID-19 IFCs, we would respond to comments
received in this final rule. In this final rule, we are responding to
public comments and finalizing certain provisions of the March 31st,
May 8th, and September 2nd COVID-19 IFCs.
3. 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 VIII. of this final rule.
4. Waiver of the 60-Day Delay in Effective Date for the Final Rule
The United States is responding to an outbreak of respiratory
disease caused by a novel (new) coronavirus that has now been detected
in more than 190
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locations internationally, including in all 50 States and the District
of Columbia. The virus has been named ``SARS CoV 2'' and the disease it
causes has been named ``Coronavirus disease 2019'' (abbreviated
``COVID-19'').
Due to the significant devotion of resources to the COVID-19
response, as discussed in section VI. of the preamble of this final
rule, we are hereby waiving the 60-day delay in the effective date for
this final rule as proposed, and replacing it with a 30-day delay in
the effective date for this final rule.
II. Summary of the Proposed Provisions, Analysis of and Response to
Public Comments, and the 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 Social Security Act (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 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 by 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 `97) delayed implementation of
the resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA `97 provided for a 4-year transition period
from the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in the November 2, 1998 final rule (63 FR 58814), effective for
services furnished in CY 1999. Based on the requirement to transition
to a resource-based system for PE over a 4-year period, payment rates
were not fully based upon resource-based PE RVUs until CY 2002. This
resource-based system was based on two significant sources of actual PE
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's
Socioeconomic Monitoring System (SMS) data. These data sources are
described in greater detail in the CY 2012 PFS final rule with comment
period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some resource costs are borne by the
facility. Medicare's payment to the facility (such as the outpatient
prospective payment system (OPPS) payment to the HOPD) would reflect
costs typically incurred by the facility. Thus, payment associated with
those specific facility resource costs is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
Health and Human Services (the Secretary) to establish a process under
which we accept and use, to the maximum extent practicable and
consistent with sound data practices, data collected or developed by
entities and organizations to supplement the data we normally collect
in determining the PE component. On May 3, 2000, we published the
interim final rule (65 FR 25664) that set forth the criteria for the
submission of these supplemental PE survey data. The criteria were
modified in response to comments received, and published in the Federal
Register (65 FR 65376) as part of a November 1, 2000 final rule. The
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246
and 68 FR 63196) extended the period during which we would accept
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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 `97 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.
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 VIII. 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 2020 PFS final rule for a discussion
of the last GPCI update (84 FR 62615 through 62623).
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 RVUs under the
PFS and proposed changes to the PE 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
[[Page 84477]]
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 titled ``CY 2021 PFS Final Rule PE/HR'' on the
CMS website under downloads for the CY 2021 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
As noted above, we have established PE/HR values for various
specialties without SMS or PPIS survey data by crosswalking them to
other similar specialties to estimate a proxy PE/HR. On this note,
stakeholders have raised concerns regarding the appropriate specialty
crosswalk used for home PT/INR monitoring services. These services are
currently classified under the independent diagnostic testing
facilities (IDTF) specialty for PE/HR purposes, due to a lack of survey
data for these services, and stakeholders have suggested to CMS that
this specialty does not reflect the indirect costs associated with
furnishing these services. Stakeholders have raised concerns that the
practice pattern of PT/INR monitoring services are markedly different
from that of the dominant parent specialty as most of the services are
furnished remotely and require long-term relationship with
beneficiaries similar to chronic therapy. Stakeholders also stated that
this is a unique request due to the lack of home PT/INR monitoring
supplier involvement in the last PPIS, and that payments for these
services are derived from previously used supplemental survey data from
the Association for Quality Imaging (AQI), blended with supplementary
survey data from the American College of Radiology (ACR)--neither of
which reflect indirect cost inputs for home PT/INR monitoring.
Therefore, we are solicited comment from the public regarding the
most accurate specialty crosswalk to use for indirect PE when it comes
to home PT/INR monitoring services. We sought information on any
additional costs associated with these services that are not reflected
in our currently assigned PE/HR for independent diagnostic testing
facilities, as well as which specialties would best capture these costs
through the use of a crosswalk.
We received public comments on our comment solicitation regarding
the most accurate specialty crosswalk to use for indirect PE for home
PT/INR monitoring services. The following is a summary of the comments
we received and our responses.
Comment: Several commenters stated that they had numerous concerns
about the labor, supplies, equipment, and utilization associated with
home PT/INR monitoring services. Commenters questioned why the typical
clinical staff type for these services is an RN when 95 percent of
Medicare claims for HCPCS code G0248 indicate that the service is
instead furnished by the IDTF provider specialty. Commenters also
questioned the clinical staff labor associated with HCPCS code G0249,
as the commenters stated that they did not believe that an
electrodiagnostic technologist is the appropriate clinical staff type
since these technologists furnish cardiac event monitoring (CEM)-
related services, not PT/INR monitoring services. Commenters stated
that they believed a patient education booklet is likely a duplicative
supply item for HCPCS code G0248, as the patient is expected to have
already received booklet(s) related to anticoagulation at previous
physician visits, and a free booklet is also supplied with INR meters.
Commenters also questioned the discrepancy between the description and
billing rules for this code, which state that four tests are performed,
and the supply details for this code, which include supplies for six
tests. Commenters stated that CMS should decrease the minutes assigned
to the home INR monitor (EQ031) equipment and questioned whether this
frequency of physician review meets Medicare medical necessity criteria
for all patients receiving such services. One commenter submitted a
shipping invoice for the INR test strip (SJ055) supply.
Response: We appreciate the additional information provided by the
commenters regarding the direct PE inputs and claims data utilization
for home PT/INR monitoring services. However, our comment solicitation
[[Page 84478]]
sought information regarding the most accurate specialty crosswalk to
use for indirect PE as well as which specialties would best capture
these costs through the use of a crosswalk. We did not propose to make
revisions to the direct PE inputs or conduct a review of the Medicare
claims data. Although we appreciate the information provided by the
commenters, we are not finalizing any changes to the direct PE inputs
for home PT/INR monitoring services. With regard to the shipping
invoice for the INR test strip supply, we welcome the submission of
invoices or other pricing information as part of our ongoing market-
based supply and equipment pricing update. However, this invoice listed
the transportation costs of shipping the test strips and not the price
of the test strips themselves, and as a result we were unable to make
use of it.
Comment: Many commenters stated that there were inherent
differences between home PT/INR monitoring services and independent
diagnostic testing facilities. Several commenters stated that given the
significant changes to technology and associated decrease in costs
since the IDTF PE/HR value was first developed, they believed that many
of the indirect PE inputs originally recognized for IDTFs in 2007 no
longer apply in 2020 and home PT/INR monitoring services should no
longer be crosswalked to them. Several commenters stated that typical
IDTF services include the use of large, capital-intensive equipment
while home PT/INR monitoring services typically involve the use of
equipment by a patient in his/her home, frequently intended for use for
the remainder of the patient's life--more like a therapeutic device
than a diagnostic one. Several commenters emphasized that PT/INR
monitoring services are very different from typical imaging and
scanning services provided by IDTFs, and because there are so few
suppliers of home PT/INR monitoring services, the distribution of
direct and indirect costs and the indirect practice cost index (IPCI)
applied to IDTFs do not accurately reflect indirect resources expended
by the specialty suppliers of home PT/INR monitoring.
Several commenters provided feedback regarding the most accurate
specialty crosswalk to use for indirect PE when it comes to home PT/INR
monitoring services. Several commenters submitted data indicating that
the direct to indirect cost percentages used to furnish home PT/INR
monitoring are in the range of 31:69 rather than the approximately
50:50 currently considered in determining the PE RVUs for these
services as IDTFs. These commenters recommended a crosswalk to the
Pathology or All Physicians specialty type based on the submitted data.
One commenter stated that they were not equipped to say which specific
indirect factors may be optimal for crosswalk due to a lack of
information on direct and indirect cost data from the suppliers but did
wish to highlight the importance of ensuring sure that home PT/INR
monitoring rates are adequate to assure access. Several commenters
stated that the payment rates for these services have fallen
dramatically over the past several years and they were very concerned
about the impact of these cuts on patient access to these critically
important services.
Response: We appreciate the detailed feedback from the commenters
regarding home PT/INR monitoring services and especially the submission
of data associated with the direct to indirect cost percentages. We
also share the concerns of the commenters regarding maintaining access
to care for these services. After consideration of the comments, we are
finalizing a crosswalk to the General Practice specialty to use for
indirect PE when it comes to home PT/INR monitoring services (HCPCS
codes G0248, G0249, and G0250). The data submitted by the commenters
indicated that the direct to indirect cost percentages to furnish home
PT/INR monitoring are in the range of 31:69, similar to the ratio
associated with the General Practice specialty. We also share the
concerns of the commenters who were uncertain which specific indirect
factors may be optimal for crosswalking due to a lack of information,
and we believe that the broad nature of the General Practice specialty
will serve as a more accurate proxy for home PT/INR monitoring services
as opposed to trying to select a more specific specialty designation.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level on the basis of
the direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion. The general
approach to developing the indirect portion of the PE RVUs is as
follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
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
[[Page 84479]]
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 titled ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2021 PFS final 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 final 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 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.
We received public comments on the proposed list of expected
specialty assignments for CY 2021. The following is a summary of the
comments we received and our responses.
Comment: One commenter stated that the 2021 expected specialty
assignment for the low volume services code list included a number of
services that were reassigned from cardiac surgery to thoracic surgery
in CY 2020. The commenter identified these services and stated that
they had concerns that CMS had erroneously assigned them as thoracic
surgery procedures instead of cardiac surgery procedures. The commenter
requested that CMS to correct the list and permanently assign the
identified codes to the requested thoracic surgery specialty
assignment.
Response: We finalized a proposal in CY 2020 to update the expected
specialty list to accurately reflect a previously finalized crosswalk
to thoracic surgery for the services in question. As we stated at the
time, we did not finalize a proposal to assign the codes in question to
the cardiac surgery specialty. Instead, we finalized a proposal to
update the incorrect
[[Page 84480]]
documentation in our expected specialty list to accurately reflect a
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. We did not propose to make further
changes to the anticipated specialty assignment of these codes for CY
2021 and we are not finalizing any changes. We direct readers to the
discussion of this topic in the CY 2020 PFS final rule (84 FR 62574
through 62578) and we reiterate again that we do not anticipate this
finalized proposal having a discernible effect on the valuation of the
affected codes 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
titled ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the 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 1.
[[Page 84481]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.000
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 accordingly. Table 2 details the manner in which the
modifiers are applied.
[[Page 84482]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.001
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.
We received public comments on equipment utilization rate
assumptions. The following is a summary of the comments we received and
our responses.
Comment: Several commenters requested that CMS review the
utilization assumptions for equipment due to decreased practice
capacity during the public health emergency (PHE) for COVID-19.
Commenters stated that equipment was used less frequently than normal
and that this should be reflected in the equipment utilization rate.
Commenters stated that any modifications to the equipment utilization
during the public health emergency also should not be subject to budget
neutrality.
Response: We disagree with the commenters that utilization
assumptions for equipment should be revisited as part of the public
health emergency. While we agree that many services had a reduced
volume of Medicare beneficiaries at times during the 2020 calendar
year, we note that equipment costs under the PFS are amortized across
the full useful life of the equipment which in the vast majority of
cases is 5-10 years. We believe that it would distort relativity to
apply a temporary decrease in utilization caused by the public health
emergency to the pricing structure of the equipment's full useful life
duration. We also note that we do not have statutory authority to
exempt any modifications to the equipment utilization assumptions from
budget neutrality calculations.
Useful Life: In the CY 2005 PFS final rule we stated that we
updated the useful life for equipment items primarily based on the
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets''
guidelines (69 FR 66246). The most recent edition of these guidelines
was published in 2018. This reference material provides an estimated
useful life for hundreds of different types of equipment, the vast
majority of which fall in the range of 5 to 10 years, and none of which
are lower than 2 years in duration. We believe that the updated
editions of this reference material remain the most accurate source for
estimating the useful life of depreciable medical equipment.
In the CY 2021 PFS proposed rule, we noted that stakeholders
including the RUC, specialty societies, and other commenters suggested
a useful life of less than 1 year for several of the new equipment
items for CY 2021, and as low as 3 months in one case. We have rarely,
if ever, received requests for equipment useful life of less than one
[[Page 84483]]
year in duration and note that these very short useful life durations
are significantly lower than anything in our current equipment
database, and if finalized would represent major outliers when compared
to the rest of the equipment. Table 3 details the distribution of
useful life durations of the equipment currently in our database:
[GRAPHIC] [TIFF OMITTED] TR28DE20.002
As Table 3 demonstrates, the vast majority of equipment items have
a useful life duration of 5 to 10 years, and only 4 out of the 777
equipment codes have a useful life duration of less than 3 years. We
also noted that due to the formula used to calculate the equipment cost
per minute, decreasing the useful life of any equipment item from 5
years to 3 months has the same effect as increasing the price of the
equipment 20 times over. In other words, decreasing the useful life
from 5 years to 0.25 years has the same multiplicative effect as
increasing the price of the equipment from $5,000 to 100,000 due to the
formula listed above. Since we currently do not have any equipment
items in our database with a useful life of less than one year, we
proposed a clarification on how to address these cases.
We disagreed that assigning a useful life at these very short
durations would be typical for new equipment, especially in light of
the data provided by the AHA's ``Estimated Useful Lives of Depreciable
Hospital Assets'' reference. The equipment life durations listed in
Table 3 were finalized over the last 15 years through the use of this
reference material. We noted concerns that assigning very low useful
life durations to equipment items would fail to maintain relativity
with other equipment on the PFS, effectively assigning a much higher
price than other equipment items with more typical useful life
durations. We noted that we believe that equipment items with very low
useful life durations represent outlier cases that are not handled
appropriately by the current equipment methodology and which we
clarified through this rulemaking. We also noted that the equipment
cost per minute formula was designed under the assumption that each
equipment item would remain in use for a period of several years and
depreciate over that span of time. Our current equipment formula is not
designed to address cases in which equipment is replaced multiple times
per year, and we believe that applying a multi-year depreciation in
these situations would not be reflective of market pricing. We noted
that we did not believe that items which are replaced on a monthly
basis can be accurately priced using a formula which assumes they will
be in use for years at a time, and that the use of such a formula would
distort relativity with the overwhelming majority of equipment items
which are in use for 5-10 years.
Therefore, we proposed to treat equipment life durations of less
than 1 year as having a duration of 1 year for the purpose of our
equipment price per minute formula. We noted that we believe that this
is the most accurate way to incorporate these short equipment life
durations within the framework of our current methodology. In the rare
cases where items are replaced every few months, we noted that we
believe that it is more accurate to treat these items as disposable
supplies with a fractional supply quantity as opposed to equipment
items with very short equipment life durations. For example, we
proposed to establish the EECP compression equipment package (SD341)
and the EECP electrical equipment package (SD342) as disposable
supplies instead of equipment items as described in the Valuation of
Specific Codes (section II.H. of this final rule) portion of the
preamble. We noted that we expect these situations to occur only
rarely, and we will evaluate them on an individual case-by-case basis.
Our criteria will be based on whether or not the item in question could
be more accurately classified as a disposable supply while maintaining
overall relativity within our PE methodology. We welcomed additional
comments from stakeholders regarding the subject of useful life
durations for new equipment items with unique useful life durations as
described above and any additional suggestions on alternative ways to
incorporate these items into our methodology or potential wider changes
to the equipment cost per minute formula more broadly.
We received public comments on our proposals associated with
equipment life duration. The following is a summary of the comments we
received and our responses.
Comment: A commenter stated that although they had asked CMS to use
0.75 years as the useful life duration for the radionuclide rod source
set (ER044) equipment, the commenter recognized that one year was in
accordance with the CMS policy to treat equipment useful life durations
of less than one year as having a duration of one year.
Response: We appreciate the feedback from the commenter and the
acknowledgment of our proposed policy.
After consideration of the public comments, we are finalizing our
proposal to treat equipment life durations of less than 1 year as
having a duration of 1 year for the purpose of our equipment price per
minute formula. In the rare cases where items are replaced every few
months, we noted that we believe that it is more accurate to treat
these items as disposable supplies with a fractional supply quantity as
opposed to equipment items with very short equipment life durations.
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
[[Page 84484]]
noted that we 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 noted that we did 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 did not believe that we have sufficient information at
present. We noted that we would continue to investigate potential
avenues for determining equipment maintenance costs across a broad
range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment
period (77 FR 68902), we updated the interest rates used in developing
an equipment cost per minute calculation (see 77 FR 68902 for a
thorough discussion of this issue). The interest rate was based on the
Small Business Administration (SBA) maximum interest rates for
different categories of loan size (equipment cost) and maturity (useful
life). The Interest rates are listed in Table 4.
[GRAPHIC] [TIFF OMITTED] TR28DE20.003
We did not propose any changes to the equipment interest rates for
CY 2021.
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 2021 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2021 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 through 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 post service 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'' and ``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 a series of clinical labor tasks associated with
pathology services in the CY 2016 PFS final rule with comment period
(80 FR 70902). We do not believe these activities would be dependent on
number of blocks or batch size, and we believe that the finalized
standard values accurately reflect the typical time it takes to perform
these clinical labor tasks.
[[Page 84485]]
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).
Following the publication of the CY 2020 PFS proposed rule, a
commenter expressed concern with the published list of common
refinements to equipment time. The commenter stated that these
refinements were the formulaic result of the applying refinements to
the clinical labor time and did not constitute separate refinements;
the commenter requested that CMS no longer include these refinements in
the table published each year. In the CY 2020 PFS final rule, we agreed
with the commenter that that these equipment time refinements did not
reflect errors in the equipment recommendations or policy discrepancies
with the RUC's equipment time recommendations. However, we believed
that it was important to publish the specific equipment times that we
were proposing (or finalizing in the case of the final rule) when they
differed from the recommended values due to the effect that these
changes can have on the direct costs associated with equipment time.
Therefore, we finalized the separation of the equipment time
refinements associated with changes in clinical labor into a separate
table of refinements. For additional details, we direct readers to the
discussion in the CY 2020 PFS final rule (84 FR 62584).
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in developing and
submitting recommendations will help us to simplify and standardize the
hundreds of different clinical labor tasks currently listed in our
direct PE database. As we did in previous calendar years, to facilitate
rulemaking for CY 2021, 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 2021 PFS final rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Equipment Recommendations for Scope Systems
During our routine reviews of direct PE input recommendations, we
have regularly found unexplained inconsistencies involving the use of
scopes and the video systems associated with them. Some of the scopes
include video systems bundled into the equipment item, some of them
include scope accessories as part of their price, and some of them are
standalone scopes with no other equipment included. It is not always
clear which equipment items related to scopes fall into which of these
categories. We have also frequently found anomalies in the equipment
recommendations, with equipment items that consist of a scope and video
system bundle recommended, along with a separate scope video system.
Based on our review, the variations do not appear to be consistent with
the different code descriptions.
To promote appropriate relativity among the services and facilitate
the transparency of our review process, during the review of the
recommended direct PE inputs for the CY 2017 PFS proposed rule, we
developed a structure that separates the scope, the associated video
system, and any scope accessories that might be typical as distinct
equipment items for each code. Under this approach, we proposed
standalone prices for each scope, and separate prices for the video
systems and accessories that are used with scopes.
(1) Scope Equipment
Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through
46177), we proposed standardizing refinements to the way scopes have
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
[[Page 84486]]
prices for the equipment items related to scopes utilized by these
services. We did not propose to apply these policies to codes with
inputs reviewed prior to CY 2017. We also solicited comment on this
separate pricing structure for scopes, scope video systems, and scope
accessories, which we 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. Based on the recommendations from the workgroup, we
proposed to establish 23 new scope equipment codes. 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
at the same amount of equipment time. This scope replacement involved
approximately 100 HCPCS codes in total and was detailed in a table
published in the CY 2020 PFS proposed rule (84 FR 40495 through 40498).
We noted that we did not receive pricing information along with the
workgroup recommendations for the other 15 new scope equipment items.
Therefore, although we proposed to establish new equipment codes for
these scopes, 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.
Following the publication of the CY 2020 PFS proposed rule,
commenters provided additional information regarding pricing for the
new scope equipment and their associated HCPCS
[[Page 84487]]
codes. Based on this information provided by the commenters, we
finalized a price for eight additional new scope equipment items and
finalized the replacement of the existing scopes with the new scope
equipment at the same amount of equipment time for approximately two
dozen additional HCPCS codes (84 FR 62593 through 62595). Table 5 lists
the CY 2020 finalized price for the new scope equipment codes:
[GRAPHIC] [TIFF OMITTED] TR28DE20.004
We noted that although we updated the scope equipment pricing for
CY 2020 such that the ES087 and ES089 scopes shared the same price with
the ES088 scope, and the ES090 scope shared the same price with the
ES085 scope, we did not mean to suggest that these scopes that shared
pricing were identical with one another. We assigned the same price to
these scopes because they replaced the same current scope equipment
codes, and because we did not have individual pricing information for
them. We noted in the CY 2021 PFS proposed rule (85 FR 50087) that we
remain open to the submission of additional invoices to establish
individual pricing for these scopes, and we welcomed more data to help
identify pricing for the remaining seven scope equipment codes that
still lack invoices.
(5) Scope Proposals for CY 2021
We did not receive further recommendations from the Scope Equipment
Reorganization Workgroup organized by the RUC following the publication
of the CY 2020 PFS final rule. However, we did receive invoices
associated with the pricing of the scope video system (monitor,
processor, digital capture, cart, printer, LED light) (ES031) equipment
item as part of the review of the Esophagogastroduodenoscopy (EGD) with
Biopsy and the Colonoscopy code families. We previously finalized a
price of $36,306 for the ES031 equipment based on the sum of 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, $1,750 for the
cart, $1,915 for the LED light, and $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.) We
received 37 invoices associated with the components of the ES031 scope
video system, which averaged out to prices of $21,988.89 for the
processor, $16,175.87 for the digital capture device, $6,987.56 for the
monitor, $7,922.80 for the printer, $4,945.45 for the cart, and
$12,652.82 for the LED light. Based on the sum of these component
prices, we proposed to update the price the ES031 scope video system
equipment to $70,673.38. We did not propose to include an additional
$1,000 to cover the expense of miscellaneous small equipment as the
products listed on the component invoices indicated that cost of cables
were already included in this significantly higher equipment pricing.
We solicited additional comments from stakeholders regarding the
pricing of the full ES031 scope equipment system as well as its
components.
As part of our market-based supply and equipment pricing
transition, we finalized a policy in CY 2019 to phase in any updated
pricing established during the 4-year transition period for very
commonly used supplies and equipment that are included in 100 or more
codes, even if invoices are provided as part of the formal review of a
code family (83 FR 59473 through 59475). Because the ES031 scope
equipment system is utilized by more than 250 HCPCS codes, we proposed
to transition this pricing increase over the remaining 2 years of the
pricing update,
[[Page 84488]]
such that the CY 2021 equipment price will be $53,489.69 before moving
to its destination price of $70,673.38 in CY 2022. We noted that this
transition policy also applies to the price of the suction machine
(Gomco) (EQ235) equipment, which, although it is not a scope, is
utilized by approximately 360 HCPCS codes, and therefore, is another
example of this pricing transition policy. We proposed to transition
the EQ235 pricing increase over the remaining 2 years of the pricing
update, such that the CY 2021 equipment price would be $1,981.66 before
moving to its destination price of $ $3,195.85 in CY 2022. As we stated
previously, this policy was intended to minimize any potential
disruptive effects during the pricing transition period due to the high
number of services that make use of these very common supply and
equipment items included in 100 or more HCPCS codes.
We also received invoices for the colonoscopy videoscope (ES033)
and gastroscopy videoscopy (ES034) as part of the review of the
Esophagogastroduodenoscopy (EGD) with Biopsy and the Colonoscopy code
families. We finalized the replacement of both of these scope equipment
items in the CY 2020 PFS final rule (84 FR 62588 through 62590),
replacing the colonoscopy videoscope (ES033) with the multi-channeled
flexible digital scope, colonoscopy (ES086) equipment item and the
gastroscopy videoscopy (ES034) with the multi-channeled flexible
digital scope, esophagoscopy gastroscopy duodenoscopy (EGD) (ES087)
equipment item. In both cases, the submitted invoices were nearly
identical to the finalized prices for the ES086 ($38,058.81) and ES087
($34,585.35) equipment. We believe that these invoices reinforce the
prices finalized through rulemaking last year, and therefore, we did
not propose to further update the prices of these scopes.
We noted that we remain open to further comments regarding the
pricing of the remaining seven scope equipment codes that still lack
invoices, as well as additional data regarding the pricing of the scope
equipment codes that currently share the same price.
We received public comments on our proposals associated with
equipment recommendations for scope systems. The following is a summary
of the comments we received and our responses.
Comment: Several commenters thanked CMS for updating the prices of
the scope video system (ES031) and Gomco suction machine (EQ235) to
reflect the submitted invoices. Commenters stated that they supported
the proposed transition in price increase for both pieces of equipment
over the remaining 2 years of the pricing update and supported the
ES031 price update to correctly account for the cost of the various
components included in this scope video system.
Response: We appreciate the support for our proposals from the
commenters.
Comment: A commenter stated that although they appreciated CMS's
efforts to ensure the accuracy of the inputs for scope equipment, the
price inputs for scope video systems do not capture all of the costs
needed for near infrared fluorescence visualization with 4K monitors.
The commenter stated that the actual cost of these processor, monitor,
and digital capture device components are 45 to 97 percent higher than
current CMS prices. The commenter encouraged CMS to seek additional
price inputs for this newer technology and planned to submit invoices
to demonstrate the costs related to the near infrared fluorescence
scope video price inputs.
Response: We appreciate the feedback from the commenter regarding
the costs associated with new technology being incorporated into scope
video systems and we look forward to the submission of invoices or
other data sources with additional pricing information. However, in the
absence of information demonstrating these additional costs, we will
continue to maintain our current scope pricing.
Comment: A commenter submitted invoices associated with three of
the eight scope equipment items that still lacked a price: The
cystoscopy rigid scope (ES070), the cystoscopy channeled flexible
digital scope (ES081), and the hysteroscopy channeled flexible digital
scope (ES082). The commenter stated that these invoices were
representative of national pricing for these scopes and compiled a list
of procedures associated with these scopes. This procedure list
submitted by the commenter also included the hysteroscopy rigid scope,
channeled (ES071) equipment item which was previously priced in CY
2020.
Response: We appreciate the additional pricing information
submitted by the commenter in helping us assign a price to the
remaining scope equipment codes. Based on this information, we are
finalizing a price of $7,270.00 for the rigid scope, cystoscopy (ES070)
equipment, a price of $22,274.36 for the channeled flexible digital
scope, cystoscopy (ES081) equipment, and a price of $19,081.82 for the
channeled flexible digital scope, hysteroscopy (ES082) equipment. When
added to the previously finalized prices for the other scope equipment
items from CY 2020, the total list is shown in Table 6.
[[Page 84489]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.005
With regard to the procedure list submitted by the commenter, we
are not finalizing the replacement of any current scope equipment with
the new scope equipment codes. We did not propose to make any such
replacements in the proposed rule and we had reservations about some of
the procedures on the submitted list, which included CPT codes that
currently do not contain scopes or any direct PE inputs at all in some
cases. We appreciate the submission of this additional information from
the commenter and we will consider the procedure list for potential use
in future rulemaking.
After consideration of the public comments, we are finalizing our
proposal to update the price the ES031 scope video system equipment to
$70,673.38 along with our proposed update to the price of the suction
machine (Gomco) (EQ235) equipment. We are also finalizing the price for
the three new scope equipment items as detailed above.
c. Technical Corrections to Direct PE Input Database and Supporting
Files
For CY 2021, we proposed to address the following inconsistencies:
Following the publication of the CY 2020 PFS final rule,
stakeholders contacted CMS and clarified that CPT code 0466T (Insertion
of chest wall respiratory sensor electrode or electrode array,
including connection to pulse generator) is always performed on an add-
on basis and would never be used as a standalone code. Therefore, we
proposed to update the global period for CPT code 0466T to add-on
status (ZZZ) to more accurately reflect the way in which this service
is performed.
We received public comments on the technical corrections to direct
PE input database and supporting files. The following is a summary of
the comments we received and our responses.
Comment: A commenter stated that they supported the proposed change
to the global period of CPT code 0466T and agreed that this technical
correction was appropriate.
Response: We appreciate the support for our proposal from the
commenter.
Comment: Several commenters stated that in the direct PE inputs for
CPT code 33202 (Insertion of epicardial electrode(s); open incision
(e.g., thoracotomy, median sternotomy, subxiphoid approach)), there are
two tables listed under the equipment inputs: An exam table (EF023) and
a power table (EF031). Commenters stated that spreadsheet information
from CPT 2007 listed a power table and an exam light for this service,
not an exam table. Commenters stated that it seemed likely that this
was an accidental data entry error and requested that the equipment
inputs for CPT code 33202 be corrected in the CMS equipment database to
include a power table and exam light.
Response: We agree with the commenters that this was likely a data
entry error confusing the exam light with the exam table. Based on the
information supplied by the commenters, we are finalizing the
replacement of the exam table with an exam light (EQ168) at the same
equipment time of 36 minutes for CPT code 33202.
Comment: Several commenters stated that in the 2020 CMS direct PE
inputs supplies listing, the ``unit'' type is missing for the skin prep
barrier wipes (SM029) supply. Commenters stated that although this
omission does not affect pricing, it makes it ambiguous what the units
mean and could have an unintended impact if there are multiple
different possible unit types, such as a liquid, where it would be
unclear if it were ounces, milliliters, or something else. Commenters
recommended that each supply item in the CMS database should have a
unit type and provided a list of the supply items in the CY 2020 PFS
final rule that were missing a unit type, with potential unit type
suggestions for each item.
[[Page 84490]]
Response: We agree with the commenters that each supply item in the
CMS database should include a unit type in order to avoid potential
confusion regarding pricing. We are finalizing the addition of the unit
types as listed in Table 7.
[GRAPHIC] [TIFF OMITTED] TR28DE20.006
All of the supply items in the CMS database should now include a
unit type with the additions from this list. We note that we did not
add a unit type for the ``No Supplies'' (SX007) category as the
commenter requested since this is not a supply item.
Comment: Several commenters questioned the proposed RVUs associated
with several occupational therapy evaluation procedures (CPT codes
97165-97167). Commenters stated that the PE valuation for these codes
appeared to be illogical, with the proposed valuation of the codes
demonstrating an inverse relationship between PE value and complexity.
Commenters stated that it was counterintuitive for the PE RVU to go
down as the level of complexity increased. Commenters stated that the
distribution of code usage has not changed in any manner to justify a
reduction in the code values and that all three evaluation codes should
reimburse at the same rate.
Response: We appreciate the commenters bringing this issue to our
attention. However, although we agree with the commenters that the
proposed valuation of these services is somewhat illogical, we do not
agree that their proposed valuation represents a technical error.
Although the three codes in question share the same work RVU and the
same direct PE inputs, they do not share the same specialty
distribution in the claims data and therefore will not necessarily
receive the same allocation of indirect PE. In response to the
comments, we are implementing a technical change which should ensure
that these three services receive the same allocation of indirect PE.
Following the publication of the proposed rule, we also discovered
a technical error in the published RVUs for three HCPCS codes. Code
G0102 (Prostate cancer screening; digital rectal examination) was
assigned the same value as CPT code 99211, the lowest level E/M
service, in the CY 2000 PFS final rule (64 FR 59414). Code G0102 was
assigned a work RVU of 0.17 which matched the work RVU of CPT code
99211 at the time. However, when we increased the work RVU for CPT code
99211 to 0.18 in CY 2010 as part of the last E/M revalution, the work
RVU for HCPCS code G0102 was not increased to match. We are correcting
this technical oversight by finalizing an increase in the work RVU of
code G0102 from 0.17 to 0.18 to match the previously finalized
crosswalk to CPT code 99211.
We also previously finalized and valued in the CY 1998 PFS final
rule (62 FR 59082) the following two G codes for use when a barium
enema is being substituted for either a screening sigmoidoscopy or
screening colonoscopy: HCPCS codes G0106 (Colorectal cancer screening;
alternative to G0104, screening sigmoidoscopy, barium enema) and G0120
(Colorectal cancer screening; alternative to G0105, screening
colonoscopy, barium enema). We established the same RVUs for these
screening G codes as for the diagnostic barium enema procedure, CPT
code 74280 (Radiologic examination, colon, including scout abdominal
radiograph(s) and delayed image(s), when performed; double-contrast
(e.g., high density barium and air) study, including glucagon, when
administered). The work RVU for codes G0106 and G0120 has matched the
work RVU for CPT code 74280 for the last two decades; however, we
reviewed CPT code 74280 last year and, in the CY 2020 PFS final rule,
increased the work RVU for CPT code 74280 to 1.26. Through an
oversight, we did not make corresponding changes in the work RVUs for
HCPCS codes G0106 and G0120. We are therefore correcting this technical
oversight by finalizing an increase in the work RVU for HCPCS codes
G0106 and G0120 to match the previously finalized crosswalk to CPT code
74280.
After consideration of the public comments, we are finalizing our
proposals along with the additions as detailed above.
[[Page 84491]]
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 2021,
we proposed to update the price of one supply and four equipment items
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 2021 for these items
instead of being phased in over 4 years. These supply and equipment
items with updated prices associated with the formal review of a code
family are listed in the valuation of specific codes section of the
preamble under Table 31: CY 2021 Invoices Received for Existing Direct
PE Inputs.
(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, enacted April 1, 2014) provides that the
Secretary may collect or obtain information from any eligible
professional or any other source on the resources directly or
indirectly related to furnishing services for which payment is made
under the PFS, and that such information may be used in the
determination of relative values for services under the PFS. Such
information may include the time involved in furnishing services; the
amounts, types and prices of PE inputs; overhead and accounting
information for practices of physicians and other suppliers, and any
other elements that would improve the valuation of services under the
PFS.
As part of our authority under section 1848(c)(2)(M) of the Act, we
initiated a market research contract with StrategyGen to conduct an in-
depth and robust market research study to update the PFS direct PE
inputs (DPEI) for supply and equipment pricing for CY 2019. These
supply and equipment prices were last systematically developed in 2004-
2005. StrategyGen submitted a report with updated pricing
recommendations for approximately 1300 supplies and 750 equipment items
currently used as direct PE inputs. This report is available as a
public use file displayed on the CMS website under downloads for the CY
2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The StrategyGen team of researchers, attorneys, physicians, and
health policy experts conducted a market research study of the supply
and equipment items currently used in the PFS direct PE input database.
Resources and methodologies included field surveys, aggregate
databases, vendor resources, market scans, market analysis, physician
substantiation, and statistical analysis to estimate and validate
current prices for medical equipment and medical supplies. StrategyGen
conducted secondary market research on each of the 2,072 DPEI medical
equipment and supply items that CMS identified from the current DPEI.
The primary and secondary resources StrategyGen used to gather price
data and other information were:
Telephone surveys with vendors for top priority items
(Vendor Survey).
Physician panel validation of market research results,
prioritized by total spending (Physician Panel).
The General Services Administration system (GSA).
An aggregate health system buyers database with discounted
prices (Buyers).
Publicly available vendor resources, that is, Amazon
Business, Cardinal Health (Vendors).
The 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 we were to adopt the pricing
updates recommended by StrategyGen. At the service level, there may be
large shifts in PE RVUs for individual codes that happened to contain
supplies and/or equipment with major changes in pricing, although we
note that codes with a sizable PE RVU decrease would be limited by the
requirement to phase in significant reductions in RVUs, as required by
section 1848(c)(7) of the Act. The phase-in requirement limits the
maximum RVU reduction for codes that are not new or revised to 19
percent in any individual calendar year.
We believe that it is important to make use of the most current
information available for supply and equipment pricing instead of
continuing to rely on pricing information that is more than a decade
old. Given the potentially significant changes in payment that would
occur, both for specific services and more broadly at the specialty
level, in the CY 2019 PFS proposed rule we proposed to phase in our use
of the new direct PE input pricing over a 4-year period using a 25/75
percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021),
and 100/0 percent (CY 2022) split between new and old pricing. This
approach is consistent with how we have previously incorporated
significant new data into the calculation of PE RVUs, such as the 4-
year transition period finalized in CY 2007 PFS final rule with comment
period when changing to the ``bottom-
[[Page 84492]]
up'' PE methodology (71 FR 69641). This transition period will not only
ease the shift to the updated supply and equipment pricing, but will
also allow interested parties an opportunity to review and respond to
the new pricing information associated with their services.
We proposed to implement this phase-in over 4 years so that supply
and equipment values transition smoothly from the prices we currently
include to the final updated prices in CY 2022. We proposed to
implement this pricing transition such that one quarter of the
difference between the current price and the fully phased-in price is
implemented for CY 2019, one third of the difference between the CY
2019 price and the final price is implemented for CY 2020, and one half
of the difference between the CY 2020 price and the final price is
implemented for CY 2021, with the new direct PE prices fully
implemented for CY 2022. An example of the transition from the current
to the fully-implemented new pricing is provided in Table 8.
[GRAPHIC] [TIFF OMITTED] TR28DE20.007
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 through 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 through 59480).
After consideration of the public comments, we finalized our
proposals
[[Page 84493]]
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 2021, we received invoice submissions for approximately a
dozen supply and equipment codes from stakeholders as part of the third
year of the market-based supply and equipment pricing update. The
submitted invoices were used in many cases to supplement the pricing
originally proposed for the CY 2019 PFS rule cycle. We 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 7 of the CY 2021 PFS proposed rule.
We finalized a policy in CY 2019 to phase in the new supply and
equipment pricing over 4 years so that supply and equipment values
transition smoothly from their current prices to the final updated
prices in CY 2022. We finalized our proposal to implement this pricing
transition such that one quarter of the difference between the current
price and the fully phased in price was implemented for CY 2019, one
third of the difference between the CY 2019 price and the final price
is implemented for CY 2020, and one half of the difference between the
CY 2020 price and the final price is implemented for CY 2021, with the
new direct PE prices fully implemented for CY 2022. An example of the
transition from the current to the fully-implemented new pricing is
provided in Table 8. For CY 2021, one half of the difference between
the CY 2020 price and the final price will be implemented as per the
previously finalized policy. Table 9 contains the list of proposed CY
2021 market-based supply and equipment pricing updates:
[GRAPHIC] [TIFF OMITTED] TR28DE20.008
The prices for the supply and equipment items listed in Table 9
were calculated based on averaging together the prices on the submitted
invoices. In the case of the vascular sheath (SD136) and RF endovenous
occlusion catheter (SD155) supplies, the price was determined by
removing the sheath or catheter from the eight submitted kit invoices
and then averaging the resulting price together with the single
standalone sheath/catheter invoice.
In addition to submitting invoices with information updating the
price of the ``Vmax 22d and 62j (PFT equip, autobox, computer system)''
(EQ041) equipment, stakeholders also clarified that the ``Vmax 229
(spirometry testing equip, computer system)'' (EQ040) and ``Vmax 29s
(spirometry testing equip, computer system)'' (EQ043) equipment items
have become obsolete and are no longer typically used in any HCPCS
codes. Based on the information supplied by the stakeholders, we
proposed to remove the EQ040 and EQ043 equipment items, replacing them
with the EQ041 equipment at the same number of minutes in the six HCPCS
codes where they are utilized.
We did not propose to update the price of additional supply and
equipment items for which invoices were submitted following the
publication of the CY 2020 PFS final rule. We did not propose to update
the price for the ``pipette, transfer 23ml'' (SL109), ``slide specimen
mailer (1-5 microscope slides)'' (SL121), ``stain, hematoxylin''
(SL135), ``stain, eosin'' (SL201), and ``stain, PAP OG-6'' (SL491)
supplies. In each case we received a single invoice for these five
supplies detailing price increases ranging from 82 percent to 160
percent above the current pricing. These supplies are commonly used in
cytopathology procedures and we disagree that the typical price for
these supplies has more than doubled since being reviewed by the
StrategyGen contractor 2 years ago for CY 2019.
We also did not propose to update the price for the ``embedding
mold'' (SL060) supply or the ``microscope, compound'' (EP060) equipment
based on the same rationale. The submitted invoices represent pricing
increases of 339 percent for the compound microscope and 7800 percent
for the embedding mold and, based on the recent review of the pricing
of these items by our contractor, we do not believe that the submitted
invoices reflect typical market-based pricing. The same stakeholder
also submitted an invoice to update the price of the surgical mask
(SB033) supply by 617 percent over the current price. However, the
invoice in question contains the price for a surgical mask with face
shield, which is described by the SB034 supply code, not the SB033
supply code. Therefore, we did not propose to update the price of the
surgical mask (SB033) supply based on this invoice. Finally, we
received an invoice for a ClosureFast Procedure Pack (CFP) but it was
unclear
[[Page 84494]]
what supply or equipment item this invoice was intended to update. As a
result, we noted in the CY 2021 PFS proposed rule that we were unable
to use this invoice to make a pricing proposal.
We received public comments on the market-based supply and
equipment pricing update. The following is a summary of the comments we
received and our responses.
Comment: Several commenters stated that they continued to support
the engagement from the agency to work with CMS contractors and
stakeholders to incorporate current pricing data based on invoices into
the calculation of direct PE cost. Commenters stated that bringing in
an outside vendor in addition to accepting invoices from stakeholders
was a reasonable approach, and that the incorporation of this new data
and the process for determining what is accepted and what is rejected
should be done in a transparent manner. Several different commenters
urged CMS to be more deliberate and transparent about this decision-
making process regarding supply and equipment pricing.
Response: We appreciate the feedback from the commenters and share
the desire for transparency in pricing. We continue to believe that it
is important to make use of the most current information available for
supply and equipment pricing through the use of market-based research,
and we agree with the need to explain the rationale behind the adoption
or rejection of invoices submitted by stakeholders. We routinely accept
public submission of invoices as part of our process for developing
payment rates for new, revised, and potentially misvalued codes. We
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. Stakeholders are
encouraged to submit invoices as part of their public comments or, if
outside the public comment process, via email at
[email protected].
Comment: A commenter stated that they supported the proposed
pricing for the UroVysion test kit (SA105) supply. The commenter stated
that establishing a price that is in line with invoice pricing ensures
that reimbursement for the service reflects accurately the cost of
resources involved in providing the service.
Response: We appreciate the support for our proposed pricing from
the commenter.
Comment: A commenter disagreed with the proposed pricing of the
lysing reagent (FACS) (SL089) supply. The commenter submitted six
invoices for the supply and requested that CMS use them to update the
pricing.
Response: We appreciate the submission of these additional invoices
for use in pricing the SL089 supply. Therefore, we are finalizing an
update in the price of this supply to $3.645 as indicated on the
submitted invoices. As part of our ongoing pricing transition, the CY
2021 price of the supply will be $3.764 before reaching the finalized
price of $3.645 in CY 2022.
Comment: One commenter disagreed with the proposed pricing of the
radiofrequency introducer kit (SA026). The commenter stated that
although some vendors now include this supply in an overall catheter
pack, it is still common that many practices purchase this item
separately. The commenter submitted two invoices for the supply and
requested that CMS use them to update the pricing.
Response: We appreciate the submission of these additional invoices
for use in pricing the SA026 supply. Therefore, we are finalizing an
update in the price of this supply to $28.575 based on an average of
the prices on the two submitted invoices. As part of our ongoing
pricing transition, the CY 2021 price of the SA026 supply will be
$32.83 before reaching the finalized price of $28.575 in CY 2022.
Comment: Several commenters disagreed with the proposed pricing of
the hydrophilic guidewire (SD089) supply. Commenters stated that $27.76
would be a more appropriate reimbursement rate and submitted an invoice
in support of their suggested pricing.
Response: We appreciate the submission of these additional invoices
for use in pricing the SD089 supply. We noted that the guidewire on the
newly submitted invoice was a different size than the guidewire on the
invoice that we previously used for pricing the SD089 supply. Since we
do not have information currently available as to which of these
guidewires would be more typical, we are averaging together the two
submitted invoices for a price of $20.555. As part of our ongoing
pricing transition, the CY 2021 price of the SD089 supply will be
$29.995 before reaching the finalized price of 20.555 in CY 2022.
Comment: A commenter disagreed with the proposed pricing of the
endovascular laser treatment kit (SA074). The commenter stated that
they were not sure that the proposed pricing was typical for the
average clinic due to the economy of scale advantages available for
larger providers. The commenter submitted three invoices for the supply
and requested that CMS use them to update the pricing.
Response: We appreciate the submission of these additional invoices
for use in pricing the SA074 supply. The unit prices on the three
submitted invoices were $431.08 (for a pack of five), $438.60 (for a
pack of two), and $535.60 for an individual supply. The price for the
individual endovascular laser treatment kit was significantly higher
than the other invoice prices and we believe that this price would not
be typical in light of the other pricing data that we have available.
Therefore, we are finalizing an update in the price of this supply to
$438.60 based on taking the median of the submitted invoices which we
believe to be more representative of typical pricing. As part of our
ongoing pricing transition, the CY 2021 price of the SA074 supply will
be $429.88 before reaching the finalized price of $438.60 in CY 2022.
Comment: A commenter disagreed with the proposed pricing of the
tubing set (Liposorber) (SC083) and plasma separator (Liposorber)
(SD188) supplies. The commenter stated that the proposed prices did not
accurately reflect the actual average prices paid by their U.S.
provider customers. The commenter submitted 45 invoices for the two
supplies and requested that CMS use them to update the pricing.
Response: We appreciate the submission of this large quantity of
additional invoices for use in pricing the SC083 and SD188 supplies.
After reviewing the invoices, we agree with the commenter that the
average sales price matches the numbers listed in their comment letter.
Therefore, we are finalizing an update in the price of the SC083 supply
to $75.71 and an update in the price of the SD188 supply to $131.42 as
indicated on the submitted invoices. As part of our ongoing pricing
transition, the CY 2021 price of the SC083 supply will be $62.28 and
the CY 2021 price of the SD188 supply will be $113.04 before reaching
their finalized prices in CY 2022.
Comment: Several commenters disagreed with the proposed pricing for
the RF endovenous ablation catheter (SD 155) and the vascular sheath
(SD 136) supplies. Commenters stated that the proposed prices did not
reflect the reality of their practice's economics and expressed concern
that such reductions could encourage office-based physicians to curtail
or cease performing these
[[Page 84495]]
procedures. Commenters stated that the proposed pricing for RF
catheters and sheaths represented the price being paid by high-volume
or large multi-location practices and did not reflect the prices paid
by smaller providers who are more typical. Due to the greater
negotiating power and high volume discounts available to larger
practices, commenters stated that the proposed supply pricing did not
seem be to what typical providers pay and that the current pricing of
$52.80 was more representative for the vascular sheath. One commenter
requested a more thorough review of the data CMS used to determine the
updated pricing for the SD136 and SD155 supplies as well as the
opportunity to provide additional data to validate their pricing.
Several commenters submitted a series of invoices for the RF endovenous
occlusion catheter (SD155) that they stated were more typical of
pricing and urged CMS to update the supply pricing accordingly.
Response: We appreciate the additional information provided by the
commenters regarding the pricing of these supplies, especially the
invoices with additional pricing data for the SD155 catheter. The
commenters are correct that the proposed pricing for the SD155 supply
was based in part on a bulk order and that ordering the catheters on an
individual basis resulted in higher prices. However, we do not agree
that it would be accurate to base the pricing of the SD155 supply
solely on the basis of individual orders with no discounts included, as
it is clear from the submitted invoices that there exists a variety of
discounts available for providers. Therefore, we are averaging together
the newly submitted invoices together with our previous invoices for
the SD155 supply and finalizing the resulting price of $487.92. As part
of our ongoing pricing transition, the CY 2021 price of the supply will
be $562.71 before reaching the finalized price of $487.92 in CY 2022.
We did not receive any invoices with updated pricing information
for the vascular sheath (SD136) supply. In the absence of additional
information, we believe that the proposed price for the vascular sheath
accurately reflects the cost of this supply and we are finalizing the
proposed price of $24.44. We continue to welcome the submission of
invoices with additional information regarding the pricing of these two
or any other supply items.
Comment: Several commenters stated that they believe the HDR
Afterload System, Nucletron--Oldelft (ER003) and the SRS System, SBRT,
Six Systems (ER083) equipment items remain significantly undervalued
relative to fair market pricing. The commenters stated that it was
imperative for CMS equipment pricing to accurately reflect marketplace
pricing given the high cost of these items and their substantial
utilization in certain radiation oncology delivery codes. One commenter
stated that the pricing for this equipment may represent a less costly
electronic brachytherapy system used to treat skin cancer or an
equipment upgrade or refurbished equipment. The commenters requested
that CMS conduct additional research regarding fair and accurate market
pricing for these two equipment items and accept newly submitted
invoices during the 60-day comment period. One commenter requested a
one-year moratorium on phasing in the StrategyGen revised pricing
inputs and maintain all direct PE inputs at 2020 levels.
Response: We share the desire of the commenter for fair and
accurate market-based pricing for these two equipment items. However,
both of these equipment items were priced based on research conducted
by our StrategyGen contractor and then were updated in response to
additional information supplied by commenters in the CY 2019 PFS final
rule (83 FR 59478-59479). In the absence of additional information, we
believe that the current prices accurately reflect the cost of these
equipment items. We continue to welcome the submission of invoices with
additional information regarding the pricing of these two or any other
equipment items. We also note that the ongoing market-based supply and
equipment pricing update was previously finalized in CY 2019 rulemaking
and we do not agree that a one-year moratorium on the continuing
pricing transition would facilitate our goal of ensuring current
pricing.
After consideration of the public comments, we are finalizing our
proposals associated with the market-based supply and equipment pricing
update as detailed above. Table 10 contains the list of finalized CY
2021 market-based supply and equipment pricing updates:
[[Page 84496]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.009
(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 2021 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. 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 will 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. Stakeholders are encouraged to submit invoices as part of their
public comments or, if outside the public comment process, via email at
[email protected].
(3) Updated Supply Pricing for Venous and Arterial Stenting Services
Following the publication of the CY 2020 PFS final rule,
stakeholders contacted CMS and presented additional information
regarding supply pricing for certain venous and arterial stenting
services. These stakeholders stated that the use of the ``stent,
vascular, deployment system, Cordis SMART'' (SA103) supply was no
longer typical in CPT codes 37238 (Transcatheter placement of an
intravascular stent(s), open or percutaneous, including radiological
supervision and interpretation and including angioplasty within the
same vessel, when performed; initial vein) and 37239 (Transcatheter
placement of an intravascular stent(s), open or percutaneous, including
radiological supervision and interpretation and including angioplasty
within the same vessel, when performed; each additional vein). The
stakeholders stated that a new venous stent system had become the
typical standard of care for these services, and they supplied ten
invoices for use in pricing this supply.
The stakeholders also requested additional information regarding
the nature of the ``stent, balloon, implantable'' (SD299) supply
included in CPT codes 37236 (Transcatheter placement of an
intravascular stent(s) (except lower extremity artery(s) for occlusive
disease, cervical carotid, extracranial vertebral or intrathoracic
carotid, intracranial, or coronary), open or percutaneous, including
radiological supervision and interpretation and including all
angioplasty within the same vessel, when performed; initial artery) and
37237 (Transcatheter placement of an intravascular stent(s) (except
lower extremity artery(s) for occlusive disease, cervical carotid,
extracranial vertebral or intrathoracic carotid, intracranial, or
coronary), open or percutaneous, including radiological supervision and
interpretation and including all angioplasty within the same vessel,
when performed; each additional artery). The stakeholders specifically
were unclear what the implantable stent balloon represented and sought
guidance on whether pricing involved a stent, a balloon, or a
combination of both.
In response to the additional information provided by the
stakeholders, we proposed to remove the SA103 supply item from CPT
codes 37238 and 37239. We proposed to replace it with a newly created
``venous stent system'' (SD340) supply at the same supply quantity. We
proposed a price of $1,750.00 for the venous stent system based on the
median price of the ten invoices supplied by the stakeholders. We
proposed the use of the median price due to the presence of several
invoices that appear to be outliers, which are not reflective of
[[Page 84497]]
market pricing for the venous stent system. With regards to the request
for additional information regarding the nature of the ``stent,
balloon, implantable'' (SD299) supply, the original invoice used to
price this supply during the CY 2015 rule cycle listed an item named
``Renal and Biliary Stent System 7.0 mm x 15 mm x 135 cm''. We welcomed
additional information from stakeholders regarding the nature and
pricing of this supply item.
We received public comments on our proposals associated with
updated supply pricing for venous and arterial stenting services. The
following is a summary of the comments we received and our responses.
Comment: Several commenters stated that they supported the proposed
change to replace the stent for CPT codes 37238 and 37239. One
commenter stated that they appreciated the additional information on
the two CPT codes and looked forward to researching this issue further.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing our
proposals associated with updated supply pricing for venous and
arterial stenting services.
(4) Myocardial PET Equipment Inputs
Following the publication of the CY 2020 PFS final rule,
stakeholders contacted CMS and presented additional information
regarding the direct PE inputs for several codes associated with
Myocardial PET services. The stakeholders stated that the nuclide rod
source set (ER044) equipment was inadvertently excluded from the direct
PE recommendations for CPT codes 78432 (Myocardial imaging, positron
emission tomography (PET), combined perfusion with metabolic evaluation
study (including ventricular wall motion[s] and/or ejection
fraction[s], when performed), dual radiotracer (eg, myocardial
viability)), 78459 (Myocardial imaging, positron emission tomography
(PET), metabolic evaluation study (including ventricular wall motion[s]
and/or ejection fraction[s], when performed), single study)), 78491
(Myocardial imaging, positron emission tomography (PET), perfusion
study (including ventricular wall motion[s] and/or ejection
fraction[s], when performed); single study, at rest or stress (exercise
or pharmacologic)), and 78492 (Myocardial imaging, positron emission
tomography (PET), perfusion study (including ventricular wall motion[s]
and/or ejection fraction[s], when performed); multiple studies at rest
and stress (exercise or pharmacologic)), and requested that CMS add
this equipment to the direct inputs for this group of CPT codes. The
stakeholders also stated that the current useful life of 5 years for
the ER044 equipment was incorrect as these sources are replaced every 9
months to 1 year. The stakeholders requested that CMS update the useful
life of ER044 to 0.75 years. Finally, the stakeholders stated that the
costs for the purchase of the Rubidium PET Generator (ER114) equipment
are captured elsewhere through the billing of HCPCS supply code A9555,
and the stakeholders recommended that we remove equipment item ER114 to
avoid incorrect billing duplication.
We noted that we appreciate the additional information submitted by
the stakeholders regarding the direct PE inputs for these Myocardial
PET services. In response to this new information, we proposed to
update the price for the nuclide rod source set (ER044) equipment to
$2,081.17 based on averaging together the price of the three submitted
invoices after removing the shipping and delivery costs according to
our standard pricing methodology. We also proposed to add the ER044
equipment to CPT codes 78432, 78459, 78491, and 78492 as requested,
assigning the same equipment time utilized by the ``PET Refurbished
Imaging Cardiac Configuration'' (ER110) equipment in each service. We
proposed to update the useful life of the ER044 equipment to one year
in accordance with our proposed policy to treat equipment useful life
durations of less than 1 year as having a duration of one year. As we
stated previously in section II.B, we have concerns that assigning very
low useful life durations of less than 1 year would fail to maintain
relativity with other equipment on the PFS, and the equipment cost per
minute formula was designed under the assumption that each equipment
item would remain in use for a period of several years and depreciate
over that span of time. We direct readers to the previous discussion
regarding equipment cost per minute methodology earlier in section
II.B. of this final rule. Finally, we are removing the ``PET Generator
(Rubidium)'' (ER114) equipment from our database as requested by the
stakeholders. We noted that since the technical components for CPT
codes 78432, 78459, 78491, and 78492 are all contractor-priced, there
will be no change to the national pricing of these codes.
We received public comments on our proposals associated with
Myocardial PET equipment inputs. The following is a summary of the
comments we received and our responses.
Comment: Several commenters stated that they agreed with and
supported all four of the CMS proposals associated with Myocardial PET
equipment inputs. Commenters also stated that they supported the
decision to maintain contractor pricing for the technical components
for all the new and revised Myocardial PET codes. Commenters stated
that the standard CMS formula and RUC PE inputs do not allow for
certain high-cost expenses that are generally part of overhead to be
factored into the RVUs and requested that contractor pricing continue
to be maintained for these services.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing our
proposals associated with Myocardial PET equipment inputs.
(5) Autologous Platelet-Rich Plasma (HCPCS Code G0460) Supply Inputs
We did not make any proposals associated with HCPCS code G0460
(Autologous platelet rich plasma for chronic wounds/ulcers, including
phlebotomy, centrifugation, and all other preparatory procedures,
administration and dressings, per treatment) in the CY 2021 PFS
proposed rule. Following the publication of the rule, stakeholders
contacted CMS regarding the creation of a new 3C patch system supply
which is topically applied for the management of exuding cutaneous
wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and
mechanically or surgically-debrided wounds. Stakeholders first sought
clarification on how CMS calculated the underlying nonfacility PE RVUs
for HCPCS code G0460. Stakeholders also stated that autologous platelet
rich plasma administration procedures furnished in clinical trials
(including the new 3C patch system) are reported using HCPCS code G0460
and requested that CMS revalue the service to reflect the PEs
associated with the new patch system supply. The stakeholders stated
that the use of the new 3C patch system will represent the typical case
for HCPCS code G0460 and the therefore the cost inputs for this supply
should be used to establish the RVUs for this code as the current MPFS
rate is substantially less than the amount it costs to furnish the 3C
patch.
We clarify for stakeholders that the valuation of the direct PE
inputs increased for HCPCS code G0460 as a result of the ongoing
market-based supply and equipment pricing update. However, there was
also a minor
[[Page 84498]]
decrease in the indirect PE allocation associated with this service,
with the net result that the proposed PE RVU coincidentally ended up
remaining the same as in the previous year. We also clarify for
stakeholders that HCPCS code G0460 is not included in the Anticipated
Specialty Assignment for Low Volume Services list, and therefore, was
unaffected by low utilization in the claims data.
We understand that the stakeholders originally believed that the
new 3C patch system would be reported using new HCPCS coding before CMS
issued a clarification that the clinical trials associated with this
supply would be reported under HCPCS code G0460. We share the concerns
of the stakeholders that patient access to the 3C patch will be
materially impacted if CMS maintains reimbursement for HCPCS G0460 at
the current rate. However, we note that we did not propose to increase
the price of HCPCS code G0460 in the PFS proposed rule, and we have
concerns about finalizing a fivefold increase in the pricing of this
service without going through notice and comment rulemaking. Therefore,
we are finalizing contractor pricing for HCPCS code G0460 for CY 2021
to allow for increased pricing for this service when it includes the 3C
patch system without establishing a new national price. We believe that
the use of contractor pricing will allow additional time to determine
the most accurate pricing for HCPCS code G0460. We are also adding the
3C patch system to our supply database under supply code SD343 at a
price of $625.00 based on an average of the submitted invoices.
(6) 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 2021, we proposed to continue with the fourth and final year
of the transition of this adjustment to the standard process for
allocating indirect PE.
We did not receive public comments on this provision, and
therefore, we are finalizing as proposed.
e. Update on Technical Expert 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 we
noted earlier in this section, our current system for setting PE RVUs
relies in part on data collected in the Physician Practice Information
Survey (PPIS), which was administered by the AMA in CY 2007 and 2008.
RAND, in its first phase of research, available at https://www.rand.org/pubs/research_reports/RR2166.html, found that the PPIS
data are outdated and may no longer reflect the resource allocation,
staffing arrangements, and cost structures that describe practitioners'
resource requirements in furnishing services to Medicare beneficiaries,
and consequently may not accurately capture the indirect PE resources
required to furnish services to Medicare FFS beneficiaries. For
example, the PPIS preceded the widespread adoption of electronic health
records, quality reporting programs, billing codes that promote team-
based care, and hospital acquisition of physician practices. Notably,
RAND found that practice ownership was strongly associated with
indirect PE, with physician-owned practices requiring 190% higher
indirect PE compared to facility-owned practices, suggesting a need to
potentially update demographic information. Additionally, RAND found
that aggregating Medicare provider specialties into broader categories
resulted in small specialty-level impacts relative to the current
system, suggesting that specialty-specific inputs may not be required
to accurately reflect resource costs.
To follow up on these and other issues raised in the first phase of
RAND's research, in the CY 2020 PFS, we announced that RAND was
convening a technical expert panel (TEP) to obtain input from
stakeholders including physicians, practice and health system managers,
health care accountants, and health policy experts. The TEP occurred on
January 10, 2020 and its report is available at https://www.rand.org/pubs/working_papers/WR1334.html. Topics discussed included identifying
issues with the current system; changes in medicine that have affected
PE; how PE inputs could be updated, including through a potential new
survey instrument; how best to aggregate PE categories if there were to
be new survey instrument; ways to maximize response rates in a
potential new survey; and using existing data to inform PFS PE rates.
In addition, RAND has issued the results of its subsequent phase of
research, available at www.rand.org/t/RR3248. This report is also
available as a public use file displayed on the CMS website under
downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Based on the results of the TEP and RAND's other ongoing research,
we are interested in potentially refining the PE methodology and
updating the data used to make payments under the PFS. We believe that
potential refinements could improve payment accuracy and strengthen
Medicare. Our goals are to balance obtaining the data as soon as
practicable and in a way that would allow stakeholders and CMS to
collectively examine many of the issues the TEP and RAND's research
identified. We noted that we were considering several questions,
including how to best incorporate market-based information, which could
be similar to the market research that we recently conducted to update
supply and equipment pricing used to determine direct PE inputs under
the PFS payment methodology. For example, stakeholders have expressed
an interest in updating the clinical labor data that we use for direct
PE inputs based on current salaries and compensation for the health
care workforce. We solicited comment regarding how we might update the
clinical labor data. We noted that historically we have used data from
the Bureau of Labor Statistics and sought comment to determine if this
is the best data source or if there is an alternative. We also noted
that we are interested in hosting a Town Hall meeting at a date to be
determined to provide an open forum for discussion with stakeholders on
our ongoing research to potentially update the PE methodology and the
underlying inputs. Finally, we welcomed feedback from all interested
parties regarding RAND's report and clarified that we were not making
any proposals based on this report for this rulemaking cycle We
encouraged stakeholders to submit feedback as part
[[Page 84499]]
of their public comments or, if outside the public comment process, via
email at [email protected].
We received public comments on the update on technical expert panel
related to PE. The following is a summary of the comments we received
and our responses.
Comment: In response to the RAND report, commenters encouraged CMS
to work with stakeholders on any new PE data collection effort.
Response: We agree that we would want to engage with stakeholders
as part of any new PE data collection effort. Our public notice and
comment rulemaking process is the venue we would use for any potential
future proposals.
Comment: Commenters were supportive of CMS convening a Town Hall
meeting.
Response: We appreciate and are encouraged by commenters' support.
We continue to believe that a Town Hall would provide open forum for
discussions with stakeholders. We remain interested in hosting this
meeting at a date to be determined.
C. 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 relative
value units (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.H. of this final rule, Valuation of
Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the American
Medical Association (AMA) Resource-Based Relative Value Scale (RVS)
Update Committee (RUC), the Medicare Payment Advisory Commission
(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 costs decline.
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 costs 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
[[Page 84500]]
facilitate the review and appropriate adjustment of potentially
misvalued services. This section also authorizes the use of analytic
contractors to identify and analyze potentially misvalued codes,
conduct surveys or collect data, and make recommendations on the review
and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well. Individuals and stakeholder groups may submit codes for review
under the potentially misvalued codes initiative to CMS in one of two
ways. Nominations may be submitted to CMS via email or through postal
mail. Email submissions should be sent to the CMS emailbox
[email protected], with the phrase ``Potentially
Misvalued Codes'' and the referencing CPT code number(s) and/or the CPT
descriptor(s) in the subject line. Physical letters for nominations
should be sent via the U.S. Postal Service to the Centers for Medicare
& Medicaid Services, 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 as 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). We continue
each year to consider and finalize a list of potentially misvalued
codes that have or will be reviewed and revised as appropriate in
future rulemaking.
3. CY 2021 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606
through 67608), we modified this process whereby the public and
stakeholders may nominate potentially misvalued codes for review by
submitting the code with supporting documentation by February 10th of
each year. Supporting documentation for codes nominated for the annual
review of potentially misvalued codes may include the following:
Documentation in peer reviewed medical literature or other
reliable data that demonstrate changes in physician work due to one or
more of the following: Technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
National surveys of work time and intensity from
professional and management societies and
[[Page 84501]]
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 submissions nominating codes for review under the
potentially misvalued code initiative, and several requests for review
of PE related inputs prior to our February 10, 2020 deadline. We refer
readers to section II.B. of this final rule, Determination of Practice
Expense RVUs, for further discussion on the PE-related submissions. The
summary of the submissions reviewed under the potentially misvalued
code initiative is discussed below.
We received multiple submissions requesting that CMS consider CPT
code 22867 (Insertion of interlaminar/interspinous process
stabilization/distraction device, without fusion, including image
guidance when performed, with open decompression, lumbar; single level)
for nomination as potentially misvalued. In their request, the
submitters suggested that the physician work assigned to this code
significantly undervalues the procedure relative to the value of CPT
code 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). The submitters stated that the work performed during
the surgical steps to perform a laminectomy for both procedures is
generally similar except for the additional intensity and complexity
involved in CPT code 22867 to implant the interspinous stabilization
device. The submitters also requested that the malpractice RVUs
assigned to this code be increased to better align with similar spine
procedures, in terms of specialty-level and service-level risk factors,
in addition to the intensity and complexity of the procedure. After
considering the information provided by the submitter, which suggests
that the current valuation for the service may not reflect the level of
intensity inherent in furnishing the service relative to other similar
services with inputs that exceed those for the nominated service, we
proposed to nominate CPT code 22867 as potentially misvalued and
welcomed public comment on this code.
We received public comments on the CY 2021 identification and
review of potentially misvalued services. The following is a summary of
the comments we received and our responses.
Comment: The AMA RUC has indicated that CPT code 22867 will be
placed on a list they call the ``next Level of Interest for review.''
Response: We acknowledge and thank the AMA RUC's placement of CPT
code 22867 on their ``next Level of Interest for review'' list and look
forward to their input, as well as input from the initial submitters of
CPT code 22867 and all other parties.
Comment: Some commenters expressed support for the nomination of
CPT code 22867 as a potentially misvalued code, but disagreed with the
comparison to CPT code 63047. Some commenters stated that CPT code
22867 was misvalued from its last review in 2016, when CMS determined a
work RVU of 13.50 over the AMA RUC recommended work RVU of 15.00.
Commenters stated that CMS already has the necessary survey data from
the specialties who perform this service--which had been surveyed and
reviewed twice by the AMA RUC with the same outcome, and that the
procedure's technology has not changed since the last survey. One
commenter also highlighted differences between CPT code 63047 and CPT
code 22867, noting that CPT code 63047 involves more postoperative work
(as an inpatient service), spends more time with intense imaging
services and device sizing, and that the decompression performed is
more extensive than CPT code 22867, all of which supports the relative
greater RVU amount for CPT code 63047.
Response: We acknowledge and appreciate comments and feedback from
CPT code 22867 stakeholders who have expressed their reasons both for
and against the nomination of this code as potentially misvalued.
Comment: Some commenters requested that CMS nominate HCPCS codes
G0442 (Annual alcohol misuse screening, 15 minutes) and G0444 (Annual
depression screening, 15 minutes) as potentially misvalued due to the
possible misinterpretation of their descriptors. These commenters
highlighted that the descriptors may appear to convey that the
physician providing the service must provide a full 15 minutes of
screening to report either of these services. The commenters stated
their understanding of the descriptor to mean ``up to 15 minutes'' to
perform the screenings, and suggested that CMS adjust the official
descriptors to say G0442 (Annual alcohol misuse screening, up to 15
minutes) and G0444 (Annual depression screening, up to 15 minutes), and
for CMS to provide an educational announcement to clarify the proposed
change.
Response: We thank the commenters for these suggestions for
clarifications on HCPCS codes G0442 and G0444 descriptors and welcome
comments and continued engagement with stakeholders on all aspects of
coding that improves accuracy and promotes clarity.
Comment: Several commenters nominated CPT code 49436 (Delayed
creation of exit site from embedded subcutaneous segment of
intraperitoneal cannula or catheter) as being potentially misvalued,
due to the PFS presently only making payment for this service in the
facility setting and not in the office setting. Commenters requested
that CMS review this code, and value the required resources for correct
payment in the office setting. They contend that the procedure can be
performed in the office, just as safely as it is done in an ASC or
outpatient setting, and that it might be a more convenient site of
service for the physician and for the patient. CPT code 49436 helps
promote home peritoneal dialysis, which falls in line with the
President's Executive Order (E.O.) on Advancing American Kidney Health
and keeps patients at home during the PHE for COVID-19 rather than
having to travel to a dialysis center three times a week.
Response: While CMS had decided not to nominate CPT code 49436 in
the proposed rule as being potentially misvalued, commenters
resubmitted their nomination during this comment period. We appreciate
all of the comments and feedback that we have received for nominating
CPT code 49436 as potentially misvalued and further to consider valuing
CPT code 49436 in the office setting. We intend to research the
information provided and understand more about the potential impact of
valuing CPT code 49436 in the office setting and may consider for
future rulemaking.
Comment: Commenters referenced codes that were publicly nominated
in CY 2019 as misvalued by a national commercial insurer. The commenter
expressed disappointment that CMS accepted these public nominations
from a private national commercial insurer, as they could potentially
represent a possible conflict of interest in their role
[[Page 84502]]
as a private commercial medical insurance and Medicare Advantage payer
to the providers of physician services. The commenter urged CMS to
evaluate how it considers public nominations from parties with possible
conflicts in payment determinations.
Response: CMS will accept and review all public nomination of
services that may be potentially misvalued, as appropriate. As we had
stated in our CY 2019 PFS final rule, we also reiterate that we
continue to be open to reviewing additional and supplemental sources of
data furnished by stakeholders, and providing such information to CMS
is not limited to the public nomination process for potentially
misvalued codes. We encourage stakeholders to continue to provide such
information for our consideration, as this information may support CMS'
review and refinement of work RVUs that are the basis for payment for
many services under the PFS.
Comment: One commenter urged CMS to use its authority to adjust CY
2018 Medicare payments for physicians' services to increase the current
rate for managing home patients (CPT code 90966 (End-stage renal
disease (ESRD) related services for home dialysis per full month, for
patients 20 years of age and older) 6.77 RVU) and to the maximum
payment amount for managing in-center patients (CPT code 90960 (End-
stage renal disease (ESRD) related services monthly, for patients 20
years of age and older; with 4 or more face-to-face visits by a
physician or other qualified health care professional per month) 8.07
RVU); however, no supporting documentation was included with this
nomination request.
Response: Should there be compelling evidence of substantial change
in the nature of CPT codes 90966 and 90960 and their relationship to
each other since their 2018 review, the commenter is free to nominate
these codes as potentially misvalued and lend support and evidence to
that effect for the next proposed rule.
After consideration of the public comments, we are finalizing our
proposal to nominate CPT code 22867 as potentially misvalued. We
appreciate all of the comments and information we have received from
stakeholders about services that they believe to be potentially
misvalued and look forward to receiving new and additional information
prior to our February 10th deadline for our next round of rulemaking.
D. Telehealth and Other Services Involving Communications Technology,
and Interim Final Rule With Comment Period for Coding and Payment of
Virtual Check-In Services
1. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
As discussed in the CY 2021 PFS proposed rule (85 FR 50095) 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.
a. Adding Services to the Medicare Telehealth Services List
In the CY 2003 PFS final rule with comment period (67 FR 79988), we
established a regulatory process for adding services to or deleting
services from the Medicare telehealth services list in accordance with
section 1834(m)(4)(F)(ii) of the Act (Sec. 410.78(f)). This process
provides the public with an ongoing opportunity to submit requests for
adding services, which are then reviewed by us and assigned to
categories established through notice and comment rulemaking.
Specifically, we assign any submitted request to add to the Medicare
telehealth services list 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 Medicare telehealth services list. 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 Medicare telehealth services list. 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 Medicare telehealth services list, including the additions
described later in this section, is available on the CMS website at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
For CY 2021, requests to add services to the Medicare telehealth
services list must have been submitted and received by February 10,
2020. Each request to add a service to the Medicare telehealth services
list must have included 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
Medicare telehealth services list, requesters are 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 in the future to add services to the Medicare telehealth
services list, including where to mail these requests, see our website
at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests To Add Services to the Medicare Telehealth Services List
for CY 2021
Under our current policy, we add services to the Medicare
telehealth services list on a Category 1 basis when we determine that
they are similar to
[[Page 84503]]
services on the existing Medicare telehealth services 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
Medicare telehealth services list that resemble those services already
on the Medicare telehealth services list. We received several requests
to add various services as Medicare telehealth services effective for
CY 2021. We also conducted an internal review of potential services to
add to the Medicare telehealth services list.
In response to the public health emergency (PHE) for Coronavirus
Disease 2019 (COVID-19), CMS undertook emergency rulemaking to add a
number of services to the Medicare telehealth services list on an
interim final basis. In the ``Medicare and Medicaid Programs; Policy
and Regulatory Revisions in Response to the COVID-19 Public Health
Emergency'' interim final rule with comment period (IFC), (which was
issued on March 31, 2020 and appeared in the April 6, 2020 Federal
Register (85 FR 19230, 19234 through 19241) (hereinafter referred to as
the ``March 31st COVID-19 IFC''), on an interim final basis for the
duration of the PHE for COVID-19, we also finalized the addition of a
number of services to the Medicare telehealth services list on a
Category 2 basis. The following is a list of those services:
Emergency Department (ED) Visits, Levels 1-5 (CPT codes
99281-99285).
Initial and Subsequent Observation and Observation
Discharge Day Management (CPT codes 99217-99220; CPT codes 99224-99226;
CPT codes 99234-99236).
Initial Hospital Care and Hospital Discharge Day
Management (CPT codes 99221-99223; CPT codes 99238-99239).
Initial nursing facility visits, All levels (Low,
Moderate, and High Complexity) and nursing facility discharge day
management (CPT codes 99304-99306; CPT codes 99315-99316).
Critical Care Services (CPT codes 99291-99292).
Domiciliary, Rest Home, or Custodial Care services, New
and Established patients (CPT codes 99327-99328; CPT codes 99334-
99337).
Home Visits, New and Established Patient, All levels (CPT
codes 99341-99345; CPT codes 99347-99350).
Inpatient Neonatal and Pediatric Critical Care, Initial
and Subsequent (CPT codes 99468-99472; CPT codes 99475-99476).
Initial and Continuing Intensive Care Services (CPT code
99477-994780).
Assessment and Care Planning for Patients with Cognitive
Impairment (CPT code 99483).
Group Psychotherapy (CPT code 90853).
End-Stage Renal Disease (ESRD) Services (CPT codes 90952,
90953, 90959, and 90962).
Psychological and Neuropsychological Testing (CPT codes
96130-96133; CPT codes 96136-96139).
Therapy Services, Physical and Occupational Therapy, All
levels (CPT codes 97161-97168; CPT codes 97110, 97112, 97116, 97535,
97750, 97755, 97760, 97761, 92521-92524, 92507).
Radiation Treatment Management Services (CPT codes 77427).
When we previously considered adding these services to the Medicare
telehealth services list, either through a public request or through
our own internal review, we considered whether these services met the
Category 1 or Category 2 criteria. In many cases, we reviewed requests
to add these services on a Category 1 basis, but did not receive or
identify information that allowed us to review the services on a
Category 2 basis. While we stated in the March 31st COVID-19 IFC that
we did not believe the context of the PHE for COVID-19 would change the
assessment of these services as Category 1, we did reassess all of
these services on a Category 2 basis in the context of the widespread
presence of COVID-19 in the community.
Given the exposure risks for beneficiaries, the health care work
force, and the community at large, we stated that in-person
interactions between professionals and patients posed an immediate
potential risk that would not have been present when we previously
reviewed these services. We were concerned that this new risk created a
unique circumstance where health care professionals might have to
choose between mitigating exposure risk for themselves and for their
patients or seeking Medicare payment for the service. For example,
certain persons, especially older adults who are particularly
vulnerable to complications from this specific viral infection; those
considered at risk because of underlying health conditions; and those
known to be recently exposed or diagnosed, and therefore, likely to
spread the virus to others, were often being directed by local public
health officials to self-isolate as much as possible. At the same time,
we noted that the risk to medical professionals treating patients is
high and we considered it likely that medical professionals would try
to treat patients as effectively as possible without exposing
themselves or their patients unnecessarily. We explained that, in some
cases, the use of telecommunications technology could mitigate the
exposure risk; and in such cases, there is a clear clinical benefit of
using such technology in furnishing the service. In other words,
patients who should not be seen by a professional in-person due to the
exposure risk were highly likely to be without access to clinically
appropriate treatment or diagnostic options unless they have access to
services furnished through interactive communication technology.
Therefore, in the context of the PHE for COVID-19, we believed that
all of the services we added met the Category 2 criteria to be added to
the Medicare telehealth services list on the basis that there was a
patient population that would otherwise not have access to clinically
appropriate treatment. We noted that, as with other services on the
Medicare telehealth services list, it may not be clinically appropriate
or possible to use telecommunications technology to furnish these
particular services to every person or in every circumstance. In the
context of the PHE for COVID-19, with specific regard to the exposure
risks noted above, we recognized the clinical benefit of access to
medically reasonable and necessary services furnished using
telecommunications technology as opposed to the potential lack of
access that could occur to mitigate the risk of disease exposure.
The following presents a discussion of these services and the
related proposals.
After reviewing the requests we received and the services we
identified for consideration, we identified the services listed in
Table 11 as being sufficiently similar to services currently on the
Medicare telehealth services list to be added on a Category 1 basis.
Therefore, we proposed to add the services in Table 11 to the Medicare
telehealth services list on a Category 1 basis for CY 2021.
[[Page 84504]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.010
[[Page 84505]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.011
We noted that we believe the services described by the HCPCS codes
in Table 11 are similar to services currently on the Medicare
telehealth services list. The HCPCS codes G2211 and G2212 are add-on
codes to the office/outpatient evaluation and management (O/O E/M)
services and are, by definition, part of the O/O E/M services with
which they are billed; they cannot be billed with any other codes.
These codes were previously described by placeholder HCPCS codes GPC1X
and 99XXX (for G2211 and G2212, respectively). For further discussion
of these codes, please see section II.F.2.c of this rule. The
Assessment of and Care Planning for Patients with Cognitive Impairment
was defined as a service meant to be billed in specific clinical
scenarios in lieu of a level 5 O/O E/M visit. As such, these services
fall within the Category 1 criteria, because they are similar to the
office visits that are already on the Medicare telehealth services
list. As it describes group therapy, CPT code 90853 is similar to the
other group therapy services currently on the Medicare telehealth
services list.
While the patient's home cannot serve as an originating site (where
the patient is located) for purposes of most Medicare telehealth
services, the SUPPORT for Patients and Communities Act amended section
1834(m)(4)(C) of the Act and added a new paragraph at section
1834(m)(7) of the Act to remove geographic limitations and authorize
the patient's home to serve as a telehealth originating site for
purposes of treatment of a substance use disorder (SUD) or a co-
occurring mental health disorder, furnished on or after July 1, 2019,
to an individual with a SUD diagnosis. These domiciliary/home visits
contain the same elements and similar descriptors to the O/O E/M
visits, and therefore, we noted that there is sufficient justification
to add them to the Medicare telehealth services list on a Category 1
basis. Additionally, we noted that, due to the vulnerability of this
particular patient population that are receiving treatment for a
diagnosed SUD or co-occurring mental health disorder, we should
maximize the availability of telehealth services for the treatment of
SUDs and co-occurring mental health disorders. We also noted that,
because the home is not generally a permissible telehealth originating
site, these services could be billed when furnished as telehealth
services only for treatment of a SUD or co-occurring mental health
disorder.
Finally, we received a request to add CPT code 96121
(Neurobehavioral status exam (clinical assessment of thinking,
reasoning and judgment, [e.g., acquired knowledge, attention, language,
memory, planning and problem solving, and visual spatial abilities]),
by physician or other qualified health care professional, both face-to-
face time with the patient and time interpreting test results and
preparing the report; each additional hour (List separately in addition
to code for primary procedure)) on the basis that this is an add-on
code to CPT code 96116 (Neurobehavioral status exam (clinical
assessment of thinking, reasoning and judgment, [e.g., acquired
knowledge, attention, language, memory, planning and problem solving,
and visual spatial abilities]), by physician or other qualified health
care professional, both face-to-face time with the patient and time
interpreting test results and preparing the report; first hour), which
is currently on the Medicare telehealth services list. In the past, we
have added services to the Medicare telehealth services list that are
add-on codes that describe a continuation or additional elements of
services currently on the Medicare telehealth services list since the
services would only be considered telehealth services when billed as an
add-on to codes already on the Medicare telehealth services list (82 FR
53008). Therefore, we proposed to add CPT code 96121 to the Medicare
telehealth services list.
We also received a request to add services to the Medicare
telehealth services list that do not meet our criteria for addition to
the Medicare telehealth services list. We did not propose to add the
services listed in Table 12 to the Medicare telehealth services list.
[GRAPHIC] [TIFF OMITTED] TR28DE20.012
We received a request to add Medical Genetics services to the
Medicare telehealth services list. We note that CPT code 96040 is
considered bundled into O/O E/M visits, which are already on the
Medicare telehealth services list. Therefore, we do not believe it is
necessary to add CPT code 96040. As we stated in the CY 2012 PFS final
rule
[[Page 84506]]
with comment period (76 FR 73096 through 73097), physicians and NPPs
who may independently bill Medicare for their services and who are
counseling individuals would generally report office or other
outpatient E/M CPT codes for office visits that involve significant
counseling, including genetic counseling, and these office visit CPT
codes are already on the Medicare telehealth services list. CPT code
96040 would only be reported by genetic counselors for genetic
counseling services. Genetic counselors are not among the practitioners
who can bill Medicare directly for their professional services, and
they are also not practitioners who can furnish telehealth services as
specified in section 1834(m)(4)(E) of the Act. As such, we noted that
we do not believe that it would be necessary or appropriate to add CPT
code 96040 to the Medicare telehealth services list.
HCPCS code S0265 is a Medication, Supplies, and Services code.
There is no separate payment under the PFS for this category of codes.
Therefore, we did not propose to add this service to the Medicare
telehealth services list.
We received public comments on the requests to add services to the
Medicare telehealth services list for CY 2021. The following is a
summary of the comments we received and our responses.
Comment: Commenters broadly supported our proposal to add HCPCS
codes and CPT codes 90853, 96121, G2212, 99483, 99334, 99335, 99347,
and 99348 to the Medicare telehealth list on a Category 1 basis.
Response: We thank the commenters for their support and feedback.
Comment: One commenter opposed the addition of G2211 to the
Medicare telehealth list on the basis they do not agree the creation of
the code.
Response: We thank the commenter for their feedback and refer them
to section II.F.2.c. of this final rule for further discussion of
payment policies for HCPCS code G2211. We note that HCPCS codes G2211
and G2212 replace GPC1X and 99XXX respectively, please see section
II.F.2.c in this final rule.
Comment: One commenter requested clarification on the addition of
CPT codes 99347 and 99348 (Home visit for the evaluation and management
of an established patient). Specifically, the commenter requested
clarification from CMS on the situations in which a home visit after
the end of the PHE for COVID-19 would be allowed via telehealth.
Response: While the patient's home cannot serve as an originating
site (where the patient is located) for purposes of most Medicare
telehealth services, the SUPPORT for Patients and Communities Act
amended section 1834(m)(4)(C) of the Act and added a new paragraph at
section 1834(m)(7) of the Act to remove geographic limitations and
authorize the patient's home to serve as a telehealth originating site
for purposes of treatment of a SUD or a co-occurring mental health
disorder, furnished on or after July 1, 2019, to an individual with a
SUD diagnosis. These domiciliary/home visits contain the same elements
and similar descriptors to the O/O E/M visits, and therefore, we
believe there is sufficient justification to add them to the Medicare
telehealth services list on a Category 1 basis. We are adding these to
the telehealth services list because an office/outpatient visit might
not always most accurately or specifically describe the type of visit
furnished to treat an individual in their home for an SUD or co-
occuring mental health disorder; and that sometimes one of the
domiciliary/home visit codes would more accurately describe the
service.
Comment: One commenter stated that Assessment and Care Planning for
Patients with Cognitive Impairment (CPT Code 99483) should not be added
at this time until more study can be done to assess the appropriateness
of this service being delivered in the telehealth context given that
many cognitive impairments and symptoms may require in-person
assessment.
Response: We continue to believe that CPT code 99483 is
sufficiently similar to an office visit to warrant addition to the
Medicare telehealth list on a permanent basis in that it involves
evaluating and managing a patient's cognitive impairment in an office/
outpatient setting. When the AMA CPT Editorial Panel created this code,
they assumed that the work associated with assessment and care planning
for patients with cognitive impairment had been reported with CPT code
99215 (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 comprehensive history; A comprehensive
examination; Medical decision making of high 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, 40 minutes are spent face-to-face with the patient and/or
family), which is currently on the Medicare telehealth list.
After considering the public comments received, we are finalizing
our proposal and adding HCPCS codes G2211 and CPT codes 90853, 96121,
G2212, 99483, 99334, 99335, 99347, and 99348 to the Medicare telehealth
list for CY 2021.
Comment: Commenters expressed opposition to CMS' decision not to
propose to add Medical Genetics services (CPT code 96040) to the
Medicare telehealth services list.
Response: We note that CPT code 96040 is not separately billable
under the PFS; it is considered bundled into O/O E/M visits, which are
already on the Medicare telehealth services list. Therefore, we believe
it is unnecessary, and could potentially be confusing, to add CPT code
96040 to the list. Only codes that are separately billable can be added
to the Medicare telehealth list. As we stated in the CY 2012 PFS final
rule with comment period (76 FR 73096 through 73097), physicians and
NPPs who furnish and bill Medicare for these services would generally
report office or other outpatient E/M CPT codes for office visits that
involve significant counseling, including genetic counseling; and the
office visit CPT codes are already on the Medicare telehealth services
list. CPT code 96040 would only be reported by genetic counselors for
genetic counseling services. Genetic counselors are not among the
practitioners who can bill Medicare directly for their professional
services, and they are also not practitioners who can furnish
telehealth services as specified in section 1834(m)(4)(E) of the Act.
As such, we do not believe that it would be necessary or appropriate to
add CPT code 96040 to the Medicare telehealth services list.
c. Proposed Temporary Addition of a Category 3 Basis for Adding to or
Deleting Services From the Medicare Telehealth Services List
Legislation enacted to address the PHE for COVID-19 provided the
Secretary with new authorities under section 1135(b)(8) of the Act, as
added by section 102 of the Coronavirus Preparedness and Response
Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020)
and subsequently amended by section 6010 of the Families First
Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section
3703 of the Coronavirus Aid, Relief, and Economic Security Act (CARES
Act) (Pub. L. 116-136, March 27, 2020)), to waive or modify Medicare
telehealth payment requirements during the PHE for COVID-19. We
established several flexibilities to accommodate these
[[Page 84507]]
changes in the delivery of care. Through waiver authority under section
1135(b)(8) of the Act, in response to the PHE for COVID-19, we removed
the geographic and site of service originating site restrictions in
section 1834(m)(4)(C) of the Act, as well as the restrictions in
section 1834(m)(4)(E) of the Act on the types of practitioners who may
furnish telehealth services, for the duration of the PHE for COVID-
19.\1\ We also used waiver authority to allow certain telehealth
services to be furnished via audio-only communication technology. In
the March 31st COVID-19 IFC, we added 89 services to the Medicare
telehealth services list on an interim basis. Through the ``Medicare
and Medicaid Programs; Additional Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency'' interim final rule
with comment period (IFC), (which was issued on May 1, 2020, and was
effective upon publication in the May 8, 2020 Federal Register (85 FR
27550 through 27649)) (hereinafter referred to as the ``May 8th COVID-
19 IFC''), on an interim basis for the duration of the PHE for COVID-
19, we removed the requirement in our regulations that we undertake
rulemaking to add or delete services on the Medicare telehealth
services list so that we could consider the addition of services on a
subregulatory basis as they were recommended by the public or
identified internally. On a subregulatory basis, we simultaneously
added 46 more services to the Medicare telehealth services list on an
interim basis when we issued the May 8th COVID-19 IFC. Finally, on
October 14, 2020 we added 11 more services to the Medicare telehealth
list on a subregulatory basis. For a full list of Medicare telehealth
services please see the CMS website: https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
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At the conclusion of the PHE for COVID-19, these waivers and
interim policies will expire, payment for Medicare telehealth services
will once again be limited by the requirements of section 1834(m) of
the Act, and we will return to the policies established through the
regular notice and comment rulemaking process, including the previously
established Medicare telehealth services list, as modified by
subsequent changes in policies and additions to the telehealth services
list adopted through rulemaking, including in this final rule. We
believe that the experiences of clinicians who are furnishing
telehealth services during the PHE for COVID-19 will be useful to
inform decisions about which of the services we added temporarily to
the Medicare telehealth services list might be appropriate to add on a
permanent basis. However, we also recognize that the annual PFS
rulemaking schedule may not align perfectly with the expiration of the
PHE for COVID-19, and that the clinicians providing services via
telehealth during the PHE may not have the opportunity to conduct the
kinds of review or develop the kind of evidence we usually consider
when adding services to the Medicare telehealth services list on a
permanent basis. In the event that the PHE for COVID-19 ends prior to
the end of CY 2021, stakeholders might not have the opportunity to use
our current consideration process for telehealth services to request
permanent additions to the Medicare telehealth services list prior to
those services being removed from the Medicare telehealth services
list. This is especially true for those services that might need to be
considered on a Category 2 basis, which involves providing supporting
documentation to illustrate the clinical benefit of such services.
Recognizing the extent to which practice patterns are shifting as a
result of the PHE for COVID-19 from a model of care based on in-person
services to one that relies on a combination of in-person services and
virtual care, we noted that we believe that it would be disruptive to
both clinical practice and beneficiary access to abruptly eliminate
Medicare payment for these services when furnished via telehealth as
soon as the PHE for COVID-19 ends without first providing an
opportunity to use information developed during the PHE to support
requests for permanent changes to the Medicare telehealth services
list.
As previously noted, in response to the PHE for COVID-19, we added
a broad range of services to the Medicare telehealth services list.
Before eliminating the full range of these services from the Medicare
telehealth services list and potentially jeopardizing beneficiary
access to those services that have been clinically beneficial, based
primarily on the timing of annual rulemaking, we noted that we believe
it would be prudent to collect information from the public regarding
which, where, and how various telehealth services have been in use in
various communities during the COVID-19 response. Feedback from
patients and clinicians is essential to helping CMS understand how the
use of telehealth services may have contributed positively to, or
negatively affected, the quality of care provided to beneficiaries
during the PHE for COVID-19, enabling us to better determine which
services should be retained on the Medicare telehealth services list
until we can give them full consideration under our established
rulemaking process.
Therefore, we proposed to create a third category of criteria for
adding services to the Medicare telehealth services list on a temporary
basis. This new category would describe services that would be included
on the Medicare telehealth services list on a temporary basis. We would
include in this category the services that were added during the PHE
for COVID-19 for which there is likely to be clinical benefit when
furnished via telehealth, but for which there is not yet sufficient
evidence available to consider the services as permanent additions
under Category 1 or Category 2 criteria. Recognizing that the services
we would add on a temporary basis under Category 3 would ultimately
need to meet the criteria under categories 1 or 2 in order to be
permanently added to the Medicare telehealth services list, and the
potential for evidence development that could continue through the
Category 3 temporary addition period, we considered each of the
services we added on an interim final basis during the PHE for COVID-
19.
In developing the proposal to add specific services on a Category 3
basis, we conducted a clinical assessment to identify those services
for which we could foresee a reasonable potential likelihood of
clinical benefit when furnished via telehealth outside the
circumstances of the PHE for COVID-19 and that we anticipate would be
able to demonstrate that clinical benefit in such a way as to meet our
Category 2 criteria in full. Any service added under the proposed
Category 3 would remain on the Medicare telehealth services list
through the calendar year in which the PHE for COVID-19 ends. When
assessing whether there was a potential likelihood of clinical benefit
for a service such that it should be added to the Medicare telehealth
services list on a Category 3 basis, we considered the following
factors:
Whether, outside of the circumstances of the PHE for
COVID-19, there are increased concerns for patient safety if the
service is furnished as a telehealth service.
Whether, outside of the circumstances of the PHE for
COVID-19, there are concerns about whether the provision of the service
via telehealth is likely to jeopardize quality of care.
[[Page 84508]]
Whether all elements of the service could fully and
effectively be performed by a remotely located clinician using two-way,
audio/video telecommunications technology.
We recognized that the circumstances of the PHE for COVID-19 have
provided clinicians with the opportunity to use telecommunications
technology in health care delivery in a scope and manner far surpassing
the telehealth services described under section 1834(m) of the Act,
particularly as a result of the removal of geographic and site of
service restrictions, and the addition of many services to the Medicare
telehealth services list. When adding services to the Medicare
telehealth services list on an interim basis during the PHE for COVID-
19, we reassessed services on a Category 2 basis in the context of the
widespread presence of COVID-19 in the community. We recognized that
healthcare access issues could arise due to the immediate potential
exposure risks to patients and healthcare workers, and that the use of
telecommunication technology could mitigate risk and facilitate
clinically appropriate treatment. In the context of the PHE for COVID-
19. We found that all of the added services met the Category 2 criteria
on the basis that there is a patient population who would otherwise not
have access to clinically appropriate care (85 FR 19234). While the
interim addition of a broad swath of services to the Medicare
telehealth services list is responsive to critical needs during the PHE
for COVID-19, the impact of adding these services to the Medicare
telehealth services list on a permanent basis is currently unknown.
Specifically, although it is possible to assess the uptake among health
care practitioners of the added telehealth services, the extent to
which service delivery via telehealth demonstrates clinical benefit
outside the conditions of the PHE for COVID-19 is not known. Adding
services to the Medicare telehealth services list on a Category 3 basis
will give the public the opportunity to gather data and generate
requests to add certain services to the Medicare telehealth services
list permanently, which would be adjudicated on a Category 1 or
Category 2 basis during future PFS annual rulemaking, while maintaining
access to telehealth services with potential likelihood of clinical
benefit. We proposed that the Category 3 criteria and the basis for
considering additions to the Medicare telehealth services list would be
temporary, to expire at the end of the calendar year in which the PHE
for COVID-19 expires.
We identified a number of services that we believe, based on our
clinical assessment, fit the Category 3 criteria enumerated above in
that we did not identify significant concerns over patient safety,
quality of care, or the ability of clinicians to provide all elements
of the service remotely if these services were to remain on the
Medicare telehealth services list for an additional period beyond the
PHE for COVID-19. Therefore, we proposed to continue including the
services listed in Table 13 on the Medicare telehealth services list
through the calendar year in which the PHE for COVID-19 ends. We
solicited public comment on the services we identified for temporary
addition to the Medicare telehealth services list through the Category
3 criteria, including whether some should not be considered as Category
3 temporary additions to the Medicare telehealth services list, or
whether services currently not proposed as Category 3 additions to the
Medicare telehealth services list should be considered as such. We
noted that while our clinical assessment indicated that the services in
Table 13 demonstrate potential likelihood of clinical benefit when
furnished as telehealth services and, as such, the potential to meet
the Category 1 or Category 2 criteria for permanent addition to the
Medicare telehealth services list with the development of additional
evidence, we solicited information from the public that would
supplement our clinical assessment and assist us in consideration of
our proposals regarding the Category 3 addition of services, even
though we recognize that formal analyses may not yet be available. The
following are examples of the types of information we sought from the
public to help inform our decisions about proposed additions under
Category 3:
By whom and for whom are the services being delivered via
telehealth during the PHE;
What practical safeguards are being employed to maintain
safety and clinical effectiveness of services delivered via telehealth;
and how are practices quickly and efficiently transitioning patients
from telehealth to in-person care as needed;
What specific health outcomes data are being or are
capable of being gathered to demonstrate clinical benefit;
How is technology being used to facilitate the acquisition
of clinical information that would otherwise be obtained by a hands-on
physical examination if the service was furnished in person. Certain
services on the Medicare telehealth services list prior to the PHE,
specifically the O/O E/M code set, involve a physical exam. With the
telehealth expansions during the PHE, clinicians may have had valuable
experience providing other telehealth services to patients in higher
acuity settings of care, such as an emergency department, that involve
a hands-on physical examination when furnished in person.
Whether patient outcomes are improved by the addition of
one or more services to the Medicare telehealth services list,
including whether inclusion on the Medicare telehealth services list
increases access, safety, patient satisfaction, and overall quality of
care;
Whether furnishing this service or services via
telecommunication technology promotes prudent use of resources;
Whether the permanent addition of specific, individual
services or categories of services to the Medicare telehealth services
list supports quick responses to the spread of infectious disease or
other emergent circumstances that may require widespread use of
telehealth; and
What is the impact on the health care workforce of the
inclusion of one or more services or categories of services on the
Medicare telehealth services list (for example, whether the health care
workforce and its capabilities to provide care are expanded).
In addition, we noted that CMS is committed to the following broad
goals, and these weigh heavily in our decision-making around the
addition, whether temporary or permanent, of a service or services to
the Medicare telehealth services list. We requested that commenters
consider these goals in conjunction with their comments on the
proposals for the treatment of the telehealth services we added on an
interim basis during the PHE for COVID-19:
Maintaining the capacity to enable rapid assessment of
patterns of care, safety, and outcomes in the Medicare, Medicaid, CHIP,
and Marketplace populations;
Establishing system safeguards to detect and avert
unintended patient harms that result from policy adjustments;
Ensuring high quality care is maintained;
Demonstrating ongoing quality improvement efforts by
Medicare participating providers, while maintaining access to necessary
care;
Establishing protections for vulnerable beneficiary
populations (those with multiple chronic conditions, functional
limitations, heart failure,
[[Page 84509]]
COPD, diabetes, dementia), and sites of heightened vulnerability (such
as nursing homes, rural communities) with high risk of adverse
outcomes;
Ensuring appropriate resource utilization and supporting
cost efficiency;
Supporting emergency preparedness and maintaining capacity
to surge for potential coronavirus resurgence or other healthcare
issues; and
Considering timing and pace of policy corrections in light
of local and regional variations in systems of care and the impact of
the PHE for COVID-19.
BILLING CODE 4120-01-P
[[Page 84510]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.013
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[GRAPHIC] [TIFF OMITTED] TR28DE20.014
[[Page 84512]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.015
[[Page 84513]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.016
[[Page 84514]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.017
[[Page 84515]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.018
[[Page 84516]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.019
BILLING CODE 4120-01-C
We received public comments on the proposed temporary addition of a
category 3 basis for adding to or deleting services from the Medicare
telehealth services list. The following is a summary of the comments we
received and our responses.
Comment: Many commenters supported our proposal to use a third,
temporary category of criteria for adding services to the Medicare
telehealth list on a provisional basis. Commenters agreed that keeping
certain services added on an interim basis during the PHE for COVID-19
on the Medicare telehealth list on a temporary basis after the end of
the PHE will give the medical community time to gather much needed data
on services in this category to support Category 2 requests through the
regular process for considering additions to the telehealth services
list, while maintaining beneficiary access and allowing practitioners
to transition back to models of care focused primarily on in-person,
rather than virtual, services. The majority of commenters also
supported adding the services CMS proposed to add to the Medicare
telehealth list on a Category 3 basis.
Response: We appreciate commenters' support for these proposals.
Comment: Most commenters supported the proposed timeframe for
services added on a Category 3 basis to remain on the Medicare
telehealth list; however, a few commenters stated that adding services
to the Medicare telehealth list on a temporary basis would create
unnecessary burden for clinicians who are attempting to both treat
patients in the midst of a pandemic and develop an evidence base to
[[Page 84517]]
support adding these services to the Medicare telehealth list
permanently. In addition, by stipulating that certain codes would
remain on the list through the year in which the PHE ends, commenters
suggested that CMS was creating ambiguity as to when services added to
the list on a Category 3 basis would expire. The commenters stated that
this would be an impediment to investing in the infrastructure
necessary to furnish these services. Some commenters requested that CMS
fund the studies necessary to demonstrate whether a given service
should be added permanently to the Medicare telehealth list, or at
least articulate clear standards CMS would use to assess efficacy.
Response: While we understand commenters' concerns that adding
services temporarily to the Medicare telehealth list without a fixed
end date would create ambiguity that could serve as a disincentive to
providing the services as telehealth services, we would note that the
PHE for COVID-19 has now been extended into CY 2021.\2\ The extension
of the PHE into CY 2021 ensures that clinicians will have at least the
entirety of 2021 to collect evidence to support a request to add these
services permanently to the Medicare telehealth list.
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Comment: Some commenters also expressed concern with the timeframe
for which services added on a Category 3 basis will be on the Medicare
telehealth list after the conclusion of the PHE. Some commenters
suggested alternative timeframes, ranging between 90 days and 2 years
after the end of the PHE. Some commenters suggested that CMS should
specify a year in which the category 3 additions to the telehealth list
will expire, such as 2022.
Response: As stated above, the PHE for COVID-19 has been extended
into CY 2021, allowing for services added to the Medicare telehealth
list on a Category 3 basis to remain there for at least the entirety of
2021. Any potential extension of this timeframe would be proposed in
future rulemaking.
After considering the public comments, we are finalizing the
additions in Table 14 to the telehealth list on a Category 3 basis
through the later of the end of the year in which the PHE ends or
December 31, 2021, as proposed.
d. Comment Solicitation on Medicare Telehealth Services Added on an
Interim Basis During the PHE for COVID-19 That CMS Did Not Propose To
Retain After the PHE Ends
In the March 31st COVID-19 IFC and the May 8th COVID-19 IFC, we
finalized on an interim basis during the PHE for COVID-19 the addition
of a number of services to the Medicare telehealth services list. While
a number of these services were previously requested by external
stakeholders and reviewed for addition as part of our standard process
for updating the Medicare telehealth services list, a few were
identified through internal review. As discussed above, we conducted a
clinical assessment of each of the services added on an interim basis
during the PHE for COVID-19 to the Medicare telehealth services list to
identify those for which we could foresee a reasonable potential
likelihood of clinical benefit when furnished via telehealth outside
the circumstances of the PHE for COVID-19. In our clinical review of
these services, we did not identify sufficient information to suggest
there is a potential likelihood of clinical benefit for the services
described below such that they could meet the Category 1 or Category 2
criteria outside the circumstances of the PHE for COVID-19. We
specifically considered the potential for these services to be
furnished, outside the circumstances of the PHE for COVID-19, without
increased concerns for patient safety or jeopardizing quality of care;
and furnished fully and effectively, including all elements of the
service, by a remotely located clinician via two-way, audio/video
telecommunications technology. After assessing these factors, we did
not find a potential likelihood that the services could meet Category 2
criteria even with development of additional evidence. As such, we
proposed not to extend them on the Medicare telehealth services list
beyond the end of the PHE for COVID-19. However, we solicited public
comment on whether any service added to the Medicare telehealth
services list on an interim basis for the duration of the PHE for
COVID-19 should be added to the Medicare telehealth services list on a
temporary, Category 3 basis, based on the criteria outlined above. We
welcomed additional information from commenters about these services.
We also sought comment on the following considerations associated
with particular services. We noted that comments on these specific
concerns would inform our final decisions on whether these services
should be added to the Medicare telehealth services list on a
temporary, Category 3 basis:
Initial and final/discharge interactions (CPT codes 99234-
99236 and 99238-99239): We noted that we believe that the potential
acuity of the patient described by these codes would require an in-
person physical exam in order to fulfill the requirements of the
service. We expressed concerns that, without an in-person physical
examination, the need for the physician or health care provider to
fully understand the health status of the person with whom they are
establishing a clinical relationship would be compromised. We noted
that we believe the need for an in-person interaction would rise beyond
any specific diagnosis, and serves as the foundation upon which any and
all clinical decisions are based for these services. We noted that,
without an in-person interaction, care planning that includes risk-
benefit considerations and clinical decision-making will be less well-
informed and create risk of patient harm.
Higher level emergency department visits (CPT codes 99284-
99285): We expressed concern that the full scope of service elements of
these codes cannot be met via two-way, audio/video telecommunications
technology as higher levels are indicated by patient characteristics,
clinical complexity, urgency for care, and require complex decision-
making. We also noted that we believe, due to the acuity of the patient
described by these codes, that an in-person physical examination is
necessary to fulfill the service requirements.
Hospital, Intensive Care Unit, Emergency care, Observation
stays (CPT codes 99217-99220; 99221-99226; 99484-99485, 99468-99472,
99475-99476, and 99477-99480): These codes describe visits that are
furnished to patients who are ill enough to require hospital evaluation
and care. We noted that we believe that the codes describe an
evaluation for these potentially high acuity patients that is
comprehensive and includes an in-person physical examination. Our view
that in-person care is necessary to fulfill the requirements of the
code is driven by the need for the physician or health provider to
fully understand the health status of the person with whom they are
establishing a clinical and therapeutic relationship. We also noted
that we believe that the need for an in-person interaction would rise
above any specific diagnosis, and serves as the foundation upon which
any and all clinical decisions are based for these services. We noted
that, without an in-
[[Page 84518]]
person interaction, care planning that includes risk-benefit
considerations and clinical decision-making would be less well-informed
and create risk of patient harm. With regard to the physical therapy,
occupational therapy, and speech-language pathology services in Table
13, we have received a number of requests that we add therapy services
to the Medicare telehealth services list. In the CY 2017 PFS final
rule, we noted that section 1834(m)(4)(E) of the Act specifies the
types of practitioners who may furnish and bill for Medicare telehealth
services as those practitioners under section 1842(b)(18)(C) of the
Act. Physical therapists (PTs), occupational therapists (OTs) and
speech-language pathologists (SLPs) are not among the practitioners
identified in section 1842(b)(18)(C) of the Act. We stated in the CY
2017 PFS final rule (81 FR 80198) that because these services are
predominantly furnished by PTs, OTs, and SLPs, we did not believe it
would be appropriate to add them to the Medicare telehealth services
list at that time. In a subsequent request to consider adding these
services for 2018, the original requester suggested that we might
propose these services to be added to the Medicare telehealth services
list so that payment can be made for them when furnished via telehealth
by physicians or practitioners who can serve as distant site
practitioners. We stated that since the majority of the codes are
furnished over 90 percent of the time by therapy professionals who are
not included on the statutory list of eligible distant site
practitioners, we believed that adding therapy services to the Medicare
telehealth services list could result in confusion about who is
authorized to furnish and bill for these services when furnished via
telehealth.
In the proposed rule, we noted that we continue to believe this is
generally the case, and we did not propose to add these services
permanently to the Medicare telehealth services list. We solicited
comment on whether these services should be added to the Medicare
telehealth services list so that, in instances when a practitioner who
is eligible to bill for telehealth services furnishes these services
via telehealth, they could bill and receive payment for them. We also
solicited comment on whether all aspects of these services can be fully
and effectively furnished via two-way, audio/video telecommunications
technology. We noted that given our clarification regarding telehealth
services furnished incident to the professional services of a physician
or practitioner (85 FR 27562), if these services were added to the
Medicare telehealth services list, they could be furnished by a
therapist and billed by a physician or practitioner who can furnish and
bill for telehealth services provided that all of the ``incident to''
requirements are met.
Comment: Commenters expressed concern that we did not propose to
add the vast majority of the interim PHE telehealth services to the
telehealth list on a Category 3 basis. Commenters stated that, by
limiting the availability of these interim PHE telehealth services to
the duration of the PHE, CMS would jeopardize access to care for
beneficiaries who have come to rely on the provision of these services
virtually, and would disrupt practice patterns for those clinicians who
were accustomed to furnishing a broader array of telehealth services
than included in the proposed permanent and temporary Category 3
additions to the Medicare telehealth list.
Response: We appreciate commenters' concerns. In response, we are
finalizing the addition of a broader array of services to the Medicare
telehealth list on a Category 3 basis, as described below.
Comment: Many commenters requested that CMS add specific interim
PHE telehealth services that we did not propose to the Medicare
telehealth list on a Category 3 basis. Most commenters did not provide
sufficient (or in some cases, any) evidence to support their requests
to be considered under Category 3 criteria. Other commenters did
provide additional evidence sufficient to consider certain services on
a Category 3 basis. Table 15 includes the complete list of services
commenters requested for addition to the CMS Medicare telehealth list
on a Category 3 basis.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
The following is a summary of these comments and our responses.
Comment: Some commenters requested that we consider adding
[[Page 84526]]
initial nursing facility visits, which are currently interim PHE
telehealth services, to the telehealth list on a Category 3 basis.
Commenters did provide information regarding how telehealth is used in
long-term care facilities; however, they did not provide information
indicating how the full scope of service elements of an initial nursing
facility visit could be furnished via two-way, audio/telecommunications
technology.
Response: We continue to believe that there are components of the
initial visit, such as the physical exam, that in the vast majority of
circumstances can only be properly performed in person given the
vulnerability and frailty of this particular patient population.
Commenters did not provide evidence to indicate otherwise. We note that
patients in a nursing facility may still receive subsequent visits as
telehealth services; however, we are not persuaded that these services,
in general, could be furnished via telehealth as described by the CPT
codes based upon information provided by commenters.
Comment: Many commenters requested that we add physical therapy,
occupational therapy, and speech language pathology services to the
Medicare telehealth list on a category 3 basis. Commenters provided
extensive information on how they furnish these services via two-way,
audio/video telecommunications technology. In response to CMS's
longstanding concerns that the practitioners who furnish and bill for
the overwhelming majority of these services are, outside of the
circumstances of the PHE for COVID-19, not among the statutorily
authorized practitioners who may independently bill Medicare for
telehealth services, commenters pointed to our proposed clarification
that telehealth services could be furnished by a therapist incident to
the professional services of a billing clinician in accordance with our
regulations at Sec. 410.26.
Response: We appreciate the additional information commenters
provided suggesting a possible scenario whereby services furnished by
therapists may be provided and billed incident to the professional
services of a physician or practitioner who is authorized to furnish
and bill for telehealth services. While we continue to have concerns as
to whether certain elements of therapy services, particularly when
provided to new patients, could be furnished in total via two-way,
audio/video telecommunications technology, we recognize that the
clarification of billing requirements for these services may allow for
additional information to be collected and submitted for consideration
by CMS. We are therefore finalizing addition of these services to the
Medicare telehealth list on a Category 3 basis.
Comment: Some commenters requested that we add several audiology
services to the Medicare telehealth list on a Category 3 basis. These
codes are currently interim PHE telehealth services. Commenters
explained that including CPT codes for device evaluation and
therapeutic services with a device is necessary to support access for
patients in needs of these assistive technologies, and that not
including them would inhibit the ability of speech language
pathologists to perform the evaluation and therapeutic services via
telehealth.
Response: We note that, outside of the circumstances of the PHE,
speech language pathologists are not eligible to independently bill for
Medicare telehealth services, although these services could possibly be
furnished by a therapist incident to an eligible billing practitioner.
Furthermore, we do not agree that the information provided by
commenters demonstrates that, under most circumstances, these services
can be furnished, in full, via two-way audio/video communication
technology given that these codes describe a new patient interaction
which would likely require hands-on, clinical assessment and direct,
one-on-one interaction/observation.
Comment: Some commenters requested that we add ESRD MCP services
with 1 monthly visit to the Medicare telehealth list on a Category 3
basis. Commenters cited information that they say demonstrates that
retaining the ESRD-specific telehealth flexibilities post-pandemic
would be valuable to both patients and health care providers and would
pose no material detriments to patient safety or quality of care.
Commenters further offered that technology exists that would enable
physicians and other practitioners to deliver effective ESRD care on a
virtual basis beyond the PHE for COVID-19. Additionally, commenters
noted that it may take time for medically complex and vulnerable
patients to travel for in-person care, and that determining when a
patient should return to a physician's office should be left to the
patient and the physician.
Response: We did not propose to add these services to the Medicare
telehealth list on a Category 3 basis due to concerns regarding the
patient receiving an adequate physical examination of the vascular
access site and in-person evaluation of the patient's fluid status when
a patient is only receiving 1 visit per month. We appreciate the
additional information provided by commenters, particularly the
information on how ESRD services are furnished using audio/video
technology outside of the circumstances of the PHE for COVID-19. Based
upon this information, we are finalizing the addition of the ESRD MCP
services with a single face-to-face visit per month to the Medicare
telehealth list on a Category 3 basis. We would note that, during the
PHE for the COVID-19 pandemic, section 3705 of the CARES Act allowed
for a waiver of the statutory provision in section 1881(b)(3)(B)(ii) of
the Act, which requires that an individual determined to have ESRD
receiving home dialysis must receive certain face-to-face clinical
assessments without the use of telehealth. Therefore, outside of the
PHE for COVID-19, for beneficiaries receiving home dialysis services, a
face-to-face ESRD-related clinical assessment must be provided in
person (without the use of telehealth) for the first 3 months of home
dialysis, and once every 3 months thereafter.
Comment: Some commenters requested that we add hospital observation
and discharge day management services to the Medicare telehealth list
on a Category 3 basis. Commenters cited information that they believe
demonstrates that telehealth services in the emergency setting have
proven to be successful and add clinical benefit to patients, and that
they should be added on a Category 3 basis, if not permanently.
Commenters stated that furnishing these services as telehealth services
can be helpful or even essential to enable patients to receive high-
quality specialty care in isolated rural communities, communities
affected by natural disasters, communities affected by local disease
outbreaks, and similar situations. Commenters also requested that we
add critical care services and established patient neonatal critical
care services to the Medicare telehealth list on a Category 3 basis,
stating that there are certain situations where it is appropriate to
provide higher level and critical care to patients via telehealth.
Commenters further offered that the clinical value of telehealth is
particularly clear for patients being treated in rural EDs or at rural
hospitals where effective telehealth collaboration for high-level cases
could facilitate clinical collaboration and decrease unnecessary
transfers. Commenters stated that there is a shortage of rural board-
certified emergency physicians, and that, if shortages of these
physicians continue, more critical care services
[[Page 84527]]
may need to be delivered via telehealth over time to ensure that
patients receive timely and necessary care. Finally, we received
requests to add level four and five emergency department visits to the
Medicare telehealth list on a Category 3 basis.
All of these requests were accompanied by robust supporting
evidence including information on teleICU and tele-stroke models of
care. Commenters also submitted clinical studies pointing to the
efficacy of telehealth in more acute care settings.
Response: We are responding to the comments on these codes together
because they are all E/M services that are furnished in a hospital or
ED setting. We did not propose to add these services to the Medicare
telehealth list on a Category 3 basis due to the presumption that in-
person assessment and care, particularly an in-person physical exam,
was necessary for patients at this level of acuity. Based upon a review
of the information provided by commenters, which included information
on how distant site practitioners could collaborate with individuals at
the originating site (which, outside of the circumstances of the PHE,
must be a medical facility) to obtain an accurate and comprehensive
evaluation of the patient, we agree that telehealth in the acute
settings described by these codes could offer an excellent opportunity
for care to patients if both the distant site and originating site
facilities/teams have the appropriate infrastructure, technology, and
training to effectively conduct such visits via telehealth. We continue
to believe that in most instances, in order to fulfill the full scope
of service elements described by codes for new patients, an in-person
physical exam is necessary; however, we agree that, for services
provided to established patients, such as established patient
observation services and established patient neonatal critical care,
and for emergency department visits and critical care services (the
latter of which is being used extensively during the PHE to support
surge capacity), more data are needed to understand how these E/M code
families are being used in the field and whether their addition to the
telehealth services list ultimately could be supported on a Category 2
basis. Therefore, we are finalizing the addition of established patient
observation services and established patient neonatal critical care
services to the Medicare telehealth list on a Category 3 basis. We are
also finalizing the addition of critical care services to the Medicare
telehealth list on a Category 3 basis.
Comment: Some commenters requested that we add electronic device
management and treatment services to the Medicare telehealth list on a
Category 3 basis, stating that safeguards are being developed to
deliver safe and effective remote management of neuromodulation
technologies during the PHE and beyond. The commenter suggested
rationale for monitoring the provision of these services through use of
these codes to ensure improved outcomes.
Response: While we appreciate the additional information as to the
safeguards being developed to ensure safe access to these services and
the information on improved outcomes, it was not clear whether the
capability for clinicians to remotely connect to a patient's hand-held
device for the purposes of electronic assessment and analysis is widely
available. It is also not within CMS's mandate under the PFS to ensure
improved outcomes. Therefore, we remain unconvinced by the evidence
provided by the commenter that these services can, in most instances,
be conducted in full using two-way, audio/video communication
technology. We were also uncertain as to which of these services
involve a direct, clinical interaction between the patient and
practitioner such that, if the service is furnished as a telehealth
service, the interaction would be facilitated by audio/video
technology; and those that do not involve such an interaction. To the
extent these services do not involve a direct, clinical interaction
between the patient and practitioner facilitated by audio/video
technology, the services would not be subject to the statutory
requirements for telehealth services under section 1834(m) of the Act,
and there would be no need to consider adding them to the telehealth
services list.
Comment: Most commenters supported CMS not adding CPT code 77427
(Radiation treatment management, 5 treatments) to the Medicare
telehealth list on a Category 3 basis. These commenters stated that,
given that most radiation oncology practices have been able to secure
adequate PPE, it was no longer necessary for radiation treatment
management to be available as a telehealth service. A few commenters
disagreed, but did not provide supporting information.
Response: We did not propose to add this service to the Medicare
telehealth list on a Category 3 basis due to concerns over whether the
full service elements described by CPT code 77427 could, in most cases,
be furnished in full via two way, audio-video communication technology.
We continue to believe this is the case and appreciate the additional
information provided by commenters as to the necessity of adding this
service to the Medicare telehealth list on a Category 3 basis.
After considering the public comments, we are finalizing the
addition of services to the Medicare telehealth list on a Category 3
basis as explained above and detailed in Table 16.
2. Analysis and Response to the Comment Solicitation on Coding and
Payment for Tele-ICU
With regard to the critical care services listed in A-D 5 we have
received a number of requests in prior years to add these services to
the Medicare telehealth services list. In response to one such request,
we finalized creation of two HCPCS G codes, G0508 (Telehealth
consultation, critical care, initial, physicians typically spend 60
minutes communicating with the patient and providers via telehealth)
and G0509 (Telehealth consultation, critical care, subsequent,
physicians typically spend 50 minutes communicating with the patient
and providers via telehealth), to describe the work associated with
furnishing consultation services via Medicare telehealth to critically
ill patients in the CY 2017 PFS final rule (81 FR 80196 through 80197).
We stated that CPT guidance makes clear that a variety of other
services are bundled into the payment rates for critical care,
including gastric intubations and vascular access procedures, among
others. While we are adding critical care services to the Medicare
telehealth list temporarily, on a Category 3 basis, we also solicited
comment on whether current coding (either through the CPT codes
describing in-person critical care or the HCPCS G codes describing
critical care consults furnished via telehealth) does not reflect
additional models of critical care delivery, specifically, models of
care delivery that utilize a combination of remote monitoring and
clinical staff at the location of the beneficiary to allow, when an
onsite practitioner is not available, for a practitioner at a distant
site to monitor vital signs and direct in-person care as needed.
We sought comment on the definition, potential coding and valuation
for this kind of remote service. Specifically, we sought comment on the
following concerns:
How to distinguish the technical component of the remote
monitoring portion of the service from the
[[Page 84528]]
diagnosis-related group (DRG) payment already being provided to the
hospital.
How to provide payment only for monitoring and
interventions furnished to Medicare beneficiaries when the remote
intensivist is monitoring multiple patients, some of which may not be
Medicare beneficiaries.
How this service intersects with both the critical care
consult G codes and the in-person critical care services.
Comment: One commenter stated that, generally, there are two models
of remote critical care services; the first of which is more of a
telehealth consultant. Services performed under this scenario may be
accurately reported via existing critical care consult G codes. The
other model of care includes physicians providing tele-ICU services,
which may be enhanced through the use of robotic technology or other
methods to complete a remote clinical assessment of the critically ill
patient. Commenters stated current critical care consult G-codes may be
used for an episodic evaluation and recommendation to the bedside team
or may be used for episodic telemedicine consults and do not reflect
current models of care. One commenter noted the tele-ICU is involved
both before and after the bedside intensivist or physician arrives and
leaves the bedside. Several commenters also stated that current CPT and
HCPCS coding does not adequately reflect the additional component of
monitoring, surveillance, coaching of bedside nurses, physicians who
are not intensivists, and active management in real-time and over
extended timeframes by tele-ICU Intensivists. Many commenters
encouraged CMS to adopt a coding proposal currently under consideration
by the CPT editorial panel and the AMA RUC.
Response: We appreciate the feedback regarding the different tele-
ICU models. As noted by commenters, the AMA is currently engaged in
evaluating coding and valuation for services similar to those
identified by commenters. We will keep these comments in mind and look
forward to evaluating any new CPT coding and AMA RUC recommendations as
part of our future annual rulemaking process.
After considering the public comments, we will consider all of the
feedback on the different tele-ICU models of care as well as potential
gaps in coding for possible future rulemaking.
[[Page 84529]]
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3. Technical Refinement to the Medicare Telehealth Services List To
Reflect Current Coding
For CY 2020, the CPT Editorial Panel deleted the six existing
Health and Behavior Assessment and Intervention procedure CPT codes and
replaced them with nine new CPT codes. The six deleted CPT codes
include CPT code 96150 (Health and behavior assessment (e.g., health-
focused clinical interview, behavioral observations,
psychophysiological monitoring, health oriented questionnaires), each
15 minutes face-to-face with the patient;
[[Page 84530]]
initial assessment), CPT code 96151 (Health and behavior assessment
(e.g., health-focused clinical interview, behavioral observations,
psychophysiological monitoring, health oriented questionnaires), each
15 minutes face-to-face with the patient; reassessment), CPT code 96152
(Health and behavior intervention, each 15 minutes, face-to-face;
individual), CPT code 96153 (Health and behavior intervention, each 15
minutes, face-to-face; group (2 or more patients)), CPT code 96154
(Health and behavior intervention, each 15 minutes, face-to-face;
family (with the patient present)), and CPT code 96155 (Health and
behavior intervention, each 15 minutes, face-to-face; family (without
the patient present)). However, we inadvertently neglected to make the
corresponding update to reflect these coding changes on the Medicare
telehealth services list in CY 2020 PFS rulemaking. Therefore, we
proposed to delete CPT codes 96150-96155 from the Medicare telehealth
services list and replace them with the following successor codes: CPT
code 96156 (Health behavior assessment, including reassessment (i.e.,
health-focused clinical interview, behavioral observations, clinical
decision making)); CPT code 96158 (Health behavior intervention,
individual, face-to-face; initial 30 minutes); CPT code 96159 (Health
behavior intervention, individual, face-to-face; each additional 15
minutes (list separately in addition to code for primary service)); CPT
code 96164 (Health behavior intervention, group (2 or more patients),
face-to-face; initial 30 minutes); CPT code 96165 (Health behavior
intervention, group (2 or more patients), face-to-face; each additional
15 minutes (list separately in addition to code for primary service));
CPT code 96167 (Health behavior intervention, family (with the patient
present), face-to-face; initial 30 minutes); CPT code 96168 (Health
behavior intervention, family (with the patient present), face-to-face
each additional 15 minutes (list separately in addition to code for
primary service)); CPT code 96170 (Health behavior intervention, family
(without the patient present), face-to-face; initial 30 minutes); and
CPT code 96171 (Health behavior intervention, family (without the
patient present), face-to-face; each additional 15 minutes (list
separately in addition to code for primary service)).
We also proposed to amend our regulations to stipulate that when
new codes are issued to replace codes that describe the same clinical
services that are currently on the Medicare telehealth services list,
we would consider those new codes to be successor codes to those that
are on the Medicare telehealth services list, and would update the
Medicare telehealth services list accordingly. At Sec. 410.78(f), we
proposed to revise the final sentence of the paragraph to read: CMS
maintains on the CMS website the Medicare telehealth services list
under this section, including the current HCPCS codes that describe the
services.
We received public comments on the technical refinement to the
Medicare telehealth services list to reflect current coding. The
following is a summary of the comments we received and our responses.
Comment: Commenters supported this proposal.
Response: We are finalizing this technical refinement as proposed.
4. Furnishing Telehealth Visits in Inpatient and Nursing Facility
Settings, and Critical Care Consultations
The long term care facility regulations at Sec. 483.30(c) require
that residents of SNFs receive an initial visit from a physician, and
periodic personal visits subsequently by either a physician or other
NPP. In the CY 2010 PFS final rule with comment period (74 FR 61762),
we stated that these regulations ensure that at least a minimal degree
of personal contact between a physician or a qualified NPP and a
resident is maintained, both at the point of admission to the facility
and periodically during the course of the resident's stay. In that rule
we stated that we believe that these federally-mandated visits should
be conducted in-person, and not as Medicare telehealth services.
Therefore, we revised Sec. 410.78 to restrict physicians and
practitioners from using telehealth to furnish the physician visits
required under Sec. 483.30(c).
During the PHE for COVID-19, we waived the requirement in 42 CFR
483.30 for physicians and NPPs to perform in-person required visits for
nursing home residents, and allowed visits to be conducted via
telehealth (https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf).
We solicited public comment on whether it would be appropriate to
maintain this flexibility on a permanent basis outside of the PHE for
COVID-19. We invited public comment on whether the in-person visit
requirement is necessary, or whether two-way, audio/video
telecommunications technology would be sufficient in instances when,
due to continued exposure risk, workforce capacity, or other factors,
the clinician determines an in-person visit is not necessary.
We also received requests to revise our frequency limitations for
telehealth subsequent inpatient and nursing facility visits. We limit
the provision of subsequent inpatient visits via Medicare telehealth to
once every 3 days and subsequent nursing facility visits to once every
30 days. We received a request to remove the frequency limitation on
the subsequent inpatient services and a separate request to revise the
subsequent nursing facility visits to once every 3 days, rather than 30
days.
As we stated in the CY 2019 PFS final rule, we believed the
potential acuity of illness of hospital inpatients is greater than that
of patients who are likely to receive services that were on the
Medicare telehealth services list at that time. We also stated that it
would be appropriate to permit some subsequent hospital care services
to be furnished through telehealth to ensure that hospitalized patients
have sufficiently frequent encounters with their admitting
practitioner. In addition, we expressed our belief that the majority of
these visits should be furnished in person to facilitate the
comprehensive, coordinated, and personal care that medically volatile,
acutely ill patients require on an ongoing basis. Because of our
concerns regarding the potential acuity of illness of hospital
inpatients, we finalized the addition of CPT codes 99231-99233 to the
Medicare telehealth services list, but limited the provision of these
subsequent hospital care services through telehealth to once every 3
days. We noted that we continue to believe that admitting practitioners
should continue to make appropriate in-person visits to all patients
who need such care during their hospitalization. Our concerns with, and
position on, the provision of subsequent hospital care services via
telehealth have not changed (83 FR 59493). Therefore, we did not
propose to modify the current policy.
In the CY 2018 PFS final rule, we reiterated that we believed it
would be appropriate to permit some subsequent nursing facility (NF)
care services to be furnished through telehealth to ensure that complex
nursing facility patients have frequent encounters with their admitting
practitioner, but because of our concerns regarding the potential
acuity and complexity of NF inpatients, we limited the provision of
subsequent NF care services furnished through telehealth to once every
30 days. We also stated that we continued to have concerns regarding
more routine use of telehealth given the potential acuity and
complexity of NF inpatients, and therefore, we were not proposing to
[[Page 84531]]
remove the frequency limitation for subsequent NF care services (83 FR
59494). We received comments from stakeholders who stated that the once
every 30-day frequency limitation for subsequent NF visits furnished
via Medicare telehealth limits access to care for Medicare
beneficiaries in the NF setting. Stakeholders stated that the use of
Medicare telehealth is crucial to maintaining a continuum of care in
this setting and that CMS should leave it up to clinicians to decide
how frequently a visit may be furnished as a Medicare telehealth
service rather than in person depending on the needs of specific
patients. We noted that we were persuaded by the comments from these
stakeholders, and therefore, we proposed to revise the frequency
limitation from one visit every 30 days to one visit every 3 days. We
noted that we believe this interval strikes the right balance between
requiring in-person visits and allowing flexibility to furnish services
via telehealth when clinically appropriate to do so. We solicited
comment on whether frequency limitations broadly are burdensome and
limit access to necessary care when services are available only through
telehealth, and how best to ensure that patients are receiving
necessary in-person care.
We received public comments on furnishing telehealth visits in
inpatient and nursing facility settings, and critical care
consultations. The following is a summary of the comments we received
and our responses.
Comment: Many commenters requested that CMS revise the long term
care facility regulations at Sec. 483.30(c), which require that
residents of NFs receive an initial visit from a physician, and
periodic personal visits subsequently by either a physician or other
NPP, to allow the initial visit to be conducted via Medicare
telehealth.
Response: As we stated in the CY 2010 PFS final rule with comment
period (74 FR 61762), we continue to believe that in-person contact
between a physician or a qualified NPP and a resident is needed at the
point of admission to the facility to ensure the appropriate level of
care.
Comment: Many commenters have stated their support for revising the
frequency limitation for subsequent nursing facility visits furnished
via telehealth from once every 30 days to once every 3 days, while
other commenters encouraged CMS to remove frequency limitations
entirely. A few commenters stated that CMS should maintain some
frequency limitations so as to not to create a disincentive for in-
person care.
Response: We thank all the commenters for their feedback. As
discussed in the proposed rule, we have received requests to revise the
frequency limitations on subsequent nursing facility visits from one
every 30 days to one every 3 days to align with the frequency
limitations in the inpatient setting; however, after additional
consideration of the issue, we noted that patients in the nursing
facility setting tend to have a longer lengths of stay compared to the
patients in the inpatient setting. As such, we have further considered
whether the frequency limitations for subsequent nursing facility
visits furnished via telehealth should be the same as for the inpatient
setting. Additionally, we acknowledge commenters' concerns about
creating a disincentive for in-person care in the absence of any
frequency limitations on services furnished through telehealth, and
that a broader view of our frequency limitation policies across the
different Part A and B care settings could potentially lead to
inadequate in-person care in certain scenarios. While we appreciate
that, in some cases, a subsequent nursing facility visit furnished via
telehealth may allow flexibility for practitioners to appropriately
treat patients, there are also situations where an in-person visit may
be more appropriate. In seeking to find the right balance between
providing greater access to care through more telehealth visits and
ensuring adequate in-person care, especially given the longer length of
stays for NF patients, we believe that one telehealth visit every 30
days may be too infrequent and once every 3 days poses a risk of
creating a disincentive for in-person care. Therefore, we believe it is
appropriate to revise the frequency limitation for subsequent nursing
facility visits to permit one Medicare telehealth visit every 14 days.
This limitation provides an appropriate balance between increased
access to care through telehealth and maintaining appropriate in-person
care.
After consideration of the public comments, we are finalizing a
policy to allow subsequent nursing visits to be furnished via Medicare
telehealth once every 14 days in the NF setting. We are not finalizing
any revisions to the frequency limitations on inpatient visits or
critical care consultations provided as telehealth services.
5. Proposed Technical Amendment To Remove References to Specific
Technology
The final sentence of our regulation at Sec. 410.78(a)(3)
prohibits the use of telephones, facsimile machines, and electronic
mail systems for purposes of furnishing Medicare telehealth services.
In the March 31st COVID-19 IFC, we added a new Sec. 410.78(a)(3)(i)
(and reserved Sec. 410.78(a)(3)(ii) for later use) to provide for an
exception that removes application of that sentence during the PHE for
COVID-19. We added the new section on an interim final basis because we
believe that the first sentence of Sec. 410.78(a)(3) adequately
describes the technology requirements for an interactive
telecommunication system that may be used to furnish a Medicare
telehealth service. That sentence defines interactive telecommunication
system as ``multimedia communications equipment that includes, at a
minimum, audio and video equipment permitting two-way, real-time
interactive communication.'' We noted that we were also concerned that
the reference to ``telephones'' in the second sentence of the
regulation as impermissible technology could cause confusion in
instances where otherwise eligible equipment, such as a smart phone,
may also be used as a telephone Because these concerns are not
situation- or time-limited to the PHE for COVID-19, we proposed to
remove the second sentence of the regulation at Sec. 410.78(a)(3) that
specified that telephones, facsimile machines, and electronic mail
systems do not meet the definition of an interactive telecommunications
system. As we proposed to adopt this change on a permanent basis, we
also proposed to delete the paragraphs at Sec. 410.78(a)(3)(i) and
(ii). We noted that we believe these amendments to our regulations
would remove outdated references to specific types of technology and
provide a clearer statement of our policy.
We received public comments on proposed technical amendment to
remove references to specific technology. The following is a summary of
the comments we received and our responses.
Comment: Commenters supported our proposal to amend the regulation.
One commenter cited our statement in the March 31st COVID-19 IFC that
mobile computing technology colloquially referred to as ``phones'' are
now ubiquitous, and the wording of the regulatory text could be
construed to prevent their use for purposes of conducting a telehealth
service. According to another commenter, advances in digital
communication technology should not be unnecessarily excluded as
communication methods for patients and clinicians to utilize for
telehealth services. Commenters agreed that the reference in the
current regulation creates confusion about use
[[Page 84532]]
of equipment such as a smart phone or even an interactive telehealth
platform operating within an electronic health information system.
Commenters agreed that the reference to ``telephones'' in the
regulation as an impermissible technology in the final sentence of
regulation at Sec. 410.78(a)(3) has caused confusion in instances
where equipment, such as smartphones, are also used as a telephone.
They state that the references in these sections of the CFR are not
situation- or time-limited to the PHE for COVID-19 and should be
deleted.
Response: We thank commenters for their support and agree with
their stated points. .
After consideration of the comments, we are finalizing this
proposed technical amendment.
6. Communication Technology-Based Services (CTBS)
In the CY 2019 PFS final rule, we finalized separate payment for a
number of services that could be furnished via telecommunications
technology, but that are not considered Medicare telehealth services.
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), and 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). We
finalized maintenance of these codes as part of the set of codes that
is only reportable by those practitioners that can furnish E/M
services. We stated that we believed this was appropriate since the
service describes a check-in directly with the billing practitioner to
assess whether an office visit is needed. However, we did note that
similar check-ins provided by nurses and other clinical staff can be
important aspects of coordinated patient care (83 FR 59486).
In the CY 2020 PFS final rule, we finalized separate payment for
HCPCS codes G2061 (Qualified nonphysician healthcare professional
online assessment and management, for an established patient, for up to
seven days, cumulative time during the 7 days; 5-10 minutes), G2062
(Qualified nonphysician healthcare professional online assessment and
management service, for an established patient, for up to seven days,
cumulative time during the 7 days; 11-20 minutes), and G2063 (Qualified
nonphysician qualified healthcare professional assessment and
management service, for an established patient, for up to seven days,
cumulative time during the 7 days; 21 or more minutes). In that rule,
we stated that these codes may be billed by NPPs consistent with the
definition of their respective benefit category, although we did not
provide specific examples (84 FR 62796).
We received a number of questions regarding which benefit
categories HCPCS codes G2061 through G2063 fall under. In the March
31st COVID-19 IFC (85 FR 19244-19245) we established on an interim
basis for the duration of the PHE for COVID-19 that these services
could be billed for example, by licensed clinical social workers and
clinical psychologists, as well as PTs, OTs, and SLPs who bill Medicare
directly for their services when the service furnished falls within the
scope of these practitioner's benefit categories. In the CY 2021 PFS
proposed rule (85 FR 50112 and 50113), we proposed to adopt that policy
on a permanent basis. We noted that this is not an exhaustive list and
we solicited comment on other benefit categories into which these
services may fall.
We also proposed to allow billing of other CTBS by certain NPPs,
consistent with the scope of these practitioners' benefit categories,
through the creation of two additional HCPCS G codes that can be billed
by practitioners who cannot independently bill for E/M services:
G2250 (Remote assessment 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 service provided within
the previous 7 days nor leading to a service or procedure within the
next 24 hours or soonest available appointment.)
G2251 (Brief communication technology-based service, e.g.
virtual check-in, by a qualified health care professional who cannot
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 a service or procedure within the next
24 hours or soonest available appointment; 5-10 minutes of medical
discussion).
We proposed to value the services identically to HCPCS codes G2010
and G2012, respectively. We acknowledged that it has been agency
policy, in general, to differentially value similar services that are
performed by practitioners who can and cannot, respectively, bill
independently for E/M services, with higher values for the service
performed by practitioners who can independently bill E/M services.
However, given the relatively low values for HCPCS codes G2010 and
G2012, we noted that we did not believe that there was a significant
differential in resource costs to warrant different values, but
solicited comment on whether we should value these services
differentially, including potentially increasing the valuation of HCPCS
codes G2010 and G2012.
Further, to facilitate billing of the CTBS by rehabilitative
therapists, we proposed to designate HCPCS codes G2250, G2251, G2061,
G2062, and G2063 as ``sometimes therapy'' services. When billed by a
private practice PT, OT, or SLP, the codes would need to include the
corresponding GO, GP, or GN therapy modifier to signify that the CTB
are furnished as therapy services furnished under an OT, PT, or SLP
plan of care.
We also noted that we proposed for CY 2021 to replace the eVisit G-
codes with corresponding CPT codes, and that this policy would also
apply to those codes.
For all of these CTBS, we also clarified that the consent from the
patient to receive these services can be documented by auxiliary staff
under general supervision, as well as by the billing practitioner.
While we continue to believe that beneficiary consent is necessary so
that the beneficiary is notified of cost sharing when receiving these
services, we noted that we did not believe that the timing or manner in
which beneficiary consent is acquired should interfere with the
provision of one of these services. We retained the requirement that,
in instances when the brief CTBS originates from a related E/M service
(including one furnished as a telehealth service) provided within the
previous 7 days by the same physician or other qualified health care
professional, this service would be considered bundled into that
previous E/M service and would not be separately billable.
We received public comments on the CTBS proposals. The following is
a summary of the comments we received and our responses.
[[Page 84533]]
Comment: Several commenters supported our proposal to replace the
eVisit G codes (G2061-G2063) with corresponding CPT codes 98970-98972
for qualified nonphysician health care professional online digital E/M
service.
Response: We thank commenters for their feedback. After
consideration of the comments received, we are finalizing our proposal
to replace G2061-G2063 with CPT codes 98970-98972.
Comment: Many commenters were supportive of the proposal to allow
NPPs, such as licensed clinical social workers, clinical psychologists,
PTs, OTs, and SLPs to bill HCPCS codes G2061 through G2063, consistent
with the definition of their respective benefit category.
Response: We thank the commenters for their support and feedback.
After consideration of the comments received, we are finalizing our
proposal to allow NPPs, such as licensed clinical social workers,
clinical psychologists, PTs, OTs, and SLPs to bill HCPCS codes G2061
through G2063, consistent with the definition of their respective
benefit category.
Comment: Commenters requested that CMS clarify that HCPCS codes
G2061 through G2063 fell within the scope of the audiology diagnostic
benefit category or the medical nutrition therapist benefit category.
Response: We disagree with the commenter. HCPCS codes G2061-G2063
describe online assessment and management while the audiology benefit
is for diagnostic testing. Therefore, we believe these services fall
outside the audiologists' benefit category. The benefit for medical
nutrition therapists is limited by statute to a few specific services
described by certain HCPCS codes, which do not include G2061-G2063.
Comment: Many commenters were supportive of the proposal to allow
billing of HCPCS codes G2250 and G2251 by certain NPPs, consistent with
the scope of these practitioners' benefit categories.
Response: We thank the commenters for their support and feedback.
After consideration of the comments received, we are finalizing our
proposal to allow billing of HCPCS codes G2250 and G2251 by certain
NPPs, consistent with the scope of these practitioners' benefit
categories.
Comment: Many commenters supported the proposal to identically
value HCPCS codes G2250 and G2251 to G2010 and G2012, respectively.
Response: We thank commenters for their support and feedback.
Comment: One commenter disagreed with the proposal to identically
value HCPCS codes G2250 and G2251 to G2010 and G2012, respectively. The
commenter stated that services furnished by NPPs should not be valued
the same as those provided by physicians and encouraged CMS to increase
the valuation of G2010 and G2012 while not offering recommended value
for G2250 and G2251.
Response: As we stated in the proposed rule, given the relatively
low values for HCPCS codes G2010 and G2012, we do not believe that
there is a significant differential in resource costs to warrant
differential values for codes G2250 and G2251, and codes G2010 and
G2012.
After consideration of the comments, we are finalizing our proposal
to identically value HCPCS codes G2250 and G2251 to G2010 and G2012,
respectively.
Comment: Several commenters urged CMS to consider increasing the
value of G2010 and G2012.
Response: We thank commenters for their feedback and will consider
this matter and propose any potential changes through future
rulemaking.
Comment: Many commenters supported the proposal to designate HCPCS
codes G2250, G2251, G2061, G2062, and G2063 as ``sometimes therapy''
services to facilitate billing of these CTBS by therapists. Including
when billed by a private practice PT, OT, or SLP, the codes would need
to include the corresponding GO, GP, or GN therapy modifier to signify
that the CTB are furnished as therapy services furnished under an OT,
PT, or SLP plan of care.
Response: We thank the commenters for their support and feedback.
After consideration of the comments received, we are finalizing our
proposal to designate HCPCS codes G2250, G2251, G2061, G2062, and G2063
as ``sometimes therapy'' services to facilitate billing of the CTBS by
therapists. Additionally, we note that when billed by a private
practice PT, OT, or SLP, the codes would need to include the
corresponding GO, GP, or GN therapy modifier to signify that the CTB
are furnished as therapy services furnished under an OT, PT, or SLP
plan of care.
Comment: Many commenters supported and thanked CMS for the
clarification that consent from the patient to receive CTBS services
can be documented by auxiliary staff under general supervision as well
as by the billing practitioner.
Response: We thank commenters for their feedback.
Comment: Several commenters encouraged CMS to permanently allow the
use of virtual check-ins and e-visits for new as well as established
patients.
Response: In the CY 2019 PFS proposed rule (83 FR 35724), we
created HCPCS code G2012 and stated our expectation that these services
would be initiated by the patient, especially since many beneficiaries
would be financially liable for sharing in the cost of these services.
Additionally, MedPAC noted particular concern regarding potential
increases in volume that are not related to ongoing, informed patient
care. CMS remains concerned about these issues outside of the PHE for
COVID-19. As such, we did not propose, and do not anticipate proposing,
to permanently allow billing for HCPCS codes G2020 and G2012 when
furnished to new patients.
Comment: One commenter suggested it may be helpful for CMS to
provide data on specialty-specific uptake of CTBS and e-Visits, both
before and after the PHE for COVID-19, in order to determine if there
are access challenges in specific specialties.
Response: We thank the commenter for their suggestion and will take
this into future consideration after the PHE for COVID-19 ends.
7. Continuation of Payment for Audio-Only Visits
a. Background
In the March 31st COVID-19 IFC, we established separate payment for
audio-only telephone E/M services (85 FR 19264 through 19266). The
telephone E/M services are CPT codes 99441 (Telephone evaluation and
management service by a physician or other qualified health care
professional who may report evaluation and management services provided
to an established patient, parent, or guardian 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); 99442
(Telephone evaluation and management service by a physician or other
qualified health care professional who may report evaluation and
management services provided to an established patient, parent, or
guardian 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; 11-20 minutes of
medical discussion); and 99443 (Telephone evaluation and management
service by a physician or other qualified health
[[Page 84534]]
care professional who may report evaluation and management services
provided to an established patient, parent, or guardian 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; 21-30 minutes of medical discussion). We
noted that, although these services were previously considered non-
covered under the PFS, in the context of the PHE for COVID-19 and with
the goal of reducing exposure risks associated with COVID-19,
especially in the case that two-way, audio and video technology is not
available to furnish a Medicare telehealth service, we believed there
are circumstances where prolonged, audio-only communication between the
practitioner and the patient could be clinically appropriate, yet not
fully replace a face-to-face visit. For example, an established patient
who was experiencing an exacerbation of their condition could have a
25-minute phone conversation with their physician during which the
physician determines that an adjustment to the patient's medication
would alleviate their symptoms. The use of CPT code 99443 in this
situation prevents a similar in-person service as the evaluation of the
patient's symptoms and determination to adjust medication could be
conducted without patient and the practitioner being in the same
location. We stated our belief that these telephone E/M codes, with
their established description and valuation, were the best way to
recognize the relative resource costs of these kinds of services and
make payment for them under the PFS. For these codes, we initially
finalized on an interim basis during the PHE for COVID-19, work RVUs as
recommended by the American Medical Association (AMA) Relative Value
Scale Update Committee (RUC), as discussed in the CY 2008 PFS final
rule with comment period (72 FR 66371), of 0.25 for CPT code 99441,
0.50 for CPT code 99442, and 0.75 for CPT code 99443. We also finalized
the RUC-recommended direct PE inputs which consist of 3 minutes of
post-service Registered Nurse/Licensed Practical Nurse/Medical
Technical Assistant clinical labor time for each code.
In the May 8th COVID-19 IFC, we noted that in the time since we
established these payment amounts, stakeholders had informed us that
use of audio-only services was more prevalent than we had previously
considered, especially because many beneficiaries were not utilizing
video-enabled communication technology from their homes. In other
words, there were many cases where practitioners would under ordinary
circumstances utilize telehealth or in-person visits to evaluate and
manage patients' medical concerns, but were instead using audio-only
interactions to manage more complex care (85 FR 27589 through 27590).
While we had previously acknowledged the likelihood that, under the
circumstances of the PHE for COVID-19, more time would be spent
interacting with the patient via audio-only technology, we stated that
the intensity of furnishing an audio-only visit to a beneficiary during
the unique circumstances of the PHE for COVID-19 was not accurately
captured by the valuation of these services we established in the March
31st COVID-19 IFC. This would be particularly true to the extent that
these audio-only services are actually serving as a substitute for
office/outpatient Medicare telehealth visits for beneficiaries not
using video-enabled telecommunications technology contrary to the
situation we anticipated when establishing payment for them in the
March 31st COVID-19 IFC. We stated that, given our understanding that
these audio-only services were being furnished primarily as a
replacement for care that would otherwise be reported as an in-person
or telehealth visit using the O/O E/M codes, we established new RVUs
for the telephone E/M services based on crosswalks to the most
analogous O/O E/M codes, based on the time requirements for the
telephone codes and the times assumed for valuation for purposes of the
O/O E/M codes. Specifically, we crosswalked CPT codes 99212, 99213, and
99214 to CPT codes 99441, 99442, and 99443, respectively. We therefore
finalized, on an interim basis and for the duration of the PHE for
COVID-19, the following work RVUs: 0.48 for CPT code 99441; 0.97 for
CPT code 99442; and 1.50 for CPT code 99443. We also finalized the
direct PE inputs associated with CPT code 99212 for CPT code 99441, the
direct PE inputs associated with CPT code 99213 for CPT code 99442, and
the direct PE inputs associated with CPT code 99214 for CPT code 99443.
We did not finalize increased payment rates for CPT codes 98966-98968
as these codes describe services furnished by practitioners who cannot
independently bill for E/M services and so these telephone assessment
and management services, by definition, are not being furnished in lieu
of an O/O E/M service. We noted that to the extent that these extended
phone services are taking place instead of O/O E/M visits (either in-
person or via telehealth), the direct crosswalk of RVUs also better
maintains overall budget neutrality and relativity under the PFS. We
stated that we believed that the resources required to furnish these
services during the PHE for COVID-19 are better captured by the RVUs
associated with the level 2-4 established patient O/O E/M visits.
Additionally, we stated that, given our understanding that these audio-
only services were being furnished as substitutes for O/O E/M services,
we recognized that they should be considered as telehealth services,
and added them to the Medicare telehealth services list for the
duration of the PHE for COVID-19. For these audio-only E/M services, we
separately issued a waiver under section 1135(b)(8) of the Act, as
amended by section 3703 of the CARES Act, of the requirements under
section 1834(m) of the Act and our regulation at Sec. 410.78 that
Medicare telehealth services must be furnished using video technology.
b. Summary of Comments Received in Response to Comment Solicitation on
Continuation of Payment for Audio-Only Visits
In the CY 2021 PFS proposed rule (85 FR 50113-50114), we did not
propose to continue to recognize CPT codes 99441, 99442, and 99443 for
payment under the PFS after conclusion of the PHE for COVID-19 because,
outside of the circumstances of the PHE, we are not able to waive the
requirement that telehealth services be furnished using an interactive
telecommunications system that includes two-way, audio/video
communication technology. However, we recognized that the need for
audio-only interaction could remain as beneficiaries continue to try to
avoid sources of potential infection, such as a doctor's office; and in
that circumstance, a longer phone conversation may be needed to
determine if an in-person visit is necessary rather than what is
described by the virtual check-in. We solicited comment on whether CMS
should develop coding and payment for a service similar to the virtual
check-in but for a longer unit of time and with an accordingly higher
value. We sought input from the public on the appropriate duration
interval for such services and the resources in both work and PE that
would be associated with furnishing them. We also solicited comment on
whether separate payment for such telephone-only services should be a
provisional policy to remain in effect until a year or some other
period after the end of the PHE for COVID-19 or if
[[Page 84535]]
it should be PFS payment policy permanently.
We received public comments on the comment solicitation on
continuation of payment for audio-only visits. The following is a
summary of the comments we received and our responses.
Comment: Commenters broadly supported maintaining the availability
of certain audio-only services after the duration of the PHE for COVID-
19. Commenters stated that many beneficiaries may not have access to or
choose not to use two-way, audio/video communication technology, and
therefore, maintaining some form of payment for audio-only services
would be crucial for ensuring access to care for this vulnerable
population. Some commenters urged CMS to continue payment for audio-
only evaluation or assessment and management services beyond the end of
the PHE for COVID-19. Other commenters stated that allowing
practitioners to furnish certain behavioral health and counseling
services via audio-only communication technology has been crucial to
ensuring access to these services and that CMS should continue payment
for these audio-only services after the conclusion of the PHE for
COVID-19. Commenters further suggested, in response to both this
proposal and in the context of the proposed revision to the agency's
regulation at Sec. 410.78(a)(3), that the statutory text laying out
the telehealth services benefit uses the term ``telecommunications
system'' but does not include an explicit definition of that term,
except to say that in the case of federal telemedicine demonstrations
in Alaska or Hawaii, the term ``includes store-and-forward technologies
that provide for the asynchronous transmission of health care
information in single or multimedia formats.'' Therefore, the statute
leaves it up to the Department of Health and Human Services (HHS) to
determine whether a telehealth telecommunications system must include
both audio and video capabilities, and HHS is free to make the
modification it proposes under this heading. Based on this assessment,
commenters stated that CMS has the authority to redefine our
longstanding regulatory interpretation of ``interactive
telecommunications system'' at Sec. 410.78 to include audio-only
services.
While the majority of commenters stated that they preferred CMS
continuing to recognize the audio evaluation/assessment and management
services outside of the PHE for COVID-19, some commenters did state
that, in the absence of continuing to recognize those codes, CMS should
provide coding and payment for a longer virtual check-in. With regard
to the valuation of a longer virtual check in, commenters provided a
few recommendations. One commenter suggested that we value this service
the same as CPT code 99213 (Office or other outpatient visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: An expanded problem focused history;
An expanded problem focused examination; Medical decision making of low
complexity. Counseling and coordination of care with other physicians,
other qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are of low to
moderate severity. Typically, 15 minutes are spent face-to-face with
the patient and/or family), other commenters suggested a range of times
for a new virtual check in, such as 11-22 minutes or 15-20 minutes.
Another commenter suggested that CMS could create more than one
additional virtual check-in code.
Response: We appreciate these comments. Section 1834(m)(2)(A) of
the Act expressly provides payment to the distant site physician or
practitioner of an amount equal to the amount that such physician or
practitioner would have been paid under this title had such service
been furnished without the use of a telecommunications system. This
means that we pay an equal amount for a service furnished using a
``telecommunications system'' as for a service furnished in person
(without the use of a telecommunications system). Section 1834(m)(1) of
the Act specifies that telehealth services must be furnished via a
``telecommunications system,'' and it includes an exception to allow
``store and forward'' technology to be considered a telecommunications
system only for purposes of certain federal demonstrations. CMS has in
place a longstanding interpretation of ``telecommunications system''
that includes only technology that enables a visit that is analogous to
an in person visit--which aligns closely with our resource-based
payment policy under the PFS, given that payment is made for a
telehealth service at the same rate as an in-person visit. Our criteria
for considering the addition of services to the telehealth services
list also rely on an assessment of whether the service furnished via
telehealth is analogous to one furnished in person. We continue to
believe that our longstanding regulatory definition of
``telecommunications system'' reflects the intent of statute.
As the audio-only assessment and management or E/M visits are by
definition replacements for in-person office visits, they would be
subject to the statutory restrictions outlined in section 1834(m) of
the Act. Outside of the circumstances of the PHE for COVID-19, we
continue to believe that our longstanding regulatory interpretation of
``telecommunications system'' precludes the use of audio-only
technology for purposes of Medicare telehealth services.
Comment: Some commenters stated that if CMS continues payment for
the audio-only E/M visits, these should continue to be paid at rates
commensurate to the level 2-4 established patient office visits,
consistent with how these services have been paid during the PHE for
COVID-19. Other commenters disagreed, stating that outside the
circumstances of the PHE for COVID-19, these services should not have
the same payment rate as in-person services.
Response: After the end of the PHE, there will be no separate
payment for the audio-only E/M visit codes. At the conclusion of the
PHE, we will assign a status of ``bundled'' and post the RUC-
recommended RVUs for these codes in accordance with our usual practice.
Comment: A few commenters requested that, if CMS continues to
recognize the audio-only evaluation/assessment and management services
or if CMS creates a longer virtual check-in service, the service should
be available to both new and established patients. A few commenters,
including MedPAC, suggested that if CMS creates a longer virtual check-
in, the policy should be provisional rather than permanent--for
example, through the calendar year in which the PHE for COVID-19 ends.
Response: We continue to believe that, outside of the circumstances
of the PHE for COVID-19, CTBS services broadly should be billed only
for established patients.
c. Interim Final Rule With Comment Period for Coding and Payment of
Virtual Check-In Services (HCPCS Code GSADX1)
i. Background
We note that we have historically established coding and payment on
an interim final basis for truly new services when it is in the public
interest to do so. Outside of the circumstances of the PHE for COVID-
19, Medicare does not provide separate payment for a service that would
be a substitute for an in-person visit but is furnished using
synchronous audio-only technology. However, we recognize that
commenters were clear about the continuing need for coding and payment
to reflect the
[[Page 84536]]
provision of lengthier audio-only services outside of the PHE for
COVID-19, if not as substitutes for in-person services, then as a tool
to determine whether an in-person visit is needed, particularly as
beneficiaries may still be cautious about exposure risks associated
with in-person services.
ii. Interim Final Policy
Given the widespread concerns expressed by commenters about the
continuing need for audio-only conversations with patients, we believe
it would be expedient to establish additional coding and payment for an
extended audio-only assessment service on an interim basis for CY 2021.
We believe that establishing payment for this service on an interim
basis will support access to care for beneficiaries who may be
reluctant to return to in-person visits unless absolutely necessary,
and allow us to consider whether this policy should be adopted on a
permanent basis. Therefore, for CY 2021, on an interim basis, we are
establishing HCPCS code G2252 (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; 11-20 minutes of medical discussion.). We are
finalizing a direct crosswalk to CPT code 99442, the value of which we
believe most accurately reflects the resources associated with a longer
service delivered via synchronous communication technology, which can
include audio-only communication. This is consistent with our approach
to valuing the virtual check-in service (HCPCS code G2012), which used
CPT code 99441 as the basis for valuation. In the case of HCPCS code
G2252 and CPT code 99442, both codes describe 11-20 minutes of medical
discussion when the practitioner may not necessarily be able to
visualize the patient, and is used when the acuity of the patient's
problem is not necessarily likely to warrant a visit, but when the
needs of the particular patient require more assessment time from the
practitioner. In the case of HCPCS code G2252, the additional time
would be used to determine the necessity of an in person visit result
in a work time/intensity that is similar to the crosswalk code. We are
finalizing a work RVU of 0.50, direct PE inputs of 3 minutes of
clinical labor code L037D, and 1 minute, 15 minutes, and 5 minutes of
pre, intra and post service time, respectively. As this service is not
a substitute for an in-person visit, but rather an assessment to
determine the need for one, the restrictions in section 1834(m) of the
Act do not apply and the only technological requirement is that the
communication technology must be synchronous. If this service
originates from a related E/M service provided within the previous 7
days or leads to an E/M service or procedure within the next 24 hours
or soonest available appointment it would be considered bundled into
that in-person service. We would consider this service to be a CTBS and
refer readers to the CY 2019 PFS final rule for additional discussion
as to why these fall outside of the restrictions in 1834(m) of the Act
(83 FR 59482 through 59491). We also note that HCPCS code GSADX1 is
subject to the same billing requirements as HCPCS code G2012.
iii. Waiver of Proposed Rulemaking for Provisions
Under the Administrative Procedure Act (APA), 5 U.S.C. 553(b), an
agency is generally required to publish a notice and solicit comment on
a proposed rule in the Federal Register before issuing a final rule.
Similarly, section 1871(b)(1) of the Act requires the Secretary to
provide for notice of a proposed rule in the Federal Register and
provide a period of not less than 60 days for public comment. The APA
provides for exceptions from the notice and comment requirements see 5
U.S.C. 553(b)(B); in cases in which the APA exceptions apply, section
1871(b)(2)(C) of the Act provides for exceptions from the notice and
60-day comment period requirements of the Act as well. Section
553(b)(B) of Title 5 and section 1871(b)(2)(C) of the Act authorize an
agency to dispense with normal rulemaking requirements if the agency
for good cause finds that the notice and comment process is
impracticable, unnecessary, or contrary to the public interest.
We find that there is good cause to waive the notice and comment
requirements under sections 553(b)(B) of the APA and section
1871(b)(2)(C) due to widespread concerns expressed by commenters about
the continuing need for audio-only conversations with patients. We
believe that establishing payment for this service on an interim basis
will support access to care for beneficiaries who may be reluctant to
return to in-person visits unless absolutely necessary, and allow us to
consider whether this policy should be adopted on a permanent basis. We
find that it would be impracticable and contrary to the public interest
to undergo notice and comment procedures before finalizing these
payment policies on an interim basis. We also find that delaying
implementation of these policies is unnecessary because the impact on
other PFS services for 2021 is negligible and the practical alternative
for this treatment is no payment under Medicare Part B. In either case,
payments for 2022 and beyond would be informed by public comments.
Therefore, we find good cause to waive the notice of proposed
rulemaking as provided under section 1871(b)(2)(C) of the Act and
section 533(b)(B) of the APA and to issue this interim final rule with
an opportunity for public comment. We are providing a 60-day public
comment period as specified in the DATES section of this document.
8. Comment Solicitation on Coding and Payment for Virtual Services
The health care community uses the term ``telehealth'' broadly to
refer to medical services furnished via communications technology.
Under current PFS payment rules, Medicare routinely pays for many of
these kinds of services. This includes some kinds of remote patient
monitoring (either as separate services or as parts of bundled
services), interpretations of diagnostic tests when furnished remotely
and, under conditions specified in section 1834(m) of the Act, services
that would otherwise be furnished in person but are instead furnished
via real-time, interactive communication technology. Over the past
several years, we have also established several PFS policies to make
separate payment for non-face-to-face services included as part of
ongoing care management. Although all of the kinds of services stated
above might be called ``telehealth'' by patients, payers of health care
services, and health care providers, we have generally used the term
``Medicare telehealth services'' to refer to the subset of services
defined in section 1834(m) of the Act. Section 1834(m) of the Act
defines Medicare telehealth services and specifies the payment amounts
and circumstances under which Medicare makes payment for a discrete set
of services, all of which must ordinarily be furnished in-person, when
they are instead furnished using interactive, real time
telecommunication technology.
In the CY 2021 PFS proposed rule, we noted that we believe that the
provisions in section 1834(m) of the Act apply particularly to the
kinds of professional services explicitly enumerated in the statutory
provisions,
[[Page 84537]]
like professional consultations, office visits, and office psychiatry
services. Generally, the services we have added to the Medicare
telehealth services list are similar to these kinds of services. As has
long been the case, certain other kinds of services that are furnished
remotely using communications technology are not considered ``Medicare
telehealth services'' and are not subject to the restrictions
articulated in section 1834(m) of the Act. This is true for services
that were routinely paid separately prior to the enactment of the
provisions in section 1834(m) of the Act and do not usually include
patient interaction (such as remote interpretation of diagnostic
imaging tests), and for services that were not discretely defined or
separately paid for at the time of enactment and that do include
patient interaction (such as chronic care management services).
In recent years, we have begun making separate payment for a number
of services that use telecommunications technology but are not
considered Medicare telehealth services. These CTB services include,
for example, certain kinds of remote patient monitoring (either as
separate services or as parts of bundled services), a virtual check-in,
and a remote asynchronous service. These services are different than
the kinds of services specified in section 1834(m) of the Act, in that
they are not the kind of services that are ordinarily furnished in
person but are routinely furnished using a telecommunications system.
In the past, we have received requests to add certain services,
such as chronic care management or remote physiologic monitoring to the
Medicare telehealth services list. However, as these services fall
outside the scope of services addressed, and the enumerated list of
services included, in section 1834(m) of the Act, they are not
considered telehealth services and, therefore, are not subject to the
same restrictions. We solicited comment on whether there are additional
services that fall outside the scope of telehealth services under
section 1834(m) of the Act where it would be helpful for us to clarify
that the services are inherently non-face-to-face, so do not need to be
on the Medicare telehealth services list in order to be billed and paid
when furnished using telecommunications technology rather than in
person with the patient present. We also solicited comment on
physicians' services that use evolving technologies to improve patient
care that may not be fully recognized by current PFS coding and
payment, including, for example, additional or more specific coding for
care management services. Finally, we solicited comment on any
impediments that contribute to healthcare provider burden and that may
result in practitioners being reluctant to bill for CTBS. We noted that
we appreciate the ongoing engagement and additional information from
stakeholders as we work to improve coding and payment for these
services that utilize telecommunications technology.
We received public comments on the comment solicitation on coding
and payment for virtual services. The following is a summary of the
comments we received and our responses.
Comment: Some commenters stated that CMS should provide utilization
information for CTBS services before, during, and after the PHE. Others
suggested that CMS establish separate coding and payment for additional
consultations that may be furnished using communication technology.
Other comments suggested that CMS issue clear and consistent guidance
on how to code for and appropriately document both telehealth and CTBS.
Commenters recommended that CMS collaborate with the AMA to accurately
value services furnished using communication technology.
Response: We thank commenters for their input and will consider
them for potential future rulemaking or future subregulatory guidance,
as appropriate.
9. Clarification of Current PFS Policies for Telehealth Services
In response to the waiver of statutory requirements and the
relaxation of regulatory requirements for telehealth during the PHE for
COVID-19, we received a number of requests to clarify existing PFS
policy for telehealth. For example, we received questions as to whether
Medicare allows incident-to billing for telehealth services,
particularly for practitioners such as counselors who are supervised by
a physician in private practice. We noted that there are no Medicare
regulations that explicitly prohibit eligible distant site
practitioners from billing for telehealth services provided incident to
their services. However, we also noted that our existing definition of
direct supervision requires on-site presence of the billing clinician
when the service is provided. That requirement could make it difficult
for a billing clinician to provide the direct supervision of services
provided via telehealth that is required for services furnished
incident to their professional services by auxiliary personnel. Under
the proposed revision to the definition of direct supervision to permit
virtual presence (FR 85 50114 and 50115), we acknowledged that billing
practitioners could more easily meet the direct supervision
requirements for telehealth services provided incident to their
services. Consequently, we noted that we believe services provided
incident to the professional services of an eligible distant site
physician or practitioner could be reported when they meet direct
supervision requirements at both the originating and distant site
through the virtual presence of the billing physician or practitioner.
Therefore, we proposed to clarify that services that may be billed
incident-to may be provided via telehealth incident to a physicians'
(or authorized NPP's) service and under the direct supervision of the
billing professional. This is consistent with a policy clarification
that we made through the May 8th COVID-19 IFC (85 FR 27562).
We also received questions as to whether services should be
reported as telehealth services when the individual physician or
practitioner furnishing the service is in the same location as the
beneficiary; for example, if the physician or practitioner furnishing
the service is in the same institutional setting but is utilizing
telecommunications technology to furnish the service due to exposure
risks. We also clarified, as we did in the May 8th COVID-19 IFC (85 FR
27562), that if audio/video technology is used in furnishing a service
when the beneficiary and the practitioner are in the same institutional
or office setting, then the practitioner should bill for the service
furnished as if it was furnished in person, and the service would not
be subject to any of the telehealth requirements under section 1834(m)
of the Act or Sec. 410.78 of our regulations.
We received public comments on these proposed clarifications of
current policies for telehealth services. The following is a summary of
the comments we received and our responses.
Comment: Several commenters supported our proposal to amend the
definition of direct supervision to permit supervision through virtual
presence because it would allow billing practitioners to more easily
meet the direct supervision requirements for telehealth services
provided ``incident to'' their services. Commenters stated that this
policy would expand access to needed care in communities that may not
have a supervising physician on site, and could make available services
that another qualified healthcare professional could provide within
their scope of practice if only they had the necessary direct
supervision.
Response: We appreciate commenters' support for this clarification.
We are
[[Page 84538]]
finalizing our proposed clarification that telehealth services may be
furnished and billed when provided incident to a distant site
physicians' (or authorized NPP's) service under the direct supervision
of the billing professional provided through virtual presence in
accordance with our regulation at Sec. 410.26.
Comment: One commenter requested that we specify in detail how time
should be counted for services furnished and billed incident to the
commenter's professional services when the required direct supervision
is provided through virtual presence.
Response: As we do not provide specific coding guidance, we suggest
that this commenter refer to the AMA CPT guidelines for using time to
bill for services furnished and also contact their Medicare
Administrative Contractor for further assistance. We further note that
time should be counted for telehealth services furnished by auxiliary
personnel incident to a billing professional's services in the same way
time is counted for other ``incident to'' services.
Comment: Commenters supported our clarification that, if audio/
video technology is used while furnishing a service when the
beneficiary and the practitioner are in the same institutional or
office setting, then the practitioner should bill for the service
furnished as if it was furnished in person. In addition, the service
would not be subject to any of the telehealth requirements, such as
geographic or site restrictions. Commenters state that this flexibility
helps conserve personal protective equipment (PPE) and supports access
to care.
Response: We appreciate commenters' support for this clarification.
Comment: One commenter recommended that CMS institute tracking
methods to accurately attribute services to the professional who
delivered the care when submitting services using Medicare's ``incident
to'' billing provision. They reasoned that, when there is a lack of
transparency regarding which clinicians are providing what services, it
is difficult, if not impossible, to appropriately measure the type or
volume of services or the quality of care delivered by each health
professional.
Response: We thank commenters for their feedback and suggestions.
We note that CMS has very clear rules about when a physician or
practitioner is permitted to bill for services furnished incident to
their own. When practitioners bill for their services, they attest to
the accuracy of the information they provide; and failure to provide
accurate information can result in civil and criminal liability.
10. Direct Supervision by Interactive Telecommunications Technology
Many services for which payment is made under the PFS can be
furnished under a level of physician or NPP supervision rather than
being performed directly by the billing practitioner. In many cases,
the supervision requirements necessitate the presence of the physician
or NPP in a particular location, usually in the same location as the
beneficiary when the service is provided. For example, as described at
Sec. 410.26, services furnished by auxiliary personnel incident to a
physician's or NPP's professional service usually require the direct
supervision of the physician or NPP. In addition to these ``incident
to'' services, there are a number of diagnostic services under the PFS
that also must be furnished under direct supervision. As currently
defined in Sec. Sec. 410.26 and 410.32(b)(3)(ii), direct supervision
means that the physician or NPP must be present in the office suite and
immediately available to furnish assistance and direction throughout
the performance of the procedure. Direct supervision does not require
the physician or NPP to be present in the room when the service or
procedure is performed.
For the duration of the PHE for COVID-19, for purposes of limiting
exposure to COVID-19, we adopted an interim final policy revising the
definition of direct supervision to include virtual presence of the
supervising physician or practitioner using interactive audio/video
real-time communications technology (85 FR 19245). We recognized that
in some cases, the physical proximity of the physician or practitioner
might present additional infection exposure risk to the patient and/or
practitioner. In the context of the PHE for COVID-19, given the risks
of exposure, the immediate risk of foregone medical care, the increased
demand for healthcare professionals, and the widespread use of
telecommunications technology, we believed that individual
practitioners were in the best position to make decisions about how to
meet the requirement to provide appropriate direct supervision based on
their clinical judgment in particular circumstances.
We proposed to extend the policy until the later of the end of the
calendar year in which the PHE for COVID-19 ends or December 31, 2021,
to recognize the different and unique circumstances faced by individual
communities that may continue after the PHE ends, and provide time to
solicit public input on circumstances where the flexibility to use
interactive audio/video real-time communications technology to provide
virtual direct supervision could still be needed and appropriate. The
extension of this flexibility would allow time for clinicians to make
adjustments and for us to obtain public input on services and
circumstances for which this policy might be appropriate on a permanent
basis. We noted that if the proposal were finalized and the PHE for
COVID-19 ended before the CY 2021 PFS final rule takes effect, the
interim policy adopted during the PHE to allow direct supervision using
real-time, interactive audio and video technology would no longer be in
effect during the period between expiration of the PHE and the date the
final policy takes effect.
Given our continued interaction with practitioners during the PHE
for COVID-19 and our growing understanding of how services may be
furnished remotely and safely, we noted that we have a better
understanding of how, in some cases, depending upon the unique
circumstances of individual patients and billing practitioners or
physicians, telecommunications technology could safely allow the
practitioner or physician's immediate availability to furnish
assistance and direction without necessarily requiring the supervising
practitioner's or physician's physical presence in the location where
the service is being furnished. In such cases, the use of real-time,
audio and video telecommunications technology may allow the supervising
practitioner or physician to observe the beneficiary and the auxiliary
staff performing the service or be engaged (Direct supervision does not
require the physician or NPP to be present in the room when the service
or procedure is performed) to provide assistance and direction of the
service through virtual means, and without the supervising practitioner
or physician being physically present.
Consequently, we proposed to revise Sec. 410.32(b)(3)(ii) to allow
direct supervision to be provided using real-time, interactive audio
and video technology through the later of the end of the calendar year
in which the PHE for COVID-19 ends or December 31, 2021. Specifically,
we proposed to continue our current rule that ``Direct supervision'' in
the office setting would mean the physician (or other supervising
practitioner) must be present in the office suite and immediately
available to furnish assistance and direction throughout the
performance of the procedure. It would not mean that the physician (or
other
[[Page 84539]]
supervising practitioner) must be present in the room when the
procedure is performed. We proposed to add that, until the later of the
end of the calendar year in which the PHE for COVID-19 ends or December
31, 2021, the presence of the physician (or other practitioner) may
include virtual presence through audio/video real-time communications
technology (excluding audio-only) subject to the clinical judgement of
the supervising physician or (other supervising practitioner). In
response to questions received since we issued the interim policy for
the PHE for COVID-19, we clarified that, to the extent our policy
allows direct supervision through virtual presence using audio/video
real-time communications technology, the requirement could be met by
the supervising physician (or other practitioner) being immediately
available to engage via audio/video technology (excluding audio-only),
and would not require real-time presence or observation of the service
via interactive audio and video technology throughout the performance
of the procedure.
While flexibility to provide direct supervision through audio/video
real-time communications technology was adopted to be responsive to
critical needs during the PHE for COVID-19 to ensure beneficiary access
to care, reduce exposure risk and to increase the capacity of
practitioners and physicians to respond to COVID-19, we expressed
concern that direct supervision through virtual presence may not be
sufficient to support PFS payment on a permanent basis, beyond the PHE
for COVID-19, due to issues of patient safety. For instance, in
complex, high-risk, surgical, interventional, or endoscopic procedures,
or anesthesia procedures, a patient's clinical status can quickly
change, and we believe it is necessary for such services to be
furnished or supervised in person to allow for rapid on-site decision-
making in the event of an adverse clinical situation. For example,
there could be a case in which a practitioner or physician uses audio/
video interactive communications to virtually supervise a nurse
performing a post-op evaluation following surgery for hip fracture, and
the nurse might note that the patient is uncooperative. In this
scenario, had a full exam been performed directly by the practitioner
or physician, or under the in-person supervision of a practitioner or
physician who was physically or immediately available in the clinic to
provide the necessary direction, the physician or practitioner would
have recognized that the patient exhibited signs of crystal-mediated
acute arthritis, and that the patient's lack of cooperation was likely
due to hypoactive delirium. Instead, the supervising practitioner or
physician may not have been able to identify this clinical issue as a
result of being available only via audio/video interactive
communications technology. In this case, the presence of the
supervising practitioner or physician through audio/video interactive
communications technology would have been insufficient. There also may
be certain patient populations that require greater clinical
attentiveness and skill than the supervising practitioner or physician
could provide via audio/video interactive communications technology.
For example, patients with cognitive impairment or dementia, or
patients with communication disabilities, may require the experience
and skill of a physically present supervising practitioner or physician
to recognize needs such as the need for specialized testing. It may not
be possible for a supervising practitioner or physician to recognize or
meet these clinical needs while being present for the service only
through audio/video interactive communications technology. Moreover,
the virtual connection between the individual performing the service
and the supervising practitioner or physician could be disrupted,
making it challenging for the supervising practitioner or physician to
remain immediately available to provide assistance and direction to the
physically present clinical staff or auxiliary personnel to furnish
appropriate care to the patient.
We solicited information from commenters as to whether there should
be any additional ``guardrails'' or limitations to ensure patient
safety/clinical appropriateness, beyond typical clinical standards, as
well as restrictions to prevent fraud or inappropriate use if we were
to finalize a policy to permit direct supervision through audio/video
interactive communications technology, with consideration of relevant
patient safety, clinical appropriateness criteria or other
restrictions, on a temporary basis through the later of the end of the
calendar year in which the PHE for COVID-19 ends or December 31, 2021,
or consider it beyond the time specified. We solicited information on
what risks this policy might introduce to beneficiaries as they receive
care from practitioners that would supervise care virtually in this
way. Further, we solicited comment on potential concerns around induced
utilization and fraud, waste, and abuse and how those concerns might be
addressed. We also invited commenters to provide data and information
about their implementation experience with direct supervision using
virtual presence during the PHE for COVID-19, and are interested in
comments on the degree of aging and disability competency training that
is required for effective use of audio/video real-time communications
technology.
We received public comments on the direct supervision by
interactive telecommunications technology. The following is a summary
of the comments we received and our responses.
Comment: Commenters supported our proposal to revise the definition
of direct supervision to allow virtual presence of the supervising
physician or practitioner using real-time, interactive audio-video
technology until the later of the end of the calendar year in which the
PHE for COVID-19 ends or December 31, 2021, stating that this revision
will greatly help reduce barriers to access, and that allowing
physicians and auxiliary personnel to provide services from two
separate locations will work to support the expansion of telehealth
services and protects frontline workers by allowing appropriate social
distancing.
Response: We thank the commenters for their support and feedback.
Comment: Many commenters requested that CMS make permanent the
current temporary regulatory flexibility allowing physicians to provide
direct supervision of clinical staff virtually, using real-time audio/
video technology. Others opposed the use of virtual direct supervision
following the termination of the PHE due to issues of patient safety,
stating it may not be possible for a supervising physician to recognize
or meet urgent clinical needs while being present for the service, and
potentially other services at the same time, only through audio/video
interactive communications technology.
We also received a variety of responses to our stated concerns that
direct supervision through virtual presence may not be sufficient to
support PFS payment on a permanent basis, beyond the PHE for COVID-19,
due to issues of patient safety. Many commenters did not share these
concerns, stating that there is no situation whereby clinical staff or
auxiliary personnel would conduct complex, high-risk, surgical,
interventional, or endoscopic procedures under any circumstance other
than in-person. Many other commenters shared our patient-safety
concerns, citing increased utilization and spending, and the potential
for
[[Page 84540]]
fraud and abuse. Many stressed that virtual supervision can be done
safely in certain scenarios, but it is not warranted in other
scenarios. More specifically, some commenters said remote supervision
would not be appropriate for in-person diagnostic or therapeutic
procedures since the physician would not be physically available to
help the individual being supervised if the need arises. Similarly,
commenters suggested that it may not be appropriate when a remote
physician is not on-site for an E/M service that requires finesse when
performing the physical examination in person. According to some
commenters, virtual direct supervision would not be appropriate for
data interpretation, such as imaging studies or certain physiologic
studies, where the patient is not physically present. A commenter
agreed with the agency's assessment that anesthesia services must be
furnished or supervised in person to allow for rapid, on-site decision-
making in the event of an adverse clinical situation. One commenter
recommended that CMS provide clarifying language in the final rule to
ensure that the supervising physician is in the United States when
using audio-visual technology for purposes of direct supervision.
Commenters offered a range of responses and suggestions in the
interest of patient safety and program integrity in response to our
request for information as to whether there should be any additional
``guardrails'' or limitations to ensure patient safety/clinical
appropriateness, beyond typical clinical standards, as well as
restrictions to prevent fraud or inappropriate use, if we were to
finalize a policy to permit direct supervision through audio/video
interactive communications technology on a temporary basis. According
to some commenters, we should defer entirely to physician judgment to
determine clinical appropriateness. Others offered suggestions
including that we should closely monitor the use of virtual direct
supervision during the interim period to gain information on potential
induced utilization or fraud, waste, and abuse concerns. Some
commenters stated that virtual direct supervision should be robustly
documented to ensure that patients are safely receiving clinically
appropriate care from members of the care team. A commenter stated that
program integrity concerns could be addressed through provider
enrollment rather than through administrative barriers. Other
suggestions included: That CMS develop a list of high risk procedures
and complex patient populations for whom this policy may not be
appropriate; that CMS limit the number of clinicians with whom a
supervising physician may simultaneously engage, as well as the number
of incident-to relationships in which a supervising physician may be
involved at a given time, via audio/video technology; that testing
sites that use interactive technologies rely on documentation and
training; that we require that a caregiver be present physically with
the patient when the services are furnished virtually; and that CMS
identify conditions under which the extension of the virtual direct
supervision policy may be revoked if evidence suggests such supervision
is inadequate.
Response: We appreciate the information and suggestions we received
in response to this request for comment. This information will allow us
to consider safety and program integrity issues in the context of
virtual supervision, and to what degree and on what basis this
flexibility could be continued following the PHE. We will consider this
and other information as we determine future policy regarding use of
communication technology to satisfy direct supervision requirements as
well as the best approach for safeguarding patient safety while
promoting use of technology to enhance access.
After consideration of the comments, we are finalizing our proposal
to allow direct supervision to be provided using real-time, interactive
audio and video technology through the later of the end of the calendar
year in which the PHE for COVID-19 ends or December 31, 2021.
11. Comment Solicitation on PFS Payment for Specimen Collection for
COVID-19 Tests
When physicians and other practitioners collect specimens for
clinical diagnostic laboratory tests as part of their professional
services, Medicare generally makes payment for the services under the
PFS, though often that payment is bundled into the payment rate for
other services, including office and outpatient visits. Typically,
collection of a specimen via nasal swab or other method during the
provision of a service might be reported as part of (bundled with) an
O/O E/M visit (CPT codes 99201 through 99205, 99211 through 99215). In
visits where a patient has a face-to-face interaction with a billing
professional with whom they have an established relationship, these
services are generally reported with a level 2 through a level 5 visit
(CPT codes 99212 through 99215). In cases where the specimen is
collected during a visit where the face-to-face interaction only
involves clinical staff of the billing professional with whom the
patient has an established relationship, these services are generally
reported using CPT code 99211.
In the May 8th COVID-19 IFC (85 FR 27604-27605), we finalized on an
interim basis that physicians and NPPs may use CPT code 99211 to bill
for services furnished incident to their professional services, for
both new and established patients, when clinical staff assess symptoms
and collect specimens for purposes of COVID-19 testing, if the billing
practitioner does not also furnish a higher level E/M service to the
patient on the same day. In the CY 2021 PFS proposed rule, we noted
that we considered whether to extend or make permanent the policy to
allow physicians and NPPs to use CPT code 99211 to bill for services
furnished incident to their professional services, for both new and
established patients, when clinical staff assess symptoms and collect
specimens for purposes of COVID-19 testing, and solicited public
comments on whether we should continue this policy for a period of
time, or permanently, after the PHE for COVID-19 ends.
We received public comments in response to our comment solicitation
on PFS payment for specimen collection for COVID-19 tests. We
appreciate the information and feedback provided. We will consider this
information for potential future rulemaking.
12. Finalization of Interim Final Rule Provisions Related to
Requirements of the Substance Use Disorder (SUD) Prevention That
Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and
Communities Act
a. Expanding Medicare Telehealth Services for the Treatment of Opioid
Use Disorder and Other SUDs
In the CY 2019 PFS interim final rule with comment period (83 FR
59452, 59496, Nov. 23, 2018), we implemented on an interim final basis
the amendments made by section 2001(a) of the SUPPORT for Patients and
Communities Act (Pub. L. 115-271, October 24, 2018) (the SUPPORT Act)
to section 1834(m) of the Act. First, section 2001(a) of the SUPPORT
Act removed the originating site geographic requirements under section
1834(m)(4)(C)(i) of the Act for telehealth services furnished on or
after July 1, 2019 for the purpose of treating individuals diagnosed
with a SUD or a co-occurring mental health disorder, as determined by
the Secretary, at an originating site described in section
[[Page 84541]]
1834(m)(4)(C)(ii) of the Act, other than an originating site described
in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act. Subclause
(IX) of section 1834(m)(4)(C)(ii) of the Act refers to a renal dialysis
facility, which is only an allowable originating site for purposes of
home dialysis monthly ESRD-related clinical assessments in section
1881(b)(3)(B) of the Act. Section 2001(a) of the SUPPORT Act also added
the home of an individual as a permissible originating site for
telehealth services for the purpose of treating individuals diagnosed
with a SUD or a co-occurring mental health disorder. Section 2001(a) of
the SUPPORT Act also amended section 1834(m)(2)(B)(ii) 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. Section 2001(b) of
the SUPPORT Act granted the Secretary specific authority to implement
the amendments made by section 2001(a) through an interim final rule,
and under that authority, we issued such an interim final rule. In
accordance with section 1834(m)(4)(C)(ii)(X) of the Act, as amended by
section 2001(a) of the SUPPORT for Patients and Communities Act, we
revised Sec. 410.78(b)(3) on an interim final basis, by adding Sec.
410.78(b)(3)(xii), which adds the home of an individual as a
permissible originating site for telehealth services furnished on or
after July 1, 2019 to individuals with a SUD diagnosis for purposes of
treatment of a SUD or a co-occurring mental health disorder. We amended
Sec. 414.65(b)(3) on an interim final basis to reflect the requirement
in section 1834(m)(2)(B)(ii) of the Act that there is no originating
site facility fee paid when the originating site for these services is
the individual's home. Additionally, we added Sec. 410.78(b)(4)(iv)(C)
on an interim final basis to specify that the geographic requirements
in section 1834(m)(4)(C)(i) of the Act do not apply for telehealth
services furnished on or after July 1, 2019, to individuals with a SUD
diagnosis for purposes of treatment of a SUD or a co-occurring mental
health disorder at an originating site other than a renal dialysis
facility. We noted that section 2001 of the SUPPORT Act did not amend
section 1834(m)(4)(F) of the Act, which limits the scope of telehealth
services to those on the Medicare telehealth list. We also noted that
practitioners would be responsible for assessing whether individuals
have a SUD diagnosis and whether it would be clinically appropriate to
furnish telehealth services for the treatment of the individual's SUD
or a co-occurring mental health disorder. By billing codes on the
Medicare telehealth list with the telehealth place of service code,
practitioners would be indicating that the codes billed were used to
furnish telehealth services to individuals with a SUD diagnosis for the
purpose of treating the SUD or a co-occurring mental health disorder.
Comment: Several commenters expressed support for the changes
authorized by section 2001(a) of the SUPPORT Act, noting that these
changes that will benefit beneficiaries and advance the use of
telehealth as a critical tool to improving access to care. One
commenter noted that the changes will mitigate barriers to treatment
for this patient population, decreasing stigma associated with seeking
mental health and SUD services caused by presenting at a qualified
originating site, allow patients to receive services at home, and open
access to telehealth services for patients living in urban areas.
Response: We thank the commenters for their comments.
Comment: A few commenters urged CMS to consider expanding this
flexibility to beneficiaries without SUDs, particularly those with
mental health disorders without a co-occurring SUD.
Response: The interim final changes we adopted to our regulations
under Sec. 410.78 described above were based on amendments to the
statute made by section 2001(a) of the SUPPORT Act. These amendments
were limited to telehealth services furnished to individuals diagnosed
with a SUD for purposes of treatment of the SUD or a co-occurring
mental health disorder. We do not have the statutory authority at this
time to expand these changes to include treatment of mental health
disorders that are not co-occurring with a SUD diagnosis.
Comment: A few commenters urged CMS to ensure that the full scope
of both SUD treatment services and applicable services for the
treatment of co-occurring mental health disorders are included in the
Medicare telehealth list in the future, citing examples such as
screening, counseling, consultation, psychiatric services, care
planning, initiation and continued management of Medication-Assisted
Treatment (MAT), and others.
Response: Thank you for your comment. We note that HCPCS codes
G2086, G2087, and G2088 were added to the Medicare Telehealth list
beginning in CY 2020 (84 FR 62628). These codes describe bundled
payments for office-based treatment for opioid use disorder, including
development of the treatment plan, care coordination, individual
therapy, and group therapy and counseling. We note that for CY 2021, we
are finalizing a revision to these code descriptions to include the
treatment of any substance use disorder rather than just OUD. See
discussion in this final rule describing expansion of these codes to be
inclusive of all SUDs beginning in CY 2021. Also, as discussed earlier
in this final rule, we are finalizing the addition of CPT codes 99347
and 99348 (Home visit for the evaluation and management of an
established patient) to the Medicare Telehealth list for CY 2021, which
could be appropriately billed for treatment of an SUD or co-occurring
mental health disorder, as well as CPT code 90853 (Group
psychotherapy). We welcome recommendations of other codes for addition
to the Medicare Telehealth list through our usual process by the
February 10th deadline.
Comment: One commenter encouraged CMS to amend section
1834(m)(4)(f) of the Act to include MAT and remote opioid treatment as
covered services on the Medicare telehealth list in order to provide
the care needed to all patients with SUDs, including Opioid Use
Disorder.
Response: We do not have the authority to amend the statute;
however, the services associated with the provision of MAT in the
office setting, such as E/M visits and psychotherapy, are on the
Medicare Telehealth List.
Comment: One commenter cautioned against creating any
administrative procedures that would complicate billing for these
services when furnished via telehealth, which could create a barrier to
implementation and stifle the ability of telehealth to be used
effectively to facilitate SUD and co-occurring mental health services,
while another commenter stated that CMS should publish clear sub-
regulatory guidance on how the current Medicare telehealth services can
be billed when treating SUD.
Response: As discussed in the CY 2019 PFS interim final rule with
comment period (83 FR 59496), we noted that practitioners are
responsible for assessing whether individuals have a SUD diagnosis and
whether it would be clinically appropriate to furnish telehealth
services for the treatment of the individual's SUD or a co-occurring
mental health disorder. By billing codes on the Medicare telehealth
list with the telehealth place of service code, practitioners would be
indicating that the codes billed were used to furnish telehealth
services to individuals with a SUD diagnosis for the purpose of
[[Page 84542]]
treating the SUD or a co-occurring mental health disorder.
In summary, after consideration of the comments, we are finalizing
the interim revisions to the regulation text at Sec. Sec. 410.78(b)(3)
and 414.65(b)(3) described above.
E. Care Management Services and Remote Physiologic Monitoring Services
1. Background
In recent years, we have updated PFS policies to improve payment
for care management and 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 describe
services that involve direct patient contact (for some services, in-
person) or do not involve direct patient contact; represent a single
encounter, monthly service, or both; are timed services; address
specific conditions; and represent the work of the billing
practitioner, auxiliary personnel (specifically, clinical staff), or
both (see Table 17). In this final rule for CY 2021, we continue our
work to improve payment for care management services through code
refinements related to remote physiologic monitoring (RPM),
transitional care management (TCM), and psychiatric collaborative care
model (CoCM) services.
[GRAPHIC] [TIFF OMITTED] TR28DE20.028
2. Digitally Stored Data Services/Remote Physiologic Monitoring/
Treatment Management Services (RPM)
RPM involves the collection and analysis of patient physiologic
data that are used to develop and manage a treatment plan related to a
chronic and/or acute health illness or condition. In recent years, we
have finalized payment for seven CPT codes in the RPM code family. Five
of the seven codes have been the focus of frequent questions from
stakeholders.
In response to proposals in the CY 2019 PFS proposed rule (83 FR
35771) and the CY 2020 PFS proposed rule (84 FR 40555 through 40556),
stakeholders requested that we clarify how we interpret aspects of the
RPM code descriptors for CPT codes 99453, 99454, 99091, and 99457.
Commenters asked us, for example, to identify who can furnish RPM
services, what kinds of devices can be used to collect data, how data
should be collected, and how ``interactive communication'' is defined.
We stated in the CY 2020 PFS final rule (84 FR 62697) that we would
provide guidance in the future about the codes. For CY 2021, we are
clarifying how we
[[Page 84543]]
read CPT code descriptors and instructions associated with CPT codes
99453, 99454, 99091, and 99457 (and the add-on code, CPT code 99458)
and their use for remote monitoring of physiologic parameters of a
patient's health.
The RPM process begins with two PE only codes, CPT codes 99453 and
99454, finalized in the CY 2019 PFS final rule (83 FR 59574 through
59576). As PE only codes, they are valued to include clinical staff
time, supplies, and equipment, including the medical device for the
typical case of remote monitoring. 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) is valued to reflect clinical staff time that includes
instructing a patient and/or caregiver about using one or more medical
devices. CPT code 99454 (Remote monitoring of physiologic parameter(s)
(e.g., weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; device(s) supply with daily recording(s) or programmed
alert(s) transmission, each 30 days) is valued to include the medical
device or devices supplied to the patient and the programming of the
medical device for repeated monitoring. We reviewed the PE inputs for
CPT code 99454 in the proposed rule and clarified that the medical
devices that are supplied to the patient and used to collect
physiologic data are considered equipment and, as such, are direct PE
inputs for the code.
Review of CPT prefatory language (CPT[supreg] 2021 Professional
Codebook (hereafter, CPT Codebook), pp. 52-53) provides additional
information about the two PE-only codes. For example, the CPT prefatory
language indicates that monitoring must occur over at least 16 days of
a 30-day period in order for CPT codes 99453 and 99454 to be billed.
Additionally, these two codes are not to be reported for a patient more
than once during a 30-day period. This language suggests that even when
multiple medical devices are provided to a patient, the services
associated with all the medical devices can be billed only once per
patient per 30-day period and only when at least 16 days of data have
been collected. We also noted that CPT code 99453 can be billed only
once per episode of care where an episode of care is defined as
``beginning when the remote physiologic monitoring service is initiated
and ends with attainment of targeted treatment goals'' (CPT Codebook,
p. 52).
Other stakeholder inquiries about CPT codes 99453 and 99454 focused
upon the kinds of medical devices that can be used to collect a
patient's physiologic data. Prefatory language in the CPT Codebook
states that ``the device must be a medical device as defined by the
FDA.'' CPT simply specifies that the device must meet the FDA's
definition of a medical device as described in section 201(h) of the
Federal, Food, Drug and Cosmetic Act (FFDCA). As discussed in the CY
2021 PFS proposed rule (85 FR 50118), we found no language in the CPT
Codebook indicating that a medical device must be FDA cleared as some
stakeholders suggested, although such clearance may be appropriate. We
also noted that we did not find information that suggested a medical
device must be prescribed by a physician, although this could be
possible depending upon the medical device. Beyond acknowledging the
CPT specification that the medical device supplied for CPT code 99454
must meet the FDA definition of a medical device, we clarified in the
proposed rule that the medical device should digitally (that is,
automatically) upload patient physiologic data (that is, data are not
patient self-recorded and/or self-reported). We also noted that use of
the medical device or devices that digitally collect and transmit a
patient's physiologic data must, as usual for most Medicare covered
services, be reasonable and necessary for the diagnosis or treatment of
the patient's illness or injury or to improve the functioning of a
malformed body member. Further, we noted that the device must be used
to collect and transmit reliable and valid physiologic data that allow
understanding of a patient's health status in order to develop and
manage a plan of treatment.
The CPT Codebook lists the RPM codes under the main heading
Evaluation and Management (E/M). We clarified in the proposed rule that
as E/M codes, CPT codes 99453, 99454, 99091, 99457, and 99458, can be
ordered and billed only by physicians or NPPs who are eligible to bill
Medicare for E/M services.
Although we initially described RPM services in the CY 2019 PFS
final rule (83 FR 59574) as services furnished to patients with chronic
conditions, we clarified in the CY 2021 PFS proposed rule (85 FR 50118)
that practitioners may furnish these services to remotely collect and
analyze physiologic data from patients with acute conditions as well as
from patients with chronic conditions.
After the data collection period for CPT codes 99453 and 99454, the
physiologic data that are collected and transmitted may be analyzed and
interpreted as described by CPT code 99091, a code that includes only
professional work (that is, there are no direct PE inputs). We
finalized payment for 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) in the CY 2018 PFS final
rule (82 FR 53013 through 53014). The valuation for CPT code 99091
includes a total time of 40 minutes of physician or NPP work, broken
down as follows: 5 minutes of preservice work (for example, chart
review); 30 minutes of intra-service work (for example, data analysis
and interpretation, report based upon the physiologic data, as well as
a possible phone call to the patient); and 5 minutes of post-service
work (that is, chart documentation). We noted that stakeholders have
expressed confusion about the specification in the code descriptor for
CPT code 99091 that the service is furnished by a ``physician or other
qualified health care professional, qualified by education, training,
licensure/regulation.'' The phrase ``physician or other qualified
health care professional'' is defined by CPT as ``an individual who is
qualified by education, training, licensure/regulation (when
applicable) and facility privileging (when applicable) who performs a
professional service within his/her scope of practice and independently
reports that professional service. These professionals are distinct
from ``clinical staff . . . [which refers to] a person who works under
the supervision of a physician or other qualified health care
professional and who is allowed by law, regulation, and facility policy
to perform or assist in the performance of a specified professional
service but does not individually report that professional service.''
\3\ Accordingly, when referring to a particular service described by a
CPT code for Medicare purposes, a physician or other qualified health
care professional is an individual whose scope of practice and Medicare
benefit category includes the service, and who is authorized to
independently bill Medicare for the service. See our previous
discussion of this in the CY 2016 PFS final rule at 80 FR 70957.
Medicare also covers and makes payment for certain services performed
by auxiliary personnel (which includes
[[Page 84544]]
clinical staff) ``incident to'' the professional services of the
billing practitioner. Our regulation at Sec. 410.26(a) defines
auxiliary personnel and delineates the conditions for payment for
``incident to'' services.
---------------------------------------------------------------------------
\3\ CPT Codebook, p. xiv.
---------------------------------------------------------------------------
After analyzing and interpreting a patient's remotely collected
physiologic data, we noted that the next step in the process of RPM is
the development of a treatment plan that is informed by the analysis
and interpretation of the patient's data. It is at this point that the
physician or NPP develops a treatment plan with the patient and/or
caregiver (that is, develops a patient-centered plan of care) and then
manages the plan until the targeted goals of the treatment plan are
attained, which signals the end of the episode of care. 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; first 20 minutes) and its add-on code, 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; each
additional 20 minutes (list separately in addition to code for primary
procedure)) describe the treatment and management services associated
with RPM. Medicare stakeholders have requested that we clarify aspects
of these two codes. The two most frequently asked questions include
``Who can furnish the services described by CPT codes 99457 and 99458?
'' and ``What does it mean to have an `interactive communication' with
a patient? ''
We addressed who can furnish CPT codes 99457 and 99458 in the CY
2020 PFS final rule (84 FR 62697 through 62698) when we designated both
codes as care management services. We explained that, like other care
management services, services described by CPT codes 99457 and 99458
can be furnished by clinical staff under the general supervision of the
physician or NPP. We noted that RPM services are not considered to be
diagnostic tests; that is, they cannot be furnished and billed by an
Independent Diagnostic Testing Facility on the order of a physician or
NPP.
The services described by CPT codes 99457 and 99458 are services
that are typically furnished remotely using communications technologies
that allow ``interactive communication,'' which we read as real-time
interaction, between a patient and the physician, NPP, or clinical
staff who provide the services. Stakeholders have requested that we
define ``interactive communication'' as used in the code descriptors
for CPT codes 99457 and 99458. We explained in the proposed rule that
we saw this remote, non-face-to-face exchange as being similar to the
exchange that occurs in providing services described by HCPCS code
G2012, Brief Communication Technology-Based Service, which we finalized
in the CY 2019 PFS final rule (83 FR 59483 through 59486). We clarified
that ``interactive communication'' for purposes of CPT codes 99457 and
99458 involves, at a minimum, a real-time synchronous, two-way audio
interaction that is capable of being enhanced with video or other kinds
of data transmission. As indicated in the code descriptor for CPT code
99457, we believed during the writing of the proposed rule that the
interactive communication should total at least 20 minutes of time with
the patient over the course of a calendar month for CPT code 99457 to
be reported. Each additional 20 minutes of interactive communication
between the patient and the physician/NPP/clinical staff would be
reported using CPT code 99458. We developed our definition of time
using the CPT Codebook. The CPT Codebook states that unless there are
code- or code-range specific instructions, parenthetical instructions,
or code descriptors to the contrary, time is considered to be ``face-
to-face'' time with the patient or patient's caregiver/medical
decision-maker. See the CPT Codebook, page xvii for more information
about measuring time. Although the services described by CPT codes
99457 and 99458 are not typically in-person services, we interpreted
time in the code descriptor to mean the time the practitioner spent in
direct, real-time interactive communication with a patient.
Lastly, we proposed to establish as permanent policy two of the
changes we made on an interim basis to the requirements for furnishing
RPM services in the March 31st and the May 8th COVID-19 IFCs. (See 85
FR 19264 and 85 FR 27605 through 27606 for the interim modifications
and clarifications to RPM services in response to the PHE for COVID-
19).
Our goals during the PHE for COVID-19 have been to reduce exposure
risks to the virus for practitioners and patients while also increasing
access to health care services. We eliminated as many obstacles as
possible to allow timely delivery of reasonable and necessary health
care. We wanted patients to be able to access services quickly and
without barriers. With the goals of reducing exposure and increasing
access to services, we finalized that RPM services could be furnished
to new patients, as well as established patients on an interim basis
for the duration of the PHE for COVID-19. We also finalized several
policies on an interim basis for the duration of the PHE for COVID-19.
These include: (1) Allowing consent to be obtained at the time services
are furnished; (2) allowing consent to be obtained by individuals
providing RPM services under contract with the billing physician or
practitioner; and (3) allowing RPM codes to be billed for a minimum of
2 days of data collection over a 30-day period, rather than the
required 16 days of data collection over a 30-day period as provided in
the CPT code descriptors.
For CY 2021, we proposed on a permanent basis to allow consent to
be obtained at the time that RPM services are furnished. Because the
CPT code descriptors do not specify that clinical staff must perform
RPM services, we also proposed to allow auxiliary personnel (which
includes other individuals who are not clinical staff but are employees
or leased or contracted employees) to furnish services described by CPT
codes 99453 and 99454 under the general supervision of the billing
physician or practitioner.
When the PHE for COVID-19 ends, we again will require that RPM
services be furnished only to an established patient. We believe that a
physician or practitioner who has an established relationship with a
patient would likely have had an opportunity to provide a new patient
E/M service. During the new patient E/M service, the physician or
practitioner would have collected relevant patient history and
conducted a physical exam, as appropriate. As a result, the physician
or practitioner would possess information needed to understand the
current medical status and needs of the patient prior to ordering RPM
services to collect and analyze the patient's physiologic data and to
develop a treatment plan. Additionally, and in keeping with the CPT
prefatory language for CPT codes 99453 and 99454, when the PHE for
COVID-19 ends, we will once again require that 16 days of data be
collected within 30 days to meet the requirements to bill CPT codes
99453 and 99454.
In response to the May 19, 2020 E.O. 13924, ``Regulatory Relief To
Support Economic Recovery,'' (85 FR 31353 through 31356), we solicited
comment from the medical community and other members of the public on
whether
[[Page 84545]]
current RPM coding accurately and adequately describes the full range
of clinical scenarios where RPM services may be of benefit to patients.
We requested information that would help us to understand whether it
would be beneficial to consider establishing coding and payment rules
that would allow practitioners to bill and be paid for RPM services
with shorter monitoring periods. We expressed interest in understanding
whether one or more codes that describe a shorter duration, for
example, 8 or more days of remote monitoring within 30 days, might be
useful. For example, CPT codes 99453 and 99454 currently require use of
a medical device as defined by the FDA in section 201(h) of FFDCA that
digitally collects and transmits 16 or more days of data every 30 days
in order for the codes to be billed; however, some patients may not
require remote monitoring for 16 or more days in a 30-day period. For
some patients, continuous short-term monitoring might be more
appropriate. For example, a post-surgical patient who is recovering at
home might benefit from remote monitoring of his or her body
temperature as a means of assessing infection and managing medications
or dosage. In some clinical situations, monitoring several times
throughout a day, over a period of 10 days, may be reasonable and
necessary. Sixteen or more days might be unnecessary. We requested
information that would help us to understand whether it would be
beneficial to consider establishing coding and payment rules that would
allow practitioners to bill and be paid for RPM services with shorter
monitoring periods. Specifically, we were interested in understanding
whether one or more codes that describe a shorter duration, for
example, 8 or more days of remote monitoring within 30 days, might be
useful. We welcomed comments including any additional information that
the medical community and other members of the public believe might
provide further clarification on how RPM services are used in clinical
practice, and how they might be coded, billed, and valued under the
Medicare PFS.
We received public comments on our clarifications and proposals
related to digitally stored data services/remote physiologic
monitoring/treatment management services. The following is a summary of
comments we received and our responses.
Comment: Overall, commenters expressed appreciation and support for
the clarifications proposed by CMS regarding RPM CPT codes 99453,
99454, 99091, and 99457 (and the add-on code, CPT code 99458).
Response: We thank commenters for their support, as well as for
suggesting additional ways we might interpret the RPM codes. We hope to
continue this dialogue as CPT creates more RPM codes.
Comment: A group of commenters disagreed with our clarification
that CPT codes 99453, 99454, 99091, 99457, and 99458 can be ordered and
billed only by physicians and NPPs who are eligible to bill Medicare
for E/M services. Some commenters suggested that we allow the CPT
Editorial Panel and the RUC to establish appropriate coding for other
practitioners.
Response: We believe that as E/M codes, CPT codes 99453, 99454,
99091, 99457, and 99458, can be ordered and billed only by physicians
or NPPs who are eligible to bill Medicare for E/M services. We agree
with commenters that additional coding would be necessary, specifically
for practitioners who cannot order and bill E/M services.
Comment: Commenters disagreed with our suggestion that CPT codes
99091 and 99457 can be billed together. Commenters reported that these
two codes are incompatible and cannot be reported in the same calendar
month or in conjunction with one another.
Response: We continue to believe that, if reasonable and necessary,
CPT codes 99091 (Collection & interpretation physiologic data) and
99457 (Remote physiologic monitoring treatment management), given their
descriptions of services in the CPT Codebook, could be reported for the
same patient. We believe the two codes, as currently described, provide
different types of services. We agree with commenters that the CPT
Codebook states on page 53, ``Do not report 99091 in conjunction with
99457.'' However, the next section states, ``Do not report 99091 for
time in a calendar month when used to meet the criteria for 99339,
99340, 99374, 99375, 99377, 99378, 99379, 99380, 99457, and 99491.'' We
note that these two statements suggest that there may be instances
where both codes could be billed for the same patient in the same month
as long as the same time was not used to meet the criteria for both CPT
codes 99091 and 99457. We remind readers that the valuation for CPT
code 99091 includes a total time of 40 minutes of physician or NPP work
broken down as follows: 5 minutes of pre-service work (for example,
chart review); 30 minutes of intra-service work (for example, data
analysis and interpretation, report based upon the physiologic data, as
well as a possible phone call to the patient); and 5 minutes of post-
service work (that is, chart documentation). We believe that in some
instances when complex data are collected, more time devoted
exclusively to data analysis and interpretation by a physician or NPP
may be necessary such that the criteria could be met to bill for both
CPT codes 99091 and 99457 within a 30-day period. The medically
necessary services associated with all the medical devices for a single
patient can be billed by only one practitioner, only once per patient
per 30-day period, and only when at least 16 days of data have been
collected.
Comment: Commenters suggested that other devices that do not meet
the FDA's definition of medical device, but collect physiologic data,
should satisfy the requirements of RPM services.
Response: We disagree with the commenters. The prefatory language
and code descriptors developed by the CPT Editorial Panel indicate the
device must meet the FDA definition of a medical device as found in
section 201(h) of the FFDCA.
Comment: One commenter stated that a coding gap exists between
physiologic and non-physiologic remote monitoring and stated that
additional coding is required for non-physiologic parameters.
Response: We thank the commenter for this insight. We look forward
to engaging with stakeholders on this topic to inform how we might
consider a ``coding gap'' that exists for services related to remote
monitoring for non-physiologic measures of health.
Comment: Several commenters suggested that CMS should allow RPM
services to be furnished to new patients, as well as to established
patients. Other commenters supported our decision to require that
patients be known to the practitioner (established patients) prior to
the start of RPM services.
Response: We continue to believe that a physician or NPP who has an
established relationship with a patient would possess the information
needed to understand the current medical status and needs of the
patient prior to ordering RPM services to collect and analyze the
patient's physiologic data and to develop a treatment plan. We note
that during the PHE for COVID-19, RPM services may be furnished and
billed for both new and established patients. We refer readers to the
March 31st COVID-19 IFC (85 FR 19264) where we adopted the policy on an
interim basis for the duration of the PHE for COVID-19 that RPM
services could be furnished to new patients as well as established
patients.
[[Page 84546]]
After considering public comments, we are not extending this
interim policy beyond the end of the PHE for COVID-19. At the
conclusion of the PHE, there will need to be an established patient-
practitioner relationship in order to bill Medicare for CPT codes
99453, 99454, 99457, and 99458.
Comment: Some commenters suggested that we permit fewer than the
required 16 days of monitoring per month that are required to bill CPT
codes 99453 and 99454. One commenter indicated that patients and health
care personnel are served best by a maximum data collection requirement
of 6 days. Another commenter stated that the 8 days we suggested would
be best. Another commenter suggested that at least 16 days of data
should be required, and when 16 days of data are not collected within
the 30-day period, that a modifier should be reported as a means of
communicating that the service duration was reduced with an associated
reduction in payment.
Response: While we agree that a full 16 days of monitoring may not
always be reasonable and necessary, we requested detailed information
about meaningful, clinical situations that require fewer days or
shorter durations of remote monitoring. We were interested in
understanding under what clinical circumstances fewer days of
monitoring would be medically reasonable and necessary and allow a
practitioner to establish clinically meaningful care. Although we
received general support for a reduction in the number of days of data
collection required to bill for CPT codes 99453 and 99454, we did not
receive specific clinical examples.
After considering public comments, we are not extending the interim
policy to permit billing for CPT codes 99453 and 99454 for fewer than
16 days in a 30-day period beyond the end of the PHE for COVID-19. At
the conclusion of the PHE for COVID-19, we will require, in accordance
with the code descriptors for CPT codes 99453 and 99454, that 16 days
of data each 30 days must be collected and transmitted to meet the
requirements to bill CPT codes 99453 and 99454.
Comment: A few commenters requested that Independent Diagnostic
Testing Facilities (IDTFs) be allowed to bill for RPM services.
Response: As we noted in the proposed rule, RPM services are not
considered to be diagnostic tests; therefore, RPM services cannot be
furnished and billed by an IDTF on the order of a physician or NPP.
Comment: Commenters agreed with our clarification that
practitioners should be allowed to furnish RPM services to patients
with acute conditions, as well as patients with chronic conditions.
Response: We thank commenters for their support of our
clarification that practitioners may furnish RPM services to patients
with acute conditions, as well as patients with chronic conditions.
In the CY 2021 PFS proposed rule, we proposed to make permanent two
policies that we adopted in the March 31st COVID-19 IFC (85 FR 19264).
We received comments on our proposed policies. The following is a
summary of the comments we received and our responses.
Comment: Commenters wrote in favor of our proposal to allow consent
to be obtained at the time the services of CPT codes 99453 and 99454
are furnished.
Response: We thank our stakeholders for their comments and support
of this proposal.
Comment: Commenters agreed with our proposal to allow auxiliary
personnel to furnish the services of CPT codes 99453 and 99454 under
the general supervision of the billing physician or practitioner.
Response: We thank commenters for their support of this proposal.
After considering comments related to these two proposals, we are
finalizing both as proposed.
3. Transitional Care Management (TCM)
Payment for TCM CPT codes 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 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 seven calendar days of discharge) was finalized in
the CY 2013 PFS final rule (77 FR 68979 through 68993). At that time,
we identified a list of 57 HCPCS codes (see 77 FR 68990 for the
original guidance) that we stated could not be billed concurrently with
TCM services because of potential duplication of services.
For CY 2020, recognizing that use of TCM services was low when
compared to the number of Medicare beneficiaries with eligible
discharges and that increased utilization of medically necessary TCM
services could improve patient outcomes, one of our proposals included
modifying our prior rule that prohibited the billing of TCM services
with many other services that we had viewed as duplicative (77 FR
68990). In the CY 2020 PFS final rule (84 FR 62685 through 62687), we
finalized a policy to allow concurrent billing of TCM services, when
reasonable and necessary, with 16 actively priced (that is, not bundled
or non-covered) codes during the 30-day period covered by TCM services.
We stated at the time that we would continue to refine our billing
policies for TCM through future notice and comment rulemaking.
In the CY 2021 PFS proposed rule (85 FR 50120), we proposed to
remove 14 additional actively priced (not bundled or non-covered) HCPCS
codes from the list of remaining HCPCS codes that cannot be billed
concurrently with TCM for CY 2021. We noted that we believe that no
overlap exists that would warrant preventing concurrent reporting
between TCM and the services of these 14 codes. We also proposed to
allow the new Chronic Care Management code HCPCS code G2058 to be
billed concurrently with TCM when reasonable and necessary. We stated
that the minutes counted for TCM services cannot also be counted
towards other services. Table 18 lists the 15 codes that we proposed
could be billed concurrently with TCM services when reasonable and
necessary. We welcomed comment on our proposal to allow these
additional services to billed concurrently with the TCM service.
We received public comments on the TCM proposals. The following is
a summary of the comments we received and our responses.
Comment: Commenters wrote in support of our proposal to allow HCPCS
code G2058 to be billed concurrently with TCM when reasonable and
necessary. Commenters agreed that time should not be double-counted,
and that services should not overlap, but should be separately
reportable.
Response: We thank the commenters for their support of our proposal
to allow HCPCS code G2058 to be billed concurrently with TCM when
reasonable and necessary.
Comment: Commenters stated that the services described by the 14
ESRD codes proposed for separate payment do not overlap or duplicate
TCM services and should be paid separately when reasonable and
necessary.
Response: We appreciate the support of commenters.
Comment: A few commenters disagreed with our proposal to allow the
[[Page 84547]]
ESRD codes and the chronic care management code HCPCS code G2058 to be
billed concurrently with TCM. These commenters instead urged CMS to
allow the RUC process and recommendations determine how these codes
should be valued/revalued and reported, rather than having CMS apply a
different approach.
Response: We recognize that some commenters would prefer that we
follow the AMA RUC recommendations for code valuations and billing
policies. We appreciate the work the AMA committees, and in particular
the RUC, do to provide recommendations. We will continue to consider
those recommendations along with other information when we develop
values and payment policies under the PFS. We believe that allowing
concurrent billing of TCM services with the proposed ESRD codes and
HCPCS code G2058, when reasonable and necessary, can improve patient
outcomes.
After considering the public comments, we are finalizing our
proposal to remove 14 additional actively priced (not bundled or non-
covered) HCPCS codes from the list of remaining HCPCS codes that cannot
be billed concurrently with TCM for CY 2021. We also are finalizing our
proposal to allow HCPCS code G2058 (which we are finalizing in this
rule as new CPT code 99439, see the codes in section II.H. for further
information) to be billed concurrently with TCM when reasonable and
necessary.
[GRAPHIC] [TIFF OMITTED] TR28DE20.029
4. Psychiatric Collaborative Care Model (CoCM) Services (HCPCS Code
G2214)
In the CY 2017 PFS final rule (81 FR 80230), we established G-codes
used to bill for monthly services furnished using the Psychiatric
Collaborative Care Model (CoCM), an evidence-based approach to
behavioral health integration that enhances ``usual'' primary care by
adding care management support and regular psychiatric inter-specialty
consultation. These G-codes were replaced by CPT codes 99492-99494,
which we established for payment under the PFS in the CY 2018 PFS final
rule (82 FR 53077).
Stakeholders have requested additional coding to capture shorter
increments of time spent, for example, when a patient is seen for
services, but is then hospitalized or referred for specialized care,
and the number of minutes required to bill for services using the
current coding is not met. To accurately account for these resources
costs, in the CY 2021 PFS proposed rule (85 FR 50121), we proposed to
establish a G-code to describe 30 minutes of behavioral health care
manager time. Since this code would describe one half of the time
described by the existing code that describes subsequent months
[[Page 84548]]
of CoCM services, we proposed to price this code based on one half the
work and direct PE inputs for 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
practitioners;
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.
Therefore, as proposed, the work RVU for the new proposed code is
0.77. We proposed that this code could be used for either the initial
month or subsequent months. We noted that the existing CPT time rules
for the CoCM services would apply. As proposed, the code would be:
GCOL1: Initial or subsequent psychiatric collaborative
care management, first 30 minutes in a 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.
We proposed that the required elements listed for CPT code 99493
would also be required elements for billing HCPCS cod GCOL1.
Additionally, we proposed that CPT time rules would apply, consistent
with the guidance in the CPT codebook for CPT codes 99492-99494.
In the CY 2017 PFS final rule (81 FR 80235), we finalized that CCM
and BHI services could be billed during the same month for the same
beneficiary if all the requirements to bill each service are separately
met. We also proposed that HCPCS code GCOL1 could be billed during the
same month as CCM and TCM services, provided that all requirements to
report each service are met and time and effort are not counted more
than once. We noted that the patient consent requirement would apply to
each service independently.
In the CY 2017 PFS final rule (81 FR 80235), we finalized that the
psychiatric CoCM services may be furnished under general supervision
because we do not believe it is clinically necessary that the
professionals on the team who provide services other than the treating
practitioner (namely, the behavioral health care manager and the
psychiatric consultant) must have the billing practitioner immediately
available to them at all times, as would be required under a higher
level of supervision. Therefore, consistent with the other codes in
this code family (CPT codes 99492-99494), we proposed to add HCPCS code
GCOL1 to the list of designated care management services for which we
allow general supervision.
We welcomed comments on the proposal to create this new code, as
well as the proposed valuation.
We received public comments on the CoCM services (HCPCS code GCOL1)
proposal. The following is a summary of the comments we received and
our responses.
Comment: Several commenters supported the creation of a new code to
describe a shorter duration of time than is captured by the existing
codes describing the psychiatric collaborative care model, noting that
this will provide greater flexibility, remove barriers, and encourage
further adoption of this model of care. One commenter opposed
implementing this code without obtaining further evidence that it is
warranted, while another commenter encouraged CMS to work with the CPT
Editorial Panel to create a CPT code that would be available for
billing by all payers. One commenter urged CMS to eliminate the
copayment and deductible for CoCM and other care management services.
Response: We note that we do not have the statutory authority to
remove application of the copayment or deductible for these services.
After considering the public comments, we are finalizing the creation
of HCPCS code GCOL1 as proposed. We note that HCPCS GCOL1 was a
placeholder code identifier. The final code is HCPCS code G2214
(Initial or subsequent psychiatric collaborative care management, first
30 minutes in a 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). We
welcome the opportunity to work with the CPT Editorial Panel in the
event they are interested in adopting this code into the CPT code set.
F. Refinements to Values for Certain Services To Reflect Revisions to
Payment for Office/Outpatient Evaluation and Management (E/M) Visits
and Promote Payment Stability During the PHE for COVID-19
1. Background
a. Evaluation and Management (E/M) Visits Overview
Physicians and other practitioners who are paid under the PFS bill
for common office visits for E/M visits using a relatively generic set
of CPT codes (Level I HCPCS codes) that distinguish visits based on the
level of complexity, site of service, and whether the patient is new or
established. These CPT codes are broadly referred to as E/M visit codes
and historically have included three key components within their code
descriptors: History of present illness (history), physical examination
(exam), and medical decision-making (MDM).\4\
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\4\ 2019 CPT Codebook, Evaluation and Management, pages 6
through 13.
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Currently, there are five levels of O/O E/M visits. There are five
codes representing each level for new patients (CPT codes 99201 through
99205), and five codes representing each level for established patients
(CPT codes 99211 through 99215). CPT code 99211 (Level 1 established
patient) is the only code in the O/O E/M visit code set that describes
a visit that may be performed by the billing practitioner or by
clinical staff under supervision, and that has no specified history,
exam or MDM (see Table 19).
In total, E/M visits billed using these CPT codes comprise
approximately 40 percent of allowed charges for PFS services; and O/O
E/M visits, in particular, comprise approximately 20 percent of allowed
charges for PFS services. Within the E/M visits represented in these
percentages, there is wide variation in the volume and level of E/M
visits billed by different specialties. According to Medicare claims
data, E/M visits are furnished by nearly all specialties, but represent
a greater share of total allowed charges for physicians and other
practitioners who do not routinely furnish procedural interventions or
diagnostic tests.
[[Page 84549]]
Generally, these practitioners include primary care practitioners and
certain other specialists such as neurologists, endocrinologists and
rheumatologists. Certain specialties, such as podiatry, tend to furnish
lower level E/M visits more often than higher level E/M visits. Some
specialties, such as dermatology, tend to bill more E/M visits on the
same day as they bill minor procedures.
b. Overview of Policies Finalized in CY 2020 for CY 2021
In the CY 2020 PFS final rule (84 FR 62844 through 62860), for the
O/O E/M visit code set (CPT codes 99201 through 99215), we finalized a
policy to generally adopt the new coding, prefatory language, and
interpretive guidance framework that has been issued by the AMA's CPT
Editorial Panel (see https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management) and will be effective January 1, 2021.
Under this new CPT coding framework, history and exam will no longer be
used to select the level of code for O/O E/M visits. Instead, an O/O E/
M visit will include a medically appropriate history and exam, when
performed. The clinically outdated system for number of body systems/
areas reviewed and examined under history and exam will no longer
apply, and the history and exam components will only be performed when,
and to the extent, reasonable and necessary, and clinically
appropriate.
The changes will include deletion of CPT code 99201 (Level 1
office/outpatient visit, new patient), which the CPT Editorial Panel
decided to eliminate because CPT codes 99201 and 99202 are both
straightforward MDM and currently largely differentiated by history and
exam elements. Table 19 provides an overview of how the level 1 and
level 2 O/O E/M visits are currently structured, demonstrating this
current overlap.
[GRAPHIC] [TIFF OMITTED] TR28DE20.030
For levels 2 through 5 O/O E/M visits, selection of the code level
to report will be based on either the level of MDM (as redefined in the
new AMA/CPT guidance framework, also available on the AMA website at
https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management) or the total time personally spent by the reporting
practitioner on the day of the visit (including face-to-face and non-
face-to-face time). We continue to believe these policies will further
our ongoing effort to reduce administrative burden, improve payment
accuracy, and update the O/O E/M visit code set to better reflect the
current practice of medicine.
Regarding prolonged visits, we finalized separate payment for a new
prolonged visit add-on CPT code (CPT code 99XXX), and discontinued the
use of CPT codes 99358 and 99359 (prolonged E/M visit without direct
patient contact) to report prolonged time associated with O/O E/M
visits. We refer readers to the CY 2020 PFS final rule for a detailed
discussion of this policy (84 FR 62849 through 62850). We are not
opposed in concept to reporting prolonged office/outpatient visit time
on a date other than the visit, but we believe there should be a single
prolonged code specific to O/O E/M visits that encompasses all related
time.
Also, we finalized separate payment for HCPCS code GPC1X, to
provide payment for visit complexity inherent to E/M 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 condition,
or a complex condition.
The AMA RUC resurveyed and revalued the revised O/O E/M visit code
set, concurrent with the CPT Editorial Panel redefining the services
and associated interpretive guidance, and provided us with its
recommendations. In the CY 2020 PFS final rule, we also addressed and
responded to the AMA RUC recommendations. We finalized new values for
CPT codes 99202 through 99215, and assigned RVUs to the new O/O E/M
prolonged visit CPT code 99XXX, as well as the new HCPCS code GPC1X.
These valuations were finalized with an effective date of January 1,
2021. In Table 20, we provide a summary of the codes and work RVUs
finalized in the CY 2020 PFS final rule for CY 2021.
[[Page 84550]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.031
c. Continuing Stakeholder Feedback
Since issuing the CY 2020 PFS final rule, we have continued to
engage with the stakeholder community on the issues addressed in this
section of our CY 2021 PFS final rule. These include the time values
for levels 2-5 O/O E/M visit codes, revaluation of services that are
analogous to O/O E/M visits, the definition and utilization assumptions
for the add-on code for office/outpatient visit complexity (GPC1X), and
the required time to report prolonged O/O E/M visits. In the CY 2021
PFS proposed rule (85 FR 50121 through 50139), we included proposals on
these topics based on continued feedback from stakeholders in the form
of public comments, written requests, meetings, and other formal and
informal discussions. In this section of our final rule, we summarize
and respond to the public comments we received in response to our CY
2021 PFS proposals, and discuss our final polices.
2. Revisions for CY 2021
a. Time Values for Levels 2-5 Office/Outpatient E/M Visit Codes
In the CY 2020 PFS proposed rule (84 FR 40675), we sought comment
on the times associated with the O/O E/M visits as recommended by the
AMA RUC. When surveying these services for purposes of valuation, the
AMA RUC requested that survey respondents consider the total time spent
on the day of the visit, as well as any pre- and post-service time
occurring within a timeframe of 3 days prior to the visit and 7 days
after, respectively. In developing its recommendations to us, the AMA
RUC then separately averaged the survey results for pre-service, day of
service, and post-service times, and the survey results for total time,
with the result that, for some of the codes, the sum of the times
associated with the three service periods does not match the RUC-
recommended total time. The approach used by the AMA RUC to develop
recommendations sometimes resulted in two conflicting sets of times:
The component times as surveyed and the total time as surveyed. In the
CY 2020 PFS final rule, we finalized adoption of the RUC-recommended
times as explained below, but stated that we would continue to consider
whether this issue has implications for the PFS broadly. When we
establish pre-, intra-, and post-service times for a service under the
PFS, these times always sum to the total time. We believe it would be
illogical for component times not to sum to the total, and this idea is
reflected in our ratesetting system, which requires component times to
sum to the total time. Commenters on the CY 2020 PFS proposed rule (84
FR 62849) stated that we should adopt the times as recommended by the
RUC, and did not provide any additional details on the times they
believed we should use when the total time is not the sum of the
component times. Table 21 illustrates the AMA RUC surveyed times for
each service period and the surveyed total time. It also shows the
actual total time calculated as the sum of the component times.
[[Page 84551]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.032
Given the lack of clarity provided by commenters on the CY 2020 PFS
proposed rule about why the sum of minutes in the components would
differ from the total minutes, and our view and systems requirement
that total time must equal the mathematical total of component times,
we proposed beginning in CY 2021 to adopt the actual total times
(defined as the sum of the component times) rather than the total times
recommended by the RUC for CPT codes 99202 through 99215. The following
is a summary of the comments we received and our responses.
Comment: Some commenters did not support our proposal to adopt the
actual total times (defined as the sum of the component times) rather
than the total times recommended by the RUC for CPT codes 99202 through
99215. These commenters further stated, if we were to use the sum of
the component times instead of the RUC-recommended median total time,
that we would not be appropriately capturing the physician time for the
office visits, which were based on a robust survey, if we were to use
the sum of the component times instead of the RUC recommended median
total time.
One commenter suggested that the median survey total time for the
office visits should be utilized to retain relativity. The commenter
explained that, while total time is usually a sum of the pre-, intra-
and immediate post-service time, for purposes of the office visit
survey, the pre-service time was described as 3 calendar days prior to
the office visit, the intra-service time was described as the calendar
day of the office visit and the post-service time was described as
within 7 days following the office visit. The commenter stated that the
median survey total time will not necessarily equal the sum of the
median times for each of the 3 time periods because of different
practitioner workflow patterns that result in different proportions of
the practitioners' times being spent in different components of the
service. However, the total times as recommended by the RUC accurately
capture the time associated with furnishing the service, regardless of
whether that work was performed on the date of encounter or other dates
surrounding the office visit. The commenter also suggested that the
median of the component times was mathematically more appropriate than
the median of the total times, because the function of a median is to
limit the influence of outlier values.
Some commenters supported our proposal, stating that the RUC's
survey methodology, which included collection of time before and after
the day of the encounter, resulted in an overestimation of time and
work, and that the total time in the CMS work time database should
reflect the sum of the pre-, intra-, and post-times collected using the
RUC survey. This methodology is consistent with the total times for all
other codes in the fee schedule.
Response: We continue to believe that it would be illogical for
component times not to sum to the total, and we reiterate that our
ratesetting programs are constructed in a manner that assumes this.
While we recognize the value of robust survey data, for purposes of
consistency and relativity, we believe we should use a consistent
methodology across the fee schedule. Also it is not clear why the RUC
surveyed time before and after the date of service since the new CPT
coding guidance instructs practitioners to report this time using CPT
codes 99358 and 99359 (although CMS will no longer recognize 99358-
99359 for this purpose, for reasons discussed elsewhere in this
section). Having considered the public comments received, we are
finalizing our proposal to adopt the actual total times (defined as the
sum of the component times) rather than the total times recommended by
the RUC for CPT codes 99202 through 99215.
b. Revaluing Services That Are Analogous to Office/Outpatient E/M
Visits
In our proposed rule, we recognized that there are services other
than the global surgical codes for which the values are closely tied to
the values of the O/O E/M visit codes. We proposed to increase the
valuations for these services commensurate with the valuation increases
we previously finalized for the O/O E/M visit codes for 2021. Our
proposals took into account input from the public (especially our 2020
comment solicitation on this topic) and our own internal review. We
proposed to increase valuations for the following:
End-Stage Renal Disease Monthly Capitation Payment (ESRD
MCP) services.
Transitional care management (TCM) services.
Maternity services.
Cognitive impairment assessment and care planning.
Annual wellness visits (AWV) and initial preventive
physical exam (IPPE).
Emergency department (ED) visits.
Therapy evaluations.
Certain behavioral healthcare services.
Many of these services were valued via a building block methodology
and have O/O E/M visits explicitly built into their definition or
valuation. We noted that, unlike the global surgical codes, some of
these services always include an O/O E/M visit(s) furnished by the
reporting practitioner as part of the service, and therefore, it may be
appropriate to adjust their valuations commensurate with any changes
made to the values for O/O E/M visits. Some of these services do not
actually include an E/M visit, but we valued them using a direct
crosswalk to the RVUs assigned to an O/O E/M visit(s), and for this
[[Page 84552]]
reason they are closely tied to values for O/O E/M visits. Overall, we
believed that the magnitude of the changes to the values of the O/O E/M
visit codes and the associated redefinitions of the codes themselves
are significant enough to warrant an assessment of the accuracy of the
values of services containing, or closely analogous to, O/O E/M visits.
We received public comments in response to the CY 2020 PFS proposed
rule in support of revaluing certain services commensurate with the new
O/O E/M visit values. There was particular support from commenters for
revaluing the ESRD (MCP) services, TCM services, cognitive impairment
assessment and care planning services, and the (ED) visits. Based on
input provided after publication of the CY 2020 PFS final rule by the
American College of Obstetricians and Gynecologists (ACOG), we also
proposed to revalue the maternity surgical packages, which, unlike
other global surgery services, were valued using a methodology,
described in more detail below, that allowed the valuation of the
composite parts of the package to sum to the total value. Additionally,
unlike the 10- and 90-day global surgical services codes (referred to
in this section as 10- and 90-day globals), we had never expressed
concerns as to the accuracy of the values of the maternity packages,
and these services were not part of the policy we adopted to transition
all 10- and 90- day globals to 0-day globals (79 FR 67591), though that
policy was overridden by statutory amendments before it took effect. We
also proposed to revalue certain physical therapy evaluations and
behavioral healthcare services as closely analogous to the office/
outpatient E/M visits. We did not propose to revalue certain
ophthalmology services that the public brought to our attention.
In general, some commenters to the CY 2021 PFS proposed rule
indicated that they believe CMS used inconsistent methodologies to
revise the proposed RVUs to reflect the marginal increase in office/
outpatient E/M visits; that other code sets should go through the same
consensus process whereby CMS, CPT and the AMA RUC all agree that the
services need to be redefined to better describe existing practice and
then be revalued; and that CMS should increase all of the global
surgical codes if any single global code is increased to reflect
changes to the office/outpatient E/M visits. Other commenters agreed
with our proposals and methodologies, and a few suggested additional
services that should be revalued as analogous to office/outpatient E/M
visits. In the following section of our final rule, we discuss the
public comments we received in greater detail, respond to the comments
and discuss our final policies. By way of overview, we note that we did
not rely on any single factor in deciding whether to consider a given
code(s) as analogous to office/outpatient E/M visits. Different factors
apply to different services, and we took into consideration all of the
factors relevant for the code(s) in question, considered together.
(1) End-Stage Renal Disease Monthly Capitation Payment Services
In the CY 2004 PFS final rule with comment period (68 FR 63216), we
established new Level II HCPCS G codes for ESRD services and
established MCP rates for them as specified under section
1881(b)(3)(A)(ii) of the Act. For ESRD center-based patients, payment
for the G codes varied based on the age of the beneficiary and the
number of face-to-face visits furnished each month (for example, 1
visit, 2-3 visits and 4 or more visits). We believed that many
physicians would provide 4 or more visits to center-based ESRD
patients, and a small proportion would provide 2 to 3 visits or only
one visit per month. Under the MCP methodology, to receive the highest
payment, a physician would have to furnish at least 4 ESRD-related
visits per month. In contrast, payment for home dialysis MCP services
only varied by the age of beneficiary. Although we did not initially
specify a frequency of required visits for home dialysis MCP services,
we stated that we expect physicians to provide clinically appropriate
care to manage the home dialysis patient.
The CPT Editorial Panel created new CPT codes to replace the G
codes for monthly ESRD-related services, and we finalized the new codes
for use under the PFS in CY 2009 (73 FR 69898). The codes created were
CPT codes 90951 through 90962 for monthly ESRD-related services with a
specified number of visits; CPT codes 90963 through 90966 for monthly
ESRD-related services for home dialysis patients; and CPT codes 90967
through 90970 for home dialysis patients with less than a full month of
services. The latter set of codes is billed per encounter and valued to
be 1/30 of the value of CPT codes 90965 and 90966.
In response to our comment solicitation in the CY 2020 PFS final
rule and interim final rule regarding whether to adjust the values of
the ESRD MCP codes to reflect the increased values of the office/
outpatient E/M visit codes, we received a number of supportive
comments. These commenters stated that the MCP bundled payments for all
ESRD-related care for a month were constructed using a building block
methodology and a number of office/outpatient E/M visits were component
parts of those bundles; and that the specified number of visits in the
code descriptor must be furnished in order to bill for the service.
Commenters also noted that although the values of office/outpatient E/M
visit codes have been increased once since the creation of the MCP G
codes and once after adoption of the MCP CPT codes, the valuation of
the ESRD MCP codes was never adjusted to account for increases to the
office/outpatient E/M visit codes. In Table 22, we provide a summary of
the visits included in the valuation of each ESRD MCP service.
[[Page 84553]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.033
In the past, we have not updated the valuation of this code set to
reflect updates to the valuation of the office/outpatient E/M visit
code set, and we do not have information on the number and level of
visits actually furnished in connection with these services. So over
time, the values of the ESRD MCP codes may have become out of step with
valuation of their constituent visits. We believe there is sufficient
reason to revalue these services to take into account the changes in
valuation for the office/outpatient E/M visits. These services were
initially valued using a building block methodology that summed the
value of the individual service from its components, and for some of
the codes in this code set, a specified number of visits must be
furnished in order to bill for the respective ESRD MCP code because
they are included in the code descriptor.
Therefore, we noted that we believe that the ESRD MCP codes should
be updated to more accurately account for the associated office/
outpatient E/M visits. We proposed to increase the work, physician
time, and PE inputs in the form of clinical staff time of the ESRD MCP
codes based on the marginal difference between the 2020 and 2021
office/outpatient E/M visit work, physician time, and PE inputs built
into each code, as summarized in Tables 23 and 24. By improving payment
accuracy for the ESRD MCP codes, we would also be supporting broader
efforts at advancing kidney health.\5\ We noted that we believe the
majority of the visits included in the ESRD MCP bundles are being
furnished, but sought comment on whether there are instances where the
number and/or level of visits being furnished are not consistent with
the number and level of visits built into the valuation of the code.
The following is a summary of the comments we received and our
responses.
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\5\ HHS Launches President Trump's `Advancing American Kidney
Health' Initiative: https://www.hhs.gov/about/news/2019/07/10/hhs-launches-president-trump-advancing-american-kidney-health-initiative.html.
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Comment: One commenter noted that CMS inadvertently indicated a
proposed work RVU of 8.04 for CPT code 90966 in in Table 19 in the CY
2021 PFS proposed rule (85 FR 50129). The commenter urged CMS to
finalize a work RVU of 8.04 for this code to help eliminate structural
barriers the commenter believes exist to home dialysis, and relieve the
disparity in modality choice, as home dialysis receives a low RVU
remuneration compared to in-center hemodialysis. Another commenter
stated that the work RVU published in Addendum B of the proposed rule,
5.52, is the more accurate value.
Response: We regret the drafting error, and we reiterate that we
did indeed propose a work RVU of 5.52 for CPT code 90966 as reflected
in Addendum B. While we appreciate the concerns regarding access to
care, we agree with comments stating that the proposed work RVU of 5.52
is the more accurate value.
Comment: Some commenters supported our proposal to increase the
value of these services in light of previous changes to the E/M visit
values. However, some commenters did not support increases to these
code values absent a formal review, stating that it would be
inconsistent to consider increasing values for some services and not
others that are closely tied to the values of the office/outpatient E/M
visit codes and/or codes that have E/M visits explicitly built into
their definition or valuation, and that these codes should be subject
to the same process for other potentially misvalued services. One
[[Page 84554]]
commenter disapproved of our proposed increasing the rates for these
services, and stated that not all of the ESRD-related service CPT codes
90951-90962 were valued with a building block methodology of discrete
E/M services. These commenters stated that CPT code 90951 was valued
using magnitude estimation with a crosswalk to CPT code 99295, while
CPT code 90954 was valued with a crosswalk to CPT code 99293. The
commenters noted that both CPT code 99293 and 99295 have since been
deleted. The commenters further stated that for the rest of the ESRD
codes, the numbers and levels of visits were not determined based on
surveys that led to use of the building block methodology; rather, they
were negotiated using magnitude estimation in comparison to the two
codes, CPT codes 99295 and 99293.
Response: Commenters are incorrect as to the methodology used to
value CPT code 90951 in the proposed rule (as summarized in Table 22).
We adopted the RUC recommended value for this service, which included
the value of 13 instances of CPT code 99214 in the bundle. It was not
valued using a crosswalk. However, we continue to believe it is
accurate to consider these services as being among those for which
values are closely tied to the values of the office/outpatient E/M
visit codes. The ESRD MCP codes have numbers of visits explicitly built
into their definitions, the majority of which we believe are taking
place. Proportionate increases for these two codes will also maintain
the relative relationships among the codes in this family.
We agree with commenters that CPT code 90954, this code was
initially valued based on a crosswalk to CPT code 99293. When CPT code
99293 was deleted, it was replaced by CPT code 99471. By crosswalking
CPT code 90954 to CPT code 99471, the relationship established between
the two services is preserved. The public may nominate any code(s) as
potentially misvalued through the usual misvalued code process or
request resurvey or valuation through the AMA RUC.
We did not receive responses to our request for comments on whether
there are instances where the number and level of visits actually
furnished by practitioners reporting the ESRD MCP services differs from
the number and level assumed in the valuation.For example, as shown in
Table 22, the valuations included specified numbers and levels of
office/outpatient E/M visits, but because the descriptors do not
require the same level and number of visits to be furnished in order to
report the services, the office/outpatient E/M visit resources assumed
to be included in the ESRD services might not actually be expended. CPT
code 90957 (End-stage renal disease (ESRD) related services monthly,
for patients 12-19 years of age to include monitoring for the adequacy
of nutrition, assessment of growth and development, and counseling of
parents; with 4 or more face-to-face visits by a physician or other
qualified health care professional per month) was valued with 1x 99215,
3x 99214, and 3x 99213. However, CPT code 90957 includes four or more
visits of unspecified levels. Similar to the global surgical codes,
this might suggest that we should not ``transfer'' the increase in
valuation of the stand-alone office/outpatient E/M visits into these
ESRD bundles. Unlike TCM, the number and level of visit included in the
ESRD service valuations does not necessarily match the actual services
furnished and billed. We continue to be concerned that the number and
level of visits built into the valuation of these codes may not
accurately reflect the number and level of visits actually being
furnished, such that they may be misvalued. We may consider this issue
through future rulemaking, as we have for the global surgical codes.
However, we still believe the ESRD MCP codes are different from the
global surgical codes in that they are valued using building block and
involve largely medical care rather than procedural care. The ESRD
monthly services include ongoing medical management of a chronic
condition, which makes them more similar to the kind of work typically
furnished and billed as office/outpatient E/M visits. Therefore, we
continue to believe that the ESRD MCP services' valuation should be
increased commensurate with the changes made to the values for office/
outpatient E/M visits at this time as was proposed, and we are
finalizing as proposed.
2. TCM Services (CPT Codes 99495 and 99496)
The goal of TCM services is to improve the health outcomes of
patients recently discharged from inpatient and certain outpatient
facility stays. We began making separate payment for TCM services in CY
2013. At that time, CPT code 99495 (Transitional Care Management
Services with the following required elements: Communication (direct
contact, telephone, electronic) with the patient and/or caregiver with
2 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) was valued to include one, level
4 established patient office/outpatient visit, while CPT code 99496
(Transitional Care Management Services with the following required
elements: Communication (direct contact, telephone, electronic) with
the patient and/or caregiver with 2 business days of discharge; medical
decision making of high complexity during the service period; face-to-
face visit within 7 calendar days of discharge) was valued to include
one, level 5 established patient office/outpatient visit (77 FR 68991).
In the CY 2020 PFS final rule (84 FR 62687), we finalized the RUC-
recommended work and direct PE inputs for the TCM codes which resulted
in small RVU increases for both codes.
Because both TCM codes include a required face-to-face E/M visit
(either a level 4 or 5 office/outpatient E/M visit), we proposed to
increase the work RVUs associated with the TCM codes directly to the
new valuations for the level 4 (CPT code 99214) and level 5 (CPT code
99215) office/outpatient E/M visits for established patients. Please
see Tables 23 and 24 for long descriptors, as well as current and final
work RVUs, physician time, and clinical staff time, for the TCM codes.
Comment: We received several comments specific to TCM, all in
support of our proposal to revalue the TCM codes, although they did not
provide specific rationale.
Response: We continue to believe that the values for services that
explicitly include a single E/M visit of a given setting and level, and
that were valued using a direct crosswalk to that visit, should be
increased to reflect the new values for the included E/M visit. At this
time, we are finalizing our proposed revised values for the two TCM
codes shown in Table 23.
3. Maternity Services
In the CY 2002 PFS final rule with comment period (66 FR 55392-
55393), we finalized separate global payment for maternity care
services. The maternity packages are unique within the PFS in that they
are the only global codes that provide a single payment for almost 12
months of services, including visits and other medical care, delivery
services (that may include surgical services), and imaging; and were
valued using a building-block methodology as opposed to the magnitude
estimation method that is commonly used to value the 10- and 90-day
global services. Seventeen CPT codes are used to bill for delivery,
antepartum, and postpartum maternity care services, and these codes are
all designated with a unique global period indicator ``MMM.''
[[Page 84555]]
For CY 2021, the AMA RUC made a recommendation to revalue these
services, along with their recommendations to revalue the 10- and 90-
day global surgical packages, to account for increases in the values of
office/outpatient E/M visits. In the CY 2020 PFS final rule, we decided
not to make changes to the valuation of 10- and 90- day global surgical
packages to reflect changes made to values for the office/outpatient E/
M visit codes while we continue to collect and analyze the data on the
number and level of office/outpatient E/M visits that are actually
being performed as part of these services.
The 10- and 90-day global surgical packages are commonly valued
using a methodology known as magnitude estimation. Magnitude estimation
refers to a methodology for valuing work that identifies 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. Since its
inception, the AMA RUC has worked under the prevailing assumption that
magnitude estimation is the standard for valuation of all physicians'
services, including those with global surgical packages. Consequently,
the work values associated with expected typical E/M visits within a
code's global period are not necessarily added to the physician work
value for the code to determine the final work RVU. The postoperative
visits in the 10- or 90-day global surgical code periods are often
valued with reference to RVUs for separately-billed E/M visits, but the
bundled post-operative visit RVUs do not directly contribute a certain
number of RVUs to the valuation of the procedures.
In contrast, the MMM codes are unique in both the length of the
global period and the methodology under which they were valued. When
CMS established values for the maternity packages, we based them on RUC
recommendations developed by the relevant specialty societies using the
building block methodology. When it is used for a CPT code representing
a bundle of services, the building block methodology components are the
CPT codes that are considered to make up the bundled code and the
inputs associated with those codes. Therefore, when the maternity
packages were valued, the work (and other inputs) associated with the
office/outpatient E/M visits in each package were explicitly included
(along with values associated with imaging and other services in the
package).
In addition, unlike the global surgical codes, we have reason to
believe the visits included in the maternity codes are actually
furnished given the evidence-based standards and professional
guidelines for obstetrical care. For example, The Guidelines for
Perinatal Care state that ``a woman with an uncomplicated first
pregnancy is examined every 4 weeks for the first 28 weeks of
gestation, every 2 weeks until 36 weeks of gestation, and weekly
thereafter.''\6\ For this reason, we excluded the maternity codes from
our recent global surgery data collection.
---------------------------------------------------------------------------
\6\ Kilpatrick SJ, Papile L, and Macones GA, eds. AAP Committee
on Fetus and Newborn and ACOG Committee on Obstetric Practice.
Guidelines for Perinatal Care. Eighth Edition. 2017. Page 150.
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Given the valuation methodology and expectations for office/
outpatient E/M visits in the maternity package codes, and the
revaluation recommendation developed by the AMA RUC, we believe that
the maternity packages should be updated to more accurately reflect the
values of the office/outpatient E/M visits included in the packages. We
believe that, due to the use of the building block valuation
methodology rather than magnitude estimation, and the likelihood that
the bundled visits are actually being furnished, the valuations
recommended to us by the AMA RUC more accurately reflect the resource
costs associated with furnishing these services. In the past, the work,
physician time, and PE for these services have not been revalued to
reflect changes to the office/outpatient E/M visits that are included
as part of the package and therefore, the valuation of the MMM surgical
packages have become misaligned with the valuation of their constituent
office visits.
When revaluing the maternity packages, the AMA RUC used a
methodology similar to what we used when revaluing the ESRD MCP codes
and TCM by adding in the marginal differences in work, physician time,
and PE in the form of clinical staff time between the current and 2021
E/M values. We noted that we believe that this method accurately
accounts for the increase in valuation relative to the office/
outpatient E/M visits. Therefore, we proposed to increase the work
RVUs, physician time, and PE inputs in the form of clinical staff time
associated with the maternity packages by accepting the revaluation
recommendation from the AMA RUC as detailed in Tables 23 and 24.
We also noted that, in addition to appropriately reflecting changes
to values of the office and outpatient E/M visits, increases made to
the valuation of the maternity package codes would be consistent with
our broader focus on improving maternal health and birth outcomes. The
proposed changes would account for additional resources involved with
additional work that is needed on the part of practitioners to improve
care for this patient population, such as risk identification and
ensuring appropriate interventions and referrals.\7\
---------------------------------------------------------------------------
\7\ https://www.hhs.gov/blog/2020/01/29/achieving-better-health-mothers-and-babies.html; https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/rural-health/21-Maternal-Health-Forum-Improving-Maternal-Health-for-Our-Communities.pdf; https://innovation.cms.gov/innovation-models/maternal-opioid-misuse-model.
---------------------------------------------------------------------------
We received public comments on our proposal. The following is a
summary of the comments we received and our responses.
Comment: Some commenters supported our proposal regarding the
global maternity codes. However, other commenters requested a fair and
relative payment for maternity care codes and for all global codes,
whether the value of the code is based on magnitude estimation,
building block methodology, or a mix of both methodologies, not any
subset of them using potentially disparate valuation methodologies.
Some commenters stated that it is unfair to apply the RUC-recommended
E/M value increases to stand-alone E/M visits, select global codes (for
example, monthly end-stage renal disease (ESRD) and bundled maternity
care), and select bundled services (for example, monthly psychiatric
management), but not to the E/M visits that are included in the global
surgical packages, and that this will disrupt the relativity of the
MPFS.
Response: We continue to believe that the maternity global surgical
packages are distinct from the 10- and 90-day globals for the reasons
articulated above. We note that commenters did not provide any
information to suggest that the number and level of visits accounted
for in the valuation of these codes are not being performed. In
addition, unlike the global surgical packages, the maternity packages
(and the ESRD monthly services discussed above) are focused on ongoing,
comprehensive medical care. This kind of care is similar to the type of
care typically furnished and billed as office/outpatient E/M visits
and, as such, makes the services analogous. Having considered the
public comments we received, we are finalizing our proposal to revalue
the maternity bundles as recommended by the AMA RUC.
[[Page 84556]]
4. Assessment and Care Planning for Patients With Cognitive Impairment
(CPT Code 99483)
In CY 2017, we established payment for HCPCS code G0505 (Assessment
and care planning for patients with cognitive impairment) to provide
payment for cognitive assessment and care planning for patients with
cognitive impairments, believing that the CPT Editorial Panel was
developing new coding for that service. In response to the CY 2017 PFS
proposed rule, the AMA RUC submitted recommended values for this code,
which we adopted in the CY 2017 PFS final rule. In CY 2018, the CPT
Editorial Panel created CPT code 99483 for reporting of this service
and in CY 2018, CMS adopted CPT code 99483 (deleting HCPCS code G0505)
without changing the service valuation. Based upon input from
commenters and the AMA RUC, the valuation of this service reflected the
complexity involved in assessment and care planning for patients with
cognitive impairment by including resource costs that are greater than
the highest valued office/outpatient E/M visit (CPT code 99205, new
patient level 5 visit) (81 FR 80352). Specifically, the service
includes an evaluation of a patient's cognitive functioning and
requires collecting pertinent history and current cognitive status all
of which require medical decision making of moderate or high
complexity.
With the forthcoming increased valuation for CPT code 99205 in CY
2021, we noted that the current work RVU for CPT code 99483 would have
a lower work RVU than a new patient level 5 office/outpatient E/M
visit. Given the way CPT code 99483 was valued initially, we noted that
this valuation would create a rank order anomaly between the two codes.
Since CPT code 99483 was valued in relation to a level 5 office/
outpatient E/M new patient visit, we believed that an adjustment to the
work, physician time, and PE for this service to reflect the marginal
difference between the value of the level 5 new patient office/
outpatient E/M visit in CY 2020 and CY 2021 would be appropriate to
maintain payment accuracy. Therefore, we proposed to adjust the work,
time, and PE in the form of clinical staff time for CPT code 99483 as
shown in Tables 23 and 24. We used the ratio between the CY 2020 and CY
2021 values for the level 5 new patient office/outpatient visits and
applied that ratio to increase the value of CPT code 99483 commensurate
with the increase to CPT code 99205.
We received public comments on the Assessment and Care Planning for
Patients with Cognitive Impairment (CPT code 99483). The following is a
summary of the comments we received and our responses.
Comment: Commenters generally supported our proposal to increase
the valuation of CPT code 99483 in order to maintain the relationship
between CPT code 99483 and the level 5 new patient office/outpatient
visit, which was an important part of the initial valuation. Commenters
stated that accurate payment for this service is essential for
maintaining access to care for beneficiaries with cognitive impairment.
However, several commenters disagreed with our proposed revaluation
of CPT code 99483. These commenters indicated that our proposed
increase to CPT code 99483 would create a rank order anomaly between
CPT codes 99205 and 99483. Commenters explained that the work RVU and
time for code 99483 were based upon survey data and magnitude
estimation. The RUC did not use any code as a crosswalk for valuation
of CPT code 99483, and CPT code 99205 is not inherent to this service.
Commenters suggested that in order to identify the relative valuation
for the services of CPT code 99483, the code should be referred to the
RUC for review.
Response: While we appreciate the additional insight into the
valuation of these codes, we continue to believe that maintaining the
value of CPT code 99483 at its current rate would create a rank order
anomaly. This service comprises a stand-alone E/M visit that is always
furnished; has most of the same components as CPT code 99205, including
identical interpretive guidance for level of medical decision making;
and was (and continues to appropriately be) valued in direct relation
to CPT code 99205. While the cognitive assessment and care planning
code was valued using magnitude estimation, these other factors provide
additional support for continuing to reflect its exact relationship
with the level 5 new patient office/outpatient visit. Therefore, we
believe these services are sufficiently analogous to warrant preserving
the same relationship. Members of the public can request that the RUC
review certain code sets at any time. After consideration of the public
comments, we are finalizing this proposal to revalue CPT code 99483 as
proposed.
5. Initial Preventive Physical Examination (IPPE) and Initial and
Subsequent Annual Wellness Visits (AWV)
In the CY 2011 PFS final rule with comment period, we finalized
separate payment for HCPCS codes G0438 (Annual wellness visit; includes
a personalized prevention plan of service (pps), initial visit) and
G0439 (Annual wellness visit, includes a personalized prevention plan
of service (pps), subsequent visit). These services were valued via a
direct crosswalk to the work, time, and direct PE inputs associated
with CPT codes 99204 and 99214, respectively. In that same rule, we
stated that the HCPCS code G0402 (Initial preventive physical
examination; face-to-face visit, services limited to new beneficiary
during the first 12 months of Medicare enrollment) was also valued
based on a direct crosswalk to the work, time, and direct PE inputs for
CPT code 99204 (75 FR 73408 through 73411).
Because these codes are valued using direct crosswalks to office/
outpatient E/M visits, we believed that to maintain payment accuracy
for the IPPE and the AWV, their values should be adjusted to reflect
the changes in value for CPT codes 99204 and 99214. Therefore, we
proposed to revise the work, physician time, and direct PE inputs for
these codes as shown in Tables 23 and 24. The following is a summary of
the comments we received and our responses.
Comment: Several commenters agreed with our proposal to revalue the
IPPE and AWV HCPCS codes. These commenters agreed that because these
services were valued using direct crosswalks to CPT codes 99204 and
99214, their values should be updated to reflect the increases to those
visits finalized for CY 2021.
Response: We thank the commenters for their support.
Comment: Several commenters disagreed with our proposal to revalue
the IPPE and AWV HCPCS codes. A commenter indicated that because the
AMA RUC has never reviewed these codes, it is unclear that the work
associated with the services represents work described by a level 4
office/outpatient E/M visit.
Response: We continue to believe that because the IPPE and AWV were
valued using direct crosswalks to CPT codes 99204 and 99214,
respectively, changes to the work associated with CPT codes 99204 and
99214 should be applied to the valuation of the IPPE and AWV codes.
Regarding the point that these codes have not been reviewed by the RUC,
we note that the IPPE and AWV are services that are unique to the
Medicare program. These services are reported using Medicare-specific
HCPCS G codes that are not applicable for other payers. As such, we do
not see a need for these codes to be reviewed by
[[Page 84557]]
the RUC. If the RUC did review them, however, we would consider any RUC
recommendations through our usual rulemaking process. As discussed
above, our decision to consider a given code(s) as analogous to the
office/outpatient E/M visits is not based on any single factor, but
rather, takes into account various applicable factors. The public may
nominate any code(s) as potentially misvalued through the usual
misvalued code process, or request that codes reviewed by the AMA RUC.
We received comments primarily in support of our proposal to
revalue the IPPE and AWV codes. Our proposed revaluations reflect
changes in value to the two office and outpatient E/M codes (that is,
CPT codes 99204 and 99214) upon which the IPPE and AWV code values were
originally crosswalked. We continue to believe that to maintain payment
accuracy, the values for the IPPE and AWV codes should be adjusted
accordingly. After considering the comments, we are finalizing as
proposed.
BILLING CODE 4120-01-P
[[Page 84558]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.034
[[Page 84559]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.035
[[Page 84560]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.036
[[Page 84561]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.037
[[Page 84562]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.038
BILLING CODE 4120-01-C
6. Emergency Department Visits
We have revalued the ED visit codes (CPT codes 99281-99285, see
Table 25 for long descriptors) under the PFS three times: In 1997,
2007, and most recently in 2020 as part of the misvalued code
initiative. In the past, consistent with AMA RUC recommendations, we
revalued these services such that the values of levels 1 through 3 of
the ED visits were equal to levels 1 through 3 new patient office/
outpatient E/M visits, and the levels 4 and 5 ED visits were valued
higher than the levels 4 and 5 new patient office/outpatient E/M visits
to reflect higher typical intensity. Also in the CY 2018 PFS final
rule, we finalized a proposal to nominate all five ED visit codes as
potentially misvalued, based on information suggesting that the work
RVUs for ED visits may not appropriately reflect the full resources
involved in furnishing these services. Specifically, some stakeholders
expressed concerns that the work RVUs for these services have been
undervalued given the increased acuity of the patient population and
the heterogeneity of the sites, such as freestanding and off-campus
EDs, where ED visits are furnished (82 FR 53018). Accordingly, the AMA
RUC resurveyed and reviewed these five codes for the April 2018 RUC
meeting, and provided a recommendation to CMS for consideration in CY
2020 rulemaking. In the CY 2020 PFS final rule (84 FR 62796), we
finalized the RUC-recommended increases to the work RVUs of 0.48 for
CPT code 99281, a work RVU of 0.93 for CPT code 99282, a work RVU of
1.42 for 99283, a work RVU of 2.60 for 99284, and a work RVU of 3.80
for CPT code 99285. The RUC did not recommend, and we did not finalize,
any change in direct PE inputs for the codes in this family. We note
that the AMA RUC submitted these recommended values to CMS prior to the
submission of the RUC-recommended revaluation of the office/outpatient
E/M visit code family.
In response to our proposal to accept the RUC-recommended values
for the ED visits, and to our comment solicitation in CY 2020 PFS
proposed rule regarding whether we should revalue certain services
commensurate with increases to the office/outpatient E/M visits (84 FR
62859 through 62860), a commenter submitted a public comment stating
that relativity between the ED visits and office/outpatient E/M visits
should be maintained, and submitting a specific recommendation for CPT
codes 99283-99285 that was higher than the RUC-recommended values. The
commenter stated we should preserve the relationship between the ED and
office/outpatient E/M visit code sets that was established in prior
years and that they believe would have likely been maintained had the
office/outpatient E/M visits been reviewed prior to the ED visits. In
order to avoid the rank order anomaly whereby an ED visit would be
valued lower than the analogous office/outpatient E/M visit in CY 2021,
we proposed in this current rulemaking cycle to adopt the values
recommended by this commenter, and as shown in Table 25. The following
is a summary of the comments we received and our responses.
Comment: One commenter supported our proposal. This commenter
stated that levels 1-3 ED visits should remain the same as the levels
1-3 new patient office visits, and that levels 4-5 ED visits should
have a higher value than the corresponding office visits due to the
complexity of the patients requiring that level of emergency care.
Response: We are finalizing as proposed, as shown in Table 25, in
order to avoid a rank order anomaly. We understand that the AMA
workgroup on E/M services is continuing to consider further changes in
coding and interpretive guidance for visit level selection for all of
the E/M visit code sets other than the office/outpatient E/M visits, in
light of the recent changes for office/outpatient visits. We will
continue to stay abreast of this important work and continue
considering the appropriate valuation of ED and other E/M visit code
sets in light of any future changes in this arena by the CPT Editorial
Panel and the AMA RUC.
Comment: Several commenters requested that we consider the nursing
facility visits (CPT codes 99304-99318), domiciliary visits (CPT codes
99324-99337), and home visits (CPT codes 99341-99350) to be analogous
to the office/outpatient E/M visits, noting that they are identical in
every way except the setting of care and vulnerability of
[[Page 84563]]
the patient population. These commenters indicated that the CPT
Editorial Panel and the AMA RUC will be reviewing these code sets in
the near future, and their primary concern was to maintain access to
care until this review is complete. Accordingly, these commenters
recommended that we increase the work RVUs for these services to the
extent necessary to maintain the payment rate for these codes at 2020
levels. These commenters provided an estimate of the revised work RVUs
necessary to achieve this as a temporary measure, stating that due to
relatively low service volume, these changes would not negatively
impact the conversion factor.
Response: We did not propose to treat and revalue nursing facility
visits, domiciliary visits and home visits as analogous to office/
outpatient E/M visits. We do not agree with the commenters' assertions
that these visits are identical to the office/outpatient E/M visit
codes. The setting of care means that these visits involve different
resources. In particular, skilled nursing facility (SNF) visits are
reported using the nursing facility visit codes, rendering them
substantially different from office/outpatient visits. For these
reasons, we do not believe the commenters' requested changes to values
for nursing facility visits, domiciliary visits, and home visits would
be appropriate at this time. Additionally, we understand that the AMA
workgroup on E/M services is continuing to consider further changes in
coding and interpretive guidance for visit level selection for all of
the E/M visit code sets other than the office/outpatient E/M visits, in
light of the forthcoming changes for office/outpatient visits. We will
continue to stay abreast of this important work and consider the
appropriate valuation of home, domiciliary, nursing facility and other
E/M visit code sets in light of any future changes in this arena by the
CPT Editorial Panel and the AMA RUC.
7. Therapy Evaluations
There are a number of services paid under the PFS that are similar
in many respects to the office/outpatient E/M visit code set, but do
not specifically include, were not valued to include, and were not
necessarily valued relative to, office/outpatient E/M visits. Some
codes inherently include work associated with assessment and work
associated with management, similar to the work included in the office/
outpatient E/M visits, which involve time spent face-to-face assessing
and treating the patient. These services include therapy evaluation
services and psychiatric diagnostic evaluation services. The
practitioners who furnish these services are prohibited by CMS from
billing E/M services due to the limitations of their Medicare benefit
categories. As such, the CPT Editorial Panel has created specific
coding to describe the services furnished by these practitioners.
Although these services are billed using specific, distinct codes
relating to therapy evaluations and psychiatric diagnostic evaluations,
we believe that a significant portion of the overall work in the codes
is for assessment and management of patients, as it is for the office/
outpatient E/M visit codes.
Therefore, we proposed to adjust the work RVUs for these services
based on a broad-based estimate of the overall change in the work
associated with assessment and management to mirror the overall
increase in the work of the office/outpatient E/M visits. We calculated
this adjustment based on a volume-weighted average of the increases to
the office/outpatient E/M visit work RVUs from CY 2020 to CY 2021.
Details on this calculation are available as a public use file on the
CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices. We proposed
to apply that percentage increase, which we estimated to be
approximately 28 percent, to the work RVUs for the therapy evaluation
and psychiatric diagnostic evaluation services codes. We noted that we
believe that it is important to the relativity of the PFS to revalue
these services to reflect the overall increase in value associated with
spending time assessing and managing patients, as reflected in the
changes to work values for the office/outpatient E/M visits,
particularly in recognition of the value of the clinicians' time which
is spent treating a growing number of patients with greater needs and
multiple medical conditions. We recognized that this is not the
methodology typically used to value services under the PFS and
solicited comment on potential alternative methodologies or specific
values for these services, particularly about whether commenters
believe it would be better to develop values using comparator codes
from the office/outpatient E/M visit code set, and if so, why.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Some commenters supported our proposal to adjust the work
RVUs for outpatient therapy evaluations and to consider alternative
approaches submitted by stakeholders in future rulemaking that may
better reflect the true values. Many commenters urged us to implement
similar increases to the work RVUs of additional therapy services,
including CPT codes 97140 (Manual therapy techniques (eg, mobilization/
manipulation, manual lymphatic drainage, manual traction), 1 or more
regions, each 15 minutes), 97537 (Community/work reintegration training
(eg, shopping, transportation, money management, avocational activities
and/or work environment/modification analysis, work task analysis, use
of assistive technology device/adaptive equipment), direct one-on-one
contact, each 15 minutes), 97542 (Wheelchair management (eg,
assessment, fitting, training), each 15 minutes), 97760 (Orthotic(s)
management and training (including assessment and fitting when not
otherwise reported), upper extremity(ies), lower extremity(ies) and/or
trunk, initial orthotic(s) encounter, each 15 minutes), 97761
(Prosthetic(s) training, upper and/or lower extremity(ies), initial
prosthetic(s) encounter, each 15 minutes), 97763 (Orthotic(s)/
prosthetic(s) management and/or training, upper extremity(ies), lower
extremity(ies), and/or trunk, subsequent orthotic(s)/prosthetic(s)
encounter, each 15 minutes), 97597 (Debridement (eg, high pressure
waterjet with/without suction, sharp selective debridement with
scissors, scalpel and forceps), open wound, (eg, fibrin, devitalized
epidermis and/or dermis, exudate, debris, biofilm), including topical
application(s), wound assessment, use of a whirlpool, when performed
and instruction(s) for ongoing care, per session, total wound(s)
surface area; first 20 sq cm or less), 97598 (Debridement (eg, high
pressure waterjet with/without suction, sharp selective debridement
with scissors, scalpel and forceps), open wound, (eg, fibrin,
devitalized epidermis and/or dermis, exudate, debris, biofilm),
including topical application(s), wound assessment, use of a whirlpool,
when performed and instruction(s) for ongoing care, per session, total
wound(s) surface area; each additional 20 sq cm, or part thereof (List
separately in addition to code for primary procedure)), 97750 (Physical
performance test or measurement (eg, musculoskeletal, functional
capacity), with written report, each 15 minutes), and 97755 (Assistive
technology assessment (eg, to restore, augment or compensate for
existing function, optimize functional tasks and/or maximize
environmental accessibility),
[[Page 84564]]
direct one-on-one contact, with written report, each 15 minutes). These
commenters stated that these services also involve assessment and
management, and thus, are analogous to office/outpatient E/M visit
codes.
Response: In the proposed rule, we discussed that these evaluations
contained types of work, specifically time spent assessing and managing
patients, that is similar to the work described by the office/
outpatient E/M visit code set. We stated that the increase in value
associated with the office/outpatient E/M visits reflected the changes
to work values, particularly in recognition of the value of the
clinicians' time spent treating a growing number of patients with
greater needs and multiple medical conditions, that could also apply to
physical therapy, occupational therapy, and speech language pathology
evaluations. The CPT codes identified by commenters involve work that
is not similar to that captured by the office/outpatient E/M codes,
such as various types of therapeutic treatment. Therefore, we do not
believe it would be appropriate to adjust the values of these codes to
reflect the changes in valuation for the office/outpatient E/M codes.
Comment: Some commenters did not support our proposal to implement
the proposed increases to these therapy codes, stating that it will
amplify a previous misvaluation by CMS for codes that do not
specifically include, were not valued to include, and were not
necessarily valued relative to, office/outpatient E/M visits. According
to the commenters, these therapy codes were originally misvalued when
CMS finalized a single RVU of 1.20 for all three codes rather than the
RUC-recommended work RVUs, which created an overvaluation in aggregate
for these services.
Response: In the proposed rule, we discussed our rationale for
proposing to increase the values of these services relative to the
increased values for the office/outpatient E/M visit code set. If the
commenters believe the therapy codes are not appropriately valued, we
note the public may nominate any code(s) as potentially misvalued
through the usual misvalued code process or request that it be surveyed
or valued through the AMA RUC.
After considering the public comments, we are finalizing the
changes in values for the therapy codes as proposed.
8. Behavioral Healthcare Services
The psychotherapy code set is divided into psychotherapy that can
be furnished as a standalone service and psychotherapy furnished in
conjunction with an office/outpatient E/M visit. The standalone
psychotherapy services are CPT codes 90832, 90834, and 90837 (See Table
25 for long descriptors). The CPT codes describing psychotherapy
furnished in conjunction with an office/outpatient E/M visit are CPT
codes 90833 (Psychotherapy, 30 minutes with patient when performed with
an evaluation and management service (List separately in addition to
the code for primary procedure)), 90836 (Psychotherapy, 45 minutes with
patient when performed with an evaluation and management service (List
separately in addition to the code for primary procedure)) and 90838
(Psychotherapy, 60 minutes with patient when performed with an
evaluation and management service (List separately in addition to the
code for primary procedure)). As the values for the office/outpatient
E/M visits are increasing, there will necessarily be an increase in the
overall value for psychotherapy furnished in conjunction with office/
outpatient E/M visits. We believe that it is important, both in terms
of supporting access to behavioral health services through appropriate
payment and maintaining relativity within this code family, to increase
the values for the standalone psychotherapy services to reflect changes
to the value of the office/outpatient E/M visits which are most
commonly furnished with the add-on psychotherapy services with
equivalent times. For example, under the finalized revaluation of the
office/outpatient E/M visits, the proportional work value of the
standalone psychotherapy CPT code 90834 (Psytx w pt 45 minutes) would
decrease relative to the combined work RVUs for CPT code 99214 (Level 4
Office/outpatient visit est) when billed with CPT code 90836 (Psytx w
pt w e/m 45 min). The current combined work RVU for CPT code 99214 when
reported with CPT code 90836 is 3.40 (1.90 + 1.50) and the current work
RVU for CPT code 90834 is 2.0. With the revaluation of the office/
outpatient E/M visits beginning for CY 2021, the combined work RVU for
CPT codes 99214 and 90836 would be 3.82 (1.90 + 1.92), while the
current work RVU for 90834 would remain at 2.0, resulting in a change
to relativity between these services.
To maintain the current relativity, which we believe to be
appropriate based on the proportionate difference between these
services, we are proposing to increase the work RVU for CPT code 90834
from 2.00 to 2.25 based on the marginal increase in work value for CPT
code 99214 from CY 2020 to CY 2021. Similarly, for CPT code 90832,
which describes 30 minutes of psychotherapy, we proposed to increase
its work RVU based on the increase to CPT code 99213, which is most
commonly billed with the 30 minutes of psychotherapy add-on, CPT code
90833. For CPT code 90837, which describes 60 minutes of psychotherapy,
we propose to increase the work RVU based on the proportional increase
to CPT codes 99214 and 90838, which is the office/outpatient E/M visit
code most frequently billed with the 60 minutes of psychotherapy add-
on. Table 25 provides a summary of the current and final RVUs for these
services.
BILLING CODE 4120-01-P
[[Page 84565]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.039
[[Page 84566]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.040
[[Page 84567]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.041
BILLING CODE 4120-01-C
We received public comments on the Behavioral Healthcare services.
The following is a summary of the comments we received and our
responses.
Comment: A few commenters did not support this proposal, stating it
relies on a flawed methodology; specifically, the stand-alone codes,
which were established for NPPs to report psychotherapy services, were
not valued based on a comparison to the psychotherapy codes delivered
in conjunction with an E/M (codes 90833, 90836 and 90838). These
commenters noted that these are two distinct codes sets: one for NPPs
and one for physicians/QHPs representing different levels of similar
work. CMS should compare psychotherapy to psychotherapy, not
psychotherapy to psychotherapy plus E/M. Accordingly, these commenters
did not support CMS's proposal to increase the values of 90832, 90834,
and 90837 to reflect changes to the value of the office/outpatient E/M
visits which are most commonly furnished with the add-on psychotherapy
services with equivalent times.
Other commenters were concerned that the increases to some of the
psychotherapy services will skew the relativity not only to the
psychotherapy services provided along with an E/M service but to other
services within the psychiatry section.
Some commenters supported increases for these services, but stated
that commensurate relativity adjustments are needed for all
Psychotherapy, Psychological and Neuropsychological Testing, and HBAI
codes. Specifically, these commenters recommended proportionate
increases to CPT codes 90791 (Psychiatric diagnostic evaluation), 90839
(Psychotherapy for crisis; first 60 minutes), 90845 (Psychoanalysis),
90847 (Family psychotherapy (conjoint psychotherapy) (with patient
present), 50 minutes), and 90853 (Group psychotherapy (other than of a
multiple-family group)), as well as to the HBAI code set (CPT codes
96156 (Health behavior assessment, or re-assessment (ie, health-focused
clinical interview, behavioral observations, clinical decision
making)), 96158 (Health behavior intervention, individual, face-to-
face; initial 30 minutes), 96159 (Health behavior intervention,
individual, face-to-face; each additional 15 minutes (List separately
in addition to code for primary service)), and 97170 (Athletic training
evaluation, moderate complexity, requiring these components: A medical
history and physical activity profile with 1-2 comorbidities that
affect physical activity; An examination of affected body area and
other symptomatic or related systems addressing a total of 3 or more
elements from any of the following: body structures, physical activity,
and/or participation deficiencies; and Clinical decision making of
moderate complexity using standardized patient assessment instrument
and/or measurable assessment of functional outcome. Typically, 30
minutes are spent face-to-face with the patient and/or family.); and to
the Psychological and Neuropsychological Testing code set (CPT codes
96116 (Neurobehavioral status exam (clinical assessment of thinking,
reasoning and judgment, [eg, acquired knowledge, attention, language,
memory, planning and problem solving, and visual spatial abilities]),
by physician or other qualified health care professional, both face-to-
face time with the patient and time interpreting test results and
preparing the report; first hour), 96121 (Neurobehavioral status exam
(clinical assessment of thinking, reasoning and judgment, [eg, acquired
knowledge, attention, language, memory, planning and problem solving,
and visual spatial abilities]), by physician or other qualified health
care professional, both face-to-face time with the patient and time
interpreting test results and preparing the report; each additional
hour (List separately in addition to code for primary procedure)),
96130 (Psychological testing evaluation services by physician or other
qualified health care professional, including integration of patient
data, interpretation of standardized test results and clinical data,
clinical decision making, treatment planning and report, and
interactive feedback to the patient, family member(s) or caregiver(s),
when performed; first hour), 96131 (Neuropsychological testing
evaluation services by physician or other qualified health care
professional, including integration of patient data, interpretation of
standardized test results and clinical data, clinical decision making,
treatment planning and report, and interactive feedback to the patient,
family member(s) or caregiver(s), when performed; first hour), 96132
(Neuropsychological testing evaluation services by physician or other
qualified health care professional, including integration of patient
data, interpretation of standardized test results and clinical data,
clinical decision making, treatment planning and report, and
interactive feedback to the patient, family member(s) or caregiver(s),
when performed; first hour), 96133 (Neuropsychological testing
evaluation services by physician or other qualified health care
professional, including integration of patient data, interpretation of
standardized test results and clinical data, clinical decision making,
treatment planning and report, and interactive feedback to the patient,
family member(s) or caregiver(s), when performed; each additional hour
(List separately in addition to code for
[[Page 84568]]
primary procedure)), 96136 (Psychological or neuropsychological test
administration and scoring by physician or other qualified health care
professional, two or more tests, any method; first 30 minutes), 96137
(Psychological or neuropsychological test administration and scoring by
physician or other qualified health care professional, two or more
tests, any method; each additional 30 minutes (List separately in
addition to code for primary procedure)), 96138 (Psychological or
neuropsychological test administration and scoring by technician, two
or more tests, any method; first 30 minutes), 96139 (Psychological or
neuropsychological test administration and scoring by technician, two
or more tests, any method; each additional 30 minutes (List separately
in addition to code for primary procedure)), and 96146 (Psychological
or neuropsychological test administration, with single automated,
standardized instrument via electronic platform, with automated result
only)), all of which were valued relative to the family of
psychotherapy services through the AMA RUC process.
Response: We identified standalone psychotherapy services for
adjustment to preserve the relative value of these services to
psychotherapy services performed in conjunction with an office/
outpatient E/M. We disagree with commenters who stated that, as the
standalone psychotherapy codes were purposefully and appropriately
valued without reference to the values of E/M services, we should not
consider updating these values to retain relativity between standalone
psychotherapy and psychotherapy billed in conjunction with an office/
outpatient E/M. With regard to requests from commenters to adjust
values of additional services, we continue to believe that our
rationale for proposing proportionate adjustments to the stand-alone
psychotherapy services does not apply to the wider psychotherapy code
set. We believe that the value of stand-alone psychotherapy is
analogous to the values of the office/outpatient E/M visit codes due to
the nature of the work performed. These services describe E/M-type
services furnished in some circumstances by practitioners who would not
bill E/M services. Health and Behavior Assessment and Intervention and
Psychological and Neuropsychological Testing are fundamentally
different in that they describe testing services.
Having considered the public comments we received, we are
finalizing our proposed increases to the values of CPT codes 90832,
90834, and 90837.
9. Ophthalmological Services
Prior to the CY 2021 PFS proposed rule, we had received a request
to revalue the following ophthalmological services that we did not
propose to revalue:
CPT code 92002: Ophthalmological services: Medical
examination and evaluation with initiation of diagnostic and treatment
program; intermediate, new patient.
CPT code 92004: Ophthalmological services:
Medical examination and evaluation with initiation of diagnostic and
treatment program; comprehensive, new patient, 1 or more visits.
CPT code 92012: Ophthalmological services:
Medical examination and evaluation, with initiation or continuation of
diagnostic and treatment program; intermediate, established patient.
CPT code 92014: Ophthalmological services:
Medical examination and evaluation, with initiation or continuation of
diagnostic and treatment program; comprehensive, established patient, 1
or more visits.
We did not propose to revalue these services because they are not
sufficiently analogous to the office/outpatient E/M visit codes. While
these ophthalmological services have historically been valued relative
to office/outpatient E/M visits, the AMA RUC has not reviewed them
since 2007. Two of these ophthalmological services can include more
than one visit, and the number of visits included in the package is
uncertain and therefore not so closely tied to office and outpatient E/
M services, which describe a single visit. In addition, starting in
2021, the office/outpatient E/M visit codes will be substantially
redefined to allow time or medical decision-making for code level
selection--concepts that do not apply to the ophthalmological visits
which rely on criteria specific to evaluation, examination, specified
technical procedures, and treatment of ocular conditions for purposes
of level selection.\8\ The number of levels is different within the two
code sets, and the number of levels has changed for office/outpatient
E/M visits. Given the revised code set and framework for level
selection for office/outpatient E/M visits, the level of office/
outpatient E/M visits to which the ophthalmological visits might be
analogous is unclear. We also noted that we are aware that
ophthalmologists report office/outpatient E/M visits as well these
ophthalmologic-specific evaluation codes. The relationship between the
two separate code sets and the reason for maintaining and using both of
them is unclear.
---------------------------------------------------------------------------
\8\ CPT Codebook pp. 656-7.
---------------------------------------------------------------------------
In the proposed rule, we also noted that the four ophthalmological
evaluation codes are frequently reported with modifier -25
(significant, separately identifiable E/M service by the same physician
on the same day of the procedure or other service), as are ED visits.
For the ophthalmological evaluations and ED visits, approximately one-
third of the time, the same-day E/M service is a zero-day global
surgical code, whereas for the office/outpatient E/M visits,
approximately one-fifth of the same-day claims are for zero-day global
services. We noted that we believe that visit/evaluation codes
furnished the same day as a minor procedure are not closely analogous
to stand-alone office/outpatient E/M visits. As we discussed in prior
rulemaking, we continue to believe that separately identifiable visits
occurring on the same day as minor procedures (such as zero-day global
procedures) have resources that are sufficiently distinct from the
costs associated with furnishing office/outpatient E/M visits to
warrant different payment (see, for example, the CY 2019 PFS final
rule, 83 FR 59639). As we were still in process of analyzing these
data, we solicited public comment on whether visits/evaluations that
are furnished frequently with same-day procedures should be revalued
commensurate with increases to the office/outpatient E/M visits, or
whether they are substantially different enough to warrant independent
valuation. We noted further that the stand-alone psychotherapy services
would be revalued to maintain relativity with the psychotherapy
services that can be performed in conjunction with an E/M visit. Stand-
alone psychotherapy services cannot be billed with office/outpatient E/
M visits while ophthalmological visits can, as well as with a separate
procedure.
We received public comments on our decision not to propose new
valuations for these ophthalmological services. The following is a
summary of the comments we received and our responses.
Comment: One commenter stated that concurrent billing with same-
day, zero-day global procedures should not be factor in whether or not
we increase the ophthalmology evaluation codes commensurate with
office/outpatient E/M visits. The commenter stated that the
intravitreal injection code accounting for much of the volume of these
zero-day global procedures (CPT code 67028) does not include an office
examination. The commenter also stated that resource
[[Page 84569]]
duplication between the same-day services is accounted for in the RUC
valuation that reduces the pre- and post-times for the procedure if it
is furnished more than 50 percent of the time with an E/M visit or eye
evaluation. Another commenter noted that the AWV can be reported the
same day as an office/outpatient E/M visit, and urged CMS not to treat
primary care and surgical specialties differentially.
Response: We continue to believe that separately identifiable
visits occurring on the same day as minor procedures (such as zero-day
global procedures) have resources that are sufficiently distinct from
the costs associated with furnishing stand-alone office/outpatient E/M
visits to warrant different payment. However, we understand that such a
policy would apply to ophthalmology evaluations, ED visits and other
services. We believe the better way to account for duplicative
resources across the fee schedule would be a payment reduction along
the lines of a multiple procedure payment reduction for services
reported using modifier -25.We will continue to consider implementing a
policy to address this issue. We note that the policy that we proposed
and declined to finalize for CY 2019 would have applied a multiple
``procedure'' payment adjustment to two visits reported the same day,
as well as a visit with a minor procedure. We are also considering
whether the office/outpatient visit complexity HCPCS add-on code GPC1X
should be reported when the visit is reported with modifier -25 (see
section II.F.2.c. of this final rule).
Comment: One commenter stated that while the ophthalmological
evaluations have not been recently revalued by the AMA RUC, the AWV has
never been reviewed by the RUC.
Response: We discuss above our rationale for considering the AWV as
an analogous service to the office/outpatient E/M services. Regarding
consideration of the AWV by the RUC, we note that the AWV is a service
described by a code that is unique to Medicare and not applicable for
other payers. As such, we do not see a need for the RUC to review this
service, but if it did, we would consider its recommendations through
our usual rulemaking process. As discussed above, our decision to
consider a given code(s) as analogous to the office/outpatient E/M
visits is not based on any single factor, but rather takes into account
various applicable factors. The public may nominate any code(s) as
potentially misvalued through the usual misvalued code process or
request that it be surveyed or valued through the AMA RUC.
Comment: The same commenter stated that all four of the
ophthalmology codes are valued based on a single visit on the date of
encounter, and the level of that visit is directly compared to levels
of office E/M codes. The commenter also stated that while the
ophthalmological codes do not rely on time to select visit level, both
code sets will be able to use MDM to select visit level, and that MDM
was a basis for prior comparison to office/outpatient E/M visit codes.
Response: We continue to note that two of these ophthalmological
services can include more than one visit, and therefore, the resource
costs are not as closely tied to office and outpatient E/M visits (that
describe a single visit) as the AWV/IPPE, TCM, cognitive impairment and
other codes we are considering to be analogous to office/outpatient E/M
visits. We disagree that reliance on time and differences in MDM
interpretive guidance are not substantial differences between the 2021
office/outpatient E/M visit codes and the ophthalmology evaluation
codes. Also, we continue to believe that the corresponding visit levels
for the two code sets are not clear, such that the level of office/
outpatient E/M visits to which the ophthalmological visits might be
analogous is not apparent. We continue to note that ophthalmologists
report office/outpatient E/M visits as well these ophthalmologic-
specific evaluation codes. The relationship between the two separate
code sets and the reason for maintaining and using both of them remains
unclear. Having considered the public comments we received, we are
finalizing our decision not to revalue the ophthalmological evaluations
commensurate with the changes to the office/outpatient EM visit
valuations for 2021. Stakeholders may still request review of these
services by the RUC or through our misvalued code initiative.
c. Comment Solicitation on the Definition of HCPCS Add-On Code G2211
Although we believe that the RUC-recommended values for the revised
office/outpatient E/M visit codes will more accurately reflect the
resources involved in furnishing a typical office/outpatient E/M visit,
we continue to believe that the typical visit described by the revised
and revalued office/outpatient E/M visit code set still does not
adequately describe or reflect the resources associated with primary
care and certain types of specialty visits. Therefore, in the CY 2020
PFS final rule (84 FR 62856), we finalized the HCPCS add-on code G2211
(which replaces temporary HCPCS add-on code GPC1X) and which describes
the ``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 condition.'' We stated that we were not restricting billing
based on specialty, but that we did assume that certain specialties
furnished these types of visits more than others.
Since the publication of the CY 2020 PFS final rule, some specialty
societies have stated that our definition of this service, as
articulated in the code descriptor and the associated preamble
discussion, is unclear. For example, some stakeholders have suggested
that HCPCS add-on code G2211, as currently described, could be
applicable for every office/outpatient E/M visit. They have also
expressed concerns regarding our utilization assumptions, since we
assumed that specialties that predominantly furnish the kind of care
described by the code would bill it with every visit. Therefore, we
solicited public comments providing additional, more specific
information regarding what aspects of the definition of HCPCS add-on
code G2211 are unclear, how we might address those concerns, and how we
might refine our utilization assumptions for the code.
We continue to believe that the time, intensity, and PE involved in
furnishing services to patients on an ongoing basis that result in a
comprehensive, longitudinal, and continuous relationship with the
patient and involves delivery of team-based care that is accessible,
coordinated with other practitioners and providers, and integrated with
the broader health care landscape, are not adequately described by the
revised office/outpatient E/M visit code set. We believe the inclusion
of HCPCS add-on code G2211 appropriately recognizes the resources
involved when practitioners furnish services that are best-suited to
patients' ongoing care needs and potentially evolving illness. We also
believe the work reflected in HCPCS add-on code G2211 is inherently
distinct from existing coding that describes preventive and care
management services. For example, the AWV describes and pays for a
static annual health assessment rather than the time, intensity, and PE
involved in furnishing services to patients on an ongoing basis.
Similarly, TCM service codes are focused on care management for 30 days
[[Page 84570]]
following a discharge rather than the time, intensity, and PE involved
in furnishing services to patients on an ongoing basis. Chronic care
management and principal care management service codes are limited to
patients with chronic condition(s). Under chronic care management
codes, patients have two or more chronic conditions that place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, whereas principal care
management services are for patients who have a single high-risk
disease of sufficient severity to place the patient at risk of
hospitalization or have been the cause of recent hospitalization. In
contrast, we believe HCPCS add-on code G2211 reflects the time,
intensity, and PE when practitioners furnish services that enable them
to build longitudinal relationships with all patients (that is, not
only those patients who have a chronic condition or single-high risk
disease) and to address the majority of patients' health care needs
with consistency and continuity over longer periods of time. For
example, in the context of primary care, HCPCS add-on code G2211 could
recognize the resources inherent in holistic, patient-centered care
that integrates the treatment of illness or injury, management of acute
and chronic health conditions, and coordination of specialty care in a
collaborative relationship with the clinical care team. In the context
of specialty care, HCPCS add-on code G2211 could recognize the
resources inherent in engaging the patient in a continuous and active
collaborative plan of care related to an identified health condition
the management of which requires the direction of a clinician with
specialized clinical knowledge, skill and experience. Such
collaborative care includes patient education, expectations and
responsibilities, shared decision-making around therapeutic goals, and
shared commitments to achieve those goals. In both examples, HCPCS add-
on code G2211 reflects the time, intensity, and PE associated with
providing services that result in care that is personalized to the
patient. Finally, we believe that the HCPCS add-on code G2211 could
bolster the efforts of practitioners in rural communities, including
NPPs, to deliver the comprehensive and longitudinal care that HCPCS
add-on code G2211 describes.
We received public comments on our comment solicitation related to
HCPCS add-on code G2211. The following is a summary of the comments we
received and our responses.
Comment: Many commenters who rely upon office/outpatient E/M visits
to report the majority of their services continued to be supportive of
HCPCS add-on code G2211. These commenters agreed with CMS that the
revised office/outpatient E/M visit codes do not adequately describe or
reflect the resources associated with primary care and certain types of
specialty visits and agreed that the code descriptor fits its intended
purpose, is well-defined, and did not allude to specific specialties.
Other commenters disagreed, maintaining that the definition of HCPCS
add-on code G2211 is unclear. Some commenters stated that it appeared
that HCPCS add-on code G2211 could be reported with most office/
outpatient E/M visits and questioned whether widespread use accurately
captured genuine longitudinal care relationships. These commenters
requested that CMS provide clinical examples for appropriate reporting.
Other commenters provided CMS with suggested clinical examples for when
HCPCS add-on code G2211 could be reported. For example, some commenters
stated that HCPCS add-on code G2211 would capture additional work by
the reporting practitioner to treat patients with disease processes
that require active monitoring outside of office/outpatient E/M visits
and are not captured in current coding. This work could include
oversight of medication refills; evaluating appropriateness of current
and new medications, including those initially prescribed by other
practitioners; and conducting medication-related monitoring and safety
activities when these activities are not part of a visit. It could also
include review of lab and imaging reports, including those requested by
another practitioner, that fall outside the timeframe of an office/
outpatient E/M visit, and do not necessitate a new visit. Finally, some
commenters suggested that CMS describe circumstances when HCPCS add-on
code G2211 would not be reported with an office/outpatient E/M visit.
Response: We appreciate all of the feedback from the commenters. We
believe that HCPCS add-on code G2211 captures the work by the reporting
practitioner for many office/outpatient E/M visits that is not
accounted for in the valuation of the primary office/outpatient E/M
visit code. In the context of primary care, a clinical example for the
use of HCPCS add-on code G2211 could be: a 68 year-old woman with
progressive congestive heart failure (CHF), diabetes, and gout, on
multiple medications, who presents to her physician for an established
patient visit. The clinician discusses the patient's current health
issues, which includes confirmation that her CHF symptoms have remained
stable over the past 3 months. She also denies symptoms to suggest
hyper- or hypoglycemia, but does note ongoing pain in her right wrist
and knee. The clinician adjusts the dosage of some of the patient's
medications, instructs the patient to take acetaminophen for her joint
pain, and orders laboratory tests to assess glycemic control, metabolic
status, and kidney function. The practitioner also discusses age
appropriate prevention with the patient and orders a pneumonia
vaccination and screening colonoscopy. In this clinical example, the
practitioner is serving as a focal point for the patient's care,
addressing the broad scope of the patient's health care needs, by
furnishing care for some or all of the patient's conditions across a
spectrum of diagnoses and organ systems with consistency and continuity
over time.
Moreover, we believe that similar visits might be furnished by
other specialists when management of a particular disease condition(s)
is ongoing or serves as a focal point of care for a patient's overall
health needs over a period of time. In other words, when care by
specialists for a particular disease condition(s) is consistent and
continuous over long periods of time, the work associated with those
visits is similar to the kind of work described above.
In contrast, there are many visits with new or established patients
where HCPCS add-on code G2211 would not be appropriately reported, such
as when the care furnished during the office/outpatient E/M visit is
provided by a professional whose relationship with the patient is of a
discrete, routine, or time-limited nature, such as a mole removal or
referral to a physician for removal of a mole; for treatment of a
simple virus; for counseling related to seasonal allergies, initial
onset gastroesophageal reflux disease; treatment for a fracture; and
where comorbidities are either not present or not addressed, and/or and
when the billing practitioner has not taken responsibility for ongoing
medical care for that particular patient with consistency and
continuity over time, or does not plan to take responsibility for
subsequent, ongoing medical care for that particular patient with
consistency and continuity over time. Reporting the add-on code with
these types of visits would be inconsistent with the code
[[Page 84571]]
descriptor, which describes care that is a continuing focal point and/
or part of ongoing care. We also would not expect that HCPCS add-on
code G2211 would be reported when the office/outpatient E/M is reported
with a payment modifier, such as the modifier -25 described in the
ophthalmological services section above. It seems likely that visits
reported with payment modifiers have resources that are sufficiently
distinct from stand-alone office/outpatient E/M visits. We will be
considering this issue to inform potential future rulemaking.
Comment: Some commenters suggested that a lack of clarity in the
definition of HCPCS add-on code G2211 poses program integrity
challenges for CMS. They pointed out that CMS has offered no
information about how appropriate use will be determined or what
documentation will be expected. Some commenters requested guidance on
what documentation would need to be included when HCPCS add-on code
G2211 is reported.
Response: We appreciate the concerns raised by the commenters.
Since HCPCS add-on code G2211 is a new service paid under the PFS, we
plan to monitor utilization for appropriate use of the add-on code,
which could inform additional efforts to refine the code descriptor, or
provide further guidance, as appropriate. With respect to
documentation, we are considering an approach to minimize burden
similar to what we finalized in the CY 2019 PFS final rule (83 FR
59560) for HCPCS add-on codes GPC1X and GCG0X. In that rule, we
discussed that we would expect that information included in the medical
record or in the claims history for a patient/practitioner combination,
such as diagnoses, the practitioner's assessment and plan for the
visit, and/or other service codes billed could serve as supporting
documentation. We believe Medicare claims data could be a useful gauge
of appropriate use of the code. For example, when billing practitioners
are separately reporting care management services for particular
beneficiaries, the G2211 add-on service would be appropriately reported
with their visits, as claims for these care management services could
indicate an ongoing, continuous relationship with the patient.
Likewise, patients returning to the same practitioner for routine
preventive services would indicate that the practitioner has taken
responsibility for ongoing medical needs for that patient with
consistency and continuity over time. In contrast, an annual visit for
ophthalmologic care, or a single episode of dermatologic care--even
when several services are billed over a few months--would not suggest
ongoing care provided with consistency and continuity over time and
would suggest an inappropriate use of the code, were it to be billed
with such visits. Additionally, to provide evidence of the ongoing
relationship between the patient and practitioner, it is possible that
use of patient relationship codes that were established under MACRA and
finalized in the CY 2018 PFS (82 FR 53234) could be further example of
evidence in the claims record to support the use of HCPCS add-on code
G2211. These codes are Level II HCPCS modifiers that help define and
distinguish the relationship and responsibility of a clinician with a
patient at the time of furnishing an item or service, facilitate the
attribution of patients and episodes to one or more clinicians, and to
allow clinicians to self-identify their patient relationships.
Comment: Some commenters recommended that HCPCS add-on code G2211
should be available for both new and established patients. A few other
commenters noted that the code descriptor for HCPCS add-on code G2211
had one version of the long descriptor in this section of the proposed
rule and another version of the long descriptor in section II.D.
Another commenter recommended an edit to the code descriptor to
eliminate the comma between ``single'' and ``serious.''
Response: We are confirming that HCPCS add-on code G2211 can be
reported for both new and established patients. With respect to the
version of the long descriptor, the version used in section II.D of the
proposed rule was a drafting error. We regret the error and have
corrected the description in section II.D of this final rule. While we
appreciate the suggested edit to the code descriptor, we did not
believe it offered additional clarification. To improve the clarity of
the code descriptor, we are finalizing a refinement for the code
description to clarify that the code applies to a single condition that
is serious, rather than any single condition. We are inserting the word
``condition'' after ``single, serious''. The revised descriptor reads
as follows, ``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 condition or a complex condition. (Add-on code, list
separately in addition to office/outpatient evaluation and management
visit, new or established).''
Comment: A few commenters recommended that CMS allow HCPCS add-on
code G2211 to be reported with E/M services furnished in domiciliary
care settings.
Response: We reiterate that we are implementing HCPCS add-on code
G2211 because we believe the that the typical visit described by the
revised and revalued office/outpatient E/M visit code set still does
not adequately describe or reflect the resources associated with
primary care and certain types of specialty visits and as such, does
not include other types of E/M visits. As the CPT Editorial Panel, the
AMA RUC and CMS consider future changes to other E/M visit code sets,
we will consider this issue in that context.
Comment: Other commenters expressed continued concern regarding the
necessity of HCPCS add-on code G2211 entirely and recommended that CMS
withdraw the code. A few stated that HCPCS add-on code G2211 is not a
separately identifiable service given the changes to the office/
outpatient E/M visit code set and that it may be duplicative to care
management services, such as TCM or CCM.
Response: As we stated in the proposed rule, we continue to believe
that the time, intensity, and PE involved in furnishing services to
patients on an ongoing basis that result in a comprehensive,
longitudinal, and continuous relationship with the patient and involves
delivery of team-based care that is accessible, coordinated with other
practitioners and providers, and integrated with the broader health
care landscape, are not adequately described by the revised office/
outpatient E/M visit code set. We also reiterate what we stated in the
proposed rule that HCPCS add-on code G2211 is inherently distinct from
coding that describes care management services. For example, TCM
service codes are focused on care management for 30 days following a
discharge rather than the time, intensity, and PE involved in
furnishing services to patients on an ongoing basis. Chronic care
management and principal care management service codes are limited to
patients with chronic condition(s). Under chronic care management
codes, patients have two or more chronic conditions that place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, whereas principal care
management services are for patients who have a single high-risk
disease of sufficient severity to place the patient at risk of
hospitalization or have been the cause of recent hospitalization. In
contrast, we believe HCPCS add-on code G2211 reflects the time,
intensity,
[[Page 84572]]
and PE when practitioners furnish services that enable them to build
longitudinal relationships with all patients (that is, not only those
patients who have a chronic condition or single-high risk disease) and
to address the majority of patients' health care needs with consistency
and continuity over longer periods of time.
Comment: Many commenters expressed concerns about the utilization
assumptions for HCPCS add-on code G2211. Commenters stated that, in the
CY 2020 PFS rulemaking cycle, CMS appeared to assume that HCPCS add-on
code G2211 would be reported with 50 percent of all office/outpatient
E/M visits; and in the CY 2021 PFS proposed rule, CMS appeared to
assume that HCPCS add-on code G2211 would be reported with 75 percent
of all office/outpatient E/M visits. Commenters noted that this
additional utilization further contributed to the redistributive effect
of the budget neutrality adjustment related to revaluing the office/
outpatient visit codes. The AMA RUC requested that CMS publish the
methodology used for the utilization assumptions in the CY 2021 PFS
proposed rule prior to HCPCS add-on code G2211's implementation.
Response: In the CY 2020 PFS rulemaking cycle, we proposed and
finalized that HCPCS add-on code G2211 would be billed with every level
of an office/outpatient E/M visit. We assumed that specialties that
rely on office/outpatient E/M visit coding to report the majority of
their services would be most likely to report HCPCS add-on code G2211
with every office/outpatient E/M visit they reported and we did not
restrict billing to any particular specialty or group of specialties.
We published the utilization estimates for HCPCS add-on code G2211 in
the CY 2020 PFS final rule in this public use file: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2020-PFS-FR-EM-Add-on-Code.zip.
In the CY 2021 PFS proposed rule, we continued to assume that the
specialties listed in the aforementioned public use file would report
HCPCS add-on code G2211 with all of their office/outpatient E/M visits.
As part of updating our data sources from CY 2018 to CY 2019 claims
data for setting rates for the CY 2021 PFS proposed rule, we included
modifier -25 utilization, meaning that we assumed that HCPCS add-on
code G2211 would also be reported with office/outpatient E/M visits
that were reported with a modifier -25. While this additional
utilization was included in the budget neutrality calculations, we note
that other proposals for CY 2021 also factor into the budget neutrality
adjustment.
As we noted above, while we would not expect that HCPCS add-on code
G2211 would be reported when the office/outpatient E/M visits is
reported with a payment modifier, such as a modifier -25, we are not
establishing any policies that prohibit reporting the add-on code under
those circumstances. Thus, we will continue to include office/
outpatient visits reported with a modifier -25 in our utilization
assumptions for HCPCS code G2211 as part of calculating the budget
neutrality adjustment for the policies we are finalizing in this rule.
As we noted above, we would not expect HCPCS add-on code G2211 to be
reported when the visit is reported with a modifier 2-5, and will
consider whether to establish an explicit prohibition in future
rulemaking. We continue to believe that separately identifiable visits
occurring on the same day as minor procedures (such as zero-day global
procedures) have resources that are sufficiently distinct from the
costs associated with furnishing stand-alone office/outpatient E/M
visits to warrant different payment. We are also analyzing our data to
determine if separately identifiable visits occurring on the same day
as another visit have resources that are sufficiently distinct from the
costs associated with furnishing stand-alone office/outpatient E/M
visits to warrant different payment. We will consider these analyses to
inform potential future rulemaking.
Comment: Many commenters recommended that CMS reexamine and lower
utilization assumptions for HCPCS add-on code G2211. These commenters
stated that utilization tends to be lower than expected in the first
year of implementation and cited the initial low utilization of the TCM
and CCM codes These commenters also stated that they expected adoption
to be slow given the necessity for medical societies to educate their
members about appropriate use, ongoing implementation of the revisions
to the office/outpatient E/M visit code set, electronic health records
integration, and the persistence of the COVID-19 pandemic in many parts
of the country. They recommended that utilization in the initial year
could be as low as 10 percent of reported office/outpatient E/M visits
and could range as high as 25 percent of reported office/outpatient E/M
visits. Other commenters recommended that CMS delay the implementation
of HCPCS add-on code G2211, citing the expected budget neutrality
offset.
Response: We acknowledge commenters' concerns that, given the
necessity of medical societies to educate their members about
appropriate use, ongoing implementation of the revisions to the office/
outpatient E/M visit code set, electronic health records integration,
and the persistence of the COVID-19 pandemic, practitioners that rely
on office/outpatient E/M visits to report the majority of their
services are not likely to report HCPCS add-on code G2211 with every
office visit. However, we disagree the utilization will be as low as
the 10 percent to 25 percent range as recommended by these commenters.
We have not implemented any additional policies that restrict the
billing of this code, and so we are assuming that utilization will be
90 percent of office/outpatient E/M visits instead of the 100 percent
that we assumed in the proposed rule.
d. Prolonged Office/Outpatient E/M Visits (CPT Code 99417/HCPSC Code
G2212)
We reviewed our final policy for 2021 regarding the reporting of
prolonged office/outpatient E/M visits finalized in the CY 2020 PFS
final rule (84 FR 62848 through 62850). To report these visits
beginning in 2021, we finalized CPT code 99417 (Prolonged office or
other outpatient evaluation and management service(s) (beyond the total
time of the primary procedure which has been selected using total
time), requiring total time with or without direct patient contact
beyond the usual service, on the date of the primary service; each
additional 15 minutes (List separately in addition to CPT codes 99205,
99215 for office or other outpatient evaluation and management
services)), which was referred to in our previous rules as temporary
CPT code 99XXX. Under CPT prefatory language, CPT code 99417 should
only be reported when time is used to select the visit level, and only
time of the physician or qualified healthcare professional is counted.
In the CY 2020 PFS final rule, we stated that our interpretation of
revised CPT prefatory language and reporting instructions would mean
that CPT code 99417 could be reported when the physician's (or NPP's)
time is used for code level selection and the time for a level 5
office/outpatient E/M visit (the floor of the level 5 time range) is
exceeded by 15 minutes or more on the date of service (84 FR 62848
through 62849). The intent of the CPT Editorial Panel was unclear
because of the use of the terms ``total time'' and ``usual service'' in
the CPT code descriptor (``requiring total time with or without direct
patient contact beyond the usual
[[Page 84573]]
service.'') The term ``total time'' is unclear because office/
outpatient E/M visits now represent a range of time, and ``total'' time
could be interpreted as including prolonged time. Further, the term,
``usual service'' is undefined. There is no longer a typical time in
the code descriptor that could be used as point of reference for when
the ``usual time'' is exceeded for all practitioners, and there would
be variation (as well as potential double counting of time) if applied
at the individual practitioner level.
Having reviewed the policy we finalized last year, we believe that
allowing reporting of CPT code 99417 after the minimum time for the
level 5 visit is exceeded by at least 15 minutes would result in double
counting time. As a specific example, the time range for CPT code 99215
is 40-54 minutes. If the reporting practitioner spent 55 minutes of
time, 14 of those minutes are included in the services described by CPT
code 99215. Therefore, only 1 minute should be counted towards the
additional 15 minutes needed to report CPT code 99417 and prolonged
services should not be reportable as we finalized last year (see Table
33 of the CY 2020 PFS final rule (84 FR 62849)). Therefore, we proposed
that when the time of the reporting physician or NPP is used to select
office/outpatient E/M visit level, CPT code 99417 could be reported
when the maximum time for the level 5 office/outpatient E/M visit is
exceeded by at least 15 minutes on the date of service. In Tables 26
and 27, we provided examples.
[GRAPHIC] [TIFF OMITTED] TR28DE20.042
[GRAPHIC] [TIFF OMITTED] TR28DE20.043
We received public comments on our proposal for use of CPT code
99417. The following is a summary of the comments we received and our
responses.
Comment: Several commenters agreed with our concerns about the lack
of clarity in the code descriptor and the potential for double-counting
time. Several other commenters disagreed with our proposal and
recommended that CMS adopt the CPT code descriptors. These commenters
stated that a change in policy by CMS could be confusing to
practitioners and disruptive to the ongoing work of medical societies
to educate practitioners about the use of these codes. Some commenters
also stated the CPT Editorial Panel intended to apply the general CPT
rule where practitioners can report a timed code once the midpoint is
reached.
Response: In the CPT 2021 Professional Edition, CPT code 99417 is
described as, ``Prolonged office or other outpatient evaluation and
management service(s) beyond the minimum required time of the primary
procedure which has been selected using total time, requiring total
time with or without direct patient contact beyond the usual service,
on the date of the primary service; each additional 15 minutes (List
separately in addition to CPT codes 99205, 99215 for office or other
outpatient evaluation and management services)).'' The terms ``total
time'' and ``usual service'' continue to be unclear.
While we prefer to align with CPT coding to reduce potential
confusion to practitioners, we continue to believe that CPT code 99417
as written is unclear and that allowing reporting of CPT code 99417
when the minimum required time for the level 5 visit is exceeded by at
least 15 minutes would result in double counting time. It has not been
our understanding that CPT intended for the midpoint time to suffice
for reporting this code, and regardless, we did not previously finalize
or intend to apply such a policy.
We continue to believe it is important for CMS and other
stakeholders to know with certainty how much time practitioners spend
furnishing office/outpatient E/M visits, in order to assess whether
resources are accurately accounted for in their valuation. This is
especially true once time can be used to select visit level, with new
times established for this code set. To resolve the lack of clarity, we
are finalizing our proposal regarding the time that may be counted for
prolonged office/outpatient E/M visits; and to resolve the potential
inconsistency of our policy with CPT code 99417, we are creating a new
HCPCS code G2212 to be used when billing Medicare for this service
instead of CPT code 99417, starting in 2021. HCPCS code G2212 is as
follows,
[[Page 84574]]
``Prolonged office or other outpatient evaluation and management
service(s) beyond the maximum required time of the primary procedure
which has been selected using total time on the date of the primary
service; each additional 15 minutes by the physician or qualified
healthcare professional, with or without direct patient contact (List
separately in addition to CPT codes 99205, 99215 for office or other
outpatient evaluation and management services) ``(Do not report G2212
on the same date of service as 99354, 99355, 99358, 99359, 99415,
99416). (Do not report G2212 for any time unit less than 15
minutes))''.''
We believe the creation of HCPCS code G2212 will serve to resolve
the potential differences between Medicare and other interpretations of
CPT rules, and better address questions we frequently receive about the
required times and what time may be counted toward the required time to
report prolonged office/outpatient E/M visits. We also note that we are
not opposed in concept to reporting prolonged office/outpatient visit
time on a date other than the visit. However, we continue to believe
there should be a single prolonged code specific to office/outpatient
E/M visits that encompasses all related time (see the CY 2020 PFS final
rule for a more detailed discussion of this issue, (84 FR 62849 through
62850)). We will continue to stay abreast of any changes in CPT coding.
The valuation for HCPCS code G2212 will be the same as for CPT code
99417.
G. Scope of Practice and Related Issues
We proposed several policies consistent with the President's E.O.
13890 on ``Protecting and Improving Medicare for Our Nation's Seniors''
to modify supervision and other requirements of the Medicare program
that limit healthcare professionals from practicing at the top of their
license (84 FR 53573, October 8, 2019, E.O. 13890). In December 2019,
we requested feedback in response to part of this E.O. seeking the
public's help in identifying additional Medicare regulations which
contain more restrictive supervision requirements than existing state
scope of practice laws, or which limit health professionals from
practicing at the top of their license (the request for feedback is
available at https://www.cms.gov/files/document/request-information-reducing-scope-practice-burden.pdf). Through review of the feedback we
received, we identified the proposed policies in section II.G. of the
CY 2021 PFS proposed rule (85 FR 50139). We noted that we believe that
physicians, NPPs, and other professionals should be able to furnish
services to Medicare beneficiaries in accordance with their scope of
practice and state licensure, including education and training, to the
extent permitted under the Medicare statute, as long as it is not
likely to result in fraud, waste or abuse or create potential risks to
beneficiary safety. The proposed policies may also help ensure an
adequate number of clinicians, in addition to physicians, are able to
furnish critical services including primary care services in areas
where there is a shortage of physicians.\9\ We noted that some of the
proposals may also help alleviate the opioid crisis.
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\9\ Zhang et al. Physician workforce in the United States of
America: forecasting nationwide shortages. Human Resources for
Health (2020); 18:8. Published online February 6, 2020 and available
online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006215/.
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We solicited information about the number and names of states that
have licensure or scope of practice laws in place, as well as any
facility-specific policies, that would impact the ability of clinicians
to exercise the flexibilities we proposed, to help us assess the
potential impact of, or challenges for, the proposed changes. We noted
that information about specific services (service-level information)
would be especially helpful. We solicited public comment on whether
applicable state laws, scope of practice, and facility policies would
permit practitioners to exercise the proposed flexibilities if we were
to adopt the proposed policies, and to what extent practitioners would
be permitted to exercise the proposed flexibilities, such as for all
diagnostic tests or only a subset.
We solicited information on these topics because the responses to
our request for feedback issued in 2019 did not indicate the number of
states that have more flexible scope of practice rules than our federal
regulations, or whether facilities (such as hospitals or nursing
facilities) have relevant policies that limit the ability of the
impacted professionals to perform certain services. For example, if
Medicare payment policy provided for payment of diagnostic tests
supervised by NPPs, there may still be facility- or state-specific
policies in place that limit NPPs' ability to supervise some or all
diagnostic tests, and those limitations would inform the potential
impact of changing our policy. While our proposed flexibility may
increase the capacity and availability of practitioners who can
supervise diagnostic tests, which would alleviate some of the demand on
physicians as the only source to perform this particular function, we
noted that we have not located information indicating the degree to
which NPP scope of practice includes supervision of auxiliary staff,
especially for the subset of services that are diagnostic tests. There
is a wide range of diagnostic tests, from a simple strep throat swab to
more sophisticated and/or invasive tests such as x-rays and cardiology
procedures. We would need to understand the scope of practice for many
types of auxiliary staff (some of whom are not licensed) who could
potentially provide these tests under the supervision of an NPP,
including RNs, LPNs, medical assistants, radiologic technicians, and
many others. To the extent practice patterns change, there could be
induced utilization that would increase costs, but this might be offset
by reduced payment rates because direct payment to NPPs is at a lower
rate than payment to physicians.
1. Teaching Physician and Resident Moonlighting Policies
a. Background
In the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the
May 8th COVID-19 IFC (85 FR 27587 through 27589), we implemented
several policies on an interim final basis related to PFS payment for
the services of teaching physicians involving residents and resident
moonlighting during the PHE for COVID-19. In the proposed rule, we
noted that we planned to address comments received on the IFCs for
those policies that we made proposals or solicited comment on in the
proposed rule when we published the PFS final rule.
b. Finalization of Interim Final Rule With Comment Period Provisions
Related to Application of Teaching Physician and Moonlighting
Regulations During the PHE for the COVID-19 Pandemic
We received public comments on the policies that we adopted on an
interim basis in the Interim Final Rule with Comment Period provisions
related to the Application of Teaching Physician and Moonlighting
Regulations During the PHE for the COVID-19 Pandemic (85 FR 19258
through 19261). The following is a summary of the comments we received
and our responses.
i. Virtual Presence of a Teaching Physician Using Audio/Video Real-Time
Communications Technology
Comment: Commenters were generally supportive of the virtual
presence policies in Sec. Sec. 415.172, 415.174, 415.180, and 415.184
that we implemented on an interim basis during the PHE for COVID-19.
Several commenters supported extending the flexibilities permanently,
while several
[[Page 84575]]
other commenters recommended continuing the policy temporarily through
the end of the PHE for COVID-19, or for a period of time following the
end of the PHE for COVID-19.
Response: We appreciate commenters' support for the virtual
presence policies adopted on an interim basis during the PHE for COVID-
19. After considering the comments, we are finalizing these policies
for the duration of the PHE for COVID-19.
Comment: One commenter, in support of the virtual presence policies
adopted on an interim basis during the PHE for COVID-19, recommended
that CMS encourage residency programs, residency review committees, and
ACGME to increase monitoring of clinical and educational work hour
standards, acknowledge the impact of the changes to the teaching
physician presence requirements on the residents and their optimal
learning environment, and share additional information regarding how to
best meet the need for reporting of information related to workload and
growing service demands, patient safety, medical error, continuity of
care, resident well-being and burnout, development of professionalism,
resident learning outcomes, and preparation for independent practice as
they relate to the use of teaching physician presence through real-time
interactive audio and video technology.
Response: We do not believe it is CMS' role to regulate or monitor
training outcomes or advocate on behalf of the residents themselves.
Organizations representing the interests of residents and overseeing
the actual operation of residency programs are in a better position to
establish rules regarding the impact of virtual presence and
involvement of teaching physicians on residency training outcomes.
Comment: One commenter noted that the GME community has learned
many lessons during the pandemic, related to resident education and
supervision. Consequently, the commenter believed that the GME
community should be provided the flexibility to test new and better
modalities of treatment and learning.
Response: We appreciate the commenter's support of our policies. As
described previously, we are finalizing these policies for the duration
of the PHE for COVID-19.
Comment: One commenter requested clarification of the definition of
``telecommunications,'' and asked whether supervision, in the context
of a teaching institution, can be performed by telephone as opposed to
a tablet or smartphone.
Response: The policy to allow a teaching physician to use audio/
video real-time communications technology for purposes of furnishing
care with a resident, and in the case of the primary care exception,
directing, managing, and reviewing the care furnished by the resident,
generally requires real-time direct observation (not mere availability)
by the teaching physician through interactive, real-time audio and
video technology, and does not include audio-only technology (for
example, telephone without video).
Comment: Several commenters expressed support for the exclusion of
surgical, high risk, interventional, endoscopic, or other complex
procedures identified under Sec. 415.172(a)(1), and anesthesia
services under Sec. 415.178 from the policy to allow the teaching
physician to be present using audio/video real-time communications
technology. One commenter recommended that the teaching physician
virtual presence policy be permitted for CPT codes 31231 (Nasal
endoscopy, diagnostic, unilateral or bilateral (separate procedure)),
31575 (Laryngoscopy, flexible; diagnostic), and 31579 (Laryngoscopy,
flexible or rigid telescopic, with stroboscopy) performed through an
endoscope.
Response: We continue to believe the requirement for the physical,
in-person presence of the teaching physician during all key or critical
portions of the procedure and immediately availability to furnish
services during the entire service or procedure is necessary for
patient safety given the risks associated with these services. In
complex, high-risk procedures, including the endoscopic procedures
associated with CPT codes 31231, 31575 and 31579, a patient's clinical
status can quickly change. To permit payment under the PFS for such
teaching physician services, we believe the services must be furnished
with a certain level of personal oversight and involvement of the
teaching physician who has the experience and judgment that is
necessary for rapid on-site decision-making during these procedures.
With respect to the procedures associated with CPT codes 31231, 31575
and 31579, we do not believe that virtual presence by a teaching
physician would provide sufficient personal involvement and control
over the service to warrant billing of the services under the PFS or
allow for the rapid on-site decision-making that could be necessary
during the procedures, which could pose an increased risk to patients.
ii. Virtual Presence of a Teaching Physician During Medicare Telehealth
Services
Comment: Commenters were generally supportive of the policy adopted
on an interim basis to allow payment under the PFS when residents
furnish telehealth services to beneficiaries with the teaching
physician present using audio/video real-time communications
technology. In addition, several commenters supported extending the
flexibility permanently.
Response: We appreciate commenters' support for the policy, adopted
on an interim basis during the PHE for COVID-19, to allow payment under
the PFS when residents furnish telehealth services to beneficiaries
with the teaching physician present using interactive, audio/video
real-time communications technology (excluding audio-only). After
considering the comments, we are finalizing this policy for the
duration of the PHE for COVID-19.
iii. Resident Moonlighting in the Inpatient Setting
Comment: Commenters were generally supportive of the policy under
Sec. 415.208 that we adopted on an interim basis during the PHE for
COVID-19 to allow PFS payment for services provided by fully licensed
residents that are not related to their approved GME program in the
inpatient setting of a hospital in which they are training, provided
that the conditions specified in Sec. 415.208(b)(2)(i) through (iii)
are met. Several commenters recommended that this policy be implemented
permanently, and some other commenters recommended that the policy be
implemented for the duration of the PHE only.
Response: We appreciate commenters' support for the moonlighting
policy we adopted on an interim basis during the PHE for COVID-19.
After considering the comments, we are finalizing this policy for the
duration of the PHE for COVID-19.
iv. Primary Care Exception Policies
Comment: Commenters were generally supportive of the policy adopted
on an interim basis under Sec. 415.174 to expand the primary care
exception to include all levels of office and outpatient E/M codes.
Some commenters recommended that this policy be implemented
permanently, and some other commenters recommended that the policy be
implemented for the duration of the PHE for COVID-19 only.
[[Page 84576]]
Response: We appreciate commenters' support of the expansion of the
primary care exception policy adopted on an interim basis during the
PHE for COVID-19. After considering the comments, we are finalizing
this policy for the duration of the PHE for COVID-19.
Comment: One commenter interpreted the policy described in Sec.
415.174 to mean that the ``immediately available supervision''
requirement described in this section could be met by the teaching
physician being ``immediately available'' via real-time audio/video
technology.
Response: Subsequent to the publication of the March 31st COVID-19
IFC, the May 8th COVID-19 IFC amended Sec. 415.174 to add a new
paragraph (c) to allow that, on an interim basis for the duration of
the PHE for COVID-19, the teaching physician may not only direct the
care furnished by residents, but also review the services provided with
the resident, during or immediately after the visit, remotely through
virtual means via interactive, audio/video real-time communications
technology (excluding audio-only).
v. Payment Under the PFS for Teaching Physician Services When Resident
Under Quarantine
Comment: A commenter supported the interim policy for the duration
of the PHE for COVID-19 to permit PFS payment for teaching physician
services that do not require face-to-face patient care when the
resident is furnishing such services while in quarantine when the
teaching physician is present through audio/video real-time
communications technology.
Response: We thank the commenter for their support. After
considering the comments, we are finalizing this policy for the
duration of the PHE for COVID-19.
c. Finalization of Interim Final Rule Provisions Related to Additional
Flexibility Under the Teaching Physician Regulations
We received public comments on the policies that we adopted on an
interim basis in the Interim Final Rule provisions related to
Additional Flexibility Under the Teaching Physician Regulations (85 FR
27587 through 27589). The following is a summary of the comments we
received and our responses.
i. Primary Care Exception Policies
Comment: Several commenters supported the policy adopted on an
interim basis to allow, under the primary care exception described in
Sec. 415.174(c), the teaching physician to direct the care furnished
by the resident, and to review the services furnished by the resident
during or immediately after the visit, remotely using audio/video real-
time communications technology. Several commenters supported a
temporary extension of the policy through the end of the PHE for COVID-
19 or through 2021, while other commenters suggested a permanent
extension of this flexibility.
Response: We appreciate the commenters' support of this policy
during the PHE for COVID-19. After considering the comments and for the
reasons discussed above, we are finalizing this policy for the duration
of the PHE for COVID-19.
Comment: Some commenters requested clarification of the phrase
``interactive audio/visual real-time communication technology'' because
CMS has used various terms when expressing technology requirements for
remote supervision and in the context of teaching physician services,
and because the presence of the slash mark in the phrase makes it
unclear whether both audio and visual communication must be utilized to
meet the requirement, or if one or the other is sufficient. One
commenter also recommended that the phrase be revised to explicitly
state that a real-time audio-only communication is sufficient in order
to meet the regulations set forth in Sec. 415.174(a)(3) for use of the
primary care exception.
Response: While we believe our statements have been clear on this
point, we clarify here that this virtual presence policy requires real-
time observation (not mere availability) by the teaching physician
through a contemporaneous, interactive combination of both audio and
video communications technology, and does not include audio-only
technology (for example, telephone without video). We note that we have
used the ``audio/video'' formulation in our regulations, and that the
``slash'' should be read consistently to mean a synchronous,
interactive, real-time combination of both audio and video technology,
which would not include audio-only communications for any portion of
the time of the furnished service.
Comment: Commenters were generally supportive of the policy adopted
on an interim basis to allow Medicare to make payment to the teaching
physician for additional services under the primary care exception,
including all levels of office and outpatient E/M codes, audio-only
telephone E/M services, transitional care management, and communication
technology-based services. Several commenters supported a temporary
extension of the policy through the end of the PHE for COVID-19 or
through 2021, while other commenters suggested a permanent expansion of
the services that residents could furnish under the primary care
exception.
Response: We appreciate commenters' support of this policy during
the PHE for COVID-19. After considering the comments, we are finalizing
the policy for the duration of the PHE for COVID-19.
Comment: Several commenters thanked CMS for the clarification that
Medicare may make payment under the PFS for teaching physician services
when a resident furnishes services permitted under the primary care
exception, including via telehealth, and the teaching physician can
provide the necessary direction, management and review of the
resident's services using interactive audio/video real-time
communications technology.
Response: We appreciate the commenters' support for this policy
during the PHE.
Comment: Several commenters supported the interim policy during the
PHE for COVID-19 that the office/outpatient E/M level selection for
services under the primary care exception when furnished via telehealth
can be based on medical decision-making or time.
Response: We thank the commenters for their support of this policy
during the PHE. This policy is similar to the policy that will apply to
all office/outpatient E/M services beginning in 2021 under policies
finalized in the CY 2020 PFS final rule and thus, we are not finalizing
it.
d. Summary of Proposed Rule Provisions and Public Comments
i. Background
In the proposed rule, we considered whether the policies
implemented on an interim basis in the March 31st COVID-19 IFC or the
May 8th COVID-19 IFC should be extended on a temporary basis (that is,
if the PHE for COVID-19 ends in 2021, these policies could be extended
to December 31, 2021, to allow for a transition period before reverting
to status quo policy) or be made permanent, and solicited public
comment. We noted that the public comments would assist us in
identifying appropriate policies that we would consider in drafting the
CY 2021 PFS final rule.
For teaching physicians, section 1842(b)(7)(A)(i)(I) of the Act
specifies
[[Page 84577]]
that in the case of physicians' services furnished to a patient in a
hospital with a teaching program, the Secretary shall not provide
payment for such services unless the physician renders sufficient
personal and identifiable physicians' services to the patient to
exercise full, personal control over the management of the portion of
the case for which payment is sought.
Regulations regarding PFS payment for teaching physician services
and services of moonlighting residents are codified in 42 CFR part 415.
In general, under Sec. 415.170, payment is made under the PFS for
services furnished in a teaching hospital setting if the services are
personally furnished by a physician who is not a resident, or the
services are furnished by a resident in the presence of a teaching
physician, with exceptions as specified in subsequent regulatory
provisions in part 415. Under Sec. 415.172, if a resident participates
in a service furnished in a teaching setting, PFS payment is made only
if the teaching physician is present during the key portion of any
service or procedure for which payment is sought. The regulation at
Sec. 415.180 states that, for the interpretation of diagnostic
radiology and other diagnostic tests, PFS payment is made if the
interpretation is performed or reviewed by a physician other than a
resident. Under Sec. 415.184, PFS payment is made for psychiatric
services furnished under an approved graduate medical education (GME)
program if the requirements of Sec. Sec. 415.170 and 415.172 are met,
except that the requirement for the presence of the teaching physician
during psychiatric services in which a resident is involved may be met
by observation of the service by use of a one-way mirror, video
equipment, or similar device.
ii. Supervision of Residents in Teaching Settings Through Audio/Video
Real-Time Communications Technology
In both the March 31st COVID-19 IFC (85 FR 19258 through 19261) and
the May 8th COVID-19 IFC (85 FR 27587 through 27589), we adopted a
policy on an interim basis during the PHE for COVID-19 that, under
Sec. 415.172, the requirement for the presence of a teaching physician
during the key portion of the service furnished with the involvement of
a resident can be met using audio/video real-time communications
technology. In other words, the teaching physician must be present,
either in person or virtually through audio/video real-time
communications technology, during the key portion of the service. This
policy generally requires real-time observation (not mere availability)
by the teaching physician through audio and video technology, and does
not include audio-only technology (for example, telephone without
video). For the primary care exception under Sec. 415.174(c), we
adopted a policy on an interim final basis for the duration of the PHE
for COVID-19 to allow the teaching physician to direct the care
furnished by the resident, and to review the services furnished by the
resident during or immediately after the visit, remotely using audio/
video real-time communications technology.
Under Sec. 415.180, we adopted a policy on an interim basis for
the duration of the PHE for COVID-19 to allow PFS payment for the
interpretation of diagnostic radiology and other diagnostic tests if
the interpretation is performed by a resident when the teaching
physician is present through audio/video real-time communications
technology. A physician other than the resident must still review the
resident's interpretation. Under Sec. 415.184, we adopted a policy on
an interim basis during the PHE for COVID-19 that the requirement for
the presence of the teaching physician during the psychiatric service
in which a resident is involved may be met by the teaching physician's
direct supervision using audio/video real-time communications
technology. We considered whether the flexibilities described above
that we implemented on an interim basis during the PHE for COVID-19
under Sec. Sec. 415.172, 415.174, 415.180, and 415.184 should be
extended on a temporary basis (that is, if the PHE ends in 2021, these
policies could be extended to December 31, 2021, to allow for a
transition period before reverting to status quo policy) or be made
permanent, and solicited public comments on whether these policies
should continue once the PHE for COVID-19 ends. We noted that the
public comments would assist us in identifying appropriate policy
continuation decisions that we would consider finalizing in the CY 2021
PFS final rule. In addition, we proposed to make a technical edit to
the regulation text at Sec. 415.184 to eliminate the term ``direct
supervision'' to conform with the language in sections Sec. Sec.
415.172, 415.174, and 415.180 regarding the presence of the teaching
physician via audio/video real-time communications technology.
While we believe it was appropriate to permit teaching physicians
to be involved in services furnished with residents through audio/video
real-time communications technology to respond to critical needs during
the PHE to reduce exposure risk and to increase the capacity of
teaching settings to respond to COVID-19, we expressed concern that
continuing to permit teaching physicians to be involved through their
virtual presence may not be sufficient to warrant PFS payment to the
teaching physician on a temporary or permanent basis. Absent the
circumstances of the PHE for COVID-19, the physical, in-person presence
of the teaching physician may be necessary to provide oversight to
ensure that care furnished to Medicare beneficiaries is medically
reasonable and necessary, and to ensure that the teaching physician
renders sufficient personal services to exercise full, personal control
of the key portion of the case.
We also noted concerns about patient safety when the teaching
physician is only virtually present. For example, in the March 31st
COVID-19 IFC, we excluded the surgical, high risk, interventional,
endoscopic, or other complex procedures identified under Sec.
415.172(a)(1), and anesthesia services under Sec. 415.178 from the
policy to allow the teaching physician to be present using audio-video
real-time communications technology because we believed the requirement
for the physical, in-person presence of the teaching physician for
either the entire procedure or the key portion of the service with
immediate availability throughout the procedure, as applicable, is
necessary for patient safety given the risks associated with these
services. In complex, high-risk, surgical, interventional, or
endoscopic procedures, or anesthesia procedures, a patient's clinical
status can quickly change. To permit payment under the PFS for these
teaching physician services, we believed the services must be furnished
with a certain level of personal oversight and involvement of the
teaching physician who has the experience and judgment that is
necessary for rapid on-site decision-making during these procedures.
We also noted that there may be circumstances in which virtual
presence of the teaching physician, considered in light of the
potential risks to patient safety and absent exposure risk concerns due
to COVID-19, does not demonstrate sufficient personal involvement in
the service to the patient to warrant payment to the teaching physician
under the PFS. For example, a resident could evaluate a patient for
change in mental status following surgery for hip fracture, perform a
physical exam and report it as unrevealing, and note that the patient
is uncooperative with a full exam. If a full exam had been performed by
the
[[Page 84578]]
teaching physician or with the physical presence of the teaching
physician (or with the teaching physician immediately available in the
clinic to provide the necessary direction, under the primary care
exception) to render personal and identifiable physicians' services to
the patient, the exam would likely have revealed crystal-mediated acute
arthritis, and that the patient's lack of cooperation was due to
hypoactive delirium. However, the teaching physician may not have been
able to identify this concern through the use of audio/video
interactive communications technology. In this case, the presence of
the teaching physician through audio/video interactive communications
technology might have been insufficient to allow the teaching physician
to render personal and identifiable physicians' services to exercise
full, personal control over the key portion of the encounter.
We stated that there also may be certain patient populations that
require greater clinical attentiveness and skill than the teaching
physician could provide via audio/video interactive communications
technology. For example, patients with cognitive impairment or dementia
may require the experience and skill to recognize a need for
specialized testing, and patients with communication disabilities may
require more experience and skill to recognize specialized needs. It
may not be possible for the teaching physician to meet these clinical
needs and exercise full, personal control while being present for the
key portion of the service through audio/video interactive
communications technology. Moreover, the virtual connection between the
teaching physician and the resident who is with the patient could be
disrupted (as with any virtual supervision scenario), rendering it
impossible for the teaching physician to provide necessary direction
for the resident to furnish appropriate care to the patient, thus
foreclosing the ability of the teaching physician to exercise full,
personal control over the key portion of the services, and potentially
putting the patient's safety at risk.
While we expressed significant concerns about extending our interim
policy to permit virtual presence of the teaching physician, whether on
a temporary or permanent basis, we noted that we believe public
comments would be helpful as we further consider the status of this
policy. For example, because COVID-19 may continue to persist in some
communities after the expiration of the PHE for COVID-19, we considered
extending our policy to permit the teaching physician to be present
through audio/video interactive communications technology on a
temporary basis until the end of the calendar year in which the PHE for
COVID-19 ends. The presence of COVID-19 may result in a need for some
teaching settings to continue to limit exposure risks, especially for
high risk patients isolated for their own protection or in cases where
the teaching physician has been exposed to the virus and must be under
quarantine. If the teaching physician is under quarantine, termination
of the policy to permit virtual presence of the teaching physician
could unintentionally limit the number of licensed practitioners
available to furnish services to Medicare patients in some communities,
and could have the unintended consequence of limiting access to
services for Medicare patients. Some communities may experience a
resurgence of COVID-19, and extending our policy until the end of the
calendar year in which the PHE for COVID-19 ends to permit PFS payment
when the teaching physician is present through audio/video real-time
communications technology could temporarily help teaching settings
remain prepared with surge capacity.
Based on the clinical experience gained during the PHE for COVID-
19, we noted that we might identify circumstances or procedures for
which the teaching physician can routinely render sufficient personal
and identifiable services to the patient to exercise full, personal
control over the management of the key portion of the case when the
services are furnished by a resident with the teaching physician
present through audio/video real-time communications technology. For
example, under ordinary circumstances for the primary care exception at
Sec. 415.174, we permit PFS payment to the teaching physician when a
resident furnishes office/outpatient evaluation and management (E/M)
visit codes of lower and mid-level complexity and annual wellness
visits without the presence of a teaching physician (these codes are
discussed in section II.F. of this final rule (85 FR XXXXX)).
Additionally, the teaching physician may be able to provide sufficient
involvement for simple procedures such as CPT code 36410 (Venipuncture,
age 3 years or older, necessitating the skill of a physician or other
qualified health care professional (separate procedure), for diagnostic
or therapeutic purposes (not to be used for routine venipuncture) or
CPT code 51701 (Insertion of non-indwelling bladder catheter (e.g.,
straight catheterization for residual urine)). For such circumstances
and procedures, we stated that it may be appropriate to continue the
virtual presence policy on a temporary or permanent basis.
We noted that having the virtual presence policy in place
temporarily or permanently would not preclude teaching physicians from
providing a greater degree of involvement in services furnished with
residents, and teaching physicians would still have discretion to
determine whether, and if so, when it is appropriate to be present
virtually rather than in person depending on the services being
furnished and the experience of the particular residents involved. We
solicited comments to help us understand how the option to provide for
teaching physician presence using audio/video real-time communications
technology would support patient safety for all patients and
particularly for at-risk patients (for example, patients who are aged
and/or who have a disability); ensure burden reduction without creating
risks to patient care or increasing fraud; avoid duplicative payment
between the PFS and the IPPS for GME programs; and support emergency
preparedness. We also solicited comments to provide data and other
information on experiences implementing this policy during the PHE for
COVID-19.
We received public comments on our proposal to make a technical
edit to the regulation text at Sec. 415.184 to eliminate the term
``direct supervision'' to conform with the language in sections
Sec. Sec. 415.172, 415.174, and 415.180 regarding the presence of the
teaching physician via audio/video real-time communications technology.
The following is a summary of the comments we received and our
responses.
Comment: Multiple commenters supported striking the term ``direct
supervision'' from Sec. 415.184 to conform to related sections
describing the requirements for supervision of residents in teaching
settings.
Response: We appreciate the commenters' support and are finalizing
the technical edit to the regulation text at Sec. 415.184 as proposed.
We also received public comments in response to the CY 2021 PFS
proposed rule on whether the policies we adopted on an interim basis
during the PHE for COVID-19 under Sec. Sec. 415.172, 415.174, 415.180,
and 415.184 should continue once the PHE ends. The following is a
summary of the comments we received and our responses.
Comment: Commenters were generally supportive of the virtual
presence policies in Sec. Sec. 415.172,
[[Page 84579]]
415.174, 415.180, and 415.184 that we implemented on an interim basis
during the PHE for COVID-19. Several commenters supported extending the
flexibilities permanently and asserted that a permanent expansion would
promote patient access to physicians' services, particularly in rural
areas, as well as continuity, convenience, flexibility, choice, and a
decrease in the spread of COVID-19. Another commenter stated that in
rural settings, it was not always possible for the teaching physician
to accompany a resident while also being present with other residents.
This commenter stated that the ability for the resident to be
physically with a patient while the teaching physician is virtually
present has increased patient access to physicians' services in rural
areas. Similarly, other commenters stated that the permanent ability
for teaching physicians to be virtually present when not physically
present could open up additional training opportunities to care for
underserved populations or increase specialty training opportunities
for rural training programs.
Commenters broadly supported the exclusion of surgical, high risk,
interventional, endoscopic, or other complex procedures, including
anesthesia, from the virtual presence policy. While supportive of the
flexibilities that we implemented on an interim basis, some commenters
recommended temporarily extending the policies through the end of the
PHE for COVID-19 to provide flexibility for communities that may
experience resurgences in COVID-19 infections. These commenters cited a
need to gather data regarding patient safety and potential impacts on
resident training outside the context of the PHE before considering
permanent implementation of the policies. For example, one commenter
noted that CMS could use data from procedures furnished by residents
during the PHE under virtual presence of the teaching physician to
determine which procedures may be appropriate for virtual supervision
on an ongoing basis.
Response: We appreciate commenters' support of the virtual presence
policies that we implemented on an interim basis during the PHE for
COVID-19. We remain concerned that, absent the circumstances of the
PHE, virtual presence may not allow the teaching physician to render
sufficient personal and identifiable physicians' services to the
patient to exercise full, personal control over the management of the
portion of the case for which the payment is sought, in accordance with
section 1842(b)(7)(A)(i)(I) of the Act in most settings. For rural
areas, however, we found compelling the commenters' statements that our
virtual presence policy has increased access to Medicare-covered
services. Accordingly, we believe that permitting the teaching
physician to meet the requirements to bill under the PFS for their
services through virtual presence when furnishing services involving
residents in rural training settings could increase access to Medicare-
covered services by preventing the beneficiary from potentially having
to travel long distances to obtain care, particularly as rural areas
have stretched and diminishing clinical workforces.\10\
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\10\ Supply and Distribution of the Primary Care Workforce in
Rural America: 2019: https://depts.washington.edu/fammed/rhrc/wp-content/uploads/sites/4/2020/06/RHRC_PB167_Larson.pdf. https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/reports/HRSA-Rural-Collaboration-Guide.pdf.
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Increasing beneficiary access to care in rural areas is also
consistent with our longstanding interest in increasing beneficiary
access to Medicare-covered services in rural areas.\11\ Further,
permitting the virtual presence of the teaching physician could
facilitate expanded training opportunities for residents in rural
settings, which have historically been in limited supply.\12\ As such,
the need to improve rural access to care for patients and training for
residents overshadows our concerns about the ability for the teaching
physician to render sufficient personal and identifiable physicians'
services through virtual presence. Accordingly, we believe it would be
appropriate to continue our policy to permit teaching physicians to
meet the requirements to bill under the PFS for their services through
virtual presence when furnishing services involving residents in rural
settings after the conclusion of the PHE for COVID-19. This policy not
only furthers our goals to increase beneficiary access to Medicare-
covered services, it also facilitates needed training opportunities in
a similar way to the longstanding primary care exception under Sec.
415.174. The primary care exception permits the teaching physician to
bill for certain types of physicians' services furnished by residents
in certain settings even when the teaching physician is not present
with the resident. Like the policy we are finalizing in this rule, the
primary care exception facilitates access to Medicare-covered services
and expanded residency training opportunities in primary care settings.
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\11\ CMS Rural Health Strategy: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
\12\ HHS awards $20 million to 27 organizations to increase the
rural workforce through the creation of new rural residency
programs: https://www.hhs.gov/about/news/2019/07/18/hhs-awards-20-million-to-27-organizations-to-increase-rural-workforce.html.
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Therefore, we are finalizing a permanent policy to permit teaching
physicians to meet the requirements to bill for their services
involving residents through virtual presence, but only for services
furnished in residency training sites that are located outside of an
OMB-defined metropolitan statistical area (MSA).\13\ In order to ensure
that the teaching physician renders sufficient personal and
identifiable physicians' services to the patient to exercise full,
personal control over the management of the portion of the case for
which the payment is sought in accordance with section
1842(b)(7)(A)(i)(I) of the Act, we are clarifying our existing
documentation requirements to specify that, when a teaching physician,
through virtual presence, furnishes services involving residents in a
residency training site located outside of a MSA, the patient's medical
record must clearly reflect how and when the teaching physician was
present for the service in accordance with our regulations. For
example, in the medical record, the teaching physician could document
their physical or virtual presence at the training site during the key
portion of a service, along with a notation describing the specific
portion(s) of the service for which the teaching physician was
virtually present, and/or that the teaching physician reviewed the
service with the resident during or immediately after the service in
accordance with the primary care exception under Sec. 415.174. We also
expect that, if the teaching physician is virtually present and bills
for services during which there is a disruption to the virtual
connection between the teaching physician and the resident who is with
the patient, the encounter would be paused until the connection
resumes, or the appointment would be rescheduled.
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\13\ Revised Delineations of Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and Combined Statistical Areas, and
Guidance on Uses of the Delineations of These Areas: https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf.
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For all other settings, we are not permanently finalizing our
teaching physician virtual presence policies; however, they will remain
in place for the duration of the PHE to provide flexibility for
communities that may experience resurgences in COVID-19 infections.
While we do not anticipate any program integrity concerns to arise from
this expanded flexibility in rural areas, we agree with commenters that
it is necessary for use to consider
[[Page 84580]]
additional data prior to proposing additional policies in this area,
which could range from expanding this flexibility to include non-rural
settings to terminating this flexibility in all settings. Specifically,
we anticipate considering to what degree the permanent establishment of
the policy to permit teaching physician virtual presence in residency
training sites that are located outside of a MSA increased patient
access to Medicare-covered services and provided additional training
opportunities for residents while enabling the teaching physician to
render sufficient personal and identifiable physicians' services. We
may use such information, obtained through, for example, a commissioned
study, analysis of Medicare claims data or another assessment
mechanism, to further study the impacts of this limited permanent
expansion of the virtual presence policy to inform potential future
rulemaking, and in an effort to prevent possible fraud, waste and
abuse.
We are amending our regulations to reflect this final policy. In
Sec. 415.172(a), to conform with the regulation text we are finalizing
to describe direct supervision in Sec. 410.32(b)(3)(ii), we are adding
language to state that, as a general rule, the required presence of a
teaching physician in order to bill under the PFS for their services at
a residency training site that is located outside of a MSA can be met
through interactive, audio/video real-time communications technology,
which, as noted above, means synchronous, interactive, audio and video
communications technology, and does not include audio-only
communications. We are also adding language to provide that, for the
duration of the PHE for COVID-19, in all teaching settings, the
required presence of a teaching physician can be met through
interactive, audio/video real-time communications technology (excluding
audio-only).
In Sec. 415.172(a)(2), we are adding language to note the
exceptions under which virtual presence is permitted in the case of E/M
services.
In Sec. 415.172(b), which discusses existing documentation
requirements, we are adding language to clarify that, for residency
training sites that are located outside of a MSA, the medical record
must clearly reflect whether the teaching physician was physically or
virtually present at the training site during the key portion of the
service. We are also adding language to clarify that, for all teaching
settings and for the duration of the PHE for COVID-19, the patient's
medical record must clearly reflect whether the teaching physician was
physically or virtually present during the key portion of the service.
Finally, we are adding language to clarify that the medical records
must contain a notation describing the specific portion(s) of the
service for which the teaching physician was present through
interactive, audio/video real-time communications technology (excluding
audio-only).
In Sec. 415.174(c), we are adding language to state that, for all
teaching settings and for the duration of the PHE for COVID-19, the
teaching physician may not only direct the care furnished by residents,
but also review the services provided with the resident, during or
immediately after the visit, remotely through interactive, audio/video
real-time communications technology (excluding audio-only).
In Sec. 415.174(d), we are adding language to state that, for
residency training sites that are located outside of a MSA, the
teaching physician may not only direct the care furnished by residents,
but also review the services provided with the resident, during or
immediately after the visit, remotely through interactive, audio/video
real-time communications technology (excluding audio-only).
In Sec. 415.180(a), we are adding language to state that, for
residency training sites that are located outside of an MSA, PFS
payment may be made for the interpretation of diagnostic radiology and
other diagnostic tests when the interpretation is performed by a
resident and when the teaching physician is present through
interactive, audio/video real-time communications technology (excluding
audio-only). We are also adding language to state that, for all
teaching settings and for the duration of the PHE for COVID-19, PFS
payment may be made for the interpretation of diagnostic radiology and
other diagnostic tests when the interpretation is performed by a
resident and when the teaching physician is present through
interactive, audio/video real-time communications technology (excluding
audio-only). Finally, we are adding language to clarify that the
medical records must document the extent of the teaching physician's
participation in the interpretation or review of the diagnostic
radiology or diagnostic test.
In Sec. 415.184, we are adding language to state that, for
residency training sites that are located outside of a MSA, the
requirement for the presence of the teaching physician during the
psychiatric service in which a resident is involved may be met using
interactive, audio/video real-time communications technology (excluding
audio-only). We are also adding language to state that, for all
teaching settings and for the duration of the PHE for COVID-19, the
requirement for the presence of the teaching physician during the
psychiatric service in which a resident is involved may be met using
interactive, audio/video real-time communications technology (excluding
audio-only). Finally, we are adding language to clarify that the
medical records must document the extent of the teaching physician's
participation in the service.
While difficult to quantify, we believe that permanently extending
the policy to permit virtual presence of teaching physicians in
residency training sites that are located outside of an MSA will
improve patient access to Medicare-covered physicians' services in
rural areas. In addition, the ability of a teaching physician to meet
the requirements to bill for services furnished involving residents
through their virtual presence in these settings will improve teaching
capabilities and potentially allow for additional resident education
opportunities in rural areas. Settings that have traditionally been
inaccessible as training sites for residents due to the limited ability
of teaching physicians to be physically present will be more readily
available, thereby affording increased access to physicians' services
to patients in these areas. However, in order to ensure that this
limited extension of the virtual presence policy is also consistent
with section 1842(b)(7)(A)(i)(I) of the Act, we are clarifying our
existing documentation requirements to specify that the medical record
must clearly reflect how and when the teaching physician was present
for the service. We believe this documentation clarification will
ensure that the teaching physician renders sufficient personal and
identifiable physicians' services to the patient to exercise full,
personal control over the management of the portion of the case for
which the payment is sought. Further, in order to minimize potential
risks to patients, we remind physicians and other practitioners that
the adoption of these virtual presence policies in residency training
sites that are located outside a MSA does not preclude teaching
physicians from being physically present when providing services
furnished with residents. We therefore urge teaching physicians to
continue to use their professional judgment to determine the
circumstances under which it is appropriate to be present virtually
rather than in person depending on the services being furnished and the
experience of the
[[Page 84581]]
particular resident(s) and/or teaching physician involved.
Comment: In response to our comment solicitation for information
regarding how the virtual presence of a teaching physician would
support patient safety, several commenters stated that guardrails exist
through the Accreditation Council for Graduate Medical Education
(ACGME) and other accrediting organizations that have standards and
systems to ensure patient safety and oversight of residents when
virtual supervision of residents occurs.
Response: We appreciate commenters' suggestions that the policies
of the ACGME and other accrediting organizations could serve as
guardrails in the context of virtual supervision; however, the
commenters provided no specific description of any such policies or any
other evidence to further identify those guardrails. Without further
information, CMS cannot opine on the sufficiency of ACGME or other
accrediting organization policies. Therefore, we continue to rely on
the clinical judgment of teaching physicians and the residents they
involve in their care to ensure appropriate patient safety.
iii. Virtual Teaching Physician Presence During Medicare Telehealth
Services
In the March 31st COVID-19 IFC (85 FR 19230), we adopted a policy
on an interim basis to allow Medicare to make payment under the PFS for
teaching physician services when a resident furnishes Medicare
telehealth services to beneficiaries while a teaching physician is
present using audio/video real-time communications technology. We also
noted that we were considering whether this policy should be extended
on a temporary basis (that is, if the PHE for COVID-19 ends in 2021,
this policy could be extended to December 31, 2021, to allow for a
transition period before reverting to status quo policy) or be made
permanent, and solicited public comments on whether this policy should
continue once the PHE for COVID-19 ends. We noted that the public
comments would assist us in identifying appropriate policy continuation
decisions that we would consider finalizing in the CY 2021 PFS final
rule. Outside the circumstances of the PHE for COVID-19, under the
requirements at section 1834(m) of the Act that discuss payment for
telehealth services, the patient would be located at a telehealth
originating site, and the teaching physician would be furnishing the
service as the distant site practitioner with the involvement of the
resident.
While teaching physician presence through audio/video real-time
communications technology when a resident furnishes Medicare telehealth
services was responsive to critical needs during the PHE for COVID-19
to reduce exposure risk and to increase the capacity of teaching
settings to respond to COVID-19, we expressed concern that the policy
to permit virtual presence of the teaching physician may not allow for
sufficient personal and identifiable physicians' services to exercise
full, personal control over the services such that PFS payment to the
teaching physician would be appropriate outside the circumstances of
the PHE for COVID-19 on a temporary or permanent basis. We also noted
concern that if the resident was furnishing the service at the distant
site and the teaching physician was at a third site and present with
the resident through audio/video real-time communications technology,
the teaching physician may not be able to render sufficient personal
and identifiable physicians' services to the patient to exercise full,
personal control over the service to warrant separate payment on the
PFS.
Absent the need to reduce exposure risk to COVID-19 during the PHE,
we also expressed some concerns about patient safety when the teaching
physician is present only virtually during a telehealth service
furnished by a resident. For example, the virtual connection between
the teaching physician and the resident who is with the patient could
be disrupted (as with any virtual supervision scenario), rendering it
impossible for the teaching physician to provide necessary direction
for the resident to furnish appropriate care to the patient, thus
foreclosing the ability of the teaching physician to exercise full,
personal control over the key portion of the service, and potentially
putting the patient's safety at risk.
However, because COVID-19 may continue to persist in some
communities and some communities may experience a resurgence of COVID-
19 after the expiration of the PHE for COVID-19, we solicited comments
about whether it would be appropriate to extend this policy on a
temporary basis until the end of the calendar year in which the PHE for
COVID-19 ends. The presence of COVID-19 may result in a need to
continue to limit exposure risks. In cases where the teaching physician
has been exposed to the virus and is under quarantine, termination of
the policy to permit virtual presence of the teaching physician could
unintentionally limit the number of licensed practitioners available to
furnish services to Medicare patients in some communities, and could
have the unintended consequence of limiting access for Medicare
patients. Finally, based on experience gained during the PHE for COVID-
19, we noted that we might identify circumstances for which the
teaching physician can routinely render sufficient personal and
identifiable services to the patient to exercise full, personal control
over the management of the key portion of the case while providing
virtual presence during Medicare telehealth services furnished by a
resident on a permanent basis. For example, under ordinary
circumstances for the primary care exception at Sec. 415.174, we
permit PFS payment to the teaching physician when a resident furnishes
office/outpatient E/M visit codes of lower and mid-level complexity and
annual wellness visits without the presence of a teaching physician
(these codes were discussed in section II.F. of the proposed rule (85
FR 50121)). For such services, we noted that it may be appropriate to
continue the virtual presence policy on a temporary or permanent basis.
We solicited comments to help us understand how the option to allow
teaching physician presence using audio/video real-time communications
technology could support patient safety for all patients and
particularly for at-risk patients (for example, patients who are aged
and/or who have a disability), ensure burden reduction without creating
risks to patient care or increasing fraud, avoid duplicative payment
between the PFS and the IPPS for GME programs, and support emergency
preparedness. We also solicited comments to provide data and other
information on experiences implementing this policy during the PHE for
COVID-19.
We received public comments on whether the policy we adopted on an
interim final basis during the PHE for COVID-19 to allow Medicare to
make payment under the PFS to the teaching physician when a resident
furnishes Medicare telehealth services to beneficiaries while a
teaching physician is present using audio/video real-time
communications technology should continue once the PHE for COVID-19
ends. The following is a summary of the comments we received and our
responses.
Comment: Commenters were generally supportive of our interim policy
to allow Medicare to make payment under the PFS to the teaching
physician when a resident furnishes Medicare telehealth services to
beneficiaries while a teaching physician
[[Page 84582]]
is present using audio/video real-time communications technology.
Several commenters supported extending the flexibility permanently,
while others recommended temporarily extending the policy through the
end of the PHE for COVID-19, and cited a need to gather data regarding
patient safety and potential impacts on resident training outside the
context of the PHE for COVID-19. One commenter stated that in rural
settings, it was not always possible for the teaching physician to
accompany a resident while also being present to other residents. This
commenter stated that the ability for the teaching physician is
virtually present has increased patient access to physicians' services
in rural areas. Similarly, other commenters stated that the permanent
ability for teaching physicians to be virtually present when not
physically present could increase training opportunities for rural
training programs, and better prepare residents for the nuances and
differences of providing care over video instead of in person.
Response: We appreciate commenters' support of our interim policy
to allow Medicare to make payment under the PFS for teaching physician
services when a resident furnishes Medicare telehealth services to
beneficiaries while a teaching physician is present using interactive,
audio/video real-time communications technology (excluding audio-only).
We remain concerned that, absent the circumstances of the PHE, a
teaching physician's presence via interactive, audio/video real-time
communications technology (excluding audio-only) when a resident is
furnishing Medicare telehealth services may not allow the teaching
physician to render sufficient personal and identifiable physicians'
services to the patient to exercise full, personal control over the
management of the portion of the case for which payment is sought, in
accordance with section 1842(b)(7)(A)(i)(I) of the Act, in most
settings. For rural areas, however, we found compelling the commenters'
statements that our virtual presence policy has increased access to
Medicare-covered services. Accordingly, we believe that a policy to
permit Medicare to make PFS payment for teaching physician services
when a resident located within a rural training setting furnishes
Medicare telehealth services to beneficiaries while a teaching
physician is present through interactive, audio/video real-time
communications technology (excluding audio-only) could increase access
to Medicare-covered services in rural areas by preventing the
beneficiary from potentially having to travel long distances to obtain
care, particularly as rural areas have stretched and diminishing
clinical workforces.\14\ Increasing beneficiary access to care in rural
areas is also consistent with our longstanding interest in increasing
beneficiary access to Medicare-covered services in rural areas;
therefore, in order to allow for more widespread access to care for
beneficiaries in rural areas, we believe it would be appropriate for a
resident located within a rural training setting to furnish telehealth
services to a beneficiary who is in a separate location within the same
rural area as the resident or within a different rural area, while a
teaching physician is present, through interactive, audio/video real-
time communications technology (excluding audio-only), in a third
location, either within the same rural training setting as the resident
or outside of that rural training setting.\15\ Further, allowing
Medicare to make PFS payment for teaching services when a resident
furnishes Medicare telehealth services to a beneficiary while a
teaching physician is present through interactive, audio/video real-
time communications technology (excluding audio-only) could facilitate
additional training opportunities for residents in rural settings,
which have historically been in limited supply.\16\ As such, the need
to improve rural access to care for patients and training for residents
overshadows our concerns about the ability for the teaching physician
to render sufficient personal and identifiable physicians' services to
the patient to exercise full, personal control over the management of
the portion of the case for which payment is sought. Accordingly, in
rural areas, we believe it would be appropriate to continue our policy
to permit teaching physicians to meet the requirements to bill under
the PFS for their services when a resident furnishes Medicare
telehealth services to beneficiaries while a teaching physician is
present through interactive, audio/video real-time communications
technology (excluding audio-only) after the conclusion of the PHE for
COVID-19. This policy not only furthers our goals to increase
beneficiary access to Medicare-covered services, it also facilitates
needed training opportunities in a similar way to the longstanding
primary care exception under Sec. 415.174. The primary care exception
permits the teaching physician to bill for certain types of physicians'
services furnished by residents in certain settings even when the
teaching physician is not present with the resident. Like the policy we
are finalizing in this rule, the primary care exception facilitates
access to Medicare-covered services and expanded residency training
opportunities in primary care settings. Therefore, we are permanently
finalizing our policy that Medicare may make payment under the PFS for
teaching physician services when a resident furnishes Medicare
telehealth services in a residency training site located outside of a
MSA to a beneficiary who is in a separate location outside the same MSA
(that is, in the same rural area) as the residency training site or is
within a rural area outside of a different MSA, while a teaching
physician is present, through interactive, audio/video real-time
communications technology (excluding audio-only), in a third location,
either within the same rural training site as the resident or outside
of that rural training site. In order to ensure that the teaching
physician renders sufficient personal and identifiable physicians'
services to the patient to exercise full, personal control over the
management of the portion of the case for which the payment is sought,
in accordance with section 1842(b)(7)(A)(i)(I) of the Act, we are
clarifying our existing documentation requirements to specify that,
when a resident furnishes Medicare telehealth services in a residency
training site located outside of a MSA and the teaching physician is
present using interactive, audio/video real-time communications
technology (excluding audio-only), the patient's medical record must
clearly reflect how and when the teaching physician was present during
the key portion of the service, in accordance with our regulations. For
example, in the medical record, the teaching physician could document
their physical or virtual presence at the training site during the key
portion of the service, along with a notation describing the specific
portion(s) of the service for which the teaching physician was
virtually present, and/or that the teaching physician reviewed the
service with the resident during or immediately after the service in
accordance with the primary
[[Page 84583]]
care exception under Sec. 415.174. We also expect that, if the
teaching physician is virtually present and bills for services during
which there is a disruption to the virtual connection between the
teaching physician and the resident who is with the patient, the
encounter would be paused until the connection resumes, or the
appointment would be rescheduled.
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\14\ A Guide for Rural Health Care Collaboration and
Coordination: https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/reports/HRSA-Rural-Collaboration-Guide.pdf.
\15\ CMS Rural Health Strategy: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
\16\ HHS awards $20 million to 27 organizations to increase the
rural workforce through the creation of new rural residency
programs: https://www.hhs.gov/about/news/2019/07/18/hhs-awards-20-million-to-27-organizations-to-increase-rural-workforce.html.
---------------------------------------------------------------------------
For all other settings, we are not permanently finalizing this
policy; however, the policy will remain in place for the duration of
the PHE for COVID-19 to provide flexibility for communities that may
experience resurgences in COVID-19 infections. While we do not
anticipate any program integrity concerns from this expanded
flexibility, we agree with commenters that it is necessary for us to
consider additional data prior to proposing additional policies in this
area, which could range from expanding this flexibility to include non-
rural settings to terminating this flexibility in all settings.
Specifically, we anticipate considering to what degree the permanent
implementation of the policy to allow PFS payment for teaching services
when a teaching physician is virtually present while a resident
furnishes Medicare telehealth services in a residency training site
located outside of an MSA increased patient access to Medicare-covered
services and provided more training opportunities for residents while
enabling the teaching physician to render sufficient personal and
identifiable physicians' services. We may use such information,
obtained through, for example, a commissioned study, analysis of
Medicare claims data or another assessment mechanism, to further study
the impacts of this limited permanent expansion of the policy to allow
PFS payment for teaching services when a teaching physician is
virtually present while a resident furnishes Medicare telehealth
services to inform potential future rulemaking, and in an effort to
prevent possible fraud, waste and abuse.
We are amending our regulations to reflect this final policy. In
Sec. 415.172(a), we are adding language to state that, in a residency
training site located outside of an MSA, a teaching physician may bill
under the PFS for services furnished when they are present with the
resident during the key portion of the service through interactive,
audio/video real-time communications technology (excluding audio-only),
including when the resident provides Medicare telehealth services. We
are also adding language to state that, for all teaching settings and
for the duration of the PHE for COVID-19, payment under the PFS is
permitted if a teaching physician is present during the key portion of
the service, including Medicare telehealth services, through
interactive, audio/video real-time communications technology (excluding
audio-only). In Sec. 415.172(b), which discusses existing
documentation requirements, we are adding language to clarify that, for
residency training sites that are located outside of a MSA, the
patient's medical record must clearly reflect whether the teaching
physician was physically or virtually present at the training site
during the key portion of the service, including for Medicare
telehealth services. We are also adding language to clarify that, for
all teaching settings and for the duration of the PHE for COVID-19, the
patient's medical record must clearly reflect whether the teaching
physician was physically or virtually present during the key portion of
the service, including for Medicare telehealth services. Finally, we
are adding language to clarify that the medical records must contain a
notation describing the specific portion(s) of the service, including
Medicare telehealth services, for which the teaching physician was
present through interactive, audio/video real-time communications
technology (excluding audio-only).
While difficult to quantify, we believe that permanently extending
our policy to allow payment under the PFS for teaching physician
services when a resident furnishes Medicare telehealth services in a
residency training site located outside of an MSA and the teaching
physician is present through interactive audio/video real-time
communications technology (excluding audio-only) will promote enhanced
patient access to Medicare-covered physicians' services in rural areas.
In addition, allowing PFS payment for teaching physician services when
a resident furnishes Medicare telehealth services in a residency
training site located outside of an MSA and the teaching physician is
present through interactive audio/video real-time communications
technology (excluding audio-only) will improve teaching capabilities
and potentially allow for additional resident education opportunities
in rural areas. Settings that have traditionally been inaccessible as
training sites for residents due to the limited ability of teaching
physicians to be physically present will be more readily available,
thereby affording increased access to physicians' services to patients
in these areas. However, in order to ensure that the limited extension
of this policy is also consistent with section 1842(b)(7)(A)(i)(I) of
the Act, we are clarifying the existint documentation requirements to
specify that the medical record must clearly reflect how and when the
teaching physician was present for the Medicare telehealth service. We
believe this documentation clarification will ensure that the teaching
physician renders sufficient personal and identifiable physicians'
services to the patient to exercise full, personal control over the
management of the portion of the case for which payment is sought.
Further, in order to minimize potential risks to patients, we remind
physicians and other practitioners that the adoption of this policy in
residency training sites that are located outside of an MSA does not
preclude teaching physicians from being physically present when a
resident is furnishing Medicare telehealth services. We therefore urge
teaching physicians to continue to use their professional judgment to
determine the circumstances under which it is appropriate to be present
virtually rather than in person, depending on the Medicare telehealth
services being furnished and the experience of the particular residents
involved.
Comment: One commenter, who favored a permanent policy to allow PFS
payment for teaching physician services when a resident furnishes
Medicare telehealth services in a residency training site located
outside of a MSA and the teaching physician is present using
interactive audio/video real-time communications technology, advocated
for the permanent extension of the policy by noting that ACGME
recognizes and endorses an expansion of telemedicine as well as the use
of audio/visual communications devices by residents and their teaching
physicians. Further, the commenter stated that, as long as the virtual
presence of teaching physicians during Medicare telehealth services
continues to adhere to ACGME standards, an optimal learning
environment, with appropriate education and supervision, would be
maintained.
Response: We appreciate the commenter's feedback regarding ACGME
standards in the context of the expansion of telemedicine and the use
of audio/visual communication devices by residents and teaching
physicians; however, the commenter provided no specific description of
ACGME's standards or any evidence to support a permanent implementation
of the policy to allow PFS payment for teaching services when a
resident furnishes Medicare telehealth services in all settings when a
teaching physician is present through interactive, audio/video
[[Page 84584]]
real-time communications technology (excluding audio-only). Without
further information, CMS cannot opine on whether or not ACGME's
standards would support a wider permanent implementation of this
policy. Therefore, we continue to rely on the clinical judgment of
teaching physicians and the residents they involve in their care to
ensure appropriate patient safety.
iv. Resident Moonlighting in the Inpatient Setting
Under certain conditions, the services of a licensed resident
physician who is ``moonlighting'' are considered to be furnished by the
individual in their capacity as a physician, rather than as a resident
in an approved GME program. As specified in the regulation at Sec.
415.208, except during the PHE for COVID-19, as defined in the
regulation at Sec. 400.200, the services of residents to inpatients of
hospitals in which the residents have their approved GME program are
not considered separately billable as physicians' services and instead
are payable under Sec. Sec. 413.75 through 413.83 regarding direct GME
payments, whether or not the services are related to the approved GME
training program. When a resident furnishes services that are not
related to their approved GME programs in an outpatient department or
emergency department of a hospital in which they have their training
program, those services can be billed separately as physicians'
services and payable under the PFS if they meet the criteria described
in our regulation at Sec. 415.208(b)(2)(i) through (iii). In addition,
under Sec. 415.208(c), services of a licensed resident furnished
outside the scope of an approved GME program when moonlighting in a
hospital or other setting that does not participate in the approved GME
program are payable under the PFS when the resident is fully licensed
to practice in the state where the services are furnished, and the
resident's time spent in patient care activities in that setting is not
counted for the purpose of Medicare direct GME payments.
In the March 31st COVID-19 IFC, we amended our regulation at Sec.
415.208 to state that, during the PHE for COVID-19, the services of
residents that are not related to their approved GME programs and are
furnished to inpatients of a hospital in which they have their training
program are separately billable physicians' services for which payment
can be made under the PFS provided that the services are identifiable
physicians' services and meet the conditions for payment of physicians'
services to beneficiaries by providers in Sec. 415.102(a), the
resident is fully licensed to practice medicine, osteopathy, dentistry,
or podiatry by the state in which the services are performed, and the
services can be separately identified from those services that are
required as part of the approved GME program. We considered whether
this flexibility that we implemented on an interim basis should be
extended on a temporary basis (that is, if the PHE for COVID-19 ends in
2021, these policies could be extended to December 31, 2021, to allow
for a transition period before reverting to status quo policy) or be
made permanent, and solicited public comments on whether this policy
should continue once the PHE ends. We expressed concerns that there may
be risks to program integrity in allowing residents to furnish
separately billable physicians' services to inpatients in the teaching
hospitals where they are training when the services are outside the
scope of their approved GME program. For example, there could be a risk
of duplicate Medicare payment for the resident's services under the
IPPS for GME and the PFS if the physicians' services furnished by
residents were not adequately separately identified from those services
that are required as part of the GME program. However, because COVID-19
may continue to persist in some communities or some communities may
experience a resurgence of COVID-19 after the expiration of the PHE, we
noted that it may be appropriate for us to extend this policy on a
temporary basis to meet the needs of teaching hospitals to ensure that
there are as many qualified practitioners available as possible. We
noted that the public comments would assist us in identifying
appropriate policy continuation decisions that we would consider
finalizing in this CY 2021 PFS final rule. We also solicited comments
to provide data and other information on experiences implementing this
policy during the PHE for COVID-19.
We received public comments from our comment solicitation in the
proposed rule regarding whether our resident moonlighting policy under
Sec. 415.208 that we implemented on an interim basis for the PHE for
COVID-19 should continue once the PHE ends. The following is a summary
of the comments we received and our responses.
Comment: Commenters were generally supportive of the policy under
Sec. 415.208 that we adopted on an interim basis during the PHE for
COVID-19. Several commenters supported extending the flexibility
permanently, while others recommended temporarily extending the policy
through the end of the PHE for COVID-19, and cited a need to maintain
surge capacity and to allow more data to be gathered regarding patient
safety and potential impacts on resident training outside the context
of the PHE. A few commenters suggested that to prevent duplicate
billing, CMS should educate practitioners about the need for sufficient
documentation to demonstrate that services furnished while residents
are moonlighting are separate from those services that are required as
part of approved GME programs.
Response: We appreciate commenters' support for our interim policy.
After considering the comments, we are finalizing our interim policy
for the services of moonlighting residents on a permanent basis.
Consequently, we are amending our regulation at Sec. 415.208(b)(2) to
state that the services of residents that are not related to their
approved GME programs and are performed in the outpatient department,
emergency department, or inpatient setting of a hospital in which they
have their training program are separately billable physicians'
services for which payment can be made under the PFS provided that the
services are identifiable physicians' services and meet the conditions
of payment for physicians' services to beneficiaries in providers in
Sec. 415.102(a), the resident is fully licensed to practice medicine,
osteopathy, dentistry, or podiatry by the State in which the services
are performed, and the services are not performed as part of the
approved GME program.
We agree with commenters about the need for sufficient
documentation to allay concerns about potential duplication of payment
with the IPPS for GME. Thus, we are also amending Sec. 415.208(b)(2)
to clarify that, regardless of whether the resident's services are
performed in the outpatient department, emergency department or
inpatient setting of a hospital in which they have their training
program, the patient's medical record must clearly reflect that the
resident furnished identifiable physician services that meet the
conditions of payment of physician services to beneficiaries in
providers in Sec. 415.102(a), that the resident is fully licensed to
practice medicine, osteopathy, dentistry, or podiatry by the State in
which the services are performed, and that the services are not
performed as part of the approved GME program. For example, in the
medical record, the resident could state that they are licensed to
practice medicine, osteopathy, dentistry or podiatry by the
[[Page 84585]]
state in which the service was performed, document that the service was
performed outside of their approved GME program, and include a notation
describing the specific physician service that was furnished,
v. Primary Care Exception Policies
The regulation at Sec. 415.174 sets forth an exception to the
conditions for PFS payment for services furnished in teaching settings
in the case of certain E/M services furnished in certain centers. Under
the so-called ``primary care exception,'' Medicare makes PFS payment in
certain teaching hospital primary care centers for certain services of
lower and mid-level complexity furnished by a resident without the
physical presence of a teaching physician. Section 415.174(a)(3)
requires that the teaching physician must not direct the care of more
than four residents at a time, and must direct the care from such
proximity as to constitute immediate availability (that is, provide
direct supervision) and must review with each resident during or
immediately after each visit, the beneficiary's medical history,
physical examination, diagnosis, and record of tests and therapies.
Section 415.174(a)(3) also requires that the teaching physician must
have no other responsibilities at the time, assume management
responsibility for the beneficiaries seen by the residents, and ensure
that the services furnished are appropriate.
As provided in the regulation at Sec. 415.174(a), the codes of
lower and mid-level complexity that can be furnished under the primary
care exception are specified in section 100 of chapter 12 of the
Medicare Claims Processing Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf). They are the
following:
CPT code 99201 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires these 3 key
components: A problem focused history; A problem focused examination;
Straightforward medical decision making. 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 self-limited or minor. Typically, 10 minutes
are spent face-to-face with the patient and/or family);
CPT code 99202 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires these 3 key
components: An expanded problem focused history; An expanded problem
focused examination; Straightforward medical decision making.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are of low to
moderate severity. Typically, 20 minutes are spent face-to-face with
the patient and/or family);
CPT code 99203 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires these 3 key
components: A detailed history; A detailed examination; Medical
decision making of low complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the presenting
problem(s) are of moderate severity. Typically, 30 minutes are spent
face-to-face with the patient and/or family);
CPT code 99211 (Office or other outpatient visit for the
evaluation and management of an established patient, that may not
require the presence of a physician or other qualified health care
professional. Usually, the presenting problem(s) are minimal.
Typically, 5 minutes are spent performing or supervising these
services);
CPT code 99212 (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 problem focused history; A problem
focused examination; Straightforward medical decision making.
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 self-limited or
minor. Typically, 10 minutes are spent face-to-face with the patient
and/or family);
CPT code 99213 (Office or other outpatient visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: An expanded problem focused history;
An expanded problem focused examination; Medical decision making of low
complexity. Counseling and coordination of care with other physicians,
other qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are of low to
moderate severity. Typically, 15 minutes are spent face-to-face with
the patient and/or family);
HCPCS code G0402 (Initial preventive physical examination;
face-to-face visit, services limited to new beneficiary during the
first 12 months of Medicare enrollment);
HCPCS code G0438 (Annual wellness visit; includes a
personalized prevention plan of service (PPS), initial visit); and
HCPCS code G0439 (Annual wellness visit, includes a
personalized prevention plan of service (PPS), subsequent visit).
In the March 31st COVID-19 IFC, we amended Sec. 415.174 of our
regulations to allow, during the PHE for COVID-19, all levels of
office/outpatient E/M visits to be furnished by the resident and billed
by the teaching physician under the primary care exception. In the May
8th COVID-19 IFC), we further expanded the list of services included in
the primary care exception during the PHE for COVID-19. We also allowed
PFS payment to the teaching physician for services furnished by
residents via telehealth under the primary care exception if the
services were also on the list of Medicare telehealth services.
We noted that we were considering whether these policies should be
extended on a temporary basis (that is, if the PHE for COVID-19 ends in
2021, these policies could be extended to December 31, 2021, to allow
for a transition period before reverting to status quo policy) or be
made permanent, and solicited public comments on whether these policies
should continue once the PHE for COVID-19 ends. We also noted that the
public comments would assist us in identifying appropriate policy
continuation decisions that we would consider finalizing in the CY 2021
PFS final rule. We also considered whether specific services added
under the primary care exception should be extended temporarily or made
permanent and solicited public comments on whether these services
should continue as part of the primary care exception once the PHE for
COVID-19 ends. These services are the following:
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
[[Page 84586]]
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);
CPT code 99205 (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 high 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, 60
minutes are spent face-to-face with the patient and/or family);
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);
CPT code 99215 (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 comprehensive history; A
comprehensive examination; Medical decision making of high 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, 40 minutes are spent face-to-face with the
patient and/or family);
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);
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);
CPT code 99421 (Online digital evaluation and management
service, for an established patient, for up to 7 days, cumulative time
during the 7 days; 5-10 minutes);
CPT code 99422 (Online digital evaluation and management
service, for an established patient, for up to 7 days, cumulative time
during the 7 days; 11-20 minutes);
CPT code 99423 (Online digital evaluation and management
service, for an established patient, for up to 7 days, cumulative time
during the 7 days; 21 or more minutes);
CPT code 99452 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or qualified health care professional, 30
minutes);
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); and
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).
We noted that expanding the array of services for which Medicare
may make PFS payment to the teaching physician when furnished by a
resident under the primary care exception was responsive to critical
needs during the PHE for COVID-19 for patients who may be quarantined
at home or who may need to be isolated for purposes of minimizing
exposure risk based on presumed or confirmed COVID-19 infection.
Because COVID-19 may continue to persist in some communities or some
communities may experience a resurgence of COVID-19 after the
expiration of the PHE for COVID-19, we also noted that it may be
appropriate for us to extend all of these services on a temporary basis
(that is, until the end of the calendar year in which the PHE for
COVID-19 ends).
However, we expressed concern that it may be inappropriate to
extend all of these services on a temporary basis or add them to the
primary care exception permanently. The intent of the primary care
exception as described in Sec. 415.174 is that E/M visits of lower and
mid-level complexity furnished by residents are simple enough to permit
a teaching physician to be able to direct and manage the care of up to
four residents at any given time and direct the care from such
proximity as to constitute immediate availability. While CPT code 99421
and HCPCS code G2012 may be simple services, others such as levels 4
and 5 office/outpatient E/M visits (CPT codes 99204 through 99205 and
CPT codes 99214 through 99215) and transitional care management codes
(CPT codes 99495 through 99496) require medical decision-making that is
of at least moderate complexity. We also noted concern that the
teaching physician may not be able to maintain sufficient personal
involvement in all of the care to warrant PFS payment for the services
being furnished by up to four residents when some or all of the
residents might be furnishing services that are more than lower and
mid-level complexity. We noted that when the teaching physician is
directing the care of a patient that requires moderate or higher
medical decision-making, the ability to be immediately available to
other residents could be compromised, potentially putting patients at
risk. Thus, we considered whether, upon expiration of the PHE for
COVID-19, we should extend on a temporary basis some or all of the
services we added to the primary care exception list during the PHE and
solicited public comments on whether these services should continue as
part of the primary care exception after the PHE ends. We also
solicited comments to provide data and other information on experiences
implementing this policy during the PHE for COVID-19.
We also considered whether our interim policy that PFS payment
could be made to the teaching physician when residents furnish
telehealth services under the primary care exception should be extended
on a temporary basis or be made permanent, and solicited public
comments on whether this policy should continue once the
[[Page 84587]]
PHE for COVID-19 ends. In these cases, outside the circumstances of the
PHE for COVID-19, the patient would be at the originating site and the
resident furnishing the care, along with the teaching physician billing
for it, would be located at the primary care center as the distant site
practitioner. If we were to temporarily extend or add permanently to
the primary care exception services such as e-visits or communication
technology-based services, we noted that it may also make sense to
permit PFS payment to the teaching physician when the resident
furnishes an office/outpatient E/M visit via telehealth, on the basis
that the patient is not physically in the clinic and that these
services all involve the use of virtual technology (for example,
patient portals for e-visits, telecommunications technology for the
office/outpatient E/M visit) to facilitate care delivery. Further, we
noted that, if we were to remove the services that we added to the
primary care exception on an interim basis, we could separately
consider continuing to permit PFS payment to the teaching physician
when the resident furnishes an office/outpatient E/M visit via
telehealth because the teaching physician would be immediately
available in the distant site clinic with the resident to direct and
manage the care.
We received public comments on the primary care exception policies.
The following is a summary of the comments we received and our
responses.
Comment: Commenters were generally supportive of the policy adopted
on an interim basis under Sec. 415.174 to allow Medicare to make
payment to the teaching physician for additional services under the
primary care exception, including all levels of office and outpatient
E/M, audio-only telephone E/M services, transitional care management,
and communication technology-based services. Commenters were also
generally supportive of our interim policy to allow Medicare to make
payment under the PFS to the teaching physician for services furnished
by residents via telehealth under the primary care exception if the
services are on the list of Medicare telehealth services. These
commenters stated that in general, the expansion of the primary care
exception increases beneficiary access to Medicare-covered services and
provides additional training opportunities for residents, particularly
in rural areas.
Several commenters supported making permanent all the services that
we implemented on an interim basis during the PHE for COVID-19. Several
other commenters supported making certain services permanent, stating
that services such as communication technology-based services (for
example, CPT codes 99421-99423 and HCPCS codes G2010 and G2012) were
simple, require low to moderate complexity medical decision-making, and
do not involve a diagnostic complexity that is beyond a resident's
skill. In addition, some commenters supported the permanent inclusion
of CPT code 99452 and stated that in some models of care, these inter-
professional consults are typically initiated by a primary care
practitioner to a specialist for a low acuity, condition-specific
question that can be answered without an in-person visit.
Some commenters supported the permanent inclusion of CPT codes
99204 and 99214, while other commenters did not. Commenters in support
of including these codes stated that office/outpatient level 4 visits
are typical visit for the Medicare population and that these visits do
not involve a level of diagnostic complexity that is beyond a
resident's skill. Other commenters stated that office/outpatient level
4 visits should be furnished with the teaching physician present,
either physically or through interactive audio/video real-time
communications technology. These commenters were concerned that
allowing office/outpatient level 4 visits to be furnished without the
presence of the teaching physician could pose risks to patient safety
and potential for abuse.
Some commenters did not support the permanent inclusion of high-
complexity services, including office/outpatient level 5 visits (CPT
codes 99205 and 99215) and transitional care management (CPT code
99496), due to the high level of medical complexity, patient safety
concerns, and potential for abuse.
Several commenters recommended temporarily extending the primary
care exception policies through the end of the PHE for COVID-19 and
cited a need to gather data regarding patient safety and potential
impacts on resident training outside the context of the PHE. Other
commenters stated that the expansion of the primary care exception has
allowed residents to be trained based on ``real life,'' which will
leave them better prepared to furnish additional services upon
completion of their residency programs.
Response: We appreciate commenters' support of our interim policy
to allow Medicare to make payment to the teaching physician when the
resident furnishes an expanded array of services under the primary care
exception. We remain concerned that permanently adding all of the
proposed services to the primary care exception may be inappropriate
because some of the services require at least a moderate level of
medical decision-making, whereas the intent of the primary care
exception as described in Sec. 415.174 is that E/M visits of lower and
mid-level complexity furnished by residents are simple enough for a
teaching physician to be able to direct and manage the care of up to
four residents at any given time and direct the care from such
proximity as to constitute immediate availability. We also remain
concerned that the teaching physician may not be able to maintain
sufficient personal involvement in all of the care to warrant PFS
payment for the services being furnished by up to four residents when
some or all of the residents might be furnishing services that are more
than lower and mid-level complexity. However, we found the comments
regarding the advantages of an expansion of services under the primary
care exception in rural areas particularly compelling. Specifically,
allowing PFS payment for additional primary care services furnished by
residents without the physical presence of a teaching physician in
rural areas could increase the availability of Medicare-covered
services, which is consistent with our longstanding interest in
increasing beneficiary access to Medicare-covered services in rural
areas\17\. For example, permitting PFS payment to the teaching
physician when the resident furnishes communication-technology based
services, an inter-professional consultation, or an office/outpatient
visit via telehealth without a teaching physician present could prevent
the beneficiary from potentially having to travel long distances to
obtain care. Accordingly, we believe that permitting Medicare to make
PFS payment to the teaching physician when the resident furnishes an
expanded array of services under the primary care exception in rural
settings could increase access to Medicare-covered services. Further,
this policy could also provide the benefit of additional training
opportunities for residents in rural settings, which have historically
been in limited supply. As such, the need to improve rural access to
care for patients and training for resident overshadows our concerns
that the teaching physician may not be able to maintain sufficient
personal involvement in all of the care to warrant PFS payment for the
services being furnished by up to four residents when
[[Page 84588]]
some or all of the residents might be furnishing services that are more
than lower and mid-level complexity. Accordingly, we are finalizing,
for residency training sites that are located outside of a MSA, a
policy to allow Medicare to make payment to the teaching physician when
the resident furnishes an expanded array of services under the primary
care exception. However, in accordance with the original intent of the
primary care exception to limit the scope of services to those of lower
and mid-level complexity, we are limiting the permanent expanded array
of services under the primary care exception to include communication-
technology based services and inter-professional consults. These
services are described by CPT codes 99421-99423, and 99452, and HCPCS
codes G2010 and G2012. We are also adding to the primary care
exception, for residency training sites that are located outside of an
MSA, Medicare telehealth services that furnished by residents. Based on
the descriptors, these codes all represent E/M services of a low-to-
mid-level complexity, which is consistent with our regulations in Sec.
415.174.
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\17\ CMS Rural Health Strategy: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
---------------------------------------------------------------------------
As noted above, some commenters supported adding office/outpatient
E/M level 4 visits (CPT codes 99204 and 99214) to the primary care
exception. While we included these services in the exception during the
PHE to meet the needs of all teaching settings to ensure that there are
as many qualified practitioners available as possible, we agree with
the commenters who stated that it is inappropriate to allow these
services to be billed by the teaching physician when furnished by
residents without the presence of a teaching physician on a permanent
basis because these services involve medical decision-making of at
least a moderate level of complexity, so the ability for the teaching
physician to be immediately available to other residents could be
compromised. Thus, we agree with the commenters who stated that adding
office/outpatient E/M level 4 visits to the primary care exception
could pose risks to patient safety. We also believe that, because the
transitional care management codes require medical decision-making of
at least moderate complexity, the ability for the teaching physician to
be immediately available to other residents could be compromised.
This policy to limit the expanded array of services permitted to be
furnished under the primary exception only to those services furnished
in residency training sites that are located outside of a MSA is
consistent with other teaching physician payment policies regarding
virtual presence and telehealth that we are finalizing as described
earlier in this final rule, and which were also similarly limited to
residency training sites that are located outside of a MSA. However,
practitioners are reminded that the permanent extension of the expanded
primary care exception in residency training sites that are located
outside of a MSA does not preclude teaching physicians from being
physically present when a resident is furnishing these primary care
services. We therefore urge teaching physicians to continue to use
their professional judgment to determine the circumstances under which
it is appropriate for residents to perform these services without the
presence of the teaching physician, depending on the Medicare service
being furnished and the experience of the particular resident involved.
For all other settings, we are not finalizing a policy to allow
Medicare to make payment to the teaching physician when the resident
furnishes an expanded array of services under the primary care
exception, including when those services are furnished under Medicare
telehealth; however, the interim policy to include an expanded set of
services under the primary care exception will remain in place for the
duration of the PHE for COVID-19 to provide flexibility for communities
that may experience resurgences in COVID-19 infections. Accordingly, at
the end of the PHE, we will be terminating the inclusion of CPT codes
99204, 99214, 99205, 99215, 99495 and 99496 from the primary care
exception for all settings.
While we do not anticipate any program integrity concerns to arise
from the final policy to expand the services that may be furnished
under the primary care exception in rural settings, we also agree with
commenters that it is necessary for us to consider additional data
prior to proposing additional policies in this area, which could range
from expanding this flexibility to include non-rural settings to
terminating this flexibility in all settings. Specifically, anticipate
considering to what degree the permanent establishment of the policy to
allow PFS payment to teaching physicians when the resident furnishes an
expanded array of services under the primary care exception in
residency training sites that are located outside of an MSA increased
patient access to care and provided more training opportunities for
residents while enabling the teaching physician to remain immediately
available. We may use such information, obtained through, for example,
a commissioned study, analysis of Medicare claims data or another
assessment mechanism, to further study the impacts of this limited
permanent expansion of the policy to allow PFS payment to teaching
physicians when the resident furnishes an expanded array of services
under the primary care exception in residency training sites of a
teaching setting that are outside of an MSA to inform potential future
rulemaking, and in an effort to prevent possible fraud, waste and
abuse.
Comment: One commenter requested clarification that when teaching
physicians meet all of the requirements of the primary care exception,
they are also able to provide direction and immediate availability thru
virtual presence for moderate to high complexity encounters, such CPT
codes 99204, 99205, 99214, and 99215.
Response: Through the end of the PHE for COVID-19, a teaching
physician that meets the requirements of the primary care exception
described in Sec. 415.174(c) to direct the care and then to review the
services furnished by each resident during or immediately after each
visit may be met through interactive, audio/video real-time
communications technology (excluding audio-only). This policy applies
for moderate to high complexity encounters, including all levels of
office/outpatient services. Once the PHE for COVID-19 ends, in
accordance with the final policy to allow PFS payment to teaching
physicians when the resident furnishes an expanded array of services
under the primary care exception in residency training sites that are
located outside of an MSA, a teaching physician may meet the
requirements of the primary care exception described in Sec. 415.174
to direct the care and then to review the services furnished by each
resident during or immediately after each visit through interactive,
audio/video real-time communications technology (excluding audio-only)
when residents furnish services that we are including under the primary
care exception, as described above. We believe that establishing this
policy for residency training sites that are located outside of an MSA
is consistent with the expansion of services that are permitted under
the primary care exception in residency training sites that are located
outside of an MSA, and that similarly, this policy will also increase
beneficiary access to Medicare-covered primary care services and
provide additional training opportunities for residents in settings to
which there has previously been limited access. However, as noted
above, the
[[Page 84589]]
services we are permanently including under the primary care exception
in residency training sites that are located outside of an MSA do not
include codes 99204, 99214, 99205, 99215, 99495 and 99496 because these
services are of moderate to high complexity, and we believe it is
inappropriate to allow these services to be furnished by residents
without the presence of a teaching physician.
We are amending our regulations to reflect this final policy. In
Sec. 415.174, we are adding a new paragraph (d) to state that, in
residency training sites that are located outside of an MSA, a teaching
physician that meets the requirements of the primary care exception
described in Sec. 415.174 may meet the requirement to direct the care
and then to review the services furnished by each resident during or
immediately after each visit through interactive, audio/video real-time
communications technology (excluding audio-only) when residents furnish
services that are included under the primary care exception associated
with these sites.
Comment: One commenter requested clarification that office/
outpatient E/M services furnished by residents under the primary care
exception described in Sec. 415.174 may be billed on the basis of
time, and also requested confirmation that, under the primary care
exception, the teaching physician need not be present with the resident
for the period of time billed.
Response: In the May 8th COVID-19 IFC, we stated that, consistent
with policy that we established in the March 31st COVID-19 IFC for
selecting the level of office/outpatient E/M visits when furnished as
Medicare telehealth services, (85 FR 19268 through 19269), the office/
outpatient E/M level selection for services under the primary care
exception when furnished via telehealth can be based on medical
decision-making or time, with time defined as all of the time
associated with the E/M on the day of the encounter; and the
requirements regarding documentation of history and/or physical exam in
the medical record do not apply. As described in section II.Z. of the
May 8th COVID-19 IFC, the typical times for purposes of level selection
for an office/outpatient E/M are the times listed in the CPT code
descriptor.
vi. Conclusion
In summary, we reminded stakeholders that during the PHE for COVID-
19 we implemented these policies on an interim basis to support our
goals of ensuring beneficiary access to necessary services and
maintenance of sufficient workforce capacity by offering flexibility to
practitioners. While we anticipated reverting to our previous teaching
physician policy that was in place prior to the PHE for COVID-19 for
the reasons discussed above, we considered whether the teaching
physician and resident moonlighting policies that we implemented on an
interim basis during the PHE for COVID-19 should be extended on a
temporary basis (that is, if the PHE ends in 2021, these policies could
be extended to December 31, 2021, to allow for a transition period
before reverting to status quo policy) or be made permanent policy for
CY 2021. As discussed above, we noted concern that the teaching
physician may not be able to maintain sufficient personal involvement
in all of the care to warrant PFS payment for the services being
furnished by up to four residents when some or all of the residents
might be furnishing services that are more than lower or mid-level
complexity. We also noted concern that when the teaching physician is
directing the care of a patient that requires moderate or higher
medical decision-making, their ability to be immediately available to
other residents could be compromised, which can potentially put
patients at risk. We noted that we would consider under which scenarios
our policies for moonlighting or virtual presence as discussed above,
should apply, if any. As discussed for our moonlighting policy, we
expressed concern that there may be risks to program integrity in
allowing residents to furnish separately billable physicians' services
to inpatients in the teaching hospitals where they are training when
the services are outside the scope of their approved GME program. For
example, there could be a risk of duplicate Medicare payment for the
resident's services under the IPPS for GME and the PFS if the
physicians' services furnished by residents were not adequately
separately identified from those services that are required as part of
the GME program. Under our discussion of virtual presence, we
highlighted concerns about how continuing to permit teaching physicians
to be involved through their virtual presence may not be sufficient to
warrant PFS payment to the teaching physician on a temporary or
permanent basis. Absent the circumstances of the PHE for COVID-19, the
physical, in-person presence of the teaching physician may be necessary
to provide oversight to ensure that care furnished to Medicare
beneficiaries is medically reasonable and necessary, and to ensure that
the teaching physician renders sufficient personal services to exercise
full, personal control of the key portion of the case. We also
discussed concerns about patient safety when the teaching physician is
only virtually present.
We noted that public comments, especially those that focused on the
variables we identified regarding the specific services included on the
primary care exception list, and clinical scenarios under which
residents could moonlight or furnish certain types of services under
the supervision of a teaching physician via virtual presence, would
assist us in identifying the appropriate policy continuation decisions
after the end of the PHE for COVID-19, which we would consider while
drafting this CY 2021 PFS final rule. As part of our review of public
comments, we would weigh and make decisions based on the potential
benefits and risks associated with the potential temporary or permanent
continuation, in whole or in part, of these policies. We noted that the
benefits of continuation may include limiting COVID-19 exposure risk
for practitioners and patients, increasing workforce capacity of
teaching settings to respond to continuing effects following the PHE
for COVID-19 as practitioners may be asked to assist with the response,
and increasing access so that we do not unintentionally limit the
number of licensed practitioners available to furnish services to
Medicare beneficiaries. We noted that the risks may include the
potential for duplicative payment with Medicare Part A reimbursement
for GME training programs, the potential for increases to cost-sharing
for Medicare beneficiaries that could result from additional Part B
claims for services furnished by the teaching physician with the
involvement of residents, and potential threats to patient safety.
Comment: Commenters were generally supportive of the teaching
physician and resident moonlighting policies that we implemented on an
interim basis during the PHE for COVID-19. Several commenters
recommended that we finalize our policies and asserted that making
these policies permanent would promote patient access to physicians'
services, particularly in rural and underserved areas and could provide
additional training opportunities for rural training programs. Other
commenters recommended that we extend the policies on a temporary
basis, to provide flexibility for communities that may experience
resurgences in COVID-19 infections. In addition, these commenters cited
a need to gather data regarding patient safety and potential
[[Page 84590]]
impacts on resident training outside the context of the PHE before
considering permanent implementation of the polices.
Response: We appreciate commenters' support of the teaching
physician and resident moonlighting policies that we implemented on an
interim basis during the PHE for COVID-19. As we reviewed these
comments, we considered the benefits and risks of finalizing the
proposals. After considering the comments, we are finalizing our
virtual presence and primary care exception policies for residency
training sites that are located outside of an MSA. We are finalizing
our resident moonlighting policies for all inpatient teaching settings.
We found compelling the comments regarding the benefits of the
virtual presence and primary care exception policies in rural settings.
Accordingly, we believe that permitting the teaching physician to meet
the requirements to bill under the PFS for their services through
virtual presence when furnishing services involving residents in rural
training settings, and allowing PFS payment for additional primary care
services furnished by residents without the physical presence of a
teaching physician in rural areas could increase access to Medicare-
covered services by preventing the beneficiary from potentially having
to travel long distances to obtain care, particularly as rural areas
have stretched and diminishing clinical workforces.\18\ Increasing
beneficiary access to care in rural areas is also consistent with our
longstanding interest in increasing beneficiary access to Medicare-
covered services in rural areas.\19\ Further, these policies could
provide the benefit of additional training opportunities for residents
in rural settings, which have historically been in limited supply.\20\
As such, the need to improve rural access to care for patients and
training for residents overshadows our aforementioned concerns about
the teaching physician's ability to render sufficient personal and
identifiable physicians' services through virtual presence, or to
maintain sufficient personal involvement in all of the care to warrant
PFS payment for the services being furnished by up to four residents
when some or all of the residents might be furnishing services that are
more than lower and mid-level complexity. Accordingly, we believe it
would be appropriate to continue these policies in rural settings after
the conclusion of the PHE for COVID-19. These policies not only further
our goal to increase beneficiary access to Medicare-covered services,
they also facilitate needed training opportunities is similar to the
rationale for the existing primary care exception under Sec. 415.174.
The primary care exception permits the teaching physician to bill for
certain types of physicians' services furnished by residents in certain
settings even when the teaching physician is not present with the
resident. Like the policies we are finalizing in this rule, the primary
care exception facilitates access to Medicare-covered services and
expanded residency training opportunities in primary care settings.
Therefore, we are finalizing our virtual presence and primary care
exception policies for residency training sites that are located
outside of an OMB-defined MSA. In addition, in order to ensure that the
teaching physician renders sufficient personal and identifiable
physicians' services to the patient to exercise full, personal control
over the management of the portion of the case for which the payment is
sought in accordance with section 1842(b)(7)(A)(i)(I) of the Act, we
are clarifying existing documentation requirements to specify that the
patient's medical record must clearly reflect how and when the teaching
physician was present during the key portion of the service, in
accordance with our regulations.
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\18\ A Guide for Rural Health Care Collaboration and
Coordination: https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/reports/HRSA-Rural-Collaboration-Guide.pdf.
\19\ CMS Rural Health Strategy. https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
\20\ HHS awards $20 million to 27 organizations to increase the
rural workforce through the creation of new rural residency
programs: https://www.hhs.gov/about/news/2019/07/18/hhs-awards-20-million-to-27-organizations-to-increase-rural-workforce.html.
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For our resident moonlighting policies, we believe that complete
documentation in the medical record would guard against the risk of
potential duplicative payment with the IPPS. Consequently, we are
clarifying that, regardless of whether the resident's services are
performed in the outpatient department, emergency department or
inpatient setting of a hospital in which they have their training
program, the patient's medical record must clearly reflect that the
resident furnished identifiable physician services that meet the
conditions of payment of physician services to beneficiaries in
providers in Sec. 415.102(a), that the resident is fully licensed to
practice medicine, osteopathy, dentistry, or podiatry by the State in
which the services are performed, and that the services are not
performed as part of the approved GME program.
For the virtual presence, primary care exception and resident
moonlighting policies, while we do not anticipate any program integrity
concerns, we agree with commenters that it is necessary for us to
consider additional data prior to proposing additional policies in this
area, which could range from expanding these flexibilities to include
non-rural settings to terminating these flexibilities in all settings.
Specifically, we anticipate considering to what degree the permanent
establishment of these policies increased patient access to Medicare-
covered services and provided additional training opportunities for
residents while enabling the teaching physician to render sufficient
personal and identifiable physicians' services. We may use such
information, obtained through, for example, a commissioned study,
analysis of Medicare claims data, or another assessment mechanism, to
further study the impacts of these policies to inform potential future
rulemaking, and in an effort to prevent possible fraud, waste and
abuse.
2. Supervision of Diagnostic Tests by Certain NPPs
In response to E.O. 13890 discussed above, we sought assistance
from stakeholders in identifying Medicare regulations that contain more
restrictive supervision requirements than existing state scope of
practice laws, or that limit health professionals from practicing at
the top of their license. In response to our request for feedback
discussed above, physician assistants (PAs) and nurse practitioners
(NPs) recommended regulatory changes that would allow them to supervise
the performance of diagnostic tests because they are currently
authorized to do so under their state scope of practice rules in many
states. In the May 8th COVID-19 IFC (85 FR 27550 through 27629), we
established on an interim basis during the PHE for COVID-19, a policy
to permit these and certain other NPPs to supervise diagnostic tests.
In the CY 2021 PFS proposed rule, we proposed to make those changes
permanent by making modifications to the regulations at Sec. 410.32.
We noted that we planned to address comments we received on the
proposals from the CY 2021 PFS proposed rule and comments received on
the May 8th COVID-19 IFC (85 FR 27550 through 27629) simultaneously in
this final rule.
Prior to the PHE for COVID-19, under Sec. 410.32(a)(2),
physicians, NPs, CNSs, PAs, certified nurse-midwives (CNMs), clinical
psychologists (CPs), and clinical social workers (CSWs) who are
treating
[[Page 84591]]
a beneficiary for a specific medical problem may order diagnostic tests
when they use the results of the tests in the management of the
beneficiary's specific medical problem. However, generally only
physicians were permitted to supervise diagnostic tests. The regulation
at Sec. 410.32(b)(1) provided as a basic general rule that all
diagnostic tests paid under the PFS must be furnished under an
appropriate level of supervision by a physician as defined in section
1861(r) of the Act. Section 410.32(b)(2) then provided for certain
exceptions to which this basic rule did not apply. For instance, under
Sec. 410.32(b)(2)(v), the requirement that diagnostic tests must be
furnished under the appropriate level of supervision by a physician did
not apply for tests performed by an NP or CNS authorized under
applicable state law to furnish the test. (We noted that, as for all
services furnished by a NP or CNS, they would have to be furnished
working in collaboration with a physician as provided in regulations at
Sec. Sec. 410.75 and 410.76, respectively). Similarly, under the
regulation at Sec. 410.32(b)(2)(vii), the requirement that diagnostic
tests must be furnished under the appropriate level of supervision by a
physician did not apply for tests performed by a CNM authorized under
applicable state law to furnish the test. This exception is in place
because the Medicare statute does not include any physician supervision
requirement for CNM services. Thus, while NPs, CNSs, PAs, and CNMs were
permitted to furnish diagnostic tests to the extent they were
authorized under state law and their scope of practice to do so, the
regulations at Sec. 410.32 did not address whether these practitioners
could supervise others who furnished diagnostic tests.
In light of stakeholder feedback to CMS on identifying additional
Medicare regulations that contain more restrictive supervision
requirements than existing state scope of practice laws, or that limit
health professionals from practicing at the top of their license,
effective January 1, 2021, we proposed to amend the basic rule under
the regulation at Sec. 410.32(b)(1) to allow NPs, CNSs, PAs or CNMs to
supervise diagnostic tests on a permanent basis as allowed by state law
and scope of practice. These NPPs have separately enumerated benefit
categories under Medicare law that permit them to furnish services that
would be physician's services if furnished by a physician, and are
authorized to receive payment under Medicare Part B for the
professional services they furnish either directly or ``incident to''
their own professional services, to the extent authorized under state
law and scope of practice.
We proposed to amend the regulation at Sec. 410.32(b)(2)(iii)(B)
on a permanent basis to specify that supervision of diagnostic
psychological and neuropsychological testing services can be done by
NPs, CNS's, PAs or CNMs to the extent that they are authorized to
perform the tests under applicable State law and scope of practice, in
addition to physicians and CPs who are currently authorized to
supervise these tests. We also proposed to amend on a permanent basis,
the regulation at Sec. 410.32 to add paragraph (b)(2)(ix) to specify
that diagnostic tests performed by a PA in accordance with their scope
of practice and State law do not require the specified level of
supervision assigned to individual tests, because the relationship of
PAs with physicians as defined under Sec. 410.74 would continue to
apply. We also proposed to make permanent the removal of the
parenthetical, previously made as part of the May 8th COVID-19 IFC (85
FR 27550 through 27629), at Sec. 410.32(b)(3) that required a general
level of physician supervision for diagnostic tests performed by a PA.
We received public comments on whether the policies we adopted on
an interim basis during the PHE for COVID-19 under Sec. 410.32 should
continue once the PHE ends. The following is a summary of the comments
we received and our responses.
Comment: We received many comments expressing appreciation for the
flexibilities that we put in place for purposes of the PHE for COVID-
19, allowing NPPs to supervise the performance of diagnostic tests and
treat patients at the top of their scope of practice. Additionally,
they encouraged CMS to make this flexibility permanent, beyond the
COVID-19 pandemic.
Response: We appreciate the feedback from these commenters and plan
to finalize these provisions as proposed, with modifications described
below.
Comment: We received a comment that certified registered nurse
anesthetists (CRNAs) should be listed among the delineated NPPs,
explaining the value of their services within the health care system.
The commenter noted that in the CY 2013 PFS final rule (77 FR 69006),
CMS indicated Medicare coverage of CRNA services within their state
scope of practice. The commenter stated that CRNAs have continuously
practiced autonomously, and provide every aspect of anesthesia delivery
as well as acute and chronic pain management services.
Response: We appreciate the information provided and are adding
CRNAs to the previously enumerated list of NPPs.
Comment: Some commenters opposed our proposed change to allow NPPs
to supervise the performance of psychological and neuropsychological
tests. These commenters provided information indicating that these
tests are not within the scope of practice of the proposed NPPs, and
require special training only available to psychologists and
physicians.
Response: We appreciate the information provided by these
commenters stating that the specified NPPs are not qualified or
authorized by their scope of practice and State law to supervise the
performance of this specific category of diagnostic tests. As directed
under the E.O. to allow NPPs to practice at the top of their license,
our intent regarding this supervision flexibility is to allow NPPs with
separate benefit categories under Medicare law to supervise the
performance of diagnostic tests, regardless of the specific category of
diagnostic tests, only to the extent their scope of practice and State
laws authorize them to do so. Accordingly, we believe that the scope of
practice and State laws for the State in which the specified NPPs
furnish diagnostic psychological and neuropsychological tests will
determine whether these NPPs are qualified to supervise the performance
of diagnostic psychological and neuropsychological tests in addition to
physicians and clinical psychologists who are already authorized to
supervise such tests.
Comment: Some commenters expressed concern about the ability of
NPPs to supervise diagnostic tests beyond the PHE for COVID-19. They
opined that such supervision should not extend beyond the PHE for
COVID-19. These commenters expressed that while NPPs are critical team
members, it is vital to maintain physician-led teams for quality and
cost of care. They cited information indicating that NPPs order more
tests and prescribe opioids more than physicians, that patients prefer
physicians, and that increasing the supply of NPPs does not increase
access to care.
Response: We appreciate the commenters' feedback; however, we did
not find sufficient evidence to support altering our proposal.
Accordingly, we are finalizing our policy as proposed on a permanent
basis and amending regulations text at Sec. 410.32(b) to include CRNAs
in the group of specified NPPs with a separately enumerated Medicare
benefit category to who are allowed to supervise the performance of
diagnostic tests, as permitted within their scope of
[[Page 84592]]
practice and State law for the State in which the test is furnished.
3. Pharmacists Providing Services Incident to Physicians' Services
Stakeholders have asked us to clarify that pharmacists can provide
services incident to the professional services of a physician or other
NPP just as other clinical staff may do. These stakeholders have asked
us, in particular, about pharmacists who provide medication management
services. Medication management is covered under both Medicare Part B
and Part D. We are reiterating the clarification we provided in the May
8th COVID-19 IFC (85 FR 27550 through 27629), that pharmacists fall
within the regulatory definition of auxiliary personnel under our
regulations at Sec. 410.26. As such, pharmacists may provide services
incident to the services, and under the appropriate level of
supervision, of the billing physician or NPP, if payment for the
services is not made under the Medicare Part D benefit. This includes
providing the services incident to the services of the billing
physician or NPP and in accordance with the pharmacist's state scope of
practice and applicable state law.
We noted that when a pharmacist provides services that are paid
under the Part D benefit, the services are not also reportable or paid
for under Part B. In addition to circumstances where medication
management is offered as part of the Part D benefit, Part B payment is
also not available for services included in the Medicare Part D
dispensing fees, such as a pharmacist's time in checking the computer
for information about an individual's coverage, measurement or mixing
of the covered Part D drug, filling the container, physically providing
or delivering the completed prescription to the Part D enrollee.
Similarly, performing required quality assurance activities consistent
with Sec. 423.153(c)(2), such as screening for potential drug therapy
problems due to therapeutic duplication, age/gender-related
contraindications, potential over-utilization and under-utilization,
drug-drug interactions, incorrect drug dosage or duration of drug
therapy, drug-allergy contraindications, and clinical abuse/misuse are
considered part of dispensing fees under Part D and are not separately
reportable services under Part B. Additionally, services and supplies
paid under the incident to benefit must be an integral, though
incidental, part of the service of a physician (or other practitioner)
in the course of diagnosis or treatment of an injury or illness (Sec.
410.26). We also noted that our manual provisions specify that
``incident to'' services must be of a type that are medically
appropriate to provide in the office setting; and that where a
physician supervises auxiliary personnel to assist him or her in
rendering services to patients and includes the charges for their
services in his or her own bills, the services of such personnel are
considered incident to the physicians' service if there is a
physicians' service rendered to which the services of such personnel
are an incidental part and there is direct supervision by the physician
(section 60.1 of chapter 15 of the Medicare Benefit Policy Manual (Pub.
100-02) available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf).
Although it is fully consistent with current CMS policy for
pharmacists to provide services incident to the services of the billing
physician or NPP, we believe this clarification may encourage
pharmacists to work with physicians and NPPs in new ways where
pharmacists are working at the top of their training, licensure and
scope of practice. It may free up the time of physicians and NPPs for
other work and increase access to medication management services, for
individuals with chronic conditions and other conditions. As an
example, we found that this clarification was helpful in recently
addressing in the May 8th COVID-19 IFC (85 FR 27550 through 27629), the
ability of pharmacies to enroll as laboratories and work with
physicians in the assessment of clinical information, specimen
collection and reporting results of COVID-19 clinical diagnostic
laboratory tests.
We received a few public comments on this clarification made in our
IFC and proposed rule. The following is a summary of the comments we
received and our responses.
Comment: We received several comments asking us to allow
pharmacists to directly bill office/outpatient E/M visit codes (CPT
codes 99202-99215), or if this is not possible, allow physicians to
bill these codes for time spent by pharmacists providing services
incident to a physician's service. One commenter questioned why we
referred to pharmacists as auxiliary staff or auxiliary personnel, and
whether the AMA CPT Editorial Panel would agree with this
classification.
Response: As mentioned above, the Medicare Part B benefit category
of services furnished ``incident to'' the professional services of a
physician, describe services furnished by the staff (or contracted
staff) of a physician under his or her supervision. Specifically,
section 1861(s)(2)(A) of the Act describes, services and supplies
(including drugs and biologicals which are not usually self-
administered by the patient) furnished as an incident to a physician's
professional service, of kinds which are commonly furnished in
physicians' offices and are commonly either rendered without charge or
included in the physicians' bills.'' Our regulation that implements
section 1861(s)(2)(A) of the Act similarly describes these services in
Sec. 410.26(b) where we specify, among other things, that ``incident
to'' services and supplies must be an integral, though incidental, part
of the service of a physician (or other practitioner) in the course of
diagnosis or treatment of an injury or illness. In the regulation at
Sec. 410.26(a), we have long used the term ``auxiliary personnel'' to
describe the individuals who may provide services incident to the
professional services of a physician or practitioner who is authorized
by law to bill Medicare for their services. The regulation defines the
term as any individual who is acting under the supervision of a
physician (or other practitioner), regardless of whether the individual
is an employee, leased employee, or independent contractor of the
physician (or other practitioner) or of the same entity that employs or
contracts with the physician (or other practitioner) and meets other
stated rules, including licensure rules imposed by the State in which
the services are being furnished. This Medicare Part B framework
applies to any individual working with the billing physician or other
practitioner to provide services on an ``incident to'' basis, for
example, a physician assistant, medical assistant, nurse, pharmacist,
administrative assistant or others, whether they have a clinical role
or not. The Medicare term ``auxiliary personnel'' could include staff
that have clinical roles and staff that do not.
The CPT codebook that delineates a common system of codes for use
by all payers, describes individuals who perform or report a given
service using different terms, ``physician or qualified health care
professional'' (QHP) and ``clinical staff.'' The CPT codebook defines
these terms as follows, ``A `physician or other qualified health care
professional' as an individual who is qualified by education, training,
licensure/regulation (when applicable), and facility privileging (when
applicable) who performs a professional service within his or her scope
of practice and independently reports that
[[Page 84593]]
professional service. These professionals are distinct from `clinical
staff.' A clinical staff member is a person who works under the
supervision of physician or other qualified healthcare professional,
and who is allowed by law, regulation, and facility policy to perform
or assist in the performance of a professional service, but does not
individually report that professional service. Other policies may also
affect who may report specific services.'' \21\ Under the PFS, we
sometimes use the term ``clinical staff'' to describe specially
qualified auxiliary personnel who perform services specifically
comprised of ``clinical staff'' time (such as chronic care management
services by clinical staff), even though our regulations refers to them
as ``auxiliary personnel.'' Under the PFS, ``clinical staff'' is a
subset of ``auxiliary personnel.''
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\21\ CPT 2021 Professional Edition, p. xiv.
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As commenters noted, pharmacists could be considered QHPs by some
other payers who provide for their direct payment. We do not consider
them such because there is no Medicare statutory benefit allowing them
to enroll, bill and receive direct payment for PFS services. As such,
pharmacists are not among the physicians and QHPs that can furnish and
bill for the 2021 office/outpatient E/M visit codes, because levels two
through five are by definition only performed and directly reported by
physicians or QHPs.\22\ For example, when time is used to select visit
level, only the time of the physician or QHP is counted. By definition,
these codes cannot be furnished and billed as ``incident to'' services;
therefore, they cannot be used to report services consisting of time
spent solely by a pharmacist working ``incident to'' the services of a
billing physician. We also note that services furnished directly by
pharmacists are listed in a separate section of the CPT Codebook that
includes codes describing Medication Therapy Management Services.\23\
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\22\ CPT 2021 Professional Edition, pp.14-17.
\23\ CPT 2021 Professional Edition, p.818.
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In summary, we agree with certain stakeholders that under the
general CPT framework, pharmacists could be considered QHPs or clinical
staff, depending on their role in a given service. However, under the
current Medicare law which includes the PFS, we do not have ability to
pay (or even price) services that are furnished and billed directly by
pharmacists. Regarding office/outpatient E/M visit levels 2 through 5
in particular, because CPT does not define these codes as clinical
staff codes and instead designed them to be directly furnished and
reported by physicians and other QHPs, they cannot be used to bill the
PFS for services performed by a pharmacist on an ``incident to'' basis.
We understand and appreciate the expanding, beneficial roles certain
pharmacists play, particularly by specially trained pharmacists with
broadened scopes of practice in certain states, commonly referred to as
collaborative practice agreements. We note that new coding might be
useful to specifically identify these particular models of care.
4. Provision of Maintenance Therapy by Therapy Assistants
a. Finalization of the Interim Final Rule Related to Provision of
Maintenance Therapy by Therapy Assistants During the PHE for COVID-19
As a means of increasing the availability of needed health care
services during the PHE for COVID-19, we amended our therapy policy on
an interim basis in the May 8th COVID-19 IFC (85 FR 27550 through
27629) to allow physical therapists (PT) and occupational therapists
(OT) that have established a therapy maintenance program for a patient
to assign a PTA or OTA to furnish the maintenance therapy services when
clinically appropriate. We indicated as part of the CY 2021 PFS
proposed rule that we would respond to comments we received in response
to our amended policy for the provision of maintenance therapy
services.
Comment: We received several comments, all of which expressed
support for allowing therapy assistants to furnish maintenance therapy
when delegated by a therapist, including one commenter that requested
the CMS make the change permanent.
Response: We appreciate the commenters' support for our adopted
interim policy to allow therapy assistants to furnish maintenance
therapy services.
After considering comments, we are finalizing our interim policy
from the May 8th COVID-19 IFC to allow physical and occupational
therapists to delegate maintenance therapy services to therapy
assistants as clinically appropriate through the end of the PHE for
COVID-19.
b. Summary of Proposals and Public Comments Related to Provision of
Maintenance Therapy by Therapy Assistants
In response to our request for feedback on scope of practice (noted
above), consistent with E.O. 13890 (84 FR 53573 through 53576),
respondents requested that we allow physical therapy assistants (PTAs)
and occupational therapy assistants (OTAs) to furnish maintenance
therapy services associated with a maintenance therapy program.
Respondents commented that our Part B therapy policy was not consistent
with policies for these services when provided to patients in skilled
nursing facilities (SNF) and home health (HH) settings paid under Part
A. Respondents also wrote that because a therapist is responsible for a
patient's care over an episode, that this should allow the therapist to
assign responsibility for maintenance therapy to an assistant when it
is clinically appropriate. Some respondents stated that permitting PTAs
and OTAs to furnish maintenance therapy services would give Medicare
patients greater access to care and give therapists more flexibility in
allocating therapy resources.
After considering respondents' concerns about the incongruity
between our Part B and Part A maintenance therapy policies and as a
means of increasing availability of needed health care services during
the PHE for COVID-19, we amended our policy on an interim final basis
in the May 8th COVID-19 IFC (85 FR 27550 through 27629) to allow the
physical therapist (PT) or occupational therapist (OT) who establishes
a maintenance program to assign a PTA or OTA to furnish maintenance
therapy services when clinically appropriate.
We explained that making this change could free-up the PT or OT to
furnish other services, particularly services related to the PHE for
COVID-19 that require a therapist's assessment and intervention skills.
We stated explicitly that the maintenance therapy services furnished by
therapist-supervised OTAs and PTAs will be paid in the same manner as
those we already pay for as rehabilitative therapy services. We
referred readers to regulatory payment conditions for Part B outpatient
occupational and physical therapy services (Sec. Sec. 410.59 and
410.60, respectively) that require, as a basic rule, that the services
be provided by an individual meeting qualifications in 42 CFR part 484
for an OT or PT, or an appropriately supervised OTA or PTA.
In the CY 2021 PFS proposed rule, we proposed to make permanent our
Part B policy for maintenance therapy services effective January 1,
2021 in order to create greater conformity in payment policy for
maintenance therapy services that are furnished and paid under Part B
with those in SNF and HH settings under Part A. We noted that if
finalized, our policy would dovetail with our
[[Page 84594]]
amended policy set forth in the May 8th COVID-19 IFC (85 FR 27550
through 27629) that grants PTs and OTs the discretion to delegate
maintenance therapy services to the PTAs and OTAs, as clinically
appropriate, for the duration of the PHE for COVID-19. If the PHE for
COVID-19 were to end prior to January 1, 2021, the therapist would need
to personally furnish the maintenance therapy services until the
finalized policy change took effect. We also noted that we planned to
address comments from the May 8th COVID-19 IFC in conjunction with the
comments from the CY 2021 PFS proposed rule in the CY 2021 PFS final
rule.
Our policy for maintenance therapy services is explained in section
220.2 of chapter 15 of the Medicare Benefit Policy Manual (see https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf). Maintenance programs that can be carried out by a
patient alone or with the assistance of caregivers are not covered.
Also, sections 230.1 and 230.2 of chapter 15 of the Medicare Benefit
Policy Manual specify that a PTA or OTA may not provide skilled
maintenance program services.
In considering this proposal, we reviewed regulatory requirements
for conditions of payment for outpatient occupational therapy, physical
therapy, and speech-language pathology services at Sec. Sec. 410.59,
410.60, and 410.62; the regulation for therapy treatment plans at Sec.
410.61; and the regulations specifying treatment plan certification and
recertification requirements at Sec. 424.24 for Part B occupational
therapy, physical therapy, and speech-language pathology services along
with the above mentioned manual provisions.
Given that we already make payment for rehabilitative services
requiring improvement in the patient's functional status when they are
furnished by PTAs and OTAs at the discretion of the supervising
therapist treating the patient in accordance with the therapist-
established plan of care, we noted that it would be appropriate for the
therapist to use that same judgment to decide whether to delegate
maintenance therapy services under the associated plan of care to a PTA
or OTA. We stated that there is little difference between the
rehabilitative therapy services furnished to improve a patient's
functional status and those for maintenance therapy services other than
the goals set by the therapist in the therapy plan. We do not believe
that the therapist-only maintenance therapy requirement is needed in
the case of outpatient physical or occupational therapy services.
Instead, we believe that it would be appropriate for an OT or PT to use
their professional judgment to assign the performance of maintenance
therapy services to an OTA or PTA when it is clinically appropriate to
do so.
As such, we proposed to allow, on a permanent basis, therapists to
delegate performance of maintenance therapy services to an OTA or PTA
for outpatient occupational and physical therapy services in Part B
settings beginning January 1, 2021. This proposal would better align
our Part B policy with that in SNFs and HH paid under Part A where
maintenance therapy services may be performed by a therapist or a
therapy assistant. Since our regulations at Sec. Sec. 410.59, 410.60,
410.61, 410.62, and 424.24, do not distinguish between rehabilitative
and maintenance therapy services, we did not propose to amend them.
Instead, we proposed to revise sections 220.2, 230.1 and 230.2 of
chapter 15 of the Medicare Benefit Policy Manual to clarify that PTs
and OTs no longer need to personally perform maintenance therapy
services and to specifically remove the prohibitions on PTAs and OTAs
from furnishing such services. We noted that we believe the proposal to
allow PTs and OTs to delegate maintenance therapy services to their
supervised assistants is in keeping with E.O. 13890 and appeals by
respondents to our request for feedback on scope of practice that
followed, rather than the alternative option of maintaining the pre-
COVID-19 policy of requiring PTs and OTs to personally furnish them,
after the PHE for COVID-19 has ended.
We noted also that therapists and therapy providers should consult
the CQ and CO modifier policies to consider whether these modifiers
should be applied to claims for services furnished in whole or in part
by PTAs and OTAs which will, beginning January 1, 2022, be paid at 85
percent of the amount that would otherwise apply for the service, as
required by section 1834(v) of the Act, which was added to section
53107 of the Bipartisan Budget Act of 2018. See the CY 2020 PFS
rulemaking for policies related to the application of CQ and CO
modifiers and the associated regulatory requirements (84 FR 40558
through 40564 (proposed rule) and 84 FR 62702 through 60708 (final
rule)).
We received public comments on the provision of maintenance therapy
to be furnished by therapy assistants. The following is a summary of
the comments we received and our responses.
Comment: Commenters expressed uniform support for our proposal to
allow therapy assistants to furnish maintenance therapy services.
Commenters indicated that having Part B policy align with current Part
A policy for Home Health and SNF settings will promote consistency as
well as continuity of care across Medicare programs.
Response: We appreciate the commenters' support for our proposal to
allow therapy assistants to furnish maintenance therapy services. After
considering comments, we are finalizing our proposal to allow physical
and occupational therapists to delegate maintenance therapy services to
therapy assistants on a permanent basis as clinically appropriate.
5. Medical Record Documentation
a. Finalization of Interim Final Rule With Comment Period Provisions
Related to Therapy Student Documentation During the PHE for the COVID-
19 Pandemic
In the May 8th COVID-19 IFC (85 FR 27556 through 27557), to
increase the availability of clinicians who may furnish healthcare
services during the PHE, we announced a general policy that there is
broad flexibility for all members of the medical team to add
documentation in the medical record which is then reviewed and verified
(signed) by the appropriate clinician. Specifically, we stated on an
interim basis during the PHE for COVID-19, any individual who has a
separately enumerated benefit under Medicare law that authorizes them
to furnish and bill for their professional services, whether or not
they are acting in a teaching role, may review and verify (sign and
date), rather than re-document, notes in the medical record made by
physicians, residents, nurses, and students (including students in
therapy or other clinical disciplines), or other members of the medical
team. We noted that although there are currently no statutory or
regulatory documentation requirements that would impact payment for
therapists when documentation is added to the medical record by persons
other than the therapist, we discussed this issue in response to
stakeholder concerns about burden and in consideration of the current
PHE for COVID-19. Specifically, this policy will ensure that
therapists, as members of the clinical workforce, are able to spend
more time furnishing therapy services, including pain management
therapies to patients that may minimize the use of opioids and other
medications, rather than spending time documenting in the medical
record. We emphasized that our established principle is focused on the
[[Page 84595]]
clinician, as described above who furnishes and bills for their
professional services rather than the individuals who may enter
information into the medical record. We emphasized that information
entered into the medical record should document that the furnished
services are reasonable and necessary.
We received public comments on Therapy Student Documentation. The
following is a summary of the comments we received and our responses.
Comment: One commenter recommended that CMS make the therapy
student documentation waiver under the PHE for COVID-19 permanent so
that it aligns with the flexibility extended to physicians and several
NPPs as promulgated in the CY 2020 PFS final rule.
Response: We appreciate the commenter's support of this provision
for student documentation and making permanent the broad flexibility
for all members of the medical team to add documentation in the medical
record which is then reviewed and verified (signed) by the appropriate
clinician.
Comment: One commenter supported these changes which will give more
flexibility to practitioners and other providing clinically appropriate
therapy services but asked that CMS clarify who would be considered
other members of the ``treatment team'' in addition to those enumerated
(that is, physicians, residents, nurses, and students)--in particular,
whether this would encompass non-licensed member.
Response: We appreciate the commenters request for clarification.
Any individual who is authorized under Medicare law to furnish and bill
for their professional services, whether or not they are acting in a
teaching role, may review and verify (sign and date) the medical record
for the services they bill, rather than re-document, notes in the
medical record made by physicians, residents, nurses, and students
(including students in therapy or other clinical disciplines), or other
members of the medical team), or other members of the medical team.
Comment: One commenter agreed with CMS that these measures should
be temporary, and should not persist once the PHE for COVID-19 has
ended. The commenter stated that training-appropriate scope of practice
standards are important to ensuring quality of care for our members.
Response: We appreciate the commenter's feedback. We are discussing
this issue in response to stakeholder concerns about burden and in
consideration of the current PHE for COVID-19. Specifically, this
policy will ensure that therapists, as members of the clinical
workforce, are able to spend more time furnishing therapy services,
including pain management therapies to patients that may minimize the
use of opioids and other medications, rather than spending time
documenting in the medical record. The provision related to therapy
student documentation was to increase the availability of clinicians
who may furnish healthcare services during the PHE for COVID-19 and on
an interim basis during the PHE for COVID-19.
In summary, we reiterate that our clarification about this policy
as discussed in the May 8th COVID-19 IFC (85 FR 27556 through 27557)
notes that any individual who has a separately enumerated benefit under
Medicare law that authorizes them to furnish and bill for their
professional services, whether or not they are acting in a teaching
role, may review and verify (sign and date), rather than re-document,
notes in the medical record made by physicians, residents, nurses, and
students (including students in therapy or other clinical disciplines),
or other members of the medical team. We emphasized that our
established principle is focused on the clinician, as described above
who furnishes and bills for their professional services rather than the
individuals who may enter information into the medical record. We
emphasized that information entered into the medical record should
document that the furnished services are reasonable and necessary.
b. Medical Record Documentation Clarification
As we established in the CY 2020 PFS final rule (84 FR 62681
through 62684), and similarly expressed in the May 8th COVID-19 IFC (85
FR 27556 through 27557), any individual who is authorized under
Medicare law to furnish and bill for their professional services,
whether or not they are acting in a teaching role, may review and
verify (sign and date) the medical record for the services they bill,
rather than re-document, notes in the medical record made by
physicians, residents, nurses, and students (including students in
therapy or other clinical disciplines), or other members of the medical
team. We noted that although there are currently no documentation
requirements that would impact payment for PTs, OTs, or SLPs when
documentation is added to the medical record by persons other than the
therapist, we are responding in this proposed rule to stakeholder
requests for clarification. Specifically, we clarified that the broad
policy principle that allows billing clinicians to review and verify
documentation added to the medical record for their services by other
members of the medical team also applies to therapists. We noted that
this would help ensure that therapists are able to spend more time
furnishing therapy services, including pain management therapies to
patients that may minimize the use of opioids and other medications,
rather than spending time documenting in the medical record. We
emphasized that, while any member of the medical team may enter
information into the medical record, only the reporting clinician may
review and verify notes made in the record by others for the services
the reporting clinician furnishes and bills. We also emphasized that
information entered into the medical record should document that the
furnished services are reasonable and necessary.
We received public comments on the medical record documentation
clarification. The following is a summary of the comments we received
and our responses.
Comment: Many commenters were in support of and commended CMS for
including therapists in the list of practitioners who may review and
verify documentation instead of having to re-document notes made by
students for Medicare Part B patients and stated that this is a
significant burden reduction that will allow for better use of
therapists' time.
Two commenters appreciated this medical record documentation
flexibility so long as the provision falls within existing scope of
practice laws and only reduces the burden of re-documenting. The
commenter noted that administrative burden is a major reason for
physician burnout and by alleviating this burden and allowing others to
share in the administrative process, physicians will spend less time
documenting and perhaps have a decrease in burnout. Another commenter
noted in rural areas, there are shortages of therapy and mental health
professionals and that documentation and paperwork take time away from
patients who need help.
A few commenters noted that this flexibility would better prepare
clinicians to enter practice by increasing safety and education on how
to document effectively and appropriately the skilled services they
provide. One commenter questioned how this flexibility may impact
documentation requirements pertaining to completion of the progress
report and Medicare's billing rules in relation to therapy students.
Another commenter requested licensed audiologists be added to the group
that can review and verify (sign and date) the documentation entered
into the medical record by members of
[[Page 84596]]
their medical team for their own, appropriately supervised services
that are paid under the PFS.
One commenter requested that CMS issue guidance to clarify that it
is possible that no additional documentation is required if the
entirety of the documentation could be included from members of the
medical team, thus allowing the billing practitioner to ``sign and
verify'' the entire note.
Response: We appreciate commenters' support of this clarification
to allow therapists to review and verify student documentation instead
of therapists having to re-document notes made by students. We
appreciate the insight provided by commenters about how the broad
flexibility would aide in burden reduction and allow for better use of
time by therapists.
This clarification similarly aligns with what was finalized in the
CY 2020 PFS final rule which provided 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. We explained that this principle would
apply across the spectrum of all Medicare-covered services paid under
the PFS. We emphasize that, while any member of the medical team may
enter information into the medical record, only the billing clinician
may review and verify notes made in the record by others for the
services the reporting clinician furnishes and bills. As we emphasized
in our proposal, information entered into the medical record should
document that the services furnished are reasonable and necessary if
the billing practitioner has signed and verified complete medical
record documentation by other members of the medical team.
Comment: One commenter supported the CMS policy to provide added
flexibility for NPPs authorized to deliver part B services including
nurse practitioners, CNSs and PAs to document teaching physician
involvement and another commenter noted they believe that the
additional flexibility will significantly reduce burden for teaching
physicians.
Response: We appreciate the support of this flexibility for NPPs to
document teaching physician involvement. We would like to reiterate
that this flexibility does not negate the teaching physician rules, or
the need to document personal services or split share rules, or other
aspects of the service provided.
Comment: One commenter urged CMS not to expand payment for
independent NPPs and pressure inappropriate scope-of-practice expansion
through these proposed rules. The commenter encouraged all advanced
nurse practitioners and physician assistants to work within their
respective licensed scope of practice in a team approach to expand
access and ensure quality of care. Another commenter expressed concern
that based on the language proposed by CMS, this policy might allow
therapists to change or modify a physician's documentation, including
their diagnostic evaluation and treatment plan.
Response: We appreciate the commenters concerns and want to
emphasize that this medical record documentation clarification only
applies to the clinician who is billing for their professional service.
The intent of this clarification is to reduce burden and allow the
billing practitioner to review and verify the documentation in the
medical record instead of re-documenting information entered by
students and other members of the medical team. The billing
practitioner needs to ensure, as we reiterated in our clarification,
that, while any member of the medical team may enter information into
the medical record, they review and verify that the information in the
medical record is accurate and complete for the services the reporting
clinician furnishes and bills.
After considering the comments received, we note that we are
reiterating what we finalized in the CY 2020 PFS final rule, that any
individual who is authorized under Medicare law to furnish and bill for
their professional services, whether or not they are acting in a
teaching role, may review and verify (sign and date) the medical record
for the services they bill, rather than re-document, notes in the
medical record made by physicians, residents, nurses, and students
(including students in therapy or other clinical disciplines), or other
members of the medical team. We emphasize that, while any member of the
medical team may enter information into the medical record, only the
reporting clinician may review and verify notes made in the record by
others for the services the reporting clinician furnishes and bills. We
want to emphasize that information entered into the medical record must
document that the furnished services are reasonable and necessary.
H. 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.C. of this proposed rule, Potentially Misvalued Services under the
PFS. Historically, when we received RUC recommendations, our process
had been to establish interim final RVUs for the potentially misvalued
codes, new codes, and any other codes for which there were coding
changes in the final rule with comment period for a year. Then, during
the 60-day period following the publication of the final rule with
comment period, we accepted public comment about those valuations. For
services furnished during the calendar year following the publication
of interim final rates, we paid for services based upon the interim
final values established in the final rule. In the final rule with
comment period for the subsequent year, we considered and responded to
public comments received on the interim final values, and typically
made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period (79 FR 67547), we
finalized a new process for establishing values for new, revised and
potentially misvalued codes. Under the new process, we include proposed
values for these services in the proposed rule, rather than
establishing them as interim final in the final rule with comment
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
new process was applicable to all codes, except for new codes that
describe truly new services. For CY 2017, we proposed new values in the
CY 2017 PFS proposed rule for the vast majority of
[[Page 84597]]
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 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
includes 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 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
[[Page 84598]]
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
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 2021 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 times 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 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. 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
[[Page 84599]]
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
suggested that CMS 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 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 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 2021 PFS final rule, CPT codes 10006 (Fine needle aspiration
biopsy, including ultrasound guidance; each additional lesion) and
57465 (Computer-aided mapping of cervix uteri during colposcopy,
including optical dynamic spectral imaging and algorithmic
quantification of the acetowhitening effect), 76513 (Ophthalmic
ultrasound, diagnostic; anterior segment ultrasound, immersion (water
bath) B-scan or high resolution biomicroscopy, unilateral or
bilateral), 93224 (External electrocardiographic recording up to 48
hours by continuous rhythm recording and storage; includes recording,
scanning analysis with report, review and interpretation by a physician
or other qualified health care professional) and 99439 (Prolonged
office or other outpatient evaluation and management service(s) (beyond
the total time of the primary procedure which has been selected using
total time), requiring total time with or without direct patient
contact beyond the usual service, on the date of the primary service;
each 15 minutes) share the identical total work time of 15 minutes.
However, these codes have very different proposed work RVUs of 1.00 and
0.81 and 0.53 and 0.39 and 0.61 respectively. In addition, CPT codes
10010 (Fine needle aspiration biopsy, including CT guidance; each
additional lesion) and 93662 (Intracardiac echocardiography during
therapeutic/diagnostic intervention, including imaging supervision and
interpretation) both share the same intraservice and total work time of
25 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 regard 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
[[Page 84600]]
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.
Comment: Several commenters stated that they were concerned about
CMS' lack of consideration for compelling evidence that services have
changed. Commenters stated that CMS appeared to dismiss the fact that
services may change due to technological advances, changes in the
patient population, shifts in the specialty of physicians providing
services or changes in the physician work or intensity required to
perform services. Commenters requested that CMS address the compelling
evidence that was submitted with the RUC recommendations when the
agency does not accept the RUC recommendation.
Response: The concept of compelling evidence was developed by the
RUC as part of its review process for individual codes to justify an
increase in valuation. The RUC's compelling evidence criteria include
documented changes in physician work, an anomalous relationship between
the code and multiple key reference services, evidence that technology
has changed physician work, analysis of other data on time and effort
measures, and evidence that incorrect assumptions were made in the
previous valuation of the service. While we appreciate the submission
of this additional information for review, we emphasize that compelling
evidence is a concept developed by the RUC for its own review process.
Compelling evidence is not part of our statutory framework which
requires that the valuation of codes should be based on time and
intensity. We do consider changes in technology, patient population,
etc. insofar as they affect the time and intensity of the service under
review. However, we do not specifically address the RUC's compelling
evidence criteria in our rulemaking since it is outside the purview of
the code valuation process stipulated by statute.
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 28 contains a list of codes and
descriptors for which we proposed work RVUs; this included all codes
for which we received RUC recommendations by February 10, 2020. As
noted in the CY 2021 PFS proposed rule, the proposed work RVUs, work
time and other payment information for all CY 2021 payable codes are
available on the CMS website under downloads for the CY 2021 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 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 29 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of the proposed rule (85 FR 50077),
Determination of Practice Expense Relative Value Units (PE RVUs), we
addressed certain refinements that would be common across codes.
Refinements to particular codes are addressed in the portions of that
section that are dedicated to particular codes. We noted that for each
refinement, we indicated the impact on direct costs for that service.
We noted 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 noted that approximately
half of the refinements listed in Table 29 result in changes under the
$0.35 threshold and are unlikely to result in a change to the RVUs.
We also noted that the direct PE inputs for CY 2021 are displayed
in the CY 2021 direct PE input files, available on the CMS website
under the downloads for the CY 2021 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 2021 PE RVUs as
displayed in Addendum B.
[[Page 84601]]
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 noted
that 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 the proposed rule (85 FR
50077), Determination of Practice Expense Relative Value Units (PE
RVUs), for more information regarding the collaborative work of CMS and
the RUC in improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. However, some recommendations include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2021 we received invoices for several new supply and
equipment items. Tables 31 and 32 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of the proposed rule (85 FR 50077), 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 31 and 32 also included 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 did not use the price listed on the invoice that
[[Page 84602]]
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 addressed 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 noted 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
2021 are available on the CMS website under downloads for the CY 2021
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 2021
(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006,
10007, 10008, 10009, 10010, 10011, and 10012)
In June 2017, the CPT Editorial Panel deleted CPT code 10022,
revised CPT code 10021, and created nine new codes to describe fine
needle aspiration procedures with and without imaging guidance. These
ten codes were surveyed and reviewed for the October 2017 and January
2018 RUC meetings. In the CY 2019 PFS final rule, we finalized the RUC-
recommended work RVU for seven of the ten codes in the family, while
finalizing a lower work RVU for CPT codes 10005 (Fine needle aspiration
biopsy, including ultrasound guidance; first lesion), 10009 (Fine
needle aspiration biopsy, including CT guidance; first lesion), and
10021 (Fine needle aspiration biopsy, without imaging guidance; first
lesion). For a full discussion of this review, we refer readers to the
CY 2019 PFS final rule (83 FR 59517 through 59521).
Following the publication of the CY 2019 PFS final rule, RUC staff
stated that CMS erroneously double-counted the utilization for new
codes that had image guidance bundled. We disagreed that this
constituted a technical error and communicated to the RUC in
conversations following the publication of the rule that the surveying
specialties could instead nominate the affected codes from these
families as being potentially misvalued. At the January 2020 RUC
meeting, the RUC reaffirmed its CY 2019 recommendations for physician
work and direct PE for the ten codes in the Fine Needle Aspiration code
family.
In discussing this group of codes, we would like to clarify again
that we disagree with the RUC and do not believe that utilization was
erroneously double-counted for this code family. We publish our
proposed utilization crosswalk each year as a public use file available
on the CMS website; the current such file is available under downloads
for the CY 2021 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. During the CY 2019 rule cycle, we proposed the
utilization crosswalk for the Fine Needle Aspiration family as it was
recommended to CMS by the RUC, and we did not receive any comments on
this subject until after the valuation of these codes had been
finalized. We proposed and finalized the utilization crosswalk for this
code family as recommended by the RUC without receiving any comments
from the RUC or other stakeholders. If the RUC or other stakeholders
believed that what CMS had proposed was incorrect or misunderstood what
the RUC had recommended, there was an opportunity to comment during the
60 days following the publication of the proposed rule. We disagreed
that the utilization crosswalk was erroneous, and we did not make a
technical correction following the publication of the CY 2019 PFS final
rule for this reason.
We also disagreed with the RUC that the utilization crosswalk was
``the principle reason CMS rejected the RUC recommendations'' for the
codes in the Fine Needle Aspiration family, as stated in the RUC's CY
2021 recommendations for this code family. As we stated in the CY 2019
PFS proposed rule and restated in the CY 2019 PFS final rule, our
refinements to the work RVUs of CPT codes 10021, 10005, and 10009 were
primarily based on changes in surveyed work time and the relationship
between the codes in the family. For example, this was our rationale
for refining the work RVU of CPT code 10021 from the RUC-recommended
value of 1.20 to the finalized value of 1.03: In reviewing CPT code
10021, we noted that the recommended intraservice time is decreasing
from 17 minutes to 15 minutes (12 percent reduction), and the
recommended total time is decreasing from 48 minutes to 33 minutes (32
percent reduction); however, the RUC-recommended work RVU is only
decreasing from 1.27 to 1.20, which is a reduction of just over 5
percent. In the case of CPT code 10021, we believed that it was more
accurate to propose a work RVU of 1.03 based on a crosswalk to CPT code
36440 to account for these decreases in the surveyed work time (83 FR
59518). We noted that this primary rationale for refining the work RVU
did not mention the utilization crosswalk at all.
When we communicated to the RUC following the publication of the CY
2019 PFS final rule that the codes in the Fine Needle Aspiration family
could be nominated as potentially misvalued, we indicated that we were
open to receiving new information about the valuation of these codes.
In reaffirming its recommendations from CY 2019, however, the RUC has
not provided any
[[Page 84603]]
new information that was not already presented for the previous CMS
review of these codes. Therefore, we did not propose any changes to the
codes in the Fine Needle Aspiration family, as the reaffirmed CY 2021
RUC recommendations are identical to the CY 2019 RUC recommendations
that already went through notice and comment rulemaking. We welcomed
the submission of new information regarding these services that was not
part of the previous CY 2019 review of the code family.
We received public comments on the Fine Needle Aspiration code
family. The following is a summary of the comments we received and our
responses.
Comment: Several commenters maintained that CMS inadvertently
double counted each bundled image guidance code during their RUC
recommendation evaluation in CY 2019 due to a misinterpretation of the
RUC's utilization crosswalk recommendations. Commenters stated that
after correcting for double counting the utilization for the newly
created bundled codes, the work pool based on the RUC-recommended
values would have instead resulted in a decrease by 15 percent using
the CMS utilizations from the CY 2019 PFS proposed rule. Commenters
stated that based on the CMS proposed reductions, the work pool for the
family would decrease by 23 percent based on the utilization data
available during the CY 2019 rulemaking.
Response: As we stated in the CY 2021 PFS proposed rule (85 FR
50152), we continue to disagree with the RUC and do not believe that
utilization was erroneously double-counted for this code family. We
proposed and finalized the utilization crosswalk for this code family
as recommended by the RUC without receiving any comments from the RUC
or other stakeholders and we did not make a technical correction
following the publication of the CY 2019 PFS final rule for this
reason.
Comment: Several commenters stated that they had new information to
provide based on reviewing actual claim data from CY 2019 to assess the
accuracy of the RVU pool estimates during the CY 2019 rulemaking
process. Commenters stated that CMS' projected RVU pool for CY 2019 for
the updated Fine Needle Aspiration code family was over twice as high
as what actually occurred in 2019 even though the utilization for the
newly created codes is largely identical to the source utilization from
CPT codes 10021 and 10022. Commenters recommended CMS to finalize the
RUC-recommended work RVUs for CPT codes 10005, 10009, and 10021.
Response: We appreciate the additional information provided by the
commenters in their review of the claims data from CY 2019. However, we
note that it is not typically part of our methodology to review the
accuracy of the RUC-recommended utilization crosswalk against the
claims data when it becomes available 2 years later. Historically,
there have been many times when the projected crosswalk overestimated
utilization for a new service. Also, there have been many times when
the projected crosswalk underestimated utilization. In the absence of a
systematic process to investigate the accuracy of these projected
utilization crosswalks across a broad range of services, we do not
believe that it would serve the interests of relativity to single out
individual code families and compare them against their projected
crosswalks. It would distort relativity to conduct this analysis in
situations where it might be advantageous for valuation while failing
to conduct the same analysis in situations where it might be
disadvantageous.
More importantly, we continue to disagree with the RUC that the
utilization crosswalk was ``the principle reason CMS rejected the RUC
recommendations'' for the codes in the Fine Needle Aspiration family,
as stated in the RUC's CY 2021 recommendations for this code family. As
we stated in the CY 2019 PFS proposed rule, restated in the CY 2019 PFS
final rule, and again restated in the CY 2021 PFS proposed rule, our
refinements to the work RVUs of CPT codes 10021, 10005, and 10009 were
primarily based on changes in surveyed work time and the relationship
between the codes in the family. We noted that this primary rationale
for refining the work RVU did not mention the utilization crosswalk at
all. We continue to believe that the changes in surveyed work time and
the relationship between the codes in the family support the work
valuations finalized in CY 2019 rulemaking.
Comment: Several commenters disagreed with the rationale provided
by CMS when the work RVUs for these codes were finalized in CY 2019
rulemaking. Commenters stated that CMS continued to use intraservice
time ratios to revalue codes and then applied inappropriate crosswalks
to justify their logic. Commenters stated that the CMS crosswalk codes,
such as CPT code 36440 (Push transfusion, blood, 2 years or younger),
are not clinically similar to the reviewed codes including the
associated risks and required decision-making. Commenters stated that
the work RVU for CPT code 10005 could be more appropriately crosswalked
to CPT code 76978 (Ultrasound, targeted dynamic microbubble sonographic
contrast characterization (non-cardiac); initial lesion) based on the
identical intraservice work time, intensity, complexity similarities,
and ultrasound service similarities. Commenters similarly stated that
the work RVU of CPT code 10021 could be more accurately crosswalked to
CPT code 95866 (Needle electromyography; hemidiaphragm). Commenters
again suggested CMS to finalize the RUC's reaffirmed work RVUs for
these services.
Response: We disagree with these valuation suggestions presented by
the commenters as they reiterate the same arguments that we considered
and ultimately did not finalize when the codes in the Fine Needle
Aspiration were previously reviewed. For a full discussion of this
subject, we direct readers to the CY 2019 PFS final rule (83 FR 59517-
59521). We continue to believe that the changes in surveyed work time
and the relationship between the codes in the family support the work
valuations finalized in CY 2019 rulemaking.
Comment: Several commenters stated that for several equipment
items, including the mayo stand (EF015), the exam table (EF023), and
the portable ultrasound unit (EQ250), it appeared that there was a
calculation error in CMS' direct PE refinement table. Commenters
provided a spreadsheet which clarified the RUC's comments on individual
refinements of direct PE inputs with suggested equipment times for
these items.
Response: We disagree with the commenters and we continue to
believe that the equipment times finalized in CY 2019 rulemaking are
correct. The finalized equipment times for these three equipment items
conform to the standard established policies for non-highly technical
equipment. The equipment times recommended by the commenters do not
conform to these standard equipment time formulas, instead adding
additional time for the ``Complete post-procedure diagnostic forms, lab
and x-ray requisitions'' (CA027) and ``Review home care instructions,
coordinate visits/prescriptions'' (CA035) clinical labor activities. In
particular, we note that the CA035 clinical labor activity is not part
of the standard established policies for non-highly technical equipment
formula; the RUC has mistakenly labeled it as such on some of their
recommended PE spreadsheets. Since
[[Page 84604]]
these clinical labor activities are not part of the standard equipment
time formula, and we have no reason to believe that they would be
typical for the services in question; we continue to believe that the
equipment times finalized in CY 2019 rulemaking are correct.
We did not propose any changes to the codes in the Fine Needle
Aspiration family and although we appreciate the information supplied
by the commenters, we are not finalizing any changes to these services.
In the event that there is a new review of these services, as opposed
to a reaffirmation of the previous review, we would look forward to
receiving any additional information or new data.
(2) Tissue Expander Other Than Breast (CPT Code 11960)
This service was included in a larger group of similarly related
codes that were recommended for review for the October 2019 RUC
meeting. The RUC recommended re-reviewing this code at a more granular
level for the January 2020 RUC meeting.
We disagreed with the RUC-recommended work RVU of 12.40 for CPT
code 11960 (tissue expander other than breast). We proposed to maintain
the current work RVU of 11.49 supported by a reference code, CPT code
45560 (repair of rectocele (separate procedure)), which has a work RVU
of 11.50. CPT code 45560 shares the same intraservice time of 90
minutes with CPT code 11960 and has a slightly higher total time of 367
minutes. The recommended total time for CPT code 11960 decreased from
444 minutes to 357 minutes, with a slight increase in intraservice time
of 78 minutes to 90 minutes. We noted that we believe the similar work
RVU of the reference CPT code 45560, as well as the reduction in total
time, supports maintaining the current work RVU of 11.49 for CPT code
11960. We proposed the RUC-recommended direct PE inputs for CPT code
11960 without refinements.
We received public comments on the Tissue Expander Other Than
Breast.
The following is a summary of the comments we received and our
responses.
Comment: Several commenters disagreed with the proposal to maintain
the current work RVU of 11.49 for CPT code 11960 (Tissue expander other
than breast) and stated that CMS should finalize the RUC-recommended
work RVU of 12.40. In particular, commenters stated they believe that
there is an anomalous relationship between current work RVU and current
physician time reflected in an inappropriate intensity. The commenters
also believe that we have not appropriately accounted for the RUC-
recommended increase in intraservice time.
Response: We acknowledge that the RUC recommended an increase in
intraservice time. However, we believe that when our review of
recommended values reveals changes in time that have been unaccounted
for in a recommended RVU, such as in the decrease of total time
unaccounted for with CPT code 11960, we believe it is appropriate to
account for that change in establishing work RVUs since the statute
explicitly identifies time as one of the two elements of the work RVUs.
To validate further our valuations for work RVUs, we incorporate
multiple methodologies, which also consider intensity of the service.
For additional information regarding our use of methodologies for code
valuation, we refer readers to our discussion of the subject in the
Methodology for Establishing Work RVUs section of this rule (section
II.H.2. of this final rule).
Comment: Commenters stated that they disagree with our use of the
chosen reference code, CPT code 45560 (Repair of rectocele (separate
procedure)). Commenters stated that they believe the chosen reference
code does not accurately support the proposed work times for this code
because it is ``low volume'' and it has been too long since the last
survey to be an accurate comparison for determining an appropriate
valuation. The commenters also stated that there is no evidence to
support a clinical comparison between CPT code 11960 and the chosen
reference code.
Response: We consider reference codes as supportive of a code
valuation rather than as a direct ``cross-walk.'' CPT code 45560 has a
work RVU of 11.50. It shares the same intraservice time of 90 minutes
with CPT code 11960 and has a slightly higher total time of 367
minutes. We do not agree that codes must share the same patient
population or utilization level to serve as an appropriate reference
code. We also recognize that it is important to use recent data
available regarding work times. However, we believe that while some
reference codes may not have been recently surveyed, they still provide
support for revision of work RVUs when survey times show a marked
decrease in time.
After consideration of these public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 11960 as proposed.
(3) Breast Implant-Expander Placement (CPT Codes 11970, 19325, 19340,
19342, and 19357)
These services were included in a larger group of 22 breast
reconstruction and similarly related codes that were recommended for
survey for the October 2019 RUC meeting. At the October 2019 RUC
meeting, these codes were recommended for a more granular review for
the January 2020 RUC meeting.
We disagreed with the RUC-recommended work RVU of 8.01 for CPT code
11970 (replacement of tissue expander with permanent implant). We
proposed a work RVU of 7.49 supported by a reference code CPT code
35701 (exploration not followed by surgical repair, artery; neck (e.g.,
carotid, subclavian)), which has a work RVU of 7.50. CPT code 35701
shares the same intraservice time of 60 minutes with CPT code 11970 and
has a slightly higher total time of 229 minutes as compared to 216
minutes. In addition, during our review of CPT code 11970, we noted
that the recommended intraservice time is decreasing from 78 minutes to
60 minutes and the recommended total time of 231 minutes is decreasing
to 216 minutes. We also noted that the proposed work RVU of 7.49 for
CPT code 11970 is equal to the total time ratio amount, which is the
current total time compared to the RUC-recommended total time. We
proposed the RUC-recommended direct PE inputs for CPT code 11970.
We disagreed with the RUC-recommended work RVU of 8.64 for CPT code
19325 (breast augmentation with implant). Although we disagreed with
the RUC-recommended work RVU, we concurred that the relative difference
in work between CPT codes 11970 and 19325 is equivalent to the RUC-
recommended interval of 0.63 RVUs. Therefore, we proposed a work RVU of
8.12 for CPT code 19325, based on the RUC-recommended interval of 0.63
additional RVUs above our proposed work RVU of 7.49 for CPT code 11970.
We noted that we believe the use of an incremental difference between
these CPT 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. We also
supported the proposed work RVU of 8.12 based on a reference code, CPT
code 25652 (open treatment of ulnar styloid fracture). CPT code 25652
shares the same intraservice time of 60 minutes and the same total time
of 225 minutes with a lower work RVU of 8.06. In addition, during our
review of CPT code
[[Page 84605]]
19325, we noted that the total time has decreased from 244 minutes to
225 minutes and the intraservice time has decreased from 90 minutes to
60 minutes. We proposed the RUC-recommended direct PE inputs for CPT
code 19325.
We disagreed with the RUC-recommended work RVU of 11.00 for CPT
code 19340 (insertion of breast implant on same day of mastectomy (i.e.
immediate)). Although we disagreed with the RUC-recommended work RVU,
we concurred that the relative difference in work between CPT codes
19325 and 19340 is equivalent to the RUC-recommended interval of 2.36
RVUs. Therefore, we proposed a work RVU of 10.48 for CPT code 19340,
based on the recommended interval of 2.36 additional RVUs above our
proposed work RVU of 8.12 for CPT code 19325. We also supported our
proposed work RVU of 10.48 based on a reference code, CPT code 47562
(laparoscopy, surgical; cholecystectomy). CPT code 47562 shares the
same intraservice time of 80 minutes and only a slightly lower total
time of 251 minutes with a similar work RVU of 10.47. In addition,
during our review of CPT code 19340, we noted that the total time has
decreased from 366 minutes to 261 minutes and the intraservice time has
decreased from 120 minutes to 80 minutes. We proposed the RUC-
recommended direct PE inputs for CPT code 19340.
We disagreed with the RUC-recommended work RVU of 11.00 for CPT
code 19342 (insertion or replacement of breast implant on different day
from mastectomy). Although we disagreed with the RUC-recommended work
RVU, we concurred that the relative difference in work between CPT
codes 19325 and 19342 is equivalent to the RUC-recommended interval of
2.36 RVUs. Therefore, we proposed a work RVU of 10.48 for CPT code
19342, based on the recommended interval of 2.36 additional RVUs above
our proposed work RVU of 8.12 for CPT code 19325. We also noted that
the RUC-recommended work RVU of 11.00 is equal to the RUC-recommended
work RVU for CPT code 19340 because they have stated that both services
involve an identical amount of physician work and similar times. We
also supported our proposed work RVU of 10.48 based on a reference
code, CPT code 47562 (laparoscopy, surgical; cholecystectomy). CPT code
47562 shares the same intraservice time of 80 minutes and only a
slightly lower total time of 251 minutes with a similar work RVU of
10.47. The total time for CPT code 19342 has decreased from 320 minutes
to 252 minutes and the intraservice time has decreased from 115 minutes
to 80 minutes. We proposed the RUC-recommended direct PE inputs for CPT
code 19342.
We disagreed with the RUC-recommended work RVU of 15.36 for CPT
code 19357 (tissue expander placement in breast reconstruction,
including subsequent expansion). Although we disagreed with the RUC-
recommended work RVU, we concurred that the relative difference in work
between CPT codes 11970 and 19357 is equivalent to the RUC-recommended
interval of 7.35 RVUs. Therefore, we proposed a work RVU of 14.84 for
CPT code 19357, based on the recommended interval of 7.35 additional
RVUs above our proposed work RVU of 7.49 for CPT code 11970. We also
supported our proposed work RVU of 14.84 based on a reference code, CPT
code 37605 (ligation; internal or common carotid artery). CPT code
37605 shares the same intraservice time of 90 minutes and only a
slightly lower total time of 342 minutes with a lower work RVU of
14.28. In addition, during our review of CPT code 19357, we noted that
the total time has decreased from 468 minutes to 344 minutes and the
intraservice time has decreased from 110 minutes to 90 minutes. We
proposed the RUC-recommended direct PE inputs for CPT code 19357.
We received public comments on the Breast Implant-Expander
Placement code family. The following is a summary of the comments we
received and our responses.
Comment: Commenters disagreed with the proposed work RVU of 7.49
for CPT code 11970 and stated that CMS should finalize the RUC-
recommended work RVU of 8.01. Commenters stated that they disagree with
the use of the total time ratio methodology for the valuation of this
code. The commenters stated that they believe the total time ratio is
invalid because it uses 30-year-old total time from the Harvard Study.
Additionally, commenters stated that they believe CMS did not consider
intensity of the service while using this methodology, which they
believe is actually much higher than what CMS has accounted for.
Commenters stated that they believe CMS substituted an arbitrary
determination of work values derived from time and a subjective
estimate of intensity based on an unknown and clinically uniformed
opinion.
Response: We disagree and continue to believe that the use of time
ratios is an appropriate method for identifying potential work RVUs for
particular PFS services. In regard to the age of the data from the
Harvard study, if we were to operate under the assumption that
previously recommended work times are now arbitrarily invalid, this
would undermine the relativity of the work RVUs on the PFS in general,
given that codes are, and have been over many years, often valued by
comparisons to codes with similar times. For CPT code 11970, survey
times showed a total time and intraservice time decrease. Therefore, we
believe the total time ratio, as a comparison of the current work time
versus the RUC-recommended work times, is an appropriate methodology to
value the work for this CPT code. For additional information regarding
our use of time ratios for code valuation, we refer readers to our
discussion of the subject in the Methodology for Establishing Work RVUs
section of this rule (section II.H.2. of this final rule).
Comment: Commenters disagreed with the proposed work RVU of 8.12
for CPT code 19325 and stated that CMS should finalize the RUC-
recommended work RVU of 8.64. Commenters also disagreed with the
proposed work RVU of 10.48 for CPT code 19340 and CPT code 19342 and
stated that we should finalize the RUC-recommended work RVU of 11.00
for both CPT codes. Commenters also stated that they disagreed with the
proposed work RVU of 14.84 for CPT code 19357 and stated that instead
we should finalize the RUC-recommended work RVU of 15.36. Commenters
stated that they do not support the use of an incremental methodology
as an appropriate method for identifying work RVUs for these PFS
services. In particular, commenters noted that they believe this
methodology adds fragility to the relative value system, as an error in
the foundation code could affect the entire code family.
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. 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. For additional
information regarding
[[Page 84606]]
our use of an incremental difference for code valuation, we refer
readers to our discussion of the subject in the Methodology for
Establishing Work RVUs section of this rule (section II.H.2. of this
final rule).
Comment: Commenters disagreed with our use of the chosen supporting
reference codes throughout the code family. For CPT code 11970, CPT
code 19325, and CPT code19357, commenters stated that they believe the
chosen reference codes are too ``low-volume'' to accurately support the
proposed work times for these codes. Additionally, commenters stated
that for CPT code 19325, CPT code 19340, CPT code 19342, and CPT code
19357, that the work values for the reference codes chosen by CMS are
too old to be accurate comparisons for determining appropriate
valuations. The commenters also stated that several of the reference
codes are not relevant for purposes of valuation because there is no
evidence to support clinical comparison.
Response: We are statutorily obligated to consider both time and
intensity in establishing work RVUs for PFS services. Additionally, we
use other methods to validate work RVUs, such as reference codes. When
using reference codes to support a proposed work RVU, we do not
consider them as a direct ``cross-walk'' between the CPT code that is
being revalued and the chosen reference code. Instead, a reference code
used as a supportive check in validating work times. We continue to
believe that the relative value system of the PFS is such that all
services are appropriately subject to comparisons to one another. We do
not agree that codes must share the same patient population or
utilization level to serve as an appropriate reference code. We also
recognize that it is important to use the most recent data available
regarding work times. However, we believe that while some reference
code values may be considered older, they still provide support for
revision of work RVUs when survey times show a marked increase or
decrease in total and intraservice time, such as was the case for this
code family.
Comment: Commenters stated that CMS must ensure that any RVU
reduction of more than 19 percent is phased in over 2 years, under
1848(c)(7) of the Act. The commenter stated that the magnitude of the
proposed RVU reductions for CPT codes 19340 and 19357 would trigger the
phase-in requirements since they would be decreasing by more than 19
percent.
Response: Section 1848(c)(7) of the Act, as added by section 220(e)
of the PAMA, 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. We proposed to exempt
all of the CPT codes in the Breast Implant-Expander Placement family
from the phase-in of significant RVU reductions required by section
1848(c)(7) of the Act due to the fact that they were designated as
``revised'' codes by CPT as a result of significant revisions to their
code descriptors. Since all of the codes in the family fall under the
revised designation, the phase-in requirement does not apply to them.
Comment: Commenters stated that they are concerned that reducing
reimbursement for the services in this code family could limit access
to breast reconstruction following mastectomy. The commenters cited a
study done by Kamali P et al., titled: Immediate Breast Reconstruction
among Patients with Medicare and Private Insurance: A Matched Cohort
Analysis. Commenters also stated that they wanted to bring to our
attention the Women's Health and Cancer Rights Act of 1998 (WHCRA). The
commenters stated that this act provides coverage protection for
patients who choose to have breast reconstruction following a
mastectomy.
Response: We remain committed to supporting the health of all
Medicare beneficiaries, as well as remaining vigilant in support of all
services related to minority and women's health. While the WHCRA (Pub.
L. 105-277, Title IX, Oct. 21, 1998) is an important federal law that
furthers protections for women's healthcare rights and access to
services, we note that Medicare does provide coverage for these
important services.
After consideration of these public comments, we are finalizing the
work RVU and direct PE inputs for the Breast Implant-Expander
(4) Breast Implant-Expander Removal (CPT Codes 11971, 19328, and 19330)
These services were included in a group of codes that were
recommended for survey for the October 2019 RUC meeting as part of a
large group of 22 breast reconstruction and similarly related services.
At its October 2019 meeting, the RUC agreed that a 22-code family was
too expansive. They recommended these codes be re-reviewed as part of a
smaller and more granular code family for the January 2020 RUC meeting.
We disagreed with the RUC-recommended work RVU of 7.02 for CPT code
11971 (removal of tissue expander w/out insertion of implant). Although
we disagreed with the RUC-recommended work RVU, we concurred that the
relative difference in work between CPT codes 11970 and 11971 is
equivalent to the RUC recommended interval of 0.99 RVUs. Therefore, we
proposed a work RVU of 6.50 for CPT code 11971, based on the
recommended interval of 0.99 RVUs below our proposed work RVU of 7.49
for CPT code 11970. We noted that as stated previously, we believed the
use of an incremental difference between these CPT codes is a valid
methodology for setting values, especially in valuing services within
families of similarly revised codes. We also supported our proposed
work RVU of 6.50 based on a reference code, CPT code 25671
(percutaneous skeletal fixation of distal radioulnar dislocation). CPT
code 25671 shares the same intraservice time of 45 minutes and a
slightly less total time of 210 minutes with a very similar work RVU of
6.46. In addition, during our review of CPT code 11971, we noted that
the total time has decreased from 303 minutes to 215 minutes and the
intraservice time has decreased from 90 to 45 minutes. We proposed the
RUC-recommended direct PE inputs for CPT code 11971.
We disagreed with the RUC-recommended work RVU of 7.44 for CPT code
19328 (removal of intact breast implant). Although we disagreed with
the RUC-recommended work RVU, we proposed increasing the current work
RVU from 6.48 to 6.92 to account for the increases in total and
intraservice time. We also concurred that the relative difference in
work between CPT codes 11971 and 19328 is equivalent to the RUC-
recommended interval of 0.42 RVUs. Therefore, we proposed a work RVU of
6.92 for CPT code 19328, based on the recommended interval of 0.42
additional RVUs above our proposed work RVU of 6.50 for CPT code 11970.
We also supported our proposed work RVU of 6.92 based on a reference
code, CPT code 28289 (Hallux rigidus correction with cheilectomy,
debridement and capsular release of the first metatarsophalangeal
joint; without implant). CPT code 28289 shares the same intraservice
time of 45 minutes and a slightly higher total time of 210 minutes with
a very similar work RVU of 6.90. The total time for CPT code 19328 has
increased from 173 minutes to 199 minutes and the intraservice time has
increased from 38 to 45 minutes. We proposed the RUC-recommended direct
PE inputs for CPT code 19328.
We proposed the RUC-recommended work RVU of 9.00 for CPT code 19330
[[Page 84607]]
(removal of ruptured breast implant, including implant contents). The
survey total time for CPT code 19330 has increased from 218 minutes to
229 minutes and the intraservice time has increased from 62 minutes to
75 minutes. We also proposed the RUC-recommended direct PE inputs for
this code without refinements.
We received public comments on the Breast Implant-Expander Removal
code family. The following is a summary of the comments we received and
our responses.
Comment: Commenters disagreed with the proposed work RVU of 6.50
for CPT code 11971 and stated that CMS should finalize the RUC-
recommended work RVU of 7.02. Commenters also disagreed with the
proposed work RVU of 6.92 for CPT code 19328 and stated that CMS should
finalize the RUC-recommended work RVU of 7.44. Commenters stated that
they do not support the proposed work RVU because they do not support
the use of an incremental methodology as an appropriate tool for
valuing services in this code family. In particular, commenters noted
that they believe this methodology is further inappropriate because it
uses a foundation code that is not within the same code family, which
adds further fragility to the use of the incremental methodology for
valuation of this code family.
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.
Comment: Commenters disagreed with our use of the chosen supporting
reference codes for CPT code 11971 and CPT code 19328. The commenters
stated that they believe there is not adequate clinical comparison for
the work portion of the service. Commenters also stated that they
believe the reference code values are too old because they are from
outdated survey results and do not have adequately comparable
intensities.
Response: When using referencing codes to support a proposed work
RVU, we do not consider them as a direct ``cross-walk'' between the CPT
code that is being revalued and the chosen reference code. Instead,
reference codes are used as a supportive check in validating work
times. We continue to believe that the relative value system of the PFS
is such that all services are appropriately subject to comparisons to
one another.
After consideration of these public comments, we find the arguments
for maintaining consistency in methodology and reducing the risk of
anomalies within the valuation of this code family to be compelling. We
are finalizing the RUC-recommended work RVU of 7.02 for CPT code 11971
and the RUC-recommended work RVU of 7.44 for CPT code 19328. We are
also finalizing the direct PE inputs as proposed.
(5) Modified Radical Mastectomy (CPT Code 19307)
The RUC recommended that CPT code 19307 (Mastectomy, modified
radical, including axillary lymph nodes, with or without pectoralis
minor muscle, but excluding pectoralis major muscle) be surveyed for
the January 2020 RUC meeting for site of service anomaly. The
Relativity Assessment Workgroup identified services performed less than
50 percent of the time in the inpatient setting yet included inpatient
hospital E/M services within the global period and with 2018 Medicare
utilization over 5,000. The RUC recommended lowering the work RVU to
17.99 which is the survey's 25th percentile.
We proposed the RUC-recommended work RVUs of 17.99 for CPT code
19307. We also proposed the RUC-recommended direct PE inputs for this
code.
We received public comments on Modified Radical Mastectomy (CPT
code 19307). The following is a summary of the comments we received and
our responses.
Comment: Commenters were overall in support of CMS proposing the
RUC recommendations for this code. One commenter noted strong support
for the process and of the RUC. Additionally, the commenters suggested
CMS to accept the RUC recommendations to extend the office and
outpatient E/M work RVU increases to the office and outpatient visits
included in 10- and 90-day globals.
Response: We appreciate the commenters' support for CMS proposing
the RUC recommendation for Modified Radical Mastectomy (CPT code 19307)
and note the commenters concern with regard to office and outpatient E/
M work RVU increases to the office and outpatient visits included in
10- and 90-day global.
After consideration of these public comments, we are finalizing as
proposed the RUC-recommended work RVU of 17.99 for CPT code 19307. We
are also finalizing as proposed the RUC-recommended direct PE inputs
for this code.
(6) Breast Lift-Reduction (CPT Codes 19316 and 19318)
These services were included in a larger code group of similarly
related services that were recommended for review for the October 2019
RUC meeting. CPT code 19316 (mastopexy) and CPT code 19318 (Breast
reduction) were then recommended for a more granular review for the
January 2020 RUC meeting.
We proposed the RUC-recommended work RVU of 11.09 for CPT code
19316 (mastopexy) and 16.03 for CPT code 19318 (Breast reduction). We
proposed the RUC-recommended direct PE inputs for this code family
without refinements.
We did not receive public comments on this code family, and are
finalizing as proposed.
(7) Secondary Breast Mound Procedure (CPT Codes 19370, 19371, and
19380)
These services were included in a large group of breast
reconstruction codes that were recommended to be surveyed for the
October 2019 RUC meeting. At the October 2019 RUC meeting, the RUC
concurred with the more granular code families but recommended these
codes be re-surveyed for the January 2020 RUC meeting.
We disagreed with the RUC-recommended work RVU of 10.0 for CPT code
19370 (Revision of peri-implant capsule, breast, including
capsulorrhaphy, and/or partial capsulectomy). We proposed to maintain
the current work RVU of 9.17 based on a supporting reference code, CPT
code 28299 (Correction, hallux valgus (bunionectomy), with
sesamoidectomy, when performed; with double osteotomy, any method),
which has a work RVU of 9.29. CPT code 28299 shares a similar
intraservice time of 75 minutes with CPT code 19370 and has a slightly
higher total time of 256 minutes. In addition, we noted during our
review of CPT code 19370 that the recommended total time has increased
minimally from 253 minutes to 255 minutes, with a slight decrease in
intraservice time of 82 minutes to 78 minutes. We noted that we believe
the similar work RVU of the supporting CPT code 28299, as well as the
minimal changes in physician work time for CPT code 19370, supports
maintaining the current work RVU of 9.17. We proposed the RUC-
recommended direct PE inputs for CPT code 19370 without refinements.
We disagreed with the RUC-recommended work RVU of 10.81 for CPT
code 19371 (Peri-implant
[[Page 84608]]
capsulectomy, breast, complete, including removal of all intra-capsular
contents). Although we disagreed with the RUC-recommended work RVU, we
concur that the relative difference in work between CPT codes 19370 and
19371 is equivalent to the RUC-recommended interval of 0.81 RVUs.
Therefore, we proposed a work RVU of 9.98 for CPT code 19371, based on
the recommended interval of 0.81 additional RVUs above our proposed
work RVU of 9.17 for CPT code 19370. We noted that as stated
previously, we believe the use of an incremental difference between
these CPT 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. We also
supported our proposed work RVU of 9.98 based on a reference code, CPT
code 25628 (Open treatment of carpal scaphoid (navicular) fracture,
includes internal fixation, when performed). CPT code 25628 shares the
same intraservice time of 90 minutes and a slightly higher total time
of 277 minutes with a work RVU of 9.67. In addition, during our review
of CPT code 19371, we noted that the total time for CPT code 19371 has
decreased from 306 minutes to 261 minutes and the intraservice time has
decreased from 117 to 90 minutes. We proposed the RUC-recommended
direct PE inputs for CPT code 19371.
We disagreed with the RUC-recommended work RVU of 12.00 for CPT
code 19380 (Revision of reconstructed breast (e.g., significant removal
of tissue, re-advancement and/or re-inset of flaps in autologous
reconstruction or significant capsular revision combined with soft
tissue excision in implant-based reconstruction)). Although we
disagreed with the RUC-recommended work RVU, we concurred that the
relative difference in work between CPT codes 19371 and 19380 is
equivalent to the RUC recommended interval of 1.19 RVUs. Therefore, we
proposed a work RVU of 11.17 for CPT code 19380, based on the
recommended interval of 1.19 additional RVUs above our proposed work
RVU of 9.98 for CPT code 19371. We also supported our proposed work RVU
of 11.17 based on a reference code, CPT code 64569 (Revision or
replacement of cranial nerve (e.g., vagus nerve) neurostimulator
electrode array, including connection to existing pulse generato). CPT
code 64569 shares the same intraservice time of 120 minutes and only a
slightly higher total time of 312 minutes with a work RVU of 11.0. The
total time increased from 277 minutes to 307 minutes and the
intraservice time has increased from 89 minutes to 120 minutes. We
proposed the RUC-recommended direct PE inputs for CPT code 19380.
We received public comments on the Secondary Breast Mound Procedure
(CPT codes 19370, 19371, and 19380). The following is a summary of the
comments we received and our responses.
Comment: Several commenters disagreed with the proposal to maintain
the current work RVU of 9.17 for CPT code 19370 (Revision of peri-
implant capsule, breast, including capsulorrhaphy, and/or partial
capsulectomy) and stated that CMS should finalize the RUC- recommended
work RVU of 10.00. Some of the commenters disagreed with comparing the
current intraservice time and total time from the Harvard study to the
RUC-recommended physician time. The commenters also believed that we
have not appropriately accounted for the CPT Editorial Panel's revised
additional physician work that is now inclusive in the code descriptor
and increased intensity.
Response: We disagree with the commenter. For CPT code 19370,
survey times showed only a slight increase in total time and slight
decrease in intraservice time. Therefore, we continue to believe that
the survey time does not support increasing the work RVU; in
particular, there was no significant change in total time.
Comment: Commenters disagreed with the proposed work RVU of 9.98
for CPT code 19371 (Peri-implant capsulectomy, breast, complete,
including removal of all intra-capsular contents) and stated that CMS
should finalize the RUC-recommended work RVU of 10.81. Commenters also
disagreed with the proposed work RVU of 11.17 for CPT code 1980
(Revision of reconstructed breast (e.g., significant removal of tissue,
re-advancement and/or re-inset of flaps in autologous reconstruction or
significant capsular revision combined with soft tissue excision in
implant-based reconstruction)) and stated that we should finalize the
RUC-recommended work RVU of 12.00. Commenters stated that they do not
support the use of an incremental methodology as an appropriate method
for identifying work RVUs for these PFS services. In particular,
commenters noted that they believe this methodology adds fragility to
the relative value system, as an error in the foundation code could
affect the entire code family.
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. 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. For additional
information regarding our use of an incremental difference for code
valuation, we refer readers to our discussion of the subject in the
Methodology for Establishing Work RVUs section of this rule (section
II.H.2. of this final rule).
Comment: For CPT codes 19370, CPT code 19371, and CPT code 19380,
commenters disagreed with our use of the chosen supporting reference
codes throughout the code family stating they were not strong reference
codes, and not relevant for purposes of valuation because there is no
evidence of clinical comparison. A commenter also stated that the
reference code used for CPT code 19380 had very low volume.
Response: We are statutorily obligated to consider both time and
intensity in establishing work RVUs for PFS services. Additionally, we
use other methods to validate work RVUs, such as reference codes. When
using referencing codes to support a proposed work RVU, we do not
consider there to be a direct ``cross-walk'' between the CPT code that
is being revalued and the chosen reference code. Instead, it is meant
to be supportive in validating work times. We continue to believe that
the relative value system of the PFS is such that all services are
appropriately subject to comparisons to one another. We do not agree
that codes must share the same patient population or utilization level
to serve as an appropriate reference code. We also recognize that it is
important to use recent available data regarding work times. However,
we believe that while some reference code values may be considered
older, they still provide support for revision of work RVUs when survey
times show a marked increase or decrease in total and intraservice
time, such as was the case for this code family.
After consideration of public comments, we are finalizing the work
RVU and direct PE inputs for the
[[Page 84609]]
Secondary Breast Mound Procedure code family as proposed.
(8) Hip-Knee Arthroplasty (CPT Codes 27130 and 27447)
CPT codes 27130 (Arthroplasty, acetabular and proximal femoral
prosthetic replacement (total hip arthroplasty), with or without
autograft or allograft) and 27447 (Arthroplasty, knee, condyle and
plateau; medial AND lateral compartments with or without patella
resurfacing (total knee arthroplasty)) were identified as potentially
misvalued codes under the CMS high expenditure procedural code screen
in the CY 2014 PFS final rule with comment period (78 FR 74334). These
codes were reviewed by the AMA RUC who provided recommendations for
work RVUs and physician time for these services for CY 2014. We agreed
with the RUC recommendation to value CPT code 27130 and CPT code 27447
equally and thus established the same CY 2014 interim final work RVUs
for these two procedures (78 FR 74334). This change resulted in a 1.12
work RVU increase for the visits in the global period. We added the
additional work to the AMA RUC-recommended work RVU of 19.60 for CPT
codes 27130 and 27447, resulting in an interim final work RVU of 20.72
for both services.
In the CY 2015 PFS final rule with comment period (79 FR 67632), we
discussed how in the CY 2014 PFS final rule with comment period, we
sought public comment regarding the appropriate work RVUs for these
services and the most appropriate reconciliation for the conflicting
information regarding time values for these services as presented to us
by the physician community. We did not find the rationales provided for
modifying the interim final work values established in CY 2014
compelling, and thus we finalized the CY 2014 interim final values for
these procedures based upon the best data we had available and to
preserve appropriate relativity with other codes.
In the CY 2019 PFS final rule (83 FR 59500 through 595303), CPT
code 27130 and CPT code 27447 were added to the list of potentially
misvalued codes. A stakeholder submitted information requesting that
CMS nominate these codes as potentially misvalued. The stakeholder
stated that there were substantial overestimates in pre-service and
post-service time including follow-up inpatient and outpatient visits
that do not take place included in the valuation of the service. As a
result, the codes were resurveyed for the October 2019 RUC meeting.
We proposed the RUC-recommended work RVU of 19.60 for CPT code
27130 and the RUC-recommended work RVU of 19.60 for CPT code 27447. We
also proposed the RUC-recommended direct PE inputs for both codes.
Additionally, we solicited comment from the medical community on how to
consider and/or include pre-optimization time (pre-service work and/or
activities to improve surgical outcomes) going forward. We also noted
that we were interested in stakeholders' thoughts on what codes could
be used to capture these pre-optimization activities that could be
billed in conjunction with the services discussed previously. Overall,
we noted interest in continuing our ongoing dialog with stakeholders
about how CMS might pay more accurately for improved clinical outcomes
that may result from increased efficiency in furnishing care through
activities, such as pre-optimization and are appreciative of
information provided by the medical community. We invited the medical
community to continue to engage with CMS on this and other topics.
We received public comments on Hip-Knee Arthroplasty (CPT codes
27130 and 27447). The following is a summary of the comments we
received and our responses.
Comment: Many commenters were overall opposed to the proposal to
reduce the work RVUs associated with CPT codes 27447 and 27130.
Commenters noted that pre-optimization time is not captured in the
current RUC survey. Commenters requested that CMS forgo any changes or
delay adoption of the reduced work RVU for these procedures until an
accurate assessment of this time can be determined. The commenters
noted that delaying the adoption of these RVUs would provide time for
CMS to work with stakeholders to better capture pre-optimization work
performed by physicians to improve surgical outcomes. One commenter
recommended the creation of a G code to account for arthroplasty pre-
optimization work.
Two commenters appreciated CMS' interest in capturing these pre-
optimization activities and seeking comment from the medical community
on how to consider and/or include pre-optimization time going forward.
Some stakeholders articulated that CMS may not have fully accounted for
the preoperative work required to make value-based care cost-effective
and high-quality. Commenters note, in light of the pandemic, that any
cuts in payment to health care providers or medically necessary
services would be harmful, and a reduction in work RVU is not justified
by a reduction in time spent on patients, but will undercut the
transition to bundled models.
One commenter was in support of CMS accepting the RUC
recommendation for hip and knee arthroplasty and believes accepting the
RUC recommendation will address the reimbursement imbalance, increase
the primary care workforce, and improve the finances in primary care.
Another commenter opposed the reduction because, if both the CF and RVU
changes take effect, it would be a 15 percent reduction for physician
payment. The commenter noted the RUC methodology does not capture the
patient pre-optimization work related to the APM incentive that
improves patient outcomes and lowers costs.
One commenter noted that patients with a higher BMI are more
complex and the RVU should go up or a separate category be made for
complicated joint replacement for those with a Body Mass Index (BMI)
over 40. Additionally, the commenter noted that implants (for these
procedures) should be reimbursed to facilities at cost or cost plus 10
percent, which would save millions of dollars per calendar year; and
the commenter also believed lowering the RVUs may cause physicians to
stop taking Medicare and reduce access to care.
One commenter noted overwhelming evidence that physicians and/or
QHPs are spending more time with the typical patient in pre-service
optimization work and stated that they believe CMS has broad authority
to remedy the issues presented by the RUC recommendations for
preservice time. Another commenter stated that there was logical
outgrowth to add preservice time to the existing code.
One commenter noted that there are issues with the existing CPT
codes in capturing arthroplasty pre-optimization activities or changes
in practice patterns, and that creation of a new G code would account
for arthroplasty pre-optimization work. For these procedures, this time
includes patient screening and education, as well as coordinating with
other health care providers to help manage the entire episode of care.
Response: We appreciate the commenters' feedback about maintaining
the work RVU and potential resource costs that are not reflected in the
RUC recommendation. We are also appreciative of the dialog we have had
with stakeholders. We continue to assess the accuracy of service
valuations, including global services paid under the PFS, and believe
it would be prudent before considering
[[Page 84610]]
further changes to better understand how existing codes that could be
billed prior to these procedures do not reflect the pre-optimization
activities as described by stakeholders.
After considering the comments received, we are finalizing the RUC-
recommended work RVU of 19.60 for CPT code 27130 and the RUC-
recommended work RVU of 19.60 for CPT code 27447. We are also
finalizing the RUC-recommended direct PE inputs for both codes. As we
continue to consider this issue and how to best reflect pre-
optimization in the valuation for the services, we welcome information
from stakeholders as to which services may be included or which coding
selections would be appropriate for various services that are or would
be provided outside of the global period. We continue to be interested
in stakeholders' thoughts and would like to discuss and consider the
potential for more accurate coding, and what kind of coding framework,
if there is currently none, could be used to capture these pre-
optimization activities.
(9) Toe Amputation (CPT Codes 28820 and 28825)
These services were identified by the RUC Relativity Assessment
Workgroup through a site of service anomaly screen based on the review
of 3 years of data (2015, 2016 and 2017) for services with utilization
over 10,000 in which a service is typically performed in the inpatient
hospital setting, yet only a half discharge day management identified
by CPT code 99238 is included. Prior to conducting the RUC survey, the
specialty societies recommended that it would be appropriate for these
services to have their global period changed from 090-day to 000-day so
the site of service is less of a contributing factor to the codes'
valuation. These codes were surveyed as a 000-day global service, and
we proposed them as 000-day global services.
We disagreed with the RUC-recommended work RVU of 4.10 for CPT code
28820 (Amputation, toe; metatarsophalangeal joint). We noted that we
believe that it would be more accurate to propose a work RVU of 3.51,
and we are supporting this value with a crosswalk to CPT code 33958
(Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support
(ECLS) provided by physician; reposition peripheral (arterial and/or
venous) cannula(e), percutaneous, 6 years and older (includes
fluoroscopic guidance, when performed)), which has a work RVU of 3.51,
to account for the decrease in the surveyed work time. We do not
believe the RUC-recommended reduction in work RVU from the current
value of 5.82 is commensurate with the RUC-recommended 102-minute
reduction in total time. We believe that a further reduction in work
RVUs is warranted given the significant reduction in RUC-recommended
physician time.
We disagreed with the RUC-recommended work RVU of 4.00 for CPT code
28825 (Amputation, toe; interphalangeal joint). We proposed a work RVU
of 3.41 based on the RUC-recommended increment relationship between
this code and CPT code 28820 (a difference of -0.10), which we apply to
our proposed value for the latter code. We noted that we do not believe
the RUC-recommended reduction in work RVU from the current value of
5.37 is commensurate with the RUC-recommended 97-minute reduction in
total time. We also noted that we believe that a further reduction in
work RVUs is warranted given the significance of RUC-recommended
reduction in physician time.
For the direct PE inputs, we proposed to refine the pre-service
clinical labor times to conform to the 000-day global period standards
for both codes in the family for CPT codes 28820 and 28825. We also
proposed to refine the clinical labor times for the ``Provide
education/obtain consent'' (CA011) and the ``Prepare room, equipment
and supplies'' (CA013) activities to conform to our established
standard time of 2 minutes each in the non-facility setting for CPT
codes 28820 and 28825. We proposed to refine the equipment time to
conform to these changes in the clinical labor time for both codes.
We received public comments on the Toe Amputation (CPT codes 28820
and 28825).The following is a summary of the comments we received and
our responses.
Comment: Commenters stated that CMS made this proposal without
demonstrating that the agency also considered the disparity between the
physician work intensity of the post-operative services that were
previously bundled in 28820 and the physician work intensity of the
skin-to-skin time of the service.
Response: We disagree with the commenter that we did not consider
the disparity in intensity between the post-operative services that
were previously bundled in CPT code 28820 and the skin-to-skin time of
the service. 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 time have been unaccounted
for in a recommended RVU, then we believe it is appropriate to account
for that change in establishing work RVUs since the statute explicitly
identifies time as one of the two elements of the work RVUs. This
includes changes in the resource of time associated with the post-
operative services that were previously bundled in CPT code 28820. 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. In the case of CPT codes 28220 and 28222, we
believe that in many cases the work time was reduced substantially but
the work RVU only minimally, which resulted in an implied increase in
the intensity of work that does not appear to be valid, and ultimately
creates work intensity anomalies.
Comment: Commenters stated that the crosswalk code that CMS used to
support its proposal to reject the RUC recommendation, CPT code 33958,
is not an appropriate reference code to use for making valuation
decisions. The commenter stated that CPT code 33958 is an atypical 000-
day global code that includes a bundled inpatient hospital visit making
it inappropriate to use as a direct work value crosswalk for a service
that does not include bundled visits and it is a low volume service.
Response: 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: One commenter stated that they would also like to remind
CMS of both the Agency's and the RUC's longstanding position that
treating all components of physician time (pre-service, intra-service,
post-service and post-operative visits) as having identical intensity
is incorrect and that inconsistently applying it to only certain
services under review creates inherent payment disparities in a payment
system which is based on relative valuation.
Response: We reiterate our previous clarification that we do not
treat all components of physician time as having
[[Page 84611]]
identical intensity. As we have consistently stated, when our review of
recommended values reveals that changes in time have been unaccounted
for in a recommended RVU, then we believe it is appropriate to account
for that change in establishing work RVUs since the statute explicitly
identifies time as one of the two elements of the work RVUs.
Comment: Commenters stated that it does not appear that CMS
considered the change in the global surgical period from a 90-day
global to a 000-day global when referencing the decrease in total time
for the procedure, which would make sense for a change in the global
period and the associated intensity for the procedure. The intra-
service time for the procedure did not change.
Response: We noted that in reviewing the recommended values for CPT
codes 28820 and 28825, the change in global periods was taken into
consideration. However, 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 time have been
unaccounted for in a recommended RVU, then we believe it is appropriate
to account for that change in establishing work RVUs since the statute
explicitly identifies time as one of the two elements of the work RVUs.
This includes changes in the resource of time associated with the post-
operative services that were previously bundled in CPT code 28820.
Comment: Several commenters stated that CMS should not impose the
standard 000-day clinical labor times for CA011 and CA013 with respect
to CPT codes 28820 and 28825 without regard to the clinically
significant information that these are major procedures that are
typically performed in a facility setting.
Response: We have reviewed all the information provided by
commenters and we believe it would be appropriate to maintain 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 provides greater
consistency among codes that share the same clinical labor tasks and
could improve relativity of values among codes. Therefore, we maintain
that these refinements are consistent with the clinical labor times of
a 000-day global service.
After consideration of the comments, we are finalizing the work
RVUs and direct PE inputs for the Toe Amputation codes as proposed.
(10) Shoulder Debridement (CPT Codes 29822 and 29823)
In September 2019, the CPT Editorial Panel approved revision of CPT
code 29822 (Arthroscopy, shoulder, surgical; debridement, limited, 1 or
2 discrete structures (e.g., humeral bone, humeral articular cartilage,
glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor
complex, labrum, articular capsule, articular side of the rotator cuff,
bursal side of the rotator cuff, subacromial bursa, foreign body[ies]))
and CPT code 29823 (Arthroscopy, shoulder, surgical; debridement,
extensive, 3 or more discrete structures (e.g., humeral bone, humeral
articular cartilage, glenoid bone, glenoid articular cartilage, biceps
tendon, biceps anchor complex, labrum, articular capsule, articular
side of the rotator cuff, bursal side of the rotator cuff, subacromial
bursa, foreign body[ies])) to clarify limited and extensive debridement
by specifying the number of discrete structures debrided and providing
examples of the structures.
We proposed the RUC-recommended work RVU of 7.03 for CPT code 29822
and 7.98 for CPT code 29823 without refinement.
For the direct PE inputs, we proposed the RUC recommendations CPT
codes 29822 and 29823 without refinement.
We did not receive public comments on this code family, and are
finalizing as proposed.
(11) Absorbable Nasal Implant Repair (CPT Codes 30468)
In September 2019, the CPT Editorial Panel approved the addition of
CPT code 30468 (Repair of nasal valve collapse with subcutaneous/
submucosal lateral wall implant(s)) to report repair of nasal valve
collapse with subcutaneous/submucosal lateral wall implant(s)).
We proposed the RUC-recommended value of 2.80 work RVUs without
refinement for CPT code 30468.
For the direct PE inputs, we also proposed the RUC-recommended
values without refinement.
We received public comments on the Absorbable Nasal Implant Repair
family (CPT code 30468). The following is a summary of the comments we
received and our responses.
Comment: Several commenters stated their support for our proposal
to adopt the RUC-recommended values without refinement.
Response: We thank commenters for their feedback and support.
After consideration of the comments, we are finalizing the work RVU
and direct PE inputs for CPT code 30468 as proposed.
(12) Lung Biopsy-CT Guidance Bundle (CPT Code 32408)
CPT codes 32405 (Biopsy, lung or mediastinum, percutaneous needle)
and 77012 (Computed tomography guidance for needle placement (e.g.,
biopsy, aspiration, injection, localization device), radiological
supervision and interpretation) were identified by the AMA through a
screen of code pairs that are reported on the same day, same patient
and same NPI number at or more than 75 percent of the time. The CPT
Editorial Panel deleted CPT code 32405 and replaced it with 32408 (Core
needle biopsy, lung or mediastinum, percutaneous, including imaging
guidance, when performed).
We did not propose the RUC-recommended work RVU of 4.00, which is
the survey median, because we believe this value somewhat overstates
the increase in intensity. Although we do not imply that the decrease
in time, when considering the aggregate time values for CPT codes 32405
and 77012, as reflected in survey values must equate to a one-to-one or
linear decrease in the valuation of work RVUs, we believe that since
the two components of work are time and intensity, significant
decreases in time should be appropriately reflected in the work RVU.
Intraservice and total time ratios using the aggregate time values of
current CPT codes 32405 and 77012 suggest a significantly lower work
RVU; however, we did not believe a decrease from the current aggregate
value of 32405 and 77012 was warranted. We noted that we believe there
is some overlap in physician work and time for the two current
services, and that the recommended increase to 4.00 does not
appropriately recognize this overlap. Therefore, we proposed a work RVU
of 3.18, which is the sum of the work RVUs of the two base codes.
We proposed the RUC-recommended direct PE inputs without
refinement.
We received public comments on Lung Biopsy-CT Guidance Bundle (CPT
code 32408). The following is a summary of the comments we received and
our responses.
Comment: A commenter disagreed with our valuation methodology,
stating that it inappropriately relies on time-based ratios. The
commenter stated this methodology is flawed and inaccurately treats all
components of the physician time as having identical intensity and is
incorrect. In addition, the commenter suggested it lacks the rigor of
the survey
[[Page 84612]]
process and RUC panel evaluation. The commenter stated that CMS does
not provide any supporting rationale or clinical information for the
proposed work RVU of 3.18 other than debating survey times, primarily
the intraservice time and total time ratios for this service, then
justifying the proposed work RVU with the work RVU sum of deleted code
32405 and imaging code 77012.
The commenter also states that CMS overlooked the compelling
evidence rationale for why this service is presently misvalued, and
that cancer treatment protocols have evolved significantly to require
more definitive tissue diagnosis including biomolecular marker
profiles. The new code 32408 has increased the total time and the
intensity/complexity, warranting the RUC-recommended work RVU of 4.00
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 time have been unaccounted
for in a recommended RVU, then we believe it is appropriate to account
for that change in establishing work RVUs since the statute explicitly
identifies time as one of the two elements of the work RVUs. Please see
above for our discussion of compelling evidence rationale. We do
consider changes in technology, patient population, etc., insofar as
they affect the time and intensity of the service under review.
However, we do not specifically address the RUC's compelling evidence
criteria in our rulemaking since it is outside the purview of the code
valuation framework stipulated by statute. In addition, we reiterate
that our proposal for this code was based on our analysis which
indicated that there is some overlap in the work described in the two
base services CPT codes 32405 and 77012. We continue to believe that a
work RVU that is in excess of the aggregate work RVU of these two codes
would result in an overestimation of intensity.
After consideration of the comments, we are finalizing the work RVU
and direct PE inputs for CPT code 32408 as proposed.
(13) Atrial Septostomy (CPT Codes 33741, 33745, 33746)
Septostomy procedures are performed on extremely small newborns and
neonates with severe forms of congenital heart disease and are
lifesaving/temporizing procedures that do not provide definitive
therapy to these critically ill patients. These procedures are not
typical of the Medicare population and are of low volume. CPT code
92992 (Atrial septectomy or septostomy; transvenous method, balloon
(e.g., Rashkind type) (includes cardiac catheterization)) and CPT code
92993 (Atrial septectomy or septostomy; blade method (Park septostomy)
(includes cardiac catheterization)), are carrier-priced codes. These
services were not formally designated as potentially misvalued in the
CY 2019 PFS final rule (83 FR 59500), but we did make mention that the
RUC had signaled its intention to review these two codes. Both services
were referred to the CPT Editorial Panel by the specialty societies who
indicated that CPT code 92992 may not have included related imaging
guidance, and also commented that CPT code 92993 was antiquated and
rarely performed. The CPT Editorial Panel deleted both CPT codes and
proposed to replace them with the following new CPT codes.
CPT code 33741 (Transcatheter atrial septostomy (TAS) for
congenital cardiac anomalies to create effective atrial flow, including
all imaging guidance by the proceduralist, when performed, any method
(e.g., Rashkind, Sang-Park, balloon, cutting balloon, blade)), is one
of three codes intended to replace the two deleted Septostomy codes.
For CPT code 33741, the RUC recommended an RVU only crosswalk to CPT
code 33340 (Percutaneous transcatheter closure of the left atrial
appendage with endocardial implant, including fluoroscopy, transseptal
puncture, catheter placement(s), left atrial angiography, left atrial
appendage angiography, when performed, and radiological supervision and
interpretation), which has a work RVU of 14.00. The RUC recommended 20
minutes of preservice evaluation time, 15 minutes of preservice
positioning time, 15 minutes preservice scrub/dress/wait time, 55
minutes intraservice time and 45 minutes immediate postservice time,
for 150 minutes total time. We proposed the RUC-recommended work RVU of
14.00 and physician times without refinement.
CPT code 33745 (Transcatheter intracardiac shunt (TIS) creation by
stent placement for congenital cardiac anomalies to establish effective
intracardiac flow, all imaging guidance by the proceduralist when
performed, left and right heart diagnostic cardiac catherization for
congenital cardiac anomalies, and target zone angioplasty, when
performed (e.g., atrial septum, Fontan fenestration, right ventricular
outflow tract, Mustard/Senning/Warden baffles); initial intracardiac
shunt) is another new procedure code proposed by the CPT Editorial
Panel. The service is currently performed on neonate infants to
children with severe forms of congenital heart disease, by having a
stent implanted inside of an infant's beating heart (and not within a
blood vessel). This stent replaces the methods described in the deleted
atrial septostomy codes utilizing the balloon and blade method. The RUC
recommended 25 minutes preservice evaluation time, 15 minutes
preservice positioning time, 15 minutes preservice scrub/dress/wait
time, 92 minutes intraservice time and 60 minutes immediate postservice
time, for 207 minutes total time. The RUC recommended 20.00 work RVUs
for CPT code 33745. We proposed to adopt the RUC-recommended work RVUs
and physician times.
CPT code 33746, (Transcatheter intracardiac shunt (TIS) creation by
stent placement for congenital cardiac anomalies to establish effective
intracardiac flow, all imaging guidance by the proceduralist when
performed, left and right heart diagnostic cardiac catherization for
congenital cardiac anomalies, and target zone angioplasty, when
performed (e.g., atrial septum, Fontan fenestration, right ventricular
outflow tract, Mustard/Senning/Warden baffles); each additional
intracardiac shunt location (List separately in addition to code for
primary procedure)), is the add-on code to the proposed new procedure
CPT code 33745, for 60 minutes of physician intraservice time. The RUC
recommended a work RVU of 10.50 for CPT code 33746. This value for the
add-on code, in comparison to the recommended work value of 20.00 RVUs
with 92 minutes/intraservice time and 207 minutes of total time for CPT
code 33745, appears to be unsupportable given the 60 minutes of
additional physician intraservice time. We proposed a work RVU of 8.00
for add-on CPT code 33746, which is the 25th percentile
value from the survey and of similar valuation from reference CPT code
93592 (Percutaneous
[[Page 84613]]
transcatheter closure of paravalvular leak; each additional occlusion
device (List separately in addition to code for primary procedure)).
This family of CPT codes are facility-only services and have no
direct PE inputs.
We received public comments on the proposed values for the Atrial
Septostomy CPT codes 33741, 33745, 33746. The following is a summary of
the comments we received and our responses.
Comment: Commenters were supportive of CMS proposing the work RVUs
as recommended by the AMA RUC for CPT code 33741, at 14.00, and for CPT
code 33745, at 20.00. Commenters disagreed with CMS proposing 8.00 work
RVUs for CPT code 33746, that differs from the AMA RUC recommended
value of 10.50. Commenters did not believe that the work RVU of 8.00
from CPT reference code 93592 (also an add-on code with the same amount
of physician time), and from the survey's 25th-percentile
work RVU value adequately reflected the resources involved in
furnishing the service and suggested instead the survey's
50th-percentile median value of 10.50 RVUs due to the
intensity of the work in CPT code 33746, which involves the typical
patient who is a small child or infant. The commenters stated that add-
on code 33746 is not intended as an extension of an initial stent
procedure described by CPT code 33745 and that CPT code 33746 is the
placement of a second stent where the work is more intense than the
primary procedure, CPT code 33745.
Response: For the new proposed CPT codes 33741 and 33745, the AMA
RUC-recommended work RVUs values are considered higher in relationship
to the physician times to perform the procedures and they note that
this higher relationship is due to these procedures' higher than
typical work intensity. The surveyed work RVU for CPT code 33741 at the
25th-percentile was 10.99 but the AMA RUC-recommended value
was 14.00, which was lower than the 50th-percentile median
value of 17.00 RVUs and about midpoint between these upper and low
quartiles. The surveyed work RVU at the 25th-percentile for
CPT code 33745 was 20.00 which the AMA RUC recommended.
The surveyed work RVU for add-on code CPT code 33746 at the 25th-
percentile was 8.00 but the AMA RUC recommended the work RVU of 10.50
from the 50th-percentile median value, based on rationale
similar to the rationale discussed above. For CPT code 33746, on the
measure of physician time alone for 60 minutes we see comparable add-on
codes with the identical amounts of physician time, valued at much less
than their recommended 10.50 work RVUs, and much less than the CMS'
referenced CPT code 93592's 8.00 work RVUs. Seeing that AMA RUC
surveyed work RVU at the 25th percentile yielded a value of
8.00 and that our comparator CPT code 93592 is also valued at 8.00 for
60 minutes of physician time, we continue to believe that 8.00 work
RVUs is the correct value for CPT code 33746.
After consideration of the comments, we are finalizing the work RVU
for CPT code 33741, CPT code 33745, and CPT code 33746, as proposed.
(14) Percutaneous Ventricular Assist Device Insertion (CPT Codes 33995,
33990, 33991, 33992, 33997, and 33993)
In May 2019, the CPT Editorial Panel approved the revision of four
codes to clarify the insertion and removal of right and left heart
percutaneous ventricular assist devices (PVAD), and the addition of two
codes to report insertion of PVAD venous access and removal of right
heart PVAD. These codes were surveyed with 000-day global periods and
reviewed at the October 2019 RUC meeting.
We proposed the RUC-recommended work RVUs for all six codes in the
family. We proposed a work RVU of 6.75 for CPT code 33990 (Insertion of
ventricular assist device, percutaneous, including radiological
supervision and interpretation; left heart, arterial access only), a
work RVU of 6.75 for CPT code 33995 (Insertion of ventricular assist
device, percutaneous, including radiological supervision and
interpretation; right heart, venous access only), a work RVU of 8.84
for CPT code 33991 (Insertion of ventricular assist device,
percutaneous, including radiological supervision and interpretation;
left heart, both arterial and venous access, with transseptal
puncture), a work RVU of 3.55 for CPT code 33992 (Removal of
percutaneous left heart ventricular assist device, arterial or arterial
and venous cannula(s), separate and distinct session from insertion), a
work RVU of 3.00 for CPT code 33997 (Removal of percutaneous right
heart ventricular assist device, venous cannula, separate and distinct
session from insertion), and a work RVU of 3.10 for CPT code 33993
(Repositioning of percutaneous right or left heart ventricular assist
device, with imaging guidance, at separate and distinct session from
insertion).
Stakeholders contacted CMS regarding the valuation of the codes in
this family following the arrival of the RUC recommendations. They
stated that the RUC recommendations did not accurately reflect the work
time of these procedures, which they stated to be increasing due to the
adoption of new technology. The stakeholders requested that CMS propose
to maintain the current work RVUs for the codes in this family and to
crosswalk the work RVU of the new codes to existing codes.
We disagreed with the stakeholders and proposed the RUC-recommended
work RVUs for each code in this family as noted previously. We noted
that in this case where the surveyed work times for the existing codes
are decreasing and the utilization of CPT code 33990 is increasing
significantly (quadrupling in the last 5 years), we have reason to
believe that practitioners are becoming more efficient at performing
the procedure, which, under the resource-based nature of the RVU
system, lends support for proposing the RUC's recommended work RVUs.
Although the incorporation of new technology can sometimes make
services more complex and difficult to perform, it can also have the
opposite effect by making services less reliant on manual skill and
technique. We disagreed with the stakeholders that the incorporation of
this new technology would necessarily be grounds for maintaining the
current work RVU, as improvements in technology are commonplace across
many different services and are not specific to this procedure. As
detailed earlier, we also have reason to believe that the improved
technology has led to greater efficiencies in the procedure which,
under the resource-based nature of the RVU system, lends further
support for proposing a lower work RVU for the existing CPT codes.
The RUC did not recommend and we did not propose any direct PE
inputs for this facility only code family. We proposed a 000-day global
period for all six codes as surveyed by the RUC.
We received public comments on the codes in the Percutaneous
Ventricular Assist Device Insertion family. The following is a summary
of the comments we received and our responses.
Comment: Several commenters supported the CMS decision to propose
the RUC-recommended work RVUs for each code in the family and
recommended that CMS finalize the proposal.
Response: We appreciate the commenters' support for our proposals.
Comment: A commenter stated that the RUC recommendations included
in the PFS proposed rule did not accurately reflect the full work
associated with percutaneous ventricular assist device (PVAD)
procedures. The commenter stated that
[[Page 84614]]
the RUC recommendations do not reflect increases in intra-procedure
time resulting from the increased usage of SmartAssist technology and
that if work value reductions continue over multiple years, it will
impede physician adoption of these new technologies, resulting in a
negative impact on patient access.
Response: We appreciate the information provided by the commenter
and we share in their concerns regarding the need to maintain patient
access to these services. However, as we stated in the proposed rule,
we have reason to believe that practitioners are becoming more
efficient at performing the procedures, which, under the resource-based
nature of the RVU system, gives support for proposing the RUC's
recommended work RVUs. We disagree with the commenter that the
incorporation of this new technology would necessarily be grounds for
maintaining the current work RVU, as improvements in technology are
commonplace across many different services and are not specific to this
procedure. We continue to believe that the RUC-recommended work RVUs
are the most accurate valuations for the codes in this family.
After consideration of the public comments, we are finalizing our
proposed work RVUs for the codes in the Percutaneous Ventricular Assist
Device Insertion family. We did not propose and we are not finalizing
any direct PE inputs for this facility only code family.
(15) Esophagogastroduodenoscopy (EGD) With Biopsy (CPT Code 43239)
In the CY 2019 PFS final rule (83 FR 59500), CPT code 43239
(Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single
or multiple) was publicly nominated for review under the potentially
misvalued code initiative. As requested, the specialty societies
conducted a survey for the April 2019 RUC meeting. The RUC survey
results showed that the current work RVU of 2.39, which is below the
survey 25th percentile work RVU of 2.50, accurately reflects
the physician work for CPT code 43239.
We proposed to maintain the current work RVU of 2.39 as recommended
by the RUC. We proposed the RUC-recommended direct PE inputs for CPT
code 43239 without refinement.
We received public comments on Esophagogastroduodenoscopy (EGD)
with Biopsy (CPT code 43239). The following is a summary of the
comments we received and our responses.
Comment: The commenters all agreed with the CMS proposal to
maintain the current work RVU of 2.39 as recommended by the RUC. The
commenters also all agreed with the CMS proposal of the RUC-recommended
direct PE inputs with without refinement.
Response: We appreciate the commenters' support for CMS proposing
the RUC recommendation for CPT code 43239.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 2.39 for CPT code 43239. We are also
finalizing the RUC-recommended direct PE inputs for CPT code 43239
without refinement.
(16) Colonoscopy (CPT Code 45385)
In the CY 2019 PFS final rule (83 FR 59500), CPT code 45385
(Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other
lesion(s) by snare technique) was publicly nominated for review under
the potentially misvalued code initiative. As requested, the specialty
societies conducted a survey for the April 2019 RUC meeting. The RUC
survey results showed that the current work RVU of 4.57, which is
slightly above the survey 25th percentile work RVU of 4.50,
accurately reflects the physician work for CPT code 45385.
We proposed to maintain the current work RVU of 4.57 as recommended
by the RUC. We proposed the RUC-recommended direct PE inputs for CPT
code 45385 without refinement.
We received public comments on Colonoscopy (CPT code 45385). The
following is a summary of the comments we received and our responses.
Comment: The commenters all agreed with the CMS proposal to
maintain the current work RVU of 4.57 as recommended by the RUC. The
commenters also all agreed with the CMS proposal of the RUC-recommended
direct PE inputs with without refinement.
Response: We appreciate the commenters' support for our proposal to
adopt the RUC recommendation for CPT code 45385.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 4.57 for CPT code 45385. We are also
finalizing the RUC-recommended direct PE inputs for CPT code 45385
without refinement.
(17) Transrectal High Intensity Focused US Prostate Ablation (CPT Codes
55880)
In May 2019, the CPT Editorial Panel established a new code to
report ablation of malignant prostate tissue with high intensity
focused ultrasound (HIFU), including ultrasound guidance. For CPT code
55880, we did not propose the RUC recommendation to use the survey
median work RVU of 20.00 to value this service because we believe total
time ratios to the two key reference codes, CPT codes 55840
(Prostatectomy, retropubic radical, with or without nerve sparing) and
55873 (Cryosurgical ablation of the prostate (includes ultrasonic
guidance and monitoring)) indicate that this value is somewhat
overstated and does not accurately reflect the physician time, and
because an analysis of all 090-global period codes with similar time
values indicates that this service is overvalued.
We proposed a work RVU of 17.73 based on a crosswalk to CPT code
69930 (Cochlear device implantation, with or without mastoidectomy)
which has similar total time and identical intraservice time values and
is more consistent with other codes of similar time. We proposed the
RUC-recommended PE inputs without refinement.
We received public comments on Transrectal High Intensity Focused
US Prostate Ablation (CPT code 55880). The following is a summary of
the comments we received and our responses.
Comment: Commenters noted that, for CPT code 55880, the RUC
recommended the survey 25th percentile work RVU of 20.00, not the
survey median work RVU, as it is misstated in the proposed rule.
Response: We regret the error, and we note that the RUC indeed
recommended the survey 25th percentile work RVU.
Comment: In response to this section, the RUC commented 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, making distinctions in the different
types of physician time, which are ``CMS/Other'' time source,
``Harvard'' time source, and ``RUC'' time source (from physician
surveys). The RUC suggested CMS use valid survey data and review the
actual relativity for all elements (physician work, time, intensity and
complexity) when developing work values for services and not foster
flawed methodologies.
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
[[Page 84615]]
associated with codes play important roles in PFS ratesetting in their
comparativeness to each other, in establishing work RVUs. The PFS is
grounded in and reliant on the original relativity of the RBRVS, and
then as services, codes and values evolve over the years, the PFS
statute contemplates maintaining and building on that base-level of
relativity. If we were to question the assumption that previously
recommended work times had routinely been over- or underestimated, this
would undermine the basis for 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 do not believe we can apply different validation weights
to any of these sources of time values while remaining consistent with
our obligation to consider time and intensity as these are currently
reflected in the fee schedule. They are all physician time 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 the current relative accuracy of a time value.
We believe that, over the years as more codes are being reviewed
and examined, the entire collective fee schedule of procedure codes
should align in a very reliable and accurate relative value system
reflecting each code's relativity with respect to other codes (in their
work RVUs, in their procedure times, and in their work intensities). 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 before deciding on the one we find
most appropriate. Our review of code values under the PFS 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 maintain the accurate relative
relationships in terms of time, work, and intensity measurements. In
some cases, where there are marked improvements in medical techniques
and technologies, we may find efficiencies in physician's work for
certain services that warrant decreases in physician's times, but we
also recognize that some improvements may introduce greater complexity
and either an increase in intensity and/or 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
clinically relevant relatedness (or non-relatedness) of procedure codes
to each other in establishing more refined work RVUs for PFS services.
Also note that physician times considered to be ``RUC'' physician times
as they are listed in the RUC database are not always necessarily AMA
RUC surveyed times. We may have adjusted AMA RUC surveyed times in our
annual review of all HCPCS codes; and the same can be said of times
that the AMA labels as ``Harvard'' or ``CMS/Other'' physician times.
Comment: Many commenters stated that the proposed work RVU was too
low to adequately reflect the work, skill and complexity required for
this procedure. Commenters were concerned about patient access, stating
that a significant number of Medicare beneficiaries with prostate
cancer will not have access to this procedure. Commenters encouraged
CMS to finalize the RUC-recommended work RVU of 20.00. Commenters
stated that CMS did not provide any supporting rationale or clinical
information for the proposed work RVU of 17.73 other than debating
survey times, primarily the total time ratios between a service that is
not currently covered to the two key reference codes, then justifying
our proposed work RVU with a crosswalk to CPT code 69930. Commenters
stated that this crosswalk is flawed in that it was surveyed 12 years
ago, and it is clinically a very different procedure. A commenter
suggested CPT code 42420 (Excision of the parotid tumor or parotid
gland) with a work RVU of 19.53 as a more appropriate crosswalk as it
is a more intense procedure than our proposed crosswalk CPT code 69930.
Response: Our proposed work RVU of 17.73 is not solely derived from
time ratios. Our analysis included comparisons to other codes of
similar time values as well as to codes with similar numbers of the
total number of post-op visits, as well as a consideration of the RUC-
recommended key reference services. These factors all indicated a work
RVU lower than the recommended 20.00. Comparison of relative intensity
values further indicates this RVU is somewhat overvalued. Our proposed
value of 17.73 produces an intensity value of 0.066, which is very
similar to the intensity value for our crosswalk CPT code 69930, which
is 0.067. We disagree that the patient populations of these two codes
are too different; the description and vignettes of CPT code 69930 do
not indicate that this is primarily a pediatric procedure. Further, we
reiterate that, 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. We continue to
believe the time values and relative intensity of this procedure
indicate that a work RVU of 17.73 is a more accurate valuation, and we
are finalizing this work RVU as proposed.
After consideration of the public comments, we are finalizing as
proposed a work RVU of 17.73, as well as the RUC-recommended direct PE
inputs without refinement.
(18) Computer-Aided Mapping of Cervix Uteri (CPT Code 57465)
In September 2019, the addition of CPT code 57465 (Computer-aided
mapping of cervix uteri during colposcopy, including optical dynamic
spectral imaging and algorithmic quantification of the acetowhitening
effect (List separately in addition to code for primary procedure)) was
approved by the CPT Editorial Panel to report computer-aided mapping of
cervix uteri during colposcopy. The RUC recommended the survey median
work RVU of 0.81 for this service.
We proposed the RUC-recommended value of 0.81 for CPT code 57465.
We also proposed the RUC-recommended direct PE inputs for this code.
We solicited comment on a new medical supply indicated on the PE
spreadsheet submitted by the RUC. A ``computer aided spectral imaging
system (colposcopy) disposal speculum'' was noted in the RUC PE meeting
materials. This name suggests it is digital. However, on the actual
invoice submitted, the supply item in question was listed as a
``disposable medium speculum'' with no mention of a spectral imaging
system or a digital component. We researched this speculum and could
not find any evidence that it has a digital component. Therefore, we
proposed to change the name of this new supply item to ``disposable
speculum, medium'' (SD337) to reflect the actual product on the invoice
submitted. We sought clarification as to what aspect of the
[[Page 84616]]
speculum is digital or if a cheaper, non-digital speculum would
suffice. We noted for example that the vaginal specula (SD118) supply
has a CY 2021 price of $1.12 and we were able to find disposable medium
specula readily available online for a price of roughly $1.00. We
proposed the new SD337 supply at the $5.80 price as listed on the
invoice submitted in the RUC materials and sought comment as to why
other disposable speculums at a lower price would not be typical for
this procedure.
We received public comments on the Computer-Aided Mapping of Cervix
Uteri code family (CPT code 57465). The following is a summary of the
comments we received and our responses.
Comment: Commenters were overall in support and appreciated CMS
proposing the RUC-recommended work RVU and the direct PE inputs for
code 57465. We also received comments with additional information on
the SD337 supply item in question. Commenters stated that in order for
the map to be successfully generated, there are stringent technical
requirements of the vaginal speculum that require it to be attached to
the optical head of the system. Commenters stated that the specula are
therefore custom designed to meet performance standards, and are an
integral part of the imaging system. One commenter noted that the
speculum referenced is typical. The coating on the plastic that
enhances the image is necessary, and without its light reflection on
plastic interferes with the image processing.
Response: We appreciate the additional information provided from
commenters and the commenters' agreement with the proposed name change
and that the item referenced is typical for the service noted.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 0.81 for CPT code 57465. We are also
finalizing the proposed RUC-recommended direct PE inputs for this code.
We are finalizing the new SD337 supply at the $5.80 price as listed on
the invoice submitted in the RUC materials based on the public comments
submitted. To clarify the nature of the supply, we are renaming SD337
to ``digital imaging speculum'' to reflect what the commenters stated
would be more accurate.
(19) Colpopexy (CPT Codes 57282 and 57283)
The CPT codes 57282 (Colpopexy, vaginal; extra-peritoneal approach
(sacrospinous, iliococcygeus)) and 57283 (Colpopexy, vaginal; intra-
peritoneal approach (uterosacral, levator myorrhaphy)) were identified
by the RUC Relativity Assessment Workgroup as services performed less
than 50 percent of the time in the inpatient setting yet include
inpatient hospital E/M services within the global period and the 2018
Medicare utilization is over 5,000. This code family was surveyed and
reviewed for the January 2020 RUC meeting. For CY 2021, the RUC
recommended a work RVU of 13.48 for CPT code 57282, and a work RVU of
13.51 for CPT code 57283.
We disagreed with the RUC-recommended work RVUs for the CPT code
family of 57282 and 57283. We proposed a work RVU of 11.63 for CPT code
57282, and also proposed to maintain the current work RVU of 11.66 for
CPT code 57283. For CPT code 57283, we based our disagreement on the
total time ratio between the current time of 349 minutes and the
recommended time established by the survey of 231 minutes. This ratio
equals 66 percent, and 66 percent of the current work RVU of 11.66 for
CPT code 57283 equals a work RVU of 7.70. When we reviewed CPT code
57283, we found that the recommended work RVU was higher than other
codes with similar time values. This is supported by the reference CPT
codes we compared to CPT code 57283 with 90 minutes of intraservice
time; reference CPT code 19350 (Nipple/areola reconstruction) has a
work RVU of 9.11 with 229 minutes of total time, and reference CPT code
47563 (Laparoscopy, surgical; cholecystectomy with cholangiography)
which has a work RVU of 11.47 with 238 minutes of total time. Although
we did 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 noted that we believe that since the two components of
work are time and intensity, significant decreases in time should be
reflected in decreases to work RVUs. The recommendation from the RUC
acknowledged that the time had decreased for CPT code 57283, and also
noted that there has been an increase in intensity due to a change in
technique and knowledge necessary to perform the service. In the case
of CPT code 57283, we noted that we believe it would be more accurate
to propose maintaining the current work RVU of 11.66 instead of the
RUC-recommended work RVU of 13.51 to account for these decreases in the
surveyed work time while still accounting for the increase in
intensity. We also noted that the intensity of CPT code 57283 would
nearly double by maintaining the proposed work RVU of 11.66, due to the
significant decreases in surveyed work time, which we believe supported
the RUC's contention that the intensity of this code has increased over
time.
For CPT code 57282, we disagreed with the RUC-recommended RVU of
13.48. We noted that the significant decrease in total time for code
57282 suggests an RVU lower than 13.48. Although we disagreed with the
RUC-recommended work RVU, we concurred that the relative difference in
work between CPT codes 57282 and 57283 is equivalent to the RUC-
recommended interval of 0.03 RVUs. We noted that we believe the use of
an incremental difference between these CPT 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. Therefore, we proposed a work RVU of 11.63 for
CPT code 57282, based on the RUC-recommended interval of 0.03 RVUs
below our proposed work RVU of 11.66 for CPT code 57283.
We proposed the RUC-recommended direct PE inputs for the CPT code
family of 57282 and 57283 without refinement.
We received public comments on the Colpopexy code family (CPT codes
57282 and 57283). The following is a summary of the comments we
received and our responses.
Comment: The commenters disagreed with our proposal to value CPT
code 57282 using an incremental methodology, and stated that the
proposal inaccurately treats all components of the physician time as
having identical intensity. The commenters would prefer that CMS
finalize the RUC-recommended value rather than values derived by
increments. Moreover, commenters stated that CMS proposed the RUC work
RVU increment (0.03) between CPT codes 57282 and 57283 for this code
family, yet disagreed with the RUC-recommended work RVU.
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 noted that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service.
[[Page 84617]]
Comment: Commenters stated that the RUC recommendation for CPT code
57282 was based on robust survey results and requested that CMS adopt
the RUC-recommended work values. The commenters stated that the current
work value and time for CPT code 57282 were derived from the Harvard
studies, and therefore, are not resource based. Commenters stated that
they could not support comparing the original Harvard value of this
service, which is over 25 years old and whose source is unknown, to
time and work derived from a recent survey. Commenters stated that CPT
code 57282 has never been surveyed by the RUC and the IWPUT for the
current times and work RVU (0.014) are inappropriately low for this
intense major surgical procedure, not that much higher than the
intensity for pre-service scrub/dress/wait time, which strongly implies
the current total times are inflated relative to the current work RVU
and not valid for comparison to the new times. Commenters stated that
the increased intra-service time can be attributed to the support
sutures being placed at multiple points of attachment, which was not
done in the past. Commenters stated that the largest difference in the
total time comes from the hospital visit time assigned by Harvard in
1992.
Response: We agree that it is important to use the recent data
available regarding time, and we acknowledge that when many years have
passed between when work 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 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 underestimated or
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 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 want to reiterate that we believe it would be irresponsible
to ignore changes in time based on the best data available and that we
are statutorily obligated to consider both time and intensity in
establishing work RVUs for PFS services. For additional information
regarding the use of old work time values in our methodology, we refer
readers to our discussion of the subject in the CY 2017 PFS final rule
(81 FR 80273 through 80274).
Comment: We received several comments regarding the decrease in
total times for CPT codes 57282 and 57283. For CPT code 57282, a few
commenters stated that the largest difference in the total time comes
from the hospital visit time assigned by Harvard in 1992, which makes
CMS' rationale to recommend a lower work RVU based on the ``significant
decrease in total time'' completely flawed and unjustified. For CPT
code 57283, the commenters disagreed that the decreased total time
should result in a lower work RVU than the RUC recommendation, and
stated that although the current times for CPT code 57283 have
decreased according to the RUC survey data, the overall intensity and
complexity has increased significantly.
Response: For CPT codes 57282 and 57283, we disagree with the
commenters 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
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. Were we to disregard intensity altogether, the work RVUs
for all services will 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. 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).
Comment: Some comments stated that the proposed rule did not
discuss the RUC's compelling evidence rationale for why CPT codes 57282
and 57283 are presently undervalued, suggesting that CMS missed
considering this rationale. Commenters stated that there has been a
change in the physician work necessary to perform these services based
on a change in technique and knowledge of the problem. Commenters
stated that there has been a change in technology due to functional MRI
studies which have increased what is known about pelvic organ prolapse
and what structures are important to successful repair. Some commenters
went on to describe the extent of dissection required and the change in
technique which is now standardized when performing CPT codes 57282 and
57283.
Response: We agree with the commenters that due to changes in
technology for CPT codes 57282 and 57283 we had reason to believe that
practitioners are becoming more efficient at performing these
procedures. While the incorporation of new technology can sometimes
make services more complex and difficult to perform, it can also have
the opposite effect by making services less reliant on manual skill and
technique. We do not agree with the commenters that a change in the
work pattern, and more dissections and greater use of sutures, would
necessarily be grounds for increasing the work RVUs as recommended by
the RUC, as improvements in technology are commonplace across many
different services and are not specific to these procedures. We also
have reason to
[[Page 84618]]
believe that the improved technology has led to greater efficiencies in
these procedures which, under the resource-based nature of the RVU
system, lends further support for the proposed work RVU of 11.63 for
CPT code 57282 and 11.66 for CPT code 57283. Also, compelling evidence
is not part of our statutory guidelines which require that the
valuation of codes should be based on time and intensity. We do
consider changes in technology, patient population, etc. insofar as
they affect the time and intensity of the service under review.
However, we do not specifically address the RUC's compelling evidence
criteria in our rulemaking since it is outside the purview of the code
valuation process stipulated by statute.
Comment: Several commenters stated that CMS is incorrect in
proposing a work RVU of 11.66 for CPT code 57283 based on referencing
codes 19350 and 47563. CPT code 19350, involves an incision made
externally on the breast to dissect a small amount of tissue at the
site where the nipple will be made. The surgical site is external to
the body without proximate anatomical structures that would be affected
by a subcutaneous incision. Also, CPT code 19350 can be performed under
local anesthesia and is performed in the office setting 19 percent of
the time. CPT code 47563 does not include the amount of dissection and
tissue reattachment that CPT code 57283 does, and the radiographic work
included in CPT code 47563 is not comparable to the intensity or risk
of CPT code 57283.
Response: 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 code
comparison or an appropriate crosswalk.
Comment: Commenters appreciated that CMS proposed to accept the
RUC-recommended direct PE inputs for CPT codes 57282 and 57283.
Response: We appreciated the commenters for their support.
After consideration of the public comments, we are finalizing the
proposed work RVU of 11.63 for CPT code 57282 and the work RVU of 11.66
for CPT code 57283. We are also finalizing the RUC-recommended direct
PE inputs for the codes in the Colpopexy family of codes (CPT codes
57282 and 57283) without refinement.
(20) Laparoscopic Colpopexy (CPT code 57425)
The CPT code 57425 (Laparoscopy, surgical, colpopexy (suspension of
vaginal apex)) was identified by the RUC Relativity Assessment
Workgroup as a service performed less than 50 percent of the time in
the inpatient setting yet includes inpatient hospital E/M services
within the global period and the 2018 Medicare utilization is over
5,000. This service was surveyed and reviewed for the January 2020 RUC
meeting.
We disagreed with the RUC-recommended work RVU of 18.02 for CPT
code 57425 and proposed to maintain the current RVU of 17.03 based on
the total time ratio between the current time of 404 minutes and the
recommended time established by the survey of 351 minutes. This was
supported by the reference CPT codes we compared to CPT code 57425 with
the same intraservice time; reference CPT code 26587 (Reconstruction of
polydactylous digit, soft tissue and bone) which has a work RVU of
14.50, and reference CPT code 20696 (Application of multiplane (pins or
wires in more than 1 plane), unilateral, external fixation with
stereotactic computer-assisted adjustment (e.g., spatial frame),
including imaging; initial and subsequent alignment(s), assessment(s),
and computation(s) of adjustment schedule(s)) which has a work RVU of
17.56. Both CPT codes 26587 and 20696 have 180 minutes of intraservice
time, which is equal to the 180 minutes of intraservice time in the RUC
recommendation for CPT code 57425, and over 400 minutes of total time.
The total time for CPT code 57425 decreased from 404 to 351 minutes and
the RUC did not appear to take this into account. Therefore, we
proposed to maintain the current work RVU of 17.03.
We proposed the RUC-recommended direct PE inputs for CPT code 57425
without refinement.
We received public comments on the Laparoscopic Colpopexy code
family (CPT code 57425). The following is a summary of the comments we
received and our responses.
Comment: The commenters disagreed that a decrease in total time for
CPT code 57425 should result in a lower work RVU than the RUC
recommendation since the intraservice time required to perform CPT code
57425 increased significantly. The commenters also stated that using a
total time ratio approach in lieu of the RUC survey data for CPT code
57425 is erroneous.
Response: For CPT code 57425, we disagree with the commenters 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 it is appropriate to account for that
change in establishing work RVUs since 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. Were we to disregard
intensity altogether, the work RVUs for all services would be developed
based solely on time values and that is definitively not the case, as
indicated by the many services that share the same time values but have
different work RVUs. 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).
Comment: Commenters stated that CMS did not discuss the RUC's
compelling evidence rationale in the proposed rule text for why CPT
code 57425 is presently undervalued, and suggested CMS missed
considering this rationale. The commenters further stated that the
surgical techniques and technology for CPT code 57425 have changed
drastically. Specifically, commenters stated that the technique has
been refined and is now much more standardized than when CPT code 57425
was last surveyed in 2003. This decreased the complication rate and has
changed the physician work. In addition, commenters stated that there
is a change in technology due to functional MRI studies which have
increased what is known about pelvic
[[Page 84619]]
organ prolapse and what is important for a successful repair. Some
commenters stated that the dissection is difficult and requires more
time, as shown in the RUC survey, for CPT code 57425.
Response: We agree with the commenters that due to a change in
technology for CPT code 57425 we had reason to believe that
practitioners are becoming more efficient at performing the procedure.
While the incorporation of new technology can sometimes make services
more complex and difficult to perform, it can also have the opposite
effect by making services less reliant on manual skill and technique.
We do not agree with the commenters that a change in the work practice
and new technology would necessarily be grounds for increasing the work
RVU to 18.02 as recommended by the RUC, as improvements in technology
are commonplace across many different services and are not specific to
this procedure. We also have reason to believe that the improved
technology has led to greater efficiencies in the procedure which,
under the resource-based nature of the RVU system, lends further
support for maintaining the current work RVU value of 17.03 for CPT
code 57425 as proposed. Also, compelling evidence is not part of our
statutory guidelines which require that the valuation of codes should
be based on time and intensity. We do consider changes in technology,
patient population, etc., insofar as they affect the time and intensity
of the service under review. However, we do not specifically address
the RUC's compelling evidence criteria in our rulemaking since it is
outside the purview of the code valuation process stipulated by
statute.
Comment: Some commenters stated that CMS is incorrect in proposing
the current work RVU of 17.03 for CPT code 57425 when referencing CPT
codes 26587 and 20696 because both procedures are performed on an
external part of the body. Commenters went on to describe how the
difficulty performing CPT codes 26587 and 20696 is not as great as
performing CPT code 57425. For CPT code 26587, the physician is
removing an external amount of tissue that includes bone and could be
considered a sixth toe or finger, and has little risk to other organs
or permanent disability. Commenters stated that there are not any close
major blood vessels or an entire nerve plexus that must be avoided with
CPT code 26587, while CPT code 57425 involves the placement of a
synthetic mesh which must be performed properly to avoid erosion into a
viscus, causing permanent long-term harm and multiple follow up
surgeries. In addition, commenters stated that CPT code 26587 is a low
volume Medicare procedure and was last reviewed by the RUC in 2001. CPT
code 20696 is fixating an external metal frame onto someone's leg,
which involves less risk and more space and visualization to perform
than CPT code 57425.
Response: 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 code
comparison or an appropriate crosswalk. We looked to CPT codes 26587
and 20696 as reference codes for comparison to CPT code 57425 based on
their total time ratios. Few other supporting codes with similar
intraservice time and total time were found. The current work RVU of
17.03 is closer to the higher end of the RVUs within this reference
code bracket that uses 26587 on the low end, and 20696 on the high end.
Comment: Commenters supported the CMS proposal of the RUC-
recommended direct PE inputs for CPT code 57425.
Response: We thank the commenters for their support.
After consideration of the public comments, we are finalizing
maintaining the current work RVU of 17.03 as proposed for CPT code
57425. We are also finalizing the RUC-recommended direct PE inputs for
the codes in the Laparoscopic Colpopexy family of codes (CPT code
57425) without refinement.
(21) Intravitreal Injection (CPT Code 67028)
CPT code 67028 (Intravitreal injection of a pharmacologic agent)
was identified via the RUC's Relativity Assessment Workgroup as a code
where the original valuation was based on a crosswalk code that had
since been revalued. The RUC recommended that CPT code 67028 should be
surveyed for the April 2019 RUC meeting. We proposed the RUC-
recommended work RVU of 1.44 for CPT code 67028.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Clean room/equipment by clinical staff'' (CA024)
activity from the RUC-recommended 5 minutes to 3 minutes for CPT code
67028, because 3 minutes is the standard time for this clinical labor
activity code, and we disagree that there would typically be a need for
2 additional minutes for cleaning, sterilizing, and re-packaging a
reusable eyelid speculum in a sterile package to prepare for its next
case. Additionally, 3 minutes is the standard time for cleaning the
room and cleaning the equipment; although we agreed that these cleaning
tasks would take place, we do not believe that the removal of the same
day E/M visit would result in the need for 2 additional minutes of
cleaning time. We noted that we are proposed to maintain the current
time for this clinical labor activity, which was previously finalized
in the CY 2011 PFS final rule at the standard value of 3 minutes (75 FR
73353). We also proposed to refine the equipment times to match the
change in clinical labor time.
We received public comments on CPT code 67028. The following is a
summary of the comments we received and our responses.
Comment: A commenter stated that they agreed with the CMS proposal
of the RUC-recommended work RVU of 1.44. However, the commenter
disagreed with the proposal to refine the clinical labor time for the
``Clean room/equipment by clinical staff'' (CA024) activity from the
RUC-recommended 5 minutes to 3 minutes. The commenter stated that the 5
minutes listed for time to clean the room/equipment was not increased
because of the absence of a same day E/M visit; rather, it was
increased to appropriately reflect the current time it takes to clean/
disinfect the room and equipment. The commenter stated that the eyelid
speculum is soaked in an antiseptic solution for a fixed period of
time, then scrubbed, repackaged, and sterilized in an autoclave, and
that an infection from an unsterile piece of equipment for this
intraocular procedure can directly lead to endophthalmitis which is
permanently blinding. The commenter also stated that they disagreed
with the CMS refinement of the equipment time for the vaccine
refrigerator (ED043) equipment since the medication must be logged into
an inventory tracking system and it is now typical for each physician
to hire a private temperature monitoring service that requires a
recurring fee.
Response: We disagree with the commenter regarding the refinements
to the direct PE inputs for CPT code 67028. As we stated in the
proposed rule, 3 minutes is the standard time for cleaning the room as
well as cleaning the equipment, not one or the other. Although we
appreciate the additional information stating that this cleaning time
is not associated with an E/M visit, we do not agree that 2 minutes of
additional clinical time would be
[[Page 84620]]
typical for this procedure, especially given that CPT code 67028
currently allocates the standard 3 minutes of clinical labor time for
cleaning activities. For the vaccine refrigerator (ED043) equipment,
the refinement to the equipment time was made to conform to the
refinement in clinical labor time associated with cleaning the room. We
also note that any fees associated with a monitoring service for the
refrigerator's temperature would be an indirect cost akin to office
rent and therefore would not be included in the direct PE inputs.
After consideration of the public comments, we are finalizing our
proposed work RVU of 1.44 and our proposed direct PE inputs for CPT
code 67028.
(22) Dilation of Eustachian Tube (CPT Codes 69705 and 69706)
In September 2019, the CPT Editorial Panel created two new codes,
CPT code 69705 (Nasopharyngoscopy, surgical, with dilation of
eustachian tube (i.e., balloon dilation); unilateral) and CPT code
69706 (Nasopharyngoscopy, surgical, with dilation of eustachian tube
(i.e., balloon dilation); bilateral) to describe the dilation of the
eustachian tube via surgical nasopharyngoscopy, unilateral and
bilateral. We proposed the RUC-recommended work RVUs of 3.00 and 4.27
for CPT codes 69705 and 69706, respectively. For the direct PE inputs,
we proposed the RUC-recommended values without refinement.
We received public comments on the Dilation of Eustachian Tube (CPT
codes 69705 and 69706). The following is a summary of the comments we
received and our responses.
Comment: Several commenters stated their support for CMS proposing
the RUC-recommended values without refinement.
Response: We thank commenters for their feedback and support.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for the codes in the Dilation of
Eustachian Tube family as proposed.
(23) X-Ray of Eye (CPT Code 70030)
CPT code 70030 (Radiologic examination, eye, for detection of
foreign body) was identified through an updated screen of CMS/Other
source codes with Medicare utilization over 20,000. We proposed the
RUC-recommended work RVU of 0.18 for this service. We proposed the RUC-
recommended direct PE inputs without refinement.
We received public comments on the X-Ray of Eye family (CPT code
70030). The following is a summary of the comments we received and our
responses.
Comment: A commenter appreciated CMS' acceptance of the RUC
recommendation for this code.
Response: We appreciate the support for our proposals.
After consideration of the public comments, we are finalizing the
proposed work RVU of 0.18 as well as the proposed direct PE inputs for
CPT code 70030.
(24) CT Head-Brain (CPT Codes 70450, 70460, and 70470)
In the CY 2019 PFS final rule (83 FR 59500 through 59503), a
stakeholder nominated CPT code 70450 (Computed tomography, head or
brain; without contrast material) as potentially misvalued, citing GAO
and MedPAC reports that suggest that work RVUs are overstated for
procedures such as these, and the specialty society surveyed family
codes 70460 (Computed tomography, head or brain; with contrast
material(s)) and 70470 (Computed tomography, head or brain; without
contrast material, followed by contrast material(s) and further
sections). We proposed the RUC recommendation to maintain the current
work RVUs of 0.85, 1.13, and 1.27 for CPT codes 70450, 70460, and
70470, respectively. For CPT code 70450, we note that the surveyed
times are nearly identical to the current times for these services, and
we believe that the RUC's reference to CPT code 70486 (Computed
tomography, maxillofacial area; without contrast material), which has
similar physician time and the same work RVU, is appropriate. For CPT
code 70460, we noted that the surveyed times are nearly identical to
the current times for these services, and we believe that the RUC's
reference to CPT code 70487 (Computed tomography, maxillofacial area;
with contrast material(s)), which has similar physician time and the
same work RVU is appropriate. Similarly, for CPT code 70470, we noted
that the surveyed times are nearly identical to the current times for
these services, and we believe that the RUC's reference to CPT code
70488 (Computed tomography, maxillofacial area; without contrast
material, followed by contrast material(s) and further sections), which
has similar physician time and the same work RVU, is appropriate. We
also noted that these codes are relatively consistently valued compared
to other codes with similar time values and a global period of XXX. We
proposed the RUC-recommended direct PE inputs without refinement.
We received public comments on the CT Head-Brain (CPT codes 70450,
70460, and 70470). The following is a summary of the comments we
received and our responses.
Comment: Commenters supported our proposal to adopt the RUC-
recommended work RVUs and PE inputs.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing as
proposed work RVUs of 0.85, 1.13, and 1.27 for CPT codes 70450, 70460,
and 70470 respectively.
(25) Screening CT of Thorax (CPT Codes 71250, 71260, 71270, and 71271)
In October 2018, AMA staff identified the CMS/Other Source codes
with 2017 Medicare utilization over 30,000. HCPCS code G0297 (Low dose
ct scan (ldct) for lung cancer screening) was identified. In January
2019, the RUC recommended to refer to CPT Editorial Panel to establish
a permanent code for this procedure. In May 2019, the CPT Editorial
Panel revised three codes and added one code to distinguish diagnostic
computed tomography, thorax from computed tomography, thorax, low dose
for lung cancer screening.
For CPT code 71250 (Computed tomography, thorax; without contrast
material), we did not propose the RUC recommendation to maintain the
current work RVU of 1.16 as we believe this does not accurately reflect
the reduction in physician work time, and because an analysis of all
XXX-global period codes with similar time values indicates that this
service is overvalued. Instead, we recommended proposing a work RVU of
1.08 based on the ratio of current to RUC-recommended intraservice
time. As support for this value, we note that it falls slightly below
CPT code 76391 (Magnetic resonance (e.g., vibration) elastography),
which has a work RVU of 1.10 and also has higher physician time values.
Similarly, for CPT code 71260 (Computed tomography, thorax; with
contrast material(s)), we did not propose the RUC recommendation to
maintain the current work RVU of 1.24 as we believe this does not
accurately reflect the reduction in physician time, and proposed a work
RVU of 1.16 based the ratio of current to RUC-recommended intraservice
time. Although we disagreed with the RUC-recommended work RVU, we
concurred that the relative difference between CPT codes 71250 and
71260 is equivalent to the RUC-recommended interval of 0.08 RVUs. As
stated previously, we noted
[[Page 84621]]
that we believe the use of an incremental difference between these CPT
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. We noted that the
proposed work RVU of 1.16 maintains the RUC-recommended interval of
0.08 additional RVUs above our proposed work RVU of 1.08 for CPT code
71250.
For CPT code 71270 (Computed tomography, thorax; without contrast
material, followed by contrast material(s) and further sections), we
did not propose the RUC recommendation to maintain the current work RVU
of 1.38 as we believed this does not accurately reflect the reduction
in physician time, and instead, we proposed a work RVU of 1.25 with a
crosswalk to CPT code 93284 (Programming device evaluation (in person)
with iterative adjustment of the implantable device to test the
function of the device and select optimal permanent programmed values
with analysis, review and report by a physician or other qualified
health care professional; multiple lead transvenous implantable
defibrillator system) and we supported this value by noting that it is
slightly higher than values suggested by the ratio of current to RUC-
recommended intraservice time For CPT code 71271 (Computed tomography,
thorax, low dose for lung cancer screening, without contrast
material(s)), we did not propose the RUC-recommended work RVU of 1.16,
but proposed a work RVU of 1.08 so that the value of this code is
consistent with that of CPT code 71250 as current code G0297 is valued
based on the value of CPT code 71250, and to maintain the relative
relationship among these codes. In the CY 2016 PFS final rule (80 FR
70974) we finalized that CPT code G0297 should be identically valued to
CPT code 71250.
We proposed the RUC-recommended direct PE inputs without refinement
for CPT codes 71250, 71260, and 71270. For the direct PE inputs for CPT
code 71271, we proposed 2 minutes for the clinical labor activity
CA011: ``Provide education/obtain consent'' rather than the RUC-
recommended 3 minutes to be consistent with other non-contrast
screening codes, and we proposed 4 minutes for the clinical labor
activity CA038 ``Coordinate post-procedure services'' rather than the
RUC-recommended 6 minutes to be consistent with other screening
services, and because we did not see any compelling evidence that this
service has changed significantly since G0297 was implemented for CY
2015 to warrant the recommended 2 additional minutes.
We received public comments on the codes in the Screening CT of
Thorax family. The following is a summary of the comments we received
and our responses.
Comment: A commenter disagreed with the use of intraservice time
ratios to account for changes in time, arguing that it negates CMS'
longstanding position that 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.
A commenter attributed the decreases in intra-service times for CPT
codes 71250 and 71270 to survey variation. The commenter stated that
reductions in pre and post-service time values do not necessarily
justify a reduction in physician work value as intraservice work has a
higher intensity than pre-service and post-service work. Additionally,
the commenter stated that at these lower ends of time in the RBRVS, it
is unreliable to draw conclusions based on single minute increments,
which may simply be a result of rounding to whole integers.
Response: While we agree that the surveyed intraservice times are
not substantially lower than they are currently, we disagree that the
differences in total time values are negligible or that they should not
be accounted for in work RVU. In addition, we note that we considered
the RUC-recommended values based on the relationship between work RVU
and time as well as through comparisons to other CPT codes of similar
time values. We continue to believe that in light of this analysis, the
RUC-recommended values are overestimations.
Comment: For CPT code 71250, a commenter disagreed with the use of
a comparison to a magnetic resonance (MR) code with higher physician
times, CPT code 76391 (Magnetic resonance (e.g., vibration)
elastography). The commenter stated that this is a suboptimal
comparison as CPT code 76391 involves work predominantly focused on a
single organ (the liver) with, in general, a single pathology
(fibrosis). In contrast, the commenter stated that CPT code 71250
requires evaluation of numerous structures in the thorax including the
heart, lungs, mediastinum, pleura and pleural space, bones, etc. which
can be affected by a multitude of pathologies. For CPT code 71260, the
RUC objected to the CMS statement that the proposed work RVUs maintain
the RUC-recommended relative difference between CPT codes 71250 and
71260, stating that time survey data and comparison codes, not ratios
and intervals, were used in arriving at the value of 1.24 for CPT code
71260.
Response: We reiterate that a comparison to all XXX-global period
codes with similar time values indicated that the RUC-recommended work
RVU was overestimated for CPT code 71250. While we recognize that the
RUC did not base its recommended valuation for CPT code 71260 on an
incremental relationship, we continue to believe the use of an
incremental difference between codes is a valid methodology for
considering appropriate values, especially in valuing services within a
family of revised codes where it is important to maintain appropriate
intra-family relativity.
Comment: For CPT code 71270, a commenter disagreed with the use of
a crosswalk to CPT code 93284 (Programming device evaluation (in
person) with iterative adjustment of the implantable device to test the
function of the device and select optimal permanent programmed values
with analysis, review and report by a physician or other qualified
health care professional; multiple lead transvenous implantable
defibrillator system) because these codes describe completely different
clinical work.
Response: 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 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.
Comment: For CPT code 71271, the RUC noted that HCPCS code G0297 is
CMS/Other sourced. Therefore, how the times and values were established
is unknown or flawed. The RUC also agreed that the physician work
involved in the new code for low-dose screening exam is comparable to
the diagnostic exam performed in CPT code 71250. While CMS finalized a
policy that HCPCS code G0297 should be identically valued to CPT code
71250 in the CY 2016 PFS final rule (80 FR 70974-70975), the G-code is
currently not valued the same. CPT code 71250 is currently valued
higher than HCPCS code G0297 because CPT code 71250 was revalued in
2016; its work RVU increasing from 1.02 to 1.16, however HCPCS code
G0297 was not revalued at that time and remains currently valued at
1.02. The RUC suggested CMS to accept a work RVU of 1.16 for CPT code
71271 and requests deletion of HCPCS code G0297. In the event this G-
code is
[[Page 84622]]
not deleted, the RUC requests that HCPCS code G0297 be crosswalked to
71271 and the same value and inputs be assigned.
Response: Our proposed work RVU of 1.08 for HCPCS code 71271 is
partly based on our assumption that this code has an identical work RVU
to CPT code 71250. Our proposed values will restore parity between the
two codes by increasing the work RVU for the former to match our
proposed value for the latter.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for the codes in the Screening CT of
Thorax family as proposed.
(26) X-Ray Bile Ducts (CPT Codes 74300, 74328, 74329, and 74330)
CPT codes 74300 (Cholangiography and/or pancreatography;
intraoperative, radiological supervision and interpretation) and 74328
(Endoscopic catheterization of the biliary ductal system, radiological
supervision and interpretation) were identified through a screen of
CMS/Other Source codes with 2017 Medicare utilization over 30,000. CPT
codes 74329 (Endoscopic catheterization of the pancreatic ductal
system, radiological supervision and interpretation) and 74330
(Combined endoscopic catheterization of the biliary and pancreatic
ductal systems, radiological supervision and interpretation) were
included as part of the same code family and the family was surveyed.
The codes describe x-rays of the liver, pancreas, and bile ducts. They
are performed in facilities and have no direct PE inputs.
We disagreed with the RUC-recommended work RVU of 0.32 for CPT code
74300. We proposed a work RVU of 0.27 based on a crosswalk to CPT code
74021 (Radiologic examination, abdomen; 3 or more views), one of the
reference services from the RUC survey and that has an intraservice
time of 4 minutes, nearly identical to the RUC's recommendation of 5
minutes of intraservice time for CPT code 74300. The proposal was
supported by CPT code 93922 (Limited bilateral noninvasive physiologic
studies of upper or lower extremity arteries) with a work RVU of 0.25
and an intraservice time of 5 minutes and a total time of 10 minutes.
These times are nearly identical to the RUC's recommended intraservice
of 5 minutes and total time of 10 minutes for CPT code 74300.
We proposed the RUC-recommended work RVU of 0.47 for CPT code 74328
(Endoscopic catheterization of the biliary ductal system, radiological
supervision and interpretation), with an intraservice time of 10
minutes and a total time of 20 minutes.
We disagreed with the RUC's recommended work RVU of 0.50 for CPT
code 74329 (Endoscopic catheterization of the pancreatic ductal system,
radiological supervision and interpretation). We proposed a crosswalk
to CPT code 74328 at a work RVU of 0.47 because the intraservice and
total times for both codes are identical and we noted that we believe
the work involved in the biliary ductal and pancreatic ductal systems
is similar.
We disagreed with the RUC's recommended work RVU of 0.70 for CPT
code 74330 (Combined endoscopic catheterization of the biliary and
pancreatic ductal systems, radiological supervision and interpretation)
and we proposed a work RVU of 0.56 based on the proposal of the RUC's
recommendation for CPT code 74328 to create internal consistency within
the code family, based on our time ratio methodology and further
supported by a reference to CPT code 93228 (External mobile
cardiovascular telemetry with electrocardiographic recording,
concurrent computerized real time data analysis and greater than 24
hours of accessible ECG data storage (retrievable with query) with ECG
triggered and patient selected events transmitted to a remote attended
surveillance center for up to 30 days; review and interpretation with
report by a physician or other qualified health care professional) with
nearly identical and total time values to CPT code 74330.
The RUC did not recommend and we did not propose any direct PE
inputs for these codes.
We received public comments on the X-Ray Bile Ducts code family.
The following is a summary of the comments we received and our
responses.
Comment: A few commenters did not support the proposal of 0.27 work
RVUs for CPT code 74300, stating that based on the RUC survey data, the
overall intensity and complexity to perform CPT code 74300 is greater
than that required to perform the key reference service of CPT code
74021. Commenters also stated that the crosswalk to CPT code 74021 was
inappropriate due to the service time difference between the codes.
Response: Based on the survey results, we disagree that the overall
intensity and complexity to perform CPT code 74300 is greater than that
required to perform CPT code 74021. Based on the survey results, only
the technical skill component of intensity suggested that CPT code
74300 may be more intense than CPT code 74021, with 67 percent of
respondents stating that CPT code 74300 was more intense. Comparing CPT
code 74300 to its key reference service CPT code 74321, 50 percent of
survey respondents reported that CPT code 74300 had identical
intensity, 50 percent of survey respondents reported physical effort as
having identical or less intensity, and 67 percent of survey
respondents reported psychological stress as having identical or less
intensity. We also disagree that the crosswalk to CPT code 74021 was
inappropriate because the RUC used CPT code 74021 as a key reference
survey in its survey. Thus, we are finalizing 0.27 work RVUs for CPT
code 73400 as proposed.
Comment: A few commenters supported the CMS proposal of 0.47 work
RVUs for CPT code 74328.
Response: We appreciate commenters' support and are finalizing 0.47
work RVUs for CPT code 74328 as proposed.
Comment: A few commenters did not support the proposal of 0.47 work
RVUs for CPT code 74329. These commenters asserted that the work
associated with assessing the pancreatic ductal system in CPT code
74329 and is more intense and complex than CPT code 74328. They also
stated that codes with identical times are not assigned the same RVU
because both the AMA RUC and CMS recognize that procedures with
equivalent times do not have equivalent intensities.
Response: While it may be true that codes that have identical times
can have different intensities, because the survey did not use CPT code
74328 as a key reference service for the valuation of CPT code 74329,
we do not believe the survey results provided sufficient evidence to
support the assertion that CPT code 74329 is more intense. Thus, we are
finalizing 0.47 work RVUs for CPT code 74329 as proposed.
Comment: A few commenters did not support the proposal of 0.56 work
RVUs for CPT code 74330. These commenters were concerned that we did
not apply our time ratio methodology correctly. The commenters also
disagreed with the use of time ratio methodologies for work valuation
for these services. Commenters stated that this use of time ratios is
not a valid methodology for the valuation of physician services.
Response: To clarify, we used an intraservice time ratio and not a
total time ratio. We disagree with the commenters and continue to
believe that the use of time ratios is one of several appropriate
methods for identifying potential work RVUs for PFS services.
We have responded to concerns about our methodology earlier in this
section
[[Page 84623]]
of this final rule. For additional information regarding the use of use
of time ratios 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), as well as a longer discussion in the CY
2017 PFS final rule (81 FR 80273 through 80274). Thus, we are
finalizing 0.56 work RVUs for CPT code 74330 as proposed.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the X-Ray Bile Ducts family as proposed. We
did not propose and we are not finalizing any direct PE inputs for
these codes.
(27) Venography (CPT Codes 75820 and 75822)
The review of CPT code 75820 (Venography, extremity, unilateral,
radiological supervision and interpretation) was prompted by the
Relativity Assessment Workgroup Medicare utilization screen of over
20,000 claims in a year. CPT code 75820 currently has a work RVU of
0.70 with 14 minutes of total time. This service involves the
supervision and interpretation of a contrast injection and imaging of
either the upper or lower extremity. For CPT code 75820, the RUC
recommended 12 minutes preservice time, 20 minutes intraservice time,
10 minutes postservice time and 42 minutes of total time. The specialty
societies' survey at the 25th percentile yielded a 1.05 work RVU, and
it is the RUC's recommended work value. We proposed the RUC-recommended
value for CPT code 75820.
CPT code 75822 (Venography, extremity, bilateral, radiological
supervision and interpretation) is reviewed as part of the family of
codes included with CPT code 75820. CPT code 75822 has a current 1.06
work RVU and 21 minutes of total time. The RUC recommended 15 minutes
preservice time, 30 minutes intraservice time, 12 minutes postservice
time and 57 minutes of total time, and the survey's 25th percentile
work RVU of 1.48. The service is similar to CPT code 75820, except that
this CPT code is bilateral, involving the supervision and
interpretation of a contrast injection and imaging of both of either
the upper or lower extremities. The RUC recommended 1.48 work RVU and
57 minutes of total time for CPT code 75822. We proposed these RUC-
recommended values for CPT code 75822.
We received public comments on the Venography services CPT codes
75820 and 75822. The following is a summary of the comments we received
and our responses.
Comment: The commenters appreciated CMS' proposal of the AMA RUC
recommended RVU values.
Response: We appreciate the commenters' support for our proposal to
adopt the RUC recommendations for CPT codes 75820 and 75822.
After consideration of the public comments, we are finalizing the
RUC recommendations for CPT codes 75820 and 75822, as proposed.
(28) Introduction of Catheter or Stent (CPT Code 75984)
The RUC recommended reviewing CPT code 75984 (Change of
percutaneous tube or drainage catheter with contrast monitoring (e.g.,
genitourinary system, abscess) radiological supervision and
interpretation) after more utilization data was available, which
resulted in this service being surveyed and reviewed for the April 2019
RUC meeting. We proposed the work RVU of 0.83 as recommended by the
RUC. We proposed the RUC-recommended direct PE inputs for CPT code
75984 without refinement.
We received public comments on the Introduction of Catheter or
Stent family (CPT code 75984). The following is a summary of the
comments we received and our responses.
Comment: Commenters supported the CMS proposal of 0.83 for the work
RVU as recommended by the RUC, as well as the proposal of the direct PE
inputs without refinements.
Response: We appreciate the commenters' support for our proposal to
adopt the RUC recommendations for CPT code 75984.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 0.83 for CPT code 75984. We are also
finalizing the RUC-recommended direct PE inputs for CPT code 75984
without refinement.
(29) Medical Physics Dose Evaluation (CPT Code 76145)
The CPT Editorial Panel created CPT code 76145 (Medical physics
dose evaluation for radiation exposure that exceeds institutional
review threshold, including report), which is a new PE-only code.
Because of the high amount of clinical staff time and the fact that
there are not analogous services, the PE Subcommittee requested that
the specialty societies conduct a PE survey. In addition, they stated
that the service is stand-alone, meaning that the medical physicist
works independently from a physician and there are no elements of the
PE that are informed by time from a physician work survey. Following
the meeting, the specialty societies developed a PE survey which was
reviewed and approved by the Research Subcommittee. We proposed the
RUC-recommended direct PE inputs for CPT code 76145 without refinement.
The following is a summary of the comments we received and our
responses.
Comment: Commenters supported the proposal to implement the RUC-
recommended direct PE inputs for CPT code 76145 without refinement.
Response: We appreciate the support for our proposals from the
commenters.
Comment: Commenters recommended that CMS remove the Deficit
Reduction Act (DRA) cap designation for CPT code 76145, stating that
this is not an imaging service but a patient-specific organ dose
assessment and evaluation performed by a medical physicist that can be
utilized across a broad spectrum of cardiology and interventional
radiology services. These dose calculations are commonly associated
with interventional procedures and not diagnostic imaging studies.
Response: We are persuaded by the commenters that this service does
not describe an imaging service as defined for purposes of the ``DRA
cap,'' also known as the ``OPPS cap,'' under section 1848(b)(4)(B) of
the Act. We note it is more akin to physics consultation services
similar to those described by CPT codes 77331 (Special dosimetry (e.g.,
TLD, microdosimetry) (specify), only when prescribed by the treating
physician), 77336 (Continuing medical physics consultation, including
assessment of treatment parameters, quality assurance of dose delivery,
and review of patient treatment documentation in support of the
radiation oncologist, reported per week of therapy), and 77370 (Special
medical radiation physics consultation). Therefore, we are not
including CPT code 76145 within the codes that are subject to the
adjustment under section 1848(b)(4) will not be subject to the OPPS
cap.
After consideration of the public comments, we are finalizing the
direct PE inputs for CPT code 76145 as proposed and removing this code
from the OPPS Cap List.
(30) Ophthalmic Ultrasound Anterior Segment (CPT Code 76513)
CPT code 76513 (Ophthalmic ultrasound, diagnostic; anterior segment
ultrasound, immersion (water bath) B-scan or high resolution
biomicroscopy) was identified by the RUC due to volume growth,
attributed to improved equipment. The CPT Editorial Panel has
[[Page 84624]]
since revised this code to clarify that it is either unilateral or
bilateral (it was previously unilateral). It was then surveyed. The
code describes a test for glaucoma and is performed on the same day as
an office/outpatient evaluation and management (O/O E/M) visit. The CPT
and RUC removed CPT code 76513 from its former code family, creating a
family of 1 service.
In reviewing this code, we noted that the recommended total time is
decreasing from 19 minutes to 15 minutes (21 percent) while the RUC-
recommended work RVU is decreasing from 0.66 to 0.60 (9 percent). We
did not believe the RUC-recommended work RVU appropriately accounts for
the substantial reductions in the surveyed work times for the
procedure. Although we did 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 noted we believe that since
the two components of work are time and intensity, significant
decreases in time should be appropriately reflected in decreases to
work RVUs. In the case of CPT code 76513, we noted that we believe that
it would be more accurate to propose a work RVU of 0.53 based on a
crosswalk to CPT code 74230 (Radiologic examination, swallowing
function, with cineradiography/videoradiography, including scout neck
radiograph(s) and delayed image(s), when performed, contrast (e.g.,
barium) study) with identical intraservice and total times.
For the direct PE inputs, we proposed to make two refinements to
the clinical labor times of CPT code 76513. We proposed a reduction of
1 minute for the clinical labor task CA009: ``Greet patient, provide
gowning, ensure appropriate medical records are available'' because the
EHR information should already be linked from the preceding O/O E/M
visit and the entry of information would be redundant and paid under
indirect PE. We also proposed a reduction of 1 minute for the clinical
labor task CA011: ``Provide education/obtain consent'' to be consistent
with the time for this clinical labor task for the services in CPT code
76513's former code family.
We received public comments on CPT code 76513. The following is a
summary of the comments we received and our responses.
Comment: A few commenters disagreed with the CMS proposed work RVU
of 0.53 and stated that CMS should finalize the RUC-recommended work
RVU value of 0.60. Commenters stated that CPT code 76513 is more
complex and intense than the proposed crosswalk of CPT code 74320 due
to a wider number of potential diagnoses, and requires placing a probe
with water bath on the patient's cornea, which is more uncomfortable
than swallowing contrast, requiring extra skill and effort to obtain
appropriate images.
Response: We appreciate the additional information from the
commenters regarding the intensity of CPT codes 76513 and 74320. In
light of this additional information, we agree with the commenters that
the diagnostic ophthalmic ultrasound service described by 76513 may
have a higher intensity than the radiologic examination service
described by CPT code 74320. Therefore, we are finalizing the RUC-
recommended work RVU of 0.60 for CPT code 76513.
Comment: A few commenters stated that the crosswalk or methodology
used in the original valuation of CPT code 76513 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.
Response: We appreciate the commenters' concerns regarding our
interpretation of older work time sources and their use in the code
valuation process for establishing work RVUs for these services. We
agree that it is important to use the most recent data available
regarding work times, and we acknowledge 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. We have responded to concerns about our methodology
earlier in this section. For additional information regarding the use
of old work time values that were established many years ago and have
not since been reviewed; 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: A few commenters disagreed with our reduction of 1 minute
of clinical labor task CA009: ``Greet patient, provide gowning, ensure
appropriate medical records are available'' and stated that our
assumption that the EHR information should already be linked from the
preceding O/O E/M visit was incorrect. Commenters stated that it is not
typical for the EHR and the ultrasound equipment to be linked and that
staff time is required to enter the data into the ultrasound equipment
software and ensure that it matches the information in the main EHR and
therefore it would be inappropriate to reduce the RUC-recommended staff
time.
Response: While we appreciate the additional information that the
EHR and the ultrasound equipment are not linked, we believe that the
staff time required to enter the data into the equipment constitutes a
data entry task and paid under indirect PE. Therefore, we are
finalizing our proposed reduction of 1 minute of clinical staff time
for CPT code 76513.
Comment: A few commenters also disagreed with our proposed
reduction of 1 minute for the clinical labor task CA011: ``Provide
education/obtain consent.'' Commenters stated that this test involves
placement of a device directly onto the ocular surface, with a risk of
corneal abrasion and associated loss of vision. Thus, a clear and
detailed explanation of what to expect was necessary to reduce patient
anxiety and increase the patient's ability to cooperate with the exam.
Thus, patient consent would require the RUC-recommended 3 minutes.
Response: We appreciate the additional information from the
commenters regarding the steps that are involved in providing education
and obtaining consent and we agree with the commenters that the
additional minute of time would be required. Thus, we are finalizing
the RUC-recommended 3 minutes of clinical staff time.
After consideration of the public comments, we are not finalizing
our proposed work RVU of 0.53 for CPT code 76513 and are instead
finalizing the RUC-recommended work RVU of 0.60. We are finalizing the
direct PE inputs as proposed, with the exception of the proposed
reduction of 1 minute for the clinical labor task CA011 as detailed
above.
(31) Dual-Energy X-Ray Absorptiometry (CPT Code 77080)
We did not make any proposals regarding CPT code 77080 (Dual-energy
X-ray absorptiometry (DXA), bone density study, 1 or more sites; axial
skeleton (e.g., hips, pelvis, spine)) in the proposed rule. Following
the publication of the CY 2021 PFS proposed rule, a stakeholder
contacted CMS and stated that Medicare payment for the CPT code 77080
has declined in the nonfacility setting from $140 in 2006 to
approximately $40 in 2020. The stakeholder stated that due to policies
proposed in the CY 2021 PFS proposed rule, payment for DXA would be
subject to an eight percent decrease bringing the payment rate to
$36.78. The stakeholder
[[Page 84625]]
suggested CMS to address DXA payment in the CY 2021 PFS final rule.
In response to the stakeholder, we note that the payment decreases
for CPT code 77080 were produced by two factors: The adoption of the
current PE methodology during CY 2007-2010 and the code's last RUC
review in CY 2014. Payment for CPT code 77080 has been stable at
approximately $40 for the last 6 years. We also note that our
ratesetting methodology proposed a modest increase in total RVUs for CY
2021 for CPT code 77080. However, the proposed decrease of 10.6 percent
to the CF resulted in the proposed payment for CPT code 77080
decreasing by approximately eight percent. This decrease would result
from implementation of budget neutrality adjustment to the PFS
conversion factor, and would not be caused by any policy changes
associated with CPT code 77080. We remind stakeholders that, in
accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions
to the RVUs under the PFS cause expenditures for the year to change by
more than $20 million, we are statutorily obligated to make budget
neutrality adjustments to ensure that expenditures do not increase or
decrease by more than $20 million. For additional information, we
direct readers to the Regulatory Impact Analysis (section VIII.) of
this rule. We may consider future rulemaking regarding CPT code 77080
under the misvalued code initiative if there is continued stakeholder
concern regarding the valuation of this service.
(32) Radiation Treatment Delivery (CPT Code 77401)
CPT code 77401 (Radiation treatment delivery, superficial and/or
ortho voltage, per day) was identified by the RUC Relativity Assessment
Workgroup through a screen of high-volume growth, for services with
2017 Medicare utilization of 10,000 or more that has increased by at
least 100 percent from 2012 through 2017. In January 2019, the RUC
recommended to refer to this service to the CPT Editorial Panel to
better define the set of services associated with delivery of
superficial radiation therapy (SRT).
We proposed the following direct PE refinements: A reduction of 2
minutes for the clinical labor task CA024: ``Clean room/equipment by
clinical staff,'' to the standard 3 minutes, and we did not propose to
include the new equipment item ER119 ``Lead Room,'' as we noted that we
did not have enough information on what this equipment item contains,
and we are requesting more information to allow us to determine if it
is more accurately priced as direct or indirect PE. CPT code 77401 is a
PE only code and we proposed to maintain the current work RVU of 0.00.
We received public comments on the Radiation Treatment Delivery
(CPT code 77401). The following is a summary of the comments we
received and our responses.
Comment: Many commenters stated that while they still believe more
should be done with regard to the work RVUs for 77401 in order to make
this treatment option more fair and equitable, the commenters greatly
appreciate CMS' willingness to increase the PE RVUs for SRT. The
commenters stated that this is a much needed increase for the modality
as a whole and should result in an increase in availability for
patients that truly need access to this technology for non-melanoma
skin cancer and keloids.
Response: We appreciate the support for our proposals from the
commenters.
Comment: Commenters provided information on the recommended new
equipment item ER 119 (``Lead Room''), noting that all states require a
lead shielded room for radiation therapy. Some commenters said that
physicians can also utilize this room for other services when not using
the SRT. Some commenters stressed that although the lead lined room may
be used for other services when there is no patient receiving
superficial radiation therapy (SRT), there should not be payment for
the lead room when SRT is not being performed.
Response: We continue to believe that, given the fact that the
lead-shielded room may be used for other types of services as indicated
by commenters, this item is not allocable specifically to CPT code
77401, but is rather a general practice cost akin to office rent
expenses. Therefore, we consider the lead-shielded room to be indirect
PE, and we are finalizing the direct PE inputs as proposed, without
including the lead lined room.
Comment: Commenters disagreed with the proposed reduction of 2
minutes for the clinical labor task CA024: ``Clean room/equipment by
clinical staff'', to the standard 3 minutes. Commenters stated that the
2 minutes were added by the RUC because the room and the equipment must
be cleaned after each use and this has increased at least 5 fold under
COVID. Commenters stated that the standard 3 minutes is for the room
only and is insufficient to do both and that CMS should restore the 2
minutes that were removed.
Response: The commenters stated that 5 minutes are necessary to
clean both the room and the equipment; however, the standard time of 3
minutes already assumes that both the room and equipment will be
cleaned. Therefore, we are finalizing this PE refinement as proposed.
After consideration of the public comments, we are finalizing the
direct PE inputs for this service as proposed.
(33) Proton Beam Treatment Delivery (CPT Codes 77520, 77522, 77523, and
77525)
In April 2018, the RUC's Relativity Assessment Workgroup (RAW)
identified CPT code 77522 (Proton treatment delivery; simple, with
compensation) and CPT code 77523 (Proton treatment delivery;
intermediate) as contractor-priced Category I CPT codes with 2017
estimated Medicare utilization over 10,000 services. Although the RAW
agreed with the specialty society that this family of codes should
remain contractor priced, the RUC determined that these services should
be surveyed for PE. CPT codes 77520 (Proton treatment delivery; simple,
without compensation) and 77525 (Proton treatment delivery; complex)
were added to the family and the group was surveyed for PE for the
April 2019 RUC meeting.
We noted in the proposed rule that we encountered significant
difficulties in reviewing the recommended direct PE inputs for the
codes in the Proton Beam Treatment Delivery family. These difficulties
were largely associated with determining a price for the two new
equipment items in the code family, the Proton Treatment Vault (ER115)
and the Proton Treatment Delivery System (ER116). These equipment items
had extraordinarily high prices of $19,001,914 and $30,400,000
respectively on the invoices submitted with the code family. By way of
comparison, the highest equipment price currently existing in our
database for CY 2021 is the ``SRS system, Linac'' (ER082) equipment
item at $4,233,825. We noted concerns that establishing equipment
pricing for the proton treatment vault and delivery system at a rate
that is so much higher than anything else in our equipment database
could distort relativity.
We also noted concerns about the information provided on the
submitted invoices used for the pricing of these two new equipment
items. The invoices for both the Proton Treatment Vault and the Proton
Treatment Delivery System contained building construction costs such as
asphalt paving, masonry and carpentry expenses, drywall packaging, and
the installation of electrical
[[Page 84626]]
systems. We noted that we understood that these proton treatment
equipment items are extremely capital-intensive and require the
construction of custom-built offices to house the equipment. However,
the expenses associated with constructing new office facilities fall
outside of our direct PE methodology, and would be more accurately
classified as a form of building maintenance or office rent under
indirect PE. We did not agree that construction costs should be
included as a form of direct PE because they are not individually
allocable to a particular patient for a particular service. Although we
agreed that the proton beam treatment practitioners do need to bear the
costs associated with the storage of this equipment, we noted that this
is a form of indirect PE under our methodology. Therefore, we noted
that we did not believe that it would serve the interests of relativity
to include these building construction costs for the proton treatment
equipment as a type of direct PE expense.
As a result, we proposed to maintain contractor pricing for CPT
codes 77520, 77522, 77523, and 77525 instead of proposing active
pricing for these services. We noted that we believe that maintaining
contractor pricing will allow the limited providers of these very
expensive services to adapt more quickly to shifts in the market-based
costs associated with the proton treatment equipment. The RUC similarly
expressed concern in its recommendations about the extremely high cost
of this equipment, agreed that these services were extremely hard to
value, and noted the difficulties that had taken place in surveying the
family of codes. The recommendations from the RUC also noted that
proton treatment is a rapidly changing technology and the change in the
treatment equipment often requires extensive modification to the vault.
We also noted that we believe that these frequent changes can be more
accurately captured through contractor pricing as opposed to the need
to update the pricing of the proton treatment equipment on an annual
basis.
As discussed in the proposed rule, if we were to propose active
pricing for the codes in this family, we believe that we would need to
remove the building construction costs from the Proton Treatment Vault
and the Proton Treatment Delivery System as forms of indirect PE, which
would substantially lower their overall equipment prices. We would also
refine the equipment times to the standard formula for highly technical
equipment, which would result in 3 minutes less time for each equipment
item (such as 14 minutes for all three equipment items in CPT code
77522).
We received public comments on the codes in the Proton Beam
Treatment Delivery family. The following is a summary of the comments
we received and our responses.
Comment: Many commenters supported the proposal to maintain
contractor pricing for CPT codes 77520, 77522, 77523, and 77525 instead
of proposing active pricing for these services. Commenters stated that
they applauded CMS for carefully considering the unintended
consequences of pricing high equipment cost items using the current CMS
methodology and agreed that contractor pricing will allow proton
therapy practitioners to adapt quickly to shifts in the market-based
costs associated with the proton treatment equipment. Commenters stated
that until there is a way to accurately reflect the price of this
advanced technology, they agreed with the proposal and requested that
CMS maintain contractor pricing for the proton treatment delivery
codes.
Response: We appreciate the support for our proposals from the
commenters.
Comment: One commenter stated that although they currently
supported the continuation of contractor pricing, the commenter also
could envision proton beam treatment pricing at some percentage of OPPS
rates (e.g., 95 percent of OPPS payment amount) as CMS looks to
potentially value PE RVUs using OPPS rates. The commenter stated that
while this rate might not adequately cover the PE component in some
larger facilities, it would allow continued support for other
facilities showing significant positive patient outcomes.
Response: We appreciate the feedback from the commenter regarding
the potential use of OPPS payment rates for PFS pricing.
Comment: One commenter disagreed with the CMS proposal to maintain
contractor pricing for CPT codes 77520, 77522, 77523, and 77525 and
recommended that CMS finalize the RUC recommendations. The commenter
stated that although it is not the purview of the RUC to make
recommendations about pricing and useful life of equipment, CMS should
accept the direct PE inputs for CPT codes 77520, 77522, 77523, and
77525 as submitted by the RUC.
Response: We disagree with the commenter and continue to believe
that the unique nature of the equipment costs associated with these
services poses problems for our PE methodology. We believe that
maintaining contractor pricing will incorporate these costs into the
payment rate while also allowing the limited practitioners of these
very expensive services to adapt more quickly to shifts in the market-
based costs associated with the proton treatment equipment.
After consideration of the comments, we are finalizing our proposal
to maintain contractor pricing for CPT codes 77520, 77522, 77523, and
77525.
(34) Immunization Administration (CPT Codes 90460, 90461, 90471, 90472,
90473, and 90474 and HCPCS Codes G0008, G0009, and G0010)
Especially in the context of the current PHE for COVID-19, it is
evident that consistent beneficiary access to vaccinations is vital to
public health. Many stakeholders have raised concerns regarding the
reductions in payment rates for vaccine administration services over
the past several years. The codes that describe these services have
generally been valued based on a direct crosswalk to CPT code 96372
(Therapeutic, prophylactic, or diagnostic injection (specify substance
or drug); subcutaneous or intramuscular). Because we proposed and
finalized reductions in valuation for that code for CY 2018 and because
the reductions in overall valuation have been subject to the multi-year
phase-in of significant reductions in RVUs, the payment rate for the
vaccine administration codes has been concurrently reduced.
In the CY 2020 PFS final rule, we acknowledged that it is in the
public interest to ensure appropriate resource costs are reflected in
the valuation of the immunization administration services that are used
to deliver vaccines, and noted that we planned to review the valuations
for these services in future rulemaking. For CY 2020, we maintained the
CY 2019 national payment amount for immunization administration
services described by HCPCS codes G0008 (Administration of influenza
virus vaccine), G0009 (Administration of pneumococcal vaccine), and
G0010 (Administration of hepatitis b vaccine) in the interim.
The RUC has recently resubmitted recommendations from 2009
regarding the appropriate valuation for the broader range of vaccine
administration services, including CPT codes 90460 (Immunization
administration through 18 years of age via any route of administration,
with counseling by physician or other qualified health care
professional; first or only component of each vaccine or toxoid
administered), 90471 (Immunization administration (includes
percutaneous, intradermal, subcutaneous, or intramuscular
[[Page 84627]]
injections); 1 vaccine (single or combination vaccine/toxoid)), and
90473 (Immunization administration by intranasal or oral route; 1
vaccine (single or combination vaccine/toxoid)). In its recommendation,
the RUC noted that the current RVUs assigned are directly crosswalked
from CPT code 96372 (like the vaccine administration G-codes had been)
and the resulting payment rates are substantially lower than current
Centers for Disease Control and Prevention (CDC) regional maximum
charges. The RUC also pointed out that appropriate payment for
immunization administration that reflects resource cost is critical in
maintaining high immunization rates in the United States, as well as
having the capacity to respond quickly to vaccinate against preventable
disease outbreaks.
We agreed with the RUC's assertions regarding the importance of
appropriate resource-based valuations for vaccine administration
services. We also recognized that the importance of these services is
increased in the context of the current PHE for COVID-19, especially
should there be a vaccine for this particular disease.
We reviewed and considered the 2009 RUC-recommended direct PE
inputs for CPT codes 90460-90474 (as well as the related G-codes) in
place of the existing policy, based on a crosswalk to CPT code 96372.
However, the RUC-recommended direct PE inputs from 2009 would result in
significant decreases in valuation for these 6 CPT codes, even compared
to the current crosswalk. At the time of the proposed rule, we did not
believe that either the existing crosswalk or the RUC recommendations
from over a decade ago reflect the relative resource costs associated
with these services. Without updated information to use in developing
rates specific to these codes based on direct PE inputs, and in
consideration of the importance of these services for Medicare
beneficiaries, as well as the public health concerns raised by
commenters, we believed that it would be most appropriate to value
these services using a crosswalk methodology that better reflects the
relative resources involved in furnishing all of these services.
Therefore, we proposed to crosswalk the valuation of CPT codes
90460, 90471, and 90473 and HCPCS codes G0008, G0009, and G0010 to CPT
code 36000 (Introduction of needle or intracatheter, vein). CPT code
36000 is a service with a nearly identical work RVU (0.18 as compared
to 0.17 for CPT codes 90460, 90471, and 90473) and a similar clinical
vignette. We noted that we believe that the additional clinical labor,
supply, and equipment resources associated with the furnishing of CPT
code 36000 more accurately capture the costs associated with these
immunization codes. We also noted that this crosswalk would result in
payment rates for vaccine administration services at approximately the
same CY 2017 rates that were paid prior to the revaluation of CPT code
96372, which had previously served as the basis of the crosswalk. We
noted that we believe that the proposed crosswalk is the most accurate
valuation of these services and would also serve to ensure the
appropriate relative resources involved in furnishing all of these
services is reflected in the payment for these critical immunization
and vaccination services in the context of the health needs of Medicare
beneficiaries.
Regarding the add-on codes associated with these services, CPT
codes 90461 (Immunization administration through 18 years of age via
any route of administration, with counseling by physician or other
qualified health care professional; each additional vaccine or toxoid
component administered), 90472 (Immunization administration (includes
percutaneous, intradermal, subcutaneous, or intramuscular injections);
each additional vaccine (single or combination vaccine/toxoid)), and
90474 (Immunization administration by intranasal or oral route; each
additional vaccine (single or combination vaccine/toxoid)), we noted
that the previous valuation methodology set their RVUs at approximately
half of the valuation for the associated base codes, described above.
Absent additional information, we proposed to maintain that approach by
valuing the three add-on codes at half of the RVUs of the
aforementioned crosswalk to CPT code 36000.
Finally, we proposed this valuation to apply to all of these
existing vaccine administration codes, using the valuation of CPT code
90471 for base codes and CPT code 90472 for add-on codes. We also noted
that should a vaccine for COVID-19 or other infectious disease become
available during CY 2021, we would anticipate applying the same
approach to valuing the administration of such vaccines, regardless of
whether separate coding for such services would need to be introduced.
We received public comments on the codes in the Immunization
Administration family. The following is a summary of the comments we
received and our responses.
Comment: Many commenters supported the proposal to crosswalk the
valuation of CPT codes 90460, 90471, and 90473 and HCPCS codes G0008,
G0009, and G0010 to CPT code 36000. Commenters stated that the current
vaccine administration rates do not adequately cover the costs of
purchasing, storing, monitoring, and administering vaccines and that
appropriate valuation and reimbursement for these services is critical
to ensuring widespread access to vaccines. Commenters agreed that the
current crosswalk does not recognize the resources needed to provide
the immunization procedure and that the proposed crosswalk to CPT code
36000 more accurately captures the direct clinical labor and resources
needed to perform immunizations.
Response: We appreciate the support for our proposals from the
commenters.
Comment: Many commenters supported the proposal to crosswalk the
valuation of CPT codes 90460, 90471, and 90473 and HCPCS codes G0008,
G0009, and G0010 to CPT code 36000 while also disagreeing with the
proposal to value the three add-on codes (CPT codes 90461, 90472, and
90474) at half of the RVUs of the aforementioned crosswalk to CPT code
36000. Commenters stated that the value of the work RVU for the add-on
Immunization Administration codes is not half of the base codes but
rather 88 percent of the value of the base codes. Commenters requested
that CMS apply the same magnitude relationship between the base and
add-on codes as in the previous valuation.
Response: We appreciate the feedback from the commenters regarding
the relationship between the base codes and add-on codes in this
family. After reviewing the issue and looking at the historic
relationship in payment rates for the base codes and add-on codes, we
agree with the commenters that the add-on codes have typically been
valued at 88 percent of the RVU of the base codes, not half of the
value. Therefore, we are finalizing the value of the three add-on codes
at 88 percent of the RVUs assigned to the immunization administration
codes.
Comment: Several commenters stated that they supported the
proposals for this code family; however, they noted that there has been
some confusion about the actual payment amount because RVUs for the
CMS-issued immunization administration HCPCS ``G'' codes are not listed
in the files sent to the contractors nor made available to the public.
The commenters suggested CMS to include the crosswalked values for the
immunization codes in the RVU files to ensure that the crosswalk is
accurately implemented, and that stakeholders can identify the rate
[[Page 84628]]
Medicare will pay for vaccine administration.
Response: HCPCS codes G0008, G0009, and G0010 are used to bill
Medicare for administration of the preventive vaccines described under
section 1861(s)(10) of the Act. They are not technically valued under
the PFS, as they do not fit within the statutory definition of
physicians' services in section 1848(j)(3) of the Act. CMS established
HCPCS codes G0008, G0009, and G0010 to describe the administration of
these preventive vaccines. As a result, no RVUs or payment amounts are
shown for these codes in the PFS tables, and payment for them is not
made under the PFS. While it is true that we have established payment
rates for these codes using a crosswalk to the values of codes listed
on the PFS, these three HCPCS codes do not have PFS rates themselves.
Comment: Several commenters requested that in the future CMS should
ensure a long-term sustainable valuation for vaccine administration by
severing any linkage to other non-related CPT codes. The commenters
recommend CMS consider determining the value of vaccine administration
codes based on actual, updated physician time and PE inputs for vaccine
administration.
Response: We agree with the commenters that it would be helpful to
be able to value the vaccine administration codes using direct PE
inputs instead of relying on crosswalks to other services; however, as
we mentioned in the proposed rule, we reviewed and considered the 2009
RUC-recommended direct PE inputs and found that they would result in
significant decreases in valuation for the six vaccine administration
CPT codes, even compared to the current crosswalk. We would welcome the
results of an updated formal review of these services as well as any
additional information that may be helpful for improved valuation.
Comment: Several commenters supported the proposal and further
suggested CMS to use its available authority to make this proposed
change in vaccine administration valuation effective prior to January
1, 2021. Commenters stated that timely and appropriate payment for
immunization administration that reflects resource cost is critical in
maintaining high immunization rates in the United States as well as
having the capacity to respond quickly to vaccinate against preventable
disease outbreaks.
Response: While we share the concerns of the commenters regarding
the importance of appropriate payment for vaccine administration, this
final rule takes effect beginning for CY 2021. We did not propose to
modify payment policies for these services for any earlier timeframe
and we continue to believe that the payment policies that we finalized
last year were appropriate for these services.
Comment: One commenter stated that Medicare pays a travel allowance
to cover the transportation and personnel expenses for specimen
collection from an individual or a patient in an inpatient facility
other than a hospital. The commenter recommended that CMS establish a
travel fee for providers/practitioners of current adult vaccines and
for COVID-19 vaccinations to support access to immunizations, following
the same approach and with the same value as established for specimen
collection.
Response: Travel and transportation fees are considered to be a
form of indirect PE under our methodology and would not be included as
a direct cost. Therefore, we do not believe it would be appropriate to
establish a separate payment for these costs under the PFS or
otherwise.
Comment: One commenter disagreed with the rationale that CMS
provided to crosswalk the PE RVUs for this set of codes to equal those
for CPT code 36000. The commenter stated that CPT code 36000 is a
bundled service that is not recognized for payment by CMS, nor has it
ever been reviewed by the RUC; and this code includes a multispecialty
visit pack that would be a duplication of resources for the vaccination
codes, and that also includes an angiocatheter, which would never be
used for vaccine administration. The commenter stated that arbitrarily
assigning a specific PE RVU to this set of vaccination codes was
another example of CMS's failure to consistently apply the same
standards to all codes in the PFS, and as such, takes payment for
resources away from one group of health care providers and assigns it
to another group of health care providers.
Response: We note that our proposal to crosswalk valuation for the
vaccine administration services was based on methodological approaches
that have long been used for valuation under the PFS and reflect our
best estimate of resource cost for these services at the time of the
proposal. As we mentioned in the proposed rule, we reviewed and
considered the 2009 RUC-recommended direct PE inputs and found that
they would result in significant decreases in valuation for the six
vaccine administration CPT codes, even compared to the current
crosswalk. We would welcome the results of an updated formal review of
these services as well as any additional information that may be
helpful for improved valuation.
After considering the comments, we are not finalizing our proposal
to crosswalk the valuation of CPT codes 90460, 90471, and 90473 and
HCPCS codes G0008, G0009, and G0010 to CPT code 36000. We are instead
finalizing a policy to maintain the CY 2019 payment for all nine of the
services in this family, including the add-on codes. We note that
maintaining the CY 2019 rates for these services will also maintain the
historical relationship between the base administration codes and the
add-on CPT codes 90461, 90472, and 90474, instead of our proposal to
value the add-on codes at 50 percent of the base codes. As previously
discussed, in our proposal, we approximated a cost for these services,
but acknowledge the concerns that were raised in the comments we
received and will continue to seek additional information that
specifically reflects the resource costs and inputs that should be
considered to establish payment for these services on a long-term
basis. Again, we would welcome the results of an updated formal review
of these services as well as any additional information that may be
helpful for valuation in the immediate future.
(35) Liver Elastography (CPT Code 91200)
CPT code 91200 (Liver elastography, mechanically induced shear wave
(e.g., vibration), without imaging, with interpretation and report) was
targeted for review through the RUC's new technology/new services
screen. The RUC reviewed 3 years of available Medicare claims data
(2016, 2017 and 2018) and surveyed the code for the January 2020
meeting.
We proposed the RUC-recommended work RVU of 0.21. We also proposed
the RUC-recommended direct PE inputs for CPT code 91200 without
refinement.
We received public comments on CPT code 91200. The following is a
summary of the comments we received and our responses.
Comment: Several commenters supported the proposal of the RUC-
recommended work RVU and direct PE inputs for CPT code 91200.
Response: We appreciate the support for our proposals from the
commenters.
Comment: Several commenters discussed the clinical benefits of
liver elastography treatments using Fibroscan equipment. Commenters
stated that this service expedites patient diagnosis and keeps care
centered in the office while allowing for non-invasive screenings of
this population to identify those
[[Page 84629]]
patients with advanced fibrosis and cirrhosis who are at high risk for
complications and costly care, allowing for earlier successful
outpatient intervention. Commenters recommended that Fibroscan
reimbursement should be increased, not decreased, which will allow
expanded utilization and access for more GI physicians providing more
widespread use of this effective and non-invasive practice based
technology.
Response: We appreciate the additional information provided by
commenters regarding the clinical benefits of the technology. However,
the PFS is a resource-based payment system and we agree with the RUC
that the resources associated with furnishing this service have
decreased over time as the technology has become more widespread.
Comment: Several commenters disagreed with the proposed price for
the Fibroscan with printer (ER101) equipment. Commenters stated that
the proposed price of $102,495 is not supported by customer invoices or
StrategyGen's market research and that there is no available data that
supports a 31 percent reduction in equipment pricing. The commenters
recommended pricing the ER101 equipment at $136,449 based on the
submission of seven new invoices. The commenters stated that the
average cost on the invoices was $180,000, which included hardware
costs and service contracts, and their recommended pricing of $136,449
included the cost for CAP, which is an integral FibroScan component and
not an optional addition. This price also included training and an S+
probe.
Response: We appreciate the additional information provided by the
commenters, especially the submission of invoices for use in pricing
the Fibroscan equipment. Based on this additional information, we agree
with the commenters that the CAP is an integral part of the Fibroscan
equipment and should be included in the price of the equipment.
However, training expenses are an indirect cost under our PE
methodology and therefore are not included in the price of the
equipment. We also noted that the S+ probe was only included on 2 of
the 7 submitted invoices and as a result we do not believe that this is
typically part of the cost of the Fibroscan equipment. (By contrast,
the CAP option was present in all cases.) Therefore, we are finalizing
an update in the price of the Fibroscan (ER101) to $125,096.21 based on
an average of six invoices, as we were unable to use one invoice since
it did not have individually itemized costs.
Comment: Several commenters stated that Medicare and commercial
payor utilization data for CPT code 91200 demonstrate that the usage of
FibroScan in the physician office setting is well below 50 percent.
Commenters stated that at a 50 percent usage rate, each FibroScan would
generate 6,250 exams per year, or 24 per day, resulting in 3,656,250
total national exams per year but the Medicare database identifies
39,556 actual in-office claims in 2018 and 51,000 in 2019, resulting in
less than 1 scan per day. Commenters stated that CMS can assign an
equipment utilization rate of lower than 50 percent and the change is
warranted by actual claims data. Commenters requested that CMS
establish an equipment utilization rate of 10 percent for CPT code
91200.
Response: We disagree with the commenters that an equipment
utilization rate of 10 percent would be typical for the Fibroscan. 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. It would distort relativity to assign
a utilization rate of 10 percent for the Fibroscan equipment which
would have the same effect as a fivefold increase in the price of the
equipment. We continue to agree with the RUC's recommended direct PE
inputs for CPT code 91200.
After considering the comments, we are finalizing the RUC-
recommended work RVU of 0.21 and the RUC-recommended direct PE inputs
for CPT code 91200. We are also finalizing an update in the price of
the Fibroscan (ER101) equipment to $125,096.21.
(36) Remote Retinal Imaging (CPT Codes 92227, 92228, and 92229)
The AMA CPT Editorial Panel revised CPT code 92227 (Imaging of
retina for detection or monitoring of disease; with remote clinical
staff review and report, unilateral or bilateral) and CPT code 92228
(Imaging of retina for detection or monitoring of disease; with remote
physician or qualified health professional review and report,
unilateral or bilateral) that are reported for the treatment of
diabetic retinopathy. Two practice sites are involved in these
services: The acquiring site (for example, a primary care practice) and
the reading site (for example, the ophthalmology practice). Both codes
can be used to report diagnostic and monitoring services and the
distinction is in whom provides the service: Physician (CPT code 92228)
or clinical staff only (CPT code 92227). Thus, only CPT code 92228
includes work, accounting for the physician at the reading site. For
both CPT codes 92227 and 92228, direct PE pays for the clinical staff
at both sites.
The AMA CPT Editorial Panel also created CPT code 92229 (Imaging of
retina for detection or monitoring of disease; with point-of-care
automated analysis with diagnostic report; unilateral or bilateral) for
point-of-care automated analysis that uses innovative artificial
intelligence technology to perform the interpretation of the eye exam,
without requiring that an ophthalmologist interpret the results. CPT
code 92229 can be used at a primary care practice site and the
artificial intelligence technology interprets the test instead of a
remotely located ophthalmologist. Because no physician is involved,
this service is PE only. We considered CPT code 92229 to be a
diagnostic service under the PFS and are created separate payment for
it.
For CPT code 92228, we proposed the RUC's recommended work RVU of
0.32. CPT codes 92227 and 92229 are PE only codes, and proposed a work
RVU of 0.00 for both codes.
For both CPT codes 92227 and 92228, we proposed the AMA RUC's
recommended direct PE inputs. We proposed two refinements to the direct
PE inputs for CPT code 92229. We proposed a reduction of 1 minute for
the clinical labor task CA009, ``Greet patient, provide gowning, ensure
appropriate medical records are available,'' to be consistent with the
amount of clinical labor for this task in CPT codes 92228 and 92227. We
did not propose the RUC's recommendation of a $25 ``per click''
analysis fee for remote imaging because we considered this a service
fee that constitutes a form of indirect PE and that this cost is
appropriately captured via the indirect PE methodology as opposed to
being included as a separate direct PE input. We did not believe that
the analysis fee would be allocated to the use of an individual patient
for an individual service, and can be better understood as an indirect
cost similar to other administrative expenses.
We received public comments on the Remote Retinal Imaging family.
The following is a summary of the comments we received and our
responses.
Comment: For CPT code 92228, a few commenters supported our
proposals for 0.32 work RVUs with no refinements to the direct PE
inputs.
Response: We appreciate the commenters' support and are finalizing
0.32 work RVUs and no refinements to the direct PE inputs as proposed.
[[Page 84630]]
Comment: For CPT code 92227, a few commenters supported our
proposals for 0.00 work RVUs with no refinements to the direct PE
inputs.
Response: We appreciate the commenters' support and are finalizing
0.00 work RVUs with no refinements to the direct PE inputs as proposed.
Comment: We received no comments on our proposal for 0.00 work RVU
for CPT code 92229.
Response: We are finalizing 0.00 work RVUs for CPT code 92229 as
proposed.
Comment: Several commenters disagreed with our proposals for the
direct PE inputs for CPT code 92229. A few commenters disagreed with
our reduction of 1 minute of clinical labor task CA009: ``Greet
patient, provide gowning, ensure appropriate medical records are
available.'' Commenters stated that it is not typical for the EHR and
the imaging and analyzing software to be linked and that staff time is
required to enter the data into the imaging and analyzing software and
ensure that it matches the information in the main EHR and therefore it
would be inappropriate to reduce the RUC-recommended staff time.
Response: While we appreciate the additional information that the
EHR and the imaging and analyzing software are not linked, we believe
that the staff time required to enter the data into the imaging and
analyzing constitutes a data entry task and is paid under indirect PE.
Therefore, we are finalizing our proposed reduction of 1 minute of
clinical staff time for CPT code 92229.
Comment: Several commenters also disagreed with the elimination of
the analysis fee for remote imaging. They asserted that the analysis
fee is a direct cost because it is directly attributable to a specific
patient and incurred for each patient. The commenters also stated that
because the analysis is conducted by artificial intelligence (AI)
software, there would be no service if the software was not used on a
per patient basis.
Response: As the PE data have aged and AI applications are
emerging, we recognize that issues involving the use of AI are complex.
While we agree that the costs for AI applications should be accounted
for in payment, AI applications are not well accounted for in our PE
methodology. In recent years, we have considered other services that
use algorithms or artificial intelligence components to render key
portions of a service. For example, in the CY 2018 OPPS final rule (82
FR 59284), we discussed the fractional flow reserve computed tomography
(FFRCT) service. We noted that that the service, which we considered to
be separate and distinct from the original coronary computed tomography
angiography service is not an image processing service but rather, the
diagnostic output from the FFRCT reports functional flow values that
can only be obtained using FFRCT. We found FFRCT to be similar to other
technologies that use algorithms, artificial intelligence, or other new
forms of analysis to determine a course of treatment, where the
analysis portion of the service cannot adequately be reflected under
the PFS payment methodology. Accordingly, we established contractor
pricing for the service and have continued to gather information from
stakeholders on payment that appropriately reflects resource cost for
this service under the PFS payment methodology for the codes below. Our
recent reviews of the overall cost for the service and specifically for
the analysis component of the service related to the analysis services
listed below have shown the costs to be similar, to the costs reflected
in payment under the CY 2021 OPPS final rule for CPT code 0503T
(analysis of fluid dynamics and simulated maximal coronary hyperemia,
generation of estimated FFR model).
We look forward to continuing to seek out new data sources and
ongoing conversations with stakeholders to help in updating the PE
methodology and the underlying data to better reflect such services. In
the meantime, we are finalizing payment based on contractor pricing for
CPT code 92229.
After consideration of the comments, we are finalizing the work
RVUs and direct PE inputs for CPT codes 92227 and 92228 as proposed and
are finalizing contractor pricing for CPT code 92229 as detailed above.
(37) Auditory Evoked Potentials (CPT Codes 92584, 92650, 92651, 92652,
and 92653)
CPT codes 92585 (Auditory evoked potentials for evoked response
audiometry and/or testing of the central nervous system; comprehensive)
and 92586 (Auditory evoked potentials for evoked response audiometry
and/or testing of the central nervous system; limited) were identified
through a RAW requested screen of CMS/Other Source codes with 2017
Medicare utilization over 30,000. Since these codes were last valued,
audiologists, the primary reporter of these services, can now report
Medicare services independently. As a result, the audiologist work for
these services is moving from PE to work.
To better describe tests of auditory function, the CPT created CPT
code 92584 (Electrocochleography) and replaced CPT codes 92585 and
92586 with four new services. We proposed the RUC-recommended work RVUs
of 1.00 for CPT code 92584, 1.00 for CPT code 92651 (Auditory evoked
potentials; for hearing status determination, broadband stimuli, with
interpretation and report), 1.50 for CPT code 92652 (Auditory evoked
potentials; for threshold estimation at multiple frequencies, with
interpretation and report), and 1.05 for CPT code 92653 (Auditory
evoked potentials; neurodiagnostic, with interpretation and report).
CPT code 92650 (Auditory evoked potentials; screening of auditory
potential with broadband stimuli, automated analysis) is a screening
service and is not payable by Medicare. Therefore, we did not propose a
valuation for this code; however, we noted we will display RUC-
recommended values associated with the code.
We proposed the RUC-recommended direct PE inputs for this code
family without refinement.
We received public comments on the Auditory Evoked Potentials codes
(CPT codes 92584, 92650, 92651, 92652, and 92653). The following is a
summary of the comments we received and our responses.
Comment: Commenters uniformly expressed support for our proposal to
accept the RUC-recommended work RVUs and direct PE inputs for CPT codes
92584, 92651, 92652, and 92653.
Response: We appreciate the commenters' support.
Comment: Commenters requested that CMS publish the RUC-recommended
work, PE, and malpractice RVUs for CPT code 92650. CPT code 92650 is a
key component of universal newborn hearing screening programs that are
widely furnished across the country. As such, it is critical for CMS to
display the total RVUs--to include the RUC's recommended work, PE, and
MP RVUs--to allow state Medicaid agencies, newborn hearing programs,
and commercial insurers to appropriately value 92650.
Response: We did not propose values for CPT code 92650 because it
is not a covered Medicare service. However, we will post the RUC-
recommended RVUs for this code.
Comment: Commenters also noted a discrepancy between Addendum B--
which indicates 92650 is an active code (status indicator ``A'')--and
the narrative in the proposed rule, which states that 92650 is a
screening code and not payable by Medicare.
Response: We acknowledge the error and have corrected it in
Addendum B.
Comment: Commenters requested that CMS create a professional and
technical
[[Page 84631]]
component (PC/TC) split for CPT codes 92650, 92651, 92652, and 92653.
Other audiology codes including CPT codes 92585 and 92586, which are
being replaced by 92650-92651, also included the PC/TC split.
Response: We appreciate commenters' suggestion that we create PC/TC
splits for CPT codes 92650, 92651, 92652, and 92653. When we reviewed
the code descriptors and the RUC recommendations for the codes, we
noted that the direct PE for the new codes no longer includes clinical
staff time. We also noted that the now deleted codes included clinical
staff time that was assigned to an audiologist. We understood that the
new codes represented changes to the service; audiologists were now
able to bill independently for the work. During our review, we did not
consider a PC/TC split and were surprised by the commenters'
suggestion. Looking forward, we may consider this suggestion during
future rulemaking.
After considering the comments, we are finalizing the work RVUs and
direct PE inputs for the codes in the Auditory Evoked Potentials family
as proposed.
(38) Vestibular Evoked Myogenic Potential Testing (CPT Codes 92517,
92518, and 92519)
In response to a 2017 RAW request, AMA staff compiled a list of
CMS/Other codes with Medicare Utilization of 30,000 or more. CPT code
92585 (Auditory evoked potentials for evoked response audiometry and/or
testing of the central nervous system; comprehensive) was identified as
one of the codes. In 2018, the AMA/RUC referred CPT code 92585 and its
family member CPT code 92586 (Auditory evoked potentials for evoked
response audiometry and/or testing of the central nervous system;
limited) to the February 2019 CPT Editorial Panel meeting to clarify
code descriptors and define the terms ``limited'' and ``comprehensive''
auditory evoked potentials.
During the discussion of CPT codes 92585 and 92586 at the February
2019 CPT Editorial Panel meeting, specialty societies introduced a new
procedure, Vestibular Evoked Myogenic Potential (VEMP), and suggested
new coding. As a result, the CPT Editorial Panel created 3 new codes:
CPT code 92517 (Vestibular evoked myogenic potential testing, with
interpretation and report; cervical (cVEMP)); CPT code 92518
(Vestibular evoked myogenic potential testing, with interpretation and
report; ocular (oVEMP)); and CPT code 92519 (Vestibular evoked myogenic
potential testing, with interpretation and report; cervical and
ocular). The RUC reviewed the three codes at its April 2019 meeting.
We proposed the RUC-recommended work RVU of 0.80 for CPT codes
92517 and 92518. For CPT code 92519, we proposed the RUC-recommended
work RVU of 1.20. We also proposed the RUC-recommended direct PE inputs
without refinement for these three VEMP codes.
We received public comments on the Vestibular Evoked Myogenic
Potential Testing family (CPT codes 92517, 92518, and 92519). The
following is a summary of the comments we received and our responses.
Comment: Commenters wrote to express support for our proposal to
accept the RUC-recommended work RVUs.
Response: We appreciate the support of commenters.
Comment: Commenters requested that CMS create a professional and
technical component (PC/TC) split for the new codes. These commenters
noted that audiologists who perform services in a facility setting
require a mechanism to accurately report the professional component for
their services. Commenters cited other vestibular testing codes such as
CPT codes 92548 and 92549 that have a PC/TC split.
Response: We appreciate commenters' interest in the creation of a
PC/TC split for CPT codes 92517, 92518, and 92519. When we reviewed the
code descriptors and the RUC recommendations, we noted that the direct
PE for this set of new codes did not include clinical staff time. As a
result, we did not consider a PC/TC split. However, as a result of the
commenters' suggestion, we may consider the PC/TC split a topic of
future rulemaking.
After consideration of public comments, we are finalizing the work
RVUs and direct PE inputs for the codes in the Vestibular Evoked
Myogenic Potential Testing family as proposed.
(39) Complete Electrocardiogram (CPT Codes 93000, 93005, and 93010)
In the CY 2019 PFS final rule (83 FR 59452), CPT code 93000 was
nominated for review under the potentially misvalued code initiative.
The RUC reviewed these services at the April 2019 meeting where the
specialty societies explained that the family of electrocardiogram
(ECG) codes were relatively unique in that CPT code 93000
(Electrocardiogram, routine ECG with at least 12 leads; with
interpretation and report) is the global service which is billed in the
hospital setting, CPT code 93005 (Electrocardiogram, routine ECG with
at least 12 leads; tracing only, without interpretation and report) is
the technical component and CPT code 93010 is the professional
component.
We proposed the RUC-recommended work RVU of 0.17, which is the
current value for both codes, for CPT codes 93000 and 93010. CPT code
93005 is a PE only technical component code, and we proposed to
maintain the current work RVU of 0.00.
For the direct PE inputs, we proposed the RUC-recommended values
without refinement.
We did not receive public comments on this code family, and
therefore, we are finalizing as proposed.
(40) External Extended ECG Monitoring (CPT Codes 93224, 93225, 93226,
93227, 93241, 93242, 93243, 93244, 93245, 93246, 93247, and 93248)
In September 2019, the CPT Editorial Panel replaced four Category
III codes with 8 new Category I codes to report external
electrocardiographic (ECG) recording by continuous rhythm recording and
storage for periods longer than 48 hours. The existing Holter monitor
codes (CPT codes 93224 through 93227) that include up to 48 hours of
continuous recording were also reviewed as part of this family of
services at the January 2020 RUC meeting.
We proposed the RUC-recommended work RVU for all 12 codes in the
family. We proposed a work RVU of 0.39 for CPT codes 93224 (External
electrocardiographic recording up to 48 hours by continuous rhythm
recording and storage; includes recording, scanning analysis with
report, review and interpretation by a physician or other qualified
health care professional) and 93227 (External electrocardiographic
recording up to 48 hours by continuous rhythm recording and storage;
review and interpretation by a physician or other qualified health care
professional); a work RVU of 0.50 for CPT codes 93241 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; includes recording, scanning
analysis with report, review and interpretation) and 93244 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; review and interpretation);
and a work RVU of 0.55 for CPT codes 93245 (External
electrocardiographic recording for more than 7 days up to 15 days by
continuous rhythm recording and storage; includes recording, scanning
analysis with report, review and interpretation) and 93248 (External
electrocardiographic recording for more
[[Page 84632]]
than 7 days up to 15 days by continuous rhythm recording and storage;
review and interpretation).
The other six codes in the family are technical component codes
that do not have a work RVU; we proposed a work RVU of 0.00 for CPT
codes 93225 (External electrocardiographic recording up to 48 hours by
continuous rhythm recording and storage; recording (includes
connection, recording, and disconnection)), 93226 (External
electrocardiographic recording up to 48 hours by continuous rhythm
recording and storage; scanning analysis with report), 93242 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; recording (includes connection
and initial recording)), 93243 (External electrocardiographic recording
for more than 48 hours up to 7 days by continuous rhythm recording and
storage; scanning analysis with report), 93246 (External
electrocardiographic recording for more than 7 days up to 15 days by
continuous rhythm recording and storage; recording (includes connection
and initial recording)), and 93247 (External electrocardiographic
recording for more than 7 days up to 15 days by continuous rhythm
recording and storage; scanning analysis with report).
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Perform procedure/service--NOT directly related to
physician work time'' (CA021) activity for CPT codes 93241, 93243,
93245, and 93247. We proposed to reduce the clinical labor time by 5
minutes for each code as the description of the tasks taking place in
the recommended materials includes activities that are considered to be
indirect PE under our methodology. The recommended materials stated
that ``incoming patch deliveries are sorted and distributed to work
queues. The return box is opened, diary book removed, top housing is
removed using a custom tool to expose USB connection, and device is
plugged in to extract serial number and diagnostic logs.'' These
unboxing and filing activities are classified as administrative
expenses under our PE methodology, and therefore, do not constitute
clinical labor as a direct expense. We proposed to remove 5 minutes
from the clinical labor to reflect these activities, which are indirect
as opposed to direct costs. We also proposed to refine the equipment
time for the desktop computer (ED021) to reflect these changes in the
clinical labor time.
We noted an inconsistency in the RUC-recommended direct PE inputs
for CPT codes 93241 and 93245. Both of these codes are the ``global
component'' for their respective group of codes, such that the direct
costs for CPT codes 93242-93244 must sum up to the direct cost of CPT
code 93241 and the direct costs for CPT codes 93246 through 93248 must
sum up to the direct cost of CPT code 93245. However, CPT codes 93241
and 93245 each contained 2 pairs of non-sterile gloves (SB022) whereas
their constituent technical component codes (93242 and 93246
respectively) only contained a single pair of non-sterile gloves.
Therefore, we proposed to refine the quantity of the non-sterile gloves
down to 1 pair for CPT codes 93241 and 93245 to correct this
inconsistency. We noted we also considered increasing the quantity of
the gloves to 2 as in CPT codes 93224 through 93227. However, we
believed that only 1 pair of gloves would typically be needed to attach
the ECGs, as the patient does not return to have the ECGs removed in
CPT codes 93241 through 93248 as opposed to CPT codes 93224 through
93227 where the patient does return for ECG removal.
We proposed the RUC-recommended equipment time of 1,474 minutes for
the Holter monitor (EQ127) equipment included in CPT codes 93224 and
93226, based on an equipment time of 34 minutes during the procedure
along with 1,440 minutes (24 hours) of equipment time thereafter. We
noted that an external stakeholder wrote to request that the number of
minutes of equipment time for the Holter monitor be increased from
1,440 minutes (24 hours) to 2,160 minutes (36 hours) to reflect the
average length of equipment time. The stakeholder wrote that the 24-
hour and 48-hour test were each performed approximately 50 percent of
the time and stated that the most accurate number of equipment minutes
would be the average time. The RUC disagreed with the stakeholder's
request in its review because it concluded that there was insufficient
evidence to warrant a change from the current 24 hours of equipment
time; the RUC-recommended equipment time for the Holter monitor was
based on the typical rather than the average service. We proposed the
RUC-recommended equipment time of 1,474 minutes because our PE
methodology is indeed based on the typical case, specifically what
would be typical and reasonable and necessary for the procedure in
question. Although we appreciated the feedback from the stakeholder,
our previously finalized PE methodology establishes pricing based on
the typical case. For a detailed explanation of the direct PE
methodology, including examples, we refer readers to the 5-year review
of work RVUs under the PFS and proposed changes to the PE methodology
CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final
rule with comment period (71 FR 69629).
The recommendations for this family of codes contain one new supply
item, the ``extended external ECG patch, medical magnetic tape
recorder'' (SD339). We did not receive a traditional invoice to
establish a price for this supply item, instead receiving pricing
information from two sources: A weighted median of claims data with the
cost of the other direct PE inputs removed, and a top-down approach
calculating the cost of the supply per service based on summing the
total costs of the health care provider and dividing by the total
number of tests furnished. The former methodology yielded a supply
price of approximately $440 while the latter methodology produced an
estimated supply price of $416.85. Stakeholders also submitted a series
of invoices from the clinical study marketplace with a price of $595.
Although we are appreciative of the data provided by the stakeholder,
we require an invoice representative of commercial market pricing to
establish a national price for a new supply or equipment item. Although
we are aware of the unusual circumstances surrounding the ``extended
external ECG patch, medical magnetic tape recorder'' in terms of how it
uploads data to the health care provider, we cannot establish supply
pricing based on an analysis of claims data and in absence of a
representative invoice.
Therefore, we proposed to employ a crosswalk to an existing supply
for use as a proxy price until we have an invoice to use for the
``extended external ECG patch, medical magnetic tape recorder'' item.
We proposed to use the ``kit, percutaneous neuro test stimulation''
(SA022) supply as our proxy item at a price of $413.24. Although this
kit is not clinically similar to the extended external ECG patch, we
believe that it is the closest match from a pricing perspective to
employ as a proxy until we are able to arrive at an invoice that is
representative of commercial market pricing. We welcomed the submission
of invoices or other additional information for use in pricing the
``extended external ECG patch, medical magnetic tape recorder'' supply.
We received public comments on the codes in the External Extended
ECG Monitoring family. The following is a
[[Page 84633]]
summary of the comments we received and our responses.
Comment: Several commenters supported the proposal of the RUC-
recommended work RVUs for all of the codes in the External Extended ECG
Monitoring family.
Response: We appreciate the support for our proposals from the
commenters.
Comment: One commenter supported the proposal to refine the
quantity of the non-sterile gloves down to 1 pair for CPT codes 93241
and 93245 to correct an inconsistency in the RUC recommendations. The
commenter agreed that this corrected a summing error.
Response: We appreciate the support for our proposals from the
commenter.
Comment: Several commenters disagreed with the proposal to reduce
the clinical labor time for the ``Perform procedure/service--NOT
directly related to physician work time'' (CA021) activity for CPT
codes 93241, 93243, 93245, and 93247 by 5 minutes. Commenters stated
that delivery and assignment tasks may be fair to characterize as
administrative, but accessing the device, connecting it, and
downloading data is more akin to the CA032 activity code (``Scan exam
documents into PACS. Complete exam in RIS system to populate images
into work queue.'') when clinical data is put into the system.
Commenters recommended that CMS reduce clinical staff time by 1 minute,
not 5, to account for the delivery sorting, distribution, and box
opening.
Response: We continue to disagree with the commenters and maintain
that the proposed reduction of 5 minutes of clinical labor time is
warranted as the activities listed by commenters are forms of indirect
PE. Data entry tasks such as connecting a device and downloading data
are typically considered to be forms of indirect PE unless they are
directly allocable to a particular patient for a particular service. We
do not agree that the suggested comparison to the CA032 activity code
would be accurate for these services, as the CA032 activity code
requires the use of a PACS workstation, which is not present in any of
these CPT codes.
Comment: Several commenters disagreed with CMS' position regarding
equipment time for the wearable holter monitor (EQ127) device.
Commenters stated that they had presented evidence to the RUC
demonstrating that about half of the services described by CPT code
93226 involve 24 hours of monitoring and about half are for 48 hours;
based on this, the commenter suggested that the ``typical'' service was
36 hours--the average of 24 and 48 hours. The commenter stated that the
RUC and CMS did not agree as both take the view that the ``typical''
service requires a binary choice between 24 and 48 hours. The commenter
stated that they believe a more accurate methodology for valuing
equipment time is to look to objective and quantifiable data such as
the average number of hours of use rather than the ``either/or''
methodology which inevitably undervalues approximately 50 percent of
tests.
Response: Although we appreciated the feedback from the
stakeholder, as we stated in the proposed rule, our previously
finalized PE methodology establishes pricing based on the typical case
and not the average result. For a detailed explanation of the direct PE
methodology, including examples, we refer readers to the 5-year review
of work RVUs under the PFS and proposed changes to the PE methodology
CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final
rule with comment period (71 FR 69629).
Comment: We received many comments regarding our proposal to price
the ``extended external ECG patch, medical magnetic tape recorder''
(SD339) supply via a proxy item at a price of $413.24. Several
commenters supported the proposed proxy pricing, stating that because
the independent diagnostic testing facilities that furnish the extended
ECG services are also the manufacturers of the devices, there are no
invoices that reflect the sale or purchase of this supply item or the
related software required to scan and analyze the extended ECG data
recorded on this patch. These commenters stated that CMS should
finalize the pricing as proposed and advised caution when reviewing
pricing for what appear to be extended ECG system components, and to
assess whether the invoiced items represent the supplies and equipment
required to furnish the typical case of the service described by the
new codes.
Other commenters strongly disagreed with the proposed proxy pricing
for the SD339 supply. Commenters stated that they were alarmed that
CMS's proposal would result in payment rates far in excess of the costs
incurred when performing these services in direct violation of CMS's
stated principles for reimbursement rates. One commenter stated that
CMS proposed rates at more than four times where they should be valued
under its standard PE cost accounting methodology. Several commenters
stated that the SD339 patch was available for purchase at roughly $100
to $120 if bought in bulk quantities, which the commenters stated made
sense because these ECG patches are not high tech equipment. Several
commenters were concerned that CMS had not followed its traditional
methodology for supply pricing by valuing the SD339 patch without
receiving an invoice submission. Commenters stated that the proposed
proxy pricing incorporated the research and development costs
associated with developing the patch, which are typically indirect
costs under the PE methodology, and CMS was therefore double-paying for
these expenses by including them as a direct cost. Commenters also
raised concerns that providers of these services might be able to make
up to $200 per patient through the sale of discounted patch kits by
profiting from the spread between the CMS payment and the much lower
cost of the product. Commenters stated that this could create an
incentive for significant overutilization of these services. One
commenter submitted a lengthy report suggesting that CMS reject the
proxy supply input approach and value the external ECG patch not as a
supply but as a form of reusable equipment. This commenter submitted a
series of invoices to support their contention that the external ECG
patch would be more accurately priced as a reusable form of equipment
at a much lower reimbursement rate.
One commenter who supported the proposed proxy pricing later
submitted a second comment responding to the commenters' criticisms of
the proposal. This commenter stated that the devices and systems
described by the invoices presented by other commenters were not
consistent with the diagnostic system typically used to furnish the
services described by these new codes. The commenter stated that there
were systemic differences between the extended external ECG patch and
the items described by the invoices referenced by other commenters. The
commenter reiterated that the proposed proxy price should be finalized
as it is supported by peer-reviewed clinical evidence from the
specialty societies.
Response: Given the conflicting information and assertions provided
by commenters, we are unable to identify accurate national pricing for
the ``extended external ECG patch, medical magnetic tape recorder''
(SD339) supply. To allow additional time to receive more pricing
information, we are finalizing contractor pricing for CY 2021 for the
four codes that include this supply input (CPT codes 93241, 93243,
93245, and 93247). We will retain the SD339 supply in our pricing
database while removing the proxy price pending additional information.
We welcome the
[[Page 84634]]
submission of additional invoices or other pricing information to
assist us to determine the most accurate values for these services.
After consideration of the comments, we are finalizing the work
RVUs and direct PE inputs for CPT codes 93224, 93225, 93226, 93227,
93242, 93244, 93246, and 93248. We are finalizing contractor pricing
for CPT codes 93241, 93243, 93245, and 93247 as detailed above.
(41) Complete Transthoracic Echocardiography (TTE) With Doppler (CPT
Code 93306)
In the CY 2019 PFS final rule (83 FR 59500), a submitter nominated
CPT code 93306 (Echocardiography, transthoracic, real-time with image
documentation (2D), includes M-mode recording, when performed,
complete, with spectral Doppler echocardiography, and with color flow
Doppler echocardiography) as potentially misvalued, citing GAO, MedPAC,
and Urban Institute reports that suggest the work RVUs are overstated.
Although the code was most recently surveyed in 2016, the specialty
societies and the RUC stated that there has been a change in the
technique and technology used to perform the procedure, so they
resurveyed the code. The RUC recommended decreasing the work RVU from
1.50 to 1.46 and we proposed this value.
Although we proposed the RUC-recommended direct PE inputs without
refinement, we noted that the RUC's recommendation included both 25 mL
and 50 mL of ultrasound transmission gel. We proposed a supply quantity
of 25 mL and sought clarification on the correct amount.
We received public comments on the proposed valuation of CPT code
93306. The following is a summary of the comments we received and our
responses.
Comment: A few commenters were supportive of our proposals for the
work RVUs and direct PE inputs for the codes in this family.
Response: We appreciate the support for our proposals from the
commenters.
Comment: A few commenters confirmed that the correct supply
quantity of the ultrasound transmission get was 25 mL.
Response: We appreciate the clarification and are finalizing the
ultrasound transmission gel supply quantity as proposed.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for CPT code 93306 as proposed.
(42) Pacing Heart Stimulation (CPT Code 93623)
Review of CPT code 93623 (Programmed stimulation and pacing after
intravenous drug infusion (List separately in addition to code for
primary procedure)), was prompted by the Relativity Assessment
Workgroup Medicare utilization screen of over 30,000 claims in a year.
This service is to create an arrhythmia by an intravenous drug infusion
and it is an add-on code with 60 minutes of total time and a current
work RVU of 2.85.
The RUC recommended the 25th percentile survey value of 2.04 work
RVUs and 20 minutes of intraservice time.
The revision of CPT code 93623 physician's time adjusting from the
current 60 minutes to 20 minutes is a significant change. We noted that
we do not believe the RUC-recommended work RVU appropriately accounts
for the substantial reductions in the surveyed work times for the
procedure. Although we do not imply that the decrease in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we noted that we believe that
since the two components of work are time and intensity, significant
decreases in time should be appropriately reflected in decreases to
work RVUs. In the case of CPT code 93623, we believed that it would be
more accurate to propose a work RVU of 0.98 based on CPT code 76810
(Ultrasound, pregnant uterus, real time with image documentation, fetal
and maternal evaluation, after first trimester ( or = 14
weeks 0 days), transabdominal approach; each additional gestation (list
separately in addition to code for primary procedure)) with 20 minutes
of intraservice time. We proposed a work RVU of 0.98 with 20 minutes of
intraservice time for CPT code 93623.
This CPT code is a facility-only service and has no direct PE
inputs.
We received public comments on the Pacing Heart Stimulation CPT
code 93623. The following is a summary of the comments we received and
our responses.
Comment: Commenters disagreed with our selection of CPT code 76810
as an equivalent comparator to CPT code 93623 in regard to the work
RVUs and the number of total minutes derived from the `CMS Other'
category listed in CMS's physician time file. Commenters stated that
the nature of the type of work and intensity for the service described
by CPT code 76810 are vastly different from Pacing Heart Stimulation.
The commenters strongly suggested that CMS accept the 25th percentile
work RVU of 2.04 from their recent survey of 46 cardiologists.
Response: We continue to believe that CPT code 76810 is a valid
reference for purposes of valuing CPT code 93623, and that the
physician time change from the current 60 minutes to 20 minutes
indicates a reduction in work RVUs. As we have discussed in previous
rules, we continue to believe that our use of the existing time values
as a point of comparison is critical to the integrity of the current
relative value system and we do not accept the characterizing of a time
source as ``CMS-Other'' as being less valid. As for CPT code 76810
having only total time instead of intraservice time, for add-on codes,
total time is almost always the equivalent of intraservice time, and
both of these add-on codes have 20 minutes of total time. We do not
regard the 20 minutes of physician time assigned to CPT code 76810 to
be any different from the 20 minutes of physician time with CPT code
93623. While the clinical nature of the work for CPT code 76810 is
different from the clinical nature of the work for CPT code 93623, our
review of the assigned RVU is based on a comparison of the physician
times and intensity assigned to each code, which are the same.
After consideration of the public comments, we are finalizing the
work and time values for CPT code 93623 as proposed.
(43) Intracardiac Echocardiography (ECG) (CPT Code 93662)
The review of CPT code 93662 (Intracardiac echocardiography during
therapeutic/diagnostic intervention, including imaging supervision and
interpretation (List separately in addition to code for primary
procedure), was prompted by the Relativity Assessment Workgroup
Medicare utilization screen of over 10,000 claims in a year that had an
increase in volume by 100 percent between the 2012 to 2017. This
procedure has since changed from its last review, in its reduced use of
fluoroscopy, now replaced with ultrasound that create arrhythmia
mapping systems with intracardiac echo images processed to produce 3-
dimensional electroanatomical maps. The physician can now visualize
better and have more accurate details for more effective catheter
ablation for a wide range of arrhythmias. CPT code 93662 currently has
a work RVU of 2.80 with 5 minutes of preservice evaluation time, 55
minutes of intraservice time, 10 minutes of immediate postservice time,
and 70 minutes of total time.
[[Page 84635]]
The survey resulted in a median intraservice time of 25 minutes, a
significant shift from the current intraservice time of 55 minutes. The
RUC recommended a work RVU of 2.53 and 25 minutes of intraservice time
for add-on CPT code 93662. We noted that we do not believe the RUC-
recommended work RVU appropriately accounts for the substantial
reductions in the surveyed work times for the procedure. Although we do
not imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believed that since the two components of work are time and
intensity, significant decreases in time should be appropriately
reflected in decreases to work RVUs. CPT code 92979 (Endoluminal
imaging of coronary vessel or graft using intravascular ultrasound
(ivus) or optical coherence tomography (oct) during diagnostic
evaluation and/or therapeutic intervention including imaging
supervision, interpretation and report; each additional vessel (list
separately in addition to code for primary procedure)), with 1.44 work
RVUs and 25 minutes of intraservice time, is a good equivalent
comparator code in light of the significant physician time reduction
from 55 minutes. A similarly proportioned reduction of physician
intraservice time from the current 55 minutes to the surveyed 25
minutes, if applied to the current work RVU would result in a value
much lower than our reference CPT code 92979's work RVU, so we proposed
a work RVU of 1.44 and 25 minutes of intraservice time for add-on CPT
code 93662.
This CPT code is a facility only service and has no direct PE
inputs.
We received public comments on the service of Intracardiac
Echocardiography (ECG) CPT code 93662. The following is a summary of
the comments we received and our responses.
Comment: The AMA RUC disagreed with our selection of CPT code 92979
as an equivalent comparator code to CPT code 93662 because of ECG's
higher technical nature, and its use of anesthesia which supports a
higher intensity and a difference in the nature of the work. As in
their AMA RUC recommendation, they referenced their selection of CPT
code 34713 (Percutaneous access and closure of femoral artery for
delivery of endograft through a large sheath (12 French or larger),
including ultrasound guidance, when performed, unilateral (List
separately in addition to code for primary procedure)) with a work RVU
of 2.50 and an intraservice time of 20 minutes. The commenters strongly
suggested that CMS accept their comparison code and the 25th percentile
work RVU of 2.53 from their recent survey of 42 cardiologists.
Response: We consider CMS' selection of CPT code 92979 to be a more
appropriate comparator to value CPT code 93662, than the AMA RUC's
selection of comparator CPT code 34713, and believe that the physician
time change from the current 55 minutes to 25 minutes indicates a
reduction in work RVUs of greater than 0.27. We also do not agree with
the AMA RUC that the increase in ECG's work intensity supports the AMA
RUC recommended 2.53 work RVUs (90% of the current value). The
substantial reduction in physician time (45%) and increase in work
intensity, is not reflected in the AMA RUC-recommended reduction of
work RVUs. CPT code 92979's intraservice time of 25 minutes and 1.44
work RVUs is a better equivalent that reflects the halving on the
physician's current time and we do not believe that the work intensity
has substantial change enough to justify the AMA RUC's recommended work
value. We note that CPT code 93662's work value is for the professional
component (26) that is set in the fee schedule and that CPT code
93622's technical component and global are also add-on codes and are
carrier-priced, meaning that if the health care provider performs both
components, their final payment will be more than the work RVUs
finalized here.
After consideration of the public comments, we are finalizing a
work RVU of 1.44 with 25 minutes of intraservice time for CPT code
93662 as proposed.
(44) Ventricular Assist Device (VAD) Interrogation (CPT Code 93750)
The review of CPT code 93750, (Interrogation of ventricular assist
device (VAD), in person, with physician or other qualified health care
professional analysis of device parameters (e.g., drivelines, alarms,
power surges), review of device function (e.g., flow and volume status,
septum status, recovery), with programming, if performed, and report)
was prompted by the Relativity Assessment Workgroup Medicare
utilization screen of over 10,000 claims in a year and had had an
increased in volume by 100 percent between the 2012 to 2017. CPT code
93750 currently has a work RVU of 0.92 with 30 minutes of intraservice
time.
For physician times, the societies' survey for CPT code 93750
yielded 6 minutes preservice time, 10 minutes intraservice time, 7
minutes immediate post-service time, and 23 minutes of total time. The
25th percentile surveyed work RVU was 0.96. The RUC compared the survey
code to CPT code 78598 (Quantitative differential pulmonary perfusion
and ventilation (e.g., aerosol or gas), including imaging when
performed) (0.85 work RVU and 5 minutes of preservice time, 10 minutes
of intraservice time, 9 minutes of immediate postservice time, and
total time of 24 minutes). The RUC recommended crosswalking the work
RVU of 0.85 from CPT code 78598 to 93750.
CPT code 93289 (Interrogation device evaluation (in person) with
analysis, review and report by a physician or other qualified health
care professional, includes connection, recording and disconnection per
patient encounter; single, dual, or multiple lead transvenous
implantable defibrillator system, including analysis of heart rhythm
derived data elements), with 0.75 work RVUs and 5 minutes of preservice
time, 10 minutes of intraservice time, 8.5 minutes of immediate
postservice time, and total time of 23.5 minutes, we noted we believe
is a more precise comparator code. CPT code 93289's intraservice times,
pre and post times, and total times are almost identical to CPT code
93750's survey times; therefore, we proposed a work RVU of 0.75 and 23
minutes of total time for CPT code 93750.
The PE Subcommittee corrected the equipment times based on the
formulas as provided by CMS. In addition, the PE Subcommittee changed
the clinical staff type for direct labor item ID CA013 Prepare Room,
Equipment and Supplies, from an RN to the RN/LPN/MTA blend and the
direct equipment item ID EQ168 light, exam was removed from CPT code
93750. We proposed to accept the RUC-recommended direct PE inputs.
We received public comments on the Ventricular Assist Device (VAD)
Interrogation CPT code 93750. The following is a summary of the
comments we received and our responses.
Comment: The AMA RUC surveyed CPT code 93750 and initially reviewed
their surveyed 25th percentile recommendation of 0.96 work RVUs for
this code, finding it to be overestimated, since the current work RVU
value is 0.92 for the current 30 minutes of physician time. Instead,
they selected CPT code 78598 as a comparator code with a work RVU of
0.85. Commenters disagreed with our selection of CPT code 93289 with a
work RVU of 0.75 as inappropriately low, but they noted that they had
originally reviewed CPT code
[[Page 84636]]
93289 only to abandon this code on the basis that it did not involve
device programming.
Response: We disagree with commenters that our selection of
comparator CPT code 93289 is inappropriate. The reduction in time from
30 minutes to 23 minutes suggests that the work RVUs should be
decreasing, and the survey's 25th percentile reflects an increase. We
do not believe the RUC-recommended work RVU appropriately accounts for
the substantial reductions in the work times for the procedure.
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 continue to believe that, since the two
components of work are time and intensity, significant decreases in
time should be appropriately reflected in decreases to work RVUs; and
that CPT code 93289 is a more appropriate comparator to CPT code 93750.
After consideration of the public comments, we are finalizing a
work RVU of 0.75 with a total time of 23 minutes for CPT code 93750, as
proposed.
(45) Spirometry (CPT Codes 94010 and 94060)
CPT code 94010 (spirometry, including graphic record, total and
timed vital capacity, expiratory flow rate measurement(s), with or
without maximal voluntary ventilation) and CPT code 94060
(Bronchodilation responsiveness, spirometry as in 94010, pre- and post-
bronchodilator administration) were identified as part of a Relativity
Assessment Workgroup (RAW) review of action plans on the status of
services that were RUC referrals to develop CPT Assistant articles.
These codes were recommended to be surveyed.
We proposed the RUC-recommended work RVU of 0.17 for CPT code 94010
(spirometry, including graphic record, total and timed vital capacity,
expiratory flow rate measurement(s), with or without maximal voluntary
ventilation) and the RUC-recommended work RVU of 0.22 for CPT code
94060 (Bronchodilation responsiveness, spirometry as in 94010, pre- and
post-bronchodilator administration). We proposed the RUC-recommended
direct PE inputs for this code family without refinements.
We did not receive public comments on this code family, and are
finalizing as proposed.
(46) Exercise Test for Bronchospasm (CPT Codes 94619, 94617, 94618, and
94621)
In 2018, the CPT Editorial Panel created CPT code 94617 (Exercise
test for bronchospasm, including pre- and post-spirometry,
electrocardiographic recording(s), and pulse oximetry), and CPT code
94618 (Pulmonary stress testing (e.g., 6-minute walk test), including
measurement of heart rate, oximetry, and oxygen titration, when
performed) from the now deleted CPT code 94620 (Pulmonary stress
testing; simple (e.g., 6-minute walk test, prolonged exercise test for
bronchospasm with pre- and post-spirometry and oximetry)), and revised
CPT code 94621 (Cardiopulmonary exercise testing, including
measurements of minute ventilation, co2 production, o2 uptake, and
electrocardiographic recordings) to better describe the specialty's
pulmonary exercise test. Shortly after the creation and revision of
these codes, the specialty society became aware of some health care
providers performing CPT code 94617 without ECG monitoring, so to more
accurately account for this work without the ECG monitoring, the CPT
Editorial Panel proposed to establish CPT code 94619 with the
descriptor, (Exercise test for bronchospasm, including pre- and post-
spirometry and pulse oximetry; without electrocardiographic
recording(s)). For the October 2019 RUC meeting, the specialty
societies surveyed CPT code 94619, and included a request to reaffirm
the values of the rest of the codes in the code family.
For CPT code 94619, the surveyed physician time yielded 5 minutes
of preservice time, 9 minutes of intraservice time, followed by 10
minutes of immediate post-service time, for a total time of 24 minutes.
This distribution of physician times is of course very similar to the
times for CPT code 94617, total time of 26 minutes, except without the
task of including an electrocardiographic recording. The RUC
recommended the survey's median work RVU of 0.49 for CPT code 94619.
We proposed the RUC's recommendation of a work RVU of 0.49 and a
total physician time of 24 minutes for CPT code 94619.
This CPT family of codes that includes CPT code 94619, are CPT
codes 94617, 94618, and 94621 and there are no changes to their
physician service times, no change to their descriptors, nor their work
RVUs, and remain as they currently are. The specialty societies
reaffirmed these current valuations and we proposed to accept them
without change.
We proposed the RUC-recommended PE changes without refinement.
We did not receive public comments on this provision, and are
finalizing as proposed.
(47) Evaluation of Wheezing (CPT Codes 94640, 94667, 94668, and 94669)
At the April 2019 RUC meeting, four PE only CPT codes from the
Evaluation of Wheezing code family were reviewed. The codes included
CPT codes 94640 (Pressurized or nonpressurized inhalation treatment for
acute airway obstruction for therapeutic purposes and/or for diagnostic
purposes such as sputum induction with an aerosol generator, nebulizer,
metered dose inhaler or intermittent positive pressure breathing (IPPB)
device), 94667 (Manipulation chest wall, such as cupping, percussing,
and vibration to facilitate lung function; initial demonstration and/or
evaluation), 94668 (Manipulation chest wall, such as cupping,
percussing, and vibration to facilitate lunch function; subsequent),
and 94669 (Mechanical chest wall oscillation to facilitate lung
function, per session).
We proposed the RUC-recommended direct PE inputs for the four PE
only codes. The RUC did not recommend work RVUs and we proposed to
maintain the current work RVU of 0.00 for all four codes.
We did not receive public comments on this code family, and are
finalizing as proposed.
(48) Exhaled Nitric Oxide Measurement (CPT Code 95012)
In January 2019, the RAW reviewed services with 2017 Medicare
utilization of 10,000 or more that had increased by at least 100
percent from 2012 through 2017. The RUC recommended that CPT code 95012
(Nitric oxide expired gas determination) be surveyed for the April 2019
meeting. We proposed the direct PE inputs for CPT code 95012 without
refinement. CPT code 95012 is a PE-only code with no work RVU, and we
proposed to maintain the current work RVU of 0.00.
We did not receive public comments on this code family and are
finalizing as proposed.
(49) Acupuncture Services (CPT Codes 97810, 97811, 97813, and 97814)
The CPT Editorial Panel created two new codes and two new add-on
codes in 2004 to describe the appropriate time or additional time and
levels of service that can be performed using acupuncture and
electroacupuncture,
[[Page 84637]]
acupuncture therapy with electrical stimulation. These codes were
designated as noncovered services since Medicare did not reimburse for
acupuncture services at the time. In January 2020, we issued a decision
memo stating that Medicare will cover acupuncture for chronic low back
pain under section 1862(a)(1)(A) of the Act (CAG-00452N). This was
reflected in the April 2020 PFS Quarterly Update which changed CPT
codes 97810 through 97814 to active payment status (CMS Change Request
11661). Because we had never conducted a review of these four
acupuncture codes, the CY 2020 payment rate consisted of the work RVUs
recommended by the RUC in 2004.
For CY 2021, we proposed to establish work RVUs for these four
acupuncture codes based on a pair of crosswalks to two recently
reviewed codes in the Dry Needling family. We proposed a work RVU of
0.48 for CPT codes 97810 (Acupuncture, 1 or more needles; without
electrical stimulation, initial 15 minutes of personal one-on-one
contact with the patient) and 97813 (Acupuncture, 1 or more needles;
with electrical stimulation, initial 15 minutes of personal one-on-one
contact with the patient) based on a crosswalk to CPT code 20561
(Needle insertion(s) without injection(s); 3 or more muscles). We
proposed a work RVU of 0.32 for CPT codes 97811 (Acupuncture, 1 or more
needles; without electrical stimulation, each additional 15 minutes of
personal one-on-one contact with the patient, with re-insertion of
needle(s)) and 97814 (Acupuncture, 1 or more needles; with electrical
stimulation, each additional 15 minutes of personal one-on-one contact
with the patient, with re-insertion of needle(s)) based on a crosswalk
to CPT code 20560 (Needle insertion(s) without injection(s); 1 or 2
muscle(s)).
CPT codes 20560 and 20561 are clinically similar services
associated with dry needling that were reviewed last year for CY 2020.
We finalized work RVUs of 0.32 and 0.48 respectively for these two
codes following our review of their associated RUC recommendations,
while noting that dry needling services were non-covered by Medicare
unless otherwise specified through a national coverage determination
(NCD) (84 FR 62722 through 62724). Like the acupuncture codes, CPT
codes 20560 and 20561 were updated to active payment status in the
April 2020 PFS Quarterly Update to reflect the Medicare coverage of
acupuncture for chronic low back pain. We noted that CPT codes 97810
and 97813 share the identical work time values with CPT code 20561, and
that CPT codes 97811 and 97814 differ from CPT code 20560 by only 1
minute of work time, 15 minutes as compared to 16 minutes. Although we
did not imply that codes with similar work times must equate to a one-
to-one or linear relationship in the valuation of work RVUs, we
believed that, since the two components of work are time and intensity,
clinically related services with similar intensities and work times
should, generally speaking, be valued similarly. Due to the similar
clinical nature of these services and their nearly identical work
times, we believed that it is more accurate to propose crosswalking CPT
codes 97810 through 97814 to the work RVUs of the Dry Needling codes,
which were finalized last year, as opposed to proposing work RVUs from
2004, which were never reviewed by CMS.
The RUC did not make any recommendations and we did not propose any
changes to the direct PE inputs for CPT codes 97810 through 97814.
We received public comments on the codes in the Acupuncture
Services family. The following is a summary of the comments we received
and our responses.
Comment: A few commenters supported the proposed work RVUs assigned
to the acupuncture codes and appreciated CMS' recent coverage
determination. The commenters stated that it is important for CMS to
provide coverage and adequate reimbursement to a broad array of
services that provide non-opioid pain management alternatives.
Response: We appreciate the support for our proposals from the
commenters.
Comment: Many commenters were supportive of the Medicare decision
to provide coverage for acupuncture services but disagreed with the
proposed valuation crosswalk to two recently reviewed codes in the Dry
Needling family. Commenters stated that the dry needling services were
not clinically similar to the acupuncture codes as CMS had claimed in
the proposed rule, as the dry needling codes do not reflect the
training or expertise required to perform an acupuncture treatment.
Commenters stated that acupuncture is more physically and mentally
intensive than inserting a dry needle into a tender muscle. Commenters
stated that the higher skill and knowledge set that is required to
perform acupuncture therapy is evidenced in the licensure requirements
to perform these services, whereas there are no standardized training
curriculums or accreditation programs for dry needling. Commenters
stated that the current acupuncture therapy codes are specifically
intended to include pre- and post-service intervention assessment/
evaluation, as per the CPT guidelines, which is lacking in the dry
needling codes. Many commenters stated that if Medicare rates are
reduced for acupuncture services then providers of acupuncture services
will not be able to afford to treat Medicare beneficiaries and this
would create additional barriers to care.
Response: We appreciate the detailed feedback from the commenters
detailing the differences between acupuncture and dry needling
services. After reviewing the comments, we agree that there are
significant differences between these services and it would not be
appropriate to use the proposed crosswalk for valuation. Therefore, we
are not finalizing our proposal to establish work RVUs for these four
acupuncture codes based crosswalks to CPT codes 20560 and 20561. We are
instead finalizing the current CY 2020 work RVUs of 0.60 for CPT code
97810, 0.50 for CPT code 97811, 0.65 for CPT code 97813, and 0.55 for
CPT code 97814. As this valuation is based on a RUC review that took
place in 2005, we welcome the prospect of an updated formal review or
other new information regarding the valuation of these services for
potential future rulemaking.
(50) Interim Final Rule With Comment Period for Coding and Payment for
Personal Protective Equipment (PPE) (CPT Code 99072)
a. Background
Following the publication of the CY 2021 PFS proposed rule, the CPT
Editorial Panel approved the creation of CPT code 99072 (Additional
supplies, materials, and clinical staff time over and above those
usually included in an office visit or other non-facility service(s),
when performed during a Public Health Emergency, as defined by law, due
to respiratory-transmitted infectious disease). During the comment
period for the proposed rule, stakeholders contacted CMS and stated
that practices have incurred significant costs of maintaining safe
offices, particularly in implementing specific infection control
measures related to screening patients, purchasing personal protective
equipment (PPE), and implementing office redesign measures to ensure
social distancing. Stakeholders requested that CMS immediately consider
implementation of relative values and payment (outside of budget
neutrality) for the newly created CPT code 99072 in recognition of
these costs.
[[Page 84638]]
Stakeholders submitted recommended direct PE inputs associated with
CPT code 99072 designed to capture the additional supplies, materials,
and clinical staff time over and above the PE inputs included in an
office visit or other nonfacility service(s) when the office visit or
other non-facility service(s) are rendered during a public health
emergency (PHE). Stakeholders submitted more than 500 invoices
associated with PPE supplies and requested that CMS use them to update
their pricing, as well as requested that N95 masks should be added to
the direct PE supply list. Stakeholders stated that payment for these
additional costs should be fully funded and not be subject to budget
neutrality, and that CMS could use remaining money from the CARES Act
funding to pay physicians for these costs and/or recognize the
decreased expenditures during the early months of the pandemic to waive
budget neutrality. Stakeholders also stated that CMS should review the
utilization assumptions for equipment due to decreased practice
capacity during the PHE for COVID-19 and that any modifications to the
equipment utilization during the PHE should not be subject to budget
neutrality.
b. Interim Final Policy
We appreciate the submission of this additional information
regarding CPT code 99072, especially the large number of invoice
submissions for use in updating the pricing of PPE supplies. We share
in the concerns of the stakeholders regarding the additional costs
borne by providers during the public health emergency. After reviewing
the information provided by the stakeholders, we are finalizing CPT
code 99072 as a bundled service on an interim basis. We believe that
use of these additional forms of PPE would be inherent to the
furnishing of separately paid services under these practitioner/patient
interactions. We agree with the stakeholders that there have been
additional costs for providers as part of the PHE for COVID-19; however
payment for the services as described under CPT code 99072 are always
bundled into payment for other services and payment for them is
subsumed by the payment for the services to which they are incident.
In recognition of the increased market-based costs for certain
types of PPE, we are finalizing on an interim basis several supply
pricing increases using the invoices submitted along with CPT code
99072. We did not previously include the N95 mask in our supply
database and we are finalizing on an interim basis its addition under
supply code SD344 at the median price of $2.36 based on 94 submitted
invoices. We are also finalizing on an interim basis an increase in the
price of the surgical mask (SB033) supply to the median price of $0.43
based on 259 submitted invoices and an increase in the price of the
surgical mask with face shield (SB034) supply to the median price of
$3.40 based on 49 submitted invoices. We are using the median price as
opposed to the average price of the submitted invoices as the median
was more typical of market-based pricing and avoided the effect of
outlier prices. The increased cost associated with these forms of PPE
will be reflected in payment for services that include these supply
inputs.
We also received additional invoices associated with non-sterile
gloves (SB022), nitrile gloves (SB023), patient gowns (SB026), and
sterile surgical gowns (SB028). We are not finalizing changes in the
prices of these supplies at this time due to concerns that we had
regarding the data on the submitted invoices. The non-sterile gloves
and nitrile gloves contained median prices which were significantly
lower than their CY 2021 prices, $0.05 as compared to $0.25 for the
non-sterile gloves and $0.06 as compared to $1.01 for the nitrile
gloves. The sterile surgical gowns followed the same pattern with a
median invoice price of $3.39 as compared to the CY 2021 price of
$5.02. We do not believe that the typical price for these supplies has
undergone significant decreases as a result of the PHE and we are not
finalizing any price changes at this time pending additional discussion
with stakeholders. For the patient gown (SB026) supply, the median
price of the 43 submitted invoices was $0.51 and the average price was
$0.67. We believe that this additional data supports the current CY
2021 price of $0.58 and we are not finalizing a price change since the
invoice data suggested that the current price remains typical during
the PHE. We also received a small quantity of invoices associated with
other PPE supplies but we did not believe that we had enough data in
these cases to determine typical pricing and therefore we are not
finalizing any additional price changes to supply items.
As described in section VIII. of this final rule, 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. We do not have
authority to waive the budget neutrality provision for CPT code 99072
unless explicitly stated by statute. In addition, as described in
section II.B. of this rule (PE section), we also disagree with the
stakeholders that utilization assumptions for equipment should be
revisited as part of the public health emergency. While we agree that
many services had a reduced volume of Medicare beneficiaries at times
during CY 2020, we note that equipment costs under the PFS are
amortized across the full useful life of the equipment, which in the
vast majority of cases is 5-10 years. We believe that it would distort
relativity to apply a temporary decrease in utilization caused by the
PHE to the pricing structure of the equipment's full useful life
duration. We also note that we do not have statutory authority to
exempt any modifications to the equipment utilization assumptions from
budget neutrality calculations.
c. Waiver of Proposed Rulemaking Provisions
Under the Administrative Procedure Act (APA), 5 U.S.C. 553(b), an
agency is generally required to publish a notice and solicit comment on
a proposed rule in the Federal Register before issuing a final rule.
Similarly, section 1871(b)(1) of the Act requires the Secretary to
provide for notice of a proposed rule in the Federal Register and
provide a period of not less than 60 days for public comment. The APA
provides for exceptions from the notice and comment requirements, see 5
U.S.C. 553(b)(B); in cases in which the APA exceptions apply, section
1871(b)(2)(C) of the Act provides for exceptions from the notice and
60-day comment period requirements of the Act as well. Section
553(b)(B) of Title 5 and section 1871(b)(2)(C) of the Act authorize an
agency to dispense with normal rulemaking requirements if the agency
for good cause finds that the notice and comment process is
impracticable, unnecessary, or contrary to the public interest.
We find that there is good cause to waive the notice and comment
requirements under sections 553(b)(B) of the APA and section
1871(b)(2)(C) due to the September 2020 creation of CPT code 99072
which did not allow for its inclusion in the proposed rule. We believe
that establishing payment for this service on an interim basis will
allow for its provision as a bundled service during the public health
emergency. We find that it would be impracticable and contrary to the
public interest to undergo notice and comment procedures before
finalizing these
[[Page 84639]]
payment policies on an interim basis. We also find that delaying
implementation of these policies is unnecessary because the impact on
other PFS services for 2021 is negligible and the practical alternative
for this treatment is no payment under Medicare Part B. In either case,
payments for 2022 and beyond would be informed by public comments.
Therefore, we find good cause to waive the notice of proposed
rulemaking as provided under section 1871(b)(2)(C) of the Act and
section 533(b)(B) of the APA and to issue this interim final rule with
an opportunity for public comment. We are providing a 60-day public
comment period as specified in the DATES section of this document. We
are seeking interim final comment on our general approach to CPT code
99072, as well as how to think about services that may not include
these specific PPE items but for which there are incurred costs as
described by the stakeholders. Additionally, we will consider the
market cost for these supply items relative to the changing conditions
in the market, as appropriate.
(51) Chronic Care Management Services (CPT Code 99439 and HCPCS Code
G2058)
We established payment for HCPCS code G2058 (Chronic care
management services, each additional 20 minutes of clinical staff time
directed by a physician or other qualified healthcare professional, per
calendar month) in the CY 2020 PFS final rule (84 FR 62690). At the
January 2020 RUC meeting, specialty societies requested a temporary
crosswalk through CY 2021 between the value established by CMS for
HCPCS code G2058 and the value of new CPT code 99439 (with a descriptor
identical to G2058). The Chronic Care Management code family will be
resurveyed during CY 2020 and is expected to be presented for review as
part of the 2022 RUC review process.
For CY 2021, we proposed the RUC-recommended work RVU of 0.54 and
the RUC-recommended direct PE inputs for CPT code 99439.
We received several public comments all in support of our proposed
valuations for Chronic Care Management Services (CPT code 99439 and
G2058). After consideration of the comments, we are finalizing as
proposed.
(52) External Counterpulsation (HCPCS Code G0166)
In the CY 2020 PFS proposed rule (84 FR 40516), an external
stakeholder nominated HCPCS code G0166 as potentially misvalued due to
concerns that the PE RVUs for this code did not fully reflect the total
resources required to deliver the service and CMS proposed G0166 as
potentially misvalued. The RUC reviewed the direct PE inputs for HCPCS
code G0166 at the October 2019 RUC meeting.
We proposed the RUC-recommended preservice period, service period
and postservice period with refinements. We proposed to replace CA010
(obtain vital signs) during the postservice of service period with
CA023 (monitor patient following procedure/service, no multitasking).
For the equipment items, we proposed to update the price of the
``EECP, external counterpulsation system'' (EQ012) equipment to
$101,247.50 based on an average of the five invoices submitted along
with the recommendations. We noted that the EQ012 equipment is the only
current equipment item in our direct PE database with an equipment
utilization rate of 25 percent and the only equipment item with a
utilization rate under 50 percent. Although we did not propose to
change the equipment utilization rate, we solicited feedback from
commenters regarding the utilization rate for the EQ012 equipment to
help us understand why it should differ from all other medical
equipment.
We also received invoices for a series of additional equipment
items: An EECP service contract, an EECP compression equipment package,
and an EECP electrical equipment package. We did not propose to
establish a price for the EECP service contract, as service contracts
are considered to be an administrative expense and a form of indirect
PE under our methodology. As for the two equipment packages, there were
a number of unusual factors involving these items that created
difficulties for our equipment methodology. Both equipment packages had
a suggested utilization rate of 25 percent, half of our typical
utilization rate of 50 percent, and both had a suggested useful life
duration of only 3 months. As we stated in section II.B. of the
proposed rule (85 FR 50082-50083), Determination of Practice Expense
RVUs, we have concerns that assigning very low useful life durations to
this type of equipment would fail to maintain relativity with other
equipment on the PFS. We also noted that the equipment cost per minute
formula was designed under the assumption that each equipment item
would remain in use for a period of several years and depreciate over
that span of time. Our current equipment formula is not designed to
address cases in which equipment is replaced multiple times per year,
and we noted that we believe that applying a multi-year depreciation in
these situations would not be reflective of market pricing. Although we
agreed that these costs should be reflected in the pricing of HCPCS
code G0166, we believed that the very frequent replacement of the items
in the two equipment packages makes them a poor fit under our equipment
methodology.
Therefore, we proposed to treat the two EECP equipment packages as
supplies instead of treating them as equipment. We proposed to
establish the EECP compression equipment package (SD341) as a supply
with a cost of $645 based on an average of the submitted invoices, and
proposed to establish the EECP electrical equipment package (SD342) as
a supply with a cost of $500 again based on an average of the submitted
invoices. Based on information provided by stakeholders, we proposed a
supply quantity of 1/325 for these two items (0.00308) based on the
supply being used on average five times per day and replaced every 3
months (5 uses * 5 days * 13 weeks = 325). We noted that we believe
that assigning these two items as supplies rather than equipment more
accurately captures the unusual circumstances associated with providing
this service.
We received public comments on External Counterpulsation. The
following is a summary of the comments we received and our responses.
Comment: Several commenters disagreed with CMS's proposal to move 3
minutes of clinical labor time for checking vitals at the end of the
session to post-procedure monitoring, stating this is not monitoring in
the sense of the CA023 activity code but taking vitals to evaluate the
effectiveness of the treatment and the patient's condition.
Response: We disagree with the commenters and continue to believe
our proposal to replace CA010 (obtain vital signs) during the
postservice of the service period with CA023 (monitor patient following
procedure/service, no multitasking) was appropriate. We understand that
the clinical labor taking place is not a monitoring activity, however
the CA010 activity code is used to describe clinical labor that takes
place before the service occurs, not afterward. We proposed to use the
CA023 activity code as the closest proxy available to describe this
clinical labor. We note that there is no change in valuation for the
service as we proposed the same 3 minutes for the CA023 activity code
as the RUC recommended under the CA010 activity code.
Comment: Several commenters disagreed with the proposal to price
the
[[Page 84640]]
``EECP, external counterpulsation system'' (EQ012) equipment at
$101,247.50. Commenters stated that one of the previous invoices used
for pricing the EQ012 equipment reflected a discount of $10,000 and was
not for the purchase of a new ECP system. Commenters stated that
although it was not explicitly listed, it was highly likely that
another invoice used for pricing was either the result of a trade-in
credit or reflected a refurbished system. Commenters submitted a new
invoice for the EQ012 equipment with a listed price of $130,890 and
requested that CMS use this invoice for pricing while disregarding the
prior invoices.
Response: We disagree with the commenters that the previous
invoices used for pricing the EQ012 equipment should be disregarded for
pricing. We do not agree that invoices from 2015 and 2017 have no
validity; while we prefer to use current invoices wherever possible, we
also believe in the importance of using multiple data points as opposed
to relying on a single invoice. We also note that the same commenter
submitted invoices for pricing the supply packages, which ranged in
date from 2012 to 2020. We have no indication that the previous
invoices were part of trade-in programs, and our pricing methodology
uses the actual market rate for supplies/equipment, which does include
discounts. We also do not agree with the commenter that the use of new
equipment would be typical in all cases as it is clear that providers
of these services can and do purchase used versions of the EQ012
equipment. As a result, we are employing our standard policy for
invoice submissions and averaging together the previously submitted
invoices with the new invoice submission, which results in a price of
$111,128.30 for the EQ012 equipment. We are finalizing this as the new
price for the EECP, external counterpulsation system.
Comment: Several commenters supported the current equipment
utilization rate of 25 percent for the EQ012 equipment. Commenters
stated that this rate reflected 80 minutes (proposed nonfacility time)
x 1.57 services per day x 5 days per week x 50 weeks = 31,400 minutes
for a total utilization rate of 20.9 percent (31,400 divided by
150,000). Commenters stated that the utilization rate was accurate
based on their experience delivering this service and their discussions
with other ECP therapy providers in different regions across the
country. One commenter disagreed with the proposed equipment
utilization rate of 25 percent and requested that CMS review the
equipment utilization for this service and explain why it differs from
all other medical equipment.
Response: We appreciate the additional information provided by the
commenters regarding the utilization rate for the EQ012 equipment.
Based on the information supplied by the commenters, we continue to
believe that the current equipment utilization rate of 25 percent is
the most accurate value for this unique type of equipment.
Comment: Several commenters provided feedback on the proposal to
establish the EECP compression equipment package (SD341) and the EECP
electrical equipment package (SD342) as disposable supplies. Commenters
were supportive of the concept of treating these items as supplies
instead of as equipment and provided additional details regarding the
supply contents and supply quantities. Commenters stated that the EECP
compression equipment package (SD341) supply should contain eight total
inputs consisting of cuffs, bladders, hoses, straps, connectors, and
specialized treatment pants. Several commenters stated that the total
cost for the SD341 supply package summed to $847.00 while other
commenters stated the cost of the same supply to be $826.75. For the
EECP electrical equipment package (SD342), commenters stated that CMS
accurately captured the finger plethysmograph and ECG cable in this
package while omitting the Spo2 probe. Commenters stated that the Spo2
probe is a required item needed to perform the pulse oximetry and the
price of the SD342 package should be updated to $752.00. Commenters
submitted an extensive list of invoices to support these requested
prices.
Response: We appreciate the additional information provided by the
commenters regarding these supply packages, especially the pricing data
contained in the submitted invoices. For the SD341 compression
equipment package, we note that the invoices show that the two sets of
cuffs are often sold together at a price of $220 instead of separately
at $245. This accounts for the difference between the $847.00 and
$826.75 prices listed by different commenters, and since the bundling
of these cuffs appears to be the typical case, we are finalizing an
update in the price of the EECP compression equipment package (SD341)
supply at $826.75. For the second supply package, we agree with the
commenters and we are finalizing an update in the price of the EECP
electrical equipment package (SD342) at $752.00.
Comment: Several commenters provided additional details regarding
the quantities for the two supply packages. Commenters stated that the
compression package items typically have to be replaced every 13 weeks
while the electrical package items typically have to be replaced every
50 weeks. Commenters stated that a provider of these services would be
highly unlikely to be able to use the same cuffs, bladders, hoses, and
straps in the SD341 supply package for 325 hours as these items would
be completely deteriorated by this point and would be likely to lose
the structural integrity needed to maintain clinical effectiveness.
Commenters stated that a 100 hour life span would be more accurate for
the SD341 supply as it reflected the typical wear and tear with
inflating the compression items at high pressure (300 mm Hg every
heartbeat) and was consistent with the manufacturer's estimated usage.
Commenters stated that the electrical package does not experience the
same level of stress and wear, and instead those items have a 400 hour
life span.
Response: We appreciate the additional information provided by the
commenters regarding the quantities for these two supply packages.
Given that the intraservice treatment time for HCPCS code G0166 lasts
for one hour, we are finalizing an update in the quantity of the SD341
supply pack to 1/100 and an update in the quantity of the SD342 supply
pack to 1/400. These updated supply quantities reflect how many times
the service can be performed before the supply package needs to be
replaced.
Comment: Several commenters disagreed with the proposal of the RUC-
recommended clinical labor time of 83 minutes. Commenters stated that
the proposed time omitted 8 minutes of required clinical activities
consistent with the ECP user manual. Commenters stated that ECP therapy
providers must check legs, conduct a patient assessment, auscultate/
assess lungs, and review change in baseline. Commenters stated that ECP
therapy providers also must perform patient checks immediately
following the service such as assess signs related to blood sugar
levels (for diabetic patients), assess the patient's lower body for
redness, blistering, and/or ulceration, and assist patients from the
treatment area following the service. Commenters stated that these are
essential safety measures to ensure patients have tolerated the
treatment well and these activities must be performed every treatment
and must be captured as part of the clinical labor time. Commenters
[[Page 84641]]
requested that CMS add 8 minutes to the total time under the CA016
activity code (``Prepare, set-up and start IV, initial positioning and
monitoring of patient''), increasing the time for this clinical
activity from 6 minutes to 14 minutes.
Response: Although we appreciate the additional information
supplied by the commenters, we continue to agree with the RUC's
recommendation of 83 minutes of total clinical labor time. The RUC
reviewed the same information provided by the commenters and concluded
that this additional clinical labor time would not be typical. We also
note that the recommended 83 minutes of total clinical labor time
already represents an increase over the prior total time of 73 minutes
for the service, with additional clinical labor time for preparing and
positioning the patient as well as completing post-procedure forms. We
believe that the typical clinical labor activities for HCPCS code G0166
are captured in the RUC-recommended clinical labor time.
After considering the comments, we are finalizing the RUC-
recommended preservice period, service period, and postservice period
clinical labor times for HCPCS code G0166 along with our proposal to
replace the CA010 clinical labor time with an equivalent 3 minutes of
CA023 clinical labor time. We are also finalizing updates in the price
of the EQ012 equipment and the SD341 and SD342 supply packages, along
with updates to the supply quantity for the two supply packages.
(53) Molecular Pathology Interpretation (HCPCS Code G0452)
At the October 2018 RUC meeting, the Relativity Assessment
Workgroup (RAW) identified HCPCS code G0452 (Molecular pathology
procedure; physician interpretation and report) as potentially
misvalued on a CMS/Other screen. The RUC had never reviewed HCPCS code
G0452 and assumptions regarding work and time were based upon a 1995
vignette. In addition, the specialty society noted that the technology
available for furnishing the service, as well as the patient population
receiving the service, had changed since the code was valued by CMS.
The RUC requested a physician work survey be completed for the
October 2019 RUC meeting. It was during the October meeting that the
work and PE values for HCPCS code G0452 were reviewed and recommended.
For CY 2021, we proposed the RUC-recommended work RVU of 0.93 and
the RUC-recommended direct PE inputs for HCPCS code G0452.
We received several public comments on Molecular Pathology
Interpretation (HCPCS code G0452) all in support of our proposal to
adopt the RUC's recommendations for the service.
After consideration of the comments, we are finalizing the work RVU
and direct PE inputs as proposed.
(54) Evaluation and Management, Observation and Provision of Self-
Administered Esketamine (HCPCS Codes G2082 and G2083)
In the CY 2020 PFS final rule (84 FR 63102 through 63104), we
issued an interim final rule with comment period (IFC) to establish
coding and payment for E/M, observation, and the provision of self-
administered Esketamine to facilitate beneficiary access to care for
treatment-resistant depression as efficiently as possible. We created
two new HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an
interim final basis. For CY 2020, we established RVUs for these
services that reflect the relative resource costs associated with the
E/M, observation and provision of the self-administered esketamine
product. The HCPCS G-codes are described as follows: HCPCS code G2082
(Office or other outpatient visit for the evaluation and management of
an established patient that requires the supervision of a physician or
other qualified health care professional and provision of up to 56 mg
of esketamine nasal self-administration, includes 2 hours post-
administration observation) and HCPCS code G2083 (Office or other
outpatient visit for the evaluation and management of an established
patient that requires the supervision of a physician or other qualified
health care professional and provision of greater than 56 mg esketamine
nasal self-administration, includes 2 hours post-administration
observation).
In developing the interim final values for these codes, we used a
building block methodology that sums the values associated with several
codes. For the overall E/M and observation elements of the services, we
incorporated the work RVUs, work time and direct PE inputs associated
with a level two office/outpatient visit for an established patient,
CPT code 99212 (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 problem focused history; A problem focused
examination; Straightforward medical decision making. 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 self limited or minor. Typically, 10 minutes
are spent face-to-face with the patient and/or family), which has a
work RVU of 0.48 and a total work time of 16 minutes, which is based on
a pre-service evaluation time of 2 minutes, an intraservice time of 10
minutes, and a postservice time of 4 minutes.
We also incorporated CPT codes 99415 (Prolonged clinical staff
service (the service beyond the typical service time) during an
evaluation and management service in the office or outpatient setting,
direct patient contact with physician supervision; first hour (List
separately in addition to code for outpatient Evaluation and Management
service)) and 99416 (Prolonged clinical staff service (the service
beyond the typical service time) during an evaluation and management
service in the office or outpatient setting, direct patient contact
with physician supervision; each additional 30 minutes (List separately
in addition to code for prolonged service))) in which neither code has
a work RVU, but includes direct PE inputs reflecting the prolonged time
for clinical staff under the direct supervision of the billing
practitioner.
In addition, to account for the cost of the provision of the self-
administered esketamine as a direct PE input, we incorporated the
wholesale acquisition cost (WAC) data from the most recent available
quarter. For HCPCS code G2082, we used a price of $590.02 for the
supply input that describes 56 mg (supply code SH109) and for HCPCS
code G2083, we used a price of $885.02 for the supply input describing
84 mg of esketamine (supply code SH110).
We sought comment on the interim final values we established for
HCPCS codes G2082 and G2083, including the assigned work RVUs, work
times, and direct PE inputs. See the CY 2021 PFS proposed rule (85 FR
50169 through 50172) for a summary of the comments we received and our
responses.
After considering the comments we received, we proposed to refine
the values for HCPCS codes G2082 and G2083 using a building block
methodology that sums the values associated with several codes. For the
overall E/M and observation elements of the services, we incorporated
the work RVUs, work time and direct PE inputs associated with a level
two office/outpatient visit for an established patient, CPT code 99212.
We also proposed to include the clinical labor for CPT codes 95076 and
95079 (in lieu of CPT codes 99415 and 99416 as detailed earlier); and
to account for the
[[Page 84642]]
cost of the provision of the self-administered esketamine as a direct
PE input, we proposed to incorporate the wholesale acquisition cost
(WAC) data from the most recent available quarter. We solicited comment
on this updated payment proposal and valuation of HCPCS code G2082 and
G2083.
We received public comments on the Evaluation and Management,
Observation and Provision of Self-Administered Esketamine (HCPCS Codes
G2082 and G2083). The following is a summary of the comments we
received and our responses.
Comment: Overall, commenters were in support of our proposal to
refine the values for HCPCS codes G2082 and G2083.
Response: We appreciate the support for our proposal to refine the
direct PE inputs of HCPCS codes G2082 and G2083, in part, by using the
clinical labor time for CPT codes 95076 and 95079, in lieu of the
clinical labor time of CPT codes 99415 and 99416, which increased the
clinical labor time from 30 minutes to 150 minutes.
Comment: A commenter stated that administering esketamine may on
occasion necessitate a higher level of E/M from the physician, and
therefore, encouraged CMS to provide the ability to bill a separate E/M
service on those occasions where medical necessity dictates a higher
level of service. The commenter also requested that CMS issue a J-code
specifically for esketamine treatment and create a HCPCS code that
separates the clinical work of the service from the cost of the
medication.
Response: HCPCS codes G2082 and G2083 are bundled services that
include, as discussed in the CY 2021 PFS proposed rule (85 FR 50169
through 50172), the E/M, observation and the provision of self-
administered esketamine. We continue to believe that HCPCS codes G2082
and G2083 should be a bundled services. We do not believe it would be
appropriate to create a J-code that could permit esketamine to be
billed separately, particularly given that the product is only
available through a restricted distribution system under a REMS;
patients must be monitored by a health care provider for at least 2
hours after receiving their Spravato dose; the prescriber and patient
must both sign a Patient Enrollment Form; and the product will only be
administered in a certified medical office where the health care
provider can monitor the patient.\24\ Additionally, we continue to
believe that the building block methodology we used incorporating CPT
code 99212 is appropriate for valuing this service. Since HCPCS codes
G2082 and G2083 already take into account E/M provided as part of these
services, it would be duplicative for a clinician to bill for a
separate E/M code along with HCPCS codes G2082 and G2083. We believe
the direct PE input refinements made for HCPCS codes G2082 and G2083,
which increased the clinical labor time to 150 minutes, are appropriate
for the necessary observation associated with esketamine
administration. However, other reasonable and necessary E/M services
may be furnished and billed for a patient on dates before and after
HCPCS codes G2082 and G2083, for example, when the services are
furnished in the course of treating and diagnosing treatment-resistant
depression. Additionally, the self-administered esketamine is
considered a supply item for this bundled service. Therefore,
esketamine cannot be billed separately along with HCPCS codes G2082 and
G2033 under the PFS.
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\24\ https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
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After consideration of public comments, we are finalizing our
proposal to refine the values for HCPCS codes G2082 and G2083 using a
building block methodology that sums the values associated with several
codes.
(55) Bundled Payments Under the PFS for Substance Use Disorders (HCPCS
Codes G2086, G2087, and G2088)
In the CY 2020 PFS final rule (84 FR 62673), we finalized the
creation of new coding and payment describing a bundled episode of care
for the treatment of Opioid Use Disorder (OUD). The codes and
descriptors we finalized for CY 2020 were:
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).
As noted in the CY 2020 PFS final rule (84 FR 62673), 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.
As discussed in the CY 2021 PFS proposed rule (85 FR 50172), we
received requests to expand these bundled payments to be inclusive of
other SUDs, not just OUD. We agreed that doing so could expand access
to needed care. We proposed to expand these bundled payments to be
inclusive of all SUDs. To accomplish this, we proposed to revise the
code descriptors for HCPCS codes G2086, G2087, and G2088 by replacing
``opioid use disorder'' with ``a substance use disorder.'' The payment
and billing rules would otherwise remain unchanged. We noted that HCPCS
codes G2086, G2087, and G2088 were added to the Medicare Telehealth
list in the CY 2020 PFS final rule (84 FR 62628). The revised code
descriptors are:
HCPCS code G2086: Office-based treatment for a substance
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 a substance
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 a substance
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).
In addition, in the CY 2020 PFS final rule we stated that we
anticipated that the services described by HCPCS codes G2086, G2087,
and G2088 would often be billed by addiction specialty practitioners,
but note that these codes are not limited to any particular physician
or NPP specialty. We also noted that consultation was not a required
condition of payment for these codes, but that consultation with a
specialist could be counted toward the minutes required for billing
HCPCS codes G2086, G2087, and G2088 (84 FR 62674). Although it is not a
requirement for billing the code, we encouraged that practitioners
consult with specialists in cases where it is warranted and refer the
patient to specialty care as needed.
[[Page 84643]]
We noted that while these codes describe treatment for any SUD,
information about which specific SUDs are being treated would provide
valuable information that can help assess local, state, and national
trends and needs. We believe it is important that the diagnosis codes
listed on the claim form reflect all SUDs being treated; however, we
also noted that we do not wish to add any additional burden on
practitioners related to claims submission, and therefore, we solicited
information on whether there are sources of data we could explore in
order to provide this information. We also solicited information on
whether there are differences in the resource costs associated with
furnishing services for the various SUDs, and accordingly whether there
is a need for more stratified coding to describe these services. We
noted that in some instances, the CPT Editorial Panel has created CPT
codes to replace G codes created by CMS, and that we welcomed such
input on those services.
We received public comments on the proposal to expand these bundled
payments to be inclusive of all SUDs. The following is a summary of the
comments we received and our responses.
Comment: Several commenters supported this proposal. Some noted
that this flexibility would permit practitioners to furnish
comprehensive services for individuals with SUDs, the majority of whom
have polysubstance use disorder. One commenter noted that every service
code can have one or more diagnosis codes connected to it on a claim,
therefore, a generic SUD treatment code still permits physicians to
specify which SUDs were treated, allowing CMS to track that information
without adding additional administration burden. Some commenters also
stated they were not aware of any significant variation in resource
costs between SUDs. One stakeholder encouraged CMS to work with the
medical societies through the CPT Editorial Panel process to examine
the different resource costs involved in treating different SUDs to
determine the need for more stratified coding, but advised that in the
meantime, CMS should finalize the proposal to ensure that more patients
have access to these critical services. A few commenters suggested that
these codes should account for risk stratification, noting that some
patients, such as pregnant or postpartum women have more complex needs
and require more frequent services. One commenter stated that expanding
the use of these codes to all SUD diagnoses may present opportunity for
fraudulent, duplicative coding, were providers to bill the codes for
each SUD diagnosis, noting that many patients with SUD use multiple
substances and require treatment for more than one substance,
therefore, the commenter recommended that CMS limit billing of these
codes to once per month per patient.
Response: We thank the commenters for their feedback. After
consideration of the comments, we are finalizing our proposal to expand
the bundled payments described by HCPCS codes G2086-G2088 to be
inclusive of all SUDs. We appreciate the commenter that pointed out
that duplicative billing could occur in cases where a beneficiary is
being treated for more than one SUD. We agree that HCPCS codes G2086-
G2088 should not be billed more than once per month per beneficiary
since these codes describe treatment for one or more SUDs.
Additionally, we welcome the opportunity to work with the medical
societies and CPT Editorial Panel to determine whether there is a need
to stratify this coding to reflect variation in service intensity,
through future rulemaking.
(56) Initiation of Medication Assisted Treatment (MAT) in the Emergency
Department (HCPCS Code G2213)
In the CY 2020 PFS proposed rule (84 FR 40545), we sought comment
on the use of medication assisted treatment (MAT) in the emergency
department (ED) setting, including initiation of MAT and the potential
for either referral or follow-up care, to better understand typical
practice patterns to help inform whether we should consider making
separate payment for such services in future rulemaking. We noted that
the term MAT generally refers to treatment of OUD that includes both an
FDA-approved medication for the treatment of OUD and behavioral/
psychosocial treatment, but that care provided in the ED typically
would include medication for the treatment of OUD and referral or
linkage to primary care or a hospital-based bridge clinic for
continuation of medication and potentially other services, including
counseling and other psychosocial services.
The public comments received in response to the comment
solicitation were supportive of us making a proposal, several citing
research that indicates improved outcomes for patients who initiate
medications for the treatment of OUD in the ED. One commenter noted
that by implementing this treatment regimen, practitioners can address
a patient's immediate withdrawal symptoms, which allows time to
coordinate care and provide a referral to substance use disorder
specialists and other community resources who can appropriately carry
out long-term treatment. Another commenter cited that the national rate
of overdose-related visits seen in EDs nearly doubled between 2005 and
2014 and noted that hospital-based care represents a critical
opportunity to initiate treatment and connect patients with OUD to
care, noting that patients who receive information about drug treatment
in the hospital post-overdose are more likely to seek treatment.\25\
The commenter also cited a randomized clinical trial that showed that
more patients were engaged in treatment 30 days after buprenorphine was
initiated in the ED and coupled with a referral, compared to
interventions that did not include buprenorphine.\26\ Another study
found that ED induction of buprenorphine was more cost-effective than
either brief intervention or referral upon discharge.\27\ One commenter
suggested that CMS institute a G-code to address this coding gap in the
short term, while a more permanent solution is pursued to address this
site-of-service specification.
---------------------------------------------------------------------------
\25\ Agency for Healthcare Research and Quality, ``Statistical
Brief #219: Opioid-Related Inpatient Stays and Emergency Department
Visits by State, 2009-2014,'' (2017), https://www.hcup-us.ahrq.gov/reports/statbriefs/sb219-Opioid-Hospital-Stays-ED-Visits-by-State.pdf.
\26\ Gail D'Onofrio et al., ``Emergency Department--Initiated
Buprenorphine/Naloxone Treatment for Opioid Dependence Randomized
Clinical Trial,'' JAMA 16, no. 313 (2015): 2002-2010, https://www.ncbi.nlm.nih.gov/pubmed/25919527.
\27\ Susan Busch et al., ``Cost Effectiveness of Emergency
Department--Initiated Treatment for Opioid Dependence,'' Journal of
Addiction 11, no. 112 (2017), https://www.ncbi.nlm.nih.gov/pubmed/28815789.
---------------------------------------------------------------------------
We were persuaded by the comments received in response to our
comment solicitation that this work is not currently accounted for in
the existing code set. To account for the resource costs involved with
initiation of medication for the treatment of opioid use disorder in
the ED and referral for follow-up care, we proposed to create one add-
on G-code to be billed with E/M visit codes used in the ED setting. We
discussed that this code would include payment for assessment, referral
to ongoing care, follow-up after treatment begins, and arranging access
to supportive services, but we note that the drug itself would be paid
separately. We proposed the following code:
HCPCS code GMAT1: Initiation of medication for the
treatment of opioid use disorder in the emergency department setting,
including assessment, referral to ongoing care, and arranging access to
supportive
[[Page 84644]]
services (List separately in addition to code for primary procedure).
To price this service, we proposed to use a direct crosswalk to the
work and direct PE inputs for HCPCS code G0397 (Alcohol/subs interv
30 min), which is assigned a work RVU of 1.30. We noted that
we believe that the work and PE described by this crosswalk code is
similar in nature and magnitude to the services described in HCPCS code
GMAT1. We noted that unlike the requirements for reference code, we did
not propose a required number of minutes to bill HCPCS code GMAT1. We
welcomed comment on the proposal and whether we should consider a
different valuation to account for the resource costs involved with
these services.
We received public comments on our proposal to create an add-on G-
code to be billed with E/M visit codes used in the ED setting. The
following is a summary of the comments we received and our responses.
Comment: Commenters were very supportive of finalizing this
proposal, noting that payment for this service will encourage hospitals
to engage in this evidence-based practice. One commenter sought
clarification on which of these elements were mandatory given that
``initiation'' of the service for patients will involve a transition of
care to other health care providers and requested that CMS provide
guidance on what ``follow-up'' is required of the emergency department
provider given that post-initiation care is administered by the
practitioner to whom the ED provider would have transitioned the
patient care.
Response: We are finalizing payment for this code as proposed. We
note that HCPCS code GMAT1 was a placeholder code in the proposed rule.
The finalized code is HCPCS code G2213 (Initiation of medication for
the treatment of opioid use disorder in the emergency department
setting, including assessment, referral to ongoing care, and arranging
access to supportive services (List separately in addition to code for
primary procedure)). In response to the request for clarification about
which elements are required in order to bill for this code,
practitioners should furnish only those activities that are clinically
appropriate for the beneficiary that is being treated.
(57) Percutaneous Creation of an Arteriovenous Fistula (AVF) (HCPCS
Codes G2170 and G2171)
We received a comment in response to the CY 2020 PFS proposed rule
(84 FR 40481), as well as inquiries from stakeholders, requesting that
we establish new coding for the percutaneous creation of an
arteriovenous fistula (AVF) used for dialysis access.
For CY 2019, based on two new technology applications for
arteriovenous fistula creation, we established two new HCPCS codes to
describe the two modalities of this service. Specifically, we
established HCPCS code C9754 (Creation of arteriovenous fistula,
percutaneous; direct, any site, including all imaging and radiologic
supervision and interpretation, when performed and secondary procedures
to redirect blood flow (e.g., transluminal balloon angioplasty, coil
embolization, when performed)) and HCPCS code C9755 (Creation of
arteriovenous fistula, percutaneous using magnetic-guided arterial and
venous catheters and radiofrequency energy, including flow-directing
procedures (e.g., vascular coil embolization with radiologic
supervision and interpretation, when performed) and fistulogram(s),
angiography, venography, and/or ultrasound, with radiologic supervision
and interpretation, when performed). The HCPCS codes were created for
institutional payment systems, and thus do not allow for payment for
the physician's work portion of the service. Stakeholders have stated
that the lack of proper coding to report the physician work associated
with these procedures is problematic, as physicians are either billing
an unlisted procedure code, or are billing other CPT codes that do not
appropriately reflect the resource cost associated with the physician
work portion of the service. Stakeholders stated that separate coding
for physician payment will allow billing when the procedures are
furnished in either a physician office or an institutional setting, and
be paid under the respective payment systems, as appropriate. We have
recognized that the lack of appropriate coding for this critical
physician's service has become an even greater burden given the PHE for
COVID-19. In order to mitigate potential health risks to beneficiaries,
physicians and practitioners as a result of having this procedure
performed in an institutional setting, we created two HCPCS G codes for
percutaneous creation of an arteriovenous fistula (AVF). The codes are
contractor priced and effective July 1, 2020. This will allow for more
accurate billing and coding of a crucial physician service that could
then be performed in both institutional and office settings, thus
mitigating unnecessary risk to beneficiaries, physicians and
practitioners caused by disease transmission. The HCPCS G codes are
described as follows:
HCPCS G code G2170 (Percutaneous arteriovenous fistula
creation (AVF), direct, any site, by tissue approximation using thermal
resistance energy, and secondary procedures to redirect blood flow
(e.g., transluminal balloon angioplasty, coil embolization) when
performed, and includes all imaging and radiologic guidance,
supervision and interpretation, when performed.)
HCPCS G code G2171 (Percutaneous arteriovenous fistula
creation (AVF), direct, any site, using magnetic-guided arterial and
venous catheters and radiofrequency energy, including flow-directing
procedures (e.g., vascular coil embolization with radiologic
supervision and interpretation, when performed) and fistulogram(s),
angiography, venography, and/or ultrasound, with radiologic supervision
and interpretation, when performed.)
We proposed to maintain contractor pricing for these HCPCS codes
for CY 2021, however, we also solicited information from stakeholders
on the resource costs involved in furnishing the services described by
HCPCS codes G2170 and G2171 to ensure proper payment for these
physician's services, for consideration in future rulemaking. We noted
that under the OPPS these services are assigned to APC 5193, which for
CY 2020 has an assigned payment rate of $15,938.20.
We received public comments on Percutaneous Creation of an
Arteriovenous Fistula (AVF) (HCPCS code G2170 and G2171).
The following is a summary of the comments we received and our
responses.
Comment: Commenters stated that they were supportive of the
creation of the HCPCS codes G2170 and G2171. Many commenters stated
that they believe this will increase access for beneficiaries by
allowing this service to be performed in outpatient settings.
Commenters were also appreciative of the creation of these codes for
use during the PHE.
Response: We appreciate the commenters' support of the creation of
HCPCS codes G2170 and G2171.
Comment: A few commenters stated that they did not understand the
logic of our proposal to contractor price HCPCS codes G2170 and G2171
to avoid disease transmission.
Response: We believe that our statement about reduced risk of
disease transmission in connection with our proposal to maintain
contractor pricing
[[Page 84645]]
for calendar year 2021 for HCPCS codes G2170 and G2171 may have been
confusing to some commenters. We created HCPCS codes G2170 and G2171 to
facilitate provision of these services outside of institutional
facility settings. We stated that expanded access to this service
outside of facility settings, especially in light of the PHE for COVID-
19, could reduce the potential health risks to beneficiaries,
physicians and other health care practitioners that could occur when
these services are furnished in higher acuity health care settings. The
proposal to contractor price these services was not related to risks of
disease transmission.
Comment: Commenters stated that they believe HCPCS codes G2170 and
G2171 should be nationally priced for calendar year 2021 and beyond.
The commenters stated that they believe contractor pricing creates
unnecessary variability and unreliable payment.
Response: CMS routinely contractor prices new HCPCS codes. The
services described by G2170 and G2171 are new technology and are just
beginning to be performed outside of the facility setting. As such, we
anticipate collecting more information for purposes of national
pricing. We expect to take these comments into consideration for future
rulemaking and we hope to continue a dialogue with stakeholders on
these important services.
Comment: A few commenters stated that they are displeased with the
publication of a proposed Local Coverage Determination (LCD) that would
limit coverage for these services.
Response: We appreciate the concern of some commenters regarding a
proposed LCD for HCPCS codes G2170 and G2171. We did not address
coverage policies for these services in the proposed rule. Such local
coverage policies are not within the scope of the CY 2021 PFS
rulemaking process.
Comment: A few commenters responded to our request for information
from stakeholders on the resource costs involved in furnishing the
services described by HCPCS codes G2170 and G2171 for consideration in
future rulemaking. Some commenters submitted invoices for various
equipment as well as a breakdown of their estimated supply and clinical
staff costs.
Response: We appreciate the information commenters provided on the
resource costs involved in furnishing these services. We will take this
information into consideration for future rulemaking.
After consideration of these public comments, we are finalizing our
proposals for HCPCS codes G2170 and G2171 with contractor pricing as
proposed, and will consider addressing national pricing through
potential future rulemaking.
(58) 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). The codes that
describe the implantation, removal, and removal and implantation of
implantable interstitial glucose sensors are currently contractor-
priced.
Category III CPT code 0446T (Creation of subcutaneous
pocket with insertion of implantable interstitial glucose sensor,
including system activation and patient training);
Category III CPT code 0447T (Removal of implantable
interstitial glucose sensor from subcutaneous pocket via incision); and
Category III CPT code 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).
In the CY 2020 PFS final rule (84 FR 62627), we requested
information from stakeholders to ensure proper payment for this
important physician's service and welcomed recommendations on
appropriate valuation for these services to be considered in future
rulemaking.
We proposed to establish national payment amounts for the codes
describing the insertion, removal, and removal and insertion of an
implantable interstitial glucose sensor, effective January 1, 2021. We
proposed a work RVU of 1.14 for Category III CPT code 0446T, a work RVU
of 1.34 for Category III CPT code 0447T, and work RVU of 1.91 for
Category III CPT code 0448T based on a crosswalk to the work RVUs, work
time, and direct PE inputs of CPT codes 11981 (Insertion, non-
biodegradable drug delivery implant), 11982 (Removal, non-biodegradable
drug delivery implant), and 11983 (Removal with reinsertion, non-
biodegradable drug delivery implant), respectively, due to the similar
clinical nature of these procedures.
We also proposed to include one supply and one equipment item to
the direct PE inputs crosswalked from CPT codes 11981-11983. We added a
new ``implantable interstitial glucose sensor'' (supply code SD334) for
Category III CPT codes 0446T and 0448T to include the supply costs of
the ``implantable interstitial glucose sensor'' (supply code SD334)
included in these procedures, which we proposed to price at $1,500.00,
based on information we received from stakeholders. We also proposed to
include the smart transmitter associated with the use of this
implantable interstitial glucose sensor. We proposed to price the smart
transmitter involved in furnishing this service by using a similar
equipment item finalized in the CY 2019 PFS final rule (83 FR 59624) as
a proxy, the ``heart failure patient physiologic monitoring equipment
package'' (EQ392); the EQ392 has a price of $1,000.00, and is similarly
used for long term remote monitoring of patients. We proposed to use
the EQ392 equipment as a proxy for the valuation of the smart
transmitter associated with the implantable interstitial glucose
sensor, to which we are assigning a time of 25,920 minutes for EQ392 in
Category III CPT codes 0446T and 0448T. We explained that this time is
derived from 60 minutes per hour times 24 hours per day times 90 days
per billing quarter, divided by 1 minute of equipment use out of every
5 minutes of time. We did not include the implantable interstitial
glucose sensor or the EQ392 equipment proxy for Category III CPT code
0447T, as it describes only a removal procedure.
We solicited comment on the proposed values for these Category III
CPT codes (0446T, 0447T, and 0448T), and we solicited comment on the
appropriateness and accuracy of the proposed work RVUs, work times, and
direct PE inputs.
We received public comments on the Insertion, Removal, and Removal
and Insertion of Implantable Interstitial Glucose Sensor System code
family. The following is a summary of the comments we received and our
responses.
Comment: Commenters supported the proposed work RVUs for the
Category III CPT codes, 1.14 for Category III CPT code 0446T, 1.34 for
Category III CPT code 0447T, and 1.91 for Category III CPT code 0448T.
Response: We appreciate the support for the proposed work RVUs for
these Category III CPT codes (0446T, 0447T, and 0448T).
Comment: Several commenters stated that they agreed with the
inclusion of
[[Page 84646]]
the ``implantable interstitial glucose sensor'' supply (SD334) for
Category III CPT codes 0446T and 0448T, which should include the supply
costs of the implantable interstitial glucose sensor at the proposed
price of $1,500.00. However, the commenters stated that the cost of the
smart transmitter equipment (EQ392) associated with the use of the
implantable interstitial glucose sensor should be included only for
Category III CPT code 0446T and not be included as part of the cost of
Category III CPT code 0448T. A commenter stated that the 90-day
implantable sensor will be implanted for the first time and linked to
the transmitter device in the first procedure, Category III CPT code
0446T. The commenter stated that there is no need to report the cost of
the transmitter with Category III CPT 0448T as the sensor will be
removed and replaced, but the patient will not receive a new smart
transmitter during this visit.
Response: We appreciate the additional information supplied by the
commenter regarding the use of the smart transmitter equipment in
Category III CPT codes 0446T and 0448T. Given that there is no need to
report the cost of the transmitter with Category III CPT 0448T because
the sensor will be removed and replaced, but the patient will not
receive a new smart transmitter during this visit, we are finalizing
the removal of the heart failure patient physiologic monitoring
equipment package (EQ392) from Category III CPT code 0448T.
After consideration of public comments, we are finalizing the work
RVUs as proposed for Category III CPT codes 0446T, 0447T, and 0448T,
and finalizing the direct PE inputs as proposed except that we are
removing the equipment package (EQ392) from the Category III CPT code
0448T in response to comments as explained above.
BILLING CODE 4120-01-P
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[[Page 84682]]
BILLING CODE 4120-01-C
I. Modifications Related to Medicare Coverage for Opioid Use Disorder
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)
1. Background
Section 2005 of the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities (SUPPORT)
Act established a new Medicare Part B benefit category for OUD
treatment services furnished by OTPs during an episode of care
beginning on or after January 1, 2020. In the CY 2020 PFS final rule
(84 FR 62630 through 62677), we implemented coverage requirements and
established new codes describing the bundled payments for episodes of
care for the treatment of OUD furnished by OTPs. We established new
codes for and finalized bundled payments for weekly episodes of care
that include methadone, oral buprenorphine, implantable buprenorphine,
injectable buprenorphine or naltrexone, and non-drug episodes of care,
as well as add-on codes for intake and periodic assessments, take-home
dosages for methadone and oral buprenorphine, and additional
counseling. We are monitoring Medicare enrollment by OTPs and
utilization of the new benefit to ensure that Medicare beneficiaries
have appropriate access to care. For CY 2021, we proposed several
refinements and also provided clarification of certain issues that
stakeholders have brought to our attention.
2. Definition of OUD Treatment Services
In the CY 2020 PFS final rule (84 FR 62631 through 62635), we
finalized a definition of ``OUD treatment services'' that reflects the
statutory definition in section 1861(jjj)(1)(A) of the Act, which
defines covered OUD treatment services to include oral, injected, and
implanted opioid agonist and antagonist treatment medications approved
by the Food and Drug Administration (FDA) under section 505 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) for use in the treatment
of OUD. There are three drugs currently approved by FDA for the
treatment of opioid dependence: Buprenorphine; methadone; and
naltrexone. In the CY 2020 PFS final rule, we noted that we had
received comments supporting the proposed definition of OUD treatment
services but also requesting that CMS include naloxone to treat opioid
overdose in that definition as a medication used in treatment of OUD.
Although we did not finalize including naloxone in the definition of
OUD treatment services in that final rule, we indicated that as we
continue to work on refining this new Medicare benefit, we would
consider including additional drugs in the definition of OUD treatment
services under our discretionary authority in section 1861(jjj)(1)(F)
of the Act to include other items and services the Secretary determines
are appropriate. As explained in the CY 2021 PFS proposed rule (85 FR
50203), we determined, after further consideration, that it would be
appropriate to propose to extend the definition of OUD treatment
services to include opioid antagonist medications, such as naloxone,
that are approved by FDA under section 505 of the FFDCA for emergency
treatment of opioid overdose.
Naloxone is an opioid antagonist indicated for the emergency
treatment of known or suspected opioid overdose, as manifested by
respiratory and/or central nervous system depression.\28\ \29\ Naloxone
should be given to a person who shows signs of an opioid overdose or
when an overdose is suspected. FDA-approved naloxone products for
overdose reversal are effective in reversing opioid overdose, including
fentanyl-involved opioid overdoses, although overdoses involving potent
(for example, fentanyl) or large quantities of opioids may require
higher-than-normal doses of naloxone or repeated administration to
reverse overdose.\30\
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\28\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.
\29\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.
\30\ https://store.samhsa.gov/sites/default/files/d7/priv/sma18-4742.pdf.
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Naloxone attaches to opioid receptors and reverses and blocks the
effects of other opioids.\31\ FDA has approved injectable naloxone,
intranasal naloxone, and naloxone auto-injector as emergency treatments
for opioid overdose. The nasal spray is a prefilled, needle-free device
that requires no assembly and can deliver a single dose into each
nostril with two sprays. The auto-injector is injected into the outer
thigh to deliver naloxone to the muscle (intramuscular). Both the nasal
spray and naloxone auto-injector are packaged in a carton containing
two doses to allow for repeat dosing if needed.\32\ \33\ These forms of
naloxone can easily be administered by persons who do not have medical
training and they may be prescribed to a patient who is receiving
medication-assisted treatment (MAT) for OUD, especially if the patient
is considered to be at risk for opioid overdose.\34\ However, it is
important to understand how to administer naloxone properly. A doctor
or pharmacist can show patients, their family members, or caregivers
how to administer naloxone.\35\ We expect that a treating practitioner
that is prescribing naloxone will also educate the patient, as
appropriate, on how to administer the specific form of naloxone
prescribed.
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\31\ https://www.drugabuse.gov/publications/drugfacts/naloxone.
\32\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.
\33\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.
\34\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naloxone.
\35\ https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/naloxone.
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The U.S. Surgeon General Jerome M. Adams, M.D., M.P.H. has released
a public health advisory stating that, ``Research shows that when
naloxone and overdose education are available to community members,
overdose deaths decrease in those communities. Therefore, increasing
the availability and targeted distribution of naloxone is a critical
component of our efforts to reduce opioid-related overdose deaths and,
when combined with the availability of effective treatment, to ending
the opioid epidemic.'' \36\
---------------------------------------------------------------------------
\36\ https://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html.
---------------------------------------------------------------------------
In the CY 2021 PFS proposed rule, we proposed to add naloxone to
the definition of OUD treatment services in order to increase access to
this important emergency treatment and to allow OTPs to be paid under
Medicare for dispensing naloxone to Medicare beneficiaries who are
receiving other OUD treatment services from the OTP. Under the
proposal, beneficiaries receiving OUD treatment services from the OTP
would be able to receive naloxone from the OTP under the OUD treatment
services benefit, to the extent it is medically reasonable and
necessary as part of their OUD treatment. We noted that naloxone is
already covered under Medicare Part D. In 2017, 72.5 percent of all
Medicare beneficiaries were enrolled in Medicare Part D plans.\37\
However, as we explained in the proposed rule, we believe allowing
beneficiaries to access this important emergency treatment at the OTP
may help to decrease barriers to access because there currently are no
copayments for services furnished by OTPs and beneficiaries would not
need to visit a separate provider to access naloxone.
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\37\ http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch14_sec.pdf.
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Accordingly, to align with efforts to end the opioid epidemic,
under the discretionary authority in section
[[Page 84683]]
1861(jjj)(1)(F) of the Act, we proposed to amend the definition of OUD
treatment services at Sec. 410.67(b) by adding Sec. 410.67(b)(8) to
include opioid antagonist medications that are approved by FDA under
section 505 of the FFDCA for the emergency treatment of known or
suspected opioid overdose. We proposed to amend the definition of OUD
treatment services under the discretionary authority in section
1861(jjj)(1)(F) of the Act rather than the authority under section
1861(jjj)(1)(A) of the Act because section 1861(jjj)(1)(A) of the Act
pertains to opioid agonist and antagonist treatment medications
(including oral, injected, or implanted versions) that are approved by
FDA under section 505 of the FFDCA for use in the treatment of opioid
use disorder. As we explained in the CY 2021 PFS proposed rule,
naloxone is not one of the three drugs currently approved by FDA for
the treatment of opioid dependence (buprenorphine, methadone, and
naltrexone); \38\ and, as a result, we do not believe naloxone fits the
criteria of section 1861(jjj)(1)(A) of the Act. We sought comment on
our proposal to expand the definition of OUD treatment services.
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\38\ https://www.fda.gov/drugs/information-drug-class/information-about-medication-assisted-treatment-mat.
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Additionally, we noted that we agree with the public health
advisory quoted previously that community education related to overdose
prevention is needed to address the opioid crisis. We believe that
prevention and community education efforts would increase awareness of
treatment options and could play a role in decreasing opioid overdose
deaths. We solicited comments on whether the definition of OUD
treatment services should be further revised to include overdose
education. Additionally, we also solicited comments on whether payment
for providing overdose education to the beneficiary and/or the
beneficiary's family or partner should be considered to be included in
the current weekly bundled payments for episodes of care or whether we
should consider establishing an add-on payment for education related to
overdose prevention when such services are furnished by OTPs. We
specifically sought information related to what inputs we might
consider in developing the payment rate for such a service, such as
payment amounts for similar services under the PFS, if we were to
include this type of education as part of the proposed new add-on codes
for naloxone discussed later in this section (HCPCS codes GOTP1 and
GOTP2), For example, in order to establish a payment rate for education
related to overdose prevention for the beneficiary and/or the
beneficiary's family or partner, we could consider a crosswalk to the
Medicare payment rate for CPT code 96161 (Administration of caregiver-
focused health risk assessment instrument (e.g., depression inventory)
for the benefit of the patient, with scoring and documentation, per
standardized instrument). The current non-facility payment rate under
the PFS for CPT code 96161 is $2.53.
a. Adjustment to the Bundled Payments for OUD Treatment Services
Consistent with the proposal to expand the definition of OUD
treatment services to include opioid antagonist medications indicated
for the emergency treatment of known or suspected opioid overdose, we
noted that we believed it would be appropriate to propose changes to
the payment rates for the bundled payments to reflect the costs of
these medications. Therefore, we proposed to adjust the bundled payment
rates through the use of add-on codes to account for instances in which
OTPs provide Medicare beneficiaries with naloxone. We explained that we
believe beneficiaries receiving naloxone will need a supply at the
start of treatment and would only require refills later if the supply
is used in an emergency. As a result, we noted that we would not expect
naloxone to be provided weekly to all patients, but only on an as-
needed basis. Accordingly, we noted that we believed that making
payment for naloxone through the use of an add-on code would be the
most accurate approach to pricing rather than including the costs of
these medications as part of the bundled payment rates for all episodes
of care.
We proposed to adopt the following add-on G codes:
HCPCS code GOTP1: Take-home supply of nasal naloxone
(provision of the services by a Medicare-enrolled Opioid Treatment
Program); List separately in addition to code for primary procedure.
HCPCS code GOTP2: Take-home supply of auto-injector
naloxone (provision of the services by a Medicare-enrolled Opioid
Treatment Program); List separately in addition to code for primary
procedure.
We proposed to adopt an approach similar to the pricing methodology
that was used to price the drug component of the bundled payments in
the CY 2020 PFS final rule to determine the payment rate for these
proposed new add-on codes for naloxone. In the CY 2020 PFS proposed
rule (84 FR 40530), we explained that 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. Therefore, we noted that we believe it
would be appropriate to use a methodology similar to the one we adopted
in the CY 2020 PFS final rule (84 FR 62650 through 62657), for purposes
of determining the payment rate for the drug component of the bundled
payments to determine the payment rates for the add on codes for
naloxone because this methodology would provide the best estimate of an
OTP's cost in dispensing naloxone.
In the CY 2020 PFS final rule, we adopted a policy under which we
apply the methodology set forth in section 1847A of the Act to
determine the payment amount for the drug component of the bundled
payment for an episode of care that includes implantable or injectable
medications, except that the payment amount shall be 100 percent of the
average sales price (ASP), if ASP is used. For oral medications, the
payment for the drug component is based on 100 percent of ASP, if ASP
data are available. However, if ASP is not available, the payment
amount for methadone will be based on the TRICARE rate and the payment
amount for oral buprenorphine is calculated using the national average
drug acquisition cost (NADAC).
We received public comments on the proposed adjustment to the
bundled payments for OUD treatment services to account for instances in
which OTPs provide Medicare beneficiaries with naloxone. The following
is a summary of the comments we received and our responses.
Comment: Commenters were overwhelmingly supportive of extending the
definition of OUD treatment services to include opioid antagonist
medications, such as naloxone.
Response: We thank commenters for their support of extending the
definition of OUD treatment services to include opioid antagonist
medications, such as naloxone. Because we continue to believe that the
availability of emergency treatment medications is an important
component of treatment for OUD, we are finalizing our proposal to amend
the definition of OUD treatment service in Sec. 410.67 to add
paragraph (b)(8) to include opioid antagonist medications approved by
the FDA under section 505 of the FFDCA for emergency treatment of known
or suspected opioid overdose.
[[Page 84684]]
Comment: Overall, commenters were in support of revising the
definition of OUD treatment services to include overdose education.
Several commenters indicated that overdose education should be included
in the currently established bundled payment. Some other commenters
suggested creating a separate add-on code and payment for providing
overdose prevention education. Some commenters supported including
community education for naloxone as an add-on service, but disagreed
with the example provided in the proposed rule (85 FR 50203 and 50204)
of using the CY 2020 Medicare payment rate for CPT code 96161 of $2.53
to determine the additional payment amount. Rather, a commenter stated
that CPT code 96161 is not commensurate with the cost of the service
nor reflective of the required staff involvement and overhead cost and
recommended a payment rate of $20 at 15-minute increments. While
another commenter thought the clinical activities are more aligned with
98960 (Education and training for patient self-management by a
qualified, nonphysician health care professional using a standardized
curriculum, face-to-face with the patient (could include caregiver/
family) each 30 minutes; individual patient). Another commenter
indicated that overdose education was proposed for Medicare Part D
plans for contract year 2021 as part of Medication Therapy Management
(MTM) and Drug Management Programs (DMP). However, no additional
payment was proposed for these services when delivered in Medicare Part
D. Another commenter stated that all patients receiving treatment at an
OTP as well as their families should receive overdose education and
urged CMS to include this payment in the add-on payments for intake
activities and periodic assessments, and in the bundled payment for the
initial month of substance use disorder treatment. One commenter stated
that the availability of naloxone and other medications that can
rapidly reverse an opioid overdose, along with education on its proper
use, will save lives. The commenter also recommended that, whether
reimbursement for overdose education is included as part of the bundled
payment or billed as an add-on service, CMS include guardrails on what
services OTPs are permitted to code as education to prevent waste and
abuse, including specific requirements regarding the quality of
services.
Response: After consideration of comments, we are revising the
definition of OUD treatment services to include overdose education. We
continue to agree with the U.S. Surgeon General's public health
advisory discussed above that community education related to overdose
prevention is needed to address the opioid crisis. Overdose education
includes educating patients and caregivers on how to recognize
respiratory depression, the signs and symptoms of a possible opioid
overdose, how to administer naloxone in the event of an overdose, and
the importance of calling 911 or getting emergency medical help right
away, even if naloxone is administered.\39\ Providing naloxone and
teaching people to use it is an effective means of preventing deaths
among people who misuse opioids. With brief training, most adults can
learn to administer life-saving naloxone.\40\ We are modifying the
proposed provision at Sec. 410.67(b)(8) to include a reference to
overdose education that is furnished in conjunction with opioid
antagonist medications. After considering the commenters'
recommendations regarding the payment rate for this type of education,
which ranged from a payment rate of $20 for each 15 minutes of
education, to no separate payment for this education, we have
determined that it would be appropriate to use a crosswalk to the CY
2020 Medicare payment rate for CPT code 96161 (Administration of
caregiver-focused health risk assessment instrument (e.g., depression
inventory) for the benefit of the patient, with scoring and
documentation, per standardized instrument), which is assigned a non-
facility payment rate under the PFS of $2.53. We believe this reference
code describes a similar level of service intensity and amount of
clinical staff time involved in furnishing overdose education. We
believe establishing a separate add-on code for overdose education to
be billed in 15-minute increments is unnecessary and may result in
overpayment for this service. As noted in the CY 2017 PFS final rule
(81 FR 80331), we recognize that practitioners' interactions with
caregivers or family members are an integral part of treatment for some
patients. Overdose education and naloxone distribution programs have
reduced opioid-related overdose for over 20 years.\41\ Therefore, as
naloxone and overdose education complement one another, we are
finalizing add-on codes for naloxone that consist of both a drug
component and a non-drug component that would account for overdose
education furnished by the OTP. Therefore, the overdose education add-
on will be included each time naloxone is furnished by the OTP. We will
consider for future rulemaking whether separate coding is needed to
allow payment for overdose education when it is furnished separate from
the OTP furnishing the patient with naloxone.
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\39\ https://www.fda.gov/media/140360/
download#:~:text=%E2%80%A2%20Naloxone%20is%20an%20FDA-
approved%20medicine%20used%20to,Signs%20of%20an%20opioid%20overdose%2
0include%20breathing%20problems%2C.
\40\ https://www.samhsa.gov/homelessness-programs-resources/hpr-resources/useful-resources-opioid-overdose-prevention.
\41\ https://www.japha.org/article/S1544-3191(17)30002-X/
fulltext.
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Comment: Several commenters were in support of creating a new code
for auto-injector naloxone and nasal naloxone. One commenter stated
that the generic version of the auto-injector naloxone is currently not
available in the marketplace.
Response: We thank the commenters for their support for creating
new codes for the auto-injector naloxone and nasal naloxone. After
consideration of the comments, we are finalizing our proposal to
establish an add-on code for nasal naloxone that is dispensed in
conjunction with an episode of care for treatment of OUD. We believe
establishing an add-on code for nasal naloxone to allow OTPs to receive
payment when they dispense this medication will allow beneficiaries
access to this important emergency treatment at OTPs and may help
decrease barriers to access because there are currently no copayments
for services furnished by OTPs and beneficiaries would not need to
visit a separate provider to access naloxone. We note that both the
brand and authorized generic formulation of the auto-injector naloxone
have been discontinued with obsolete dates effective September 4,
2020.\42\ Therefore, we are not finalizing our proposal to create an
add-on code for auto-injector naloxone.
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\42\ https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209862.
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After consideration of comments, we are extending the definition of
OUD treatment services to include short acting opioid antagonist
medications, such as naloxone. We are further revising the definition
of OUD treatment services to include overdose education furnished in
conjunction with providing an opioid antagonist medication. We are also
finalizing our proposal to create a code for nasal naloxone: HCPCS code
G2215 (Take-home supply of nasal naloxone (provision of the services by
a
[[Page 84685]]
Medicare-enrolled Opioid Treatment Program)); List separately in
addition to code for primary procedure.), which will include both a
drug component and a non-drug component for overdose education. The
payment for the non-drug component of this code will be determined
using a crosswalk to the Medicare payment rate for CPT code 96161 of
$2.53.
Drug Pricing for Nasal Naloxone
Consistent with the approach that we adopted for pricing the drug
component of the weekly bundled payments, we proposed to price the add-
on code describing the take home supply of nasal naloxone, using the
same methodology we previously adopted for pricing the drug component
of episodes of care that include implantable or injectable medications.
Accordingly, the payment methodology would be based upon the
methodology set forth in section 1847A of the Act, except that payment
amounts determined based on ASP and wholesale acquisition cost (WAC)
would not include any add-on percentages. In the CY 2021 PFS proposed
rule (85 FR 50204), we acknowledged that nasal naloxone is not an oral,
implantable or injectable medication; however, ASP data are available.
We explained that, as noted in the CY 2020 PFS final rule (84 FR
62653), we believe using ASP provides a transparent and public
benchmark for manufacturers' pricing as it reflects the manufacturers'
actual sales prices to all purchasers (with limited exceptions as noted
in section 1847A(c)(2) of the Act) and is the only pricing methodology
that includes off-invoice rebates and discounts as described in section
1847A(c)(3) of the Act. Therefore, we believe ASP to be the most
market-based approach to set drug prices. We sought public comment on
our proposal to use ASP+0 to price the add-on payment for nasal
naloxone and other potential sources of pricing data for nasal naloxone
either generally or specifically with respect to acquisition by OTPs.
We received public comments on the proposed drug pricing for nasal
naloxone. The following is a summary of the comments we received and
our responses.
Comment: Several commenters opposed the proposed ASP + 0 payment
for nasal naloxone and asserted that if payment for nasal naloxone is
below cost, OTPs would not be able to offer this medication to Medicare
beneficiaries. A commenter indicated that this product is made by one
manufacturer that does not offer volume discounts. Commenters generally
recommended including an add-on payment similar to other drugs. A
couple of commenters stated that the cost for OTPs to purchase nasal
naloxone is $125. Accordingly, they recommended a payment of cost + 6
percent for nasal naloxone ($125 + 6 percent). A commenter indicated
the cost + 6 percent payment rate would avoid imposing a financial loss
on OTPs for providing naloxone and take into account OTP overhead costs
(for example, training, security), thereby encouraging OTPs to provide
this critical medication. A few commenters were in support of the
proposed ASP + 0 payment for nasal naloxone. One commenter agreed that
setting the payment rate for nasal naloxone at ASP is a reasonable
approach.
Response: After review of the comments, we are finalizing our
proposal to apply the payment methodology set forth in section 1847A of
the Act to determine the payment for the nasal naloxone. However, as
proposed, payment amounts for nasal naloxone, determined based on ASP
and wholesale acquisition cost (WAC) will not include any add-on
percentages. The use of ASP provides a transparent and public benchmark
for the acquisition cost of a drug 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. We believe
this approach is most consistent with the approach we adopted in the CY
2020 PFS final rule for pricing the drug component of an episode of
care that includes implantable or injectable medications. For the
reasons discussed in the CY 2020 PFS final rule (84 FR 62652 and
62653), we continue to believe that limiting the payment amount 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 will incentivize
the use of the most clinically appropriate drug for a given patient. We
understand that many OTPs purchase medications directly from drug
manufacturers, thereby limiting the markup from distribution channels.
We continue to believe that 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. We
believe that our proposed approach of paying for nasal naloxone 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.
We are interested in continuing to obtain feedback regarding access
concerns related to naloxone payment. We will monitor utilization of
these codes in the claims data to determine whether CMS should consider
proposing changes in the future to the payment policies finalized in
this rule.
Drug Pricing for Auto-Injector Naloxone
We proposed to price the add-on code describing the take-home
supply of auto-injector naloxone, using the lowest pricing available
(the lower of ASP + 0, WAC + 0, or NADAC). Currently, there is no ASP
or NADAC reported or calculated for auto-injector naloxone.
Accordingly, we proposed to use WAC + 0 to determine the pricing for
the add-on payment for auto-injector naloxone. We explained that we
believe 100 percent of WAC is a closer estimate of the actual
acquisition cost for OTPs compared to WAC with an add-on percentage
because, as defined in section 1847A(c)(6)(B) of the Act, WAC does not
include prompt pay discounts, rebates or reductions in price. Thus,
there should be no need to pay an add-on percentage to ensure OTPs are
reimbursed for their acquisition costs for auto-injector naloxone.
However, we also noted that in the future, using the lowest pricing
available for auto-injector naloxone may be most appropriate, because
if ASP and/or NADAC pricing were to become available for auto-injector
naloxone, they would be more reflective of actual costs than a list
price.
We noted that auto-injector naloxone was available in both a
generic and brand name version. We explained that we had considered
comparing the Medicare Part D utilization for each formulation to
determine the frequency with which the generic and brand name versions
might dispensed by OTPs. However, because the generic auto-injector
naloxone was rather new to the marketplace \43\, we acknowledged that
there were limited utilization data available for the generic product.
Based on historical information reflecting a
[[Page 84686]]
trend of increased generic utilization uptake,\44\ we explained that we
believed that in most cases where the auto-injector naloxone would be
prescribed and dispensed by OTPs to beneficiaries, it would be the
generic formulation of the product. Therefore, we noted that we
believed using the price for the generic formulation would be a
reasonable approach to pricing the proposed add-on code for auto-
injector naloxone and would ensure that beneficiaries who need this
drug as part of their treatment for OUD would have access to it and
that OTPs would receive a reasonable payment for dispensing the drug.
Accordingly, we proposed to use the price of the generic formulation,
determined as WAC + 0, to pay for auto-injector naloxone when the drug
is provided by an OTP as part of an episode of care. We sought comment
on our proposed pricing methodology to pay for auto-injector naloxone
and other potential sources of pricing data for auto-injector naloxone
either generally or specifically with respect to acquisition by OTPs.
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\43\ https://kaleo.com/in-the-news/authorized-generic-for-evzio-naloxone-hcl-injection-to-be-available-at-a-reduced-list-price-of-178/.
\44\ In 2015, approximately 87 percent of prescriptions filled
under Part D were for generic drugs, compared with 61 percent in
2007. http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch14_sec.pdf.
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We received public comments on the proposed drug pricing for auto-
injector naloxone. The following is a summary of the comments we
received and our response.
Comment: One commenter pointed out that generic auto-injector
naloxone is not currently available in the marketplace and stated that
the brand name auto-injector naloxone costs about $4,000. The commenter
stated that the proposed payment rate for auto-injector naloxone is
inadequate and should be revised to accurately reflect the true
acquisition cost of the drug. Another commenter recommended a payment
rate of cost plus 6 percent for auto-injector naloxone. Some other
commenters also recommended including an add-on of plus 6 percent to
the payment rate, similar to other drugs.
Response: As previously discussed, both the brand name auto-
injector (Evzio) and authorized generic naloxone auto-injector were
recently discontinued with obsolete dates effective September 4, 2020.
Because auto-injector naloxone is no longer available in the
marketplace, we are not finalizing the proposed code and pricing for
auto-injector naloxone.
Frequency Limit
In the CY 2021 PFS proposed rule (85 FR 50205), we noted that
Medicare Part D allows prescription drug plans to place quantity limits
(QL) on most drugs, including on naloxone. While most Medicare Part D
plans do not limit the amount of naloxone a beneficiary is able to
receive in a given month, when they do, they most frequently allow a
plan enrollee a maximum of 4 units per 30 days (2 boxes of 2 units). In
the current contract year (2020) only 22 percent of Medicare Part D
formularies apply a QL to naloxone (115/535 formularies), while for the
2021 contract year only 19 percent of Medicare Part D formularies plan
to apply a QL to this product (106/564 formularies). However, a review
of Medicare Part D claims data shows that beneficiaries who use
naloxone most frequently use only one box (2 units) within a 30-day
period even though nearly all plans would have permitted additional
doses. We also noted that under TRICARE, auto-injector naloxone is
covered for a maximum quantity of one carton at retail network
pharmacies for up to a 30-day supply.\45\ We explained our belief that
it would be appropriate to apply a similar limit on the frequency of
the add-on payment for naloxone dispensed by OTPs. We stated that
applying a frequency limit would assist in enhancing patient safety and
discourage misuse, waste and abuse. Furthermore, we noted that such a
limitation was reasonable because there are other services that OTPs
should already be performing, and which are already included in the
weekly bundled payments for episodes of care, such as counseling and
individual and group therapy, that should limit the need for this
emergency treatment. However, we noted that we do not want to limit
access to naloxone when it is a medically reasonable and necessary part
of the treatment for OUD. Therefore, we proposed to limit Medicare
payment to OTPs for naloxone to one add-on code (HCPCS code GOTP1 or
GOTP2) every 30 days to the extent that it is medically reasonable and
necessary. We sought comment on whether this proposed limit was
reasonable and whether special circumstances may arise under which more
frequent payment would be medically reasonable and necessary and the
types of circumstances that should qualify for more frequent payment.
However, we noted that we also expect OTPs and their treating
practitioners will use their clinical judgment as to whether there may
be cases in which a referral to a higher level of care may be needed
for some beneficiaries in order to reduce the risk of overdose and the
need for more frequent emergency treatment. We proposed to add Sec.
410.67(d)(4)(i)(E) to describe payment for a take-home supply of opioid
antagonist medications that are approved by FDA under section 505 of
the FFDCA for the emergency treatment of known or suspected opioid
overdose.
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\45\ https://www.express-scripts.com/static/formularySearch/2.9.6/#/formularySearch/drugSearch.
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We invited public comments on the proposed pricing for nasal
naloxone and auto-injector naloxone. We also sought comment on the
proposal to limit payment for the proposed add-on codes for take-home
supplies of these medications to once every 30 days to the extent that
it is medically reasonable and necessary.
We received public comments on the proposed frequency limit. The
following is a summary of the comments we received and our responses.
Comment: Several commenters did not support imposing frequency
limits on the provision of naloxone to once per month and stated that
clinicians should determine medical necessity, noting that naloxone is
a life-saving drug and patient access should not be limited. One
commenter recommended that exceptions be allowed for patients with a
recent (within the last 30 days) overdose. Other commenters supported
the proposed frequency limit and found it reasonable.
Response: After consideration of the comments, we are finalizing a
frequency limit on Medicare payments to OTPs for naloxone to one add-on
code (HCPCS code G2215 or G2216) every 30 days. However, we agree with
commenters that access to naloxone should not be limited when it is a
medically reasonable and necessary part of the treatment for OUD.
Therefore, we will allow exceptions to this limit in the case where the
beneficiary overdoses and uses the initial supply of naloxone dispensed
by the OTP to the extent that it is medically reasonable and necessary
to furnish additional naloxone. We note that section 1862(a)(1)(A) of
the Act requires that in order for payment to made for most Part A and
Part B services furnished to Medicare beneficiaries, those services
must be reasonable and necessary for the diagnosis or treatment of
illness or injury or to improve the malfunctioning of a malformed body
member. If an additional supply of naloxone is needed within 30 days of
the original supply being provided, OTPs must document in the medical
record the reason for the exception. Additionally, CMS will monitor
utilization of these codes in the claims data and will refer cases of
disproportionate use for further review.
Additionally, we sought comment on whether we should consider
creating a
[[Page 84687]]
code and establishing an add-on payment for injectable naloxone. We
noted that all three forms of naloxone (injectable, auto-injector, and
nasal spray) are FDA-approved and may be considered as options for
community distribution.
It is important to understand how to administer naloxone properly,
therefore, we defer to the clinical judgment of practitioners in the
OTP as to which formulation of naloxone would be the most appropriate
to dispense to a patient. Brief education on how to administer naloxone
using a syringe can be obtained from the provider of the naloxone kit
or from http://prescribetoprevent.org/.\46\ Additionally, we note that
in this final rule, we are including overdose education in the non-drug
component of the payment rate for both of the new add-on codes for
naloxone (HCPCS codes G2215 and G2216), and expect that when OTPs
provide beneficiaries with a supply of naloxone, they will also inform
them about how to use the medication they are being given.
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\46\ https://store.samhsa.gov/sites/default/files/d7/priv/sma18-4742.pdf.
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We stated in the CY 2021 PFS proposed rule (85 FR 50205) that if we
were to establish an add-on payment for injectable naloxone, we would
consider using the same methodology we adopted for pricing the drug
component of an episode of care that includes implantable or injectable
medications, as described in Sec. 410.67(d)(2)(i)(A).
We received public comments in response to our request for input on
whether we should create a code and establish an add-on payment for
injectable naloxone. The following is a summary of the comments we
received and our responses.
Comment: Commenters supported the creation of coding and payment
for injectable naloxone. Some commenters stated that ensuring payment
for all three forms of FDA-approved naloxone would allow providers to
select the most appropriate form of naloxone for the particular
Medicare beneficiary and provide options in the case of drug shortages.
The commenters also noted that traditionally, injectable naloxone is
the least expensive form, but can be more difficult to administer in an
overdose emergency. Another commenter stated that they believe
formulations of naloxone that are intended for use by medical
professionals (that is, injectable naloxone) are also valuable in the
prevention and treatment of opioid overdose. The commenter stated that
given that it is highly probable that OTP providers will be in a
position to provide care to a beneficiary who has overdosed, the
availability of injectable naloxone at these facilities can facilitate
timely opioid overdose reversal. Some commenters stated that the
payment rate for injectable naloxone must be adequate and another
stated that they believe payment should align with payment for other
Medicare Part B medications (that is, ASP plus 6 percent).
Response: We agree with the commenters that providing for Medicare
payment to OTPs for all available forms of FDA-approved naloxone will
allow practitioners in OTPs to select the most appropriate form of
naloxone for the beneficiary, provide options in the case of drug
shortages, and expand access to treatment for opioid overdoses.
Although we acknowledge that individuals experiencing an opioid
overdose will not be able to use injectable naloxone to treat an
overdose themselves,\47\ self-administration of naloxone is not
necessarily a goal of overdose death prevention training. A safer, more
reliable approach may be to prescribe naloxone to at-risk patients and
train and also equip members of their household and social networks in
overdose prevention and response.\48\
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\47\ https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/opioid-overdose.
\48\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4019939/.
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After consideration of the comments received, we are finalizing a
second new add-on code to cover the cost of providing patients with a
supply of injectable naloxone. We recognize the importance of making
injectable naloxone available to Medicare beneficiaries. Additionally,
creating a new add-on code for injectable and nasal naloxone will
provide options in the case of drug shortages or in the event a drug is
no longer available in the market, as occurred with auto-injector
naloxone.
The add-on code for injectable naloxone is HCPCS code G2216 (Take-
home supply of injectable naloxone (provision of the services by a
Medicare-enrolled Opioid Treatment Program); List separately in
addition to code for primary procedure.), which will include both a
drug component and a non-drug component. As stated in previous
rulemaking (84 FR 62650), we use the typical maintenance dose to
calculate the drug component for the OTP benefit. According to the
package insert,\49\ \50\ an initial dose of 0.4 mg to 2 mg of
injectable naloxone may be administered through intravenous,
intramuscular, or subcutaneous routes. If needed, it may be repeated at
two- to three-minute intervals up to a total dose of 10mg. Because the
information we have is not based upon a typical dose, we are contractor
pricing this code for CY 2021. This will provide beneficiaries access
to injectable naloxone under the OTP benefit and will also allow us the
opportunity to obtain more information to better understand the typical
dosage of injectable naloxone, in order to potentially establish
national pricing for injectable naloxone through future rulemaking. The
payment for the non-drug component of this code will be determined
using a crosswalk to the Medicare payment rate for CPT code 96161 of
$2.53, as discussed previously in conjunction with the new code for
nasal naloxone (HCPCS G2215).
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\49\ http://labeling.pfizer.com/ShowLabeling.aspx?id=4541.
\50\ https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f0932877-1f3b-4d5e-82d2-dd6c53db4730&type=display.
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Table 34 details the new add-on codes for nasal naloxone and
injectable naloxone, and the accompanying payment amounts, which
reflect the cost of the drug plus an additional $ 2.53 for overdose
education, as discussed previously in this section.
[[Page 84688]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.079
Duplicative Payment
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 Medicare Part B or Part D for items and services furnished by an
OTP. In the CY 2021 PFS proposed rule (85 FR 50206), we noted that
under the proposal, OTPs would be able to provide naloxone to Medicare
beneficiaries and bill for it as an add-on to the bundled payment for
the episode of care. Consistent with Sec. 410.67(e), the beneficiary's
copayment amount would remain zero. We also noted that naloxone may
also be appropriately available to beneficiaries through other Medicare
benefits, including, for example, Medicare Part D, under which the
beneficiary would be responsible for the applicable cost sharing. As
discussed in the CY 2020 PFS final rule (84 FR 62664) and codified at
Sec. 410.67(d)(5), we define 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
medication (that is, same drug, dosage and formulation) is also
separately paid under Medicare Part B or Part D for the same
beneficiary on the same date of service. Because we proposed to pay for
naloxone as an add-on to the weekly bundled payment, any payment to an
OTP for naloxone would be duplicative if the same medication is
separately paid under Medicare Part B or Part D for the same
beneficiary on the same date of service. Consistent with Sec.
410.67(d)(5), CMS would recoup any duplicative payment made to an OTP
for naloxone.
Additionally, we noted that we understand some OTPs negotiate
arrangements whereby community pharmacies supply MAT-related
medications to OTPs. However, we reiterated that, as stated in the CY
2020 PFS final rule, if the OTP provides reasonable and 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. Thus,
naloxone billed by an OTP as an add-on to the bundled payment should
not be reported to or paid under a Medicare Part D plan. We noted that
we expect OTPs will take reasonable steps to prevent duplicative
payment for naloxone furnished under their care by ensuring it is not
reported or billed under a different Medicare benefit. We also noted
that we intend to monitor for duplicative payments, and would take
appropriate action as needed when and if such duplicative payments are
identified.
We received public comments on the discussion of duplicative
payment for naloxone. The following is a summary of the comments we
received and our responses.
Comment: Several commenters opposed recoupment of duplicative
payments made to OTPs for naloxone. One commenter noted that OTPs do
not have the capacity to be aware of or prevent other providers from
prescribing naloxone through Medicare Part D. A commenter recommended
that CMS inform health plans if a member is receiving services from an
OTP, but acknowledged this may be difficult due to privacy laws. A
commenter stated that CMS should either establish a means of
coordination or recoup payment from Medicare Part D plans and other
healthcare providers if naloxone is provided outside of the OTP.
Another commenter stated that if the proposal to establish an add-on
payment for naloxone is finalized, CMS will need to provide
instructions to guard against duplicative payment.
Response: As we are finalizing the proposal to pay for naloxone as
an add-on to the weekly bundled payment, we reiterate that consistent
with Sec. 410.67(d)(5), any payment to an OTP for naloxone would be
duplicative if a claim for the same medication is separately paid under
Medicare Part B or Part D for the same beneficiary on the same date of
service, and CMS would recoup any duplicative payment made to an OTP
for naloxone. 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 Medicare Part B or Part D for items and services furnished by an
OTP. Therefore, for purposes of implementing section 1834(w)(1) of the
Act, payment for medications delivered, administered or dispensed to
the beneficiary as part of the OTP bundled payment is considered
duplicative if delivery, administration or dispensing of the same
medication was also separately paid under Medicare Part B or D. CMS
would recoup any duplicative payment made to an OTP for naloxone
because OTPs will be in the best position to know whether naloxone that
is included as part of the beneficiary's treatment plan is being
furnished by the OTP or by another provider or supplier given that the
OTP is responsible for managing the beneficiary's overall OUD
treatment. OTPs should make a good faith effort to ensure that no
duplicative payments are made for naloxone, for example, by inquiring
whether the beneficiary has already received a supply of naloxone
through Medicare Part B or D. Please see the CY 2020 PFS final rule (84
FR 62663 and 62664) for a more detailed discussion of our policy on
duplicative payments.
3. WAC Pricing
Section 1834(w) of the Act gives the Secretary significant
discretion to establish bundled payment rates for OUD treatment
services. In the CY 2020 PFS final rule, we finalized a payment
methodology for the drug component of
[[Page 84689]]
the bundled payment rates for OUD treatment services, under which we
use the payment methodology set forth in section 1847A of the Act
(which bases most payment on ASP) to set the payment rates for
implantable and injectable drugs and limited the payment amount for
these drugs to 100 percent of the volume-weighted ASP for a drug
category or code, if ASP is used. We codified this payment methodology
at Sec. 410.67(d)(2)(i)(A).
Section 1847A of the Act provides for the use of other payment
methodologies in certain circumstances, including payment based on WAC
or average manufacturer price (AMP). In the CY 2020 PFS final rule, we
limited payments to OTPs for injectable and implantable drugs to 100
percent of ASP, but did not otherwise diverge from the payment
methodology that would apply under section 1847A of the Act. In the CY
2021 PFS proposed rule (85 FR 50206), we noted our belief that it was
necessary to amend the OTP drug pricing methodology in order to limit
WAC-based payments to 100 percent of WAC. As discussed previously, we
proposed to use WAC pricing to determine the payment rate for the add-
on code for the auto-injector naloxone. Although none of the drugs that
are currently included in the drug component of an episode of care is
currently paid based on WAC, we also noted that it is possible that we
may use WAC to determine the payment for the drug component of an
episode of care in the future, and we wanted to establish, in advance,
the methodology that would apply for purposes of determining the
payment rate.
As authorized under section 1847A of the Act, some Medicare Part B
drugs are paid based on WAC. For example, for single source drugs,
payment is 106 percent of the lesser of WAC or ASP (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), 103 percent of WAC
is used. Additionally, there are some instances where drugs lack ASP
data for reasons other than being new, for example, in cases where the
manufacturer had no sales in a reporting quarter. In those situations,
the Medicare payment method varies, but in some cases, the payment may
be 106 percent of the WAC.\51\ As we stated in the CY 2020 PFS final
rule (84 FR 62651), 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.
The WAC is defined in section 1847A(c)(6)(B) as the manufacturer's list
price for a drug to wholesalers or direct purchasers in the United
States, not including prompt pay or other discounts, rebates, or
reductions in price. A drug's WAC is ultimately controlled by the
manufacturer. Unlike ASP, a drug's WAC does not incorporate prompt-pay
or other discounts. If discounts are available on drugs reimbursed by
Medicare at 106 percent of WAC, then Medicare is paying more for drugs
than it otherwise would under the ASP-based formula.\52\ Therefore,
consistent with our existing policy to set the payment amount at 100
percent of the ASP, if ASP is used to determine the payment for the
drug component of an episode of care, we proposed that when WAC-based
pricing is used, the payment amount shall be WAC + 0. We proposed to
amend the provision at Sec. 410.67(d)(2)(i)(A) to reflect this
limitation.
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\51\ http://www.medpac.gov/-blog-/requiring-reporting-of-sales-price-data/2019/06/14/payment-for-part-b-drugs.
\52\ http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf.
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We solicited comments on this proposed alternative pricing
methodology when the payment for an implantable or injectable
medication included in the drug component of an episode of care is
determined using the methodology set forth in section 1847A of the Act,
and ASP pricing data are not available.
We received public comments on the WAC pricing proposal. The
following is a summary of the comments we received and our responses.
Comment: A commenter expressed concern with CMS establishing
payment rates for medications that deviate from the standard
methodology under Medicare Part B of paying for drugs at the current
rate of ASP plus 6 percent. The commenter also stated that they were
concerned that limiting payment to Wholesale Acquisition Cost (WAC)
when ASP is not available would limit OTPs' ability to treat Medicare
beneficiaries effectively. Another commenter supported the use of WAC +
0 and stated, in reference to auto-injector naloxone, that any payments
above WAC would likely only serve to encourage price increases in the
market more broadly.
Response: We thank the commenters for their feedback on our
proposal that when the payment for an implantable or injectable
medication included in the drug component of an episode of care is
determined using the methodology set forth in section 1847A of the Act,
and ASP pricing data are not available, and WAC-based pricing is used,
the payment amount shall be WAC + 0. We continue to believe that
payment structures that are closely tailored to the provider's
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. Because WAC
does not include prompt pay discounts, rebates or price reductions, we
believe WAC could be a much higher than acquisition cost. However, we
continue to believe that 100 percent of WAC is a closer estimate of the
actual acquisition cost for OTPs compared to WAC with an add-on
percentage. Therefore, we are finalizing our proposal that when WAC-
based pricing is used, the payment amount shall be WAC + 0. We are also
finalizing the proposed amendment to the provision at Sec.
410.67(d)(2)(i)(A) to reflect this pricing methodology.
4. Billing and Payment Policies
a. Institutional Claim Forms
As discussed in the CY 2021 PFS proposed rule (85 FR 50207), we
have received several requests to allow OTPs to bill on an
institutional claim form. We were informed by representatives from the
state of New York that all OTPs in New York state bill on institutional
claim forms, not just those that are part of a hospital system. Given
the public health need related to the opioid epidemic, we explained
that we were exploring claims processing flexibilities requested by
some OTPs that would allow them to bill services on institutional
claims. See also section III.B. of this final rule, OTP Provider
Enrollment Regulation Updates for Institutional Claim Submissions, for
a discussion related to OTP enrollment as it relates to institutional
claims. As we explained in the CY 2021 PFS proposed rule, there would
be no differences in coverage or payment between services billed on the
institutional claim form versus the professional claim form. We noted
that the National Uniform Billing Committee (NUBC) approved a new Type
Of Bill (087x) for Freestanding Non-residential Opioid Treatment
Program provider billing, as well as a new condition code (89) for
Opioid Treatment Program/Indicates claim for opioid treatment program
services, to be used on hospital based OTP claims (TOB 013x and 085x).
We sought information on the reasons this claims-processing flexibility
is necessary for OTPs, and stated that we would address any changes to
provider billing policies
[[Page 84690]]
in subsequent claims processing instructions.
We received public comments on allowing OTPs to bill on an
institutional claim form. The following is a summary of the comments we
received and our response.
Comment: Several commenters expressed support for allowing this
flexibility. One commenter noted that they anticipate there will be a
significant increase in OTP enrollment as a result of this flexibility,
especially in states that have a significant number of hospital-based
OTPs. Another commenter noted that allowing OTPs to submit claims on
the institutional claim form (837i) will help to facilitate the
processing of crossover claims between Medicare and Medicaid.
Response: We are continuing to explore how best to implement these
flexibilities. We will provide notice of any relevant changes through
claims processing instructions.
b. Periodic Assessments
In the CY 2020 PFS final rule (84 FR 62634), we stated that we
understood that intake activities and periodic assessments are integral
services for the establishment and maintenance of OUD treatment for a
beneficiary at an OTP, and therefore, we believed it was reasonable to
include these services in the definition of OUD treatment services.
Accordingly, we finalized a definition of OUD treatment services in
Sec. 410.67(b) that reflected the required intake activities and
periodic assessments. We stated it was our understanding that these
services are furnished much less frequently than the other services
included in the weekly bundled payments; therefore, we created add-on G
codes to describe these services, which would allow us to make more
targeted payments for these services. We noted that the add-on code
describing intake activities should only be billed for new patients
(that is, patients starting treatment at the OTP). We agreed with the
commenters that the level 4 office/outpatient E/M visits for new and
established patients 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. The finalized add-on codes are 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 health care 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) and HCPCS code G2077 (Periodic assessment; assessing
periodically by qualified personnel to determine the most appropriate
combination of services and treatment). The medical services described
by these add-on codes can 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 (NPs) and physician assistants (PAs). The other
assessments, including psychosocial assessments can be furnished by
practitioners who are eligible to do so under state law and their scope
of licensure. We noted that to bill for the add-on code, the services
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 (84 FR 62647).
As we explained in the CY 2021 PFS proposed rule (85 FR 50207), we
have received inquiries from stakeholders related to what activities
would qualify to bill the add-on code for periodic assessments, HCPCS
code G2077. In the CY 2020 PFS final rule (84 FR 62647), we noted that
the add-on code describing periodic assessments can 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 noted 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. Based on our understanding of the
typical resources costs involved in furnishing periodic assessments, we
priced HCPCS code G2077 based on a crosswalk to a level 4 office/
outpatient E/M visit. Consistent with our understanding of the expected
acuity of patients with OUD receiving services at OTPs, including the
likelihood of the patient having multiple co-morbidities and presenting
with problems that are of moderate to high severity and requiring
medical decision making of moderate complexity, as well as the
associated payment rate assigned to this code, we explained that we
believe it is important for the clinician to be able to visually assess
the patient as part of any periodic assessment. Therefore, for CY 2021,
we proposed that in order to bill for HCPCS code G2077, a face-to-face
medical exam or biopsychosocial assessment would need to have been
performed. Accordingly, we proposed to amend the definition of periodic
assessment in Sec. 410.67(b)(7) to provide that the definition is
limited to a face-to-face encounter.
Additionally, we noted that in the May 8th COVID-19 IFC, CMS
revised Sec. 410.67(b)(7) on an interim final basis to allow periodic
assessments to be furnished during the PHE for COVID-19 via two-way
interactive audio-video communication technology and, in cases where
beneficiaries do not have access to two-way audio-video communication
technology, to permit the periodic assessments to be furnished using
audio-only telephone calls rather than via two-way interactive audio-
video communication technology, provided all other applicable
requirements are met. We explained our belief that allowing periodic
assessments to be furnished via two-way interactive audio-video
communication technology beyond the conclusion of the PHE for COVID-19
would help to expand access to care for patients who may have a
difficult time getting to the OTP in person. Therefore, in the proposed
rule, we proposed to revise Sec. 410.67(b)(7) to allow periodic
assessments to be furnished via two-way interactive audio-video
communication technology, provided all other applicable requirements
are met. We noted that we are currently permitting the use of audio-
only telephone calls to furnish these services during the PHE for
COVID-19, because we believe it is important to maintain access to
these services while the public is following infection control
guidelines to stay at home and practice social distancing, and not all
beneficiaries receiving OUD treatment services from OTPs may have
access to interactive audio-video communication technology. However, we
did not believe this flexibility would be needed in order to ensure
access after the PHE for COVID-19 ends. Therefore, we did not propose
to extend the flexibility to use audio-only telephone services to
furnish periodic assessments once the PHE for COVID-19 has ended.
[[Page 84691]]
We noted that we would consider payment for any periodic assessment-
related services furnished via audio-only telephone calls to be
included in the bundled payment for a weekly episode of care, but that
audio-only telephone services would not qualify for billing HCPCS code
G2077 after the end of the PHE for COVID-19. We sought input from the
public on whether we should consider continuing to make add-on payments
for audio-only periodic assessments furnished by OTPs after the
conclusion of the PHE for COVID-19, and if so, whether the payment rate
for audio-only services should reflect any differences in resource
costs.
We received public comments on the proposals related to periodic
assessments. The following is a summary of the comments we received and
our responses.
Comment: Commenters supported our proposal to allow OTPs to utilize
two-way interactive audio-video communication to satisfy the proposed
requirement that periodic assessments include a face-to-face encounter.
Several commenters requested that CMS allow audio only communication to
continue to be used for periodic assessments beyond the PHE for
beneficiaries who do not have video capabilities, noting that many
individuals who receive treatment at OTPs do not have access to devices
with audio-video capability and beneficiaries in rural areas may not
have broadband internet access.
Response: While we believe it is important to allow the flexibility
to furnish periodic assessments via audio-only telephone calls during
the PHE for COVID-19, we continue to have concerns about continuing
this flexibility after the end of the PHE. For example, we are
concerned that the effectiveness and/or quality of the care furnished
during these interactions may be lower when practitioners cannot
observe visual cues while furnishing these assessments. Therefore,
after consideration of the comments, we are finalizing our proposal
that in order to bill for HCPCS code G2077, a face-to-face medical exam
or biopsychosocial assessment would need to have been performed.
Additionally, we are finalizing our proposal to revise Sec.
410.67(b)(7) to provide that periodic assessments must be furnished
during a face-to-face encounter, but may be furnished via two-way
interactive audio-video communication technology, as clinically
appropriate, provided all other applicable requirements are met. We
plan to analyze differences in utilization in the claims data during
and after the PHE for COVID-19, and are interested in feedback related
to differences in frequency, effectiveness, and quality of care
furnished by OTPs when services are furnished via audio-only
communication in order to help assess whether we should consider making
any changes to our current policies regarding the use of communication
technology in future rulemaking.
c. Date of Service
In the CY 2020 PFS final rule (84 FR 62641), we defined an episode
of care as a 1-week (contiguous 7-day) period at Sec. 410.67(b). We
have received inquiries related to the date of service used on claims
for the weekly bundles and add-on codes, particularly related to an
approach that many providers informed us they use, which is to
establish a ``standard billing cycle'' in which episodes of care for
all patients at that OTP begin on the same day of the week. We do not
believe that the definition of an episode of care that was finalized
for CY 2020 precludes the use of a ``standard billing cycle.''
Therefore, OTPs may choose to apply a standard billing cycle by setting
a particular day of the week to begin all episodes of care. In this
case, the date of service would be the first day of the OTP's billing
cycle. If a beneficiary starts treatment at the OTP on a day that is in
the middle of the OTP's standard weekly billing cycle, the OTP may
still bill the applicable code for that episode of care provided that
the threshold to bill for the code has been met. Alternatively, OTPs
may choose to adopt weekly billing cycles that vary across patients.
Under this approach, the initial date of service will depend upon the
day of the week when the patient was first admitted to the program or
when Medicare billing began. Therefore, under this approach of adopting
weekly billing cycles that vary across patients, when a patient is
beginning treatment or re-starting treatment after a break in
treatment, the date of service would reflect the first day the patient
was seen and the date of service for subsequent consecutive episodes of
care would be the first day after the previous 7-day period ends. For
the codes describing add-on services (HCPCS codes G2076-G2080), the
date of service should reflect the date that service was furnished;
however, if the OTP has chosen to apply a standard weekly billing
cycle, the date of service for codes describing add-on services may be
the same as the first day in the weekly billing cycle.
In the CY 2021 PFS proposed rule (50208), we noted that this
approach is consistent with earlier guidance that was issued in the OTP
Billing and Payment Fact sheet that is posted on the CMS OTP web page
(https://www.cms.gov/files/document/otp-billing-and-payment-fact-sheet.pdf).
We received public comments on the discussion of the date of
service used on claims in the proposed rule. The following is a summary
of the comments we received and our responses.
Comment: Commenters expressed support for the flexibility to use
either a ``standard billing cycle'' or a weekly billing cycle that
varies across patients.
Response: We intend to continue to offer this flexibility to OTPs.
Additionally, we note that the current policies regarding the date of
services for add-on codes will apply to the new add-on codes we are
adopting in this final rule for nasal naloxone and injectable naloxone.
d. Coding
In the CY 2021 PFS proposed rule (85 FR 50208), we explained that
we recognize the importance of allowing OTPs to become accustomed to
billing Medicare using the coding that was established in the CY 2020
PFS final rule; however, we remain interested in refining the code set
through future rulemaking, including stratifying the coding and
associated payment amounts to account for significant differences in
resource costs among patients, especially in relation to amounts of
expected counseling. In the CY 2020 PFS final rule (84 FR 62645), we
finalized an add-on code to describe an adjustment to the bundled
payment when additional counseling or therapy services are furnished,
HCPCS code G2080. 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. We stated
that we have received feedback from stakeholders noting a range of OTP
attendance patterns that represent a continuum of care and service
intensity, noting significant differences in services received during
the induction phase versus the maintenance phase. We also understand
that patients' needs for service may fluctuate over time, depending on
a variety of factors and circumstances. We sought comments on how we
might better account for differences in resource costs among patients
over the course of treatment. We noted that we would consider the
comments received in developing any proposed refinements to our coding
policies in future rulemaking.
We received public comments on the discussion of billing and
payment policies in the proposed rule. The
[[Page 84692]]
following is a summary of the comments we received and our responses.
Comment: Commenters expressed support for CMS' retaining the coding
framework that was established in the CY 2020 rulemaking. A few
commenters stated that CMS should maintain the current bundle structure
because it has proven to be successful and viable during the first year
of the new Medicare Part B benefit for OUD treatment services furnished
by OTPs, and therefore there is no need to overly tinker with a
functioning reimbursement structure. Another commenter stated that the
current bundled payment methodology, with the ability to bill for
additional counseling via add-on codes has worked remarkably well due
to its simplicity. They stated that the current bundled payments
reflect the costs associated with treating a patient with average needs
and that while some patients require greater services and some require
less, it usually balances out from a reimbursement-to-costs standpoint.
They also stated that they have found that Medicare beneficiaries
generally are a more health care service intensive population than non-
Medicare patients, and therefore many OTPs are working to increase
counseling resources to meet the unique needs of the Medicare
population. They also stated that changing the current bundled payment
methodology would undermine the progress OTPs have made in this area
and therefore recommended that CMS maintain the current bundled payment
structure.
Response: We are pleased to hear that the coding and payment
policies that we established in CY 2020 PFS final rule have been
effective and well received. We plan to retain the current coding
structure for 2021, and will continue to consider any refinements to
that structure for future rulemaking.
5. Annual Updates
In the CY 2020 PFS final rule (84 FR 62667 through 62669), we
finalized a policy under which 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.
The payment for the non-drug component of the bundled payment for OUD
treatment services will be updated annually based upon the Medicare
Economic Index. The current payment rates, as finalized in the CY 2020
PFS final rule, both with and without locality adjustments, can be
found on the CMS OTP web page under Billing and Payment at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Opioid-Treatment-Program/billing-payment. The list of the payment rates for OUD
treatment services furnished by OTPs, with the annual update applied
for CY 2021, is available in the file called CY 2021 PFS final rule OTP
Payment Rates on the CMS website under downloads for the CY 2021 PFS
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.
Comment: Commenters stated that using the Medicare Economic Index
(MEI), which focuses more narrowly on physician practices, to update
the payment rates for the non-drug component of the bundled payments
does not ensure that Medicare payment rates for OTPs keep pace with
growing practice costs. The commenters stated that OTPs' cost
structures are more similar to HOPDs than they are to physician
offices, in that they employ interdisciplinary teams, including medical
directors, doctors, counselors, nurses, pharmacists, laboratory
technicians, social workers, and case managers, to provide care to
patients. They also noted that like hospitals, OTPs serve patients 7
days per week and go through extensive accreditation and certification
process and are subject to thorough inspections by deferral regulators.
OTPs are also required to employ diversion control systems to ensure
treatment medication is being used properly, while physicians in the
office setting who prescribe buprenorphine are not subject to those
requirements. Commenters stated that given these similarities between
OTPs and HOPDs, the IPPS market basket update would be a more accurate
measure of annual price growth in the OTP setting for the non-drug
component of the OTP bundled payment rates, noting that TRICARE
increases its payments to OTPs by the IPPS update factor annually.
Response: We did not propose any changes for CY 2021 to the annual
update process that was established in the CY 2020 PFS final rule (84
FR 62667), however, we will consider this feedback for future
rulemaking.
J. Technical Correction to the Definition of Public Health Emergency
In the March 31st COVID-19 IFC (85 FR 19285), we amended 42 CFR
part 400 by adding the definition of ``Public Health Emergency.'' We
made an inadvertent typographical error in the regulations at Sec.
400.200 by referring to the authority for the Public Health Emergency
(PHE) as the ``Public Health Security Act'' rather than the ``Public
Health Service Act.'' We are correcting this error in this final rule
and amending Sec. 400.200 by revising the definition. Public Health
Emergency (PHE) now means the Public Health Emergency determined to
exist nationwide as of January 27, 2020, by the Secretary pursuant to
section 319 of the Public Health Service Act on January 31, 2020, as a
result of confirmed cases of COVID-19, including any subsequent
renewals. This revised definition has an applicability date of March 1,
2020, which is the same applicability date as the March 31st COVID-19
IFC.
III. Summary of the Proposals for Other Part B Provisions, Analysis of
and Responses to Public Comments, and Provisions of the Final Rule
A. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and
Phase-In of Payment Reductions, and Comment Solicitation on Payment for
Specimen Collection for COVID-19 Clinical Diagnostic Laboratory Tests
1. Background on the Clinical Laboratory Fee Schedule
Prior to January 1, 2018, Medicare paid for clinical diagnostic
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule
(CLFS), with certain exceptions, under section 1833(a), (b), and (h) of
the Act. Under the previous payment system, CDLTs were paid based on
the lesser of: (1) The amount billed; (2) the local fee schedule amount
established by the Medicare Administrative Contractor (MAC); or (3) a
national limitation amount (NLA), which is a percentage of the median
of all the local fee schedule amounts (or 100 percent of the median for
new tests furnished on or after January 1, 2001). In practice, most
tests were paid at the NLA. Under the previous payment system, the CLFS
amounts were updated for inflation based on the percentage change in
the Consumer Price Index for All Urban Consumers (CPI-U), and reduced
by a multi-factor productivity adjustment and other statutory
adjustments, but were not otherwise updated or changed. Coinsurance and
deductibles generally do not apply to CDLTs paid under the CLFS.
Section 1834A of the Act, as established by section 216(a) of the
Protecting Access to Medicare Act of 2014 (PAMA), required significant
changes to how Medicare pays for CDLTs under the CLFS. In the June 23,
2016 Federal Register (81 FR 41036), we published a final rule entitled
Medicare Clinical Diagnostic Laboratory Tests
[[Page 84693]]
Payment System (CLFS final rule), that implemented section 1834A of the
Act at 42 CFR part 414, subpart G.
Under the CLFS final rule, ``reporting entities'' must report to
CMS during a ``data reporting period'' ``applicable information''
collected during a ``data collection period'' for their component
``applicable laboratories.'' The first data collection period occurred
from January 1, 2016 through June 30, 2016. The first data reporting
period occurred from January 1, 2017 through March 31, 2017. On March
30, 2017, we announced a 60-day period of enforcement discretion for
the application of the Secretary's potential assessment of Civil
Monetary Penalties (CMPs) for failure to report applicable information
with respect to the initial data reporting period. This announcement is
available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we
solicited public comments from applicable laboratories and reporting
entities to better understand the applicable laboratories' experiences
with data reporting, data collection, and other compliance requirements
for the first data collection and reporting periods. We discussed these
comments in the CY 2018 PFS final rule (82 FR 53181 through 53182) and
stated that we would consider the comments for potential future
rulemaking or guidance.
As part of the CY 2019 Medicare PFS rulemaking, we finalized two
changes to the definition of ``applicable laboratory'' at Sec. 414.502
(see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850; 83 FR
35855 through 35862). First, we excluded Medicare Advantage (MA) plan
payments under Part C from the denominator of the Medicare revenues
threshold calculation, in an effort to broaden the types of
laboratories qualifying as an applicable laboratory. Specifically,
excluding MA plan payments could allow additional laboratories of all
types serving a significant population of beneficiaries enrolled in
Medicare Part C to meet the majority of Medicare revenues threshold and
potentially qualify as an applicable laboratory (if they also meet the
low expenditure threshold) and report data to CMS during the data
reporting period. Because MA plan payments are now excluded from the
total Medicare revenues calculation, the denominator amount (total
Medicare revenues) would decrease. If the denominator amount decreases,
the likelihood increases that a laboratory would qualify as an
applicable laboratory. This is because the laboratory's PFS and CLFS
revenues are being compared to a lower total Medicare payment amount
(than what they would have been compared to if MA plan payments
remained in the denominator). Second, consistent with our goal of
obtaining a broader representation of laboratories that could
potentially qualify as an applicable laboratory and report data, we
also amended the definition of applicable laboratory to include
hospital outreach laboratories that bill Medicare Part B using the CMS-
1450 14x Type of Bill.
2. Payment Requirements for Clinical Diagnostic Laboratory Tests
In general, under section 1834A of the Act, the payment amount for
each CDLT on the CLFS furnished beginning January 1, 2018, is based on
the applicable information collected during the data collection period
and reported to CMS during the data reporting period, and is equal to
the weighted median of the private payor rates for the test. The
weighted median is calculated by arraying the distribution of all
private payor rates, weighted by the volume for each payor and each
laboratory. The payment amounts established under the CLFS are not
subject to any other adjustment, such as geographic, budget neutrality,
or annual update, as required by section 1834A(b)(4)(B) of the Act.
Additionally, section 1834A(b)(3) of the Act, implemented at Sec.
414.507(d), provides for a phase-in of payment reductions, limiting the
amounts the CLFS rates for each CDLT (that is not a new advanced
diagnostic laboratory test (ADLT) or new CDLT) can be reduced as
compared to the payment rates for the preceding year. Under the
provisions enacted by section 216(a) of PAMA, for the first 3 years
after implementation (CY 2018 through CY 2020), the reduction cannot be
more than 10 percent per year, and for the next 3 years (CY 2021
through CY 2023), the reduction cannot be more than 15 percent per
year. Under section 1834A(a)(1) and (b) of the Act, as enacted by PAMA,
for CDLTs that are not ADLTs, the data collection period, data
reporting period, and payment rate update occur every 3 years. As such,
the second data collection period for CDLTs that are not ADLTs occurred
from January 1, 2019 through June 30, 2019, and the next data reporting
period was scheduled to take place from January 1, 2020 through March
31, 2020, with the next update to the Medicare payment rates for these
tests based on that reported applicable information scheduled to take
effect as of January 1, 2021.
Section 216(a) of PAMA established a new subcategory of CDLTs known
as ADLTs, with separate reporting and payment requirements under
section 1834A of the Act. As defined in Sec. 414.502, an ADLT is a
CDLT covered under Medicare Part B that is offered and furnished only
by a single laboratory, and cannot be sold for use by a laboratory
other than the single laboratory that designed the test or a successor
owner. Also, an ADLT must meet either Criterion (A), which implements
section 1834A(d)(5)(A) of the Act, or Criterion (B), which implements
section 1834A(d)(5)(B) of the Act, as follows:
Criterion (A): The test is an analysis of multiple
biomarkers of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or
proteins; when combined with an empirically derived algorithm, yields a
result that predicts the probability a specific individual patient will
develop a certain condition(s) or respond to a particular therapy(ies);
provides new clinical diagnostic information that cannot be obtained
from any other test or combination of tests; and may include other
assays; or:
Criterion (B): The test is cleared or approved by the FDA.
Generally, under section 1834A(d) of the Act, the Medicare payment
rate for a new ADLT is equal to its actual list charge during an
initial period of 3 calendar quarters. After the new ADLT initial
period, ADLTs are paid using the same methodology based on the weighted
median of private payor rates as other CDLTs. However, under section
1834A(d)(3) of the Act, updates to the Medicare payment rates for ADLTs
occur annually instead of every 3 years.
Additional information on the private payor rate-based CLFS is
detailed in the CLFS final rule (81 FR 41036 through 41101) and is
available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-regulations.
3. Statutory Revisions to the Data Reporting Period and Phase-In of
Payment Reductions
Section 105(a) of the Further Consolidated Appropriations Act, 2020
(FCAA) (Pub. L. 116-94, enacted on December 20, 2019), and section 3718
of the Coronavirus Aid, Relief, and Economic Security Act, 2020 (CARES
Act) (Pub. L. 116-136, enacted on March 27, 2020), made revisions to
the CLFS requirements for the next data reporting period for CDLTs that
are not ADLTs under section 1834A of the Act. Additionally, the CARES
Act made
[[Page 84694]]
revisions to the phase-in of payment reductions under section 1834A of
the Act. Specifically, section 105(a)(1) of the FCAA amended the data
reporting requirements in section 1834A(a) of the Act to delay the next
data reporting period for CDLTs that are not ADLTs by 1 year, so that
data reporting would be required during the period of January 1, 2021
through March 31, 2021; the 3-year data reporting cycle for CDLTs that
are not ADLTs would resume after that data reporting period. Section
105(a)(1) of the FCAA also specified that the data collection period
that applies to the data reporting period of January 1, 2021 through
March 30, 2021 would be the period of January 1, 2019 through June 30,
2019, which is the same data collection period that would have applied
absent the amendments. In addition, section 105(a)(2) of the FCAA
amended section 1834A(b)(3) of the Act regarding the phase-in of
payment reductions to provide that payments may not be reduced by more
than 10 percent as compared to the amount established for the preceding
year through CY 2020, and for CYs 2021 through 2023, payment may not be
reduced by more than 15 percent as compared to the amount established
for the preceding year. These statutory changes were consistent with
our regulations implementing the private payor rate-based CLFS (81 FR
41036;Sec. 414.507(d)).
Subsequently, section 3718 of the CARES Act further amended the
data reporting requirements for CDLTs that are not ADLTs and the phase-
in of payment reductions under the CLFS. Specifically, section 3718(a)
of the CARES Act amended section 1834A(a)(1)(B) of the Act to delay the
next data reporting period for CDLTs that are not ADLTs by one
additional year, to require data reporting during the period of January
1, 2022 through March 31, 2022. As amended by the CARES Act, section
1834A(a)(1)(B) of the Act now provides that in the case of reporting
with respect to CDLTs that are not ADLTs, the Secretary shall revise
the reporting period under subparagraph (A) such that-(i) no reporting
is required during the period beginning January 1, 2020, and ending
December 31, 2021; (ii) reporting is required during the period
beginning January 1, 2022, and ending March 31, 2022; and (iii)
reporting is required every 3 years after the period described in
clause (ii).
The CARES Act did not modify the data collection period that
applies to the next data reporting period for these tests. Thus, under
section 1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of
the FCAA, the next data reporting period for CDLTs that are not ADLTs
(January 1, 2022 through March 31, 2022) will be based on the data
collection period of January 1, 2019 through June 30, 2019. In Sec.
414.502, the current definition of data collection period is defined as
the 6 months from January 1 through June 30 during which applicable
information is collected and that precedes the data reporting period.
Additionally, in Sec. 414.502 the data reporting period is defined as
the 3-month period, January 1 through March 31, during which a
reporting entity reports applicable information to CMS and that follows
the preceding data collection period. Unless we revised our current
definitions of data collection period and data reporting period, the
definitions would have been incorrect with regard to the data
collection period that applies to the next data reporting period.
Therefore, we proposed to revise the definitions of data collection
period and data reporting period in Sec. 414.502 to reflect that the
data collection period will be January 1, 2019 through June 30, 2019
for the data reporting period of January 1, 2022 through March 31,
2022.
Section 3718(b) of the CARES Act further amended the provisions in
section 1834A(b)(3) of the Act regarding the phase-in of payment
reductions under the CLFS. First, it extended the statutory phase-in of
payment reductions resulting from private payor rate implementation by
an additional year, that is, through CY 2024. It further amended
section 1834A(b)(3)(B)(ii) of the Act to specify that the applicable
percent for CY 2021 is 0 percent, meaning that the payment amount
determined for a CDLT for CY 2021 shall not result in any reduction in
payment as compared to the payment amount for that test for CY 2020.
Section 3718(b) of the CARES Act further amended section
1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of
15 percent will apply for CYs 2022 through 2024, instead of CYs 2021
through 2023.
4. Conforming Regulatory Changes
In accordance with section 105(a) of the FCAA and section 3718 of
the CARES Act, we proposed to make conforming changes to the data
reporting and payment requirements at part 414, subpart G.
Specifically, we proposed to revise Sec. 414.502 to update the
definitions of both the data collection period and data reporting
period, specifying that for the data reporting period of January 1,
2022 through March 31, 2022, the data collection period is January 1,
2019 through June 30, 2019. We also proposed to revise Sec.
414.504(a)(1) to indicate that initially, data reporting begins January
1, 2017 and is required every 3 years beginning January 2022. In
addition, we proposed conforming changes to our requirements for the
phase-in of payment reductions to reflect the CARES Act amendments.
Specifically, we proposed to revise Sec. 414.507(d) to indicate that
for CY 2021, payment may not be reduced by more than 0.0 percent as
compared to the amount established for CY 2020, and for CYs 2022
through 2024, payment may not be reduced by more than 15 percent as
compared to the amount established for the preceding year.
We received public comments on the revised data reporting
requirements and phase-in of payment reductions for the CLFS. The
following is a summary of the comments we received and our responses.
Comment: Several commenters expressed support for the proposed
conforming regulatory changes to the data reporting and payment
requirements.
Response: We appreciate the commenters' support for these changes
that reflect the recent statutory revisions required by section 105(a)
of the FCAA and section 3718 of the CARES Act.
Comment: One commenter suggested that CMS delay implementation of
the phase-in of payment reductions under the CLFS.
Response: We note that the phase-in of payment reductions to the
CLFS payment amounts is statutory; therefore, we are unable to delay
implementation. Additionally, we note that there will be a 0.0% payment
reduction for CY 2021 and, for CYs 2022 through 2024, payment may not
be reduced by more than 15 percent as compared to the amount
established for the preceding year.
In consideration of these public comments and in accordance with
section 105(a) of the FCAA and section 3718 of the CARES Act, we are
finalizing the proposed conforming changes to the data reporting and
payment requirements at part 414, subpart G.
5. Response to the Comment Solicitation on Payment for Specimen
Collection for COVID-19 Clinical Diagnostic Laboratory Tests
In the ``Medicare and Medicaid Programs; Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency'' interim
final rule with comment period (March 31st COVID-19 IFC), which
displayed and became effective on March 31, 2020 and
[[Page 84695]]
appeared in the April 6, 2020 Federal Register (85 FR 19230), we
established that Medicare will pay a nominal specimen collection fee
and associated travel allowance to independent laboratories for the
collection of specimens for COVID-19 clinical diagnostic laboratory
testing for homebound and non-hospital inpatients (85 FR 19256 through
19258). This policy provides independent laboratories with additional
resources to provide COVID-19 testing and helps with efforts to limit
patients' exposure to the general population and alleviate patients'
unease with leaving the home. To identify specimen collection for
COVID-19 testing specifically, we established two new level II HCPCS
codes: Code G2023 (specimen collection for severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]),
any specimen source); and code G2024 (specimen collection for severe
acute respiratory syndrome coronavirus 2 (SARS-Cov-2) (Coronavirus
disease [COVID19]), from an individual in a SNF or by a laboratory on
behalf of a HHA, any specimen source), for independent laboratories to
use when billing Medicare for the nominal specimen collection fee for
COVID-19 testing for the duration of the PHE for COVID-19.
We indicated in the March 31st COVID-19 IFC that this specimen
collection fee policy was established for the duration of the PHE for
COVID-19 (85 FR 19256). In the CY 2021 PFS proposed rule, we requested
comments on whether we should delete HCPCS codes G2023 and G2024 once
the PHE for COVID-19 ends (85 FR 50211). We noted that comments
received may inform a future proposal. Specifically, we sought public
input on why these codes, and their corresponding payment amounts,
which are higher than the nominal specimen collection fees for other
conditions, would be necessary or useful outside of the context of the
PHE for COVID-19. We stated that we were particularly interested in why
separate, increased payment for specimen collection specifically for
COVID-19 tests, in contrast to other tests, may be needed following the
end of the PHE.
We received public comments on the specimen collection fees for
COVID-19 clinical diagnostic laboratory tests. The following is a
summary of the comments we received and our response.
Comment: Several commenters expressed support for permanently
extending payment for specimen collection for COVID-19 tests after the
PHE, as commenters expect the COVID-19 virus to be present into CY
2021, thus making it appropriate for CMS to continue to pay for
specimen collection. Commenters recommended that CMS expand and
permanently authorize the specimen collection fees under HCPCS codes
G2023 and G2024 to apply to all CDLTs to compensate for the supplies,
equipment, and sterilization protocols required for safe and
uncontaminated specimen collection and handling in the presence of
COVID-19. Commenters noted that COVID-19 will continue to spread and
may become an ongoing and/or seasonal infectious disease event, and
because of this possibility, they expect that the heightened safety
precautions, the need for personal protective equipment, and the
requirement for special training for specimen collection will persist
beyond the immediate PHE.
Commenters also recommended that CMS confirm that HCPCS code G2023
applies to any site where clinical laboratory personnel collect
specimens, and not solely to homebound and nonhospital inpatients. Some
commenters requested that CMS confirm that when a laboratory receives a
health care professional's order for COVID-19 test specimen collection
in a beneficiary's home, the laboratory may consider this order to be a
determination by the health care professional that the beneficiary is
homebound, and therefore, the laboratory is eligible for the increased
specimen collection fee represented by HCPCS code G2023.
Response: We appreciate the comments regarding the nominal specimen
collection fees and associated travel allowance to independent
laboratories for the collection of specimens for COVID-19 clinical
diagnostic laboratory testing. We plan to take this feedback into
consideration for possible future rulemaking or guidance.
B. OTP Provider Enrollment Regulation Updates for Institutional Claim
Submissions
1. Modifications to OTP Enrollment Process
a. Background
Under 42 CFR 424.510, a provider or supplier must complete, sign,
and submit to its assigned Medicare Administrative Contractor (MAC) the
Form CMS-855 (OMB Control No. 0938-0685) application to enroll in the
Medicare program and obtain Medicare billing privileges. The Form CMS-
855, which can be submitted via paper or electronically through the
internet-based Provider Enrollment, Chain, and Ownership System (PECOS)
process (SORN: 09-70-0532, Provider Enrollment, Chain, and Ownership
System), captures information about the provider or supplier that CMS
or its MACs reviews and verifies to determine whether the provider or
supplier meets all Medicare requirements. (The specific Form CMS-855
application (of which there are several variations) to be completed
will depend upon the type of provider or supplier submitting said
application.) This process of enrollment helps ensure that: (1) All
prospective providers and suppliers are carefully screened and
reviewed; and (2) unqualified providers and suppliers are kept out of
the Medicare program, which helps protect the Trust Funds and Medicare
beneficiaries. Indeed, without this process, billions of taxpayer
dollars might be paid to fraudulent or otherwise non-compliant parties.
b. Completion of Form CMS-855
Existing Sec. 424.67 outlines a number of enrollment requirements
for OTPs. One requirement, addressed in Sec. 424.67(b)(1), is that
OTPs must complete the Form CMS-855B application (Medicare Enrollment
Application: Clinics/Group Practices and Certain Other Suppliers; OMB
#: 0938-0685) to enroll in Medicare. The reference to the Form CMS-855B
in Sec. 424.67(b)(1) was predicated in part on the assumption that
OTPs would generally submit the CMS-1500 claim form (Health Insurance
Claim Form; OMB Control No.: 0938-1197) to receive payment for their
services. However, as mentioned previously in section II.I.4. of the CY
2021 PFS proposed rule (85 FR 50074), we have received requests to
allow OTPs to bill for services on an institutional claim form
(specifically, the 837I). To do so, these OTPs would have to enroll in
Medicare via the Form CMS-855A (Medicare Enrollment Application for
Institutional Providers (OMB #: 0938-0685)). To account for
circumstances where an OTP wishes to pursue Form CMS-855A enrollment
for the reason stated above, we proposed the following revisions to
Sec. 424.67:
Current Sec. 424.67(b)(1) states that a newly enrolling
OTP must fully complete and submit the Form CMS-855B application (or
its successor application). We proposed to revise this paragraph to
state that the newly enrolling OTP must fully complete and submit, as
applicable, the Form CMS-855A or Form CMS-855B application (or their
successor applications).
Existing Sec. 424.67(b)(1)(ii) requires the OTP to
certify compliance with the requirements and standards described in
paragraphs Sec. 424.67(b) and (d) via the Form CMS-855B and/or the
applicable
[[Page 84696]]
supplement or attachment thereto. We proposed to revise this paragraph
such that the OTP must certify compliance with the above-referenced
requirements and standards via the Form CMS-855A or Form CMS-855B (as
applicable) and/or the applicable supplement or attachment thereto.
Existing Sec. 424.67(b)(5) requires the OTP to report on
the Form CMS-855B and/or any applicable supplement all OTP staff who
meet the definition of ``managing employee'' in Sec. 424.502. We
proposed to change this to state that the OTP must report on the Form
CMS-855A or Form CMS-855B (as applicable) and/or any applicable
supplement all OTP staff who meet this definition.
We believed these revisions would accomplish two objectives. First,
they would permit OTPs to submit a Form CMS-855A in lieu of a Form CMS-
855B based on their preferred method of billing. Second, they would
confirm that the requirements of Sec. 424.67 apply to all OTPs
regardless of whether they complete the Form CMS-855A or the Form CMS-
855B.
c. Screening Activities Associated With Risk Designation
Section 424.518 outlines provider enrollment screening categories
and requirements based on our assessment of the degree of risk of
fraud, waste, and abuse posed by a particular category of provider or
supplier. In general, the higher the level of risk that a certain
provider or supplier type presents, the greater the degree of scrutiny
with which we will screen and review enrollment applications submitted
by providers or suppliers within that category. There are three levels
of screening addressed in Sec. 424.518: Limited; moderate; and high.
Irrespective of which level a provider or supplier type falls within,
the MAC performs certain minimum screening functions upon receipt of an
initial enrollment application, a revalidation application, or an
application to add a new practice location. These include:
Verification that the provider or supplier meets all
applicable federal regulations and state requirements for their
provider or supplier type.
State license verifications.
Database reviews on a pre- and post-enrollment basis to
ensure that providers and suppliers continue to meet the enrollment
criteria for their provider or supplier type.
Providers and suppliers at the moderate and high categorical risk
levels must also undergo a site visit. Moreover, for those in the high
categorical risk level, the MAC performs two additional functions under
Sec. 424.518(c)(2). First, the MAC requires the submission of a set of
fingerprints for a national background check from all individuals who
maintain a 5 percent or greater direct or indirect ownership interest
in the provider or supplier. Second, it conducts a fingerprint-based
criminal history record check of the Federal Bureau of Investigation's
(FBI) Integrated Automated Fingerprint Identification System on all
individuals who maintain a 5 percent or greater direct or indirect
ownership interest in the provider or supplier. These additional
verification activities are intended to correspond to the heightened
risk involved with such provider or supplier types.
For newly enrolling OTPs, those that have been fully and
continuously certified by the Substance Abuse and Mental Health
Services Administration (SAMHSA) since October 23, 2018 fall within the
moderate level of categorical screening. OTPs that have not been so
certified since the aforementioned date are subject to the high
screening level. As discussed in the CY 2021 PFS proposed rule (85 FR
50074), we recognize that certain providers and suppliers have already
enrolled as OTPs via the Form CMS-855B--and, accordingly, undergone a
site visit and, if applicable, fingerprinting--but would seek to newly
enroll via the Form CMS-855A should our proposals be finalized. (Said
enrollment would be considered ``new'' for purposes of enrollment
because the OTP would be enrolling via a different variation of the
Form CMS-855.) While not seeking to minimize the importance of the
enhanced screening activities associated with the moderate and high
categorical levels, we do not wish to unduly burden currently enrolled
OTPs that would pursue Form CMS-855A enrollment as an OTP. More
specifically, we noted that we did not believe such OTPs should have to
undergo another site visit and, if applicable, fingerprinting when they
previously did so as an OTP via their original Form CMS-855B
enrollment. This, in our view, would constitute an unnecessary
expenditure of CMS, MAC, and OTP resources. We add that the same would
hold true if, in the future, an OTP that is enrolled via the Form CMS-
855A under revised Sec. 424.67(b) decides to change to a Form CMS-855B
enrollment. In both cases, we believe a duplication of effort should be
avoided to the extent consistent with safeguarding the integrity of the
Medicare program.
Existing Sec. 424.67(b)(3) states that an enrolling OTP must
successfully complete the assigned categorical risk level screening
required under, as applicable, Sec. 424.518(b) and (c) (which outline
the screening requirements for newly enrolling parties in,
respectively, the moderate and high categorical levels). Given the
foregoing discussion, we proposed several changes to Sec.
424.67(b)(3). First, we proposed to redesignate existing Sec.
424.67(b)(3) as new Sec. 424.67(b)(3)(i), though with an exception to
its requirements. Second, and to address this exception, we proposed to
add paragraph (b)(3)(ii) to state that currently enrolled OTPs that are
changing their OTP enrollment from a Form CMS-855B to a Form CMS-855A,
or vice versa, must successfully complete the limited level of
categorical screening under Sec. 424.518(a) if the OTP has already
completed, as applicable, the moderate or high level of categorical
screening under Sec. 424.518(b) or (c), respectively. Third, we
proposed to redesignate existing Sec. 424.518(a)(1)(xii) through
(xvii) as Sec. 424.518(a)(1)(xiii) through (xviii). Fourth, proposed
new Sec. 424.518(a)(1)(xii) would add OTPs that fall within the
purview of new paragraph (b)(3)(ii) to the provider and supplier types
subject to limited risk categorical screening.
d. Additional OTP Enrollment Clarifications Regarding the Form CMS-855A
We proposed three additional clarifications related to our
previously mentioned OTP enrollment provisions. To incorporate these
into Sec. 424.67, we proposed to redesignate existing paragraphs (c),
(d), (e), and (f) as paragraphs (d), (e), (f), and (g), respectively.
The three clarifications would be included in new paragraph (c).
With the redesignation of existing paragraph (d) as paragraph (e),
we also proposed to change the reference to:
Paragraph (d) in existing paragraph (b)(1)(ii) to
paragraph (e).
Paragraph (d)(1) in existing paragraph (d)(2)(i) to
paragraph (e)(1) in redesignated paragraph (e)(2)(i).
(1) Single Enrollment
We proposed in new Sec. 424.67(c)(1) that an OTP may only be
enrolled as such via the Form CMS-855A or the Form CMS-855B but not
both. The OTP, in other words, must opt for either Form CMS-855A
enrollment or Form CMS-855B enrollment. This is to help ensure that the
OTP does not bill twice for the same service via separate claim
vehicles (specifically, the CMS-1500 and the 837I).
[[Page 84697]]
(2) Effective Date of Billing
Section 424.520(d) outlines the effective date of billing
privileges for newly enrolling OTPs (and certain other provider and
supplier types). This date is the later of: (1) The date of the OTP's
filing of a Medicare enrollment application that was subsequently
approved by a Medicare contractor; or (2) the date that the OTP first
began furnishing services at a new practice location. In a similar
vein, Sec. 424.521(a) states that OTPs (and certain other provider and
supplier types) may retrospectively bill for services when the OTP has
met all program requirements (including state licensure requirements),
and services were provided at the enrolled practice location for up
to--
30 days prior to their effective date if circumstances
precluded enrollment in advance of providing services to Medicare
beneficiaries; or
90 days prior to their effective date if a Presidentially-
declared disaster under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 through 5206 (Stafford Act)
precluded enrollment in advance of providing services to Medicare
beneficiaries.
In light of proposed Sec. 424.67(c)(1) (and as further explained
in the collection of information section of this proposed rule), we
anticipate that a number of OTPs would end their existing enrollment
and apply as a new OTP via, as applicable, the Form CMS-855A or Form
CMS-855B. Given this, we believe it is important to clarify for
stakeholders the new enrollment's effective date of billing.
Accordingly, at Sec. 424.67, we proposed in new paragraph (c)(2) that
if a Form CMS-855B-enrolled OTP changes to a Form CMS-855A enrollment,
or vice versa, the effective date of billing that was established for
the OTP's prior enrollment under Sec. Sec. 424.520(d) and 424.521(a)
would be applied to the OTP's new enrollment. This would allow OTPs
that have been unable to bill for furnished services via their
preferred claim form (and have consequently chosen to delay the
submission of these claims for services) to do so retroactive to the
effective billing date of its prior enrollment. To illustrate, suppose
an OTP initially enrolled via the Form CMS-855B in 2020. The effective
date of billing was April 1, 2020. Wishing to submit an 837I claim form
for the services it has provided since April 1, 2020, the OTP elects to
end its Form CMS-855B enrollment and enroll via the Form CMS-855A
pursuant to revised Sec. 424.67. It successfully does the latter in
March 2021. Under Sec. 424.67(c)(2), the billing effective date of the
Form CMS-855A enrollment would be retroactive to April 1, 2020.
However, we noted in the proposed rule that the time limits for filing
claims found in Sec. 424.44 would continue to apply. Specifically, all
Medicare Part A and Part B claims must be filed within 1 calendar year
after the date of service unless one of a very limited number of
exceptions applies. Switching from a Form CMS-855B enrollment to a Form
CMS-855A enrollment, or vice versa, is not grounds for an exception.
We recognized that not every OTP that seeks to change its
enrollment will have chosen to withhold submission of all of its claims
under its prior enrollment. (Using our example in the previous
paragraph, the OTP may have submitted some claims via the CMS-1500
while planning to eventually submit the remaining ones via the 837I.)
Irrespective of this, CMS has long had operational safeguards in place
to prevent double-billing for the same service. Said protections would
be used in the scenario described in proposed Sec. 424.67(c)(2) so
that claims submitted under the prior enrollment could not be
resubmitted under the new one.
(3) Application Fee
As stated in Sec. 424.514, prospective and revalidating
institutional providers that are submitting a Medicare enrollment
application generally must pay the applicable application fee in
accordance with Sec. 424.514. (For CY 2020, the fee amount is $595.)
The term ``institutional provider'' is defined in Sec. 424.502 as any
provider or supplier that submits a paper Medicare enrollment
application using the Form CMS-855A, Form CMS-855B (not including
physician and NPP organizations, which are exempt from the fee
requirement if they are enrolling as a physician or NPP organization),
Form CMS-855S, Form CMS-20134, or an associated internet-based PECOS
enrollment application.
As stated previously, OTPs currently complete the Form CMS-855B to
enroll in Medicare. They are considered ``institutional providers'' (as
defined in Sec. 424.502) and must pay an application fee, a
requirement addressed in existing Sec. 424.67(b)(2). Since the
existing OTPs referenced in new paragraph (c)(2) would be enrolling as
new providers via the Form CMS-855A or Form CMS-855B (as applicable),
we stated our belief in the proposed rule that they would fall within
the scope of both (1) the aforementioned definition of ``institutional
provider'' and (2) Sec. 424.514(a)(1); as described therein, Sec.
424.514(a)(1) applies to prospective institutional providers that are
submitting an initial application. To clarify this issue for the OTP
community, we proposed to add language to Sec. 424.67(b)(2) stating
that compliance with the application fee requirements in Sec. 424.514
would also apply to those OTPs enrolling under the circumstances
described in Sec. 424.67(c)(2).
We emphasized that the flexibilities described in this section
III.B. are complementary to those in section II.I. (``Medicare Coverage
for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid
Treatment Programs (OTPs))'' regarding OTP billing via the 837I. Our
OTP enrollment revisions are intended to facilitate greater flexibility
for OTPs.
We received the following public comment on our OTP provider
enrollment proposals:
Comment: Several commenters supported our proposal to permit an OTP
to enroll via the Form CMS-855B or the Form CMS-855A. One commenter
also questioned whether this applies to a Medicare OTP Part B provider
sharing the same clinical space as a Medicare Part A provider.
Response: We appreciate the commenters' support. However, we
emphasize that an OTP may only enroll as such via the Form-855B or the
Form-855A, not both. In the situation the OTP appears to describe, the
OTP operating in the clinical space in question would have to elect
which of the two available enrollment mechanisms to pursue.
Based on the comments received, we are finalizing our provisions
pertaining to OTP enrollment as proposed.
C. Payment for Principal Care Management (PCM) Services in Rural Health
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
1. Background
a. RHC and FQHC Payment Methodologies
RHC and FQHC visits generally are face-to-face encounters between a
patient and one or more RHC or FQHC practitioners during which time one
or more RHC or FQHC qualifying services are furnished. RHC and FQHC
practitioners are physicians, nurse practitioners (NPs), physician
assistants (PA), certified nurse midwives (CNMs), clinical
psychologists (CPs), and clinical social workers, and under certain
conditions, a registered nurse or licensed practical nurse furnishing
care to a homebound RHC or FQHC patient. A Transitional Care Management
(TCM) service can also be an RHC or FQHC
[[Page 84698]]
visit. In addition, a Diabetes Self-Management Training (DSMT) service
or a Medical Nutrition Therapy (MNT) service furnished by a certified
DSMT or MNT program may also count as an FQHC visit. Only medically
necessary medical, mental health, or qualified preventive health
services that require the skill level of an RHC or FQHC practitioner
are RHC or FQHC billable visits. Services furnished by auxiliary
personnel (for example, nurses, medical assistants, or other clinical
personnel acting under the supervision of the RHC or FQHC practitioner)
are considered incident to the visit and are included in the per visit
payment.
RHCs are paid an all-inclusive rate (AIR) for all medically
necessary medical and mental health services and qualified preventive
health services furnished on the same day (with some exceptions). In
general, the A/B Medicare Administrative Contractor (MAC) calculates
the AIR for the year for each RHC by dividing total allowable costs by
the total number of visits for all patients. Productivity, payment
limits, and other factors are also considered in the calculation.
Allowable costs must be reasonable and necessary and may include
practitioner compensation, overhead, equipment, space, supplies,
personnel, and other costs incident to the delivery of RHC services.
The AIR is subject to a payment limit, except for certain provider-
based RHCs that have an exception to the payment limit.
FQHCs were paid under the same AIR methodology until October 1,
2014 when, in accordance with section 1834(o) of the Act (as added by
section 10501(i)(3) of the Affordable Care Act), they began to
transition to an FQHC PPS system in which they are paid based on the
lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate
is adjusted for geographic differences in the cost of services by the
FQHC PPS geographic adjustment factor (GAF).
b. Care Management Services in RHCs and FQHCs
In the CY 2018 PFS final rule with comment period (82 FR53180), we
finalized revisions to the payment methodology for Chronic Care
Management (CCM) services furnished by RHCs and FQHCs and established
requirements for general Behavioral Health Integration (BHI) and
psychiatric Collaborative Care Management (CoCM) services furnished in
RHCs and FQHCs, beginning on January 1, 2019. Specifically, we revised
Sec. 405.2464(c) to permit RHCs and FQHCs to bill for care management
services (HCPCS codes G0511 and G0512).
HCPCS code, G0511, is a General Care Management code for use by
RHCs or FQHCs when at least 20 minutes of qualified CCM or general BHI
services are furnished to a patient in a calendar month.
The payment amount for HCPCS code G0511 is set at the average of
the 3 national non-facility PFS payment rates for the CCM and general
BHI codes and updated annually based on the PFS amounts. The 3 codes
are CPT 99490 (20 minutes or more of CCM services), CPT 99487 (60
minutes or more of complex CCM services), and CPT 99484 (20 minutes or
more of BHI services).
In the CY 2019 PFS final rule with comment period (83 FR 59687), we
added CPT code 99491 (30 minutes or more of CCM furnished by a
physician or other qualified health care professional) as a general
care management service and included it in the calculation of HCPCS
code G0511. Beginning January 1, 2019, the payment for HCPCS code G0511
is set at the average of the national non-facility PFS payment rates
for CPT codes 99490, 99487, 99484, and 99491 and is updated annually
based on the PFS amounts. Additional information on CCM requirements is
available on the CMS Care Management web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html, and on the CMS RHC and FQHC web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and
https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
2. Requirements for PCM Services in RHCs and FQHCs
In the CY 2020 PFS final rule with comment (84 FR 62692), we
established a separate payment for PCM services. PCM services include
comprehensive care management services for a single high-risk disease
or complex condition, typically expected to last at least 3 months and
may have led to a recent hospitalization, and/or placed the patient at
significant risk of death. Beginning January 1, 2020, practitioners
billing under the PFS can bill for PCM services using HCPCS codes G2064
or G2065.
HCPCS code G2064 is for at least 30 minutes of PCM services
furnished by physicians or NPPs during a 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.
HCPCS code G2065 is for at least 30 minutes of PCM services
furnished by clinical staff under the direct supervision of a physician
or NPP with the following elements: One complex chronic condition
lasting at least 3 months, which is the focus of the care plan; the
condition is of sufficient severity to place patient at risk of
hospitalization or have been cause of a recent hospitalization; the
condition requires development or revision of disease-specific care
plan; the condition requires frequent adjustments in the medication
regimen; and/or the management of the condition is unusually complex
due to comorbidities.
In the CY 2021 PFS proposed rule (85 FR 50214), we stated that a
national stakeholder organization representing rural health clinics
requested that RHCs be allowed to furnish and bill for PCM services. We
agreed that there can be significant resources involved in care
management for a single high-risk disease or complex chronic condition,
and that the requirements for the new PCM codes are similar to the
requirements for the care management services described by HCPCS code
G0511. We explained that these are services that do not currently meet
the requirements for an RHC or FQHC billable visit, and they provide an
array of care management services that are not generally included in
the RHC AIR or the FQHC PPS. Therefore, we proposed to add HCPCS codes
G2064 and G2065 to G0511 as a comprehensive care management service for
RHCs and FQHCs starting January 1, 2021. The payment rate for HCPCS
G0511 is set at the average of the national non-facility PFS payment
rate for the RHC and FQHC care management and general behavioral health
codes (CPT codes 99490, 99487, 99484, and 99491), and we proposed that
these 2 new codes be added to the calculation of the G0511 payment
rate.
3. Other Options Considered
In the CY 2021 PFS proposed rule (85 FR 50214), we stated that we
also considered creating a separate G code for PCM services. We did not
propose this approach because PCM and CCM are similar services and
grouping them together is consistent with an integrated approach to
care with reduced reporting
[[Page 84699]]
requirements. As we stated in the CY 2018 PFS final rule, if a new care
management code is proposed and subsequently finalized for
practitioners billing under the PFS, we would review the new code to
determine if it should be included in the calculation of the RHC and
FQHC General Care Management Code. The determination of whether a new
care management code should be added to the codes used to determine the
payment rate is based on the applicability of the service in RHCs and
FQHCs, and may result in either an increase or decrease in the payment
amount for HCPCS code G0511.
4. Implementation
In the CY 2021 PFS proposed rule (85 FR 50214), we explained that
if this proposal is finalized as proposed, RHCs and FQHCs that furnish
PCM services would also be able to bill the services using HCPCS code
G0511, either alone or with other payable services on an RHC or FQHC
claim for dates of service on or after January 1, 2021. The payment
rate for HCPCS code G0511 would continue to be the average of the
national non-facility PFS payment rates for the RHC/FQHC care
management and general behavioral health codes (CPT codes 99484, 99487,
99490, and 99491). HCPCS G2064 and G2065 would be added to G0511 to
calculate a new average for the national non-facility PFS payment rate.
The payment rate for HCPCS code G0511 would be updated annually based
on the PFS amounts for these codes.
We received approximately 27 public comments on the proposed
requirements for PCM services in RHCs and FQHCs from a mix of
stakeholders, including individuals, associations, advocate groups, and
provider groups. The following is a summary of the comments we received
and our responses.
Comment: All commenters supported the proposal to add the PCM HCPCS
codes to the general care management HCPCS code (G0511) for care
management services furnished in RHCs and FQHCs. One commenter
recommended we create two new G codes for PCM services furnished in
RHCs and FQHCs. A few commenters suggested that CMS waive the
coinsurance for PCM services.
Response: Per the comment that recommended that we create two new G
codes, we considered creating new G codes for PCM services as we stated
in the CY 2021 PFS proposed rule (85 FR 50214); however, we explained
that since the requirements for PCM services are similar to the
requirements for care management services furnished in an RHC and FQHC,
grouping them together is consistent with an integrated approach to
care with reduced reporting requirements.
Regarding the comment suggesting that CMS waive the coinsurance for
PCM services, we remind commenters that we have no authority to waive
coinsurance for care management services. Coinsurance for care
management services is 20 percent of lesser of submitted charges or the
payment rate for general care management HCPCS code.
Comment: We received several public comments that were out-of-scope
for this rule. Commenters requested that CMS expand certain
flexibilities provided during the PHE for COVID-19, including the
addition of services to the Medicare Telehealth Services List. In
addition, several commenters requested that CMS create a separate G
code for remote physiologic monitoring (RPM) services and add RPM
treatment management services (RPMTMS) to the general care management
services.
Response: We appreciate the feedback from commenters, and will
continue to monitor Medicare telehealth services during the PHE for
COVID-19. RHCs are paid an 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. We may
consider analyzing the RPMTMS services and how they would impact the
payment for general care management services in future rulemaking;
however, we note that we did not specifically make any proposals
associated with these subjects in the CY 2021 PFS proposed rule.
In consideration of these public comments, we are finalizing the
proposal to add the PCM HCPCS codes, G2064 and G2065, to the general
care management code, G0511, as a comprehensive care management service
for RHCs and FQHCs, starting January 1, 2021 as proposed. We are also
finalizing that when RHCs and FQHCs furnish PCM services, they will
also be able to bill the services using HCPCS code G0511, either alone
or with other payable services on an RHC or FQHC claim for dates of
service on or after January 1, 2021. The payment rate for HCPCS code
G0511 will be the average of the national non-facility PFS payment
rates for the RHC/FQHC care management and general behavioral health
codes (CPT codes 99484, 99487, 99490, and 99491) with the addition of
HCPCS G2064 and G2065. That is, the PCM services will be added to G0511
to calculate a new average for the national non-facility PFS payment
rate. The payment rate for HCPCS code G0511 will be updated annually
based on the PFS amounts for these codes.
D. Changes to the Federally Qualified Health Center Prospective Payment
System (FQHC PPS) for CY 2021: Rebasing and Revising of the FQHC Market
Basket
1. Background
Section 10501(i)(3)(A) of the Affordable Care Act added section
1834(o) of the Act to establish a payment system for the costs of FQHC
services under Medicare Part B based on prospectively set rates. In the
Prospective Payment System (PPS) for FQHC final rule published in the
May 2, 2014 Federal Register (79 FR 25436), we implemented a
methodology and payment rates for the FQHC PPS. Beginning on October 1,
2014, FQHCs began to transition to the FQHC PPS based on their cost
reporting periods, and as of January 1, 2016, all FQHCs have been paid
under the FQHC PPS.
Section 1834(o)(2)(B)(ii) of the Act requires that the payment for
the first year after the implementation year be increased by the
percentage increase in the Medicare Economic Index (MEI). Therefore, in
CY 2016, the FQHC PPS base payment rate was increased by the MEI. The
MEI is based on 2006 data from the American Medical Association (AMA)
for self-employed physicians and was used in the PFS sustainable growth
rate (SGR) formula to determine the CF for physician service payments.
(See the CY 2014 PFS final rule (78 FR 74264) for a complete discussion
of the 2006-based MEI.) Section 1834(o)(2)(B)(ii) of the Act also
requires that beginning in CY 2017, the FQHC PPS base payment rate will
be increased by the percentage increase in a market basket of FQHC
goods and services, or if such an index is not available, by the
percentage increase in the MEI.
Beginning with CY 2017, FQHC PPS payments were updated using a
2013-based market basket reflecting the operating and capital cost
structures for freestanding FQHC facilities (hereafter referred to as
the FQHC market basket). A complete discussion of the 2013-based FQHC
market basket can be found in the CY 2017 PFS final rule (81 FR 80393
through 80403).
In the CY 2021 PFS proposed rule (85 FR 50214 through 50223), we
proposed
[[Page 84700]]
to rebase and revise the 2013-based FQHC market basket to reflect a
2017 base year. The proposed 2017-based FQHC market basket is primarily
based on Medicare cost report data for FQHCs for 2017, which are for
cost reporting periods beginning on and after October 1, 2016, and
prior to September 31, 2017. We proposed to use data from cost reports
beginning in FY 2017 because these data are the latest available
complete data for purposes of calculating cost weights for the market
basket at the time of rulemaking.
In the following discussion, we provide an overview of the proposed
FQHC market basket, describe the proposed methodologies for developing
the 2017-based FQHC market basket, and provide information on the
proposed price proxies. We then describe any comments received,
responses to these comments, and our final decision for this final
rule.
2. Overview of the 2017-Based FQHC Market Basket
Similar to the 2013-based FQHC market basket, the proposed 2017-
based FQHC market basket is a fixed-weight, Laspeyres-type price index.
A Laspeyres price index measures the change in price, over time, of the
same mix of goods and services purchased in the base period. Any
changes in the quantity or mix (that is, intensity) of goods and
services purchased over time are not measured. The index itself is
constructed using three steps. First, a base period is selected (we
proposed to use 2017 as the base period) and total base period
expenditures are estimated for a set of mutually exclusive and
exhaustive spending categories, with the proportion of total costs that
each category represents being calculated. These proportions are called
``cost weights'' or ``expenditure weights.'' Second, each expenditure
category is matched to an appropriate price or wage variable, referred
to as a ``price proxy.'' In almost every instance, these price proxies
are derived from publicly available statistical series that are
published on a consistent schedule (preferably at least on a quarterly
basis). Finally, the expenditure weight for each cost category is
multiplied by the level of its respective price proxy. The sum of these
products (that is, the expenditure weights multiplied by their price
levels) for all cost categories yields the composite index level of the
market basket in a given period. Repeating this step for other periods
produces a series of market basket levels over time. Dividing an index
level for a given period by an index level for an earlier period
produces a rate of growth in the input price index over that timeframe.
As noted above, the market basket is described as a fixed-weight index
because it represents the change in price over time of a constant mix
(quantity and intensity) of goods and services needed to furnish FQHC
services. The effects on total expenditures resulting from changes in
the mix of goods and services purchased subsequent to the base period
are not measured. For example, a FQHC hiring more nurse practitioners
to accommodate the needs of patients would increase the volume of goods
and services purchased by the FQHC, but would not be factored into the
price change measured by a fixed-weight FQHC market basket. Only when
the index is rebased would changes in the quantity and intensity be
captured, with those changes being reflected in the cost weights.
Therefore, we rebase the market basket periodically so that the cost
weights reflect a recent mix of goods and services that FQHCs purchase
(FQHC inputs) to furnish inpatient care.
3. Development of the 2017-Based FQHC Market Basket Cost Categories and
Weights
We solicited public comments on the proposed methodology for
deriving the 2017-based FQHC market basket.
a. Use of Medicare Cost Report Data
We proposed a 2017-based FQHC market basket that consists of eleven
major cost categories and a residual derived from the 2017 Medicare
cost reports (CMS Form 224-14, OMB Control Number 0938-1298) for FQHCs,
hereafter referred to as the 2014 Medicare Cost Report form. The eleven
cost categories are FQHC Practitioner Wages and Salaries, FQHC
Practitioner Employee Benefits, FQHC Practitioner Contract Labor,
Clinical Staff Wages and Salaries, Clinical Staff Employee Benefits,
Clinical Staff Contract Labor, Non-Health Staff Compensation, Medical
Supplies, Pharmaceuticals, Fixed Capital and Moveable Capital. The
residual category reflects all remaining costs not captured in the 11
cost categories such as non-medical supplies and utilities for example.
We noted that for the 2013-based FQHC market basket, we estimated six
cost categories from the Medicare cost reports (CMS Form 222-92, OMB
Control Number 0938-0107), hereafter referred to as the 1992 Medicare
cost report form: FQHC Practitioner Compensation, Clinical Staff
Compensation, Non-Health Staff Compensation, Pharmaceuticals, Fixed
Capital and Moveable Capital.
The resulting 2017-based FQHC market basket cost weights reflect
Medicare allowable costs. We proposed to define Medicare allowable
costs for freestanding FQHC facilities as the total expenses reported
on: Worksheet A, columns 1 and 2, lines 1 through 7 and lines 9 through
12; Worksheet A, column 1, lines 23 through 36; and Worksheet S3 Part
II, columns 1 and 2, lines 2 through 14. We noted that we continue to
exclude Professional Liability Insurance (PLI) costs from the total
Medicare allowable costs because FQHCs that receive section 330 grant
funds also are eligible to apply for medical malpractice coverage under
Federally Supported Health Centers Assistance Act (FSHCAA) of 1992
(Pub. L. 102-501) and FSHCAA of 1995 (Pub. L. 104-73 amending section
224 of the Public Health Service Act).
The following is a summary of how we proposed to derive the eleven
major cost category weights. Prior to estimating any costs, we remove
any providers that did not report any total gross patient revenues as
reported on the FQHC cost report Worksheet F-1, line 1, column 4.
(1) FQHC Practitioner Wages and Salaries Costs
A FQHC practitioner is defined as one of the following occupations:
Physicians; nurse practitioners (NPs); physician assistants (PAs);
certified-nurse midwife (CNMs); clinical psychologist (CPs); and
clinical social workers (CSWs). We proposed to derive FQHC Practitioner
Wages and Salaries costs as the sum of direct care costs salaries as
reported on Worksheet A, column 1, lines 23, 25, 26, 29, 30, and 31.
These lines represent the wages and salaries costs for physicians, PAs,
NPs, CNMs, CPs, and CSWs. For the 2013-based FQHC market basket, we
estimated FQHC Practitioner Total Compensation costs based on a similar
methodology using cost data reported on Worksheet A of the 1992
Medicare cost report form (81 FR 80394) for specific details on the
prior methodology.
(2) FQHC Practitioner Employee Benefits Costs
Effective with the implementation of the 2014 Medicare cost report
form, we began collecting Employee Benefits and Contract Labor data on
Worksheet S-3, part II and proposed to derive FQHC Practitioner
Employee Benefits costs using data obtained from that worksheet.
Approximately 66 percent of FQHCs included in the sample of FQHCs
reporting Salary costs also reported data on Worksheet S-3, part II for
2017. We continue to encourage all providers to report these data on
the
[[Page 84701]]
Medicare cost report. Therefore, we proposed to calculate FQHC
Practitioner Employee Benefits costs using Worksheet S-3, part II data.
Specifically, we proposed to use data from Worksheet S-3, part II,
column 2, lines 2, 3, 4, 7, 8, and 9 to derive FQHC Practitioner
Employee Benefits costs. These lines represent the employee benefits
costs for physicians, PAs, NPs, CNMs, CPs, and CSWs. Our analysis of
the Worksheet S-3, part II data submitted by these FQHCs indicates that
we had a large enough sample to enable us to produce a reasonable
Employee Benefits cost weight.
For the 2013-based FQHC market basket, we did not have data at the
level of detail to separately estimate FQHC Practitioner Employee
Benefits costs, and instead computed FQHC Practitioner Total
Compensation costs, which reflected costs for wages and salaries,
employee benefits, and contract labor together. Anytime direct costs
can be obtained for a cost category directly from the Medicare Cost
Reports we consider that to be a technical improvement to the market
basket weight methodology as it allows the index to reflect the
relative shares specific to the provider type. Therefore, as discussed
in the CY 2021 PFS proposed rule, we noted that we believe the proposed
method of separately estimating FQHC Practitioner Employee Benefits is
a technical improvement over the 2013-based FQHC market basket.
(3) FQHC Practitioner Contract Labor Costs
FQHC Practitioner Contract labor costs are primarily associated
with direct patient care services. Contract labor costs for services
such as accounting, billing, and legal are estimated using other
government data sources as described below. Approximately 60 percent of
FQHCs reported contract labor costs on Worksheet S-3, part II, which we
noted that we believe is an adequate sample size to enable us to
produce a reasonable FQHC Practitioner Contract Labor cost weight.
Therefore, we proposed to derive the FQHC Practitioner Contract Labor
costs for the proposed 2017-based FQHC market basket from data reported
on Worksheet S-3, part II, column 1, lines 2, 3, 4, 7, 8, and 9. These
lines represent the contract labor costs for physicians, PAs, NPs,
CNMs, CPs, and CSWs. We would also add in the costs for physician
services under agreement as reported on Worksheet A, column 2, line 24
to derive the total FQHC Practitioner Contract Labor cost weight in the
2017-based FQHC market basket.
For the 2013-based FQHC market basket, we did not have data at the
level of detail to separately estimate FQHC Practitioner Contract Labor
costs and instead computed FQHC Practitioner Total Compensation costs,
which reflected costs for wages and salaries, employee benefits, and
contract labor together. As noted previously, anytime direct costs can
be obtained for a cost category directly from the Medicare Cost Reports
we consider that to be a technical improvement to the market basket
weight methodology as it allows the index to reflect the relative
shares specific to the provider type. Therefore, we noted that we
believe the proposed method of separately estimating FQHC Practitioner
Contract Labor is a technical improvement over the 2013-based FQHC
market basket.
(4) Clinical Staff Wages and Salaries Costs
Clinical Compensation includes any health-related clinical staff
who does not fall under the definition of a FQHC Practitioner described
in paragraph. We proposed to derive Clinical Staff Wages and Salaries
costs as the sum of direct care costs salaries as reported on Worksheet
A, column 1, lines 27, 28, 32, 33, 34, 35, and 36. These lines
represent the wages and salaries costs for visiting registered nurses
(RNs), visiting licensed practical nurses (LPNs), laboratory
technicians, registered dietician/Certified DSMT/MNT educators,
physical therapists (PTs), occupational therapists (OTs), and other
allied health personnel.
For the 2013-based FQHC market basket, we estimated a
clinical staff total compensation cost based on a similar methodology
using cost data reported on Worksheet A of Medicare Cost Report Form
CMS-222-92, (see 81 FR 80394 for specific details on the prior
methodology).
(5) Clinical Staff Employee Benefits Costs
Effective with the implementation of the 2014 Medicare cost report
form, we began collecting employee benefits and contract labor data on
Worksheet S-3, part II and proposed to derive clinical staff employee
benefits costs using data obtained from that worksheet. Approximately
64 percent of FQHCs included in the sample of FQHCs reporting salary
expenses also reported data on Worksheet S-3, part II for 2017. We
noted that we continue to encourage all providers to report these data
on the Medicare cost report. Therefore, we proposed to calculate
clinical staff employee benefits costs using Worksheet S-3, part II,
column 2, lines 5, 6, 10, 11, 12, 13, and 14. These lines represent the
employee benefits costs for visiting RNs, visiting LPNs, laboratory
technicians, registered dietician/Certified DSMT/MNT educators, PTs,
OTs, and other allied health personnel.
For the 2013-based FQHC market basket, we did not have
data at the level of detail to separately estimate clinical staff
employee benefits costs and instead computed clinical staff total
compensation costs, which reflected costs for wages and salaries,
employee benefits, and contract labor together. We noted that we
believe the proposed method of separately estimating clinical staff
employee benefits is a technical improvement over the 2013-based FQHC
market basket.
(6) Clinical Staff Contract Labor Costs
We proposed to derive the clinical staff contract labor costs for
the proposed 2017-based FQHC market basket from data reported on
Worksheet S-3, part II, column 1, lines 5, 6, 10, 11, 12, 13, and 14 to
derive clinical staff contract labor costs. These lines represent the
contract labor costs for visiting RNs, visiting LPNs, laboratory
technicians, registered dietician/Certified DSMT/MNT educators, PTs,
OTs, and other allied health personnel.
For the 2013-based FQHC market basket, we did not have data at the
level of detail to separately estimate clinical staff contract labor
costs and instead computed clinical staff total compensation costs,
which reflected costs for wages and salaries, employee benefits, and
contract labor together. We noted that we believe the proposed method
of separately estimating FQHC clinical staff contract labor is a
technical improvement over the 2013-based FQHC market basket.
(7) Non-Health Staff Compensation Costs
Non-Health Staff Compensation includes wage and salary costs for
personnel in general service cost centers including: Employee Benefits
department; Administrative & General; Plant Operation & Maintenance;
Janitorial; Medical Records; Pharmacy; Transportation; and Other
General Services. Specifically, non-health staff compensation costs are
derived as the sum of compensation costs as reported on Worksheet A,
column 1 for lines 3, 4, 5, 6, 7, 9, 10, 11, and 12. Additionally, we
add a portion of employee benefit costs reported on Worksheet A, line
3, column 2 accounting for the non-health staff. We
[[Page 84702]]
estimate the ratio of non-health staff related wages and salaries as a
percentage of total wages and salaries. We then apply the percentage of
non-health staff related wages and salary costs to the total employee
benefits costs (Worksheet A, line 3, column 2) for each FQHC. We noted
that we believe this is a reasonable estimate of non-health staff
employee benefits. We proposed to only use the costs from column 1 for
most of the general service cost centers other than employee benefits
since we believe that there are noncompensation costs reported in
column 2 (such as maintenance and janitorial supplies). The remaining
other costs for the general service categories are reflected in the
remaining proposed cost categories as explained in more detail below.
(8) Pharmaceuticals Costs
We proposed to calculate pharmaceuticals costs using the non-salary
costs for the pharmacy cost center reported on Worksheet A, column 2,
line 9. We proposed to exclude the costs for drugs charged to patients
as reported on Worksheet A, line 67 since these drugs are not included
in the Medicare allowable costs for the FQHC PPS and are separately
reimbursed. For the 2013-based FQHC market basket we were not able to
exclude non-reimbursable drug costs (such as drugs charged to patient
costs) from the pharmacy cost weight as the 1992 Medicare cost report
form did not capture these costs separately. We noted that we believe
our proposed methodology is a technical improvement as it is more
consistent with the FQHC PPS reimbursement.
(9) Medical Supplies
We proposed to calculate medical supplies costs using the non-
salary costs for the medical supplies cost center reported on Worksheet
A, column 2, line 10. The medical supplies cost weight for the 2013-
based FQHC market basket was derived based on the relative share of the
medical supply costs in the MEI since these costs were not separately
reported on the 1992 Medicare cost report form (81 FR 80395 through
80396). Since these costs are now directly reported by FQHC providers
we noted that we believe that the proposed method is a technical
improvement to the method used in the 2013-based FQHC market basket.
(10) Fixed Capital
We proposed that fixed capital costs be equal to costs reported on
Worksheet A, line 1, column 2 of the Medicare Cost Report. A similar
methodology was used for the 2013-based FQHC market basket.
(11) Moveable Capital Costs
We proposed that moveable capital costs be equal to the capital
costs as reported on Worksheet A, line 2, column 2. A similar
methodology was used for the 2013-based FQHC market basket.
Comment: Several commenters expressed support, as well as some
concerns with the proposed use of the Medicare cost reports.
Specifically, the commenters supported the proposed use of the Medicare
cost report data to derive eleven major cost categories in the 2017-
based FQHC market basket--an increase from 6 cost categories used in
the 2013-based FQHC market basket. They stated this calculation will
give a broader base to more accurately compute the increasing costs of
providing FQHC services.
The commenters also agreed with the proposed lines included in the
calculation of the Medicare Allowable total expenses (Worksheet A,
columns 1 and 2, lines 1 through 7 and lines 9 through 12; Worksheet A,
column 1, lines 23 through 36; and Worksheet S3 Part II, columns 1 and
2, lines 2 through 14). However, they disagreed with the use of columns
1 and 2 from Worksheet A to capture a health center's expenses because
they reflect their internal accounting records in accordance with
generally accepted accounting principles (GAAP). The commenters noted
that the net expenses as listed in Worksheet A, column 7 of the
Medicare cost report most accurately reflects Medicare allowable cost
for a community health center as these reflect the reclassification
entries which are common on the Medicare cost report, particularly for
expenses related to compensation and drugs. They also noted that CMS
must factor in the reclassification and adjustment entries that are
recorded on health center Medicare cost reports to accurately calculate
a 2017-based market basket that reflects the change in Medicare
allowable costs. Furthermore, the commenters noted that the costs that
are used to calculate the costs per visits in Worksheet B reflect the
reclassifications and adjustments and so the 2017-based FQHC market
basket should be calculated using the same cost information.
Response: Using the data from the net cost column (column 7)
presents unique challenges because a detailed breakdown of the net
expenses is not provided on the FQHC cost report, particularly for
employee benefits, which is why we proposed to utilize the data from
Worksheet A column 1 and 2 to estimate salary and all other costs.
Specifically, the FQHC cost report does not have a detailed step down
of the net expenses allocated to each General Service cost center like
other provider cost reports such as the hospice cost report (CMS Form
1984-14). This means that for some categories, particularly Employee
Benefits cost center, we must make assumptions on how the total
employee benefit costs are allocated across cost centers. On the other
hand, Worksheet B on the hospice cost report gives a detailed
allocation of General Service cost centers' net expenses (including
employee benefits) across the patient-care cost centers.
Based on the commenters' concerns, we reviewed the FQHC Medicare
cost report data and found that a large percentage of providers had
reclassifications and adjustments and these had an impact on the
distribution of total expenses among the major cost weight categories,
particularly pharmaceuticals and FQHC practitioner salaries. Therefore,
based on public comments, for this final rule we are revising our
methodology from the proposed rule to reflect the use of net expenses
as reported on Worksheet A, column 7 rather than the proposed Worksheet
A, column 1 and column 2 to derive the FQHC cost share weights. Below
we provide the revised detailed methodology for the major market basket
cost weights in response to public comment.
In response to public comments to use net costs rather than total
costs to derive the FQHC market basket cost weights, we are defining
Medicare allowable costs for freestanding FQHC facilities as the total
expenses reported on: Worksheet A, column 7, for lines 1 through 7,
lines 9 through 12, and lines 23 through 36. These are the same cost
centers that were used in the proposed market basket for which the
commenters agreed was appropriate.
(1-3) FQHC Practitioner Compensation (Wages & Salaries, Benefits, and
Contract Labor)
In response to public comment to use net costs rather than total
costs to derive the FQHC market basket cost weights, we are defining
the FQHC Practitioner Compensation as the sum of net expenses (that is,
costs after reclassifications and adjustments) as reported on Worksheet
A, column 7, lines 23, 25, 26, 29, 30, and 31. These lines represent
the total net costs for physicians, PAs, NPs, CNMs, CPs, and CSWs--the
same lines that were used for the proposed methodology for which the
commenters agreed was appropriate. Using this finalized methodology, we
derive a 2017-based FQHC market
[[Page 84703]]
basket FQHC Practitioner Compensation cost weight of 28.4 percent
compared to the proposed rule with 30.0 percent.
To further divide the FQHC Practitioner Compensation costs into
FQHC Practitioner Wages and Salaries, Benefits, and Contract Labor
costs, we are using the shares derived for each of these costs using
the proposed methodologies for each FQHC provider as described in
sections III.D.3.a.1, D.3.a.2 and D.3.a.3 of this final rule.
Specifically, for each line included in the FQHC Practitioner category,
the FQHC Practitioner Wages and Salaries costs is equal to the FQHC
Practitioner Compensation costs as described above multiplied by the
FQHC Practitioner Wages and Salaries costs (described in section
III.D.3.a.1 of this final rule) as a percent of FQHC Practitioner
Compensation costs. This revised methodology reflects the net expenses
(Worksheet A, column 7) to address the commenters' concerns while also
using the Medicare cost report data to reflect the split among the
types of compensation costs: Wages and salaries, employee benefits, and
contract labor.
Therefore, for this final rule, in response to public comment to
use net costs rather than total costs to derive the FQHC market basket
cost weights, the FQHC Practitioner Wages and Salaries cost weight is
19.4 percent, and accounts for 68 percent of the FQHC Practitioner
Compensation cost weight. The FQHC Practitioner Employee Benefit cost
weight is 4.5 percent, and accounts for 16 percent of the FQHC
Practitioner Compensation cost weight. The FQHC Practitioner Contract
Labor cost weight is 4.6 percent, and accounts for 16 percent of the
FQHC Practitioner Compensation cost weight.
(4-6) Clinical Staff Compensation (Wages & Salaries, Benefits, and
Contract Labor)
In response to public comment to use net costs rather than total
costs to derive the FQHC market basket cost weights, we are defining
Clinical Staff Compensation costs as the sum of net expenses (that is,
costs after reclassifications and adjustments) as reported on Worksheet
A, column 7, lines 27, 28, 32, 33, 34, 35, and 36. These lines
represent the net expenses for visiting RNs, visiting LPNs, laboratory
technicians, registered dietician/Certified DSMT/MNT educators, PTs,
OTs, and other allied health personnel--the same lines that were used
for the proposed methodology for which the commenters agreed was
appropriate. Using this finalized methodology, we derive a 2017-based
FQHC market basket Clinical Staff Compensation cost weight of 16.8
percent compared to the proposed rule with 16.2 percent.
To further divide the Clinical Staff Compensation costs into
Clinical Staff Wages and Salaries, Clinical Staff Employee Benefits,
and Clinical Staff Contract Labor costs, we are using the shares
derived for each of these costs using the proposed methodologies for
each FQHC provider as described in sections III.D.3.a.4, D.3.a.5 and
D.3.a.6. of this final rule. Specifically, for each line included in
the Clinical Staff Compensation category, the Clinical Staff Wages and
Salaries costs is equal to the Clinical Staff Compensation costs as
described above multiplied by the Clinical Staff Wages and Salaries
costs (described in section III.D.3.a.4. of this final rule) as a
percent of Clinical Staff Compensation costs. This same methodology is
being used for the FQHC Practitioner Wages and Salaries, Employee
Benefits, and Contract Labor, which again reflects the net expenses
(Worksheet A, column 7) to address the commenters concerns. Therefore,
for this final rule, the Clinical Staff Wages and Salaries cost weight
is 12.9 percent, which accounts for 77 percent of the Clinical Staff
Compensation cost weight. The Clinical Staff Employee Benefit cost
weight is 3.1 percent, which accounts for 18 percent of the Clinical
Staff Compensation cost weight. The Clinical Staff Contract Labor cost
weight is 0.8 percent, which accounts for 5 percent of the Clinical
Staff Compensation cost weight.
(7) Non-Health Staff Compensation Costs
As stated above, the Non-Health Staff Compensation costs are for
personnel in general service cost centers including: Employee Benefits
department; Administrative & General; Plant Operation & Maintenance;
Janitorial; Medical Records; Pharmacy; Medical Supplies;
Transportation; and Other General Services.
In response to public comment to use net costs rather than total
costs to derive the FQHC market basket cost weights, we are defining
Non-Health Staff Compensation costs using net expenses (that is, costs
after reclassifications and adjustments) as the estimated share of
compensation costs from Worksheet A, column 7 for lines 3, 4, 5, 6, 7,
9, 10, 11, and 12. Since the net expenses for the General Service Cost
centers include both compensation and other costs we estimate the share
of net expenses for each general service cost center that reflects
compensation costs.
First, we estimate a share of Non-Health Staff Wages and Salaries
costs for each general service cost center as reported on Worksheet A,
column 1 for lines 3, 4, 5, 6, 7, 9, 10, 11, and 12 divided by
Worksheet A, column 1 and 2 for lines 3, 4, 5, 6, 7, 9, 10, 11, and 12.
Then, we multiply the Non-Health Staff Net expenses (that is, costs
after reclassifications and adjustments) by the Non-Health Staff Wages
and Salaries share to derive estimated Non-Health Staff Wages and
Salaries for each general service cost center (lines 3-7 and lines 9-
12).
Second, we estimate Non-Health Staff Employee Benefit costs by
multiplying the Non-Health Staff Wages and Salaries costs (step one) by
the facility benefit to salary ratio. Finally, we add the derived Non-
Health Staff Wages and Salaries costs and the derived Non-Health Staff
Employee Benefits costs for each general service cost center (line 3-7
and lines 9-12). The results is the 2017-based FQHC market basket Non-
health Staff Compensation cost weight of 27.2 percent compared to the
proposed rule with 25.4 percent.
(8) Pharmaceuticals Costs
In response to public comment to use net costs rather than total
costs to derive the FQHC market basket cost weights, we are calculating
Pharmaceuticals costs as the non-compensation costs for the pharmacy
cost center. We define this as Worksheet A, column 7, line 9 less
derived Pharmacy compensation costs. Similar to the methodology used
for the Non-Health Staff compensation, we derive estimated Pharmacy
compensation costs.
First we derive the share of pharmacy wages and salaries as
Worksheet A, column 1, line 9 divided by the sum of Worksheet A, Column
1 & 2, for line 9. Then, we multiply the pharmacy wages and salaries
share by pharmacy net expenses (Worksheet A, column 7, line 9).
Second, we estimate Pharmacy employee benefits by multiplying the
derived Pharmacy wages and salaries by the facility benefit to salary
ratio. The derived Pharmacy compensation costs are equal to the sum of
the estimated pharmacy wages and salaries and pharmacy benefits costs.
Using this finalized methodology, we derive a 2017-based FQHC market
basket Pharmacy cost weight of 2.4 percent compared to the proposed
rule with 3.9 percent.
(9) Medical Supplies
In response to public comment to use net costs rather than total
costs to derive the FQHC market basket cost weights, we are calculating
medical supplies costs as the non-compensation costs for
[[Page 84704]]
the Medical Supplies costs center. We define this as Worksheet A,
column 7, line 10 less derived Medical Supplies compensation costs.
Similar to the methodology used for the Non-Health Staff compensation,
we estimate Medical Supplies compensation costs.
First, we derive the share of medical supplies wages and salaries
as Worksheet A, column 1, line 10 divided by the sum of Worksheet A,
Column 1 & 2, line 10. Then, we multiply the medical supplies wages and
salaries share by the medical supplies net expense (Worksheet A, column
7, line 10).
Second we estimate Medical Supplies employee benefits by
multiplying the derived Medical Supplies wages and salaries by the
facility benefit to salary ratio. The derived Medical Supplies
compensation costs are equal to the sum of the estimated medical
supplies wages and salaries and medical supplies benefits costs. Using
this finalized methodology, we derive a 2017-based FQHC market basket
Medical Supplies cost weight of 2.2 percent compared to the proposed
rule with 2.4 percent.
(10) Fixed Capital
In response to public comment to use net costs rather than total
costs to derive the FQHC market basket cost weights, we are defining
fixed capital costs to be equal to costs reported on Worksheet A, line
1, column 7 of the Medicare Cost Report. Using this finalized
methodology, we derive a 2017-based FQHC market basket fixed capital
cost weight of 4.4 percent compared to the proposed rule with 4.6
percent.
(11) Moveable Capital Costs
In response to public comment to use net costs rather than total
costs to derive the FQHC market basket cost weights, we are defining
moveable capital costs to be equal to the capital costs as reported on
Worksheet A, line 2, column 7. Using this finalized methodology, we
derive a 2017-based FQHC market basket Moveable Capital cost weight of
2.0 percent compared to the proposed rule with 1.9 percent.
b. Major Cost Category Computation
After we derive costs for the major cost categories for each
provider using the Medicare cost report data as previously described,
we proposed to trim the data for outliers. For each of the eleven major
cost categories, we proposed to divide the calculated costs for the
category by total Medicare allowable costs calculated for the provider
to obtain cost weights for the universe of FQHC providers. For the
2017-based FQHC market basket (similar to the 2013-based FQHC market
basket), we proposed that total Medicare allowable costs would be equal
to the total costs as reported on Worksheet A, columns 1 and 2, lines 1
through 7 and lines 9 through 12; Worksheet A, column 1, lines 23
through 36; and Worksheet S3 Part II, columns 1 and 2, lines 2 through
14. In response to public comment to use net costs rather than total
costs to derive the FQHC market basket cost weights, we are defining
Medicare allowable costs for freestanding FQHC facilities as the total
net expenses (after reclassifications and adjustments) reported on:
Worksheet A, column 7, for lines 1 through 7, lines 9 through 12; and
lines 23 through 36. These are the same cost centers that were used in
the proposed market basket for which the commenters agreed was
appropriate.
For the FQHC Practitioner Wages and Salaries, FQHC Practitioner
Employee Benefits, FQHC Practitioner Contract Labor, Clinical Staff
Wages and Salaries, Clinical Staff Employee Benefits, Clinical Staff
Contract Labor, Non-Health Staff Compensation, Pharmaceuticals, Medical
Supplies, Fixed Capital, and Moveable Capital cost weights, after
excluding cost weights that are less than or equal to zero, we proposed
to then remove those providers whose derived cost weights fall in the
top and bottom 5 percent of provider-specific derived cost weights to
ensure the exclusion of outliers. A 5 percent trim is the standard trim
applied to the mean cost weights in all CMS market baskets and is
consistent with the trimming used in the 2013-based FQHC market basket.
After the outliers have been excluded, we add the costs for each
category across all remaining providers. We proposed to then divide
this by the sum of total Medicare allowable costs across all remaining
providers to obtain a cost weight for the 2017-based FQHC market basket
for the given category. This trimming process is done for each cost
weight separately. We did not receive any comments on this proposal,
and therefore, we are going to use the same trimming methodology to
remove outliers as proposed but with the revised cost weights
reflecting the new methodology in response to public comment.
Finally, we proposed to calculate the residual ``All Other'' cost
weight that reflects all remaining costs that are not captured in the
eleven major cost categories listed. We referred readers to Table 35
for the resulting cost weights for these major cost categories.
Table 35 also shows the proposed and final 2017-based FQHC market
basket cost weights compared to the 2013-based FQHC market basket cost
weights.
[[Page 84705]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.080
The total compensation cost weight of 72.5 percent (sum of FQHC
Practitioner Compensation, Clinical Compensation, Non-health Staff
Compensation) calculated from the Medicare cost reports for the final
2017-based FQHC market basket is approximately 4.0 percentage point
higher than the total compensation cost weight for the 2013-based FQHC
market basket (68.6 percent). The 2017-based cost weight for FQHC
Practitioner Compensation are about 3 percentage points lower compared
to the 2013-based FQHC market basket, while the clinical staff
compensation cost weight is about 7 percentage points higher. Part of
the reason for the shift in the weights between compensation categories
may be due to the change to the FQHC Medicare cost report form. On the
1992 Medicare cost report form (used for the 2013-based FQHC market
basket), there were four open ended ``fill-in'' categories for
healthcare staff costs and costs under agreement. Since we were unable
to determine what specific category the ``other health care staff''
costs should be allocated to (that is, either FQHC practitioner, or
clinical staff) we used a methodology where we applied the expenses for
the ``other health care staff costs'' between the categories for FQHC
practitioner and clinical staff, based on the relative shares of
expenses for both categories, excluding the open-ended fill in lines of
Worksheet A, lines 9-11 and line 15. This may have resulted in an over
allocation of some of the 2013 expenses to the FQHC Practitioner
category relative to the clinical staff. On the 2014 Medicare cost
report form, there is no longer an ambiguous category for other direct
patient care staff costs.
The final 2017-based Pharmaceuticals cost weight is roughly 2.7
percentage points lower than the cost weight in the 2013-based FQHC
market basket. The pharmaceutical costs included in the weight for
2017-based FQHC market basket includes only non-compensation costs
reported in Pharmacy (under general services). We believe the cost
share is lower with the new data because there is more specificity on
where to report reimbursable and non-reimbursable drugs. Additionally,
using the net expense data (that is after reclassifications and
adjustments) results in a lower share for pharmacy expenses relative to
if total costs are used. This implies that there are notable
reclassifications and adjustments to the Medicare Allowable pharmacy
expenses as mentioned by commenters as a reason for the concern for not
using Net expense data.
As we did for the 2013-based FQHC market basket, we proposed to
allocate the contract labor cost weight to the Wages and Salaries and
Employee Benefits cost weights based on their relative proportions
under the assumption that contract labor costs comprise both Wages and
Salaries and Employee Benefits for both FQHC Practitioners and Clinical
Staff. The contract labor allocation proportion for Wages and Salaries
is equal to the Wages and Salaries cost weight as a percent of the sum
of the Wages and Salaries cost weight and the Employee Benefits cost
weight. This rounded percentage based on the proposed cost weights was
82 percent for FQHC Practitioners and 80 percent for clinical staff.
Therefore, we proposed to allocate 82 percent of the FQHC Practitioner
Contract Labor cost weight to the FQHC Practitioner Wages and Salaries
cost weight and 18 percent to the FQHC Practitioner Employee Benefits
cost weight. Similarly, we proposed to allocate 80 percent of the
clinical staff contract labor cost weight to the Clinical Staff Wages
and Salaries cost weight and 20 percent to the clinical staff employee
benefits cost weight. In response to comment, in the final 2017-based
FQHC market basket, we are allocating 81 percent of the FQHC
Practitioner Contract Labor to FQHC Practitioner Wages and Salaries and
19 percent to the FQHC Practitioner Employee Benefits. We are also
allocating 81 percent of the Clinical Staff Contract Labor to Clinical
Staff Wages and Salaries and 19 percent to
[[Page 84706]]
the Clinical Staff Employee Benefits. We refer readers to Table 36 that
shows the final Wages and Salaries and Employee Benefits cost weights
after Contract Labor cost weight allocation for the final 2017-based
FQHC market basket.
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c. Derivation of the Detailed Operating Cost Weights
To further divide the ``All Other'' residual cost weight estimated
from the 2017 Medicare cost report data into more detailed cost
categories, we proposed to use the 2012 Benchmark Input-Output (I-O)
``Use Tables/Before Redefinitions/Purchaser Value'' for NAICS 621100,
Offices of Physicians, published by the Bureau of Economic Analysis
(BEA). We note that the BEA benchmark I-O data is used to further
disaggregate residual expenses in other CMS market baskets. Therefore,
we noted that we believe the data from this industry are the most
technically appropriate for disaggregation of the residual expenses
since both physician offices and FQHCs provide similar types of care.
These data are publicly available at https://www.bea.gov/industry/input-output-accounts-data. For the 2013-based FQHC market basket, we
used the relative shares of certain categories from the 2006-based MEI
(81 FR 80396).
The BEA Benchmark I-O data are scheduled for publication every 5
years with the most recent data available for 2012. The 2012 Benchmark
I-O data are derived from the 2012 Economic Census and are the building
blocks for BEA's economic accounts. Therefore, they represent the most
comprehensive and complete set of data on the economic processes or
mechanisms by which output is produced and distributed.\53\ BEA also
produces Annual I-O estimates. However, while based on a similar
methodology, these estimates reflect less comprehensive and less
detailed data sources and are subject to revision when benchmark data
becomes available. Instead of using the less detailed Annual I-O data,
we proposed to inflate the 2012 Benchmark I-O data forward to 2017 by
applying the annual price changes from the respective price proxies to
the appropriate market basket cost categories that are obtained from
the 2012 Benchmark I-O data. We repeated this practice for each year.
We then calculated the cost shares that each cost category represents
of the 2012 data inflated to 2017. These resulting 2017 cost shares
were applied to the ``All Other'' residual cost weight to obtain the
detailed cost weights for the proposed 2017-based FQHC market basket.
For example, the cost for Medical Equipment represents 7.2 percent of
the sum of the ``All Other'' 2012 Benchmark I-O Offices of Physicians
Expenditures inflated to 2017. Therefore, the proposed Medical
Equipment cost weight represents 7.2 percent of the proposed 2017-based
FQHC market basket's ``All Other'' cost category (16.5 percent),
yielding a Medical Equipment cost weight of 1.2 percent in the 2017-
based FQHC market basket (0.072 x 16.5 percent = 1.2 percent).
Using this methodology, we proposed to derive six detailed FQHC
market basket cost category weights from the proposed 2017-based FQHC
market basket residual cost weight (15.5 percent). These categories
are: (1) Utilities; (2) Medical Equipment; (3) Miscellaneous Products;
(4) Professional, Scientific, and Technical Services; (5)
Administrative Support and Waste Management Services; (6) All Other
Services. We note that for the 2013-based FQHC market basket, we had
Telephone and Postage cost weights. For the 2017-based FQHC market
basket, we proposed to include Telephone and Postage costs in the
Miscellaneous Products cost weight due to the small amount of costs in
this category (each were less than .05 percent).
We did not receive any comments on our proposed derivation of the
detailed operating cost weights. Therefore, we are finalizing our
methodology as proposed. In response to public comment to use net costs
rather than total costs to derive the FQHC market basket cost weights,
the ``All Other'' residual cost weight was revised from the proposed
rule to reflect the revised methodology as explained in section
III.D.3.a of this final rule. The ``All Other'' residual cost weight is
16.5 percent compared to the proposed 15.5 percent weight.
d. 2017-Based FQHC Market Basket Cost Categories and Weights
Table 37 shows the cost categories and weights for the Final 2017-
based FQHC market basket compared to the proposed 2017-based FQHC
market basket and the 2013-based FQHC market basket.
[[Page 84707]]
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4. Selection of Price Proxies
After developing the cost weights for the 2017-based FQHC market
basket, we selected the most appropriate wage and price proxies
currently available to represent the rate of price change for each
expenditure category. For the majority of the cost weights, we base the
price proxies on U.S. Bureau of Labor Statistics (BLS) data, as they
produce indexes that best meet the criteria of reliability, timeliness,
availability, and relevance, and group them into one of the following
BLS categories:
Employment Cost Indexes. Employment Cost Indexes (ECIs)
measure the rate of change in employment wage rates and employer costs
for employee benefits per hour worked. These indexes are fixed-weight
indexes and strictly measure the change in wage rates and employee
benefits per hour. ECIs are superior to Average Hourly Earnings (AHE)
as price proxies for input price indexes because they are not affected
by shifts in occupation or industry mix, and because they measure pure
price change and are available by both occupational group and by
industry. The industry ECIs are based on the North American Industry
Classification System (NAICS) and the occupational ECIs are based on
the Standard Occupational Classification System (SOC).
Producer Price Indexes. Producer Price Indexes (PPIs)
measure the average change over time in the selling prices received by
domestic producers for their output. The prices included in the PPI are
from the first commercial transaction for many products and some
services (https://www.bls.gov/ppi/).
Consumer Price Indexes. Consumer Price Indexes (CPIs)
measure the average change over time in the prices paid by urban
consumers for a market basket of consumer goods and services (https://www.bls.gov/cpi/). CPIs are only used when the purchases are similar to
those of retail consumers rather than purchases at the producer level,
or if no appropriate PPIs are available.
We evaluate the price proxies using the criteria of reliability,
timeliness, availability, and relevance:
Reliability. Reliability indicates that the index is based
on valid statistical methods and has low sampling variability. Widely
accepted statistical methods ensure that the data were collected and
aggregated in a way that can be replicated. Low sampling variability is
desirable because it indicates that the sample reflects the typical
members of the population. (Sampling variability is variation that
occurs by chance because only a sample was surveyed rather than the
entire population.)
Timeliness. Timeliness implies that the proxy is published
regularly, preferably at least once a quarter. The market baskets are
updated quarterly, and therefore, it is important for the
[[Page 84708]]
underlying price proxies to be up-to-date, reflecting the most recent
data available. We believe that using proxies that are published
regularly (at least quarterly, whenever possible) helps to ensure that
we are using the most recent data available to update the market
basket. We strive to use publications that are disseminated frequently,
because we believe that this is an optimal way to stay abreast of the
most current data available.
Availability. Availability means that the proxy is
publicly available. We prefer that our proxies are publicly available
because this will help ensure that our market basket updates are as
transparent to the public as possible. In addition, this enables the
public to be able to obtain the price proxy data on a regular basis.
Relevance. Relevance means that the proxy is applicable
and representative of the cost category weight to which it is applied.
The CPIs, PPIs, and ECIs that we have selected meet these criteria.
Therefore, we believe that they continue to be the best measure of
price changes for the cost categories to which they would be applied.
Table 38 lists all price proxies we proposed to use in the 2017-
based FQHC market basket. Below is a detailed explanation of the price
proxies we proposed for each cost category, many of which are the same
as those used for the 2013-based FQHC market basket.
a. Price Proxies for the 2017-Based FQHC Market Basket
(1) FQHC Practitioner Wages and Salaries
We proposed to use the ECI for Wages and Salaries for Private
Industry Workers in Professional and Related (BLS series code
CIU2010000120000I) to measure price growth of this category. There is
no specific ECI for physicians or FQHC Practitioners, and therefore, we
proposed to use an index that is based on professionals that receive
advanced training similar to those performing at the FQHC Practitioner
level of care. This index is consistent with the price proxy used to
measure wages and salaries inflation pressure for physicians own time
in the Medicare Economic Index (MEI) and is based on the MEI technical
panel recommendation from 2012 (78 FR 74266 through 74271).
Additionally, this price proxy is consistent with the proxy used for
FQHC practitioner compensation in the 2013-based FQHC market basket (81
FR 80397). We noted that the 2013-based FQHC market basket has a single
cost category for Total Compensation reflecting both wages and salaries
and employee benefits costs for FQHC Practitioners and this single
compensation category uses the similar price proxy, the ECI Total
Compensation for Private Industry Workers in Professional and Related,
reflecting both types of compensation costs together rather than
separately (81 FR 80397).
(2) FQHC Practitioner Employee Benefits
We proposed to use the ECI for Total Benefits for Private Industry
Workers in Professional and Related to measure price growth of this
category. This ECI is calculated using the ECI for Total Compensation
for Private Industry Workers in Professional and Related (BLS series
code CIU1016220000000I) and the relative importance of wages and
salaries within total compensation. The 2013-based FQHC market basket
did not include a separate category for FQHC Practitioner employee
benefit costs.
(3) Clinical Staff Wages and Salaries
We proposed to use the ECI for Wages and Salaries for all Civilian
Workers in Health Care and Social Assistance (BLS series code
CIU1026200000000I) to measure the price growth of this cost category.
This cost category consists of wage and salary costs for Nurses,
Laboratory Technicians, and all other healthcare staff not included in
the FQHC Practitioner compensation categories. Based on the clinical
staff composition of these workers, we noted that we believe that the
ECI for health-related workers is an appropriate proxy to measure wage
and salary price pressures for these workers. We noted that the 2013-
based FQHC market basket has a single cost category for Total
Compensation reflecting both wages and salaries and employee benefits
costs for Clinical Staff and this single compensation category uses the
similar price proxy, the ECI Total Compensation for all Civilian
Workers in Health Care and Social Assistance, reflecting both types of
compensation costs together rather than separately (81 FR 80398).
(4) Clinical Staff Employee Benefits
We proposed to use the ECI for Total Benefits for all Civilian
Workers in Health Care and Social Assistance to measure price growth of
this category. This ECI is calculated using the ECI for Total
Compensation for all Civilian Workers in Health Care and Social
Assistance (BLS series code CIU1016220000000I) and the relative
importance of wages and salaries within total compensation. The 2013-
based FQHC market basket did not include a separate category for
Clinical Staff employee benefit costs.
(5) Non-Health Staff Compensation
We proposed to continue to use the ECI for Total Compensation for
Private Industry Workers in Office and Administrative Support (BLS
series code CIU2010000220000I) to measure the price growth of this cost
category. The Non-health Staff Compensation cost weight is
predominately attributable to administrative and facility type
occupations, as reported in the data from the Medicare cost reports.
This is the same price proxy used in the 2013-based FQHC market basket
(81 FR 80398).
(6) Pharmaceuticals
We proposed to continue to use the PPI Commodities for
Pharmaceuticals for Human Use, Prescription (BLS series code
WPUSI07003) to measure the price growth of this cost category. This
price proxy is used to measure prices of Pharmaceuticals in other CMS
market baskets, such as 2014-based Inpatient Prospective Payment System
and 2014-based Skilled Nursing Facility market baskets. This is the
same proxy used in the 2013-based FQHC market basket (81 FR 80398).
(7) Utilities
We proposed to continue to use the CPI for Fuel and Utilities (BLS
series code CUUR0000SAH2) to measure the price growth of this cost
category. This is the same proxy used in the 2013-based FQHC market
basket (81 FR 80398).
(8) Medical Equipment
We proposed to continue to use the PPI Commodities for Surgical and
Medical Instruments (BLS series code WPU1562) as the price proxy for
this category. This is the same proxy used in the 2013-based FQHC
market basket (81 FR 80398).
(9) Medical Supplies
We proposed to continue to use a 50/50 blended index that comprises
the PPI Commodities for Medical and Surgical Appliances and Supplies
(BLS series code WPU156301) and the CPI-U for Medical Equipment and
Supplies (BLS series code CUUR0000SEMG). The 50/50 blend is used in all
market baskets where we do not have an accurate split available. We
noted that we believe FQHCs purchase the types of supplies contained
within these proxies, including such items as bandages,
[[Page 84709]]
dressings, catheters, intravenous equipment, syringes, and other
general disposable medical supplies, via wholesale purchase, as well as
at the retail level. Consequently, we proposed to combine the two
aforementioned indexes to reflect those modes of purchase. This is the
same blended price proxy used in the 2013-based FQHC market basket (81
FR 80398).
(10) Miscellaneous Products
We proposed to use the CPI for All Items Less Food and Energy (BLS
series code CUUR0000SA0L1E) to measure the price growth of this cost
category. We noted that we believe that using the CPI for All Items
Less Food and Energy is appropriate as it reflects a general level of
inflation. This is the same proxy used in the 2013-based FQHC market
basket (81 FR 80398).
(11) Professional, Scientific, and Technical Services
We proposed to continue to use the ECI for Total Compensation for
Private Industry Workers in Professional, Scientific, and Technical
Services (BLS series code CIU2015400000000I) to measure the price
growth of this cost category. This is the same proxy used in the 2013-
based FQHC market basket (81 FR 80398).
(12) Administrative and Facilities Support Services
We proposed to continue to use the ECI Total Compensation for
Private Industry Workers in Office and Administrative Support (BLS
series code CIU2010000220000I) to measure the price growth of this cost
category. This is the same proxy used in the 2013-based FQHC market
basket (81 FR 80398).
(13) All Other Services
We proposed to continue to use the ECI for Total Compensation for
Private Industry Workers in Service Occupations (BLS series code
CIU2010000300000I) to measure the price growth of this cost category.
This is the same proxy used in the 2013-based FQHC market basket (81 FR
80398).
(14) Fixed Capital
We proposed to continue to use the PPI Industry for Lessors of
Nonresidential Buildings (BLS series code PCU531120531120) to measure
the price growth of this cost category (81 FR 80398). This is the same
price proxy used in the 2013-based FQHC market basket. We noted that we
believe this continues to be the most appropriate price proxy since
fixed capital expenses in FQHCs should reflect inflation for the rental
and purchase of business office space.
(15) Moveable Capital
We proposed to continue to use the PPI Commodities for Machinery
and Equipment (BLS series code WPU11) to measure the price growth of
this cost category as this cost category represents nonmedical moveable
equipment. This is the same proxy used in the 2013-based FQHC market
basket (81 FR 80398).
We did not receive any comments on the proposed price proxies in
the 2017-based FQHC market basket, and therefore, we are finalizing
this proposal without modification.
c. Summary of Price Proxies of the Final 2017-Based FQHC Market Basket
Table 38 shows the cost categories and associated price proxies for
the 2017-based FQHC market basket.
[GRAPHIC] [TIFF OMITTED] TR28DE20.083
[[Page 84710]]
Comment: Several commenters applauded CMS, both for implementing an
FQHC[hyphen]specific market basket adjuster, per section 1834(o)(2)(B)
of the Act, and for taking the initiative to rebase the market basket
percentage, effective in 2021, using more recent cost data. One
commenter stated they had been a long[hyphen]term supporter of the FQHC
specific market basket serving as the annual update method for health
centers, in both Medicare and Medicaid. The commenter stated that they
believe that the alternative, the MEI, is outdated and does not
appropriately capture the services that health centers provide and
therefore is not an appropriate update factor. The commenters
appreciated that CMS updates the calculation periodically so that the
cost weights reflect a current mix of goods and services purchased in
providing FQHC services. The commenters stated that they did not have
concerns with the overall structure of the calculation, and they noted
that they believe the use of a fixed[hyphen]weight,
Laspeyres[hyphen]type price index that uses cost weights and price
proxies (based on publicly available cost indexes) is a reasonable way
to measure the increase in the price over time of goods and services
needed to furnish FQHC services.
Response: We appreciate the commenters' support of the FQHC market
basket and the periodic rebasing and revision of the market basket to
account for changes in the mix of goods and services purchased in
providing FQHC services as well as the general methodological approach
of using Medicare Cost Report data, a Laspeyres-type index formula, and
the use of publically available price proxies when available and
appropriate.
In response to public comment, we are finalizing the 2017-basd FQHC
market basket with modification effective with CY 2021 FQHC PPS update.
5. CY 2021 Productivity Adjusted Market Basket Update for FQHCs
For CY 2021 (that is, January 1, 2021 through December 31, 2021),
we proposed to use the 2017-based FQHC market basket increase factor to
update the PPS payments to FQHCs. Consistent with CMS practice, we
estimated the market basket update for the FQHC PPS based on the most
recent forecast from IGI. IGI is a nationally recognized economic and
financial forecasting firm with which we contract to forecast the
components of the market baskets and multifactor productivity (MFP). We
proposed to use the update based on the most recent historical data
available at the time of publication of the final rule. For example,
the final CY 2021 FQHC update would be based on the four-quarter
moving-average percent change of the 2017-based FQHC market basket
through the second quarter of 2020 (based on the final rule's statutory
publication schedule). At the time of the proposed rule, we did not
have the second quarter of 2020 historical data, and therefore, we
proposed to use the most recent projection available at the time.
Based on IGI's third quarter 2020 forecast with historical data
through the second quarter of 2020, the final 2017-based FQHC market
basket increase factor for CY 2021 is 2.4 percent. For comparison, the
2013-based FQHC market basket update is projected to be 2.3 percent in
CY 2021; this estimate is based on IGI's third quarter 2020 forecast
(with historical data through the second quarter of 2020). We note that
the forecast used for the proposed market basket update was developed
prior to the economic impacts of the COVID-19 pandemic. The lower final
update (2.4 percent) for CY 2021 relative to the proposed rule (2.5
percent) is primarily driven by slower anticipated compensation growth
for both health-related and other occupations as labor markets have
been significantly impacted during the recession that started in
February 2020.
Section 1834(o)(2)(B)(ii) of the Act describes the methods for
determining updates to FQHC PPS payment. We have included a
productivity adjustment to the FQHC PPS annual payment update since
implementation of the FQHC PPS (81 FR 80393) and we proposed to
continue to include a productivity adjustment to the 2017-based FQHC
market basket. We proposed to use the most recent estimate of the 10-
year moving average of changes in annual private nonfarm business
(economy-wide) multifactor productivity (MFP), which is the same
measure of MFP applied to other CMS Market Basket updates including the
MEI. The BLS publishes the official measure of private nonfarm business
MFP (see http://www.bls.gov/mfp for the published BLS historical MFP
data). For the final FQHC market basket update, we proposed to use the
most recent historical estimate of annual MFP as published by the BLS.
Generally, the most recent historical MFP estimate is lagged 2 years
from the payment year.
Therefore, we proposed to use the 10-year moving average percent
change in annual private nonfarm business MFP through 2019 as published
by BLS in the CY 2021 FQHC market basket update. We noted that MFP is
derived by subtracting the contribution of labor and capital input
growth from output growth. Since at the time of development of the
proposed rule the 2019 MFP was not yet published by BLS, we proposed to
use IGI's first quarter 2020 forecast of MFP. A complete description of
the MFP projection methodology is available at http://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/MarketBasketResearch.html.
Using IGI's first quarter 2020 forecast, the productivity
adjustment for CY 2021 (the 10-year moving average of MFP for the
period ending CY 2019) was projected to be 0.6 percent. Therefore, the
proposed CY 2021 productivity-adjusted FQHC Market basket update was
1.9 percent, based on IGI's first quarter 2020 forecast with historical
data through the fourth quarter of 2019. This reflected a 2.5-percent
increase in the proposed 2017-based FQHC market basket and a 0.6-
percent adjustment for productivity. Finally, we proposed that if more
recent data subsequently become available, we would use such data, if
appropriate, to determine the CY 2021 market basket update and the MFP
adjustment for the final rule.
For this final rule, as proposed, we are using the latest
historical data for MFP as published by the BLS to determine the MFP
adjustment. The 10-year moving average percent change in MFP for the
period ending CY 2019 as published by BLS is 0.7 percent. Therefore,
the final CY 2021 productivity-adjusted FQHC Market basket update is
1.7 percent, based on IGI's third quarter 2020 forecast with historical
data through the second quarter of 2020. This reflects a 2.4 percent
increase in the final 2017-based FQHC market basket less a 0.7
percentage point adjustment for productivity.
E. Comprehensive Screenings for Seniors: Section 2002 of the Substance
Use-Disorder Prevention That Promote Opioid Recovery and Treatment for
Patients and Communities Act (SUPPORT Act)
Opioid overdose deaths continue to impact communities across the
United States. In 2018, about 47,000 Americans died as a result of an
opioid overdose, where 32 percent of these deaths involved a
prescription opioid.\54\ In addition to the risk of death from
overdose, opioids carry a number of other health risks, including
respiratory
[[Page 84711]]
depression, drowsiness, confusion, nausea, increased drug tolerance,
and physical dependence. An estimated 1.4 million people in the United
States have substance use disorders (SUDs) involving prescription
opioid pain relievers.\55\
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\54\ Wilson N, Kariisa M, Seth P, et al. Drug and Opioid-
Involved Overdose Deaths--United States, 2017-2018. MMWR Morb Mortal
Wkly Rep 2020;69:290-297.
\55\ Substance Abuse and Mental Health Services Administration.
(2020). Key substance use and mental health indicators in the United
States: Results from the 2019 National Survey on Drug Use and Health
(HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville,
MD: Center for Behavioral Health Statistics and Quality, Substance
Abuse and Mental Health Services Administration. Retrieved from
https://www.samhsa.gov/data/.
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CMS has a vital role in addressing opioid use disorder prevention,
treatment and recovery. The intent of the SUPPORT Act (Pub. L. 115-271,
enacted on October 24, 2018) is to provide for opioid use disorder
prevention, treatment and recovery. In section 2002 of the SUPPORT Act,
Comprehensive Screening for Seniors, the Congress required the Initial
Preventive Physical Examination (IPPE) and Annual Wellness Visit (AWV)
to include screening for potential SUDs and a review of any current
opioid prescriptions. We believe that these provisions are
complementary to the existing components of the IPPE and AWV. We
proposed to add these new elements to the IPPE and AWV regulations, to
draw attention to their importance and fulfil the section 2002 SUPPORT
Act requirements. In the CY 2021 PFS proposed rule (85 FR at 50224), we
provided background on the IPPE and AWV, discussed how the requirements
of the SUPPORT Act are related to the IPPE and AWV, and made proposals
to implement these provisions.
1. Background: IPPE and AWV
a. IPPE Required Elements
The IPPE is defined in section 1861(ww) of the Act and codified in
regulations at Sec. 410.16. The IPPE must be performed within 1 year
after the effective date of a beneficiary's first Medicare Part B
coverage period as stated in section 1861(hhh)(4)(G) of the Act. The
IPPE includes all of the following services furnished to an eligible
beneficiary by a physician or other qualified NPP with the goal of
health promotion and disease detection:
Review of the beneficiary's medical and social history
with attention to modifiable risk factors for disease, as those terms
are defined in Sec. 410.16.
Review of the beneficiary's potential (risk factors) for
depression, including current or past experiences with depression or
other mood disorders, based on the use of an appropriate screening
instrument for persons without a current diagnosis of depression, which
the physician or other qualified NPP may select from various available
standardized screening tests designed for this purpose and recognized
by national professional medical organizations.
Review of the beneficiary's functional ability, and level
of safety as those terms are defined in Sec. 410.16 based on the use
of appropriate screening questions or a screening questionnaire, which
the physician or other qualified NPP may select from various available
screening questions or standardized questionnaires designed for this
purpose and recognized by national professional medical organizations.
An examination to include measurement of the beneficiary's
height, weight, body mass index, blood pressure, a visual acuity
screen, and other factors as deemed appropriate, based on the
beneficiary's medical and social history, and current clinical
standards.
End-of-life planning upon agreement with the individual.
Education, counseling, and referral, as deemed appropriate
by the physician or qualified NPP, based on the results of the review
and evaluation services described in Sec. 410.16.
Education, counseling, and referral, including a brief
written plan such as a checklist provided to the individual for
obtaining an electrocardiogram, as appropriate, and the appropriate
screening and other preventive services that are covered as separate
Medicare Part B benefits.
b. AWV Required Elements
Section 1861(hhh) of the Act expanded Medicare coverage under Part
B to include an AWV effective for services furnished on or after
January 1, 2011. We codified the AWV at Sec. 410.15.
The AWV is a wellness visit that focuses on identification of
certain risk factors, personalized health advice, and referral for
additional preventive services and lifestyle interventions (which may
or may not be covered by Medicare). The elements included in the AWV
differ from comprehensive physical examination protocols with which
some providers may be familiar since it is a visit that is specifically
designed to provide personalized prevention plan services as defined in
the Act. The AWV includes a health risk assessment (HRA) and the AWV
takes into account the results of the HRA.
The AWV may be performed when the beneficiary is no longer within
12 months after the effective date of his or her first Medicare Part B
coverage period and when the beneficiary has not received either an
IPPE or AWV within the past 12 months. The AWV may be performed by a
physician, NPP (physician assistant, nurse practitioner, or clinical
nurse specialist), medical professional (including a health educator, a
registered dietitian, or nutrition professional, or other licensed
practitioner) or a team of such medical professionals, working under
the direct supervision of a physician. In summary, the first AWV
includes the following:
Review (and administration if needed) of a health risk
assessment (as defined in Sec. 410.15).
Establishment of an individual's medical and family
history.
Establishment of a list of current providers and suppliers
that are regularly involved in providing medical care to the
individual.
Measurement of an individual's height, weight, body-mass
index (or waist circumference, if appropriate), blood pressure, and
other routine measurements as deemed appropriate, based on the
beneficiary's medical and family history.
Detection of any cognitive impairment that the individual
may have, as that term is defined in Sec. 410.15.
Review of the individual's potential (risk factors) for
depression, including current or past experiences with depression or
other mood disorders, based on the use of an appropriate screening
instrument for persons without a current diagnosis of depression, which
the health professional may select from various available standardized
screening tests designed for this purpose and recognized by national
medical professional organizations.
Review of the individual's functional ability and level of
safety, based on direct observation or the use of appropriate screening
questions or a screening questionnaire, which the health professional
as defined in Sec. 410.15 may select from various available screening
questions or standardized questionnaires designed for this purpose and
recognized by national professional medical organizations.
Establishment of the following:
++ A written screening schedule for the individual such as a
checklist for the next 5 to 10 years, as appropriate, based on
recommendations of the United States Preventive Services Task Force
(USPSTF) and the Advisory Committee on Immunization Practices, and the
individual's health risk assessment (as that term is defined in Sec.
410.15), health
[[Page 84712]]
status, screening history, and age-appropriate preventive services
covered by Medicare.
++ A list of risk factors and conditions for which primary,
secondary or tertiary interventions are recommended or are underway for
the individual, including any mental health conditions or any such risk
factors or conditions that have been identified through an IPPE (as
described under Sec. 410.16), and a list of treatment options and
their associated risks and benefits.
++ Furnishing of personalized health advice to the individual and a
referral, as appropriate, to health education or preventive counseling
services or programs aimed at reducing identified risk factors and
improving self-management, or community-based lifestyle interventions
to reduce health risks and promote self-management and wellness,
including weight loss, physical activity, smoking cessation, fall
prevention, and nutrition.
++ At the discretion of the beneficiary, furnish advance care
planning services to include discussion about future care decisions
that may need to be made, how the beneficiary can let others know about
care preferences, and explanation of advance directives which may
involve the completion of standard forms.
++ Any other element determined appropriate through the national
coverage determination process.
In summary, subsequent AWVs include the following:
Review (and administration, if needed) of an updated
health risk assessment (as defined in Sec. 410.15).
An update of the individual's medical and family history.
An update of the list of current providers and suppliers
that are regularly involved in providing medical care to the individual
as that list was developed for the first AWV providing personalized
prevention plan services or the previous subsequent AWV providing
personalized prevention plan services.
Measurement of an individual's weight (or waist
circumference), blood pressure and other routine measurements as deemed
appropriate, based on the individual's medical and family history.
Detection of any cognitive impairment that the individual
may have, as that term is defined in Sec. 410.15.
An update to the following:
++ The written screening schedule for the individual as that
schedule is defined in paragraph (a) of Sec. 410.15 for the first AWV
providing personalized prevention plan services.
++ The list of risk factors and conditions for which primary,
secondary or tertiary interventions are recommended or are underway for
the individual as that list was developed at the first AWV providing
personalized prevention plan services or the previous subsequent AWV
providing personalized prevention plan services.
++ Furnishing of personalized health advice to the individual and a
referral, as appropriate, to health education or preventive counseling
services or programs as that advice and related services are defined in
paragraph (a) of Sec. 410.15.
++ At the discretion of the beneficiary, furnish advance care
planning services to include discussion about future care decisions
that may need to be made, how the beneficiary can let others know about
care preferences, and explanation of advance directives which may
involve the completion of standard forms.
++ Any other element determined appropriate through the national
coverage determination process.
2. Section 2002 of the SUPPORT Act Requirement
In section 2002 of the SUPPORT Act, sections 1861(ww) and
1861(hhh)(2) of the Act were amended to include a review of any current
opioid prescriptions and screening for potential SUDs as elements of
the IPPE and AWV, effective January 1, 2020.
3. Revisions to Section 2002 of the SUPPORT Act Requirements
We proposed to add the requirements of section 2002 of the SUPPORT
Act to our regulations at Sec. Sec. 410.15 and 410.16 for the AWV and
IPPE, respectively.
Section 2002 of the SUPPORT Act, requires a review of any current
opioid prescriptions as part of the IPPE and AWV. Such review includes
a review of the potential risk factors to the individual for opioid use
disorder, an evaluation of the individual's severity of pain and
current treatment plan, educational information on non-opioid treatment
options, and a referral to a specialist, as appropriate. Section 2002
of the SUPPORT Act also requires adding an element to the IPPE and AWV
to include screening for potential SUDs. Along with the screening for
SUD, a referral for treatment, as appropriate, was added to the AWV.
The definitions and conditions for and limitations on coverage of
the IPPE outlined in Sec. 410.16 includes a review of the
beneficiary's medical and social history. The medical history is
defined to include a review of current medications, which would include
a review of current opioid prescriptions. Furthermore, social history
is defined to include, at a minimum, a history of alcohol, tobacco, and
illicit drug use. Illicit drug use may include the non-medical use of
prescription drugs. The physician or other qualified health
professional may then provide education, counseling, and referral, as
deemed appropriate, based on the results of the review and evaluation
services provided during the IPPE.
The definitions and conditions for and limitations on coverage of
the AWV in Sec. 410.15 includes a health risk assessment, which
entails an evaluation of psychosocial risks, including but not limited
to, depression/life satisfaction, stress, anger, loneliness/social
isolation, pain, and fatigue. The patient's substance use, if
applicable, could be reviewed as part of the health risk assessment.
The AWV also covers establishment of, or an update to the individual's
medical and family history. The medical history includes medication
use, and may have included a review of any opioid prescriptions. The
health professional may also establish or update a list of risk factors
and conditions for which primary, secondary or tertiary interventions
are recommended or are underway for the individual, including any
mental health conditions or any such risk factors or conditions that
have been identified through the initial or subsequent AWV or IPPE, and
a list of treatment options and their associated risks and benefits. If
the clinician detected, through the above methods for screening, that a
patient was at high-risk for SUD in the course of the visit, it would
have been appropriate to note in the patient's IPPE written plan or the
AWV personalized prevention plan and to have referred the patient for
further assessment and treatment.
Awareness of a patient's use of substances, including nonmedical
use of prescription drugs and illicit drug use, is an important aspect
of the IPPE and AWV. In general, screening for potential SUDs may
include screening questions, the use of a specific tool, screening for
licit and/or illicit drugs (for example, alcohol, non-medical use of
prescription opioids, methamphetamine, heroin, cocaine, and other
substances), review of the beneficiary's medical and social history and
medical records, or prescription drug monitoring program query when
clinically indicated. Given the existing elements of the IPPE and AWV,
we do not expect the proposed new regulatory elements to add
significant burdens on physicians and practitioners who furnish these
services because review of medical and social
[[Page 84713]]
history, risk factor identification, education, counseling, and
referrals are already fundamental parts of the IPPE and AWV. The new
regulatory elements elevate the importance of physicians' and other
qualified health professionals' vigilance in identifying and addressing
opioid risks and SUDs in Medicare beneficiaries.
4. Summary of Proposed Regulatory Text Changes
We proposed to add elements to our regulations to reflect the
provisions of section 2002 of the SUPPORT Act. Consistent with sections
1861(ww) and 1861(hhh)(2) of the Act, we proposed to amend Sec. Sec.
410.15 and 410.16 by: (1) Adding the term ``screening for potential
substance use disorders''; (2) Adding the term ``a review of any
current opioid prescriptions'' and its definition; and (3) revising the
``Initial Preventive Physical Examination,'' ``first annual wellness
visit providing personalized prevention plan services,'' and
``subsequent annual wellness visit providing personalized prevention
plan services''.
a. ``Screening for Potential Substance Use Disorders''
We proposed to revise Sec. Sec. 410.15 and 410.16 by adding the
element ``Screening for Potential Substance Use Disorders'' and
describing the requirement as a review of the individual's potential
risk factors for SUD and referral for treatment as appropriate.
b. Definition of ``a review of any current opioid prescriptions''
We proposed to revise Sec. Sec. 410.15 and 410.16 by adding the
element ``a review of any current opioid prescriptions'' and defining
such term, consistent with section 1861(ww)(4) of the Act, as a review
of any current opioid prescriptions, including a review of the
potential risk factors to the individual for opioid use disorder, an
evaluation of the individuals' severity of pain and current treatment
plan, the provision of information on non-opioid treatment options, and
a referral to a specialist, as appropriate.
c. Proposed Changes to the ``Initial Preventive Physical Examination,''
``First Annual Wellness Visit'' and ``Subsequent Annual Wellness
Visit''
In Sec. Sec. 410.15 and 410.16, we adopted the components of the
IPPE and AWV, consistent with the statutory elements described in
sections 1861(ww) and 1861(hhh)(2) of the Act. The IPPE, first and
subsequent AWVs are meant to represent a beneficiary visit focused on
prevention. Among other things, the IPPE and AWV encourage
beneficiaries to obtain the preventive services covered by Medicare
that are appropriate for them. First and subsequent AWVs also include
elements that focus on the furnishing of personalized health advice and
referral, as appropriate, to health education, preventive counseling
services, or programs aimed at reducing identified risk factors and
improving self-management, or community-based lifestyle interventions.
We proposed to revise ``initial preventive physical examination,''
``first annual wellness visit providing personalized prevention plan
services,'' and ``subsequent annual wellness visit providing
personalized prevention plan services'' by adding:
In Sec. 410.15(a):
++ A revised paragraph (xi) to the definition of the term ``First
annual wellness visit providing personalized prevention plan
services,'' and a revised paragraph (ix) to the definition of the term
``Subsequent annual wellness visit'' that would add furnishing of a
review of any current opioid prescriptions as that term is defined in
this section.
++ A new paragraph (xii) to the definition of ``First annual
wellness visit providing personalized prevention plan services,'' and a
new paragraph (x) to the definition of ``Subsequent annual wellness
visit'' that would add screening for potential SUDs including a review
of the individual's potential risk factors for SUD and referral for
treatment as appropriate.
++ A new paragraph (xiii) to the definition of ``First annual
wellness visit providing personalized prevention plan services,'' and a
new paragraph (xi) to the definition of ``Subsequent annual wellness
visit'' that would add any other element determined appropriate through
the national coverage determination process.
In Sec. 410.16:
++ A revised paragraph (a)(6) to the definition of ``Initial
preventive physical examination'' that would include a review of any
current opioid prescriptions as that term is defined in this section.
++ A revised paragraph (a)(7) to the definition of ``Initial
preventive physical examination'' that would add screening for
potential SUDs to include a review of the individual's potential risk
factors for SUD and referral for treatment as appropriate.
++ A new paragraph (a)(8) to the definition of ``Initial preventive
physical examination'' that would add, education, counseling, and
referral, as deemed appropriate by the physician or qualified NPP,
based on the results of the review and evaluation services described in
this section.
++ A new paragraph (a)(9) to the definition of ``Initial preventive
physical examination'' that would include, education, counseling, and
referral, including a brief written plan such as a checklist provided
to the individual for obtaining an electrocardiogram, as appropriate,
and the appropriate screening and other preventive services that are
covered as separate Medicare Part B benefits as described in sections
1861(s)(10), (jj), (nn), (oo), (pp), (qq)(1), (rr), (uu), (vv),
(xx)(1), (yy), (bbb), and (ddd) of the Act.
5. Summary of Public Comments and Responses
We received public comments on the proposed revisions to the
requirements under section 2002 of the SUPPORT Act. The following is a
summary of the comments we received and our responses.
Comment: The vast majority of commenters supported the proposal to
add the requirements of section 2002 of the SUPPORT Act to the
regulations at Sec. Sec. 410.15 and 410.16. Commenters stated that
they believe these provisions are complementary to the existing
components of the IPPE and AWV and help underscore the importance of
prevention and appropriate pain management to stymie the opioid
epidemic and detect substance use disorders on a regular schedule.
Furthermore, commenters specifically noted that while Medicare has
previously emphasized a review of opioid prescriptions is appropriate
when collecting a patient's medical and social history within the IPPE
and AWV, adding explicit requirements to the regulations regarding
opioid prescription review and substance use disorder screening is an
important distinction and welcomed by the majority of commenters.
Response: We appreciate the commenters for their support of CMS'
efforts to include section 2002 of the SUPPORT ACT in the regulations,
which are intended to strengthen provider engagement with patients on
appropriate pain management and detection of substance use disorders
through the IPPE and AWV.
Comment: According to one commenter a thorough patient assessment
for pain and opioid use could take 30-90 minutes and such services
should not be part of the AWV or IPPE but should be a separate
encounter.
[[Page 84714]]
Response: We thank the commenter for highlighting the time it can
take for practitioners to appropriately care for patients with pain.
Section 2002 of the SUPPORT Act modified the statute to require the
addition of certain additional services to the AWV and IPPE. We are not
adopting the commenter's suggestion to only pay for these additional
services as a separate encounter. We note, however, that there are
other opportunities throughout the year outside of the AWV and IPPE,
such as E/M services for practitioners to evaluate their patient's
pain, consider treatment options and review medications when those
services would be reasonable and necessary. In addition, other
medically necessary services may be provided on the same date of
service as an AWV or IPPE. The Part B deductible and coinsurance or
copayment obligations would apply to those additional medically
necessary services.
Comment: Some commenters advocated for CMS to increase the payment
rate for the AWV and IPPE as a result of these additional required
elements. Another commenter stated that the increase in reimbursement
for CY 2021 will offset the additional work related to these new
requirements. One commenter agreed with CMS that the new elements are
aligned and similar to the services already being furnished during the
visits and, therefore, would not result in significant added burden.
One commenter disagreed with adding the requirements to the AWV and
IPPE under section 2002 of the SUPPORT Act because practitioners
already address prescriptions and substance abuse issues during these
visits and formally including them adds to the paperwork and
documentation burden around the visits.
Response: We note that we are required by law through section 2002
of the SUPPORT Act to include the new elements in the AWV and IPPE.
Commenters had various opinions about the appropriate payment rate
for the AWV and IPPE with the additional requirements. We note for
commenters that in section III.F. of this final rule, we finalized
increases in the values of office/outpatient E/M visit codes for CY
2021. The AWV and IPPE services are valued via direct cross walk from
the office/outpatient E/M visits. To maintain payment accuracy for the
IPPE and the AWV, we finalized adjusting the valuation of these
services to reflect the changes in value for E/M services to which they
are crosswalked. The payment increase coincides with but is not related
to the newly required elements in the AWV and IPPE.
We continue to agree with commenters who believe any additional
burden for the new required elements will be minimal and we disagree
with commenters that state the additional work will be a significant
burden.
Comment: Commenters requested CMS clarify in more detail what is
required of practitioners to meet the new required elements of the AWV
and IPPE. One commenter specifically requested clarification that if a
patient is found at risk for potential substance use disorder after
screening that a comprehensive evaluation of that finding is not part
of the AWV and IPPE. Another commenter specifically requested
clarification around screening.
Response: In an effort to minimize burden and allow flexibility, we
have not been more prescriptive with the regulatory language. We
believe this allows practitioners to tailor screening to their
patients. Medically necessary services beyond the scope of those
required as part of the AWV and IPPE, as discussed in an earlier
response, may be provided on the same date of service as an AWV or
IPPE. The deductible and coinsurance or copayment may apply for these
other medically necessary services.
Comment: One commenter asked for clarification on how CMS will
enforce these new requirements.
Response: We are planning to enforce the new elements of the AWV
and IPPE in the same manner as other services furnished to Medicare
beneficiaries.
Comment: One commenter asked CMS to consider the community pharmacy
as a provider of screening and referral services.
Response: We appreciate that the commenter is looking to expand
access to screening and referral services by including community
pharmacies as potential suppliers of these services, but this expansion
would exceed the scope of our proposed rule. We did not seek to amend
the definition of either ``health professional'' for the AWV or the
definition of ``qualified nonphysician practitioner'' for the IPPE. The
types of practitioners that are eligible to furnish the AWV are
specified in section 1861(hhh)(3) of the Act and defined in our
regulations in Sec. 410.15(a). For the IPPE, the practitioners
eligible to furnish these services under certain conditions are based
on statutory requirements in sections 1861(s)(2)(K) and (ww)(1) of the
Act and are defined in our regulations at Sec. 410.16(a).
As a result of the comments, we are finalizing the proposal to add
explicit requirements to the regulations regarding opioid prescription
review and substance use disorder screening. Specifically, we are
adding the requirements of section 2002 of the SUPPORT Act to
Sec. Sec. 410.15 and 410.16 for the AWV and IPPE, respectively.
We did not receive public comments on our proposed regulatory text,
and, therefore, we are finalizing the regulatory language as proposed.
F. Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals (EPs)
1. Background
Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory
basis for incentive payments made to Medicaid EPs and eligible
hospitals for the adoption, implementation, upgrade, and meaningful use
of Certified EHR Technology (CEHRT). We have implemented these
statutory provisions in prior rulemakings to establish the Medicaid
Promoting Interoperability Program.
Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the
Act, and the definition of ``meaningful EHR user'' in regulations at
Sec. 495.4, one of the requirements of being a meaningful EHR user is
to successfully report the clinical quality measures selected by CMS to
CMS or a state, as applicable, in the form and manner specified by CMS
or the state, as applicable. Section 1848(o)(2)(B)(iii) of the Act
requires that in selecting electronic clinical quality measures (eCQMs)
for EPs to report under the Promoting Interoperability Program, and in
establishing the form and manner of reporting, the Secretary shall seek
to avoid redundant or duplicative reporting otherwise required. We have
taken steps to align various quality reporting and payment programs
that include the submission of eCQMs.
In the CY 2020 PFS final rule (84 FR 62568, 62900), we established
for 2020 that Medicaid EPs are required to report on any six eCQMs that
are relevant to the EP's scope of practice, regardless of whether they
report via attestation or electronically. We also adopted the Merit-
based Incentive Payment System (MIPS) requirement that EPs report on at
least one outcome measure (or, if an applicable outcome measure is not
available or relevant, one other high priority measure). We explained
that if no outcome or high priority measure is relevant to a Medicaid
EP's scope of practice, the EP may report on any six eCQMs that are
relevant.
[[Page 84715]]
2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting
Interoperability Program for 2021
We annually review and revise the list of eCQMs for each MIPS
performance year to reflect updated clinical standards and guidelines.
In Appendix 1 of the CY 2021 PFS proposed rule (85 FR 50412), we
proposed to amend the list of available eCQMs for the CY 2021
performance period. In Appendix 1 of this final rule, we list the
clinical quality measures added (Table Group A), removed (Table Group
C), and changed (Table Group D) for the CY 2021 performance period. To
keep eCQM specifications current and minimize complexity, we proposed
to align the eCQMs available for Medicaid EPs in 2021 with those
available for MIPS eligible clinicians for the CY 2021 performance
period. Specifically, we proposed that the eCQMs available for Medicaid
EPs in 2021 would consist of the list of quality measures available
under the eCQM collection type on the final list of quality measures
established for the MIPS CY 2021 performance period.
In previous years, CMS proposals to align the list of eCQMs for
MIPS and the Medicaid Promoting Interoperability Program for EPs
received positive comments that indicated that alignment between these
two programs would help reduce health care provider reporting burden
(84 FR 62900; see also 83 FR 59452, 59702). These comments thus suggest
that aligning the eCQM lists might encourage EP participation in the
Medicaid Promoting Interoperability Program by giving Medicaid EPs that
are also MIPS eligible clinicians the ability to report the same eCQMs
for both programs. Not aligning the eCQM lists could lead to increased
burden, because EPs might have to report on different eCQMs for the
Medicaid Promoting Interoperability Program if they opt to report on
newly added eCQMs for MIPS. In addition, we believe that aligning the
eCQMs available in each program would help to ensure the most uniform
application of up-to-date clinical standards and guidelines possible.
As discussed in the CY 2021 PFS proposed rule (85 FR 50227), we
anticipate that the proposal would reduce burden for Medicaid EPs by
aligning the requirements for multiple reporting programs, and that the
system changes required for EPs to implement this change would not be
significant, particularly in light of our belief that many EPs would
report eCQMs to meet the quality performance category of MIPS, and
therefore, should be prepared to report on the available eCQMs for
2021. We noted that we expect that the proposal would have only a
minimal impact on states, by requiring minor adjustments to state
systems for 2021 to maintain current eCQM lists and specifications.
For 2021, we proposed to again require (as we did for 2020) that
Medicaid EPs report on any six eCQMs that are relevant to their scope
of practice, regardless of whether they report via attestation or
electronically. This policy of allowing Medicaid EPs to report on any
six measures relevant to their scope of practice would generally align
with the MIPS data submission requirement for eligible clinicians using
the eCQM collection type for the quality performance category, which is
established at Sec. 414.1335(a)(1). MIPS eligible clinicians who elect
to submit eCQMs must generally submit data on at least six quality
measures, including at least one outcome measure (or, if an applicable
outcome measure is not available, one other high priority measure). We
referred readers to Sec. 414.1335(a) for the data submission criteria
that apply to individual MIPS eligible clinicians and groups that elect
to submit data with other collection types.
In addition, as we did for 2020, we proposed that for 2021, EPs in
the Medicaid Promoting Interoperability Program would be required to
report on at least one outcome measure (or, if an outcome measure is
not available or relevant, one other high priority measure). We noted
that this policy would improve alignment with the MIPS quality
performance category requirements for eligible clinicians using the
eCQM collection type. We also proposed that if no outcome or high
priority measures are relevant to a Medicaid EP's scope of practice,
the clinician may report on any six eCQMs that are relevant, as was the
policy in 2020.
In the CY 2020 PFS final rule (84 FR 62899 and 62900), we
established the following three methods to identify which of the
available measures are high priority measures for EPs participating in
the Medicaid Promoting Interoperability Program. We proposed to use the
same three methods for identifying high priority eCQMs for the Medicaid
Promoting Interoperability Program for 2021:
The same set of measures that are identified as high
priority measures for reporting on the quality performance category for
eligible clinicians participating in MIPS.
All e-specified measures from the previous year's core set
of quality measures for Medicaid and the Children's Health Insurance
Program (CHIP) (Child Core Set) or the core set of health care quality
measures for adults enrolled in Medicaid (Adult Core Set) (hereinafter
together referred to as ``Core Sets'') that are also included on the
MIPS list of eCQMs.
Sections 1139A and 1139B of the Act require the Secretary to
identify and publish core sets of health care quality measures for
child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries.
These measure sets are required by statute to be updated annually and
are voluntarily reported by states to CMS. These Core Sets are composed
of measures that specifically focus on populations served by the
Medicaid and CHIP programs and are of particular importance to their
care. The MIPS eCQM list includes several, but not all, of the measures
in the Core Sets. Because the Core Sets are released at the beginning
of each year, it is not possible to update the list of high-priority
eCQMs with those added to the current year's Core Sets.
The eCQMs that would be available for Medicaid EPs to report in
2021, that are both part of the Core Sets and on the MIPS list of
eCQMs, and that would be considered high priority measures under the
proposal are: CMS2, ``Preventive Care and Screening: Screening for
Depression and Follow-Up Plan''; CMS122, ``Diabetes: Hemoglobin A1c
(HbA1c) Poor Control (>9%)''; CMS125, ``Breast Cancer Screening'';
CMS128, ``Anti-depressant Medication Management''; CMS136, ``Follow-Up
Care for Children Prescribed ADHD Medication (ADD)''; CMS137,
``Initiation and Engagement of Alcohol and Other Drug Dependence
Treatment''; CMS153, ``Chlamydia Screening for Women''; CMS155,
``Weight Assessment and Counseling for Nutrition and Physical Activity
for Children and Adolescents''; and CMS165, ``Controlling High Blood
Pressure.''
Through an amendment to Sec. 495.332(f), we gave each
state the flexibility to identify which of the eCQMs available for
reporting in the Medicaid Promoting Interoperability Program are high
priority measures for Medicaid EPs in that state, with review and
approval by CMS, through the State Medicaid HIT Plan (SMHP). States are
thus able to identify high priority measures that align with their
state health goals or other programs within the state.
All eCQMs identified via any of these three methods are high
priority measures for EPs participating in the Medicaid Promoting
Interoperability Program for 2020. We proposed to use
[[Page 84716]]
the same three methods for identifying high priority eCQMs for the
Medicaid Promoting Interoperability Program for 2021. We solicited
comments as to whether any of these methods should be altered or
removed, or whether any additional methods should be considered for
2021.
Finally, we note that the eCQM reporting period in 2021 for EPs in
the Medicaid Promoting Interoperability Program is a minimum of any
continuous 90-day period within CY 2021, provided that the end date for
this period falls before October 31, 2021, or falls before a state-
specific alternative date prior to October 31, 2021 that is specified
in the SMHP, as described in Sec. 495.332(f)(4). This 2021 eCQM
reporting period will help ensure that states can issue all Medicaid
Promoting Interoperability Program payments on or before December 31,
2021. (See 83 FR 59452, 59704 through 59706).
We received public comments on our proposals for eCQM reporting
requirements for EPs under the Medicaid Promoting Interoperability
Program for 2021. The following is a summary of the comments we
received and our responses.
Comment: The overwhelming majority of commenters supported our
proposals and stated that having the same eCQM specifications for the
Medicaid Promoting Interoperability program and the MIPS quality
performance category requirements for eligible clinicians using the
eCQM collection type would indeed reduce the reporting burden on health
care providers.
Response: We appreciate the support for our proposals.
Comment: Two commenters noted that the accuracy of eCQM data may be
skewed by the timeline necessitating that EPs submit less than a full
year of data. They explain that some measures are seasonal, such as
those related to influenza, and an EP may report data that do not
represent their true level of care over a full year. We also note that
both of these commenters supported our proposals.
Response: We acknowledge and understand that reporting periods of
less than a year may result in inaccurate or incomplete data. However,
the applicable meaningful use requirement to receive an incentive
payment is that an EP must simply report the eCQM data to the state.
The actual data reported are not used to determine whether an EP is
eligible for an incentive payment as a meaningful user of CEHRT.
Furthermore, the length of the eCQM reporting period for Medicaid EPs
in 2021 is consistent with the length of the eCQM reporting period for
2020. Therefore, health care providers and states should already be
aware of issues regarding the statistical validity of partial-year eCQM
data. Additionally, when we established the 90-day eCQM reporting
period for 2020, we concluded that, generally, the potential data
quality issues associated with a shorter eCQM reporting period were
outweighed by the benefits of that shorter period to all stakeholders
(including to states preparing for the final year of the Medicaid
Promoting Interoperability program in 2021), and that establishing 90-
day eCQM reporting periods in both 2020 and 2021 might provide better
data for comparison across the 2 years (see 84 FR 62901 and 62902).
Finally, when we established the 90-day eCQM reporting period for 2021,
we noted that it would help ensure that states can make all incentive
payments before the statutory deadline (see 83 FR 59705).
Comment: One health care provider commented that the statutory
deadline created a shortened time period to update the eCQM
specifications in their EHR, which could have cost and staff workload
implications. The commenter suggested that we allow EPs the option to
report using 2020 specifications or to extend the reporting and payment
deadlines.
Response: The December 31, 2021 deadline for payments is statutory
and we do not have the authority to alter that deadline. In the 2019
PFS final rule (83 FR 59452), we explained that for states to make
payments by that deadline, there must be sufficient time after EHR and
eCQM reporting periods end for Medicaid EPs to attest to states, for
states to conduct their prepayment processes, and for states to issue
payments. Therefore, we amended Sec. 495.4 to provide that the EHR
reporting period in 2021 for all EPs in the Medicaid Promoting
Interoperability Program will be a minimum of any continuous 90-day
period within CY 2021, provided that the end date for this period falls
before October 31, 2021, to help ensure that states can issue all
Medicaid Promoting Interoperability Program payments on or before
December 31, 2021. We also established that the eCQM reporting period
in 2021 for EPs in the Medicaid Promoting Interoperability Program will
be a minimum of any continuous 90-day period within CY 2021, provided
that the end date for this period falls before October 31, 2021, to
help ensure that states can issue all Medicaid Promoting
Interoperability Program payments on or before December 31, 2021.
However, we also allowed states the flexibility to set alternative,
earlier final end dates for EHR or eCQM reporting periods for Medicaid
EPs in CY 2021, with prior approval from us, through their State
Medicaid HIT Plans (SMHP). Any alternative end date for CY 2021 EHR and
eCQM reporting periods set by a state may not be any earlier than the
day prior to the attestation deadline for Medicaid EPs attesting to
that state. For more information, see our discussion of the EHR and
eCQM reporting periods for 2021 at 83 FR 59704-6.
We believe that allowing some EPs to report eCQMs in 2021 according
to 2020 specifications, and some to report eCQMs in 2021 according to
2021 specifications, could cause undue confusion about the requirements
for providers participating in the Medicaid Promoting Interoperability
Program and/or MIPS and increase the administrative burden on states to
determine which EPs submitted data in accordance with which
specifications. As explained above, we believe that the latest eCQM
specifications provide the most up-to-date clinical standards and
guidelines. Furthermore, none of the EHR vendors who submitted comments
indicated that the accelerated 2021 timeline would pose an obstacle to
issuing system updates in time for EPs to attest to meaningful use. For
the reasons explained in our proposal, we believe that maintaining a
single set of the most up-to-date eCQM specifications for EPs to use in
2021 reduces the burden on EPs who may be reporting to multiple quality
programs.
After considering public comments, we are finalizing the proposals
in this section as proposed.
G. Medicare Shared Savings Program
On March 23, 2010, the Patient Protection and Affordable Care Act
(Pub. L. 111-148) was enacted, followed by enactment of the Health Care
and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30,
2010, which amended certain provisions of the Patient Protection and
Affordable Care Act (hereinafter collectively referred to as ``the
Affordable Care Act''). Section 3022 of the Affordable Care Act amended
Title XVIII of the Act (42 U.S.C. 1395 et seq.) by adding section 1899
to the Act to establish the Medicare Shared Savings Program (Shared
Savings Program) to facilitate coordination and cooperation among
healthcare providers to improve the quality of care for Medicare fee-
for-service (FFS) beneficiaries and reduce the rate of growth in
expenditures under Medicare Parts A and B. (See 42 U.S.C. 1395jjj.)
Eligible groups of providers and suppliers, including physicians,
hospitals, and other healthcare
[[Page 84717]]
providers, may participate in the Shared Savings Program by forming or
participating in an Accountable Care Organization (ACO). Under the
Shared Savings Program, providers of services and suppliers that
participate in an ACO continue to receive traditional Medicare FFS
payments under Parts A and B, but the ACO may be eligible to receive a
shared savings payment if it meets specified quality and savings
requirements.
Section 1899 of the Act has been amended through subsequent
legislation. The requirements for assignment of Medicare FFS
beneficiaries to ACOs participating under the program were amended by
the 21st Century Cures Act (Pub. L. 114-255). The Bipartisan Budget Act
of 2018 (Pub. L. 115-123, enacted on February 9, 2018), further amended
section 1899 of the Act to provide for the following: Expanded use of
telehealth services by physicians or practitioners participating in an
applicable ACO to furnish services to prospectively assigned
beneficiaries, greater flexibility in the assignment of Medicare FFS
beneficiaries to ACOs by allowing ACOs in tracks under retrospective
beneficiary assignment a choice of prospective assignment for the
agreement period; permitting Medicare FFS beneficiaries to voluntarily
identify an ACO professional as their primary care provider and
requiring that such beneficiaries be notified of the ability to make
and change such identification, and mandating that any such voluntary
identification will supersede claims-based assignment; and allowing
ACOs under certain two-sided models to establish CMS-approved
beneficiary incentive programs.
The Shared Savings Program regulations are codified at 42 CFR part
425. The final rule establishing the Shared Savings Program appeared in
the November 2, 2011 Federal Register (Medicare Program; Medicare
Shared Savings Program: Accountable Care Organizations; final rule (76
FR 67802) (hereinafter referred to as the ``November 2011 final
rule'')). A subsequent major update to the program rules appeared in
the June 9, 2015 Federal Register (Medicare Program; Medicare Shared
Savings Program: Accountable Care Organizations; final rule (80 FR
32692) (hereinafter referred to as the ``June 2015 final rule'')). The
final rule entitled, ``Medicare Program; Medicare Shared Savings
Program; Accountable Care Organizations--Revised Benchmark Rebasing
Methodology, Facilitating Transition to Performance-Based Risk, and
Administrative Finality of Financial Calculations,'' which addressed
changes related to the program's financial benchmark methodology,
appeared in the June 10, 2016 Federal Register (81 FR 37950)
(hereinafter referred to as the ``June 2016 final rule''). A final
rule, ``Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2019;
Medicare Shared Savings Program Requirements; Quality Payment Program;
Medicaid Promoting Interoperability Program; Quality Payment Program--
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS
Payment Year; Provisions From the Medicare Shared Savings Program--
Accountable Care Organizations--Pathways to Success; and Expanding the
Use of Telehealth Services for the Treatment of Opioid Use Disorder
Under the Substance Use-Disorder Prevention That Promotes Opioid
Recovery and Treatment (SUPPORT) for Patients and Communities Act'',
appeared in the November 23, 2018 Federal Register (83 FR 59452)
(herein referred to as the ``November 2018 final rule'' or the ``CY
2019 PFS final rule''). In the November 2018 final rule, we finalized a
voluntary 6-month extension for existing ACOs whose participation
agreements would otherwise expire on December 31, 2018; allowed
beneficiaries greater flexibility in designating their primary care
provider and in the use of that designation for purposes of assigning
the beneficiary to an ACO if the clinician they align with is
participating in an ACO; revised the definition of primary care
services used in beneficiary assignment; provided relief for ACOs and
their clinicians impacted by extreme and uncontrollable circumstances
in performance year 2018 and subsequent years; established a new
Certified Electronic Health Record Technology (CEHRT) use threshold
requirement; and reduced the Shared Savings Program quality measure set
from 31 to 23 measures (83 FR 59940 through 59990 and 59707 through
59715).
A final rule redesigning the Shared Savings Program appeared in the
December 31, 2018 Federal Register (Medicare Program: Medicare Shared
Savings Program; Accountable Care Organizations-Pathways to Success and
Uncontrollable Circumstances Policies for Performance Year 2017; final
rule) (83 FR 67816) (hereinafter referred to as the ``December 2018
final rule''). In the December 2018 final rule, we finalized a number
of policies for the Shared Savings Program, including a redesign of the
participation options available under the program to encourage ACOs to
transition to two-sided models; new tools to support coordination of
care across settings and strengthen beneficiary engagement; and
revisions to ensure rigorous benchmarking.
In the interim final rule with comment period (IFC) entitled
``Medicare and Medicaid Programs; Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency'', which was effective
on the March 31st date of display and appeared in the April 6, 2020
Federal Register (85 FR 19230) (hereinafter referred to as the ``March
31st COVID-19 IFC''), we removed the restriction which prevented the
application of the Shared Savings Program extreme and uncontrollable
circumstances policy for disasters that occur during the quality
reporting period if the reporting period is extended, to offer relief
under the Shared Savings Program to all ACOs that may be unable to
completely and accurately report quality data for 2019 due to the PHE
for COVID-19 (85 FR 19267 and 19268). In the IFC entitled ``Medicare
and Medicaid Programs; Basic Health Program, and Exchanges; Additional
Policy and Regulatory Revisions in Response to the COVID-19 Public
Health Emergency and Delay of Certain Reporting Requirements for the
Skilled Nursing Facility Quality Reporting Program'' which was
effective on May 8th and appeared in the May 8, 2020 Federal Register
(85 FR 27573 through 27587) (hereinafter referred to as the ``May 8th
COVID-19 IFC''), we modified Shared Savings Program policies to: (1)
Allow ACOs whose current agreement periods expire on December 31, 2020,
the option to extend their existing agreement period by 1-year, and
allow ACOs in the BASIC track's glide path the option to elect to
maintain their current level of participation for performance year
2021; (2) adjust program calculations to remove payment amounts for
episodes of care for treatment of COVID-19; and (3) expand the
definition of primary care services for purposes of determining
beneficiary assignment to include telehealth codes for virtual check-
ins, e-visits, and telephonic communication. We also clarified the
applicability of the program's extreme and uncontrollable circumstances
policy to mitigate shared losses for the period of the PHE for COVID-19
starting in January 2020.
We have also made use of the annual CY PFS rules to address quality
reporting for the Shared Savings Program and certain other issues.
Refer to the CY 2020 PFS proposed rule for a summary of policies
finalized in prior rules (84 FR 40705).
[[Page 84718]]
Policies applicable to Shared Savings Program ACOs for purposes of
reporting for other programs have also continued to evolve based on
changes in the law. The Medicare Access and CHIP Reauthorization Act of
2015 (Pub. L. 114-10) (MACRA) established the Quality Payment Program.
In the CY 2017 Quality Payment Program final rule with comment period
(81 FR 77008), we established regulations for the Merit-Based Incentive
Payment System (MIPS) and Advanced Alternative Payment Models (APMs)
and related policies applicable to eligible clinicians who participate
in the Shared Savings Program. These policies included requirements for
Shared Savings Program ACOs regarding reporting for the MIPS Quality
performance category and a policy that gives ACOs full credit for the
MIPS Improvement Activities performance category based on their
participation in the Shared Savings Program.
In the CY 2021 PFS proposed rule (85 FR 50229), we explained our
belief that the changes we were proposing to the quality reporting
requirements under the Shared Savings Program for performance year 2021
and subsequent years would reduce ACO burden by establishing a smaller
measure set, out of which ACOs would only be required to actively
report 3 measures. This would represent a significant reduction in
reporting requirements from the 10 measures on which ACOs are currently
required to actively report. Under our proposal, reporting for these
measures would begin in January 2022, for the 2021 performance year. We
also noted that we believed this timeline would allow organizations
sufficient time to prepare to report on the new measure set. In
addition, the reporting options for the three ACO-reported measures
would leverage existing MIPS collection types and more closely align
existing CEHRT and registries used by ACOs and their clinicians,
including use of APIs to submit data.
In sections III.G.1 through III.G.4 of this final rule, we
summarize and respond to public comments we received on proposed
modifications to the Shared Savings Program's policies discussed in
section III.G. of the CY 2021 PFS proposed rule (85 FR 50228 through
50252). Some commenters' suggestions for modifications to Shared
Savings Program policies went beyond the scope of the policies
addressed in section III.G. of the CY 2021 PFS proposed rule, and will
not be addressed in this section of this final rule. As a general
summary, in sections III.G.1 through III.G.4 of this final rule we are
finalizing the following changes to the Shared Savings Program's
regulations to:
Modify the approach to measuring ACO quality performance
under the Shared Savings Program which includes:
++ Applying the Alternative Payment Model (APM) Performance Pathway
(APP) to Shared Savings Program ACOs for performance years beginning on
or after January 1, 2021. Specifically, we are finalizing that:
--For performance year 2021, ACOs will be required to report
quality data via the APP, and can choose to report either the 10
measures under the CMS Web Interface or the 3 eCQM/MIPS CQM measures.
In addition, ACOs will be required to field the CAHPS for MIPS survey,
and CMS will calculate 2 measures using administrative claims data.
--For performance year 2022 and subsequent performance years, ACOs
will be required to actively report quality data on the 3 eCQM/MIPS CQM
measures via the APP. In addition, ACOs will be required to field the
CAHPS for MIPS survey, and CMS will calculate two measures using
administrative claims data.
++ Revising the Shared Savings Program Quality Performance
Standard. ACOs will meet the quality performance standard if:
--For performance years 2021 and 2022, ACOs achieve a quality
performance score that is equivalent to or higher than the 30th
percentile across all MIPS Quality performance category scores; and
--For performance year 2023 and subsequent performance years, ACOs
achieve a quality performance score that is equivalent to or higher
than the 40th percentile across all MIPS Quality performance category
scores.
++ Changing the methodology for determining shared savings and
shared losses based on ACO quality performance.
++ Revising the approach to monitoring ACO quality performance and
addressing ACOs that fail to meet the Quality Performance Standard.
++ Updating the process used to validate ACO Quality Data
Reporting, where we are finalizing that CMS retains the right to audit
and validate quality data reported by an ACO via the APP according to
the MIPS DVA process for performance years beginning on or after
January 1, 2021.
++ Updating the extreme and uncontrollable circumstances policy as
it relates to quality performance.
Update the definition of primary care services used in
beneficiary assignment, and codify in regulations the adjustment that
is made to an ACO's historical benchmark to reflect any changes to the
beneficiary assignment methodology specified in part 425, subpart E,
during an ACO's agreement period, including revisions to the definition
of primary care services at Sec. 425.402(c).
Revise the repayment mechanism arrangement policy in the
following manner:
++ To reduce the repayment mechanism amount for certain ACOs
entering an agreement period starting on January 1, 2022, and in
subsequent years.
++ To allow a one-time opportunity for certain ACOs that renewed
for a new agreement period beginning on July 1, 2019, or January 1,
2020, to elect to decrease the amount of their existing repayment
mechanisms.
++ To permit a re-entering ACO that is the same legal entity as an
ACO that previously participated in the program, to use its existing
repayment mechanism to support its new agreement period, in a similar
manner as applies to renewing ACOs.
In section III.G.5. of this final rule, we summarize and respond to
public comments received in response to the May 8th COVID-19 IFC, and
discuss our final policies after taking into consideration the public
comments.
1. Quality and Other Reporting Requirements
a. Background
Section 1899(b)(3)(C) of the Act states that the Secretary shall
establish quality performance standards to assess the quality of care
furnished by ACOs and seek to improve the quality of care furnished by
ACOs over time by specifying higher standards, new measures, or both.
In the November 2011 final rule establishing the Shared Savings
Program, we adopted a quality measure set spanning four domains:
patient experience of care, care coordination/patient safety,
preventative health, and at-risk population (76 FR 67872 through
67891). Since then, we have updated the measures that comprise the
quality performance measure set for the Shared Savings Program through
rulemaking in the CY 2015, 2016, 2017, and 2019 PFS final rules (79 FR
67907 through 67920, 80 FR 71263 through 71268, 81 FR 80484 through
80489, and 83 FR 59707 through 59715 respectively).
As we stated in the November 2011 final rule (76 FR 67872), our
principal goal in selecting quality measures for ACOs has been to
identify measures of success in the delivery of high-quality
[[Page 84719]]
health care at the individual and population levels, with a focus on
outcomes. In the CY 2019 PFS final rule, we finalized that for
performance years (or a performance period) starting in 2019 and
subsequent years, 23 quality measures would be used to determine ACO
quality performance (83 FR 59707 through 59715). The information used
to determine ACO performance on these quality measures is submitted by
the ACO through the CMS Web Interface, calculated by us from
administrative claims data, and collected via a patient experience of
care survey referred to as the Consumer Assessment of Healthcare
Provider and Systems (CAHPS) for ACOs Survey.
Eligible clinicians who are participating in an ACO and who are
subject to MIPS (MIPS eligible clinicians) are currently scored under
the APM scoring standard under MIPS (81 FR 77260). These MIPS eligible
clinicians include any eligible clinicians who are participating in an
ACO in a track, or payment model within a track (Track 1 and Levels A
through D of the BASIC track) of the Shared Savings Program that is not
an Advanced APM, as well as those MIPS eligible clinicians
participating in an ACO in a track, or payment model within a track
(Track 2, Level E of the BASIC track, and the ENHANCED track, or the
Medicare ACO Track 1+ Model (Track 1+ Model)) that is an Advanced APM,
but who do not become Qualifying APM Participants (QPs) as specified in
Sec. 414.1425, and are not otherwise excluded from MIPS.
b. Applying the Alternative Payment Model (APM) Performance Pathway
(APP) to Shared Savings Program ACOs
As provided in section 1899(d)(2) of the Act and Sec. 425.502(a)
of the Shared Savings Program regulations, ACOs must meet a quality
performance standard to qualify to share in savings. In the CY 2017 PFS
final rule, we finalized revisions to Sec. 425.502 related to the
quality performance standard and minimum attainment, including
clarifying that the quality performance standard is the overall
standard the ACO must meet to qualify to share in savings; defining the
minimum attainment level for pay for performance measures at the 30th
percent or the 30th percentile of the quality performance benchmark and
for pay for reporting measures at the level of complete and accurate
reporting; specifying that only pay for performance measures are
assessed on a sliding scale while pay for reporting measures earn the
maximum number of points for a measure when the minimum attainment
level is met (81 FR 80492 through 80494).
We explained in the CY 2021 PFS proposed rule (85 FR 50230) that
currently, the quality performance standard is based on an ACO's
experience in the program rather than its financial track. The quality
performance standard is currently defined at the level of full and
complete reporting (pay-for-reporting (P4R)) for the first performance
year of an ACO's first agreement period under the Shared Savings
Program. In the second or subsequent years of the ACO's first agreement
period and all years of subsequent agreement periods, quality measures
are scored as pay-for-performance (P4P) according to the phase-in
schedule for the specific measure and the ACO's performance year in the
Shared Savings Program:
For all performance years, ACOs must completely and
accurately report all quality data used to calculate and assess their
quality performance.
CMS designates a performance benchmark and minimum
attainment level for each P4P measure and establishes a point scale for
the measure. An ACO's quality performance for a measure is evaluated
using the appropriate point scale, and these measure-specific scores
are used to calculate the final quality score for the ACO.
ACOs must meet minimum attainment (defined as 30 percent
or the 30th percentile of the performance benchmark for P4P measures)
on at least one measure in each domain to be eligible to share in any
savings generated (Sec. 425.502(d)(2)(iii)(A)).
In the CY 2020 PFS proposed rule (84 FR 40709 through 40713), we
sought comment on how we might align the Shared Savings Program quality
reporting requirements and scoring methodology more closely with the
MIPS quality reporting and scoring methodology. We discussed utilizing
the MIPS Quality performance category score to adjust shared savings
and shared losses under the Shared Savings Program, as applicable. We
also sought comment on a possible new approach to determining the
threshold for minimum attainment. Under this potential policy, minimum
attainment would continue to be defined as complete and accurate
reporting for ACOs in their first performance year of their first
agreement period, while a MIPS Quality performance category score at or
above the 4th decile across all MIPS Quality performance category
scores would be required for ACOs in all other performance years under
the Shared Savings Program. ACOs with MIPS Quality performance category
scores below the 4th decile of all MIPS Quality performance category
scores would not meet the quality performance standard for the Shared
Savings Program, and thus, would not be eligible to share in savings or
would owe the maximum shared losses, if applicable. In addition, we
sought comment on a potential policy under which ACOs with quality
scores below the 4th decile of all MIPS Quality performance category
scores would be subject to compliance actions and possible termination.
We noted in the CY 2021 PFS proposed rule (85 FR 50230) that the
majority of feedback received in response to our comment solicitation
did not support this approach as it would hold ACOs to a higher
standard to be eligible to share in savings, if earned. In addition,
commenters that opposed aligning the Shared Savings Program quality
score with the MIPS Quality performance category score, stated that
significant restructuring of the Shared Savings Program quality
performance requirements would introduce more confusion for ACOs that
are also transitioning into new tracks under the December 2018 final
rule. Commenters also expressed concern regarding the uncertainty
associated with such an approach, as we had also proposed extensive
revisions to MIPS as the program transitions to MIPS Value Pathways.
Furthermore, commenters noted that ACOs are unique in that they are
responsible for the total cost of care of their beneficiaries and
should not be compared to clinicians in MIPS who are not participating
in total cost of care programs.
In the CY 2021 PFS proposed rule (85 FR 50230 and 50231), we
acknowledged the commenters' concerns, but noted that section
1899(b)(3)(C) of the Act not only gives us discretion to establish
quality performance standards for the Shared Savings Program, but also
indicates that we should seek to improve the quality of care furnished
by ACOs over time by specifying higher standards, new measures, or both
for purposes of assessing quality of care. The Shared Savings Program
is now in its eighth performance year, and 85 percent of ACOs
participating in the program are considered PY3 ACOs for purposes of
quality reporting, with 65 percent of those ACOs participating in a
second or subsequent agreement period. In light of the maturity of the
program and consistent with section 1899(b)(3)(C) of the Act, we stated
that we believe that it is appropriate to require a higher standard of
care in order for ACOs to continue to share in any savings they
achieve. In addition, holding ACOs to a higher standard is in line with
CMS' goals of incentivizing
[[Page 84720]]
value-based care and driving the Medicare system to greater value and
quality. However, we explained that after taking into consideration the
stakeholder feedback, we had also considered ways to reduce reporting
burden, offer more flexibility in the way quality data can be reported
and submitted, and create a more meaningful measure set that would
focus on population health measures and be more outcome-oriented, while
also including patient experience of care metrics.
We stated in the CY 2021 PFS proposed rule (85 FR 50231) that
although the Alternative Payment Model Performance Pathway (APP) was
designed for all MIPS APMs, it is also responsive to the concerns
raised by commenters in their responses to our solicitation in the CY
2020 PFS proposed rule, while still taking into consideration the
maturity of the Shared Savings Program, ACOs' quality performance over
time, and the intent of section 1899(b)(3)(C) of the Act. The APP
contains a narrower measure set than has previously been used for
Shared Savings Program quality measurement, 6 measures versus the
current 23 scored measures, and is specifically intended for use in
APMs and population health. The design of the APP aligns with
stakeholder interests expressed through comments on our solicitation
about aligning the Shared Savings Program with MIPS in the CY 2020 PFS
proposed rule. These comments suggested adopting a smaller, more
focused measure set in recognition of the fact that APM Entities are
incentivized through the terms of the respective APMs to improve value.
The measure set proposed for the APP aligns with the Meaningful
Measures framework by identifying measures that address the highest
priorities for quality measurement and improvement, while also reducing
reporting burden, promoting alignment of measures and consolidation of
reporting requirements across CMS programs moving payment toward value,
and identifying consumers' key quality performance metrics. We noted
that the measures proposed for inclusion in the APP measure set
encompass the meaningful measure domains of patient voice, wellness and
prevention, seamless communication, chronic disease management, and
behavioral health. For these reasons, we stated in the CY 2021 PFS
proposed rule that we believe that the proposed APP, along with the
narrower measure set, which comprises it, would be appropriate to
assess the quality performance of Shared Savings Program ACOs.
The construction of the proposed APP for Shared Savings Program
ACOs and the proposed measures within it were described in detail in
section III.G.1.b.(1) of the CY 2021 PFS proposed rule (85 FR 50231
through 50235). A detailed discussion of the proposal for use of the
APP for MIPS APMs more generally can be found in section IV.A.3.b. of
the CY 2021 PFS proposed rule (85 FR 50285 through 50288).
(1) APM Performance Pathway for Shared Savings Program ACOs
In section III.G.1.b.(1) of the CY 2021 PFS proposed rule (85 FR
50231 through 50235), we described the proposals related to the APM
Performance Pathway for Shared Savings Program ACOs. In response to the
stakeholder feedback and in order to improve alignment and integration
with the Quality Payment Program policies and operations, align with
CMS' Meaningful Measure Framework, increase participation in APMs and
Advanced APMs by reducing reporting burden, and raise the quality
performance standard under the Shared Savings Program, we proposed to
revise the Shared Savings Program quality performance standard
effective for performance year 2021 and subsequent performance years.
We explained that the proposed revision would align the Shared Savings
Program quality performance standard with the proposed APP under the
Quality Payment Program as participants in the Shared Savings Program
would be required to report quality for purposes of the Shared Savings
Program via the APP, which was described in more detail in section
IV.A.3.b. of the CY 2021 PFS proposed rule (85 FR 50285 through 50288).
At a high level, we proposed that the APP would replace the current
Shared Savings Program quality measure set to streamline reporting
requirements for Shared Savings Program ACOs and would be a
complementary path to the MIPS Value Pathways. The APP is designed to
reduce reporting burden, create new scoring opportunities for
participants in MIPS APMs, and encourage participation in APMs.
Under this proposed new approach, ACOs would only need to report
one set of quality metrics that would satisfy the reporting
requirements under both MIPS and the Shared Savings Program. There
would not be separate quality reporting requirements under the Shared
Savings Program, as under the proposed new approach the quality
measures reported for purposes of the APP would also be used to
determine the quality performance of the ACO for purposes of the Shared
Savings Program, which is used for purposes of calculating shared
savings and also shared losses, where applicable. We stated that we
believe this approach of streamlining the quality reporting
requirements under the Shared Savings Program while maintaining
alignment with the Quality Payment Program will help ACOs and their
participating providers and suppliers dedicate their finite resources
to engaging in efforts to improve quality and reduce costs for their
assigned beneficiary population. In addition, we explained that using a
single methodology to measure quality performance under both the Shared
Savings Program and MIPS would allow ACOs to better focus on increasing
the value of healthcare, improving care, and engaging patients. It
would also reduce burden as ACOs would be able to track to a smaller
set of measures under a unified scoring methodology.
We received many public comments on the proposals to apply the APP
to determine the quality performance of Shared Savings Program ACOs.
The following is a summary of the comments we received and our
responses.
Comment: We received many comments on the proposal to apply the APP
to determine quality performance of Shared Savings Program ACOs.
Supportive commenters noted that this proposal would align reporting
requirements for MIPS and the Shared Savings Program, shift the focus
from process measures to clinical outcomes, move toward eliminating
unnecessary and inappropriate measures, focus on appropriate measures
for ACO accountability, and provide entities more flexibility for
reporting and allow MIPS eligible clinicians the option of reporting
quality data separately from the ACO for purposes of MIPS scoring.
Further, one commenter noted that alignment between MIPS and quality
reporting requirements for Advanced APMs would create a better
glidepath for healthcare providers looking to transition away from fee-
for-service. Additionally, commenters noted that streamlined reporting
requirements, a smaller set of measures, and a unified scoring
methodology for the Shared Savings Program and MIPS would result in
reduced burden for ACOs and allow ACOs to dedicate limited resources
toward improving care for beneficiaries. One commenter noted that
alignment of Shared Savings Program quality reporting requirements
under the APP with reporting requirements under the MIPS program would
minimize the
[[Page 84721]]
barrier for practices transitioning to an APM.
However, a majority of commenters expressed concerns about the
proposal. The most common concerns were the time, effort, and cost
involved in transitioning to a new measure set, new reporting
mechanisms, and all-payer reporting, with potentially unintended
negative impacts on quality, particularly during a time when healthcare
organizations are impacted by the PHE for COVID-19. Specific concerns
included the time needed to identify and implement new data collection
mechanisms, modify operational workflows and clinical strategies to
align with the six APP quality measures, secure new technology
capabilities, assess and respond to the impacts of the PHE for COVID-
19, understand the differences in measure specifications, train
clinicians and office staff on a new reporting platform, and evaluate
performance against the consolidated measure set to understand the
impact this change will have on scoring standards. Comments included
requests that implementation of the APP be delayed until 2022 or later;
a voluntary transition period be offered to allow time for ACOs to
adapt to the new requirements; a modified plan be implemented to allow
ACOs to only report on a sample of patients while they prepare to
implement automated population measurement; the first year following
implementation of the APP be a pay-for-reporting year; exemptions to
reporting requirements be offered; a bonus be offered to ACOs that are
able to make the transition in 2021 without penalizing ACOs that need
more time to prepare; and the timelines for implementing the APP and
implementing the MIPS Value Pathways be aligned. One commenter
requested that if the proposal is delayed until 2022 that CMS confirm
the measure set that will be used starting in performance year 2022 in
the CY 2021 PFS final rule so that ACOs have time to prepare.
Commenters suggested that more stakeholder feedback should be collected
before the proposed changes are finalized and that CMS should provide
time for provider education, outreach, and support between finalizing a
rule and implementing significant revisions to the quality reporting
requirements.
Some commenters supported sunsetting the CMS Web Interface as a way
to meet the CMS objective of increasing the utilization of CEHRT and
digital quality measures or interoperability initiatives; but, many
commenters had concerns about sunsetting the CMS Web Interface. Several
commenters requested that sunsetting the CMS Web Interface should
either be a gradual transition or be delayed to allow organizations to
prepare for the transition to reporting under the APP and ease
financial constraints practices are currently facing due to the PHE for
COVID-19.
One commenter noted that even small changes to the program design
could cause significant variance in performance for ACOs. The commenter
recommended that CMS keep the current measure set, reporting mechanism,
and scoring methods in place for performance 2021. Additionally, the
commenter stated that healthcare providers should not be held
accountable for performance against a benchmark that would not be set
until the performance period closed and expressed concern that the PHE
would continue to impact quality improvement efforts in 2021. The
commenter recommended that CMS continue to monitor data submitted
through the CMS Web Interface, evaluate the impact of the PHE for
COVID-19 on quality performance, and revert all measures to pay-for-
reporting or provide ACOs with the option to choose historical
performance scores.
Other concerns raised by commenters included that the proposed APP
does not align with the approach CMS uses to assess the quality of care
furnished by other non-fee-for-service providers, such as Medicare
Advantage organizations, even though the proposal would align quality
scoring under the Shared Savings Program with MIPS. Two commenters
noted that aligning requirements for Advanced APMs with MIPS program
methodologies was a step backwards. One of these commenters stated that
the guiding principle should be to ensure that there are strong
incentives to participate in Advanced APMs relative to traditional
Medicare fee-for-service, including being excluded from MIPS quality
reporting processes, to increase the uptake of participation in
Advanced APMs and decrease the need for MIPS over time. The other
commenter stated that APMs should not have to align with MIPS, but
rather MIPS reporting requirements should be structured to encourage
clinicians to participate in APMs. Several commenters had concerns
about changes to how ACO quality is reported, scored, and assessed and
recommended that CMS obtain more stakeholder feedback before moving
forward. One commenter expressed concern that the proposed APP does not
support the Shared Savings Program's commitment to improved value,
stating that the quality performance of ACOs should not be evaluated
for purposes of the Shared Savings Program in the same manner as under
other APMs or for individual MIPS clinicians because each APM has
specific goals and objectives. Further, commenters noted that ACOs are
distinct from single physician groups or hospital systems because ACOs
are focused on managing population health and total cost of care for
their aligned Medicare patient population, and therefore, should not be
evaluated and assessed in the same manner as other types of healthcare
providers. One commenter noted that the proposed APP will require
significant investments while healthcare providers are still recovering
from the PHE and this may disproportionately disadvantage smaller and
rural ACOs and multi-practice independent physician ACOs operating many
EHR systems.
Response: We thank commenters for their detailed feedback on the
proposal to apply the APP to Shared Savings Program ACOs beginning in
performance year 2021. We appreciate the support for our proposal, but
also understand the concerns raised by a number of commenters about the
proposed implementation of the APP for Shared Savings Program ACOs
starting in performance year 2021. The primary concern expressed by
commenters centered around the timeline for ACOs to implement
appropriate infrastructure changes in order to be able to report under
the APP beginning in performance year 2021, particularly given the PHE
for COVID-19. Commenters also raised concerns about the proposed
removal of the CMS Web Interface as a collection type. In addition,
commenters were concerned about the proposed APP measure set, including
use of measures based on all payer data. In light of the significant
concerns raised by the commenters about implementing the APP for Shared
Savings Program ACOs beginning in performance year 2021, we are
modifying our proposal to apply the APP to determine the quality
performance of Shared Savings Program ACOs as described below.
As discussed in section IV.A.3.c.1.c. of this final rule, we are
extending the use of the CMS Web Interface as a collection type for the
Quality Payment Program for CY 2021, and will sunset the CMS Web
Interface starting with CY 2022. Accordingly, we are also modifying the
quality measure set for the APP for Shared Savings Program ACOs to add
the CMS Web Interface as an additional reporting option for performance
year 2021, as discussed in this section and section IV.A.3.b. of this
final rule. In addition, as discussed in
[[Page 84722]]
section III.G.1.c. of this final rule, we are modifying the proposed
quality performance standard to include a gradual phase-in of the
increase in the level of quality performance that would be required for
ACOs to meet the quality performance standard under the APP for Shared
Savings Program ACOs. We believe that these changes alleviate many of
the concerns raised by commenters about the implementation of the APP
for Shared Savings Program ACOs beginning in performance year 2021.
Therefore, we are finalizing, with modifications, our proposed
revisions to the quality reporting requirements under the Shared
Savings Program effective for performance year 2021 and subsequent
performance years. These revisions will align the Shared Savings
Program quality reporting requirements with the requirements that will
apply under the APP under the Quality Payment Program as Shared Savings
Program ACOs will be required to report quality data for purposes of
the Shared Savings Program via the APP. Under this new approach, ACOs
will only need to report one set of quality metrics via the APP that
will satisfy the quality reporting requirements under both the Shared
Savings Program and the MIPS. As discussed in the CY 2021 PFS proposed
rule (85 FR 50231), there will not be separate quality reporting
requirements under the Shared Savings Program as the quality measures
reported for purposes of the APP will be used to determine the quality
performance of the ACO for purposes of calculating shared savings and
also shared losses, where applicable. The final APP quality measure set
is listed in Tables 40 and 46 in this final rule. The policies
finalized for the APP are discussed in section IV.A.3.b. of this final
rule. In order to meet the quality reporting requirements under the
Shared Savings Program, ACOs must meet the requirements described below
and summarized in Table 39.
For performance year 2021, ACOs will be required to report
quality data via the APP, and can choose to actively report either the
10 measures under the CMS Web Interface or the 3 eCQM/MIPS CQM
measures. In addition, ACOs will be required to field the CAHPS for
MIPS survey, and CMS will calculate 2 measures using administrative
claims data.
As noted in Tables 40 and 46 in this final rule three of the CMS
Web Interface measures (Statin Therapy for the Prevention and Treatment
of Cardiovascular Disease (Quality ID# 438); Depression Remission at
Twelve Months (Quality ID# 370), and Preventive Care and Screening:
Screening for Depression and Follow-up Plan (Quality ID# 134)) do not
have benchmarks, and therefore, will not be scored. However, these
measures are required to be reported in order to complete the CMS Web
Interface dataset. Based on the ACO's chosen reporting option, either 6
or 10 measures will be included in the calculation of the ACO's quality
performance score.
For performance year 2022 and subsequent performance
years, ACOs will be required to actively report quality data on the 3
eCQM/MIPS CQM measures via the APP. In addition, ACOs will be required
to field the CAHPS for MIPS survey, and CMS will calculate two measures
using administrative claims data. All 6 measures will be included in
the calculation of the ACO's quality performance score.
[[Page 84723]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.084
The quality reporting requirements described above will provide
ACOs with a one-year transition period during performance year 2021
where they will have the option either to continue to report via the
CMS Web Interface or to report on the 3 eCQM/CQM MIPS measures before
being required to report on the 3 eCQM/MIPS CQM measures beginning in
performance year 2022. As discussed in section III.G.1.c. of this final
rule, we are also finalizing policies to phase-in the increase in the
quality performance standard over 3 years. We believe that the phase-in
policies, as summarized in Table 39, for applying the APP to Shared
Savings Program ACOs address concerns raised by the commenters
regarding the proposed timeline for implementing the APP and also help
to mitigate the impact of the PHE for COVID-19 on ACOs. The phase-in
policies provide ACOs with additional time to set up their systems and
educate providers and office staff in order to report on the 3 eCQM/
MIPS CQM measures beginning in performance year 2022 and will also
allow ACOs to become familiar with the new quality reporting
requirements under the APP and gain experience reporting on the new
measures before they are assessed under the higher quality performance
standard beginning in performance year 2023. Commenters' concerns
related to the APP quality measure set are addressed later in this
section.
In the CY 2021 PFS proposed rule, we explained that the APP is
designed to reduce reporting burden by enabling ACOs to track to a
smaller set of measures under a unified scoring methodology. The
policies we are adopting in this final rule are consistent with our
goal of reducing reporting burden for ACOs. Under our final policies,
the total number of measures will be reduced from 23 to either 6 or 13
measures (depending on the ACO's chosen reporting option) for
performance year 2021 and to 6 measures beginning in performance year
2022.
For the commenter that expressed concern that providers should not
be held accountable for performance against a benchmark that would not
be set until the end of the performance period, we note that as
discussed in section IV.A.3.d.1.b.ii. of this final rule, we are not
finalizing the proposal to use performance period benchmarks and
instead will continue to use historical benchmarks for quality measures
for the CY 2021 MIPS performance period.
We stated in the CY 2021 PFS proposed rule (85 FR 50231) that,
under the APP proposed in section III.C.3.b., eligible clinicians in
Shared Savings Program ACOs would continue to receive full credit for
the improvement activities performance category in 2021 based on their
performance of activities required under Sec. 425.112 of the Shared
Savings Program regulations, as they do under current MIPS scoring
policy. We also proposed that under the APP, the Promoting
Interoperability performance category would be reported and scored by
MIPS eligible clinicians and groups and calculated in the same manner
described at Sec. 414.1375. Shared Savings Program ACOs are not
currently assessed on the MIPS Cost performance category as they are
already subject to cost and utilization performance
[[Page 84724]]
assessments as part of the Shared Savings Program, and we proposed that
the cost performance category would continue to be weighted at zero
percent under the APP. Under the proposed APP, the four performance
categories would be weighted as follows: Quality: 50 percent; Promoting
Interoperability: 30 percent; Improvement Activities: 20 percent; and
Cost: 0 percent. These policies are being finalized as proposed in
section IV.A.3.b.4. of this final rule.
Under the APP, the quality performance score will be calculated for
ACOs based on the same MIPS benchmarks that are used for other non-ACO
group and individual reporters and reflect the method of data
submission (for example, eCQM measures have benchmarks calculated using
EHR data and CQM measures have benchmarks calculated using data for
each specific non-EHR collection type). As discussed in section
IV.A.3.d.1.b.ii of this final rule, we are not finalizing the proposal
to use performance period benchmarks and instead will continue to use
historical benchmarks for quality measures for the CY 2021 MIPS
performance period. However, we note that, for the measures reported
under the CMS Web Interface for performance year 2021, we will continue
to use the Shared Savings Program benchmarks developed for the CMS Web
Interface for performance year 2020. These Shared Savings Program
benchmarks are based on data reported by ACOs, physicians, and groups
through the CMS Web Interface, claims, and/or a registry from 2016,
2017, and 2018. The use of the Shared Savings Program benchmarks for
the CMS Web Interface measures for performance year 2021 will allow us
to be consistent with the approach currently used for scoring CMS Web
Interface measures in the Shared Savings Program. We note that the
Shared Savings Program benchmarks will also be used for the CMS Web
Interface measures reported by groups and virtual groups under MIPS.
In the proposed CY 2021 PFS proposed rule (85 FR 50231 and 50232)
we proposed that ACOs would be scored on the measures they report and
will receive zero points for those measures they do not report. For
example, if an ACO reported all three measures it is actively required
to report but did not field a CAHPS for MIPS survey measure, the ACO
would receive zero points for the CAHPS for MIPS survey measure, and
that zero would be included in its MIPS Quality performance category
score, along with its performance rates on the three measures it did
actively report as well as the two claims-based measures included in
the APP measure set. This proposed approach aligns with scoring under
MIPS, rather than the current Shared Savings Program quality
performance scoring methodology, which uses quality benchmarks
established specifically for the Shared Savings Program and awards zero
points for quality for ACOs that report some but not all of the
required measures. We also noted that we believe this approach would be
less punitive for ACOs than the current quality performance standard,
under which ACOs that fail to completely report all quality measures
receive a zero score for quality. We also noted that we believe that
alignment with the MIPS scoring methodology would reduce the burden on
ACOs of tracking to two different scoring methodologies. However, we
proposed that if an ACO does not report any of the three APP measures
it is required to actively report and does not field a CAHPS for MIPS
survey the ACO would not meet the quality performance standard for
purposes of the Shared Savings Program and would not be able to share
in savings and would owe maximum shared losses, if applicable. We
explained that if an ACO does not report any of the three measures it
is required to actively report and does not field a CAHPS for MIPS
survey, we did not believe that the remaining two claims-based measures
in the APP core measure set would be sufficient to assess the quality
of care provided by an ACO to its assigned beneficiaries and would
likely not allow the ACO to achieve a MIPS Quality performance category
score at or above the 40th percentile. Under our proposal, there would
be no quality ``phase in'' for new ACOs or for newly introduced
measures or for quality measures that undergo significant changes. All
ACOs, regardless of performance year and agreement period, would be
scored on all the measures in the APP for purposes of the Shared
Savings Program quality performance standard.
We did not receive any comments on the proposal that if an ACO does
not report any of the three APP measures it is required to actively
report and does not field a CAHPS for MIPS survey, the ACO would not
meet the quality performance standard.
Consistent with the quality reporting requirements finalized for
Shared Savings Program ACOs under the APP, as discussed above, we are
finalizing that:
For performance year 2021: If an ACO does not report any
of the ten CMS Web Interface measures or any of the three eCQM/MIPS CQM
measures it is actively required to report and does not field a CAHPS
for MIPS survey via the APP, the ACO would not meet the quality
performance standard for purposes of the Shared Savings Program.
For performance year 2022 and subsequent performance
years: If an ACO does not report any of the three eCQM/MIPS CQM
measures it is actively required to report and does not field a CAHPS
for MIPS survey via the APP, the ACO would not meet the quality
performance standard for purposes of the Shared Savings Program.
Comment: We received several comments related to the proposal to
remove the pay-for-reporting year for ACOs in the first year of their
first agreement period. Commenters expressed concern that new ACOs may
require an initial performance year in the Shared Savings Program to
build operations before they will be prepared to meet pay-for-
performance standards. One commenter noted that new ACOs should have 1-
2 years to learn the quality measures and plan improvement processes.
Additionally, commenters expressed that removing the pay-for-reporting
option for new ACOs would deter participation in the Shared Savings
Program and negatively impact ACOs that are comprised of smaller
physician practices and do not have hospital system support.
Response: We appreciate the commenters' concerns regarding the
removal of the pay-for-reporting year for ACOs beginning an initial
agreement period under the Shared Savings Program. The goal of the
proposal was to align the Shared Savings Program quality performance
standard with the APP under the Quality Payment Program, and there is
no pay-for-reporting policy under the Quality Payment Program. However,
in recognition of the concerns expressed by the commenters, we are
modifying our original proposal and finalizing the following policy:
Beginning January 1, 2022, for ACOs in the first performance year of
their first agreement period under the Shared Savings Program, an ACO
would meet the quality performance standard if it meets the MIPS data
completeness and case minimum requirements on all three of the eCQM/
MIPS CQM measures and fields the CAHPS for MIPS survey via the APP. The
scoring policy under MIPS would be the same as for other ACOs.
We note that, as a result of CMS' decision to forgo an application
cycle for a January 1, 2021 agreement start date in the Shared Savings
Program, there will be no ACOs whose first
[[Page 84725]]
performance year of its first agreement period under the Shared Savings
Program will begin on January 1, 2021. Therefore, this policy will be
applicable for ACOs that are in the first performance year of their
first agreement period in performance year 2022 or a subsequent
performance year. We believe continuing this policy under the APP will
provide new ACOs with additional time to set up their systems and
educate providers and office staff, become familiar with the quality
reporting requirements under the APP, and gain experience reporting on
the measures under the APP before their performance is assessed in
order to share in savings.
Comment: We received several comments related to the proposal to
remove the pay-for-reporting year for newly introduced quality measures
and quality measures that have undergone significant changes.
Commenters suggested that a pay-for-reporting transition year ensures
that quality measures that are new or have undergone significant
changes do not have unintended consequences and allows potential issues
with measure specifications to be identified before ACOs are held
accountable for measure performance. Additionally, commenters suggested
that a pay-for-reporting transition year would allow ACOs to adjust
workflows and operations to ensure that quality data for the new or
significantly changed measure is appropriately captured.
Response: We appreciate the commenters' concerns regarding the
removal of the pay-for-reporting year under the Shared Savings Program
for newly introduced quality measures and quality measures that undergo
significant changes. We note that for each quality measure that an ACO
submits that has significant changes, the total available measure
achievement points are reduced by 10 points under the APP under current
MIPS scoring policy (Sec. 414.1380(b)(1)(vii)(A)). We believe that
adopting these policies for the Shared Savings Program is consistent
with our goal to align the quality scoring methodology under the Shared
Savings Program with MIPS. Therefore, we are finalizing our proposal to
remove the pay-for-reporting year under the Shared Savings Program for
newly introduced quality measures and quality measures that undergo
significant changes.
In the CY 2021 PFS proposed rule (85 FR 50232), we stated that for
MIPS scoring purposes, an ACO that fails to report via the APP would
receive a zero in the Quality performance category under MIPS. If an
ACO fails to report via the APP on behalf of its ACO participants then
the ACO participants could report outside the ACO, on behalf of the
MIPS eligible clinicians who bill through the TIN of the ACO
participant and receive a MIPS Quality performance category score
calculated at the ACO participant level. If ACO participants report
outside the ACO via the APP, they would be eligible to earn full credit
for improvement activities based on ACO participation. If ACO
participants choose to report outside the ACO via a different MIPS
reporting option, then regular MIPS scoring rules would apply (that is,
eligibility to earn full credit for improvement activities and zero
cost category weight would not be applied). We proposed in the CY 2021
PFS proposed rule (85 FR 50285) that MIPS eligible clinicians
participating in ACOs also would have the option of reporting outside
the APP, or within it at an individual or group level, for purposes of
being scored under MIPS.
Comment: One commenter supported the proposal to allow reporting at
the clinician, group practice, or ACO level for purposes of MIPS
scoring as it would allow clinicians more flexibility and allow
clinicians to be recognized for the work they are doing both inside and
outside the context of the ACO. Other commenters expressed concerns
regarding a policy under which individual clinicians and group TINs
would have the option to report outside of the ACO for the purposes of
MIPS scoring. The commenters expressed concerns that this approach
would cause unnecessary confusion and instability and could fracture
the foundation of the ACO by negating the commitment to the ACO.
Similarly, one provider expressed concern that individual reporting
adds a layer of complexity that is not conducive to ACO shared
learnings and best practice identification. Additionally, commenters
were concerned that this approach would not allow for a fair assessment
of quality improvement efforts by clinicians or group practices
participating in ACOs because certain organizations could select
measures for which they have the highest historical performance. One
commenter was concerned that reporting separately could
disproportionately impact rural and smaller providers. The commenter
recommended that CMS instead maintain the APM Scoring Standard approach
for all ACO clinicians.
Another commenter had concerns that allowing TINs and/or NPIs to
report data on their own, outside of the ACO, would cause even more
confusion, citing previous concerns with the QPP help desk not
understanding Medicare Shared Savings Program reporting requirements.
Specifically, the commenter was concerned that ACO participant
practices would think they do not need to report on the same measures
that the ACO is required to report on under the Medicare Shared Savings
Program.
Response: Policies related to eligible clinicians and groups
reporting outside of the APP are discussed in detail in section
IV.A.3.c.5 of this final rule. We note that the policy discussion above
relates to ACO participants reporting outside of the ACO via the APP
when the ACO fails to report data via the APP on behalf of its
participant TINs. Eligible clinicians participating in an ACO may
report to MIPS independently at the individual or TIN level. If ACO
participants report outside the ACO via the APP, they will be eligible
to earn full credit for improvement activities based on ACO
participation and to have the cost performance category reweighted.
However, if ACO participants report to MIPS according to traditional
MIPS rules, as a group or individual MIPS eligible clinician, MIPS
scoring rules apply. These policies are discussed in further detail in
section IV.A.3.b. of this final rule. Additionally, we refer readers to
section IV.A.3.e. of this final rule for information concerning our
final policy on the hierarchy that will apply when more than one final
score is associated with a TIN/NPI. We also refer readers to the
discussion earlier in this section where we are finalizing our proposal
that if an ACO does not report any of the three APP measures it is
required to actively report and does not field a CAHPS for MIPS survey,
the ACO would not meet the quality performance standard.
In the CY 2021 PFS proposed rule (85 FR 50232 and 50233), we
proposed that for performance year 2021 and subsequent performance
years, ACOs would be assessed on a smaller measure set under the APP
for Shared Savings Program ACOs. The measures ACOs would be scored on
would decrease from 23 measures to 6 measures and the number of
measures on which ACOs would be required to actively report would be
reduced from 10 to 3.
ACOs would report under the APP on the following 3 measures:
Quality ID#: 001: Diabetes: Hemoglobin A1c (HbA1c) Poor
Control (>9%);
Quality ID#: 134 Preventive Care and Screening: Screening
for Depression and Follow-Up Plan; and
Quality ID#: 236 Controlling High Blood Pressure.
ACOs would report these measures via a submission method of their
choice
[[Page 84726]]
that aligns with the MIPS data submission types for groups at Sec.
414.1325(c) (direct, login and upload, or a third-party intermediary,
described at Sec. 414.1400, submitting on behalf of the ACO). ACOs
would receive a score of between 3 to 10 points for each measure that
meets the data completeness and case minimum requirements, which would
be determined by comparing measure performance to established
benchmarks. In addition, ACOs would need to field a CAHPS for MIPS
survey and would be measured on two claims-based measures: The
Hospital-Wide, 30-day, All-Cause Unplanned Readmission (HWR) Rate for
the Merit-Based Incentive Payment Program (MIPS) Eligible Clinician
Groups; and the All-Cause Unplanned Admissions for Patients with
Multiple Chronic Conditions (MCC). Please see Table 36 in the CY 2021
PFS proposed rule (85 FR 50233) for full details on the measures
proposed under the APP.
The measures proposed for inclusion in the measure set for the APP
would align with the Meaningful Measures framework by identifying the
highest priorities for quality measurement and improvement with the
goals of reducing burden, promoting alignment, moving payment toward
value, and identifying key quality performance metrics for consumers.
The proposed measures would also encompass the meaningful measure
domains of patient voice, wellness and prevention, seamless
communication, chronic disease management, and behavioral health. We
explained that we believe that the measures included in the APP are
appropriate to assess the quality performance of Shared Savings Program
ACOs as they focus on the management of chronic health conditions that
are high priority and have high prevalence among the population of
Medicare beneficiaries assigned to ACOs. We also noted that we believe
that the measure set chosen for inclusion within the APP would move the
quality measure set used in the Shared Savings Program toward a more
outcome based, primary care focused measure set. In addition to
creating a pathway that would reduce reporting burden for ACOs and
allow their participating MIPS eligible clinicians to meet requirements
under MIPS through a smaller measure set, requiring ACOs to report
through the APP would also eliminate differences in the way ACOs are
scored under the Shared Savings Program, as compared to the way their
MIPS eligible clinicians are scored under MIPS.
We noted that under the current Shared Savings Program quality
scoring methodology, the CAHPS for ACOs survey is counted as ten
separate measures, while under the APP, the CAHPS for MIPS survey would
be counted as one. We explained that we continue to value the patient
voice and believe it should play a significant role in quality scoring.
Using the CAHPS for MIPS survey would achieve that goal while further
aligning the way in which the quality performance of ACOs and their
MIPS eligible clinicians is scored under the Shared Savings Program and
under MIPS, respectively. We noted that under the current Shared
Savings quality scoring methodology, the 10 CAHPS for ACOs survey
measures are scored as one domain, which makes up 25 percent of the
Shared Savings Program quality score. In contrast, under the proposed
approach, the CAHPS for MIPS survey would be counted as one measure out
of the 6 measures that would be included in the calculation of the
ACO's quality score under the APP. Both of these approaches have a
similar weighting, which would maintain the relevance of patient voice.
We also noted that we believed that the proposed approach under the APP
of combining the CAHPS survey measures into a single measure for
quality scoring purposes would allow Shared Savings Program ACOs to
effectively target resources toward improving their assigned
beneficiaries' experience of care in the areas for improvement on which
they choose to focus, rather than having to track to ten separate
survey measures, as is currently required by the CAHPS for ACOs used
under the Shared Savings Program. We believed this approach would
strike the right balance in reducing burden on ACOs and their
participating providers and suppliers while preserving the patient's
voice.
Shared Savings Program ACOs are currently required to report on a
set of ten measures via the CMS Web Interface. While these measures
were appropriate for use in the program in the past because they are
primary care focused, we explained that we now recognize that the
majority of the measures have highly clustered performance. This means
that they cannot meaningfully distinguish quality performance across
groups or ACOs. We also noted that we recognize the value in the use of
primary care-focused measures and in that developing the proposed
measure set for use under the APP, we had sought to preserve the
measures we believed most reflect high priority quality measurement
areas while also placing more emphasis on outcome-based claims
measures, which minimize reporting burden and reflect greater
opportunity for improvement.
We received many public comments on the proposed APP quality
measure set as applied to Shared Savings Program quality performance
scoring. The following is a summary of the comments we received and our
responses. Please refer to section IV.A.3.b.(3)a. of this final rule
for further discussion of comments and responses on the APP measure
set.
Comment: Many commenters were supportive of the overall goal of
simplifying reporting and aligning quality measurement approaches
across federal programs. Several commenters were supportive of the
reduction in the number of measures to reduce burden for healthcare
providers, including the reporting burden placed on rural primary care
practices. One commenter supported the proposed measure set, stating
that it was adequate to address the chronic conditions among Medicare
beneficiaries. One commenter indicated that the proposed reduced
measure set focused on clinical outcomes and patient experience and is
less burdensome for healthcare providers. One commenter supported this
proposal and specifically stated that requiring former users of the CMS
Web Interface to report all payer data will result in more patients
receiving the benefit of services captured in the quality metrics, such
as depression screening and pneumococcal vaccination status, rather
than practices focusing those wellness measures solely on Medicare
patients.
Response: We thank commenters for their positive feedback on the
proposed APP quality measure set. The reduced measure set is intended
to reduce reporting burden on ACOs and focus on quality measures that
address patient outcomes and appreciate hearing that commenters also
believe that the proposed measure set is consistent with those goals.
Comment: Several commenters were concerned that the proposed
measure set is not appropriate for healthcare providers, such as ACOs,
that are responsible for the total cost of care for the populations
they serve and will not allow for robust assessment of clinical
quality. Some commenters noted that the reduction in measures would
significantly increase the impact of each measure on an ACO's overall
quality score, which could risk over-emphasizing certain metrics and
underlying patient conditions, as well as create more disruption when
the measure set is revised. Additionally, several commenters were
concerned that reducing the quality measure set would de-emphasize
quality and would
[[Page 84727]]
not allow for a representative assessment of ACOs' quality improvement
efforts, making it more difficult for ACOs to distinguish themselves
based on the care they provide. One commenter was concerned that the
reduction in measures would limit the ability for consumers to evaluate
and compare the quality of providers. Another commenter had concerns
that reducing the number of ACO quality measures would make specialists
less likely to participate in the Shared Savings Program. Another
commenter stated that the proposed measures are not relevant to
ophthalmology specialty practices and suggested that the same measure
sets used in MIPS be permitted for reporting through the APP or a
protocol be put in place to determine if the measures are relevant to
the clinicians reporting under the APP.
One commenter expressed concern that the narrower quality measure
set would not appropriately protect patients because it would narrow
the lens through which quality is assessed. Several commenters
recommended that CMS work with stakeholders to refine the current set
of measures to make it more appropriate for ACOs, which are responsible
for total cost of care for the populations they serve. Another
commenter stated that CMS should clarify if the outcome measures
selected are representative of all of the different types of
populations that ACOs treat and recommended that CMS take patient
compliance and case mix into consideration when selecting measures
because some patients may take longer to achieve health goals and ACOs
may not have the same relative volume of patients with diagnoses such
as diabetes and hypertension. One commenter suggested that CMS
demonstrate that the proposed measures are of high significance to
beneficiaries. Due to the impacts of the PHE for COVID-19, one
commenter recommended that measures, such as breast cancer and
colorectal cancer screening, be removed or treated as pay-for-reporting
for performance year 2021.
Some commenters also expressed concern that the limited measure set
would allow little room for random variation in one measure because
random variation in one measure will have a larger impact when there
are fewer measures to absorb the impact. One commenter stated that the
limited measure set puts ACOs at a disadvantage compared to entities
that are able to report outside of the APP and who can choose from
larger pool of measures. Commenters also expressed concern that the
reduction in the number of measures was too drastic and may have
unforeseeable impacts on quality scoring for ACOs. One commenter
suggested a more gradual, phased reduction where measures would be
removed in rounds based on level of priority so that the impact of
reducing the size of the measure set could be evaluated before
additional measures are removed. Commenters also suggested that CMS
monitor the smaller measure set to ensure the measures are not overly
sensitive to minor changes in performance, random variation, or risk
adjustment methodologies.
Other commenters suggested that CMS consider a broader measure set,
and many commenters made recommendations for measures to be added to
the measure set. One commenter suggested that a larger set of quality
measures would be worth the additional burden because it would protect
ACOs against errors in scoring, changes in risk adjustment methodology,
and anomalies. Another commenter noted that while reducing the number
of measures will reduce burden, ACOs also experience administrative
burden due to year-to-year changes in the Shared Savings Program and
the lack of alignment in measures between programs.
Response: We appreciate the commenters' concerns and
recommendations regarding the narrower set of quality metrics that we
proposed for the APP and its appropriateness for assessing the quality
of care furnished by ACOs and their ACO participants. The transition to
the APP measure set is intended to reduce reporting burden and
eliminate differences in the way ACOs are scored compared to their MIPS
eligible clinicians, while also moving toward a more outcome-based,
primary care focused measure set. Additionally, we selected the
measures to be included in the measure set because they are broadly
applicable for the primary care population and population health goals
that are associated with the Shared Savings Program. These measures
align with the Meaningful Measures framework while also being
appropriate for assessing ACO quality performance as they focus on
prevalent and high priority chronic health conditions. For example,
hypertension and diabetes are chronic conditions that are applicable to
both primary care practitioners and specialists.
Comment: Several commenters expressed concern that two of the six
proposed quality measures (Measure # 479 Hospital-Wide, 30-day, All-
Cause Unplanned Readmission (HWR) Rate for MIPS Eligible Clinician
Groups and Measure # TBD Risk Standardized, All-Cause Unplanned
Admissions for Multiple Chronic Conditions for ACOs) are focused on
utilization even though the Shared Savings Program provides financial
incentives for reducing avoidable hospital admissions and readmissions.
Additionally, commenters stated that ACOs should be evaluated on
quality measures that reflect core ACO competencies, such as care
coordination activities and preventative health.
Response: Under the Shared Savings Program, an ACO that lowers
growth in Medicare Parts A and B expenditures such that performance
year expenditures for the ACO's assigned beneficiary population are
below the ACO's updated historical benchmark by an amount that meets or
exceeds the applicable minimum savings rate, may be eligible to share
in savings. We do not believe that the incentive for ACOs to lower
growth in expenditures, in order to generate shared savings, conflicts
with assessment of the quality of care furnished by an ACO that
includes measures of utilization, such as Measure # 479 Hospital-Wide,
30-day, All-Cause Unplanned Readmission (HWR) Rate for MIPS Eligible
Clinician Groups and Measure # TBD Risk Standardized, All-Cause
Unplanned Admissions for Multiple Chronic Conditions for ACOs. We note
that section 1899(b)(3)(A) of the Act requires the Secretary to
determine appropriate measures to assess the quality of care furnished
by the ACO, such as measures of clinical processes and outcomes;
patient, and, wherever practicable, caregiver experience of care; and
utilization (such as rates of hospital admission for ambulatory
sensitive conditions). Additionally, regarding the commenters' concerns
about quality measures addressing core ACO competencies, we note that
the APP measure set includes measures that address preventive health
and care coordination. For example, the All-Cause Readmission (HWR) and
All-Cause Unplanned Admissions for Multiple Chronic Condition measures
fall into the Meaningful Measure domain of Promoting Effective
Communication and Coordination of Care and the Preventive Care and
Screening: Screening for Depression and Follow up plan falls into the
Meaningful Measure domain of Promoting Effective Prevention & Treatment
of Chronic Disease.
Comment: Several commenters expressed concerns about data
collection methods in light of the increasing use of telehealth visits,
as well as the various measure types (such as eCQM/MIPS CQM measures,
CAHPS
[[Page 84728]]
for MIPS survey measures, and claims-based measures) used in the APP
measure set. Commenters recommended that the measures selected be
viewed through the lens of the current PHE environment and that all
quality measures allow data to be collected during telehealth visits
because many ACO participants have been relying on telehealth visits to
continue seeing their patients during the PHE.
Response: We understand commenters' concerns related to the PHE for
COVID-19. For the claims-based measures in the APP measure set,
telehealth codes are not used to exclude claims from the measure
calculation algorithm or the claims used to identify comorbidities as
part of the risk adjustment model. Nine out of the ten CMS Web
Interface measures, which are in the measure set for performance year
2021, allow the requirements for inclusion in the numerator to be met
during a telehealth encounter. Quality ID#: 438 is the only measure
that does not allow the quality action required to meet numerator
compliance, to occur during a telehealth encounter. Similar to the Web
Interface measures, the three eCQM/MIPS CQM measures in the APP measure
set allow the requirements for inclusion in the numerator to be met
during a telehealth encounter.
Comment: Commenters suggested that further consideration was needed
to determine the appropriate composition of the quality measure set by
measure type (that is, proportion of clinical, patient experience, and
administrative claims measures) and the appropriate balance between
clinical outcome measures and preventive care measures. One commenter
recommended that, to the extent possible, CMS make use of
administrative claims data, including CPT Category II codes, to
determine measure performance with an opportunity for ACOs to provide
supplementary data to reduce healthcare provider burden. One commenter
supported the inclusion of eCQMs because eCQMs tie the use of
technology to the Quality performance category by encouraging the
proper use of EHRs and increase the reliability of data based upon not
having human manipulation or intervention, but did not support the
inclusion of administrative claims measures, citing concerns with
reliability of the data and the cost to large practices.
Response: In response to comments on the appropriate composition of
the quality measure set by measure type (that is, proportion of
clinical, patient experience, and administrative claims measures) and
the appropriate balance between clinical outcome measures and
preventive care measures, we note that the APP measure set is intended
to assess a sample of the areas where ACOs should be focused on
improving the quality of care; it is expected that ACOs should be
working to improve quality in additional areas as well. We appreciate
the commenters' concerns regarding the use of administrative claims
measures. Administrative claims measures have historically been used
successfully to measure ACO quality performance under the Shared
Savings Program. CMS calculates the administrative claims measures for
ACOs, which minimizes the burden associated with these measures.
Comment: Commenters stated they would like to see more publicly
available comparative data on ACO performance on the core quality
measures under the Shared Savings Program, such as ACO-14, Influenza
Immunization; ACO-19, Colorectal Cancer Screening; ACO-20, Breast
Cancer Screening; and the previously used Pneumonia Vaccination
measure. The commenters asserted that ACOs cannot be fairly assessed if
they are only measured on the proposed APP measures because the
measures do not reflect the true purpose of ACOs and the work they do
in quality improvement.
Response: Each year when CMS releases the Shared Savings Program
Financial and Quality reconciliation results, Public Use files (PUFs)
are posted that provide the public with comparative data on the quality
results for a given performance year. We note that data on the measures
referenced by the commenters are publicly available in these PUF files.
We disagree with commenters that ACOs cannot be fairly assessed if they
are only measured on the measures in the APP measure set. As discussed
above, we believe that the measures in the APP measure set are broadly
applicable for the primary care population and population health goals
that are associated with the Shared Savings Program. These measures
align with the Meaningful Measures framework while also being
appropriate for assessing ACO quality performance as they focus on high
prevalence, high cost, and high priority chronic health conditions.
Comment: Several commenters expressed concern that half of an ACO's
quality score would depend on the CAHPS measure and two administrative
claims measures. One commenter asserted that these measures have
potential for unpredictability because minor differences in CAHPS
scores can cause significant variation in ACOs' overall quality scores
and there can be variance in scores on administrative claims measures
related to risk adjustment changes. These commenters also expressed
concern that CMS does not publish detailed measure specifications for
the CAHPS or administrative claims measures. One commenter was
concerned that the readmission measure would have a greater impact on
the overall quality score under our proposed changes to the quality
measure set because the commenter believes that the readmission measure
is volatile.
Response: In regard to commenters' concern that the number of CAHPS
measures is disproportionately high compared to clinical quality and
outcomes measures, we note that under the new APP, the results of the
CAHPS survey will account for a smaller proportion of ACOs' total
quality score. Under the current scoring methodology, the CAHPS
measures make up 1 domain or 25 percent of an ACO's quality score.
Under the APP for Shared Savings Program ACOs that we are finalizing in
this final rule, the results on the CAHPS measures will be combined to
calculate a single composite score that will account for one sixth of
the ACO's quality score or 16.7 percent or one tenth of the ACO's
quality score or 10.0 percent, depending on which measure set the ACO
reports on in 2021. Under both measure sets, patients' experience of
care will meaningfully contribute to the overall quality score, while
at the same time allowing other important measures of quality to also
meaningfully contribute to the overall quality score.
Comment: Some commenters expressed concern that quality measures in
the APP quality measure set have narrow performance ranges. One
commenter suggested an alternative approach to calculating the
benchmarks for quality measures that includes creating expanded
percentiles due to concern that the current percentiles result in too
narrow of a performance range where variation could be due to a small
number of events or beneficiaries.
Response: We appreciate the commenter's recommendations regarding
calculating benchmarks. We note that the seven CMS Web Interface
measures with benchmarks for performance year 2020 are flat benchmarks
that are used in accordance with Sec. 425.502(b)(2)(ii) for measures
that have clustered high performance rates. For the measures reported
under the CMS Web Interface for performance year 2021, we will continue
to use the Shared Savings Program benchmarks developed for the CMS Web
Interface for performance year 2020.
[[Page 84729]]
We believe this practice addresses commenters' concerns about
clustered performance having an adverse effect on ACOs' performance on
the web interface measures. We refer readers to the MIPS benchmarking
policy as defined at Sec. 414.1380(b)(1)(ii), topped out measure
scoring as defined at Sec. 414.1380(b)(1)(iv), and flat percentage
benchmark policy as defined at Sec. 414.1380(b)(1)(ii)(C).
Comment: Several commenters suggested that CMS conduct further
testing for risk adjustment of outcome measures, including social risk
factors. These commenters requested CMS test the measures to ensure
that minor changes to the risk adjustment methodology did not have
significant impacts on the ACOs' quality scores. One commenter
suggested that CMS enhance the risk adjustment of the outcome measures
to address the high-risk patient populations of ACOs. Another commenter
expressed concern that CMS should not include measures in the quality
measure set used to assess ACO quality performance until they have been
appropriately risk adjusted for sociodemographic factors, including
socioeconomic status. The commenter explained that without appropriate
risk adjustment for outcomes measures, such as the proposed readmission
measure, the APP measure set could disproportionately impact the
quality performance of ACOs that have an assigned beneficiary
population served by ``essential hospitals''.
Response: Both of the proposed claims-based measures are risk-
adjusted with beneficiary demographic characteristics and a wide range
of clinical comorbidities to improve comparison of measure performance
between organizations. These measures use a large number of
Hierarchical Condition Category (HCC) comorbidity categories that
account for many high-risk conditions among beneficiaries, which helps
to adjust for differences in patient populations between ACOs. Risk
adjusting in this manner is in accordance with best practices for risk
adjustment to account for the higher level of risk for certain
beneficiaries. We also note that the revised MCC measure has an
additional risk adjustment not present in the original MCC measure that
is in the current Shared Savings Program measure set. The revised
measure adjusts for two area level social risk factors: (1) AHRQ socio-
economic status (SES) index; and (2) specialist density. The original
MCC measure does not contain any social risk factors in the risk
adjustment.
We received several comments regarding the feasibility of using the
alternative MIPS reporting options for purposes of quality reporting
under the Shared Savings Program, which are summarized below.
Comment: Several commenters requested clarification of whether ACOs
would report quality data for all patients regardless of attribution or
payer status. Additionally, commenters explained that ACOs often
operate using multiple EHR systems and requested clarification of
whether ACOs would report separately for each EHR system. Several
commenters expressed concern that using the alternative MIPS reporting
options would result in ACOs being evaluated on the quality of the care
furnished to all of the patients they serve. These commenters were
concerned that this data would not be a true reflection of an ACO's
quality improvement efforts and objected that it would not be fair to
measure ACO quality based on non-attributed patients. Commenters also
expressed concern that ACOs may not have the legal ability to access
data for patients that are not attributed to the ACO, which may skew
any assessment of quality. Additionally, one commenter noted that the
differences between community health center populations and private
practice populations would be magnified by the requirement to report on
all patients served and that unlike the administrative claims measures
that use HCC risk adjustment, the three clinical quality measures do
not have similar adjustments. The commenter recommended that ``CMS use
the same eligibility category definitions used in cost calculations for
peer groups that can be assumed to carry forward to the entire patient
population.'' The commenter also recommended that CMS further consider
whether reporting for all patients will improve or worsen disparities
and urged CMS to seek to incentivize improvement of disparities between
patients served by community health centers and private practices
through clinical quality and claims based measurement and benchmarking.
Another commenter noted that current measure specifications would
result in patients being eligible for measure denominators regardless
of provider specialty designation and recommended that CMS incorporate
logic into the measures to require a qualifying visit with a primary
care provider. This commenter also recommended that CMS modify the
reporting requirements for the eCQM/MIPS CQM measures to exclude
patients who are not assigned to the ACO for purposes of reporting
under the Medicare Shared Savings Program. The commenter explained that
if reporting on the measures is not limited to the ACO's assigned
beneficiary population, ACOs that include an Academic Medical Center
(AMC) could be particularly negatively impacted because AMCs often care
for patients who have primary care providers in other states and
patients that are seen for short term destination services.
Some commenters expressed concern that vendors and developers would
require additional lead time to update and test systems, configure
tools and measurement algorithms to aggregate data at an ACO level, and
handle the wave of new entities reporting using eCQMs/MIPS CQMs.
Several commenters also noted that some ACOs would need to revise
vendor participation agreements and contracts to allow them to access
and report on data across all patients served by their ACO
participants, which may cause further delays. Additionally, commenters
also expressed concern that measure results may be unreliable due to
vendors interpreting measure specifications differently.
Although some commenters acknowledged that ACOs would be reporting
fewer quality metrics under the proposed APP, these commenters believe
the proposal would increase reporting burden because ACOs would be
required to report on a larger pool of patients and to become familiar
with new data collection and reporting mechanisms. The commenters
recommended that if we were to finalize the proposed eCQM/MIPS CQM
measures, ACOs should be required to report on a sample population or a
maximum of 50 percent of ACO beneficiaries. Alternatively, one
commenter suggested that instead of ACOs being responsible for
aggregating data for the eCQM/MIPS CQM measures included in the APP to
create an ACO-wide score, CMS should be responsible for aggregating
data on behalf of the ACO. The commenter stated that this process would
reduce burden on the ACOs. Other commenters suggested that ACOs should
only be required to report eCQMs for assigned beneficiaries while ACOs
are transitioning away from the CMS Web Interface reporting mechanism
and that CMS should work with industry leaders to create QRDA III
aggregate TIN level reporting for assigned beneficiaries so that each
ACO Participant TIN could submit the QRDA III file via the QPP website
and CMS would calculate performance scores for the ACO. Additionally,
commenters suggested that some ACOs may not have the time or financial
capacity to explore other data collection and reporting mechanism
workflows, especially due
[[Page 84730]]
to constraints caused by the PHE for COVID-19. For example, commenters
explained that some ACOs would need to pay fees to modify EHRs, obtain
new EHR interfaces and aggregation tools, update performance
dashboards, and potentially work with a registry, and that these costs
could pose a significant hardship for smaller ACOs.
Response: We acknowledge the concerns raised by the commenters
about the change to reporting eCQMs/CQM MIPS measures, the need for
time to transition to this new data collection format and collecting
data on all-payer data and the time needed to set up new
infrastructures for submitting this data to CMS. The CMS Quality
Measurement Strategy is continuing to drive towards patient-centered,
value-based care through the development, selection, and implementation
of measurement that includes accelerating the move to digital measures,
promoting the use of all payer data, increasing alignment of measures,
and unleashing the voice of the patient through the use of patient
reported outcomes. The APP measures include all-payer, patient-centric,
and population-based outcome measures that are designed to promote the
goals of the CMS Quality Measurement Strategy and align with the
Meaningful Measures framework.
While the three eCQM/MIPS CQM measures are based on all payer data,
we believe they are appropriate for assessing the quality of care
furnished by the ACO as required by section 1899(b)(3) of the Act.
These measures focus on the management of chronic health conditions
that are a high priority and have high prevalence among Medicare
beneficiaries. To the extent that these conditions are also prevalent
among other populations of patients that receive services from the
eligible clinicians participating in an ACO, we believe it is relevant
to consider the quality of care that is furnished by ACO participants
across all of their patients as part of assessing the overall quality
of care furnished by the ACO. We also note that measuring care delivery
to all patients is appropriate because improving care processes and
practices is expected to improve care for all patients (for example,
improvements to an electronic health record would be expected to
improve care for all patients, not just Medicare patients).
Additionally, CMS would not want ACOs participating in the Shared
Savings Program to improve care for Medicare beneficiaries by reducing
care quality for non-Medicare beneficiaries. Thus looking at the
overall quality of care furnished to all patients is consistent with
the goal of improving care furnished by ACOs by ensuring that care
delivery is improving across all patients, rather than encouraging ACOs
to focus disproportionately on improving measure performance for
Medicare beneficiaries.
In addition, we believe the use of all-payer measures will provide
an additional incentive for ACO participants to standardize care
processes across all of their patient populations, which should improve
the quality of care for all patients, including the ACO's assigned
Medicare beneficiaries, while also making it easier to capture and
report required data because ACOs would only need to capture and report
one set of quality metrics to satisfy the reporting requirements under
both MIPS and the Shared Savings Program.
With regard to concerns about reporting the three eCQM/CQM
measures, ACOs will need to determine which collection type, either
eCQM specifications captured via an EHR or MIPS CQM specifications
intended to be used by groups or ACOs submitting measures via qualified
registry, they will use to collect and report quality measure data. The
ACO will report data in the aggregate on behalf of its ACO participants
using the relevant measure specifications and could submit data via the
following MIPS submission types using either direct login, such as
application program interface or API, or sign in and upload. For
example, the ACO could, on behalf of its ACO participants combine the
results from all the ACO participant TIN QRDA 3 files, by adding
numerators, denominators, etc. and create an aggregate QRDA3 file (or
other compliant file format) and submit as an ACO to CMS. ACOs could
also contract with a third party intermediary (such as a registry) to
submit data on behalf of the ACO. We acknowledge commenters' concerns
about the time needed to set up new infrastructures to report all-payer
data; therefore, we are finalizing a phase-in approach to the quality
reporting requirements under the Shared Savings Program. For
performance year 2021, ACOs can opt to report 10 measures via the CMS
Web Interface or the three eCQM/CQM measures as part of the APP. If an
ACO opts to report via the CMS Web Interface, the requirements for
which patients must be included for purposes of quality reporting would
remain unchanged, ACOs would report on the provided beneficiary sample.
As discussed earlier in this section, in order to meet the quality
reporting requirements under the Shared Savings Program and the MIPS,
ACOs must meet the following requirements:
For performance year 2021, ACOs will be required to report
quality data via the APP, and an ACO can choose to actively report
either the 10 measures under the CMS Web Interface or the 3 eCQM/MIPS
CQM measures. In addition, ACOs will be required to field the CAHPS for
MIPS survey, and CMS will calculate 2 measures using administrative
claims data.
For performance year 2022 and subsequent performance
years, ACOs will be required to actively report quality data on the 3
eCQM/MIPS CQM measures via the APP. In addition, ACOs will be required
to field the CAHPS for MIPS survey, and CMS will calculate two measures
using administrative claims data.
As discussed in section III.G.1.c. of this final rule, we are also
finalizing policies to phase-in the increase in the quality performance
standard over 3 years. We believe that the phase-in policies for
applying the APP to Shared Savings Program ACOs and increasing the
quality performance standard address the concerns raised by the
commenters regarding the proposed timeline for implementing APP and the
challenges of reporting on the measures in the APP measure set. The
quality reporting requirements described above will provide ACOs with a
one-year transition period during performance year 2021 in which they
will have the option either to continue to report via the CMS Web
Interface or to report on the 3 eCQM/CQM MIPS measures before being
required to report on the 3 eCQM/MIPS CQM measures beginning in
performance year 2022. This transition period, coupled with the phase-
in of the new quality performance standard discussed earlier in this
section, will provide ACOs with additional time to set up their systems
and educate providers and office staff in order to be prepared report
on the 3 eCQM/MIPS CQM measures beginning in performance year 2022 and
will also allow ACOs to become familiar with the new quality reporting
requirements under the APP and gain experience reporting on the new
measures before they are assessed under the higher quality performance
standard beginning in performance year 2023.
We received comments on the individual measures in the proposed
measure set, which are summarized below.
Comment: We received several comments related to the proposal to
include the CAHPS for MIPS measure in the APP for Shared Savings
Program ACOs. One commenter noted support for the measures included in
the CAHPS for MIPS. Several commenters
[[Page 84731]]
expressed concerns related to the CAHPS for MIPS measure. Specifically,
the commenters noted that for this measure, small differences in
quality can result in large quality score differences. The commenters
stated that these differences are not meaningful and recommended that
CMS work with stakeholders to improve the measure specifications before
this measure is used as part of a limited quality measure set.
Additionally, commenters were concerned that CMS has not detailed how
the single composite CAHPS measure score will be calculated and were
concerned with how the CAHPS measures are collected. Specifically,
several commenters were concerned that the CAHPS measures use a small
patient sample and rely on patients to recollect experiences that took
place months before. One commenter had concerns about the small sample
size for the CAHPS survey, citing previous experience with anomalies
and unpredictable measure adjustments. Another commenter was concerned
that the CAHPS sample size is the same for all ACOs regardless of ACO
size; sampled patients do not represent the full population that ACOs
serve; healthcare providers cannot provide supplemental information,
such as more accurate contact information, in an effort to reach more
patients; and surveys are only administered once annually with results
received midway through the following performance year. Commenters
recommended that CMS release additional information regarding how the
CAHPS measure score will be calculated as soon as possible and
recommended that CMS consider using a larger sample and modify the
survey so that it is shorter and takes place closer in time to the care
that beneficiaries are asked to assess.
Another commenter expressed concern that survey fatigue among
patients was leading to declining survey response rates. The commenter
recommended that CMS allow providers to use surveys already in place
rather than requiring administration of an additional CAHPS for MIPS
survey. Another commenter expressed concern over the subjective nature
of the survey leading to significant variation in scores over time.
Another commenter noted that the methodology of the CAHPS for MIPS and
CAHPS for ACO surveys differ, with the CAHPS for MIPS survey having
minimum survey size requirements as a function of the Taxpayer
Identification Number (TIN) and the CAHPS for ACOs survey having
minimum survey size requirements as a function of the ACO. The
commenter requested that CMS be explicit if it intends to make any
changes in the survey methodology with this proposal because shifting
the survey size requirement to be based on TINs rather than the ACO as
a whole will result in substantial financial burden to ACOs.
Response: We appreciate the commenters' concerns and
recommendations regarding the CAHPS for MIPS measure. The CAHPS for
MIPS survey uses the same survey instrument to assess the same patient
experience domains as the CAHPS for ACO survey that is currently
successfully used to measure ACO quality. The same shortened,
streamlined version of the survey was implemented for both CAHPS for
ACOs and CAHPS for MIPS in 2018, reflecting efforts by CMS to reduce
the number of questions. We conducted analyses to assess the impact of
aligning CAHPS scoring and benchmarking using 2019 CAHPS for ACOs and
CAHPS for MIPS survey data. In 2019, the two programs used identical
survey instruments. Analyses examined the impact of alignment on SSM
scores, benchmarks, and quality points by comparing newly calculated
SSM scores, benchmarks and quality points under the aligned approach to
the official SSM scores, benchmarks, and quality points calculated
under the original 2019 approach. The results of these analyses
indicate that scoring ACOs using the MIPS methodology resulted in ACOs
having a similar distribution of quality points as MIPS groups, which
is wider than the distribution of quality points using the ACO scoring
methodology. The wider score distribution is largely due to the
differences across the two programs in the approach to benchmarking;
CAHPS for ACOs uses flat percentage benchmarks for summary survey
measures for which the 60th percentile of scores is greater than or
equal to 80, or for which the 90th percentile of scores is greater than
or equal to 95. CAHPS for MIPS does not use a flat percentage approach.
While the shift away from flat percentage benchmarks may have the
effect of creating larger differences in quality scores across Shared
Savings Program ACOs, we believe that the scores will better reflect
small differences in quality performance and will support the goal to
improve the Shared Savings Program quality standard over time.
Beneficiaries assigned to an ACO or MIPS group, who are eligible
for the CAHPS for MIPS or CAHPS for ACOs survey, are randomly selected
for inclusion in the sample. Each ACO or MIPS group sample is therefore
representative of the ACO or group population. Sample size requirements
for both CAHPS for MIPS and CAHPS for ACOs were established using the
results of analyses that sought to establish measures that allowed for
meaningful comparisons to be made across ACOs and MIPS groups. Samples
are drawn at the ACO level for CAHPS for ACOs, and at the MIPS group
TIN level for groups. Target samples for all participating ACOs,
groups, and virtual groups is 860; for ACOs, groups, and virtual groups
with 860 or more survey-eligible patients, a random sample of 860
patients is drawn. In addition, groups and virtual groups with fewer
than 860 survey-eligible patients are eligible to participate if they
meet the following minimum sampling thresholds: Large groups or virtual
groups with 100 or more eligible clinicians: 416 eligible patients;
medium groups or virtual groups with 25-99 eligible clinicians: 255
eligible patients; and small groups or virtual groups with 2-24
eligible clinicians: 125 eligible patients. CMS will continue to draw
the CAHPS survey samples for Shared Savings Program ACOs administering
the CAHPS for MIPS survey at the Shared Savings Program ACO level, with
a target sample size of 860 going forward.
Both surveys ask respondents to provide responses about their
experiences of primary care during the previous 6 months. This look
back period is used across many CAHPS survey efforts and enables a
beneficiary to reflect on multiple care experiences with the focal
provider named on the survey. While response rates have declined over
time, the CAHPS for MIPS and CAHPS for ACOs surveys still reliably
capture important information about the quality of care from patients'
perspective, which are not captured via other data sources such as
administrative claims data. We refer readers to section IV.A.3.b.3.a.
of this final rule for additional details on the CAHPS for MIPS
measure. With the alignment of CAHPS for ACOs with CAHPS for MIPS, the
benchmarking and scoring methodology used for CAHPS for MIPS will be
used. A single set of benchmarks will be calculated using data from all
applicable CAHPS for MIPS reporters. The CAHPS for MIPS survey is
scored as one quality measure, which is a different scoring approach
from the current SSP quality scoring methodology that scores the ten
CAHPS for ACOs summary survey measures in one patient/caregiver
experience quality domain. As described in the CY 2017 Quality Payment
Program final rule, each summary survey measure (SSM)
[[Page 84732]]
will have an individual benchmark and each SSM will be scored
individually and compared against the benchmark to establish the number
of points earned. The CAHPS score will be the average number of points
across SSMs (81 FR 77284).
We received comments on the Hospital-Wide, 30-day, All-Cause
Unplanned Readmission (HWR) Rate for MIPS Eligible Clinician Groups
measure, which are summarized below.
Comment: Several commenters expressed concerns related to the
Hospital-Wide, 30-day, All-Cause Unplanned Readmission (HWR) Rate for
MIPS Eligible Clinician Groups measure. One commenter did not support
this measure. Another commenter recommended that CMS consider NCQA's
Plan All-Cause Readmission (PCR) measure instead because health plans
use the PCR measure more widely as it is an NCQA accreditation
requirement and the PCR measure is more robust and broader than the HWR
measure because it includes patients 18 and older, while the HWR
measure only includes patients 65 and older. Another commenter was
concerned that the measure was sensitive to risk adjustment and has a
narrow range, which negatively impacts ``community health center
ACOs''. Another commenter noted that readmissions are low volume and
can be influenced by factors outside the control of healthcare
providers. Additionally, the commenter explained that an unintended
consequence can occur when an ACO's base number of admissions is low
compared to other ACOs with high numbers of admissions because it
increases the sensitivity of this measure. This commenter suggested
that CMS consider the Ambulatory Sensitive Condition Acute Composite
measure instead. Other commenters noted that for this measure, small
differences in performance can result in large quality score
differences. The commenters stated that these differences in
performance are not meaningful and recommended that CMS work with
stakeholders to improve the measure specifications before this measure
is used as part of a limited quality measure set. One commenter noted
concerns about unintended consequences due to the measure not
adequately considering the competing risk of mortality. This commenter
suggested using an alternative measure, such as risk-adjusted home
time.
Response: The proposed Hospital-Wide, 30-day, All-Cause Unplanned
Readmission (HWR) Rate for MIPS Eligible Clinician Groups measure is a
re-specified version of NQF #1789 (Hospital-Wide All-Cause Unplanned
Readmission Measure), and an adapted version of NQF #1789 that is
currently being used successfully to assess ACO quality performance
(ACO-8: Risk-standardized, All Condition Readmission (ACR)). We note
that the MIPS HWR is clinically aligned to the ACO ACR measure, with
the same cohort inclusion and exclusion criteria, outcome, measurement
period, and risk adjustment variables, but the attribution and risk-
standardized readmission rate calculation methodologies differ between
the two measures. The ACO ACR measure attributes beneficiaries to ACOs
prior to measurement, whereas the MIPS HWR measure is attributed to
three clinician groups--primary inpatient provider, discharge
clinician, and primary outpatient provider--based on measure
specifications and care utilization data. In addition, the ACO ACR uses
hierarchical logistic regression modeling to calculate risk adjustment
while the MIPS HWR cannot use hierarchical logistic regression modeling
because of attribution to multiple providers.
We believe that this re-specified version of NQF #1789 will provide
a meaningful assessment of ACO quality performance. We will use the
MIPS HWR three clinician group attribution method to attribute episodes
at the ACO level. However, we will monitor and evaluate the ACOs'
performance on the MIPS HWR measure to ensure compatibility including
evaluating attribution at the ACO level, as well as refinements to risk
adjustment and risk stratification and may revisit the decision to
include this measure in the APP measure set for Shared Savings Program
ACOs in future rulemaking. Both the MIPS HWR and ACO ACR measures will
undergo the NQF endorsement/re-endorsement process during 2021, and we
welcome stakeholder feedback on these measures.
We received comments on the three eCQM/CQM MIPS measures and the
Risk Standardized, All-Cause Unplanned Admissions for Multiple Chronic
Conditions for ACOs measure. These comments are summarized and
responded to in section IV.A.3.B. of this final rule.
Table 40 lists the measures included in the final APP measure set.
[[Page 84733]]
[GRAPHIC] [TIFF OMITTED] TR28DE20.085
In the CY 2021 PFS proposed rule (85 FR 50234), we noted that in
addition to the measures included in the proposed APP measure set,
based on recommendations from MedPAC in its 2015 Report to Congress:
Medicare and the Health Care Delivery System,\56\ we were considering
adding a ``Days at Home'' measure that is currently under development,
to the APP core measure set in future years, once it has been through
the MAP pre-rulemaking process. We explained that any future additions
to the measure set, including to add a ``Days at Home'' measure would
be proposed and finalized through notice and comment rulemaking.
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\56\ http://medpac.gov/docs/default-source/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf.
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While CMS is not proposing to incorporate a ``Days at Home''
measure at this time, we received several public comments and
recommendations about this measure. We greatly appreciate the
commenters' views on a ``Days at Home'' measure, and we will take this
feedback into consideration as this measure is developed and considered
during future rulemaking cycles.
In addition, in the CY 2021 PFS proposed rule (85 FR 50234), we
noted that we have received feedback from a few ACOs, including ACOs
that have a significant number of beneficiaries in long-term care
facilities or who are chronically ill or high-risk home bound
[[Page 84734]]
patients, that the measures ACOs are required to report are not always
applicable to their patient population. Although we proposed to require
ACOs to report via the APP, we also sought comment on an alternative
approach that could be used in the event the three measures ACOs are
required to actively report on are not applicable to their beneficiary
population and there are more appropriate measure available under MIPS.
Under this alternate approach, ACOs could opt out of the APP and report
to MIPS as an APM entity. If the ACO decides to report as an APM entity
to MIPS outside of the APP, CAHPS for MIPS would become optional;
however, the ACO would be required to report PI and IA and would also
be subject to cost under MIPS. In the event an ACO decides to report as
an APM entity to MIPS outside the APP, we would use the ACO's MIPS
Quality performance category score to determine if the ACO met the
Shared Savings Program quality performance standard.
We sought comment on this alternative reporting approach for ACOs
in the event the three measures ACOs are required to actively report
are not applicable to their beneficiary population.
The following is a summary of the comments we received on this
alternative approach and our response.
Comment: One commenter supported this approach as it would allow
more flexibility for clinicians to be recognized for the work they are
doing inside and outside the context of an ACO. A few commenters stated
that they believed all three eCQM/MIPS CQM measures were applicable to
all ACOs and expressed concerns that allowing some ACOs to report under
this alternative approach would make program evaluation challenging and
would not allow for a fair assessment of quality across ACOs because
certain organizations would have the opportunity to select measures for
which they have the highest historical performance.
Response: We appreciate the commenter's feedback on the alternate
approach and CMS will consider the commenters' feedback as part of the
development of any future policies in connection with this alternative
approach.
c. Shared Savings Program Quality Performance Standard
The quality performance standard is the minimum performance level
ACOs must achieve in order to share in any savings earned, avoid
maximum shared losses under certain payment tracks, and avoid quality-
related compliance actions. We proposed to increase the level of
quality performance that would be required for all ACOs to meet the
Shared Savings Program quality performance standard. As discussed in
the CY 2021 PFS proposed rule (85 FR 50234), we explained that we
believed the proposed changes would simplify the Shared Savings Program
quality performance standard and were also consistent with the
statutory requirement that we seek to improve the quality of care
furnished by ACOs over time by specifying higher standards, new
measures or both (section 1899(b)(3)(C) of the Act). We proposed to
increase the quality performance standard for all ACOs to achievement
of a quality performance score equivalent to the 40th percentile or
above across all MIPS Quality performance category scores, excluding
entities/providers eligible for facility-based scoring. We proposed to
exclude entities/providers eligible for facility-based scoring from the
overall MIPS quality score because facility-based scoring is determined
using the Hospital Value Based Purchasing (HVBP) Total Performance
Score (TPS), which includes quality and cost.
Given that the statute requires that we seek to increase the
quality performance standard over time, we explained our belief that
changing the quality performance standard from the 30th percentile on
one measure in each domain to a requirement that ACOs achieve a quality
performance score equivalent to the 40th percentile or above across all
MIPS Quality performance category scores, excluding entities/providers
eligible for facility-based scoring, would be the next incremental step
in increasing the quality performance standard. In the CY 2021 PFS
proposed rule, we summarized the quality performance results for ACOs
participating in the program in performance year 2018. Since the
proposed rule was issued, we now have updated 2019 results. Under the
current Shared Savings Program quality measurement methodology, 98.71
percent or 534 ACOs participating in the program in 2019 met the
quality performance standard of complete and accurate reporting for
ACOs in the first year of their first agreement period or the 30th
percentile on one measure in each domain, for ACOs in their second or
subsequent years of participation in the program. Of these ACOs, 497
were ACOs in second or subsequent years of participation in the program
for which most quality measures were scored as pay-for-performance
(P4P).
As discussed in the CY 2021 PFS proposed rule (85 FR 50234),
eligible clinicians participating in Shared Savings Program ACOs who
obtain QP status would continue to be exempt from MIPS, and therefore,
would not be subject to MIPS payment adjustments. ACOs participating in
a track (or payment model within a track) that is an Advanced APM may
elect to report on behalf of their eligible clinicians who do not meet
the threshold to earn QP status but do meet the lower payment or
patient count threshold to achieve Partial QP status, and these Partial
QPs would be subject to a MIPS payment adjustment. Conversely, if an
ACO does not elect to report for the Partial QPs, they would not
receive a MIPS score or payment adjustment and would have no reporting
responsibilities for MIPS. We also explained that utilizing the MIPS
Quality performance category scoring methodology to assess the quality
performance for purposes of the Shared Savings Program of ACOs
participating in tracks (or payment models within a track) that qualify
as an Advanced APM would not change whether the eligible clinicians
participating in the ACO obtain QP status and are excluded from MIPS,
nor would it change the eligible clinicians' eligibility to receive
Advanced APM incentive payments.
We received public comments on the proposal to revise the Shared
Savings Program quality performance standard. The following is a
summary of the comments we received and our responses.
Comment: We received several comments in support of increasing the
quality performance standard to the 40th percentile of MIPS Quality
performance category scores, all noting that the proposal aligned with
CMS' goal of improving quality and reducing cost. We also received many
comments opposing the overall approach of changing the quality
performance standard to the 40th percentile of all MIPS Quality
Performance Category Scores. Several commenters noted the potential
uncertainty that ACOs would experience because they would not have a
clear indication ahead of the performance year of what standards need
to be met to be eligible to receive shared savings. Commenters
suggested that CMS set a threshold for the number of measures that must
meet the 40th percentile benchmark of at least 50 percent of all
measures. Other commenters suggested that the quality performance
standard should remain at the current level to allow more time for ACOs
to familiarize the new reporting requirements under the APP. One
commenter suggested that the MIPS scoring methodology is flawed and
introducing a change in the quality performance standard now would
cause
[[Page 84735]]
instability in the Shared Savings Program. One commenter expressed
concerns over ACOs' abilities to meet thresholds on certain measures.
One commenter noted that moving the quality performance standard to the
40th percentile would pose difficulties for organizations struggling
with the readmission and unplanned admission for multiple chronic
condition metrics. One commenter noted that the threshold change is
drastic and also noted that with CAHPS data supplied only at the ACO
level, not at the individual TIN level, it is hard to provide feedback
to each participant TIN, and with ACOs trying to handle the current
pandemic, it is difficult to influence performance in this area. In
addition, several commenters expressed concerns over the potential
impact of the pandemic and other natural disasters on quality
performance and the uncertainty ACOs could face and suggested the
implementation of a new quality performance standard should be delayed.
Commenters expressed concern over the limited time to gain familiarity
with the new requirements and difficulty meeting this new quality
performance standard for certain measures. Several commenters expressed
concerns regarding the shift from a domain-based scoring approach to
the proposed approach of requiring an ACO to achieve an overall quality
score equivalent to the 40th percentile of all MIPS quality performance
category scores. One commenter expressed concerns that such a scoring
approach would have major financial implications for the sustainability
of the Shared Savings Program as financial implications for ACOs are
much higher than MIPS participants.
Response: We appreciate the commenters' feedback on our proposal to
revise the Shared Savings Program quality performance standard. In
light of the concerns raised by the commenters, we are finalizing a
modified version of our original proposal to allow for a gradual phase-
in of the increase in the level of quality performance that would be
required for all ACOs to meet the Shared Savings Program quality
performance standard. Specifically, we are finalizing that an ACO would
meet the quality performance standard if:
For performance years 2021 and 2022, the ACO achieves a
quality performance score that is equivalent to or higher than the 30th
percentile across all MIPS Quality performance category scores; and
For performance year 2023 and subsequent performance
years, the ACO achieves a quality performance score that is equivalent
to or higher than the 40th percentile across all MIPS Quality
performance category scores.
Achieving the applicable quality performance standard for a
performance year will enable the ACO to share in the maximum amount of
savings based on their Track, avoid maximum shared losses under certain
payment tracks, and avoid quality-related compliance actions for that
performance year.
These policies are summarized in Table 39 in this final rule. The
impact on shared savings payments as a result of these final policies
is described in section VIII.H.7.a. of this final rule. We are also
finalizing our proposal to exclude entities/providers eligible for
facility-based scoring from the determination of the overall MIPS
Quality performance category score because facility-based scoring is
determined using the Hospital Value Based Purchasing (HVBP) Total
Performance Score (TPS), which includes quality and cost.
We believe that this phase-in of the quality performance standard,
coupled with our decision to phase-in the reporting requirements under
the APP for Shared Savings Program ACOs, as described in section
III.G.1.b.(1). of this final rule, will alleviate many of the concerns
raised by the commenters, especially those related to the PHE for
COVID-19 and other natural disasters in 2020. We will monitor ACO
performance under the new quality reporting requirements to determine
the impact of this measured increase to the quality performance
standard and may revisit this policy in future rulemaking if necessary
to promote an attainable quality performance standard and degree of
improvement. With respect to the concerns raised by commenters
regarding the limited time to gain familiarity with the new
requirements, the phase-in policies will give ACOs additional time to
set up their systems to report all payer data on the three eCQM/MIPS
CQM measures under the APP. The phase-in will also allow ACOs
additional time to become familiar with the new quality reporting
requirements and gain experience reporting on the new measures under
the APP before they are assessed under the increased quality
performance standard beginning in performance year 2023. We note that
the quality performance standard that we are adopting for performance
years 2021 and 2022 is analogous to the current quality performance
standard, under which ACOs are required to achieve the 30th percentile
on one measure in each domain. Therefore, we believe that this approach
to phasing in the new, higher quality performance standard is
consistent with the statutory requirement in section 1899(b)(3)(C) of
the Act that we seek to increase the quality of care furnished by ACOs
over time. We also note that ACOs will not be required to meet the 30th
or 40th percentile (depending on the performance year) for all measures
reported under the APP in order to meet the quality performance
standard. If an ACO performs poorly on one measure under the APP, the
ACO may still be able to meet the quality performance standard based on
its performance across the remainder of the measures set. For
commenters that expressed concern that ACOs would not have an
indication prior to the start of the performance year of what standards
would need to be met to be eligible to receive shared savings, we note
that, as discussed in section IV.A.3.d.(1)b.ii. of this final rule, we
are not finalizing the proposal to use performance period year
benchmarks and instead will continue to use historical benchmarks for
quality measures for the CY 2021 MIPS performance period.
Comment: We received several comments related to how the quality
performance standard would be assessed and applied. One commenter
expressed uncertainty about whether CMS would assess the quality
performance standard based on the aggregate score on all quality
measures or require a 40th percentile score on each individual measure.
Other commenters noted that they were uncertain if the quality
performance standard was meant to apply across all domains in the
aggregate, or across each individual domain at the 40th percentile.
Response: Under the phase-in we are adopting in this final rule, an
ACO's quality performance score must be equivalent to or higher than
the 30th or 40th percentile (depending on the performance year) across
all MIPS Quality performance category scores in order to meet the
quality performance standard. ACOs will not be required to achieve a
performance score that is equivalent to or higher than the 30th or the
40th percentile (depending on the performance year) on each individual
measure in order to meet the quality performance standard. We are also
clarifying that each ACO's quality performance score will be calculated
using the ACO's performance on the measures reported under the APP, any
applicable MIPS bonus points, and quality improvement points. Please
refer to section IV.A.3.b. of this final rule for information on
scoring under the APP. Unlike the scoring methodology currently used in
the Shared Savings Program, there are no quality domains
[[Page 84736]]
under the APP; rather, each measure will be weighted equally.
In the CY 2021 PFS proposed rule (85 FR 50234 and 50235), we
proposed to specify in a new section of the Shared Savings Program
regulations at Sec. 425.510, policies governing the application of the
APP to Shared Savings Program ACOs for performance years beginning on
or after January 1, 2021. As proposed, this new section would include a
general provision specifying that CMS establishes quality performance
measures to assess the quality of care furnished by the ACO. If the ACO
demonstrates to CMS that it has satisfied the quality performance
requirements, and meets all other applicable requirements, the ACO is
eligible to receive shared savings. We proposed that this general
provision would also indicate that CMS seeks to improve the quality of
care furnished by ACOs over time by specifying higher standards, new
measures, or both. In the proposed new section, we also specified the
requirement that ACOs must report quality data via the APP established
under Sec. 414.1367 according to the method of submission established
by CMS, and that CMS retains the right to audit and validate quality
data reported by an ACO according to Sec. 414.1390.
We did not receive any public comments on the proposed regulation
at Sec. 425.510. We are finalizing Sec. 425.510 as proposed.
We also proposed to specify in a new section of the Shared Savings
Program regulations at Sec. 425.512 provisions for determining the ACO
quality performance standard for performance years beginning on or
after January 1, 2021. We proposed to specify that the quality
performance standard is the overall standard the ACO must meet in order
to be eligible to receive shared savings for a performance year, and
that an ACO will not qualify to share in savings in any year it fails
to meet the quality performance standard. Further, we proposed to
specify that for all ACOs, CMS designates the quality performance
standard as the ACO reporting quality data via the APP established
under Sec. 414.1367, according to the method of submission established
by CMS and achieving a quality performance score that is equivalent to
or higher than the 40th percentile across all MIPS Quality performance
category scores, excluding entities/providers eligible for facility-
based scoring. In addition, we proposed to specify that if an ACO does
not report any of the three measures ACOs are actively required to
report and does not field a CAHPS survey, the ACO would not meet the
quality performance standard.
We did not receive any public comments on the proposed regulation
at Sec. 425.512. However, as a result of our decision to modify our
original proposal to provide for a phase-in of the new quality
reporting requirements under the APP for Shared Savings Program ACOs,
as described in section III.G.1.b.1. of this final rule, and the
increase in the quality performance standard, as described earlier in
this section, we are finalizing the proposed regulations at Sec.
425.512 with modifications, as described below.
Revising Sec. 425.512(a)(3) to provide that:
For performance years 2021 and 2022. CMS designates the
quality performance standard for all ACOs, with the exception of ACOs
in the first performance year of their first agreement period, as the
ACO reporting quality data via the APP established under Sec.
414.1367, according to the method of submission established by CMS and
achieving a quality performance score that is equivalent to or higher
than the 30th percentile across all MIPS Quality performance category
scores, excluding entities/providers eligible for facility-based
scoring.
For performance year 2021. If an ACO does not report any
of the ten CMS Web Interface measures or any of the three measures it
is actively required to report and does not field a CAHPS for MIPS
survey via the APP, the ACO will not meet the quality performance
standard.