Proposed Rule2021-14973
Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements.
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 23, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This major proposed rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare provider enrollment policies; requirements for prepayment and post-payment medical review activities; requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan, or a Medicare Advantage Prescription Drug (MA- PD) plan; updates to the Medicare Ground Ambulance Data Collection System; changes to the Medicare Diabetes Prevention Program (MDPP) expanded model; and amendments to the physician self-referral law regulations.
Full Text
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[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Proposed Rules]
[Pages 39104-39907]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14973]
[[Page 39103]]
Vol. 86
Friday,
No. 139
July 23, 2021
Part II
Book 2 of 2 Books
Pages 39103-39938
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 403, 405, et al.
Medicare Program; CY 2022 Payment Policies Under the Physician Fee
Schedule and Other Changes to Part B Payment Policies; Medicare Shared
Savings Program Requirements; Provider Enrollment Regulation Updates;
Provider and Supplier Prepayment and Post-Payment Medical Review
Requirements; Proposed Rule
Federal Register / Vol. 86 , No. 139 / Friday, July 23, 2021 /
Proposed Rules
[[Page 39104]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 405, 410, 411, 414, 415, 423, 424, and 425
[CMS-1751-P]
RIN 0938-AU42
Medicare Program; CY 2022 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment Policies; Medicare
Shared Savings Program Requirements; Provider Enrollment Regulation
Updates; Provider and Supplier Prepayment and Post-Payment Medical
Review Requirements.
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This major proposed rule addresses: Changes to the physician
fee schedule (PFS); other changes to Medicare Part B payment policies
to ensure that payment systems are updated to reflect changes in
medical practice, relative value of services, and changes in the
statute; Medicare Shared Savings Program requirements; updates to the
Quality Payment Program; Medicare coverage of opioid use disorder
services furnished by opioid treatment programs; updates to certain
Medicare provider enrollment policies; requirements for prepayment and
post-payment medical review activities; requirement for electronic
prescribing for controlled substances for a covered Part D drug under a
prescription drug plan, or a Medicare Advantage Prescription Drug (MA-
PD) plan; updates to the Medicare Ground Ambulance Data Collection
System; changes to the Medicare Diabetes Prevention Program (MDPP)
expanded model; and amendments to the physician self-referral law
regulations.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 13,
2021.
ADDRESSES: In commenting, please refer to file code CMS-1751-P.
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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-1751-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1751-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
FOR FURTHER INFORMATION CONTACT:
<a href="/cdn-cgi/l/email-protection#72361b041b011b1d1c1d1422001311061b061b1d1c1700211700041b11170132111f015c1a1a015c151d04"><span class="__cf_email__" data-cfemail="d692bfa0bfa5bfb9b8b9b086a4b7b5a2bfa2bfb9b8b3a485b3a4a0bfb5b3a596b5bba5f8bebea5f8b1b9a0">[email protected]</span></a>, for any issues not
identified below.
Michael Soracoe, (410) 786-6312, for issues related to practice
expense, work RVUs, conversion factor, and PFS specialty-specific
impacts.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Donta Henson, (410) 786-1947, Patrick Sartini, (410) 786-9252, and
Larry Chan, (410) 786-6864, for issues related to telehealth services
and other services involving communications technology.
Julie Adams, (410) 786-8932, for issues related to payment for
anesthesia services.
Sarah Leipnik, (410) 786-3933, for issues related to split (or
shared) services.
Christiane LaBonte, (410) 786-7237, for issues related to indirect
practice expense, PFS payment for critical care services, and PFS
payment for teaching physician services.
<a href="/cdn-cgi/l/email-protection#612508170812080e0f0e0731130002150815080e0f0413320413170802041221020c124f0909124f060e17"><span class="__cf_email__" data-cfemail="99ddf0eff0eaf0f6f7f6ffc9ebf8faedf0edf0f6f7fcebcafcebeff0fafcead9faf4eab7f1f1eab7fef6ef">[email protected]</span></a>, for issues related to
payment for vaccine administration services.
Regina Walker-Wren, (410) 786-9160, for issues related to billing
for services of physician assistants.
Pamela West, (410) 786-2302, for issues related to PFS payment for
therapy services, medical nutrition therapy services, and services of
registered dieticians and nutrition professionals.
Liane Grayson, (410) 786-6583, and Donta Henson, (410) 786-1947,
for issues related to coinsurance for certain colorectal cancer
screening services.
Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs.
Laura Kennedy, (410) 786-3377, for issues related to drugs payable
under Part B.
Heather Hostetler, (410) 786-4515, and Elizabeth Truong, 410-786-
6005, for issues related to removal of select national coverage
determinations.
Sarah Fulton, (410) 786-2749, for issues related to Appropriate Use
Criteria for Advanced Diagnostic Imaging (AUC); and Pulmonary
Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac
Rehabilitation.
Rachel Katonak, (410) 786-8564, for issues related to Medical
Nutrition Therapy.
Fiona Larbi, (410) 786-7224, for issues related to the Medicare
Shared Savings Program (Shared Savings Program) Quality performance
standard and quality reporting requirements.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or <a href="/cdn-cgi/l/email-protection#bae9d2dbc8dfdee9dbccd3d4ddc9eac8d5ddc8dbd7fad9d7c994d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="7d2e151c0f18192e1c0b14131a0e2d0f121a0f1c103d1e100e5315150e531a120b">[email protected]</span></a>, for issues related to Shared
Savings Program beneficiary assignment, repayment mechanism
requirements, and benchmarking methodology.
Naseem Tarmohamed, (410) 786-0814, or
<a href="/cdn-cgi/l/email-protection#7e2d161f0c1b1a2d1f081710190d2e0c11190c1f133e1d130d5016160d50191108"><span class="__cf_email__" data-cfemail="03506b627166675062756a6d647053716c6471626e43606e702d6b6b702d646c75">[email protected]</span></a>, for inquiries related to Shared
Savings Program application, compliance and beneficiary notification
requirements.
Amy Gruber, <a href="/cdn-cgi/l/email-protection#13527e71667f727d707657726772507c7f7f7670677a7c7d53707e603d7b7b603d747c65"><span class="__cf_email__" data-cfemail="cb8aa6a9bea7aaa5a8ae8faabfaa88a4a7a7aea8bfa2a4a58ba8a6b8e5a3a3b8e5aca4bd">[email protected]</span></a>, for issues related
to the Medicare Ground Ambulance Data Collection System.
Juliana Tiongson, (410) 786-0342, for issues related to the
Medicare Diabetes Prevention Program (MDPP).
Laura Ashbaugh, (410) 786-1113, for issues related to Clinical
Laboratory Fee Schedule: Laboratory Specimen Collection and Travel
Allowance and Use of Electronic Travel Logs.
Frank Whelan, (410) 786-1302, for issues related to Medicare
provider enrollment regulation updates.
Thomas J. Kessler, (410) 786-1991, for issues related to provider
and supplier prepayment and post-payment medical review requirements.
Lindsey Baldwin, (410) 786-1694, and Michele Franklin, (410) 786-
9226, for issues related to Medicare coverage of opioid use disorder
treatment services furnished by opioid treatment programs.
Lisa O. Wilson, (410) 786-8852, or Meredith Larson, (410) 786-7923,
for inquiries related to the physician self-referral law.
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.
Kathleen Ott, (410) 786-4246, for issues related to open payments.
[[Page 39105]]
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).
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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> 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 proposed rule are available on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html</a>. 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
2022 PFS proposed rule, refer to item CMS-1751-P. Readers with
questions related to accessing any of the Addenda or other supporting
documents referenced in this proposed rule and posted on the CMS
website identified above should contact
<a href="/cdn-cgi/l/email-protection#1a5e736c7369737574757c4a687b796e736e7375747f68497f686c73797f695a79776934727269347d756c"><span class="__cf_email__" data-cfemail="06426f706f756f6968696056746765726f726f69686374556374706f65637546656b75286e6e7528616970">[email protected]</span></a>.
CPT (Current Procedural Terminology) Copyright Notice: Throughout
this proposed rule, we use CPT codes and descriptions to refer to a
variety of services. We note that CPT codes and descriptions are
copyright 2020 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
This major proposed rule proposes to revise payment polices under
the Medicare PFS and makes other policy changes, including proposals to
implement certain provisions of the Consolidated Appropriations Act,
2021 (CAA, 2021) (Pub. L. 116-260, December 27, 2020), 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 major proposed rule includes proposals
regarding other Medicare payment policies described in sections III.
and IV.
A. 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 each year by regulation the payment
amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major proposed rule, we are proposing to establish RVUs for
CY 2022 for the PFS to ensure that our payment systems are updated to
reflect changes in medical practice and the relative value of services,
as well as changes in the statute. This proposed rule also includes
discussions and provisions regarding several other Medicare Part B
payment policies.
Specifically, this proposed rule addresses:
<bullet> Practice Expense RVUs (section II.B.)
<bullet> Potentially Misvalued Services Under the PFS (section
II.C.)
<bullet> Telehealth and Other Services Involving Communications
Technology (section II.D.)
<bullet> Valuation of Specific Codes (section II.E.)
<bullet> Evaluation and Management Visits (section II.F.)
<bullet> Billing for Physician Assistant Services (section II.G.)
<bullet> Therapy Services (section II.H.)
<bullet> Changes to Beneficiary Coinsurance for Additional
Procedures Furnished During the Same Clinical Encounter as Certain
Colorectal Cancer Screening Tests (section II.I.)
<bullet> Vaccine Administration Services (section II.J.)
<bullet> Payment for Medical Nutrition Therapy Services and Related
Services (section II.K.)
<bullet> Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (sections III.A., III.B., and III.C.)
<bullet> Requiring Certain Manufacturers to Report Drug Pricing
Information for Part B and Determination of ASP for Certain Self-
administered Drug Products (sections III.D.1. and 2.)
<bullet> Medicare Part B Drug Payment for Drugs Approved under
Section 505(b)(2) of the Federal Food, Drug, & Cosmetic Act (section
III.E.)
<bullet> Appropriate Use Criteria for Advanced Diagnostic Imaging
(section III.F.)
<bullet> Removal of Select National Coverage Determinations
(section III.G.)
<bullet> Pulmonary Rehabilitation, Cardiac Rehabilitation and
Intensive Cardiac Rehabilitation (section III.H.)
<bullet> Medical Nutrition Therapy (section III.I.)
<bullet> Medicare Shared Savings Program (section III.J.)
<bullet> Medicare Ground Ambulance Data Collection System (section
III.K.)
<bullet> Medicare Diabetes Prevention Program (MDPP) (section
III.L.)
<bullet> Clinical Laboratory Fee Schedule: Laboratory Specimen
Collection and Travel Allowance for Clinical Diagnostic Laboratory
Tests and Use of Electronic Travel Logs (section III.M.)
<bullet> Medicare Provider and Supplier Enrollment Changes (section
III.N.1.)
<bullet> Provider/Supplier Medical Review Requirements: Addition of
Provider/Supplier Requirements related to Prepayment and Post-payment
Reviews (section III.N.2.)
<bullet> Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.O.)
<bullet> Updates to the Physician Self-Referral Regulations
(section III.P.)
<bullet> Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D Drug under a Prescription Drug Plan or
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.Q.)
<bullet> Open Payments (section III.R.)
<bullet> Updates to the Quality Payment Program (section IV.)
<bullet> Collection of Information Requirements (section V.)
<bullet> Response to Comments (section VI.)
<bullet> Regulatory Impact Analysis (section VII.)
[[Page 39106]]
3. Summary of Costs and Benefits
We have determined that this proposed rule is economically
significant. For a detailed discussion of the economic impacts, see
section VII., Regulatory Impact Analysis, of this proposed rule.
II. Provisions of the Proposed Rule for the PFS
A. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the 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 (OBRA '89) (Pub. L. 101-239, December 19,
1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
(Pub. L. 101-508, November 5, 1990). 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 proposed rule, unless otherwise noted,
the term ``practitioner'' is used to describe both physicians and
nonphysician practitioners (NPPs) who are permitted to bill Medicare
under the PFS for the services they furnish to Medicare beneficiaries.
1. Development of the RVUs
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
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, 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 (BBA `97)
(Pub. L. 105-33, August 5, 1997) 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 (BBRA)
(Pub. L. 106-113, November 29, 1999) directed the Secretary of Health
and Human Services (the Secretary) to establish a process under which
we accept and use, to the maximum extent practicable and consistent
with sound data practices, data collected or developed by entities and
organizations to supplement the data we normally collect in determining
the PE component. On May 3, 2000, we published the interim final rule
(65 FR 25664) that set forth the criteria for the submission of these
supplemental PE survey data. The criteria were modified in response to
comments received, and published in the Federal Register (65 FR 65376)
as part of a November 1, 2000 final rule. The PFS final rules published
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended
the period during which we would accept these supplemental data through
March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with
[[Page 39107]]
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 from one another. We
completed 5-year reviews of work RVUs that were effective for calendar
years 1997, 2002, 2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the 5-year reviews, beginning for CY 2009, CMS and
the RUC identified and reviewed a number of potentially misvalued codes
on an annual basis based on various identification screens. This annual
review of work and PE RVUs for potentially misvalued codes was
supplemented by the amendments to section 1848 of the Act, as enacted
by section 3134 of the Affordable Care Act, that require the agency to
periodically identify, review and adjust values for potentially
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
As described in section VII. of this proposed rule, the Regulatory
Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of
the Act, if revisions to the RVUs cause expenditures for the year to
change by more than $20 million, we will 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 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,
[[Page 39108]]
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 2022 PFS proposed rule PE/HR'' on the
CMS website under downloads for the CY 2022 PFS proposed rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
For CY 2022, we have incorporated the available utilization data
for two new specialties, each of which became a recognized Medicare
specialty during 2020. These specialties are Micrographic Dermatologic
Surgery (MDS) and Adult Congenital Heart Disease (ACHD). We are
proposing to use proxy PE/HR values for these new specialties, as there
are no PPIS data for these specialties, by crosswalking the PE/HR as
follows from specialties that furnish similar services in the Medicare
claims data:
<bullet> Micrographic Dermatologic Surgery (MDS) from Dermatology;
and
<bullet> Adult Congenital Heart Disease (ACHD from Cardiology.
These updates are reflected in the ``CY 2022 PFS proposed rule PE/
HR'' file available on the CMS website under the supporting data files
for the CY 2022 PFS proposed rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
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 based on 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:
<bullet> 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).
<bullet> 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,
[[Page 39109]]
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.
<bullet> Then, we incorporate the specialty-specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: Facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: A
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct readers to the file titled ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2022 PFS proposed rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>. This file
contains a table that illustrates the calculation of PE RVUs as
described in this proposed rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to a RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Codes with low Medicare service volume require special attention
since billing or enrollment irregularities for a given year can result
in significant changes in specialty mix assignment. We finalized a
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning specialty mix based on the specialties
of the practitioners reporting the services in the claims data, we 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.
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:
<bullet> 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.
<bullet> If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect
[[Page 39110]]
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.
<bullet> The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
<bullet> 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
<bullet> 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.
BILLING CODE 4120-01-P
[[Page 39111]]
[GRAPHIC] [TIFF OMITTED] TP23JY21.000
<bullet> Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
<bullet> Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
<bullet> 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).
<bullet> 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 39112]]
[GRAPHIC] [TIFF OMITTED] TP23JY21.001
BILLING CODE 4120-01-C
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.
Beginning in CY 2022, section 1834(v)(1) of the Act requires that
we apply a 15 percent payment reduction for outpatient occupational
therapy services and outpatient physical therapy services that are
provided, in whole or in part, by a physical therapist assistant (PTA)
or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the
Act required CMS to establish modifiers to identify these services,
which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661),
creating the CQ and CO payment modifiers for services provided in whole
or in part by PTAs and OTAs, respectively. These payment modifiers are
required to be used on claims for services with dates of service
beginning January 1, 2020, as specified in the CY 2020 PFS final rule
(84 FR 62702 through 62708). We will apply the 15 percent payment
reduction to therapy services provided by PTAs (using the CQ modifier)
or OTAs (using the CO modifier), as required by statute. Under sections
1834(k) and 1848 of the Act, payment is made for outpatient therapy
services at 80 percent of the lesser of the actual charge or applicable
fee schedule amount (the allowed charge). The remaining 20 percent is
the beneficiary copayment. For therapy services to which the new
discount applies, payment will be made at 85 percent of the 80 percent
of allowed charges. Therefore, the volume discount factor for therapy
services to which the CQ and CO modifiers apply is: (0.20 + (0.80*
0.85), which equals 88 percent.
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.
<bullet> 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)[and] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally 150,000 minutes.
usage = variable, see discussion below in this proposed rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this proposed
rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
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.
[[Page 39113]]
In the CY 2021 PFS final rule, we finalized a 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 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 a more detailed discussion of
the methodology associated with very short equipment life durations, we
refer readers to the CY 2021 PFS final rule (85 FR 84482 through
84483).
<bullet> Maintenance: We finalized the 5 percent factor for annual
maintenance 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 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 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.
<bullet> 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 3.
[GRAPHIC] [TIFF OMITTED] TP23JY21.002
We are not proposing any changes to the equipment interest rates
for CY 2022.
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 2022 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2022 PFS
proposed rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
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
[[Page 39114]]
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.
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 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 2022, 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 2022 PFS proposed rule at
<a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
b. Technical Corrections to Direct PE Input Database and Supporting
Files
For CY 2022, we are proposing to address the following:
<bullet> Following the publication of the CY 2021 PFS proposed
rule, several commenters questioned the proposed RVUs associated with
several occupational therapy evaluation procedures (CPT codes 97165
through 97167). Commenters stated that the PE valuation for these codes
appeared to be illogical as 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. In response to the commenters, we
noted that although the three codes in question shared the same work
RVU and the same direct PE inputs, they did not share the same
specialty distribution in the claims data and therefore would not
necessarily receive the same allocation of indirect PE. In the CY 2021
PFS final rule (85 FR 84490), we finalized the implementation of a
technical change intended to ensure that these three services received
the same allocation of indirect PE. We agreed with commenters that it
was important to avoid a potential rank order anomaly in which the
simple case for a service was valued higher than the complex case.
After the publication of the CY 2021 PFS final rule, stakeholders
stated their appreciation for the technical change made in the final
rule to ensure that the indirect PE allocation was the same for all
three levels of occupational therapy evaluation codes. However,
stakeholders expressed concern that the PE RVUs we finalized for CPT
codes
[[Page 39115]]
97165-97167 decreased as compared to the PE RVUs we proposed for CY
2021. Stakeholders stated that nothing had occurred in the past year
that would account for a reduction to the proposed PE for these codes,
especially in a year where the proposed PE increased for the
corresponding physical therapy evaluation procedures (CPT codes 97161-
97163), and stakeholders questioned whether there had been an error in
applying the indirect PE methodology.
We reviewed the indirect PE allocation for CPT codes 97165-97167 in
response to the stakeholder inquiry and we do not agree that there was
an error in applying the indirect PE methodology. We finalized a
technical change in the CY 2021 PFS final rule intended to ensure that
these three services received the same allocation of indirect PE, which
achieved its desired goal of assigning equivalent indirect PE to these
three services. However, by forcing CPT codes 97165-97167 to have the
same indirect PE allocation, the indirect PE values for these codes no
longer relied on the claims data, which ended up affecting the indirect
practice cost index for the wider occupational therapy specialty.
Because CPT codes 97165-97167 are high volume services, this resulted
in a lower indirect practice cost index for the occupational therapy
specialty and a smaller allocation of indirect PE for CY 2021 than
initially proposed.
We are addressing this issue for CY 2022 by proposing to assign all
claims data associated with CPT codes 97165-97167 to the occupational
therapy specialty. This should ensure that CPT codes 97165-97167 would
always receive the same indirect PE allocation as well as preventing
any fluctuations to the indirect practice cost index for the wider
occupational therapy specialty. This proposal is intended to avoid a
potential rank order anomaly in which the simple case for a service is
valued higher than the complex case. As the utilization for CPT codes
97165-97167 is overwhelmingly identified as performed by occupational
therapists, we do not anticipate that assigning all of the claims data
for these codes to the occupational therapy specialty will have a
noticeable effect on their valuation. We are soliciting public comments
regarding this proposal, and specifically on what commenters suggest as
the most appropriate method of assigning indirect PE allocation for
these services.
<bullet> In the CY 2020 PFS final rule (84 FR 63102 through 63104),
we created two new HCPCS G codes, G2082 and G2083, effective January 1,
2020 on an interim final basis for the provision of self-administered
esketamine. In the CY 2021 PFS final rule, we finalized a proposal to
refine the values for HCPCS codes G2082 and G2083 using a building
block methodology that summed the values associated with several codes
(85 FR 84641 through 84642). Following the publication of the CY 2021
PFS final rule, stakeholders expressed their concern that the finalized
PE RVU had decreased for HCPCS codes G2082 and G2083 as compared to the
proposed valuation and as compared to the previous CY 2020 interim
final valuation. Stakeholders questioned whether there had been an
error in the PE allocation since CMS had finalized increases in the
direct PE inputs for the services.
We reviewed the indirect PE allocation for HCPCS codes G2082 and
G2083 in response to the stakeholder inquiry and discovered a technical
change that was applied in error. Specifically, we inadvertently
assigned a different physician specialty than we intended (``All
Physicians'') to HCPCS codes G2082 and G2083 for indirect PE allocation
in our ratesetting process during valuation of these codes in the CY
2020 PFS final rule, and continued that assignment into the CY 2021 PFS
proposed rule. This specialty assignment caused the PE value for these
services to be higher than anticipated for CY 2020. We intended to
revise the assigned physician specialty for these codes to ``General
Practice'' in the CY 2021 PFS final rule; however, we neglected to
discuss this change in the course of PFS rulemaking for CY 2021. Since
we initially applied this technical change in the CY 2021 PFS final
rule without providing an explanation, we issued a correction notice
(86 FR 14690) to remove this change from the CY 2021 PFS final rule,
and to instead maintain the All Physicians specialty assignment through
CY 2021. We apologize for any confusion this may have caused.
For CY 2022, we are proposing to maintain the currently assigned
physician specialty for indirect PE allocation for HCPCS codes G2082
and G2083. We are proposing to assign these two services to the All
Physicians specialty for indirect PE allocation which will maintain
payment consistency with the rates published in the CY 2020 PFS final
rule and the CY 2021 PFS proposed rule. Although we had previously
intended to assign the General Practice specialty to these codes,
stakeholders have provided additional information about these services
suggesting that maintaining the All Physicians specialty assignment for
these codes will help maintain payment stability and preserve access to
this care for beneficiaries. We are soliciting public comments to help
us discern which specialty would be the most appropriate to use for
indirect PE allocation for HCPCS codes G2082 and G2083. We note that
the PE methodology, which relies on the allocation of indirect costs
based on the magnitude of direct costs, should appropriately reflect
the typical costs for the specialty the commenters suggest. For
example, we do not believe it would be appropriate to assign the
Psychiatry specialty for these services given that HCPCS codes G2082
and G2083 include the high direct costs associated with esketamine
supplies. The Psychiatry specialty is an outlier compared to most other
specialties, allocating indirect costs at a 15:1 ratio based on direct
costs because psychiatry services typically have very low direct costs.
Assignment of most other specialties would result in allocation of
direct costs at roughly a 3:1 ratio. We request that commenters explain
in their comments how the indirect PE allocation would affect the
payment for these services. Specifically, to ensure appropriate payment
for HCPCS codes G2082 and G2083, we would like to get a better
understanding of the indirect costs associated with these services,
relative to other services furnished by the suggested specialty.
<bullet> A stakeholder contacted us regarding a potential error
involving the intraservice work time for CPT code 35860 (Exploration
for postoperative hemorrhage, thrombosis or infection; extremity). The
stakeholder stated that the RUC recommended an intraservice work time
of 90 minutes for this code when it was last reviewed in the CY 2012
PFS final rule and we finalized the work time without refinement at 60
minutes (76 FR 73131). The stakeholder requested that the intraservice
work time for CPT code 35860 should be updated to 90 minutes.
We reviewed the intraservice work time for CPT code 35860 and found
that the RUC inadvertently recommended a time of 60 minutes for the
code, which we proposed and finalized without comment in rulemaking for
the CY 2012 PFS. As a result, we do not believe that this is a
technical error on our part. However, since the stakeholder has
clarified that the RUC intended to recommend 90 minutes of intraservice
work time for CPT code 35860 based on the surveyed median time, we are
proposing to update the intraservice work time to 90 minutes to match
the survey results.
[[Page 39116]]
c. 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 2022,
we are proposing to update the price of six supplies and two equipment
items in response to the public submission of invoices. Since this is
the final year of the supply and equipment pricing update, the new
pricing for each of these supply and equipment items will take effect
for CY 2022 as there are no remaining years of the transition. The six
supply and equipment items with proposed updated prices are listed in
the valuation of specific codes section of the preamble under Table 16:
CY 2022 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, 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 <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
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:
<bullet> Telephone surveys with vendors for top priority items
(Vendor Survey).
<bullet> Physician panel validation of market research results,
prioritized by total spending (Physician Panel).
<bullet> The General Services Administration system (GSA).
<bullet> An aggregate health system buyers database with discounted
prices (Buyers).
<bullet> Publicly available vendor resources, that is, Amazon
Business, Cardinal Health (Vendors).
<bullet> 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 39117]]
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 4.
[GRAPHIC] [TIFF OMITTED] TP23JY21.003
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 39118]]
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 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 updated supply and equipment pricing, including the submission
of additional invoices for consideration.
For CY 2022, we received invoice submissions from stakeholders for
approximately half a dozen supply and equipment codes as part of the
fourth year of the market-based supply and equipment pricing update. We
used these submitted invoices in many cases to supplement the pricing
originally proposed for the CY 2019 PFS rule cycle. We reviewed the
invoices, as well as our own 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 review, we are proposing to update the prices of six supply
items listed in the valuation of specific codes section of the preamble
under Table 16: CY 2022 Invoices Received for Existing Direct PE
Inputs. Since this is the final year of the supply and equipment
pricing update, the new pricing for each of these supply and equipment
items would take effect immediately for CY 2022.
The proposed prices for the supply and equipment items listed in
Table 16 of CY 2022 were generally calculated following our standard
methodology of averaging together the prices on the submitted invoices.
In the case of the Liquid coverslip (Ventana 650-010) (SL479) supply,
we are proposing a price of $0.051 based on the median invoice due to
the presence of an outlier invoice that substantially increased the
pricing when using an average. We believe that the proposed price of
$0.051 would be more typical for the SL479 supply based on the pricing
information contained on the other submitted invoices. We also received
several invoices for the 3C patch system (SD343) supply; however, since
we established a price of $625.00 for this supply in last year's CY
2021 PFS final rule and the submitted invoices had an average price of
$612.50, we are not proposing to update the price. We believe that the
submitted invoices confirm that the current pricing of $625.00 is
typical for the SD343 supply.
(2) Invoice Submission
The full list of updated supply and equipment pricing as
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 2022 PFS proposed rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
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 with their
public comments or, if outside the notice and comment rulemaking
process, via email at <a href="/cdn-cgi/l/email-protection#0454415b54766d67615b4d6a7471705b517460657061446769772a6c6c772a636b72"><span class="__cf_email__" data-cfemail="a3f3e6fcf3d1cac0c6fceacdd3d6d7fcf6d3c7c2d7c6e3c0ced08dcbcbd08dc4ccd5">[email protected]</span></a>.
(3) 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 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 suggested that, therefore, the cost inputs
for this supply should be used to establish the RVUs for this code, as
the current PFS payment rate is substantially less than the amount it
costs to furnish the 3C patch.
We want to clarify that the direct PE inputs for HCPCS code G0460
increased for CY 2021 as a result of the ongoing market-based supply
and equipment pricing update. However, there was also a minor decrease
in the indirect PE allocation associated with this service for CY 2021,
with the net result that the proposed PE RVU coincidentally ended up
remaining the same as in the previous year. We also clarify 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. In addition, as a contractor priced
service, HCPCS code G0460 is unaffected by inclusion or exclusion from
this list.
We share the concerns of the stakeholders that patient access to
the 3C patch could be materially impacted if CMS maintains the current
PE RVUs for HCPCS G0460. In the CY 2021 PFS final rule, we established
contractor pricing for HCPCS code G0460 for CY 2021. We believe that
the use of contractor pricing again for CY 2022 will allow us
additional time to consider the most appropriate resource inputs and PE
RVUs for HCPCS code G0460. We also added 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. We are proposing to maintain
contractor pricing for CY 2022 for HCPCS code G0460 as we do not
currently have sufficient information to establish national pricing. It
remains unclear to us what the typical supply inputs would be for HCPCS
code G0460 and whether they would include the use of the new 3C patch
system. We believe that it would be more appropriate to maintain
contractor pricing for the service, which will allow for more
flexibility in pricing. We are soliciting any additional information
that commenters can supply that CMS should consider to establish
national payment for HCPCS code G0460.
d. Clinical Labor Pricing Update
Section 220(a) of the PAMA 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
[[Page 39119]]
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.
Since 2019, we have been updating the supply and equipment prices
used for PE as part of a market-based pricing transition; CY 2022 will
be the final year of this 4-year transition. We initiated a market
research contract with StrategyGen to conduct an in-depth and robust
market research study to update the supply and equipment pricing for CY
2019, and we finalized a policy in CY 2019 to phase in the new pricing
over a period of 4 years. However, we did not propose to update the
clinical labor pricing, and the pricing for clinical labor has remained
unchanged during this pricing transition. Clinical labor rates were
last updated for CY 2002 using Bureau of Labor Statistics (BLS) data
and other supplementary sources where BLS data were not available; we
refer readers to the full discussion in the CY 2002 PFS final rule for
additional details (66 FR 55257 through 55262).
Stakeholders have raised concerns that the long delay since
clinical labor pricing was last updated has created a significant
disparity between CMS' clinical wage data and the market average for
clinical labor. In recent years, a number of stakeholders have
suggested that certain wage rates are inadequate because they do not
reflect current labor rate information. Some stakeholders have also
stated that updating the supply and equipment pricing without updating
the clinical labor pricing could create distortions in the allocation
of direct PE. Since the pool of aggregated direct PE inputs is budget
neutral, if these rates are not routinely updated, clinical labor may
become undervalued over time relative to equipment and supplies,
especially since the supply and equipment prices are in the process of
being updated. There has been considerable stakeholder interest in
updating the clinical labor rates, and when we solicited comment on
this topic in past rules, such as in the CY 2019 PFS final rule (83 FR
59480), stakeholders supported the idea.
Therefore, we are proposing to update the clinical labor pricing
for CY 2022, in conjunction with the final year of the supply and
equipment pricing update. We believe it is important to update the
clinical labor pricing to maintain relativity with the recent supply
and equipment pricing updates. We are proposing to use the methodology
outlined in the CY 2002 PFS final rule (66 FR 55257), which draws
primarily from BLS wage data, to calculate updated clinical labor
pricing. As we stated in the CY 2002 PFS final rule, the BLS'
reputation for publishing valid estimates that are nationally
representative led to the choice to use the BLS data as the main
source. We believe that the BLS wage data continues to be the most
accurate source to use as a basis for clinical labor pricing and this
data will appropriately reflect changes in clinical labor resource
inputs for purposes of setting PE RVUs under the PFS. We used the most
current BLS survey data (2019) as the main source of wage data for this
proposal.
We recognize that the BLS survey of wage data does not cover all
the staff types contained in our direct PE database. Therefore, we
crosswalked or extrapolated the wages for several staff types using
supplementary data sources for verification whenever possible. In
situations where the price wages of clinical labor types were not
referenced in the BLS data, we have used the national salary data from
the Salary Expert, an online project of the Economic Research Institute
that surveys national and local salary ranges and averages for
thousands of job titles using mainly government sources. (A detailed
explanation of the methodology used by Salary Expert to estimate
specific job salaries can be found at <a href="http://www.salaryexpert.com">www.salaryexpert.com</a>). We
previously used Salary Expert information as the primary backup source
of wage data during the last update of clinical labor pricing in CY
2002. If we did not have direct BLS wage data available for a clinical
labor type, we used the wage data from Salary Expert as a reference for
pricing, then crosswalked these clinical labor types to a proxy BLS
labor category rate that most closely matched the reference wage data,
similar to the crosswalks used in our PE/HR allocation. For example,
there is no direct BLS wage data for the Mammography Technologist
(L043) clinical labor type; we used the wage data from Salary Expert as
a reference and identified the BLS wage data for Respiratory Therapists
as the best proxy category. We calculated rates for the ``blend''
clinical labor categories by combining the rates for each labor type in
the blend and then dividing by the total number of labor types in the
blend.
As in the CY 2002 clinical labor pricing update, the proposed cost
per minute for each clinical staff type was derived by dividing the
average hourly wage rate by 60 to arrive at the per minute cost. In
cases where an hourly wage rate was not available for a clinical staff
type, the proposed cost per minute for the clinical staff type was
derived by dividing the annual salary (converted to 2021 dollars using
the Medicare Economic Index) by 2080 (the number of hours in a typical
work year) to arrive at the hourly wage rate and then again by 60 to
arrive at the per minute cost. To account for the employers' cost of
providing fringe benefits, such as sick leave, we used the same
benefits multiplier of 1.366 as employed in CY 2002. As an example of
this process, for the Physical Therapy Aide (L023A) clinical labor
type, the BLS data reflected an average hourly wage rate of $14.03,
which we multiplied by the 1.366 benefits modifier and then divided by
60 minutes to arrive at the proposed per-minute rate of $0.32.
Table 5 lists our proposed updates to the clinical labor prices.
The BLS occupational code used as a source of wage data is listed for
each clinical labor type; for the ``blend'' clinical labor types, this
may include multiple BLS occupational codes and other clinical labor
types which were calculated separately and then averaged together.
Clinical labor types without a direct BLS labor category where we are
employing a proxy BLS wage rate are indicated with an asterisk in Table
5.
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We are proposing to use the 75th percentile of the average wage
data for the Medical Physicist (L152A) clinical labor type because we
believe this level
[[Page 39121]]
would most closely fit with the historic wage data for this clinical
labor type. A Medical Physicist is a specific type of physicist, and
the available BLS wage data describes the more general category of
physicist which is paid at a lower rate. In this specific case, the
75th percentile more accurately describes the clinical labor type in
question based on how it has historically been paid. We are also
proposing to maintain the current clinical labor pricing for the
Behavioral Health Care Manager (L057B) clinical labor type rather than
update it. Although the BLS data reflected a decreased clinical labor
rate for the Behavioral Health Care Manager labor type, we do not
believe that the typical wages have decreased for this clinical labor
type given that every other clinical labor type has increased over the
past 5 years since the Behavioral Health Care Manager clinical labor
type was created. The Behavioral Health Care Manager labor type was
initially established in the CY 2017 PFS final rule (81 FR 80350). It
seems more likely that we misidentified the proper BLS category for
this clinical labor type than that wages have decreased since 2017. We
believe that the clinical labor rate for the Behavioral Health Care
Manager should be held constant for CY 2022 pending additional public
feedback.
We are soliciting comments on the proposed updated clinical labor
pricing. We are particularly interested in additional wage data for the
clinical labor types for which we lacked direct BLS wage data and made
use of proxy labor categories for pricing. We understand that the
clinical labor undertaken by, for example, a Histotechnologist (L037B)
is not the same as the clinical labor provided by the Health
Information Technologist category of BLS wage data that we employed as
a proxy for pricing. Although these occupations are not directly
analogous to each other in terms of the work they do, we nonetheless
believe that the proposed crosswalks are appropriate in terms of the
resulting hourly wage data. We appreciate any additional information
that commenters can supply both in terms of direct wage data, as well
as identifying the most accurate types of BLS categories that could be
used as proxies to update pricing for clinical labor types that lack
direct BLS wage data. We isolated the anticipated effects of the
clinical labor pricing update on specialty payment impacts by comparing
the proposed CY 2022 PFS rates with and without the clinical labor
pricing updates in place:
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The potential effects of the clinical labor pricing update on
specialty payment impacts are largely driven by the share that labor
costs represent of the direct PE inputs for each specialty. Specialties
with a substantially lower or higher than average share of direct costs
attributable to labor would experience significant declines or
increases, respectively, if this proposal is finalized. For example,
the Family Practice specialty has a higher share of direct costs
associated with clinical labor, and payments to services comprising the
specialty would be expected to increase as a result of this clinical
labor pricing update. In contrast, Diagnostic Testing Facilities have a
lower share of direct costs that are associated with clinical labor,
and payments to services comprising the specialty would be expected to
decrease. Other specialty-level payment impacts for the proposed
clinical labor pricing changes are driven by changes in wage rates for
a clinical labor category that affects a given specialty more than
average. One such example would be the proposed increase of 11 percent
for Oncology nurses as opposed to the average increase for nurses of 63
percent. We emphasize that these are not the projected impacts by
specialty of all the policies we are proposing in this proposed rule
for CY 2022, only the anticipated effect of the isolated clinical labor
pricing update, should this clinical labor pricing update be finalized
as proposed.
When updates to our payment methodology based on new data produce
significant shifts in payment, we often consider whether it would be
appropriate to implement the updates through a phased transition across
several calendar years. For example, we utilized a 4-year transition
for the market-based supply and equipment pricing update concluding in
CY 2022. We are considering the use of a similar 4-year transition to
implement the clinical labor pricing update. A multi-year transition
could smooth out the increases and decreases in payment caused by the
pricing update for affected stakeholders, promoting payment stability.
However, a phased transition would delay the full implementation of
updated pricing and continue to rely in part on outdated data for
clinical labor pricing. We discuss a potential 4-year transition for
the clinical labor pricing update as an alternative considered in the
Regulatory Impact Analysis (section VII.I) of this rule.
e. Proposal To Establish Values for Remote Retinal Imaging (CPT Code
92229), Comment Solicitation for Fractional Flow Reserve Derived From
Computed Tomography (CPT Code 0503T), and Comment Solicitation for
Codes Involving Innovative Technology
Rapid advances in innovative technology are having a profound
effect on every facet of the economy, including in the delivery of
health care. Emerging and evolving technologies are introducing
advances in treatment options that have the potential to increase
access to care for Medicare beneficiaries, improve outcomes, and reduce
overall costs to the program. While new services have emerged over the
last several years, it is possible that the COVID-19 public health
emergency (PHE) could be accelerating the supply and demand for these
innovations. Emerging and evolving technologies could be useful tools
for improving disparities in care that have been exacerbated by the
PHE. Some of these new applications have codes for which innovative
technology is substituting for and/or augmenting physician work. For
example, the CPT Editorial Panel created CPT code 92229 (Imaging of
retina for detection or monitoring of disease; point-of-care automated
analysis and report, unilateral or bilateral), a diagnostic test for
diabetic retinopathy that uses a software algorithm, and the RUC
provided valuation recommendations which included a retinal camera and
an analysis fee for remote imaging. In the CY 2021 PFS final rule (85
FR 84629 through 84630), we considered CPT code 92229 to be a
diagnostic service under the PFS, contractor-priced it, and stated that
we would have ongoing conversations with stakeholders. The following
section will discuss proposed policies to establish RVUs for CPT code
92229, solicit feedback to establish RVUs for CPT code 0503T
(Noninvasive estimated coronary fractional flow reserve (FFR) derived
from coronary computed tomography angiography data using computation
fluid dynamics physiologic simulation software analysis of functional
data to assess the severity of coronary artery disease; analysis of
fluid dynamics and simulated maximal coronary hyperemia, and generation
of estimated FFR model), and solicit feedback to help us better
understand the resource costs for services involving the use of
innovative technologies such as software algorithms and artificial
intelligence (AI).
In our discussion of CPT code 92229 in the CY 2021 PFS final rule
(85 FR 84629 through 84630), we wrote that as the data used in our PE
methodology have aged, and more services have begun to include
innovative technology such as software algorithms and AI, these
innovative applications are not well accounted for in our PE
methodology. As described earlier in this section, PE resources
involved in furnishing services are characterized as either direct or
indirect costs. Direct costs of the PE resources involved in furnish a
service are estimated for each code and include clinical labor, medical
supplies, and medical equipment. Indirect costs include administrative
labor, office expenses, and all other expenses. Indirect PE is
allocated to each service based on physician work, direct costs, and a
specialty-specific indirect percentage. The source of the specialty
specific indirect percentage was the Physician Practice Information
Survey (PPIS), last administered in 2007 and 2008, when emerging
technologies that rely primarily on software, licensing, and analysis
fees, with minimal costs in equipment and hardware may not have been
typical. Thus, these costs are not well accounted for in the PE
methodology.
Consistent with our PE methodology and as we have stated in past
PFS rulemaking (83 FR 59557), we have considered most computer software
and associated analysis and licensing fees to be indirect costs tied to
costs for associated hardware that is considered to be medical
equipment. In the case of CPT code 92229, the hardware is a retinal
camera used for remote imaging. Given that indirect costs are based on
physician work, direct costs, and
[[Page 39124]]
specialty-specific indirect percentages that can include high-cost
equipment, our concern is that if we were to consider an analysis fee
to be a supply cost, as was recommended by the RUC, it is possible that
we would inadvertently allocate too many indirect costs for a supply
item that may not require additional indirect expenses. Unlike a piece
of equipment, such as the retinal camera, an analysis fee for software
does not require physical space in an office or administrative staff
hours to maintain it.
However, increasingly, stakeholders have routinely expressed
concerns with our policy to consider analysis fees as indirect costs,
especially for evolving technologies that rely primarily on these fees
with minimal costs in equipment or hardware. In comments in the CY 2021
PFS final rule (85 FR 84629 through 84630) responding to our proposal
to price the analysis fee for remote imaging as an indirect cost,
stakeholders stated that there would be no service if the software was
not used. There are two aspects that distinguish CPT code 92229 from
other services. First, most of the RUC's recommended resource costs for
CPT code 92229 were for the analysis fee, rather than high-cost
equipment or other supplies that require commensurate indirect costs to
accommodate for space or administrative labor. Second, the innovative
technology incorporated into the service is a software algorithm, which
interprets data collected during the test, either augmenting the work
of the physician or NPP performing the test, or in some cases replacing
at least some work that a physician would typically furnish. In
general, it is possible that physician work time and intensity of
furnishing care to patients could be affected as more services that
involve innovative technologies such as software algorithms or AI
become available.
We finalized a policy to establish contractor pricing for CPT code
92229 (85 FR 84629 through 84630) because analysis fees for software
algorithms and AI applications are not well accounted for our PE
methodology, and to recognize that practitioners do incur resource
costs for purchase and ongoing use of the software. We stated that we
would continue to seek out new data sources and have ongoing
conversations with stakeholders while also considering other approaches
to reflect overall resource costs for these technologies in our PE
methodology.
As we described in the CY 2021 PFS final rule (85 FR 84498 through
84499), the RAND Corporation is currently studying potential
improvements to CMS' PE allocation methodology and the data that
underlie it. RAND has found that the PPIS data last collected in 2007-
2008 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. Our
experience with the challenge of accurately accounting for resource
costs for innovative and emerging technologies such as ongoing service-
specific software costs that are included in CPT code 92229 is another
reason we continue to be interested in potentially refining the PE
methodology and updating the data used to establish RVUs and payment
rates under the PFS. We commonly employ a crosswalk to recognize
resource costs when we lack the inputs that we would need to calculate
work, PE, and/or malpractice RVUs for a service otherwise. When we use
a crosswalk to value a service, we substitute the established RVUs for
other services with similar resource costs in the physician office
setting to set RVUs and the national payment rates for that particular
service.
For CY 2022, we are proposing to establish values for CPT code
92229 using our crosswalk approach, and thus this service would no
longer be contractor-priced. We continue to believe that the software
algorithm present in the analysis fee for CPT code 92229 is not well
accounted for in our PE methodology; however, we recognize that
practitioners are incurring resource costs for purchase of the software
and its ongoing use. We are proposing to use a crosswalk that reflects
the overall relative resource costs for this service while we continue
to consider potentially refining the PE methodology and updating the
data we use to establish PE RVUs under the PFS. Specifically, we are
proposing a crosswalk to CPT code 92325 (Modification of contact lens
(separate procedure), with medical supervision of adaptation), a PE-
only code used for the eye, as we believe it reflects overall resource
costs for CPT code 92229 in the physician office setting. We recognize
that the services described by CPT code 92325 are not the same as the
services in CPT code 92229; however, we believe that the total resource
costs would be similar across these two codes. We believe that
crosswalking the RVUs for CPT code 92229 to a code with similar
resource costs allows CMS to recognize that practitioners are incurring
resource costs for the purchase and ongoing use of the software
employed in CPT code 92229, which would not typically be considered
direct PE under our current methodology. We are also soliciting
comments on our proposal to crosswalk CPT code 92229 to CPT code 92325,
and whether other codes would provide a more appropriate crosswalk in
terms of resource costs. In addition, as discussed in section II.E of
this proposed rule, we are proposing to use our crosswalk approach for
CPT code 77X01 (Trabecular bone score (TBS), structural condition of
the bone microarchitecture; using dual X-ray absorptiometry (DXA) or
other imaging data on gray-scale variogram, calculation, with
interpretation and report on fracture risk) and CPT code 77X03
(Trabecular bone score (TBS), structural condition of the bone
microarchitecture; using dual X-ray absorptiometry (DXA) or other
imaging data on gray-scale variogram, calculation, with interpretation
and report on fracture risk, technical calculation only).
We are aware of other services that use similar innovative
technologies to those used for the diagnostic test for diabetic
retinopathy and trabecular bone score, and that those technologies also
are not well-accounted for in our PE methodology. For CY 2018, the AMA
CPT Editorial Panel established four new Category III CPT codes for
fractional flow reserve derived from computed tomography (FFRCT): CPT
code 0501T (Noninvasive estimated coronary fractional flow reserve
(FFR) derived from coronary computed tomography angiography data using
computation fluid dynamics physiologic simulation software analysis of
functional data to assess the severity of coronary artery disease; data
preparation and transmission, analysis of fluid dynamics and simulated
maximal coronary hyperemia, generation of estimated FFR model, with
anatomical data review in comparison with estimated FFR model to
reconcile discordant data, interpretation and report) CPT code 0502T
(Noninvasive estimated coronary fractional flow reserve (FFR) derived
from coronary computed tomography angiography data using computation
fluid dynamics physiologic simulation software analysis of functional
data to assess the severity of coronary artery disease; data
preparation and transmission); CPT code 0503T (Noninvasive estimated
coronary fractional flow reserve (FFR) derived from coronary computed
tomography angiography data using computation fluid dynamics
physiologic
[[Page 39125]]
simulation software analysis of functional data to assess the severity
of coronary artery disease; analysis of fluid dynamics and simulated
maximal coronary hyperemia, and generation of estimated FFR model); and
CPT code 0504T (Noninvasive estimated coronary fractional flow reserve
(FFR) derived from coronary computed tomography angiography data using
computation fluid dynamics physiologic simulation software analysis of
functional data to assess the severity of coronary artery disease;
anatomical data review in comparison with estimated FFR model to
reconcile discordant data, interpretation and report). FFRCT is a
noninvasive diagnostic service that allows physicians to measure
coronary artery disease in a patient through coronary CT scans. It uses
a proprietary data analysis process performed at a central facility to
develop a three-dimensional image of a patient's coronary arteries,
which allows physicians to identify the fractional flow reserve to
assess whether or not patients should undergo further invasive testing
or treatment (typically, a coronary angiogram). We understand that
FFRCT can show through non-invasive imaging whether a beneficiary has
coronary artery disease thereby potentially avoiding an invasive
coronary procedure. Medicare began payment for CPT code 0503T in the
hospital outpatient department setting under the Outpatient Prospective
Payment System (OPPS) in CY 2018 (82 FR 59284). For the PFS, we
typically assign contractor pricing for Category III codes since they
are temporary codes assigned to emerging technology and services. We
followed this established process for Category III codes by assigning
and listing them as contractor pricing in Appendix B in the CY 2018 PFS
final rule (available at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices</a>-Items/
CMS-1676-F). We have since been trying to understand the costs of the
PE resource inputs for CPT code 0503T in the physician office setting.
In the CY 2021 PFS final rule, we stated that we found FFRCT to be
similar to other technologies that use algorithms, artificial
intelligence, or other innovative forms of analysis to determine a
course of treatment, where the analysis portion of the service cannot
adequately be reflected under the PE methodology; and that our recent
reviews for the overall cost of CPT code 0503T have shown the costs in
the physician office setting to be similar to costs reflected in
payment under the OPPS (85 FR 84630). For the CY 2021 OPPS/ASC final
rule, we found that the geometric mean cost reported by hospital
outpatient departments for the service was $804.35 (85 FR 85943). We
believe the costs reported under the OPPS are instructive as they
reflect actual costs that hospitals incurred in furnishing the service
described by CPT code 0503T to Medicare beneficiaries, and, as we
stated in the CY 2021 PFS final rule, we believe that these costs would
be similar in the physician office setting. Using the geometric mean
costs under the OPPS as a proxy, we then searched for services paid
under the PFS that could potentially serve as a crosswalk.
Specifically, we looked for services paid under the PFS that include
only a technical component because CPT code 0503T is a technical
component-only service, and that have similar total costs to CPT code
0503T. We identified the following potential crosswalks, and seek
public comment on which, if any of them, would be appropriate: CPT code
93455 (Catheter placement in coronary artery(s) for coronary
angiography, including intraprocedural injection(s) for coronary
angiography, imaging supervision and interpretation; with catheter
placement(s) in bypass graft(s) (internal mammary, free arterial,
venous grafts) including intraprocedural injection(s) for bypass graft
angiography) and CPT code 93458 (Catheter placement in coronary
artery(s) for coronary angiography, including intraprocedural
injection(s) for coronary angiography, imaging supervision and
interpretation; with left heart catheterization including
intraprocedural injection(s) for left ventriculography, when
performed). We are also seeking comment on whether other codes would
provide a more appropriate crosswalk in terms of resource costs.
We are also more broadly soliciting public comment to help us
better understand the resource costs for services involving the use of
innovative technologies, including but not limited to software
algorithms and AI. Specifically, we are requesting commenters consider
the following questions:
<bullet> To what extent are services involving innovative
technologies such as software algorithms and/or AI substitutes and/or
supplements for physician work? To what extent do these services
involving innovative technology inform, augment, or replace physician
work? For example, CPT code 92229 is a PE-only code in which the
software algorithm may be substituting for some work of an
ophthalmologist to diagnose/detect diabetic retinopathy. CPT code 77X01
is a service in which the trabecular bone score software may be
supplementing physician work to predict and detect fracture risk. CPT
code 0503T may be both substituting for, and supplementing physician
work to detect coronary artery disease.
<bullet> How has innovative technology such as software algorithms
and/or AI affected physician work time and intensity of furnishing
services involving the use of such technology to Medicare
beneficiaries? For example, if a new software algorithm or AI
technology for a diagnostic test results in a reduction in the amount
of time that a practitioner spends reviewing and interpreting the
results of a diagnostic test that previously did not involve such
software algorithm or AI technology, and if the software algorithm or
AI could be considered in part a substitute for at least some physician
work, it may follow that the intensity of the service decreases. It is
also possible that a software algorithm for a diagnostic test that is
supplementing other tests to establish a diagnosis or treatment pathway
for a particular condition could result in an increase in the amount of
time that a practitioner spends explaining the test to a patient and
then reviewing the results.
<bullet> How is innovative technology such as software algorithms
and/or AI changing cost structures in the physician office setting? As
discussed previously, the PPIS data that underlie the PE methodology
were last collected in 2007 and 2008, which was prior to the widespread
adoption of electronic health records and services that involve care
management, non-face-to-face and/or asynchronous remote care; the need
to use electronic clinical quality measure data to support quality
improvement, disparity identification and resolution, and value based
payment; and the emergence of software algorithms and/or AI and other
technologies that use data to inform, augment, or replace physician
work in the delivery of health care. Do costs for innovative technology
such as software algorithms and/or AI to furnish services to patients
involve a one-time investment and/or recurring costs? How should CMS
consider costs for software algorithms and/or AI that use patient data
that were previously collected as part of another service? As
technology adoption grows, do these costs decrease over time?
<bullet> How is innovative technology affecting beneficiary access
to Medicare-covered services? How are services involving software
algorithms and/or AI being furnished to Medicare beneficiaries and what
is important for
[[Page 39126]]
CMS to understand as it considers how to accurately pay for services
involving software algorithms and/or AI? For example, it is possible
that services that involve software algorithms and/or AI may allow a
practitioner to more efficiently furnish care to more Medicare
beneficiaries, potentially increasing access to care. Additionally, to
what extent have services that involve innovative technology such as
software algorithms and/or AI affected access to Medicare-covered
services in rural and/or underserved areas, or for beneficiaries that
may face barriers (homelessness, lack of access to transportation,
lower levels of health literacy, lower rates of internet access, mental
illness, having a high number of chronic conditions/frailty, etc.) in
obtaining health care?
<bullet> Compared to other services paid under the PFS, are
services that are driven by or supported by innovative technology such
as software algorithms and/or AI at greater risk of overutilization or
more subject to fraud, waste, and abuse? As we are considering
appropriate payment for services enabled by new technologies, there are
considerations for program integrity. For example, section 218(b) of
the PAMA required that we establish an Appropriate Use Criteria Program
to promote appropriate use of advanced diagnostic imaging services
provided to Medicare beneficiaries.\1\ To what extent do services
involving innovative technology require mechanisms such as appropriate
use criteria to guard against overutilization, fraud, waste, or abuse?
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\1\ Appropriate Use Criteria Program. <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program</a>.
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<bullet> Compared to other services paid under the PFS, are
services driven by or supported by innovative technology such as
software algorithms and/or AI associated with improvements in the
quality of care or improvements in health equity? For example,
increased access to services to detect diabetic retinopathy such as the
service described by CPT code 92229 could eventually lead to fewer
beneficiaries losing their vision. Because CPT code 92229 can be
furnished in a primary care practice's office and may not require the
specialized services of an ophthalmologist, more beneficiaries could
have access to a test, including those who live in areas with fewer
ophthalmologists. Additionally, taking into consideration that a
software algorithm and/or AI may introduce bias into clinical decision
making that could influence outcomes for racial and ethnic minorities
and people who are socioeconomically disadvantaged, are there
guardrails, such as removing the source of bias in a software algorithm
and/or AI, that Medicare should require as part of considering payment
amounts for services enabled by software algorithm and/or AI?
<bullet> Our proposals to use crosswalks to set values for codes
describing diabetic retinopathy and trabecular bone score would allow
us to account for overall resource costs involved in furnishing the
services. The possible crosswalks for FFRCT may also account for
overall resource costs involved in furnishing the service. We also
believe it is important to accurately account for resource costs for
innovative and emerging technologies such as ongoing service-specific
software costs and, as explained above, such costs are not well
accounted for in the PE methodology. We continue to be interested in
potentially refining the PE methodology and updating the underlying
data, including the PPIS data that are the data source that underpins
the indirect PE allocation. How might CMS consider updating such data
to reflect ongoing advances in technology so that we could establish
appropriate relative values without resorting to crosswalks? The RAND
Corporation laid out a number of issues for CMS to consider in two
reports. We refer readers to RAND's first phase of research, available
at <a href="https://www.rand.org/pubs/research_reports/RR2166.html">https://www.rand.org/pubs/research_reports/RR2166.html</a>, and RAND's
second phase of research, available at <a href="https://www.rand.org/pubs/research_reports/RR3248.html">https://www.rand.org/pubs/research_reports/RR3248.html</a>.
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.E. of this proposed 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
statute. 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 (<a href="http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0">http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0</a>), 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
[[Page 39127]]
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 (<a href="http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf">http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf</a>), 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:
<bullet> Codes that have experienced the fastest growth.
<bullet> Codes that have experienced substantial changes in PE.
<bullet> 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.
<bullet> Codes which are multiple codes that are frequently billed
in conjunction with furnishing a single service.
<bullet> Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
<bullet> Codes that have not been subject to review since
implementation of the fee schedule.
<bullet> Codes that account for the majority of spending under the
PFS.
<bullet> Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
<bullet> Codes for which there may be a change in the typical site
of service since the code was last valued.
<bullet> Codes for which there is a significant difference in
payment for the same service between different sites of service.
<bullet> Codes for which there may be anomalies in relative values
within a family of codes.
<bullet> Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
<bullet> Codes with high intraservice work per unit of time.
<bullet> Codes with high PE RVUs.
<bullet> Codes with high cost supplies.
<bullet> Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well. Individuals and stakeholder groups may submit codes for review
under the potentially misvalued codes initiative to CMS in one of two
ways. Nominations may be submitted to CMS via email or through postal
mail. Email submissions should be sent to the CMS emailbox
<a href="/cdn-cgi/l/email-protection#9fd2fafbf6fcfeedfacff7e6ecf6fcf6fef1d9fafaccfcf7fafbeaf3fadffcf2ecb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="fcb19998959f9d8e99ac94858f959f959d92ba9999af9f949998899099bc9f918fd294948fd29b938a">[email protected]</span></a>, 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
[[Page 39128]]
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 2022 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:
<bullet> 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.
<bullet> An anomalous relationship between the code being proposed
for review and other codes.
<bullet> Evidence that technology has changed physician work.
<bullet> Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
<bullet> 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.
<bullet> 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.
<bullet> 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).
<bullet> National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate for each nominated code whether we
agree with its inclusion as a potentially misvalued code. The public
has the opportunity to comment on these and all other proposed
potentially misvalued codes. In that year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
In this proposed rule, we are soliciting comments regarding the
potentially misvalued codes nominated by the public to inform our
decision on whether to establish the codes as potentially misvalued in
the CY 2022 PFS final rule. We received public nominations for
potentially misvalued codes by February 10th. We display these public
nominations on our public website, including the submitter's name and
their associated organization to provide full transparency. Among the
public nominations that we received this year, one was a request for
CMS to review a PE-related input for a code. We refer readers to
section II.B. of this proposed rule, Determination of PE RVUs, for
further discussion on the PE-related submission. The summary of this
year's submissions under the potentially misvalued code initiative are
discussed below.
A stakeholder nominated CPT code 22551 (Fusion of spine bones with
removal of disc at upper spinal column, anterior approach, complex)
``and common related services'' as potentially misvalued. Citing the CY
2021 PFS final rule (84 FR 84501) where CMS agreed with the public
nomination of CPT code 22867 (Insertion of interlaminar/interspinous
process stabilization/distraction device, without fusion, including
image guidance when performed, with open decompression, lumbar; single
level) as potentially misvalued, and discussed the relationship between
CPT code 22867 and 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), this stakeholder
suggests that there are additional CPT code values related to spine
procedures that are in need of contemporaneous review with CPT code
22867. The stakeholder believes that CMS has an interest in reviewing
associated anterior cervical discectomy and fusion (ACDF) procedures as
well, and suggests that CPT code 22551 ``and common related services''
can result in cumulative RVUs that do not sufficiently reflect
physician work, time, or outcomes.
In their submission, the stakeholder expressed concern that there
is a discrepancy between the typical total RVUs for codes billed for
vertebral fusion procedures performed using three synthetic cage
devices with plate and vertebral fusion procedures performed using
three allografts with plate. Both methods of vertebral fusion are
described by CPT code 22551 (includes a 90-day global period), which
has a work RVU of 25.00. Both methods of vertebral fusion involve two
units of CPT code 22552 (Arthrodesis, anterior interbody, including
disc space preparation, discectomy, osteophytectomy and decompression
of spinal cord and/or nerve roots; cervical below C2, each additional
interspace (List separately in addition to code for primary procedure)
(ZZZ global period)) with a total work RVU of 13.00 (6.50 x 2); and
both methods of vertebral fusion involve 1 unit of CPT code 22846
(Anterior instrumentation; 4 to 7 vertebral segments (List separately
in addition to code for primary procedure) (ZZZ global period)) with a
work RVU of 12.40. The vertebral fusion method employing three
synthetic cage devices with a plate would involve CPT code 22853
(Insertion of interbody biomechanical device(s) (e.g., synthetic cage,
mesh) with integral anterior instrumentation for device anchoring
(e.g., screws, flanges), when performed, to intervertebral disc space
in conjunction with interbody arthrodesis, each interspace (List
separately in addition to code for primary procedure) (ZZZ global
period)) for the insertion of synthetic cage devices for a total work
RVU of 12.75 (4.25 x 3), and CPT code 20930 (Allograft, morselized, or
[[Page 39129]]
placement of osteopromotive material, for spine surgery only (List
separately in addition to code for primary procedure)) with a work RVU
of 0.00 (because Medicare considers this code to be bundled into codes
for other services). The stakeholder stated that the total work RVUs
for the typical vertebral fusion employing three synthetic cage devices
with plate would be 63.15 work RVUs.
In contrast, the stakeholder asserted that the vertebral fusion
method employing three allografts with plate involves the same set of
services and codes (CPT code 22551 (090 global period) and CPT code
22846 (ZZZ global period)), but instead of CPT codes 22853 or 20930,
involve CPT code 20931 (Allograft, structural, for spine surgery only
(List separately in addition to code for primary procedure) (ZZZ global
period) with a work RVU of 1.81. Altogether, the total work RVUs for
CPT codes involved in this vertebral fusion method is 52.21. The
stakeholder suggested that this difference in total work RVUs, 63.15
versus 52.21, is evidence that these services are misvalued, and that
the total work RVUs do not reflect the differences in the amount of
work, resources, and intensity between the two vertebral fusion
methods.
This stakeholder's description of the potential misvaluation of CPT
code 22551 ``and common related services'' differs from the CMS
approach to identifying potentially misvalued services by using certain
criteria, as described in the beginning of this section. Our
determination that one or more codes are potentially misvalued
generally revolves around the specific RVUs assigned to an individual
code, or several codes within a family of codes. CMS generally does not
examine the summed differences in total RVUs based on billing patterns
using different codes in different scenarios, representing different
physician work, and then comparing the two methods of a procedure, in
this case, the use or non-use, of the synthetic cage devices in the
vertebral fusion with removal of the disc in the upper spinal column.
We do not believe that the stakeholder has provided support for the
premise that CPT code 22551 alone is misvalued, or that any of the
codes identified as common related services are misvalued. Therefore,
we are not inclined to propose this code as potentially misvalued.
However, we welcome additional comment, including any analysis or
studies demonstrating that one or more of these codes meet the criteria
listed above under ``Identification and Review of Potentially Misvalued
Services,'' particularly in regard to any changes in the resources to
providing a service, or are otherwise potentially misvalued.
A stakeholder nominated CPT code 49436 (Delayed creation of exit
site from embedded subcutaneous segment of intraperitoneal cannula or
catheter) as potentially misvalued, as it has not been valued for
payment in the non-facility/office setting. This stakeholder did not
include in their submission detailed recommendations for the items,
quantities, and unit costs for the supplies, equipment types, and
clinical labor (if any), that might be incurred in the non-facility/
office setting, all of which are key factors when determining potential
valuation or mis-valuation of a service. Medicare claims data for 2018,
2019, and 2020 show that CPT code 49436 is solely performed in the
facility ambulatory surgical center (ASC) setting. We are not inclined
to propose this code as potentially misvalued; however, we welcome
additional comment, including any analysis or studies demonstrating
that this code meets the criteria listed above under ``Identification
and Review of Potentially Misvalued Services,'' particularly in regard
to any changes in the resources to providing a service, or is otherwise
potentially misvalued.
A stakeholder nominated CPT code 55880 (Ablation of malignant
prostate tissue, transrectal, with high intensity-focused ultrasound
(HIFU), including ultrasound guidance) as potentially misvalued, as it
has not been valued in the non-facility/office setting. This
stakeholder also did not include in their submission detailed
recommendations for items, quantities, and unit costs for the supplies,
equipment types, and clinical labor (if any), that might be incurred in
the non-facility/office setting, all of which are key factors when
determining valuation or mis-valuation. This stakeholder stated that
the advances in High Intensity Focused Ultrasound (HIFU) technology
toward the destruction of cancerous tissues in the prostate gland have
matured to the point where this procedure is now equally as effective
and as safe as the cryoablation procedure described by CPT code 55873
(Cryosurgical ablation of the prostate (includes ultrasonic guidance
and monitoring)), which is currently valued in the non-facility/office
setting (186.69 total RVUs, approximately $6,514) and has been for
approximately 10 years. We note that CPT code 55880 was reviewed and
valued in the CY 2021 PFS final rule (85 FR 84614 through 84615) in the
facility setting only. Accordingly, we do not have enough claims data
for this code to make accurate comparisons to similar codes that may be
furnished in non-facility settings. There is no case presented here
that constitutes a misvaluation of CPT code 55880, and therefore, we
are not inclined to put this code forward as potentially misvalued for
CY 2022; however, we welcome additional comment, including any analysis
or studies demonstrating that this code meets the criteria listed above
under ``Identification and Review of Potentially Misvalued Services,''
particularly in regard to any changes in the resources to providing a
service, or is otherwise potentially misvalued.
A stakeholder nominated CPT code 59200 (Insertion cervical dilator
(e.g., laminaria, prostaglandin) as potentially misvalued because the
direct PE inputs do not include the supply item, Dilapan-S. This
stakeholder had sought to establish a Level II HCPCS code for Dilapan-
S, but CMS did not find sufficient evidence to support that request.
The stakeholder now submits Dilapan-S to be considered as PE supply
input to a Level I CPT code(s). This stakeholder seeks to add Dilapan-S
to the nonfacility/office PE inputs for CPT code 59200. Specifically,
the stakeholder recommends adding 4 rods of Dilapan-S at $80.00 per
unit, for a total of $320.00, as a replacement for the current PE
supply item, laminaria tent (a small rod of dehydrated seaweed that
when inserted in the cervix, rehydrates, absorbing the water from the
surrounding tissue in the woman's body), which is currently listed at
$4.0683 per unit, with a total of 3 units, for a total of $12.20. We
welcome additional comment, including any analysis or studies
demonstrating that this code meets the criteria listed above under
``Identification and Review of Potentially Misvalued Services,''
particularly in regard to any changes in the resources to providing a
service, or is otherwise potentially misvalued.
A stakeholder nominated CPT codes 66982 through 66986 as
potentially misvalued, as they have not been valued in the non-
facility/office setting. This stakeholder did not submit other details
or reasoning to support their nomination. We note that some of these
cataract-related procedures were initially reviewed and valued in CY
2020 PFS final rule (84 FR 62751), and that presently, additional codes
in this family are scheduled to be reviewed and valued in this CY 2022
PFS proposed rule (we refer readers to section II.E. of this proposed
rule, Valuation of Specific Codes). The highest utilization of these
cataract codes are CPT code 66982 (Extracapsular cataract removal with
insertion of intraocular lens prosthesis
[[Page 39130]]
(1-stage procedure), manual or mechanical technique (e.g., irrigation
and aspiration or phacoemulsification), complex, requiring devices or
techniques not generally used in routine cataract surgery (e.g., iris
expansion device, suture support for intraocular lens, or primary
posterior capsulorrhexis) or performed on patients in the amblyogenic
developmental stage; without endoscopic cyclophotocoagulation) and CPT
code 66984 (Extracapsular cataract removal with insertion of
intraocular lens prosthesis (1-stage procedure), manual or mechanical
technique (e.g., irrigation and aspiration or phacoemulsification);
without endoscopic cyclophotocoagulation). In 2018 and 2019, these
services were almost all performed in the ASC facility setting, but
based on 2020 claims, the most common setting appears to have shifted
to the hospital inpatient or hospital outpatient facility setting.
There is no case presented here that constitutes a misvaluation of CPT
codes 66982 to 66986, and therefore, we are not inclined to put this
code family forward as potentially misvalued for CY 2022; however, we
welcome additional comment, including any analysis or studies
demonstrating that one or more of these codes meet the criteria listed
above under ``Identification and Review of Potentially Misvalued
Services,'' particularly in regard to any changes in the resources to
providing a service, or are otherwise potentially misvalued.
[GRAPHIC] [TIFF OMITTED] TP23JY21.007
D. Telehealth and Other Services Involving Communications Technology,
and Interim Final Rule With Comment Period for Coding and Payment of
Virtual Check-In Services--Payment for Medicare Telehealth Services
Under Section 1834(m) of the Act
As discussed in prior rulemaking, several conditions must be met
for Medicare to make payment for telehealth services under the PFS. See
further details and full discussion of the scope of Medicare telehealth
services in the CY 2018 PFS final rule (82 FR 53006) and CY 2021 PFS
final rule (85 FR 84502) and in 42 CFR 410.78 and 414.65.
1. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
a. Proposed Changes 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 (42 CFR 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:
<bullet> 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.
<bullet> 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 other clinical benefits that we would
consider include the following:
<bullet> Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
<bullet> Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
<bullet> Reduced rate of complications.
<bullet> Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
<bullet> Decreased number of future hospitalizations or physician
visits.
<bullet> More rapid beneficial resolution of the disease process
treatment.
<bullet> Decreased pain, bleeding, or other quantifiable symptom.
<bullet> Reduced recovery time.
<bullet> Category 3: In the CY 2021 PFS final rule (85 FR 84507),
we created a third category of criteria for adding services to the
Medicare telehealth services list on a temporary basis following the
end of the PHE for the COVID-19 pandemic. This new category describes
services that were added to the Medicare telehealth services list
during the PHE for which there is likely to be clinical benefit when
furnished via telehealth, but there is not yet sufficient evidence
available to consider the services for permanent addition under the
Category 1 or Category 2 criteria. Services added on a temporary,
Category 3 basis would ultimately need to meet the criteria under
Category 1 or 2 in order to be permanently added to the Medicare
telehealth services list. 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
[[Page 39131]]
when furnished via telehealth. We considered the following factors:
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are 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.
++ Whether all elements of the service could fully and effectively
be performed by a remotely located clinician using two-way, audio/video
telecommunications technology.
In the CY 2021 PFS final rule (85 FR 84507), we also temporarily
added several services to the Medicare telehealth services list using
the Category 3 criteria described above. In this proposed rule, we are
considering additional requests to add services to the Medicare
telehealth services list on a Category 3 basis using the previously
described Category 3 criteria.
The Medicare telehealth services list, including the additions
described later in this section, is available on the CMS website at
<a href="https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html">https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html</a>.
Beginning in CY 2019, we stated that for CY 2019 and onward, we
intend to accept requests through February 10, consistent with the
deadline for our receipt of code valuation recommendations from the RUC
(83 FR 59491). For CY 2022, requests to add services to the Medicare
telehealth services list must have been submitted and received by
February 10, 2021. 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 <a href="https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html">https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html</a>.
b. Requests To Add Services to the Medicare Telehealth Services List
for CY 2022
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 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 permanently add various services to
the Medicare telehealth services list effective for CY 2022. We found
that none of the requests we received by the February 10th submission
deadline met our Category 1 or Category 2 criteria for permanent
addition to the Medicare telehealth services list. The requested
services are listed in Table 8.
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We remind stakeholders that the criterion for adding services to
the Medicare telehealth list under Category 1 is that the requested
services are similar to professional consultations, office visits, and
office psychiatry services that are currently on the Medicare
telehealth services list, and that the criterion for adding services
under Category 2 is that there is evidence of clinical benefit if
provided as telehealth. As explained below, we find that none of the
requested services met the Category 1 criterion.
We received a request to permanently add CPT code 51741 (Complex
uroflowmetry (e.g., calibrated electronic equipment)) to the Medicare
telehealth services list. This CPT code describes the acquisition of
uroflowmetric information and analysis of that information. The code
includes a technical component and a professional component. The
technical component describes the acquisition of the uroflowmetric
information when billed as a standalone service. The professional
component describes the analysis for the uroflowmetric information when
it is billed as a standalone service. As we have explained in previous
rulemaking (see 83 FR 59483), the remote interpretation of diagnostic
tests is not considered to be a telehealth service under section
1834(m) of the Act or our regulation at Sec. 410.78. We do not believe
that the technical component, which would include acquisition of the
uroflowmetric
[[Page 39134]]
information, would meet the criterion to be added on a Category 1 basis
because it is not similar to other services on the Medicare telehealth
list. Moreover, we do not believe the uroflowmetric information can be
accurately and effectively collected using two-way, audio/video
communication technology to the degree that would make the results
clinically useful. We believe the patient would need to be in the same
location as the equipment; thus, making it impracticable to achieve via
telehealth. Due to these concerns, we do not believe that the submitted
information demonstrates sufficient clinical benefit to support the
addition of CPT code 51741 to the Medicare telehealth services list.
We received a request to permanently add several biofeedback,
services, CPT codes 90901, 90912, and 90913, to the Medicare telehealth
services list. We do not believe these services are similar to Category
1 services on the Medicare telehealth list in that these services
describe the application of electrodes directly to the patient's skin
and using them to monitor the patient's response. Therefore, we do not
believe they meet the criterion for addition to the Medicare telehealth
services list on a Category 1 basis. We also believe that proper
application of electrodes and monitoring of the patient's response
would require the furnishing practitioner to be in the same physical
location as the beneficiary. As such, we do not believe these services
would meet the criteria for addition to the Medicare telehealth list on
a Category 2 basis. When we reviewed these biofeedback services on a
Category 2 basis, we found that the information supplied with the
requests was not detailed enough to determine if the objective
functional outcomes (that is, Activities of Daily Living (ADLs) and
Instrumental Activities of Daily Living (IADLs) of the telehealth
patients) were similar to that of patients treated in person. Moreover,
we believe that the ADLs/IADLs alone are not sufficient to determine if
these services, when performed via telehealth, demonstrate a clinical
benefit to a patient. We would request that stakeholders supply a more
comprehensive set of objective data in order to fully illustrate any
benefits, to better enable us to evaluate all outcomes.
We received requests to permanently add Neuropsychological/
Psychological Testing services, CPT codes 96130-96133 and 96136-96139,
to the Medicare telehealth services list. We separately reviewed each
of the services in these two code families. In prior years' rulemaking,
we have declined to add these services on a Category 1 basis because,
in contrast to other services on the telehealth list these services
require close observation by the furnishing practitioner to monitor how
a patient responds and progresses through the testing (see 81 FR
80197). We continue to believe that this is the case. All of these
codes describe services that involve a very thorough observation and
testing process, and require the tester to observe the following: Speed
of responses; the ability to adjust focus; written, sometimes manual
tasks; following tasks that display the patients' visuospatial mapping
abilities, pattern recognition, abstraction, calculation--all while
appreciating that the patient may be distracted or aided by
environmental cues. The tester must also maintain some subjective
amount of flexibility to allow the patient to be in their environment.
Additionally, the tester has to maintain professional scrutiny through
dynamic tasks. Given all of the above, remote observation by the
furnishing practitioner to accomplish the testing in question seems
impractical and potentially creates the risk of inaccuracies in
diagnosis and subsequent treatment. We note that the information
supplied by stakeholders did not address these concerns, and as such,
we have concerns over patient safety and the ability of these services
to be accurately and thoroughly performed via telehealth to demonstrate
a clinical benefit to Medicare beneficiaries. Therefore, we do not
believe these services meet the Category 2 criteria for permanent
addition to the Medicare telehealth list of services. Consequently, we
are not proposing to add these services to the Medicare telehealth
services list. We encourage stakeholders to submit information
addressing the concerns we have stated in any future requests to have
these services added to the Medicare telehealth list of services.
We received requests to add Therapy Procedures, CPT codes 97110,
97112, 97116, 97150, and 97530; Physical Therapy Evaluations, CPT codes
97161-97164; Therapy Personal Care services, CPT codes 97535, 97537,
and 97542; and Therapy Tests and Measurements services, CPT codes
97750, 97755, and 97763, to the Medicare telehealth services list. In
the CY 2017 PFS final rule (81 FR 80198), 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 also stated in the CY 2017 PFS
final rule 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 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. We continue to believe this to
be true; however, we reviewed each therapy service separately, and have
categorized them together here for convenience as the same set of
information accompanied the request for each of these services.
We determined that these services did not meet the Category 1
criteria for addition to the Medicare telehealth services because they
are therapeutic in nature and in many instances involve direct physical
contact between the practitioner and the patient. In assessing the
evidence that was supplied by stakeholders in support of adding these
services to the Medicare telehealth services list on a Category 2
basis, we concluded that it did not provide sufficient detail to
determine whether all of the necessary elements of the service could be
furnished remotely, and whether the objective functional outcomes of
ADL and IADL for the telehealth patients were similar to those of
patients receiving the services in person. As we stated above when
discussing the request to add certain biofeedback services to the
telehealth list, we do not believe ADLs and IADLS alone are sufficient
to demonstrate clinical benefit to a Medicare beneficiary. We have
enumerated above some examples of the types of clinical benefits we
would consider when evaluating services using the Category 2 criterion.
Therefore, we do not believe the supplied information demonstrates
that the services meet either the Category 1 or the Category 2
criteria. We are not
[[Page 39135]]
proposing to add these services to the Medicare telehealth services
list. We continue to encourage commenters to supply sufficient data for
us to be able to see all measurements/parameters performed, so that we
may evaluate all outcomes.
We received requests to add the services in Table 9, and we note
that these services are generally not separately payable under the
Medicare PFS. Given that these services are not separately payable when
furnished in-person, they would not be separately payable when
furnished as telehealth. Section 1834(m)(2)(A) of the Act provides that
payment for a service when furnished as a telehealth services is equal
to the payment when the service is furnished in person. CPT code 90849
has a restricted payment status, indicating that claims must be
adjudicated on a case-by-case basis when furnished in-person.
Accordingly, any separate payment for that service would require
special consideration and not be routine. Therefore, we do not believe
this service should be added to the Medicare telehealth list. CPT codes
98960-98962 are bundled services, and therefore, payment for these
services is always bundled into payment of other services. For that
reason, we are not proposing to add them to the Medicare list of
telehealth services.
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We received requests to temporarily add Neurostimulators, CPT codes
95970-95972, and Neurostimulators, Analysis-Programming services, CPT
codes 95983 and 95984, to the Medicare telehealth services list using
the Category 3 criteria (see Table 10). In their submission, the
requestor noted they would conduct a future study and would submit the
study data to CMS at a later date. These services are on the expanded
telehealth services list for the PHE, but were not added by CMS on a
category 3 basis in the CY 2021 PFS final rule. We do not yet have
sufficient information to adjudicate whether these services are likely
to meet the category 1 or category 2 criteria given additional time on
the Medicare telehealth services list, without having evaluated the
full data, and we encourage commenters to submit all available
information, when available, for future consideration. As a result, we
are not proposing to add these services to the Medicare telehealth list
of services on a Category 3 basis at this time.
[[Page 39136]]
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c. Revised Timeframe for Consideration of Services Added to the
Telehealth List on a Temporary Basis
In the CY 2021 PFS final rule (85 FR 84506), in response to the PHE
for COVID-19, we created a third category of criteria for adding
services to the Medicare telehealth services list on a temporary basis.
We included in this category the services that were added during the
PHE for COVID-19 for which we believed 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. We recognized that
the services we added 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
that there was a potential for evidence development that could continue
through the Category 3 temporary addition period. We also stated that
any service added on a temporary basis under Category 3 would remain on
the Medicare telehealth services list through the end of the calendar
year in which the PHE for COVID-19 ends.
We added 135 services to the Medicare telehealth list in CY 2020 on
an interim basis in response to the PHE for COVID-19 through the
interim final rule with comment period (IFC) (March 31st COVID-19 IFC
(85 FR 19234-19243) and the subregulatory process established in the
May 8th COVID-19 IFC (85 FR 27550-27649). Since the publication of the
May 8th COVID-19 IFC, we have added several services to the Medicare
telehealth list of services using this subregulatory process (please
see <a href="https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes">https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes</a> for the list of codes available for
telehealth under the PFS). As discussed in the CY 2021 PFS final rule
(FR 85 84507), at the conclusion of the PHE for COVID-19, associated
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. Services that were
temporarily added on an interim basis during the PHE for COVID-19 would
not be continued on the list after the end of the PHE for COVID-19.
Numerous stakeholders have continued to note that there is
uncertainty about when the PHE for COVID-19 may end, and express
concerns that the services added to the telehealth list on a temporary
basis could be removed from the list before practitioners have had time
to compile
[[Page 39137]]
and submit evidence to support the permanent addition of these services
on a Category 1 or Category 2 basis. To respond to these continuing
concerns, we are proposing to revise the timeframe for inclusion of the
services we added to the Medicare telehealth services list on a
temporary, Category 3 basis. Extending the temporary inclusion of these
services on the telehealth list will allow additional time for
stakeholders to collect, analyze and submit data on those services to
support their consideration for permanent addition to the list on a
Category 1 or Category 2 basis.
We propose to retain all services added to the Medicare telehealth
services list on a Category 3 basis until the end of CY 2023. This will
allow us time to collect more information regarding utilization of
these services during the pandemic, and provide stakeholders the
opportunity to continue to develop support for the permanent addition
of appropriate services to the telehealth list through our regular
consideration process, which includes notice-and-comment rulemaking. By
keeping these services on the Medicare telehealth services list through
CY 2023, we will facilitate the submission of requests to add services
permanently to the Medicare telehealth services list for consideration
in the CY 2023 PFS rulemaking process and for consideration in the CY
2024 PFS rule.
See Table 11 for a list of services that were added to the Medicare
telehealth services list on an interim basis to respond to the PHE for
COVID-19, but were not extended on a temporary Category 3 basis in the
CY 2021 PFS final rule. Under our current policy, these services will
be removed from the Medicare telehealth services list as of the date
that the PHE for COVID-19 ends. We recognize that, during the time
between the publication of the CY 2021 PFS final rule and this proposed
rule, practitioners may have used that time to compile new evidence of
clinical benefit to support addition to the Medicare telehealth
services list on a category 3 basis, including information that
suggests that a certain service would likely meet the category 1 or
category 2 criteria if provided with more time. We are soliciting
comment on whether any of the services that were added to the Medicare
telehealth list for the duration of the PHE for COVID-19 should now be
added to the Medicare telehealth list on a Category 3 basis to allow
for additional data collection for submission for CMS to consider as
part of the rulemaking process described in prior paragraphs.
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d. Implementation of Provisions of the Consolidated Appropriations Act,
2021 (CAA)
The Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116-260,
December 27, 2020) included a number of provisions pertaining to
Medicare telehealth services. The Medicare telehealth statute at
section 1834(m)(4)(C) of the Act generally limits the scope of
telehealth services to those furnished in rural areas and in certain
enumerated types of ``originating sites'' including physician offices,
hospitals, and other medical care settings. Section 1834(m)(7) of the
Act, (as added by section 2001(a) of the SUPPORT for Patients and
Communities Act (Pub. L. 115-271, October 24, 2018), specifies that the
geographic restrictions under section 1834(m)(4)(C)(i) of the Act do
not apply, and includes the patient's home as a permissible originating
site, for telehealth services furnished to a patient with a diagnosed
substance use disorder (SUD) for treatment of that disorder or a co-
occurring mental health disorder. Section 123(a) of Division CC of the
CAA amended section 1834(m)(7)(A) of the Act to broaden the scope of
services for which the geographic restrictions under section
1834(m)(4)(C)(i) of the Act do not apply and for which the patient's
home is a permissible originating site to include telehealth services
furnished for the purpose of diagnosis, evaluation, or treatment of a
mental health disorder, effective for services furnished on or after
the end of the PHE for COVID-19.\2\
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\2\ We note that neither the SUPPORT Act nor the CAA amended
section 1862 of the Act. Section 1862(a)(4) of the Act and our
corresponding regulation at 42 CFR 411.9 prohibit Medicare payment
for services that are not furnished within the United States. Both
the originating site and the distant site are subject to the
statutory payment exclusion.
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Section 123(a) of the CAA also added subparagraph (B) to section
1834(m)(7) of the Act to prohibit payment for a telehealth service
furnished in the patient's home under paragraph (7) unless the
physician or practitioner furnishes an item or service in-person,
without the use of telehealth, within 6 months prior to the first time
the physician or practitioner furnishes a telehealth service to the
beneficiary, and thereafter, at such times as the Secretary determines
appropriate. However, section 123(a) of the CAA added a clarification
at section 1834(m)(7)(B)(ii) of the Act that the periodic requirement
for an in-person item or service does not apply if payment for the
telehealth service furnished would have been allowed without the new
amendments. As such, the requirement for a periodic in-person item or
service applies only for telehealth services furnished for purposes of
diagnosis, evaluation, or treatment of a mental health disorder other
than for treatment of a diagnosed SUD or co-occurring mental health
disorder, and only in locations that do not meet the geographic
requirements in section 1834(m)(4)(C)(i) of the Act or when the
originating site is the home of the patient, regardless of geography.
We are seeking comment on whether we
[[Page 39146]]
should adopt a claims-based mechanism to distinguish between the mental
health telehealth services that are within the scope of the CAA
amendments and those that are not (in other words, the services for
which payment was newly authorized by the CAA amendments, and those for
which payment was authorized before the CAA amendments), and if so,
what that mechanism should be. In the event that we need to distinguish
between the mental health telehealth services that are within the scope
of the CAA amendments and those that are not we are also seeking
comment on whether a clarification should be added to the regulation at
Sec. 410.78 as follows (which would take into account the other
amendments we are proposing to Sec. 410.78):
The requirement that the physician or practitioner must furnish an
item or service in person, without the use of telehealth, within a
specified time frame shall not apply to telehealth services furnished
for treatment of a diagnosed substance use disorder or co-occurring
mental health disorder, or to services furnished in an originating site
described in paragraphs (b)(3)(i) through (viii) or (xiii) that meets
the geographic requirements specified in paragraph (b)(4) other than
(b)(4)(iv)(D).
As we noted above, section 123(a) of the CAA amends section
1834(m)(7)(B)(i)(I) of the Act to prohibit payment for telehealth
services under that paragraph unless the physician or practitioner
furnished an item or service to the patient in person, without the use
of telehealth, within 6 months before the first telehealth service.
Thereafter, section 1834(m)(7)(B)(i)(II) of the Act leaves the
Secretary discretion to specify the times or intervals at which an in-
person, non-telehealth service is required as a condition of payment
for these telehealth services. Therefore, in order to implement the new
statutory requirement to specify when an in-person service is required,
we propose that, as a condition of payment for a mental health
telehealth service described in section 1834(m)(7)(A) of the Act other
than services described in section 1834(m)(7)(B)(ii) of the Act (that
is, services for which payment was authorized before the CAA
amendments), the billing physician or practitioner must have furnished
an in-person, non-telehealth service to the beneficiary within the 6-
month period before the date of the telehealth service.
We are also seeking comment on whether the required in-person, non-
telehealth service could also be furnished by another physician or
practitioner of the same specialty and same subspecialty within the
same group as the physician or practitioner who furnishes the
telehealth service. We note that the language in the CAA states that
the physician or practitioner furnishing the in-person, non-telehealth
service must be the same person as the practitioner furnishing the
telehealth service. There are several circumstances, however, under
which we have historically treated the billing practitioner and other
practitioners of the same specialty or subspecialty in the same group
as if they were the same individual. For instance, for purposes of
deciding whether a patient is a new or established patient, or whether
to bill for initial or subsequent visit, practitioners of the same
specialty/subspecialty in the same group are treated as the same
person. For example, when Physician A and Physician B are of the same
specialty and subspecialty and in the same group, if Physician A
furnishes an initial critical care service to a patient, and Physician
B subsequently furnishes additional critical care services to the same
beneficiary for the same condition on the same day, Physician B would
bill for a subsequent critical care service rather than an initial
critical care visit. As we explain in in section II.F.2 of this
proposed rule, because practitioners in the same specialty and same
group often cover for one another to provide concurrent services, we
believe the total time for critical care services furnished to a
patient on the same day by the practitioners in the same group with the
same specialty should be reflected as if it were a single set of
critical care services furnished to the patient. See section II.F.2 of
this proposed rule for further discussion of our current and proposed
policies for billing critica
[…truncated; see source link]Indexed from Federal Register on July 23, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.