Proposed Rule2023-14624
Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program
Primary source
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Published
August 7, 2023
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; payment for dental services inextricably linked to specific covered medical services; 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 and Medicaid provider and supplier enrollment policies, electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); updates to the Ambulance Fee Schedule regulations and the Medicare Ground Ambulance Data Collection System; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; expansion of the diabetes screening and diabetes definitions; pulmonary rehabilitation, cardiac rehabilitation and intensive cardiac rehabilitation expansion of supervising practitioners; appropriate use criteria for advanced diagnostic imaging; early release of Medicare Advantage risk adjustment data; a social determinants of health risk assessment in the annual wellness visit and Basic Health Program.
Full Text
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[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Proposed Rules]
[Pages 52262-53197]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14624]
[[Page 52261]]
Vol. 88
Monday,
No. 150
August 7, 2023
Part II
Book 2 of 2 Books
Pages 52261-53348
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 411, et al.
Medicare and Medicaid Programs; CY 2024 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment and Coverage
Policies; Medicare Shared Savings Program Requirements; Medicare
Advantage; Medicare and Medicaid Provider and Supplier Enrollment
Policies; and Basic Health Program; Proposed Rule
Federal Register / Vol. 88 , No. 150 / Monday, August 7, 2023 /
Proposed Rules
[[Page 52262]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 418, 422, 423, 424, 425, 455,
489, 491, 495, 498, and 600
[CMS-1784-P]
RIN 0938-AV07
Medicare and Medicaid Programs; CY 2024 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements;
Medicare Advantage; Medicare and Medicaid Provider and Supplier
Enrollment Policies; and Basic Health Program
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; payment for dental services inextricably linked to specific
covered medical services; 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 and Medicaid provider and supplier enrollment
policies, electronic prescribing for controlled substances for a
covered Part D drug under a prescription drug plan or an MA-PD plan
under the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act (SUPPORT Act);
updates to the Ambulance Fee Schedule regulations and the Medicare
Ground Ambulance Data Collection System; codification of the Inflation
Reduction Act and Consolidated Appropriations Act, 2023 provisions;
expansion of the diabetes screening and diabetes definitions; pulmonary
rehabilitation, cardiac rehabilitation and intensive cardiac
rehabilitation expansion of supervising practitioners; appropriate use
criteria for advanced diagnostic imaging; early release of Medicare
Advantage risk adjustment data; a social determinants of health risk
assessment in the annual wellness visit and Basic Health Program.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 11,
2023.
ADDRESSES: In commenting, please refer to file code CMS-1784-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-1784-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-1784-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
FOR FURTHER INFORMATION CONTACT:
<a href="/cdn-cgi/l/email-protection#e6ab83828f85879483b68e9f958f858f8788a08383b5858e8382938a83a6858b95c88e8e95c8818990"><span class="__cf_email__" data-cfemail="5a173f3e33393b283f0a3223293339333b341c3f3f0939323f3e2f363f1a39372974323229743d352c">[email protected]</span></a>, for any issues not identified
below. Please indicate the specific issue in the subject line of the
email.
Michael Soracoe, (410) 786-6312, and Morgan Kitzmiller, (410) 786-
1623, for issues related to practice expense, work RVUs, conversion
factor, and PFS specialty-specific impacts.
Kris Corwin, (410) 786-8864, for issues related to the comment
solicitation on strategies for updates to practice expense data
collection and methodology.
<a href="/cdn-cgi/l/email-protection#753810111c16140710251d0c061c161c141b33101026161d1011001910351618065b1d1d065b121a03"><span class="__cf_email__" data-cfemail="93def6f7faf0f2e1f6c3fbeae0faf0faf2fdd5f6f6c0f0fbf6f7e6fff6d3f0fee0bdfbfbe0bdf4fce5">[email protected]</span></a>, for issues related to
caregiver training services, community health integration services,
social determinants of health risk assessment, and principal illness
navigation services.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Kris Corwin, (410) 786-8864, Patrick Sartini, (410) 786-9252, and
Larry Chan, (410) 786-6864, for issues related to direct supervision
using two-way audio/video communication technology, telehealth, and
other services involving communications technology.
Tamika Brock, (312) 886-7904, for issues related to teaching
physician services.
Lindsey Baldwin, (410) 786-1694, Regina Walker-Wren, (410) 786-
9160, Erick Carrera, (410) 786-8949, or
<a href="/cdn-cgi/l/email-protection#f8b59d9c919b998a9da890818b919b919996be9d9dab9b909d9c8d949db89b958bd690908bd69f978e"><span class="__cf_email__" data-cfemail="d79ab2b3beb4b6a5b287bfaea4beb4beb6b991b2b284b4bfb2b3a2bbb297b4baa4f9bfbfa4f9b0b8a1">[email protected]</span></a>, for issues related to
advancing access to behavioral health.
<a href="/cdn-cgi/l/email-protection#bdf0d8d9d4dedccfd8edd5c4ced4ded4dcd3fbd8d8eeded5d8d9c8d1d8fdded0ce93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="f6bb93929f95978493a69e8f859f959f9798b09393a5959e9392839a93b6959b85d89e9e85d8919980">[email protected]</span></a>, for issues related to PFS
payment for evaluation and management services.
Morgan Kitzmiller, (410) 786-1623, for issues related to geographic
practice cost indices (GPCIs).
Zehra Hussain, (214) 767-4463, or
<a href="/cdn-cgi/l/email-protection#1b567e7f72787a697e4b7362687278727a755d7e7e4878737e7f6e777e5b78766835737368357c746d"><span class="__cf_email__" data-cfemail="074a62636e64667562576f7e746e646e666941626254646f6263726b6247646a74296f6f7429606871">[email protected]</span></a>, for issues related to payment
of skin substitutes.
Pamela West, (410) 786-2302, for issues related to supervision of
outpatient therapy services, KX modifier thresholds, diabetes self-
management training (DSMT) services, and DSMT telehealth services.
Laura Ashbaugh, (410) 786-1113, and Erick Carrera, (410) 786-8949,
Zehra Hussain, (214) 767-4463, or
<a href="/cdn-cgi/l/email-protection#a4e9c1c0cdc7c5d6c1f4ccddd7cdc7cdc5cae2c1c1f7c7ccc1c0d1c8c1e4c7c9d78accccd78ac3cbd2"><span class="__cf_email__" data-cfemail="a1ecc4c5c8c2c0d3c4f1c9d8d2c8c2c8c0cfe7c4c4f2c2c9c4c5d4cdc4e1c2ccd28fc9c9d28fc6ced7">[email protected]</span></a>, for issues related to dental
services inextricably linked to specific covered medical services.
Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, and
Rachel Radzyner, (410) 786-8215, for issues related to Drugs and
Biological Products Paid Under Medicare Part B.
<a href="/cdn-cgi/l/email-protection#0b466e6f62686a796e5b6372786268626a654d6e6e5868636e6f7e676e4b68667825636378256c647d"><span class="__cf_email__" data-cfemail="034e66676a60627166536b7a706a606a626d45666650606b6667766f6643606e702d6b6b702d646c75">[email protected]</span></a>, for issues related to
complex drug administration.
Laura Ashbaugh, (410) 786-1113, Ariana Pitcher,
<a href="/cdn-cgi/l/email-protection#84e5f6ede5eae5aaf4edf0e7ece1f6c4e7e9f7aaececf7aae3ebf2"><span class="__cf_email__" data-cfemail="68091a010906094618011c0b000d1a280b051b4600001b460f071e">[email protected]</span></a>, Rasheeda Arthur, (410) 786-3434, or
<a href="/cdn-cgi/l/email-protection#6a29262c393523041b1f0318030f192a09071944020219440d051c"><span class="__cf_email__" data-cfemail="cb88878d989482a5babea2b9a2aeb88ba8a6b8e5a3a3b8e5aca4bd">[email protected]</span></a> for issues related to Clinical Laboratory
Fee Schedule.
Lisa Parker, (410) 786-4949, or <a href="/cdn-cgi/l/email-protection#0741564f442a57575447646a74296f6f7429606871"><span class="__cf_email__" data-cfemail="3b7d6a7378166b6b687b58564815535348155c544d">[email protected]</span></a>, for issues
related to FQHC payments.
Michele Franklin, (410) 786-9226, or <a href="/cdn-cgi/l/email-protection#75273d36351618065b1d1d065b121a03"><span class="__cf_email__" data-cfemail="9cced4dfdcfff1efb2f4f4efb2fbf3ea">[email protected]</span></a>, for issues
related to RHC and FQHC Conditions for Certification or Coverage.
Kianna Banks (410) 786-3498 and Cara Meyer (667) 290-9856, for
issues related to RHCs and FQHCs definitions of staff.
Sarah Fulton, (410) 786-2749, for issues related to pulmonary
rehabilitation, cardiac rehabilitation and intensive cardiac
rehabilitation expansion of supervising practitioners.
Lindsey Baldwin, (410) 786-1694, Ariana Pitcher,
<a href="/cdn-cgi/l/email-protection#10716279717e713e6079647378756250737d633e7878633e777f66"><span class="__cf_email__" data-cfemail="0667746f67686728766f72656e637446656b75286e6e7528616970">[email protected]</span></a>, or <a href="/cdn-cgi/l/email-protection#b3fce7e3ecfed6d7dad0d2c1d6f3d0dec09ddbdbc09dd4dcc5"><span class="__cf_email__" data-cfemail="317e65616e7c5455585250435471525c421f5959421f565e47">[email protected]</span></a>, for issues
related to Medicare coverage of opioid use
[[Page 52263]]
disorder treatment services furnished by opioid treatment programs.
Sabrina Ahmed, (410) 786-7499, or <a href="/cdn-cgi/l/email-protection#6a39020b180f0e390b1c03040d193a18050d180b072a09071944020219440d051c"><span class="__cf_email__" data-cfemail="44172c253621201725322d2a233714362b23362529042729376a2c2c376a232b32">[email protected]</span></a>,
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#abf8c3cad9cecff8caddc2c5ccd8fbd9c4ccd9cac6ebc8c6d885c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="9ac9f2fbe8fffec9fbecf3f4fde9cae8f5fde8fbf7daf9f7e9b4f2f2e9b4fdf5ec">[email protected]</span></a>, for issues related to Shared
Savings Program beneficiary assignment and benchmarking methodology.
Lucy Bertocci, (667) 290-8833, or <a href="/cdn-cgi/l/email-protection#affcc7ceddcacbfcced9c6c1c8dcffddc0c8ddcec2efccc2dc81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="a1f2c9c0d3c4c5f2c0d7c8cfc6d2f1d3cec6d3c0cce1c2ccd28fc9c9d28fc6ced7">[email protected]</span></a>,
for inquiries related to Shared Savings Program advance investment
payments, and eligibility requirements.
Rachel Radzyner, (410) 786-8215, and Michelle Cruse, (443) 478-
6390, for issues related to preventive vaccine administration services.
Mollie Howerton (410) 786-5395, for issues related to Medicare
Diabetes Prevention Program.
Sarah Fulton (410) 786-2749, for issues related to appropriate use
criteria for advanced diagnostic imaging.
Frank Whelan, (410) 786-1302, for issues related to Medicare and
Medicaid provider and supplier enrollment regulation updates.
Daniel Feller (410) 786-6913 for issues related to expanding
diabetes screening and definitions.
Daniel Feller (410) 786-6913 for issues related to a social
determinants of health risk assessment in the annual wellness visit.
Mei Zhang, (410) 786-7837, and Kimberly Go, (410) 786-4560, 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 (section 2003 of the SUPPORT Act).
Amy Gruber, (410) 786-1542, or <a href="/cdn-cgi/l/email-protection#7b3a16190e171a15181e3f1a0f1a381417171e180f1214153b18160855131308551c140d"><span class="__cf_email__" data-cfemail="73321e11061f121d101637120712301c1f1f1610071a1c1d33101e005d1b1b005d141c05">[email protected]</span></a>,
for issues related to the Ambulance Fee Schedule (AFS) and the Medicare
Ground Ambulance Data Collection System.
Mary Rossi-Coajou (410) 786-6051, for issues related to hospice
Conditions of Participation.
Cameron Ingram (410) 409-8023 for issues related to Histopathology,
Cytology, and Clinical Cytogenetics Regulations under CLIA of 1988.
Meg Barry (410) 786-1536, for issues related to the Basic Health
Program (BHP) provisions.
Renee O'Neill, (410) 786-8821, or Sophia Sugumar, (410) 786-1648,
for inquiries related to Merit-based Incentive Payment System (MIPS).
Richard Jensen, (410) 786-6126, 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 commenter will take actions to harm an 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
2024 PFS proposed rule, refer to item CMS-1784-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#3d705859545e5c4f586d55444e545e545c537b58586e5e5558594851587d5e504e1355554e135a524b"><span class="__cf_email__" data-cfemail="98d5fdfcf1fbf9eafdc8f0e1ebf1fbf1f9f6defdfdcbfbf0fdfcedf4fdd8fbf5ebb6f0f0ebb6fff7ee">[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 annual 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,
2023 (Pub. L. 117-328, September 29, 2022), Inflation Reduction Act of
2022 (IRA) (Pub. L. 117-169, August 16, 2022), Consolidated
Appropriations Act, 2022 (Pub. L. 117-103, March 15, 2022),
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 for Patients and
Communities Act (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. of this proposed rule.
This rulemaking proposes to update the Rural Health Clinic (RHC)
and Federally Qualified Health Clinic (FQHC) Conditions for
Certification and Conditions for Coverage (CfCs), respectively, to
implement the provisions of the Consolidated Appropriations Act (CAA),
2023 (Pub. L. 117-328, December 29, 2022), now allowing payment under
Medicare Part B for services furnished by a Marriage and Family
Therapist (MFT) or Mental Health Counselor (MHC).
This rulemaking would also update the Hospice Conditions of
Participation (CoPs) to implement division FF, section 4121 of the CAA
2023 regarding the addition of marriage and family therapists (MFTs) or
mental health counselors (MHCs) as part of the hospice
interdisciplinary team and would make changes to the hospice personnel
requirements. This rulemaking would also seek to further advance
Medicare's overall value-based care strategy of growth, alignment, and
equity through the Medicare Shared Savings Program (MSSP) and the
Quality Payment Program (QPP). The structure of the programs enables us
to develop a set of tools for measuring and encouraging improvements in
care, which may support a shift to clinician payment over time into
Advanced Alternative Payment Models (APMs) and accountable care
arrangements which reduce care fragmentation and unnecessary costs for
patients and the health system.
This rulemaking would also update the Ambulance Fee Schedule
regulations to implement division FF, section 4103 of the CAA 2023
regarding the ground ambulance extenders provisions and would also
provide further changes and clarifications to the
[[Page 52264]]
Medicare Ground Ambulance Data Collection System.
This rulemaking would also update Medicare and Medicaid provider
and supplier enrollment regulations.
B. 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 each year we establish, 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.
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 2024 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, Medicare and Medicaid provider and supplier
enrollment policies, and other policies regarding programs administered
by CMS.
Specifically, this proposed rule addresses:
<bullet> Background (section II.A.)
<bullet> Determination of PE RVUs (section II.B.)
<bullet> Potentially Misvalued Services Under the PFS (section II.C.)
<bullet> Payment for Medicare Telehealth Services Under Section 1834(m)
of the Social Security Act (the Act) (section II.D.)
<bullet> Valuation of Specific Codes (section II.E.)
<bullet> Evaluation and Management (E/M) Visits (section II.F.)
<bullet> Geographic Practice Cost Indices (GPCI) (section II.G.)
<bullet> Payment for Skin Substitutes (section II.H.)
<bullet> Supervision of Outpatient Therapy Services, KX Modifier
Thresholds, Diabetes Self-Management Training (DSMT) Services by
Registered Dietitians and Nutrition Professional, and DSMT Telehealth
Services (section II.I.)
<bullet> Advancing Access to Behavioral Health (section II.J.)
<bullet> Proposals on Medicare Parts A and B Payment for Dental
Services Inextricably Linked to Specific Covered Medical Services
(section II.K.)
<bullet> Drugs and Biological Products Paid Under Medicare Part B
(section III.A.)
<bullet> Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (section III.B.)
<bullet> Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) Conditions for Certification or Coverage (CfCs)
(section III.C.)
<bullet> Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions (section III.D.)
<bullet> Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive
Cardiac Rehabilitation Expansion of Supervising Practitioners (section
III.E.)
<bullet> Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.F.)
<bullet> Medicare Shared Savings Program (section III.G.)
<bullet> Medicare Part B Payment for Preventive Vaccine Administration
Services (section III.H.)
<bullet> Medicare Diabetes Prevention Program Expanded Model (section
III.I.)
<bullet> Appropriate Use Criteria for Advanced Diagnostic Imaging
(section III.J.)
<bullet> Medicare and Medicaid Provider and Supplier Enrollment
(section III.K.)
<bullet> Expand Diabetes Screening and Diabetes Definitions (section
III.L.)
<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.M.)
<bullet> Proposed Changes to the Regulations Associated with the
Ambulance Fee Schedule and the Medicare Ground Ambulance Data
Collection System (GADCS) (section III.N.)
<bullet> Hospice: Changes to the Hospice Conditions of Participation
(section III.O.)
<bullet> RFI: Histopathology, Cytology, and Clinical Cytogenetics
Regulations under the Clinical Laboratory Improvement Amendments (CLIA)
of 1988 (section III.P.)
<bullet> Changes to the Basic Health Program Regulations (section
III.Q.)
<bullet> Updates to the Definitions of Certified Electronic Health
Record Technology (section III.R.)
<bullet> A Social Determinants of Health Risk Assessment in the Annual
Wellness Visit (section III.S.)
<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.)
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
In accordance with section 1848 of the Act, CMS has paid for
physicians' services under the Medicare physician fee schedule (PFS)
since January 1, 1992. 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 Medicare 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.
B. Determination of PE RVUs
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a
[[Page 52265]]
service that reflects the general categories of physician and
practitioner expenses, such as office rent and personnel wages, but
excluding malpractice (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 Physician Fee Schedule (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 Relative Value Scale Update Committee (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 in the CY 2007 PFS proposed rule (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
Socioeconomic Monitoring System (SMS). The AMA administered a new
survey in CY 2007 and CY 2008, the Physician Practice Information
Survey (PPIS). The PPIS is a multispecialty, nationally representative,
PE survey of both physicians and NPPs paid under the PFS using a survey
instrument and methods highly consistent with those used for the SMS
and the supplemental surveys. The PPIS gathered information from 3,656
respondents across 51 physician specialty and health care professional
groups. We believe the PPIS is the most comprehensive source of PE
survey information available. We used the PPIS data to update the PE/HR
data for the CY 2010 PFS for almost all of the Medicare recognized
specialties that participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by cross-walking 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 cross-walked PE/
HR, we instead used the PPIS based PE/HR. We use cross-walks for
specialties that did not participate in the PPIS. These cross-walks
have been generally established through notice and comment rulemaking
and are available in the file titled ``CY 2024 PFS proposed rule PE/
HR'' on the CMS website under downloads for the CY 2024 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
[[Page 52266]]
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, 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
direct 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 2024 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 an 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 52983) 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 interested parties. We display
this list of expected
[[Page 52267]]
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 interested parties 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 52983) 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 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 BN.
(See ``Specialties excluded from ratesetting calculation'' later in
this proposed rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable 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.
[[Page 52268]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.000
<bullet> Cross-walk certain low volume physician specialties:
Cross-walk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
<bullet> Physical therapy utilization: Cross-walk 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
[[Page 52269]]
accordingly. Table 2 details the manner in which the modifiers are
applied.
[GRAPHIC] [TIFF OMITTED] TP07AU23.001
We also adjust 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 required 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 applied 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
proposed rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1 (1/((1 +
interest rate)- life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage=1); generally, 150,000 minutes
usage = variable, see discussion below in this proposed rule
price = price of the particular piece of equipment
life of equipment = useful life of the particular piece of equipment
maintenance = factor for maintenance; 0.05
interest rate = variable, see discussion below in this proposed rule
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
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
[[Page 52270]]
types of equipment, the vast majority of which fall in the range of 5
to 10 years, and none of which are lower than 2 years in duration. We
believe that the updated editions of this reference material remain the
most accurate source for estimating the useful life of depreciable
medical equipment.
In the CY 2021 PFS 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] TP07AU23.002
We are not proposing any changes to the equipment interest rates
for CY 2024.
3. Adjusting RVUs To Match the PE Share of the Medicare Economic Index
(MEI)
In the past, we have stated that we believe that the MEI is the
best measure available of the relative weights of the three components
in payments under the PFS--work, practice expense (PE), and malpractice
(MP). Accordingly, we believe that to assure that the PFS payments
reflect the relative resources in each of these PFS components as
required by section 1848(c)(3) of the Act, the RVUs used in developing
rates should reflect the same weights in each component as the Medicare
Economic Index (MEI). In the past, we have proposed (and subsequently,
finalized) to accomplish this by holding the work RVUs constant and
adjusting the PE RVUs, MP RVUs, and CF to produce the appropriate
balance in RVUs among the three PFS components and payment rates for
individual services, that is, that the total RVUs on the PFS are
proportioned to approximately 51 percent work RVUs, 45 percent PE RVUs,
and 4 percent MP RVUs. As the MEI cost shares are updated, we would
typically propose to modify steps 3 and 10 to adjust the aggregate
pools of PE costs (direct PE in step 3 and indirect PE in step 10) in
proportion to the change in the PE share in the rebased and revised MEI
cost share weights, and to recalibrate the relativity adjustment that
we apply in step 18 as described ``3. Adjusting RVUs To Match PE Share
of the Medicare Economic Index (MEI)'' of the CY 2023 PFS final rule
(87 FR 69414 and 69415) and CY 2014 PFS final rule (78 FR 74236 and
74237). The most recent recalibration was done for the CY 2014 RVUs.
In the CY 2014 PFS proposed rule (78 FR 43287 through 43288) and
final rule (78 FR 74236 through 74237), we detailed the steps necessary
to accomplish this result (see steps 3, 10, and 18). The CY 2014
proposed and final adjustments were consistent with our longstanding
practice to make adjustments to match the RVUs for the PFS components
with the MEI cost share weights for the components, including the
adjustments described in the CY 1999 PFS final rule (63 FR 58829), CY
2004 PFS final rule (68 FR 63246 and 63247), and CY 2011 PFS final rule
(75 FR 73275).
In the CY 2023 PFS final rule (87 FR 69688 through 69711), we
finalized to rebase and revise the Medicare Economic Index (MEI) to
reflect more current market conditions faced by physicians in
furnishing physicians' services. We also finalized a delay of the
adjustments to the PE pools in steps 3 and 10 and the recalibration of
the relativity adjustment in step 18 until the public had an
opportunity to comment on the rebased and revised MEI (87 FR 69414
through 69416). Because we finalized significant methodological and
data source changes to the MEI in the CY 2023 PFS final rule and
significant time has elapsed since the last rebasing and revision of
the MEI in CY 2014, we believed that delaying the implementation of the
finalized CY
[[Page 52271]]
2023 rebased and revised MEI was consistent with our efforts to balance
payment stability and predictability with incorporating new data
through more routine updates. We refer readers to the discussion of our
comment solicitation in the CY 2023 PFS final rule (87 FR 69429 through
69432), where we reviewed our ongoing efforts to update data inputs for
PE to aid stability, transparency, efficiency, and data adequacy. We
also solicited comment in the CY 2023 PFS proposed rule on when and how
to best incorporate the CY 2023 rebased and revised MEI into PFS
ratesetting, and whether it would be appropriate to consider a
transition to full implementation for potential future rulemaking. We
presented the impacts of implementing the rebased and revised MEI in
PFS ratesetting through a 4-year transition and through full immediate
implementation, that is, with no transition period in the CY 2023 PFS
proposed rule. We also solicited comment on other implementation
strategies for potential future rulemaking in the CY 2023 PFS proposed
rule. In the CY 2023 PFS final rule, we discussed that many commenters
supported our proposed delayed implementation and many commenters
expressed concerns with the redistributive impacts of the
implementation of the rebased and revised MEI in PFS ratesetting. Many
commenters also noted that the AMA has said it intends to collect
practice cost data from physician practices in the near future which
could be used to derive cost share weights for the MEI and RVU shares.
In light of the AMA's intended data collection efforts in the near
future and because the methodological and data source changes to the
MEI finalized in the CY 2023 PFS final rule would have significant
impacts on PFS payments, we continue to believe that delaying the
implementation of the finalized 2017-based MEI cost weights for the
RVUs is consistent with our efforts to balance payment stability and
predictability with incorporating new data through more routine
updates. Therefore, we are not proposing to incorporate the 2017-based
MEI in PFS ratesetting for CY 2024.
As discussed above, in the CY 2023 PFS rulemaking, we finalized to
rebase and revise the MEI to reflect more current market conditions
faced by physicians in furnishing physicians' services. The final 2017-
based MEI relies on a methodology that uses publicly available data
sources for input costs that represent all types of physician practice
ownership, not limited to only self-employed physicians. The 2006-based
MEI relied on the 2006 AMA PPIS survey data; as of this CY 2024
rulemaking, this survey had not been updated. Given the changes in the
physician and supplier industry and the time since the last update to
the base year, we finalized a methodology that would allow us to update
the MEI on a consistent basis in the future. The 2017-based MEI cost
weights are derived predominantly from the annual expense data from the
U.S. Census Bureau's Services Annual Survey (SAS, <a href="https://www.census.gov/programs-surveys/sas.html">https://www.census.gov/programs-surveys/sas.html</a>). We supplement the 2017 SAS
expense data by using several data sources to further disaggregate
compensation costs and all other residual costs (87 FR 69688 through
69708).
We continue to review more recently available data from the Census
Bureau Services Annual Survey, the main data source for the major
components of the 2017-based MEI weights. Data is currently available
through 2021. Given that the impact of the PHE may influence the 2020
and 2021 data, we continue to evaluate whether the recent trends are
reflective of sustained shifts in cost structures or were temporary as
a result of the COVID-19 PHE. The 2022 data from the Services Annual
Survey will be available later this year. We will monitor that data and
any other data that may become available related to physician services'
input expenses and will propose any changes to the MEI, if appropriate,
in future rulemaking.
4. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2024 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2024 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 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
[[Page 52272]]
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, one
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 2023, 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 cross-walked to
the new listing of clinical labor activity codes. These lists are
available on the CMS website under downloads for the CY 2024 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. 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. Beginning in
CY 2019 and continuing through CY 2022, we conducted a market-based
supply and equipment pricing update, using information developed by our
contractor, StrategyGen, which updated pricing recommendations for
approximately 1300 supplies and 750 equipment items currently used as
direct PE inputs. Given the potentially significant changes in payment
that would occur, in the CY 2019 PFS final rule we finalized a policy
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. We believed that implementing the proposed updated prices
with a 4-year phase-in would improve payment accuracy, while
maintaining stability and allowing interested parties the opportunity
to address potential concerns about changes in payment for particular
items. This 4-year transition period to update supply and equipment
pricing concluded in CY 2022; for a more detailed discussion, we refer
readers to the CY 2019 PFS final rule with comment period (83 FR 59473
through 59480).
For CY 2024, we are proposing to update the price of 16 supplies
and two equipment items in response to the public submission of
invoices following the publication of the CY 2023 PFS final rule. The
16 supply and equipment items with proposed updated prices are listed
in the valuation of specific codes section of the preamble under Table
14, CY 2024 Invoices Received for Existing Direct PE Inputs.
[[Page 52273]]
We are not proposing to update the price of another eleven supplies
which were the subject of public submission of invoices. Our rationale
for not updating these prices is detailed below:
<bullet> Extended external ECG patch, medical magnetic tape
recorder (SD339): We received additional invoices for the SD339 supply
from an interested party. Upon review of the invoices, we determined
that they contained the identical price point that we previously
incorporated into last year's rule when we finalized a price of $260.35
for the supply item (87 FR 69514 through 69516). Since these invoices
did not contain any new information, we are maintaining the previously
finalized price of $260.35 for the SD339 supply.
<bullet> Permanent marking pen (SL477), Liquid coverslip (Ventana
650-010) (SL479), EZ Prep (10X) (Ventana 950-102) (SL481), Cell
Conditioning 1 (Ventana 950-124) (SL482), and Hematoxylin II (Ventana
790-2208) (SL483): We received invoices from interested parties for use
in updating the price of these laboratory supplies. In each case,
however, we were able to find the same supply item available for sale
online at the current price or cheaper. Therefore, we do not believe
that the submitted invoices represent typical market pricing for these
supplies and we are not proposing to update their prices.
<bullet> Mask, surgical (SB033), scalpel with blade, surgical (#10-
20) (SF033), eye shield, non-fog (SG049), gauze, non-sterile 4in x 4in
(SG051), and towel, paper (Bounty) (per sheet) (SK082): We received
invoices from interested parties for use in updating the price of these
common supply items. In each case, we received a single invoice and
once again we were able to find the same supply items available for
sale online at the current price or cheaper. Generally speaking, we
avoid updating the price for common supply items like the SB033
surgical mask (included in approximately 380 HCPCS codes) based on the
submission of a single invoice, as an invoice unrepresentative of
current market pricing will have far-reaching effects across the PFS.
We did not find that the typical price for a surgical mask had
increased by more than 60% since the supply and equipment pricing
update concluded in CY 2022, and as such we are maintaining the current
price for these supply items.
(1) Invoice Submission
We remind readers that 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. Interested parties 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#59091c06092b303a3c061037292c2d060c293d382d3c193a342a7731312a773e362f"><span class="__cf_email__" data-cfemail="eabaafb5ba9883898fb5a3849a9f9eb5bf9a8e8b9e8faa898799c4828299c48d859c">[email protected]</span></a>.
c. 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 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.
Beginning in CY 2019, we updated the supply and equipment prices
used for PE as part of a market-based pricing transition; CY 2022 was
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).
Interested parties raised concerns that the long delay since
clinical labor pricing was last updated created a significant disparity
between CMS' clinical wage data and the market average for clinical
labor. In recent years, a number of interested parties suggested that
certain wage rates were inadequate because they did not reflect current
labor rate information. Some interested parties also stated that
updating the supply and equipment pricing without updating the clinical
labor pricing could create distortions in the allocation of direct PE.
They argued that 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 was considerable interest among
interested parties 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), interested parties supported the idea.
Therefore, we proposed to update the clinical labor pricing for CY
2022, in conjunction with the final year of the supply and equipment
pricing update (86 FR 39118 through 39123). We believed it was
important to update the clinical labor pricing to maintain relativity
with the recent supply and equipment pricing updates. We proposed 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 our
CY 2022 clinical labor proposal.
We recognized that the BLS survey of wage data does not cover all
the staff types contained in our direct PE database. Therefore, we
cross-walked 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 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
[[Page 52274]]
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
cross-walked 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. We ultimately finalized the use of
median BLS wage data, as opposed to mean BLS wage data, in response to
comments in the CY 2022 PFS final rule. To account for the employers'
cost of providing fringe benefits, such as sick leave, we finalized the
use of a benefits multiplier of 1.296 based on a BLS release from June
17, 2021 (USDL-21-1094). As an example of this process, for the
Physical Therapy Aide (L023A) clinical labor type, the BLS data
reflected a median hourly wage rate of $12.98, which we multiplied by
the 1.296 benefits modifier and then divided by 60 minutes to arrive at
the finalized per-minute rate of $0.28.
After considering the comments on our CY 2022 proposals, we agreed
with commenters that the use of a multi-year transition would help
smooth out the changes in payment resulting from the clinical labor
pricing update, avoiding potentially disruptive changes in payment for
affected interested parties, and promoting payment stability from year-
to-year. We believed it would be appropriate to use a 4-year
transition, as we have for several other broad-based updates or
methodological changes. While we recognized that using a 4-year
transition to implement the update means that we will continue to rely
in part on outdated data for clinical labor pricing until the change is
fully completed in CY 2025, we agreed with the commenters that these
significant updates to PE valuation should be implemented in the same
way, and for the same reasons, as for other major updates to pricing
such as the recent supply and equipment update. Therefore, we finalized
the implementation of the clinical labor pricing update over 4 years to
transition from current prices to the final updated prices in CY 2025.
We finalized the implementation of this pricing transition over 4
years, such that one quarter of the difference between the current
price and the fully phased-in price is implemented for CY 2022, one
third of the difference between the CY 2022 price and the final price
is implemented for CY 2023, and one half of the difference between the
CY 2023 price and the final price is implemented for CY 2024, with the
new direct PE prices fully implemented for CY 2025. (86 FR 65025) An
example of the transition from the current to the fully-implemented new
pricing that we finalized in the CY 2022 PFS final rule is provided in
Table 4.
[GRAPHIC] [TIFF OMITTED] TP07AU23.003
(1) CY 2023 Clinical Labor Pricing Updates
For CY 2023, we received information from one interested party
regarding the pricing of the Histotechnologist (L037B) clinical labor
type. The interested party provided data from the 2019 Wage Survey of
Medical Laboratories which supported an increase in the per-minute rate
from the $0.55 finalized in the CY 2022 PFS final rule to $0.64. This
rate of $0.64 for the L037B clinical labor type is a close match to the
online salary data that we had for the Histotechnologist and matches
the $0.64 rate that we initially proposed for L037B in the CY 2022 PFS
proposed rule. Based on the wage data provided by the commenter, we
proposed this $0.64 rate for the L037B clinical labor type for CY 2023;
we also proposed a slight increase in the pricing for the Lab Tech/
Histotechnologist (L035A) clinical labor type from $0.55 to $0.60 as it
is a blend of the wage rate for the Lab Technician (L033A) and
Histotechnologist clinical labor types. We also proposed the same
increase to $0.60 for the Angio Technician (L041A) clinical labor type,
as we previously established a policy in the CY 2022 PFS final rule
that the pricing for the L041A clinical labor type would match the rate
for the L035A clinical labor type (86 FR 65032).
Based on comments received on the CY 2023 proposed rule, we
finalized a change in the descriptive text of the L041A clinical labor
type from ``Angio Technician'' to ``Vascular Interventional
Technologist''. We also finalized an update in the pricing of three
clinical labor types: from $0.60 to $0.84 for the Vascular
Interventional Technologist (L041A), from $0.63 to $0.79 for the
Mammography Technologist (L043A), and from $0.76 to $0.78 for the CT
Technologist (L046A) based on submitted wage data from the 2022
Radiologic Technologist Wage and Salary Survey (87 FR 69422 through
69425).
[[Page 52275]]
(2) CY 2024 Clinical Labor Pricing Update Proposals
We did not receive new wage data or other additional information
for use in clinical labor pricing from interested parties prior to the
publication of the CY 2024 PFS proposed rule. Therefore, our proposed
clinical labor pricing for CY 2024 is based on the clinical labor
pricing that we finalized in the CY 2023 PFS final rule, incremented an
additional step for Year 3 of the update:
BILLING CODE 4120-01-C
[[Page 52276]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.004
[[Page 52277]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.005
As was the case for the market-based supply and equipment pricing
update, the clinical labor rates will remain open for public comment
over the course of the 4-year transition period. We updated the pricing
of a number of clinical labor types in the CY 2022 and CY 2023 PFS
final rules in response to information provided by commenters. For the
full discussion of the clinical labor pricing update, we direct readers
to the CY 2022 PFS final rule (86 FR 65020 through 65037).
d. Technical Corrections to Direct PE Input Database and Supporting
Files
Following the publication of the CY 2023 PFS proposed rule, an
interested party notified CMS that CPT code 86153 (Cell enumeration
using immunologic selection and identification in fluid specimen (e.g.,
circulating tumor cells in blood); physician interpretation and report,
when required) appeared to be missing its work time in the Physician
Work Time public use file. We reviewed the request from the interested
party and determined that this was indeed an unintended technical
error; we stated in the CY 2013 PFS final rule that we were finalizing
0 minutes pre-service time, 20 minutes intraservice time, and 0 minutes
post-service time to CPT code 86153 (77 FR 69059), however work time
was inadvertently completely missing for this code. Therefore, we are
proposing to add the correct 20 minutes of intraservice work time to
CPT code 86153 for CY 2024.
5. Soliciting Public Comment on Strategies for Updates to Practice
Expense Data Collection and Methodology
a. Background
The AMA PPIS was first introduced in 2007 as a means to collect
comprehensive and reliable data on the direct and indirect PEs incurred
by physicians (72 FR 66222). In considering the use of PPIS data, the
goal was to improve the accuracy and consistency of PE RVUs used in the
PFS. The data collection process included a stratified random sample of
physicians across various specialties, and the survey was administered
between August 2007 and March 2008. Data points from that period of
time that are integrated into PFS calculations today. In the CY 2009
PFS proposed rule (73 FR 38507 through 3850), we discussed the indirect
PE methodology that used data from the AMA's survey that predated the
PPIS. In CY 2010 PFS rulemaking, we announced our intent to incorporate
the AMA PPIS data into the PFS ratesetting process, which would first
affect the PE RVU. In the CY 2010 PFS proposed rule, we outlined a 4-
year transition period, during which we would phase in the AMA PPIS
data, replacing the existing PE data sources (74 FR 33554). We also
explained that our proposals intended to update survey data only (74 FR
33530 through 33531). In our CY 2010 final rule, we finalized our
proposal, with minor adjustments based on public comments (74 FR 61749
through 61750). We responded to the comments we received about the
transition to using the PPIS to inform indirect PE allocations (74 FR
61750). In the responses, we acknowledged concerns about potential gaps
in the data, which could impact the allocation of indirect PE for
certain physician specialties and suppliers, which are issues that
remain important today. The CY 2010 PFS final rule explains that
section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub.
L. 106-113, November 29, 1999) directed 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. BBRA required us to
establish criteria for accepting supplemental survey data. Since the
supplemental surveys were specific to individual specialties and not
part of a comprehensive multispecialty survey, we had required that
certain precision levels be met in order to ensure that the
supplemental data was sufficiently valid, and acceptable for use in the
development of the PE RVUs. At the time, our rationale included the
assumption that because the PPIS is a contemporaneous, consistently
collected, and comprehensive multispecialty survey, we do not believe
similar precision requirements are necessary, and we did not propose to
establish them for the use of the PPIS data (74 FR 61742). We noted
potential gaps in the data, which could impact the allocation of
indirect PE for certain physician and suppliers. The CY 2010 final rule
adopted the proposal, with minor adjustments based on public comments,
and explained that these minor adjustments were in part due to non-
response bias that results when the characteristics of survey
respondents differ in meaningful ways, such as in the mix of practices
sizes, from the general population (74 FR 61749 through 61750).
Throughout the 4-year transition period, from CY 2010 to CY 2013,
we gradually incorporated the AMA PPIS data into the PFS rates,
replacing the previous data sources. The process involved addressing
concerns and making adjustments as necessary, such as refining the PFS
ratesetting methodology in consideration of interested party feedback.
For background on the refinements that we considered after the
transition began, we refer readers to discussions in the CY 2011-2014
final rules (75 FR 73178 through 73179; 76 FR 73033 through 73034; 77
FR 98892; 78 FR 74272 through 74276).
In the CY 2011 PFS proposed rule, we requested comments on the
methodology for calculating indirect PE RVUs, explicitly seeking input
on using survey data, allocation methods, and potential improvements
(75 FR 40050). In our CY 2011 PFS final rule, we addressed comments
regarding the methodology for indirect PE calculations, focusing on
using survey data, allocation methods, and potential improvements (75
FR 73178 through 73179). We recognized some limitations of the current
PFS ratesetting methodology but maintained that the approach was the
most appropriate at the time. In the CY 2012 PFS final rule, we
responded to comments related to indirect PE methodology, including
concerns about allocating indirect PE to specific services and using
the AMA
[[Page 52278]]
PPIS data for certain specialties (76 FR 73033 through 73034). We
indicated that CMS would continue to review and refine the methodology
and work with interested parties to address their concerns. In the CY
PFS 2014 final rule, we responded to comments about fully implementing
the AMA PPIS data. By 2014, the AMA PPIS data had been fully integrated
into the PFS, serving as the primary source for determining indirect PE
inputs (78 FR 74235). We continued to review data and the PE
methodology annually, considering interested party feedback and
evaluating the need for updates or refinements to ensure the accuracy
and relevance of PE RVUs (79 FR 67548). In the years following the full
implementation of the AMA PPIS data, we further engaged with interested
parties, thought leaders and subject matter experts to improve our PE
inputs' accuracy and reliability. For further background, we refer
readers to our discussions in final rules for CY 2016-2022 (80 FR
70892; 81 FR 80175; 82 FR 52980 through 52981; 83 FR 59455 through
59456; 84 FR 62572; 85 FR 84476 through 84478; 86 FR 62572).
In our CY 2023 PFS final rule, we issued an RFI to solicit public
comment on strategies to update PE data collection and methodology (87
FR 69429 to 69432). We solicited comments on current and evolving
trends in health care business arrangements, the use of technology, or
similar topics that might affect or factor into PE calculations. We
remind readers that we have worked with interested parties and CMS
contractors for years to study the landscape and identify possible
strategies to reshape the PE portion of physician payments. The
fundamental issues are clear, but thought leaders and subject matter
experts have advocated for more than one tenable approach to updating
our PE methodology.
As described in last year's rule, we have continued interest in
developing a roadmap for updates to our PE methodology that account for
changes in the health care landscape. Of various considerations
necessary to form a roadmap for updates, we reiterate that allocations
of indirect PE continue to present a wide range of challenges and
opportunities. As discussed in multiple cycles of previous rulemaking,
our PE methodology relies on AMA PPIS data, which may represent the
best aggregated available source of information at this time. However,
we acknowledge the limitations and challenges interested parties have
raised about using the current data for indirect PE allocations, which
we have also examined in related ongoing research. We noted in last
year's rule that there are several competing concerns that CMS must
take into account when considering updated data sources, which also
should support and enable ongoing refinements to our PE methodology.
Many commenters last year asked that CMS wait for the AMA to
complete a refresh of AMA survey data. We responded to these comments
by explaining the tension that waiting creates in light of concerns
raised by other interested parties. Waiting for refreshed survey data
would result in CMS using data nearly 20 years old to form indirect PE
inputs to set rates for services on the PFS. We remind readers that
many of the critical issues discussed in the background and history
above are mainly unchanged and possibly would not be addressed by an
updated survey alone but may also require revisions to the PFS
ratesetting methodology.
b. Request for Information
We continue to encourage interested parties to provide feedback and
suggestions to CMS that give an evidentiary basis to shape optimal PE
data collection and methodological adjustments over time. Submissions
should discuss the feasibility and burden of implementing any suggested
adjustments and highlight opportunities to optimize the cadence,
frequency, and phase-in of resulting adjustments. We continue to
consider ways that we may engage in dialogue with interested parties to
better understand how to address possible long-term policies and
methods for PFS ratesetting. We believe some of those concerns may be
alleviated by having ways to refresh data and make transparent how the
information affects valuations for services payable under the PFS more
accurately and precisely.
Considering our ratesetting methodology and prior experiences
implementing new data, we are issuing a follow-up solicitation for
general information. We seek comments from interested parties on
strategies to incorporate information that could address known
challenges we experienced in implementing the initial AMA PPIS data.
Our current methodology relies on the AMA PPIS data, legislatively
mandated supplemental data sources (for, example, we use supplemental
survey data collected in 2003, as required by section 1848(c)(2)(H)(i)
of the Act to set rates for oncology and hematology specialties), and
in some cases crosswalks to allocate indirect PE as necessary for
certain specialties and provider types.
We also seek to understand whether, upon completion of the updated
PPIS data collection effort by the AMA, contingencies or alternatives
may be necessary and available to address lack of data availability or
response rates for a given specialty, set of specialties, or specific
service suppliers who are paid under the PFS.
In light of the considerations discussed above, we request feedback
on the following:
(1) If CMS should consider aggregating data for certain physician
specialties to generate indirect allocators so that PE/HR calculations
based on PPIS data would be less likely to over-allocate (or under-
allocate) indirect PE to a given set of services, specialties, or
practice types. Further, what thresholds or methodological approaches
could be employed to establish such aggregations?
(2) Whether aggregations of services, for purposes of assigning PE
inputs, represent a fair, stable and accurate means to account for
indirect PEs across various specialties or practice types?
(3) If and how CMS should balance factors that influence indirect
PE inputs when these factors are likely driven by a difference in
geographic location or setting of care, specific to individual
practitioners (or practitioner types) versus other specialty/practice-
specific characteristics (for example, practice size, patient
population served)?
(4) What possible unintended consequences may result if CMS were to
act upon the respondents' recommendations for any of highlighted
considerations above?
(5) Whether specific types of outliers or non-response bias may
require different analytical approaches and methodological adjustments
to integrate refreshed data?
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
[[Page 52279]]
potentially misvalued codes, and to make appropriate adjustments.
As discussed in section II.E. of this proposed rule, under
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), MedPAC, and other interested
parties. 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 considered information provided by
other interested parties such as from the general medical-related
community and the public. We conducted 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 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 rise.
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 (76 FR 73026, 73058 through 73059),
other individuals and groups submit nominations for review of
potentially misvalued codes as well. Individuals and groups may submit
[[Page 52280]]
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 at <a href="/cdn-cgi/l/email-protection#4f022a2b262c2e3d2a1f27363c262c262e21092a2a1c2c272a2b3a232a0f2c223c6127273c61282039"><span class="__cf_email__" data-cfemail="38755d5c515b594a5d6850414b515b5159567e5d5d6b5b505d5c4d545d785b554b1650504b165f574e">[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 CY 2012 PFS final rule with comment period (76 FR 73052 through
73055). In the same CY 2012 PFS final rule with comment period, 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 CY 2013 PFS final rule with comment period (77 FR 68892,
68896 through 68897), 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'').\1\
In the CY 2019 PFS proposed rule (73 FR 38589), 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 of Work RVUs
proposed rule (76 FR 32410, 32419), 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.
---------------------------------------------------------------------------
\1\ The research team and panels of experts at the Harvard
School of Public Health developed the original work RVUs for most
CPT codes, in a cooperative agreement with the Department of Health
and Human Services (HHS). Experts from both inside and outside the
Federal Government obtained input from numerous physician specialty
groups. This input was incorporated into the initial PFS, which was
implemented on January 1, 1992.
---------------------------------------------------------------------------
3. CY 2024 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 67548,
67606 through 67608), we modified this process whereby the public and
interested parties 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 each year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
In each proposed rule, we seek nominations from the public and from
interested parties of codes that they believe we should consider as
potentially misvalued. We receive public nominations for potentially
misvalued codes by February 10th and we display these nominations on
our public website, where we include the submitter's name and their
associated organization for full transparency. We sometimes receive
submissions for specific, PE-related inputs for codes, and discuss
these PE-related submissions, as necessary under the Determination of
PE RVUs section of the rule. We summarize below this year's submissions
under the potentially misvalued code initiative. For CY 2024, we
received 10 nominations concerning various codes. The nominations are
as follows:
(1) CPT Code 59200
In the CY 2022 PFS proposed rule, an interested party nominated CPT
code 59200 (Insertion cervical dilator (e.g., laminaria,
prostaglandin)) (000 zero day global code) as potentially misvalued,
because the direct PE inputs for this code do not include the supply
item, Dilapan-S. Previous parties had initially sought to establish a
Level II HCPCS code for Dilapan-S, but CMS did not find sufficient
evidence to support that request. The same interested party then
submitted Dilapan-S to be considered as a practice expense (PE) supply
input to a Level I CPT code 59200 (86 FR 65045). This year, a different
interested party has nominated CPT code 59200 again, and provided the
same reasoning as to why this code is potentially misvalued.
[[Page 52281]]
Specifically, the current nominee recommends adding 4 rods of
Dilapan-S at $80.00 per unit, for a total of $320.00 to this one PE
supply inputs, as a replacement for the current PE supply item--
laminaria tent (a small rod of dehydrated seaweed that rehydrates,
absorbing the water from the surrounding tissue). The laminaria tent is
currently listed at $4.0683 per unit, with a total of 3 units, for a
total of $12.20. The current nominee stated that Dilapan-S is more
consistent and reliable, and suggested that it had higher patient
satisfaction than the laminaria tent, and that it was less likely to
cause leukocytosis. CPT code 59200 is a relatively low volume code,
with respect to Medicare claims and, as the nominator has stated, this
service is more typically billed for the Medicaid population, as
evidenced by 1.3 million Medicaid claims for this service. Medicaid
programs are able to set their own payment policies, which can be
different from Medicare payment policies. The current Medicare payment
for CPT code 59200 in CY 2023 is about $108.10 in the nonfacility/
office setting, which is much less than the typical cost of the
Dilapan-S supplies requested by the interested party. The requested 4
rods of Dilapan-S would increase the supply costs of CPT code 59200 by
a factor of five and represent an enormous increase in the direct costs
for the service.
We do not agree that CPT code 59200 is potentially misvalued, and
we do not agree with interested parties that the use of the Dilapan-S
supply would be typical for this service. By including the increased
direct costs of the service ($320.00, the typical cost of four units of
this supply item, Dilapan-S) in the valuation for this code, the cost
of this service will expand both Medicare spending and cost sharing for
any beneficiary who receives this service. The cost of Dilapan-S is
over 19 times higher than the cost of the current supply item
(laminaria tent) for CPT code 59200. We do agree with the nominator
that CPT code 59200 is much more frequently reported in the Medicaid
population, and therefore, we suggest that interested parties submit a
request for new and separate Medicaid payments to Medicaid.
We are not proposing to consider this code as potentially misvalued
for CY 2024, though we welcome comments on this nomination for further
consideration. We are soliciting comments on CPT code 59200 and whether
the absence of supply item Dilapan-S makes the nonfacility/office
Medicare payment for this service potentially misvalued.
(2) CPT Code 27279
CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or
minimally invasive (indirect visualization), with image guidance,
includes obtaining bone graft when performed, and placement of
transfixing device) (090 day global code) has been nominated as
misvalued due to the absence of separate direct PE inputs for this 090
day global code in the nonfacility office setting. Currently, the PFS
only prices CPT code 27279 in the facility setting, at about $826.85
for the physician's professional services, but the nominators are
seeking separate direct PE inputs for this service to better account
for valuation when performed in the nonfacility/office setting. These
PE amounts for CPT code 27279 are expected to be approximately
$21,897.63 in total, which is the Medicare outpatient payment amount
for CY 2023.
The nominator claims that CPT code 27279 can be safely and
effectively furnished in the nonfacility setting, and that this
procedure has a low risk profile, similar to kyphoplasty (CPT codes
22513, 22514, and 22515), which is currently furnished in the
nonfacility setting. The nominator describes Kyphoplasty as ``a
percutaneous minimally invasive procedure depositing poly methyl
methacrylate via canula into vertebral bodies near neural structures.''
The nominator states that permitting payment for direct PE inputs for
CPT code 27279 in the nonfacility/office setting would increase access
to this service for Medicare patients. One sample invoice for
$17,985.00 with three units of the itemized supply item IFuse-3D
Implant 7.0 mm x 55 mm, US ($5,995.00 per unit) was submitted with this
nomination to illustrate the high direct PE costs for CPT code 27279,
should CMS value this code in the nonfacility/office setting.
We are concerned about whether this 090 day surgical service can be
safely and effectively furnished in the non-facility/office setting
(for example, in an office-based surgical suite). We welcome comments
on the nomination of CPT code 27279 for consideration as potentially
misvalued.
(3) CPT Codes 99221, 99222, and 99223
An interested party nominated the Hospital Inpatient and
Observation Care visit CPT codes 99221 (Initial hospital care, per day,
for the evaluation and management of a patient, which requires these 3
key components: A detailed or comprehensive history; A detailed or
comprehensive examination; and Medical decision making that is
straightforward or of low complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the problem(s)
requiring admission are of low severity. Typically, 30 minutes are
spent at the bedside and on the patient's hospital floor or unit.),
99222 (Initial hospital care, per day, for the evaluation and
management of a patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of moderate complexity. Counseling and/or coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of moderate severity. Typically, 50
minutes are spent at the bedside and on the patient's hospital floor or
unit.), and 99223 (Initial hospital care, per day, for the evaluation
and management of a patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of high complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the problem(s)
requiring admission are of high severity. Typically, 70 minutes are
spent at the bedside and on the patient's hospital floor or unit.) as
potentially misvalued. CMS reviewed these codes in the CY 2023 final
rule (87 FR 69588) and established new physician work times and new
work RVU payments for these codes. The nominator disagrees with these
values and asserts that these ``facility-based codes are always
inherently (or proportionately) more intense than E/M services provided
in other settings [in particular],'' with patients presenting with
potentially infectious diseases, such as meningitis; pneumonia;
tuberculosis; HIV/AIDS; Ebola virus; Zika virus; and, most recently,
SARS-CoV-2 and mpox, and that the inpatient setting has a predominance
of more seriously ill patients, who are sometimes immunocompromised
and/or have multiple drug interaction issues and/or with comorbidities,
making them extraordinarily more complex than those patients typically
found in the
[[Page 52282]]
office setting (with many of these infections being health care-
associated infections and antibiotic-resistant bacterial infections).
It should be noted that these new requests did not offer appreciably
new information relative to last year's nomination/consideration.
The nominator seeks a new work RVU value of 1.92 for CPT code
99221, a new work RVU of 2.79 for CPT code 99222, and a new work value
of 4.25 for CPT code 99223. Currently, CPT code 99221 has a work RVU of
1.63, a reduction of 15.1 percent from its 1.92 work RVU from CY 2022.
CPT code 99222 had a work RVU of 2.61 in CY 2022 and is now at 2.60.
CPT code 99223 had a work RVU of 3.86 in CY 2022. It now has a value of
3.50, which is a reduction of 9.3 percent. The nominator has requested
that the work RVU for CPT code 99221 be restored back to 1.92, that the
work RVU of CPT code 99222 be increased to 2.79, and that the work RVU
of CPT code 99223 be increased to 4.25 (please see Table 6 for a
comparison of work RVU values for CY 2022, CY 2023, and of those
requested by the nominator).
[GRAPHIC] [TIFF OMITTED] TP07AU23.006
After consideration of this nomination and their requests for
higher work RVUs for CPT codes 99221, 99222, and 99223, we are
proposing to maintain the values that we finalized for these codes in
the CY 2023 PFS final rule (87 FR 69588). Even so, we welcome comments
on the nomination of these codes as potentially misvalued.
(4) CPT Codes 36514, 36516, 36522
An interested party nominated CPT codes 36514 (Therapeutic
apheresis; for plasma pheresis), 36516 (Therapeutic apheresis; with
extracorporeal immunoadsorption, selective adsorption or selective
filtration and plasma reinfusion), and 36522 (Photopheresis,
extracorporeal) (all 000 zero day global codes) as potentially
misvalued. The interested party stated that the direct PE of clinical
labor L042A, ``RN/LPN'' (for labor rate of $0.525 per minute) was
incorrect and should be changed to a more specific entry of ``a
therapeutic apheresis nurse specialist (RN)'' (for a labor rate of
about $1.06 to $1.14 per minute), which would approximately double all
three of these codes' clinical labor PE entries. In addition, the
nominator disagrees with the current direct PE of supply item SC085,
``Tubing set, plasma exchange'' at $186.12 per item, and believes that
this should be worth $248.77 per item with CPT code 36514, using a
quantity of one item. The nominator believes that supply item SC084,
``Tubing set, blood warmer,'' that we currently have listed at $8.01
per item, should be worth $14.71 per item with CPT code 36514, also
using a quantity of one item. Sample invoices (not actual invoices)
were submitted for illustration and support. We welcome comments on the
nomination of these codes as potentially misvalued, or not.
(5) CPT Codes 44205 and 44204
An interested party nominated CPT code 44205 (Laparoscopy,
surgical; colectomy, partial, with removal of terminal ileum with
ileocolostomy), as potentially misvalued, requesting that payment for
this code be made equivalent to the payment for CPT code 44204
(Laparoscopy, surgical; colectomy, partial, with anastomosis), which is
a higher amount. Both codes are 090 day global codes, currently valued
only in the facility setting. CPT code 44204 has a total RVU of 45.62
for CY 2023 and CPT code 44205 has a total RVU of 39.62 for CY 2023,
with a difference of 6.00 RVUs. CPT code 44204 is associated with 5 to
6 percent more physician work time: 455.0 minutes in total, as compared
to 428.5 minutes in total for CPT code 44205. The work RVU for CPT code
44204 is also 15 percent higher than the work RVU for CPT code 44205.
The direct PE entries for both codes are the same with regard to
supplies, equipment, and clinical labor, except that in the clinical
labor and equipment entries, the number of usage minutes is higher for
CPT code 44204.
Though these two codes appear to be similar, they are still
different in their purpose, physician work times, and direct PEs, with
CPT code 44204 involving more time and resources (and having a higher
payment, accordingly). For these reasons, we are not inclined to agree
that CPT code 44205 is potentially misvalued when compared to CPT code
44204, or to modify this payment differential by paying a higher amount
for CPT code 44205. We are soliciting feedback regarding the nomination
of CPT code 44205 as potentially misvalued.
(6) CPT Codes 93655 and 93657
An interested party nominated CPT codes 93655 (Intracardiac
catheter ablation of a discrete mechanism of arrhythmia which is
distinct from the primary ablated mechanism, including repeat
diagnostic maneuvers, to treat a spontaneous or induced arrhythmia
(List separately in addition to code for primary procedure)) and 93657
(Additional linear or focal intracardiac catheter ablation of the left
or right atrium for treatment of atrial fibrillation remaining after
completion of pulmonary vein isolation (List separately in addition to
code for primary procedure)), as potentially misvalued. These two add-
on codes were part of our code review in the cardiac ablation code
family in the CY 2022 (86 FR 65108) and CY 2023 (87 FR 69516) final
rules.
The nominator reiterates that the primary procedures involve ``high
intensity clinical decision making, complexity in the intraoperative
skills required for treatment, morbidity/mortality risks to the
patient, and work intensity'' and that the work RVUs for both of these
add-on codes should reflect the AMA RUC recommended 7.00 work RVUs. We
disagreed with this value in CY 2022, and we continue to believe that a
work RVU of 5.50 is appropriate for the 60 minutes of physician service
time for both codes. We see no reason to reconsider our valuation of
CPT codes 93655 and
[[Page 52283]]
93657 for CY 2022 or CY 2023, and we do not consider these codes to be
potentially misvalued now. We are not proposing to nominate these codes
as potentially misvalued for CY 2024.
(7) CPT Code 94762 and 95800
An interested party nominated CPT code 94762 (Noninvasive ear or
pulse oximetry for oxygen saturation; by continuous overnight
monitoring (separate procedure)) as potentially misvalued due to the PE
items listed for this code, which were last reviewed in 2009. There is
no physician work/professional component associated with this code. The
nominator states that the technology behind this code has changed
considerably over the last 14 years, and that the listed equipment
items for CPT code 94762, EQ212 ``pulse oxymetry recording software
(prolonged monitoring)'' and EQ353 ``Pulse oximeter 920 M Plus'' are
now typically found in a one-time use supply item: SD263 ``WatchPAT
pneumo-opt slp probes'' (extended external overnight pulse oximeter
device probe and battery with bluetooth, medical magnetic tape
recorder) (WatchPAT One Device) costing $99.00 each, derived from two
sample invoices (not actual invoices) that were included with the
nomination. According to our PE supply list, item SD263 costs $73.32,
which is $25.68 less than the amounts found in the sample invoices
submitted by the nominators. The nominator retains equipment item EQ212
``pulse oxymetry recording software (prolonged monitoring)'', and
replaces equipment item EQ353 with ED021, a ``computer, desktop, w-
monitor.'' Payment for CPT code 94762 is currently $25.75 in the
nonfacility office setting. There were 122,207 allowed service claims
for CPT code 94762 in CY 2021. The facility payment amount for CPT code
94762 under the Medicare Hospital Outpatient Prospective Payment System
(OPPS) is currently $145.43.
The same interested party who nominated CPT code 94762 also
nominated CPT code 95800 (Sleep study, unattended, simultaneous
recording; heart rate, oxygen saturation, respiratory analysis (e.g.,
by airflow or peripheral arterial tone), and sleep time) as potentially
misvalued, requesting that CMS update PE items for this code, which
were last reviewed in 2017. CPT code 95800 currently includes the entry
of a one-time use supply item, SD263 ``WatchPAT pneumo-opt slp probes''
(extended external overnight pulse oximeter device probe and battery
with bluetooth, medical magnetic tape recorder) (WatchPAT One Device),
which costs $73.32 per item, in contrast to the pricing in the sample
invoice--$99.00 each (case of 12 x $99.00 = $1,188.00). This is a
$25.68 difference in this supply item's cost.
The nominator excludes the current equipment for this code (EQ335
``WatchPAT 200 Unit with strap, cables, charger, booklet and patient
video'' and EQ336 ``Oximetry and Airflow Device'') and instead includes
ED021 (``computer, desktop, w-monitor'') in the PE for this code. We
note that we have not previously included ED021 as a specialized
equipment item dedicated to this function (and EQ212 ``pulse oxymetry
recording software (prolonged monitoring)'' is also not included in the
PE for CPT code 95800, as it is with CPT code 94762). The nominator
included the PE listings for CPT code 93245 (Heart rhythm recording,
analysis, interpretation and report of continuous external EKG over
more than 1 week up to 1 weeks) as an example of how PE supply items
for CPT code 95800 should be structured, but this code includes a
supply item, SD339 ``extended external ECG patch, medical magnetic tape
recorder'' and equipment item ED021 ``computer, desktop, w-monitor,''
which is presumed to be used to record the data from the ECG patch and
to be used to analyze this data. CMS currently pays a total of $150.80
for CPT code 95800 in the non-facility office setting, and there were
53,793 allowed services for this code in CY 2021.
There is not clear evidence whether the WatchPAT One Device needs,
or does not need, the specific monitoring and recording system
(equipment item EQ212 ``pulse oxymetry recording software (prolonged
monitoring)'') for CPT code 95800 as opposed to any other system/
process. The interested party has requested the practice expense
changes discussed above as support for their argument that these CPT
codes are potentially misvalued (See Table 7.)
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[[Page 52284]]
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We welcome comments as to whether or not these codes are
potentially misvalued.
(8) CPT Codes 0596T and 0597T
An interested party has nominated CPT codes 0596T (Initial
insertion of temporary valve-pump in female urethra) and 0597T
(Replacement of temporary valve-pump in female urethra) as potentially
misvalued due to MAC pricing, which is determined on a case-by-case
basis. These temporary CPT category III codes are all procedure status
``C'' (contractor priced), and the interested party is seeking status
``A'' (for active payment status) to account for physician work,
nonfacility PE, and professional liability costs. The nominator states
that the MAC-determined payment amounts have been inappropriately low,
and do not account for the time and the work that the physician expends
for these services, or for all of the PE costs associated with the
Vesiflo inFlow System. For CPT code 0596T, the nominator expects a
physician to spend 60 minutes of work on installing this Vesiflo inFlow
System. The nonfacility office PE items include a power table, a mayo
stand, an examination light, clinical labor time of a RN/LPN/MTA
totaling to 73 minutes, and a list of supplies summing to $1,902.76,
primarily from the inFlow Measuring Device of $140.00, the inflow
Device of $495.00, and the inflow Activator Kit of $1,250.00, making up
about 99 percent of the total cost of supplies.
For CPT code 0597T, the nominator expects a physician to spend 25
minutes of work replacing this Vesiflo inFlow System. The nonfacility
office PE items include a power table, a mayo stand, an examination
light, clinical labor time of a RN/LPN/MTA totaling to 38 minutes, and
a list of supplies summing to $505.30, primarily from the inflow device
of $495.00, making up about 98 percent of the total cost of supplies. A
sample invoice is included in this nomination (as opposed to an actual
invoice).
We welcome comments as to whether or not these two temporary
category II CPT codes, CPT codes 0596T and 0597T, are potentially
misvalued, and whether these codes should remain contractor priced or
not.
[[Page 52285]]
(9) CPT Code 93000
An interested party has nominated CPT code 93000
(Electrocardiogram, routine ECG with at least 12 leads; with
interpretation and report) as potentially misvalued, arguing that we
should increase Medicare payment for CPT code 93000 to $35.64, when
used in conjunction with other supplies and services, to adequately
compensate practitioners for their PE item costs for: (1) $6.10 for EKG
leads; (2) $21.19 for a nurse visit of typically 5 minutes time (as
illustrated by CPT code 99211 (Office or other outpatient visit for the
evaluation and management of an established patient, that may not
require the presence of a physician or other qualified health care
professional. Usually, the presenting problem(s) are minimal.
Typically, 5 minutes are spent performing or supervising these
services.)); and (3) $7.64 for the interpretation and report for the
EKG service (as illustrated by CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only).
The interested party is asking for the grouping of these services to be
valued at $35.64 (the actual sum of these inputs is $34.93). No
invoices or other evidence were provided for consideration.
For CY 2023, the national payment amounts under the PFS for CPT
codes 93000, 93010, and 99211 in the nonfacility office setting are as
follows:
<bullet> CPT code 93000; total RVUs 0.43 x CF $33.8872 = $14.57.
<bullet> CPT code 93010; total RVUs 0.24 x CF $33.8872 = $8.13.
<bullet> CPT code 99211; total RVUs 0.69 x CF $33.8872 = $23.38.
<bullet> Sum total $46.08.
After consideration, we are not proposing to nominate CPT code
93000 as potentially misvalued for CY 2024. The sum of a mix of
services is not a persuasive indication that one code--in this case,
CPT code 93000--is potentially misvalued.
(10) 19 Therapy codes
An interested party has nominated 19 therapy codes as potentially
misvalued. These 19 therapy codes were last reviewed by CMS in the CY
2018 PFS final rule (82 FR 53073 through 53074). The interested party
stated that the direct PE clinical labor minutes as recommended by the
AMA Relative Value Scale Update Committee (RUC) and Healthcare
Professional Advisory Committee (HCPAC) Review Board might have had
inappropriate multiple procedure payment reductions (MPPR) applied to
their PE clinical labor time entries. The nominators are now seeking
correction for those clinical labor time entries, which, if adjusted in
accordance with the recommendations of the nominators, would likely
result in slightly higher or nominally changed payments for the 19
therapy codes.
We have reviewed the clinical labor time entries for these 19
therapy codes, and we are now reconsidering the values established in
the CY 2018 final rule. We do not believe that MPPR should be applied
to these 19 nominated therapy codes' clinical labor time entries
(listed in Table 8), and as a result, we would like the AMA RUC HCPAC
recommendations from January 2017 to be re-reviewed. We recommend
nomination of these 19 codes as potentially misvalued for CY 2024, and
we welcome comments on this nomination.
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BILLING CODE 4120-01-C
D. 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. 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 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 signs or
symptoms.
<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 public health emergency (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 will 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 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 2024, requests to add services to the Medicare
Telehealth Services List must have been submitted and received by
February 10, 2023. 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 2024
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
[[Page 52287]]
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 also note that section 4113 of Division FF, Title IV, Subtitle A
of the Consolidated Appropriations Act, 2023 (CAA, 2023) (Pub. L. 117-
328, December 29, 2022) extends the telehealth policies enacted in the
Consolidated Appropriations Act, 2022 (CAA, 2022) (Pub. L. 117-103,
March 15, 2022) through December 31, 2024, if the PHE ends prior to
that date, as discussed in section II.D.c. of this proposed rule.
We received several requests to permanently add various services to
the Medicare Telehealth Services List effective for CY 2024. 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 9.
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[[Page 52289]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.010
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We remind interested parties 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 listed in Table 9 1 met the Category 1 criterion.
(1) Cardiovascular Procedures
We received a request to permanently add CPT code 93793
(Anticoagulant management for a patient taking warfarin, must include
review and interpretation of a new home, office, or lab international
normalized ratio (INR) test result, patient instructions, dosage
adjustment (as needed), and scheduling
[[Page 52290]]
of additional test(s), when performed)) to the Medicare Telehealth
Services List. We do not consider this service to be a Medicare
telehealth service, because the service is not an inherently face-to-
face service--a patient need not be present in order for the service to
be furnished in its entirety. For example, in many instances, clinical
staff will not change a patient's warfarin dosage as a result of the
lab INR test result, and they may or may not confirm the need for a
follow-up test via phone; either way there is no need for a face-to-
face encounter with a practitioner. As we have explained in previous
rulemaking (83 FR 59483), certain kinds of services that are furnished
remotely using communications technology are not considered Medicare
telehealth services and are not subject to the restrictions articulated
in section 1834(m) of the Act. This is true for services that were
routinely paid separately prior to the enactment of section 1834(m) of
the Act and do not usually include patient interaction such as the
remote interpretation of diagnostic tests. We do not consider CPT code
93793 to be a telehealth service under section 1834(m) of the Act or
our regulation at Sec. 410.78. Therefore, we are not proposing to add
this service to the Medicare Telehealth Services List on a Category 1
basis.
(2) Cardiovascular and Pulmonary Rehab
We received multiple requests to permanently add the following CPT
codes to the Medicare Telehealth Services List:
<bullet> 93797 (Physician or other qualified health care
professional services for outpatient cardiac rehabilitation; without
continuous ECG monitoring (per session)); and
<bullet> 94624 (Physician or other qualified health care
professional services for outpatient pulmonary rehabilitation; without
continuous oximetry monitoring (per session)).
In the CY 2022 PFS final rule (86 FR 65048), we explained that some
services were added temporarily to the Medicare Telehealth Services
List on an emergency basis to allow practitioners and beneficiaries to
have access to medically necessary care while avoiding both risk for
infection and further burdening healthcare settings during the PHE for
COVID-19. In the same rule, we considered available evidence and noted
that as evidence evolves on this subject matter, we welcome further
discussions with interested parties on the topic. In subsequent cycles
of annual rulemaking, we have continued conversations with interested
parties that furnish, support, and use Cardiovascular and Pulmonary
Rehabilitation services. In our CY 2022 PFS final rule (86 FR 65055),
we acknowledged that commenters provided a number of studies on the
safety and efficacy of these services when furnished via telehealth,
and we added the codes to the list on a temporary, Category 3 basis.
We note that some evidence submissions and ongoing discussions with
interested parties have focused on the clinical benefits of patients
receiving these services in the home. We note that, while demonstrating
the clinical benefits of services is important to our decision whether
to add a service to the Medicare Telehealth Services List, there are
other considerations when deciding whether to add codes to the list on
a permanent basis. For example, while the CAA, 2023, does extend
certain COVID-19 PHE flexibilities, including allowing the
beneficiary's home to serve as an originating site, such flexibilities
are only extended through the end of CY 2024. Under current law,
beginning on January 1, 2025, the beneficiary's home can be an
originating site only for Medicare telehealth services furnished for:
(1) the diagnosis, evaluation, or treatment of a mental health
disorder; or (2) a beneficiary with a diagnosed substance use disorder
(SUD) for purposes of treatment of the SUD or a co-occurring mental
health disorder; or (3) monthly ESRD-related clinical assessments
furnished to a beneficiary who is receiving home dialysis, beginning
January 1, 2025. Therefore, in the absence of further action by
Congress, CPT codes 93797 and 94626 will not be able to be furnished
via telehealth to a beneficiary in the home beginning January 1, 2025.
As such, we are not proposing to include these services permanently on
the Medicare Telehealth Services List on a Category 1 basis. We are
instead proposing to continue to include these services on the Medicare
Telehealth Services List through CY 2024. We would then remove CPT
codes 93797 and 94626 from the Medicare Telehealth Services List for CY
2025.
(3) Deep Brain Stimulation
We received a request to permanently add the following CPT codes to
the Medicare Telehealth Services List:
<bullet> 95970 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (e.g., contact group[s], interleaving,
amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet
mode, dose lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with brain, cranial nerve, spinal cord, peripheral nerve,
or sacral nerve, neurostimulator pulse generator/transmitter, without
programming);
<bullet> 95983 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (e.g., contact group[s], interleaving,
amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet
mode, dose lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with brain neurostimulator pulse generator/transmitter
programming, first 15 minutes face-to-face time with physician or other
qualified health care professional); and
<bullet> 95984 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (e.g., contact group[s], interleaving,
amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet
mode, dose lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with brain neurostimulator pulse generator/transmitter
programming, each additional 15 minutes face-to-face time with
physician or other qualified health care professional (List separately
in addition to code for primary procedure)).
In our CY 2023 proposed rule (85 FR 45891), we explained that these
services do not meet the Category 1 criterion for permanent addition to
the Medicare Telehealth Services List. Additionally, we discussed
concerns about whether the full scope of service elements could be
furnished via two-way, audio-video communication technology,
particularly since it is unclear whether the connection between the
implanted device and the analysis/calibration equipment can be done
remotely. Additionally, we are concerned about the immediate safety of
the patient if the calibration of the neurostimulator were done
incorrectly or if some other problem occurred. However, we did include
these services on the Medicare Telehealth Services List on a temporary
basis during the PHE to allow additional time for additional
information to be gathered and presented. Based on this information, we
believe there is some possible clinical benefit for these services when
furnished via telehealth; however, there is not yet sufficient evidence
available to consider the services for permanent addition under
[[Page 52291]]
the Category 2 criterion. We are proposing to keep these services on
the Medicare Telehealth Services List for CY 2024. We would consider
additional evidence in future rulemaking to determine whether to add
the services to the Medicare Telehealth Services List on a permanent
basis.
(4) Therapy
We received requests to add Therapy Procedures: CPT codes 97110,
97112, 97116; Physical Therapy Evaluations: CPT codes 97161-97164;
Therapy Personal Care services: CPT code 97530; and Therapy Tests and
Measurements services: CPT codes 97750, 97763 and Biofeedback: 90901,
to the Medicare Telehealth Services List on a Category 1 or 2 basis. We
have considered these codes over several years, in multiple cycles of
annual rulemaking. In the CY 2017 final rule (81 FR 80198), we first
assessed a request to add CPT codes 97110, 97112, and 97116 (the
therapy codes) to the Medicare Telehealth Services List. We did not add
the codes to the Medicare Telehealth Services List at the time, because
there was no emergency waiver providing an exception to the
requirements under section 1834(m)(4)(E) of the Act, and physical
therapists, occupational therapists, and speech-language pathologists
were not eligible telehealth practitioners. In the CY 2018 final rule
(82 FR 53008 and 53009), we reiterated our initial assessment that the
codes were not appropriate to add to the Medicare Telehealth Services
List, because the majority of the therapy codes listed above are
furnished over 90 percent of the time by therapy professionals who are
not included on the list of distant site practitioners who can furnish
telehealth services at section 1834(m)(4)(E) of the Act. We stated that
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 (82
FR 53009).
Section 3703 of Division A, Title III, Subtitle D of the
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L.
116-136, enacted March 27, 2020) amended section 1135(b)(8) of the Act
to give the Secretary emergency authorities to waive or modify Medicare
telehealth payment requirements under section 1834(m) of the Act during
the PHE for COVID-19. Using this authority, CMS issued a set of
emergency waivers that included waiving the restrictions in section
1834(m)(4)(E) of the Act on the types of practitioners who may furnish
telehealth services. This allowed for therapy professionals to furnish
telehealth services for the duration of the PHE. In the CY 2022 final
rule (86 FR 65051), we reviewed another round of submissions requesting
that CMS add therapy codes to the Medicare Telehealth Services List,
and we again determined that these codes did not meet the Category 1
criterion for addition to the list. In the CY 2023 PFS final rule (87
FR 69451), through our review of evidence that was submitted by
interested parties in support of adding these services to the Medicare
Telehealth Services List on a Category 2 basis, we concluded that there
was not sufficient information to determine whether all of the
necessary elements of these services could be furnished remotely.
In reviewing this year's request, the evidence submission includes
evidence similar to what was submitted last year, with a few new
additions suggesting that some elements of the individual services may
have clinical benefit when furnished via telehealth, but not resolving
uncertainty about whether other elements of the services can be fully
furnished remotely via telehealth. The evidence submitted also suggests
that receiving therapy services via telehealth in the home may offer
some practical benefits, such as use of actual stairs in therapy
exercise instead of artificial stairs, or meal preparation instructions
focused on available kitchen tools and equipment. However, the evidence
submitted for review leaves open questions as to whether such
differences in the setting of care translate to a clinical benefit that
is more than minor or incidental, in typical circumstances for the
typical population of beneficiaries who may receive therapy services
via telehealth.
We note that for any submission, including submissions received for
these therapy services, we consider all elements of a service as
described by a particular HCPCS code and apply our review criteria to
the specific code. While some submitted information may focus on an
individual service within one specific clinical scenario, and furnished
within one specific individual model of care delivery, that information
may not be generalizable to the varied settings and scenarios under
which the service would be typically furnished via telehealth. We
reiterate that available evidence should give a reasonable degree of
certainty that all elements of the service could fully and effectively
be furnished by a remotely-located clinician using two-way, audio/video
telecommunications technology.
Based on the evidence we reviewed, we continue to question whether
the findings from therapy studies that focused on a specific clinical
issue for a narrow population (for example, joint replacement of a
specific joint) translate to clinical benefit for some or many of the
various other clinical issues that would typically be addressed when
therapists furnish therapy services via telehealth to beneficiaries.
Despite the evidence, we are still uncertain as to whether all of the
elements of a therapy service could typically be furnished through use
of only real-time, two-way audio/video communications technology.
Because we continue to have these questions, we are not proposing to
add these services to the Medicare Telehealth Services List on a
Category 1 or 2 basis, for the same reasons described in our CY 2018
through CY 2023 rulemaking cycles. Also, we continue to believe that
adding these therapy services to the Medicare Telehealth Services List
permanently would potentially generate confusion. As discussed in last
year's final rule, we note that we do not have authority to expand the
list of eligible Medicare telehealth practitioners to include
therapists (PTs, OTs, or SLPs) after CY 2024 (87 FR 69449 through
69451). We note that the CAA, 2023, did not permanently change the list
of practitioners who can furnish and bill for telehealth services;
rather, the CAA, 2023, extended the current telehealth flexibilities
through the end of CY 2024. That said, we are proposing to keep these
therapy services on the Medicare Telehealth Services List until the end
of CY 2024. We will consider any further action with regard to these
codes in future rulemaking.
(5) Hospital Care, Emergency Department and Hospital
We received a request to permanently add the following CPT codes to
the Medicare Telehealth Services List:
<bullet> 99221 (Initial hospital inpatient or observation care, per
day, for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and straightforward or
low level medical decision making. When using total time on the date of
the encounter for code selection, 40 minutes must be met or exceeded.)
<bullet> 99222 (Initial hospital inpatient or observation care, per
day, for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and moderate level of
medical decision making. When using total time on the date of the
[[Page 52292]]
encounter for code selection, 55 minutes must be met or exceeded.)
<bullet> 99223 (Initial hospital inpatient or observation care, per
day, for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and moderate level of
medical decision making. When using total time on the date of the
encounter for code selection, 55 minutes must be met or exceeded.)
<bullet> 99234 (Hospital inpatient or observation care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and straightforward or low level of medical
decision making. When using total time on the date of the encounter for
code selection, 45 minutes must be met or exceeded.)
<bullet> 99235 (Hospital inpatient or observation care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and moderate level of medical decision
making. When using total time on the date of the encounter for code
selection, 70 minutes must be met or exceeded.)
<bullet> 99236 (Hospital inpatient or observation care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and high level of medical decision making.
When using total time on the date of the encounter for code selection,
85 minutes must be met or exceeded.)
<bullet> 99238 (Hospital inpatient or observation discharge day
management; 30 minutes or less on the date of the encounter)
<bullet> 99239 (Hospital inpatient or observation discharge day
management; more than 30 minutes on the date of the encounter)
<bullet> 99281 (Emergency department visit for the evaluation and
management of a patient that may not require the presence of a
physician or other qualified health care professional)
<bullet> 99282 (Emergency department visit for the evaluation and
management of a patient, which requires a medically appropriate history
and/or examination and straightforward medical decision making)
<bullet> 99283 (Emergency department visit for the evaluation and
management of a patient, which requires a medically appropriate history
and/or examination and low level of medical decision making)
In the March 31, 2020 interim final rule with comment period (IFC-
1) (85 FR 19234), we added the above services to the Medicare
Telehealth Services List on a Category 2 basis for the duration of the
PHE for COVID-19, for telehealth services with dates of service
beginning March 1, 2020 through the end of the PHE (including any
renewals of the PHE). When we previously considered adding these
services to the Medicare Telehealth Services List, either through a
public request or through our own internal review, we considered
whether these services met the Category 1 or Category 2 criteria. In
many cases, we reviewed requests to add these services to the Medicare
Telehealth Services List on a Category 1 basis, but did not receive or
identify information that allowed us to determine whether these
services should be added on a Category 2 basis (CY 2017 PFS final rule,
at 81 FR 80194 to 80197). We reiterate that, while we do not believe
the context of the PHE for COVID-19 changes the assessment of whether
these services meet the Category 1 criterion, we reassessed all of
these services to determine whether they meet the criteria for
inclusion on the Medicare Telehealth Services List on a Category 2
basis, in the context of the widespread presence of COVID-19 in the
community. Given the exposure risks for beneficiaries, the health care
work force, and the community at large, in-person interaction between
professionals and patients posed an immediate potential risk that would
not have been present when we previously reviewed these services in
2017. This risk created a unique circumstance where health care
professionals needed to weigh the risks associated with disease
exposure. For further background, in the CY 2021 final rule (FR 84506
through 84509), we explained the reasoning and considerations necessary
for assigning a Category 3 status to certain codes that were added to
the Medicare Telehealth Services List on a temporary basis during the
PHE for COVID-19. We believe that some risk of COVID-19 remains, but
also remain uncertain that available evidence gives clear support for
continuing to include these services on a permanent basis under the
Category 2 criterion.
As discussed in the CY 2023 PFS final rule (86 FR 69450), we
believe these hospital and emergency department services may continue
to be furnished safely via two-way, audio-video communication
technology. We are not proposing to add these services to the list on a
permanent basis at this time, but we are proposing that they would
remain available on the Medicare Telehealth Services List through CY
2024.
(6) Health and Well-Being Coaching
We received a request to permanently add the following three Health
and Well-being Coaching services to the Medicare Telehealth Services
List:
<bullet> CPT code 0591T (Health and well-being coaching face-to-
face; individual, initial assessment);
<bullet> CPT code 0592T (Health and well-being coaching face-to-
face; individual, follow-up session, at least 30 minutes); and
<bullet> CPT code 0593T (Health and well-being coaching face-to-
face; group (2 or more individuals), at least 30 minutes).
We are not proposing to add these health and well-being coaching
services to the Medicare Telehealth Services List on a permanent basis,
but we are proposing to add them to the list on a temporary basis for
CY 2024. The evidence included in the submitter's request notes that
these codes are similar to others already available on the Medicare
Telehealth Services List. Further, it appears that all elements of
these services may be furnished when using two-way interactive
communications technology to replace the face-to-face elements of the
service. The submission, which contained two published metanalyses of
literature on the clinical topic and an additional pre-publication
meta-analysis that focuses on outcomes and benefits of the delivery of
virtual health and well-being coaching, leaves some open questions as
to whether Medicare beneficiaries would receive meaningful clinical
benefit from receiving virtual-only health and well-being coaching.
While the evidence is clearly evolving, it does suggest that these
services could possibly meet Category 2 criteria for inclusion on the
Medicare Telehealth Services List as more evidence builds. We also note
that the published meta-analyses in the submission make clear that
further study is necessary for a broader range of medical
professionals, because conceptual articles and research and existing
practice articles focus on nurses, but are sparse or silent about other
general categories of medical professionals. As a reminder, we would
expect that any evidence in support of adding these codes on a
permanent basis should also establish clinical benefit when delivered
directly by or under the supervision of the types of professionals who
are Medicare telehealth practitioners. The metanalyses demonstrate that
health
[[Page 52293]]
coaching only requires a few hours of training, and few articles
submitted to CMS discuss the intensity of health coach training at all.
The pre-publication metanalysis submitted for review draws less than
definitive conclusions about ``potential benefits'' of health and well-
being coaching and hedges that authors, ``did not find evidence of
long-term benefit, possibly due to the paucity of studies examining
longer-term outcomes. We caution that the certainty in the evidence for
the majority of outcomes was either very low or low, primarily due to
high risk of bias, heterogeneity, and impression.'' The submission and
its content are sufficient to serve as a basis for adding the codes to
the Medicare Telehealth Services List on a temporary basis, and we
appreciate the thoughtful and transparent way the submission lays out
gaps in available evidence. More time is needed to potentially close
these gaps. We are not aware of any evidence to suggest that it would
be inappropriate to assign a temporary status. Therefore, we are
proposing to add the services to the Medicare Telehealth Services List
on a temporary basis.
(7) CMS Proposal To Add New Codes to the List
In addition to the health and wellbeing coaching services submitted
as requests, we are proposing to add HCPCS code GXXX5 (Administration
of a standardized, evidence-based Social Determinants of Health Risk
Assessment tool, 5-15 minutes) to the Medicare Telehealth Services
List. Our proposal to add HCPCS code GXXX5 to the list is contingent
upon finalizing the service code description that we propose in section
II.E of this proposed rule. We refer readers to the proposal in section
II.E for further background. We are proposing that HCPCS code GXXX5, if
finalized as proposed, receive a permanent status on the Medicare
Telehealth Services List. One element of the service describes a face-
to-face encounter between the clinician and beneficiary. Practitioners
use clinical judgement to determine whether to complete the SDOH
screening with or without direct patient interaction. Because the
service description, as defined in section II.E. of this proposed rule,
expects that a patient encounter may be necessary for accurate and
complete screening, we believe that this element of the service
describes an inherently face-to-face clinical activity. Further, the
use of two-way interactive audio-video technology, as a substitute to
in-person interaction, means an analogous level of care, in that using
either modality would not affect the accuracy or validity of the
results gathered via a standardized screening tool. As discussed in
section II.E. of this proposed rule, we are proposing that this service
must be furnished by the practitioner on the same date they furnish an
E/M visit, as the SDOH assessment would be reasonable and necessary
when used to inform the patient's diagnosis, and treatment plan
established during the visit. Therefore, we believe it describes a
service that is sufficiently similar to services currently on the
Telehealth list, specifically E/M services, and that this service be
added on a permanent basis.
c. Proposed Clarifications and Revisions to the Process for Considering
Changes to the Medicare Telehealth Services List
1. Overview
In CY 2020, CMS issued an array of waivers and new flexibilities
for Medicare telehealth services to respond to the serious public
health threats posed by the spread of COVID-19 (85 FR 19230). Our goal
was to give individuals and entities that provide services to Medicare
beneficiaries needed flexibilities to respond effectively to the
serious public health threats posed by the spread of COVID-19.
Recognizing the urgency of this situation and understanding that some
pre-existing Medicare payment rules (including the statutory
restrictions on telehealth originating sites and telehealth
practitioners) needed to be modified in order to allow patients and
practitioners to have access to necessary care while mitigating the
risks from COVID-19, we used waiver and regulatory authorities to
change certain Medicare payment rules during the PHE for COVID-19 so
that physicians and other practitioners, home health and hospice
providers, inpatient rehabilitation facilities, rural health clinics
(RHCs), and federally qualified health centers (FQHCs) would be allowed
broad flexibilities to furnish services using remote communications
technology to avoid exposure risks to health care providers, patients,
and the community.
In 2003, as required by section 1834(m)(4)(F)(ii), we established a
process for adding or deleting services from the Medicare Telehealth
Services List, which included consideration under two categories of
criteria (Categories 1 and 2) (67 FR 79988). We finalized revisions to
the Category 2 review criterion in the CY 2012 PFS final rule (76 FR
73102). Prior to CY 2020, CMS had not added any service to the Medicare
Telehealth Services List on a temporary basis. In CY 2020, in response
to the PHE for COVID-19, we revised the criteria for adding or removing
services on the Medicare Telehealth Services List using a combination
of emergency waiver authority and interim final rule making, so that
some services would be available for the duration of the PHE on a
``temporary Category 2 basis.'' (85 FR 19234). In the CY 2021 PFS final
rule (85 FR 84507), we created a third, temporary category for services
included on the Medicare Telehealth Services List on a temporary basis.
This new Category 3 includes many, but not all of the services that we
added temporarily to the Medicare Telehealth Services List during the
COVID-19 PHE. Specifically, we reviewed the services we added
temporarily in response to the COVID-19 PHE and identified those for
which there is likely to be clinical benefit when furnished via
telehealth, but there is not yet sufficient evidence available to add
the services as permanent additions to the list. Services added to the
Medicare Telehealth Services List on a temporary, Category 3 basis will
ultimately need to meet the Category 1 or 2 criteria in order to be
added to the Medicare Telehealth Services List on a permanent basis.
Between CY 2020 and CY 2023, we added many services to the Medicare
Telehealth List on a temporary basis during the PHE, and through
rulemaking, we also added many of these services on a Category 3 basis.
Subsequent requests and evidence submitted to CMS supported possible
status changes for some of the services that are currently included on
the Medicare Telehealth Services List on a Category 3 basis. However,
submissions sometimes confused our use of waiver authority and
regulatory flexibilities tied to the COVID-19 PHE which allow us to
temporarily add services to the Medicare Telehealth Services List
through the end of the PHE, with the generally applicable categories
and criteria we use to consider changes to the Medicare Telehealth
Services List outside the circumstances of the COVID-19 PHE. Now that
the PHE for COVID-19 has ended, we intend to clarify and modify our
process for making changes to the Medicare Telehealth Services List. We
believe these clarifications will help address potential confusion
among interested parties that submit requests for additions to the
Medicare Telehealth List stemming from the distinction between services
that were added to the telehealth list on the basis of COVID-19 PHE-
related authorities versus services that were added temporarily on a
[[Page 52294]]
Category 3 basis, which does not rely on any PHE-related authority.
Specifically, we created the Category 3 basis for considering changes
in the Medicare Telehealth Services List as part of the process we are
required to establish under section 1834(m)(4)(F)(2) for considering
changes to the list in part because, with the significant expansion of
remotely-furnished services in response to the COVID-19 PHE, we
recognized the emergence of new data suggesting that there may be
clinical benefit when certain services are delivered via telehealth,
but more time is needed to develop additional evidence to support
potential addition of the services on a permanent, Category 1 or
Category 2 basis. Under Category 3, services are added to the list on a
temporary basis to allow them to continue to be furnished via
telehealth while additional evidence is developed.
In brief, throughout the COVID-19 PHE, we have reviewed all
requests to add services to the Medicare Telehealth Services List and
assessed whether the services in question should be added to the list,
temporarily or permanently, under any of the criteria for Category 1,
2, or 3. Further, we did not reject any submissions from interested
parties simply because they requested consideration under a specific
category, and the submitted data did not support adding the service to
the Medicare Telehealth Services List on that basis. Instead, we
considered whether the service(s) should be added to the Medicare
Telehealth Services List on any basis.
To avoid potential continuing confusion among those who submit
requests to add services to the Medicare Telehealth Services List, and
as we consider the expiration of the Medicare telehealth flexibilities
extended by the CAA, 2023 through the end of CY 2024, we believe it
would be beneficial to simplify our current taxonomy and multicategory
approach to considering submitted requests. Further, we believe that
simplification toward a binary classification approach could address
the confusion we have noticed from interested parties submitting
requests during the PHE. Our proposal would restore the simple binary
that existed with Category 1 and 2, without displacing or disregarding
the flexibility of Category 3. We propose to simply classify and
consider additions to the Medicare Telehealth Services List as either
permanent, or provisional.
At bottom, to consider a request to add a service to the Medicare
Telehealth Services List, we need evidence that supports how the
telehealth service is either clinically equivalent to a telehealth
service already permanently on the list, or evidence that presents
studies where findings suggest a clinical benefit sufficient for the
service to remain on the list to allow time for confirmative study. We
reemphasize the need for clinical evidence because that evidence serves
as the principal basis for our consideration of a request; and it is
sometimes missing from submissions we receive.
For example, we have received some submissions requesting the
addition of services to the Medicare Telehealth Services List that are
essentially framed as position papers advocating for changes in
statutory requirements of section 1834(m) of the Act. While we do give
such requests due consideration, the omission of clinical evidence to
support the addition of a service to the Medicare Telehealth Services
List using our established criteria generally leads us to conclude that
the service should not be proposed for addition to the list. A fair and
consistent review process for any and all submissions relies on a
standard application of uniform, repeatable procedures for any
individual submission, just as sound evidence should describe
repeatable methods and replicable findings. Submissions that rely on
narrative arguments for changes in the substantive requirements do not
fit within such a fair and consistent review process. Therefore, we
believe the following restatement of requirements and our review
process is appropriate. We also propose some procedural refinements to
the review process, specifically incorporating additional
considerations into our evaluation of services, that we believe would
serve to maintain scope and focus in a post-PHE context. We discuss
these proposed changes in detail in the following section.
Section 1834(m)(4)(F)(ii) of the Act requires that the Secretary
establish a process that provides, on an annual basis, for the addition
or deletion of services (and HCPCS codes), to the definition of
telehealth services for which payment can be made when furnished via
telehealth under the conditions specified in section 1834(m). As
specified at Sec. 410.78(f), with the exception of a temporary policy
that was limited to the PHE for COVID-19, we make changes to the list
of Medicare telehealth services through the annual physician fee
schedule rulemaking process. The proposed revisions to our current
permanent policies, specifically our proposed assignment of a
``permanent'' or ``provisional'' status to a service and changes in
status as described below, reflect the stepwise method by which we
propose to consider future requests to add services to, remove services
from, or change the status of, services on the Medicare Telehealth
Services List, beginning for the CY 2025 Medicare Telehealth Services
List, which will include submissions received no later than February
10, 2024.
2. Proposed Steps of Analysis for Services Under Consideration for
Addition, or Removal, or a Change in Status, as Updates to the Medicare
Telehealth Services List
Step 1. Determine whether the service is separately payable under
the PFS.
When considering whether to add, remove, or change the status of a
service on the Medicare Telehealth Services List, we are proposing to
first determine whether the service, as described by the individual
HCPCS code, is separately payable under the PFS. Under section
1834(m)(1) of the Act, Medicare telehealth services are limited to
those for which payment can be made to the physician or practitioner
when furnished using an interactive telecommunications system
notwithstanding that the practitioner furnishing the services is not in
the same location as the beneficiary; and under section 1834(m)(2)(A)
of the Act, Medicare pays the same amount for a telehealth service as
if the service is furnished in person. As such, Medicare telehealth
services are limited to those services for which separate Medicare
payment can be made under the PFS. Thus, through Step 1, we would
answer the threshold question of whether a service is separately
payable under the PFS. During the PHE, many submissions for addition to
the Medicare Telehealth Services List advocated for CMS to change the
definition of ``Medicare telehealth service'' for their specific
service; some of those submissions were for services that were not
separately payable under the PFS.\2\ (87 FR 69449). We anticipate that
Step 1, if finalized, will encourage submissions that focus on a
separately payable PFS service, and that the evidence included with
those submissions will show how use of interactive, two-way, audio/
video telecommunications technology allows a practitioner to complete
an entire, specific service, described by a HCPCS
[[Page 52295]]
code, that is equivalent to an in-person service.
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\2\ Services on the Medicare Telehealth List are used in the
definition of Medicare telehealth. Some submissions may have
conflated the distinction. Step 1 clarifies. Refer to the CMS
website instructions for a Request for Addition at <a href="https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition">https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition</a>.
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We recognize that certain codes that had non-payable or bundled
(not separately payable) status under the PFS before the PHE for COVID-
19 were temporarily included on the Medicare Telehealth Services List
to facilitate access to health care services during the PHE. However,
the PHE for COVID-19 has now expired.
We believe that proposed Step 1, if finalized, would lessen the
administrative burden of our telehealth services review process for
both CMS and the public. We note that before gathering evidence and
preparing to submit a request to add a service to the Medicare
Telehealth Services List, the submitter should first check the payment
status for a given service and ensure that the service (as identified
by a HCPCS code), is a covered and separately payable service under the
PFS (as identified by payment status indicators A, C, T, or R on our
public use files). For a full list of all PFS payment status indicators
and descriptions, see the Medicare Claims Processing Manual (IOM Pub.
100-04, chapter 23, section 30.2.2) and the Addendum for the MPFSDB
File Record Layout. Researchers and others preparing submissions should
also refer to the data dictionaries available at <a href="https://resdac.org/cms-data/files/carrier-ffs/data-documentation">https://resdac.org/cms-data/files/carrier-ffs/data-documentation</a>, to review whether the
methodology and conclusions contained in supporting evidence, or a
submission itself, applies an appropriate methodology to study both
individual services and individuals that are representative of the
Medicare population.
We further propose that, if we find that a service identified in a
submission is not separately payable under the PFS, we would not
conduct any further review of that service. We would identify the code
submitted for consideration and explain that we are not proposing it
for addition. CMS sends confirmation from
<a href="/cdn-cgi/l/email-protection#bdfef0eee2c9d8d1d8d5d8dcd1c9d5cfd8cbd4d8cafdded0ce93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="20636d737f54454c454845414c544852455649455760434d530e4848530e474f56">[email protected]</span></a> when we receive a submission
requesting addition of a service to, removal of a service from, or a
change in status for a service included on, the Medicare Telehealth
Services List. We are proposing to inform each submitter in the
confirmation whether the submission was complete, lacking required
information, or outside the scope of issues we consider under the
process for considering changes in the Medicare Telehealth Services
List. We note that we also expect submissions to include copies of any
source material used to support assertions, which has been the
longstanding direction included in our website instructions. For
further background, refer to details available on our website at
<a href="https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition">https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition</a>.
Step 2. Determine whether the service is subject to the provisions
of section 1834(m) of the Act.
If we determine at Step 1 that a service is separately payable
under the PFS, we propose to apply Step 2 under which we would
determine whether the service at issue is subject to the provisions of
section 1834(m) of the Act. A service is subject to the provisions of
section 1834(m) of the Act when at least some elements of the service,
when delivered via telehealth, are a substitute for an in-person, face-
to-face encounter, and all of those face-to-face elements of the
service are furnished using an interactive telecommunications system as
defined in Sec. 410.78(a)(3). The aim of this step is to determine
whether the service is, in whole or in part, inherently a face-to-face
service. As we discussed in the CY 2018 PFS final rule (83 FR 59483),
it has long been the case that certain services that are furnished
remotely using communications technology are not considered Medicare
telehealth services and are not subject to the requirements of section
1834(m) of the Act. We are proposing Step 2 to emphasize the
circumstances under which the criteria under section 1834(m) of the Act
apply, and also highlight circumstances in which the criteria under
section 1834(m) of the Act do not apply. As previously noted, section
1834(m) of the Act provides for payment to a physician or practitioner
for a service furnished via an interactive telecommunications system
notwithstanding that the furnishing practitioner and patient are not in
the same location at the same amount that would have been paid if the
service was furnished without the telecommunications system. We read
this to mean that the scope of section 1834(m) of the Act is limited to
services that would ordinarily be furnished with the furnishing
practitioner and patient in the same location.
Our application of Step 2 remains consistent with longstanding
policy. We reiterate that there is a range of services delivered using
certain telecommunications technology that do not fall within the scope
of Medicare telehealth services, though they are separately payable
under the PFS. Such services generally include services that do not
require the presence of, or involve interaction with, the patient (for
example, remote interpretation of diagnostic imaging tests, and certain
care management services). Other examples include virtual check-ins, e-
visits, and remote patient monitoring services which involve the use of
telecommunications technology to facilitate interactions between the
patient and practitioner, but do not serve as a substitute for an in-
person encounter, for example, to assess whether an in-person or
telehealth visit is needed or to transmit health information to the
practitioner.
In determining whether a service is subject to the provisions of
section 1834(m) of the Act, we will consider whether one or more of the
elements of the service, as described by the particular HCPCS code at
issue, ordinarily involve direct, face-to-face interaction between the
patient and practitioner such that the use of an interactive
telecommunications system to deliver the service would be a substitute
for an in-person visit. For interested parties preparing a request to
add a service to the Medicare Telehealth Services List, we believe this
Step 2 clarifies that a service must be inherently a face-to-face
service. We believe reframing this Step 2 has the practical advantage
of refining and improving consistency. We do not believe it would be
appropriate to add a service to the Medicare Telehealth Services List
if it is not subject to section 1834(m) of the Act. We would explain
our finding in notice and comment rulemaking.
Step 3. Review the elements of the service as described by the
HCPCS code and determine whether each of them is capable of being
furnished using an interactive telecommunications system as defined in
Sec. 410.78(a)(3).
We believe that the proposed Step 3 is fundamental to our
commitment to health equity, as this step could have a beneficial
impact on access to care for vulnerable populations. Step 3 is
corollary to Step 2, and used to determine whether one or more elements
of a service are capable of being delivered via an interactive
telecommunication system as defined in Sec. 410.78(a)(3). In Step 3,
we consider whether one or more face-to-face component(s) of the
service, if furnished via audio-video communications technology, would
be equivalent to the service being furnished in-person, and we seek
information from submitters to demonstrate evidence of substantial
clinical improvement in different beneficiary populations that may
benefit from the requested service when furnished via telehealth,
including, for example, in rural populations. The services are not
equivalent when the
[[Page 52296]]
clinical actions, or patient interaction, would not be of similar
content as an in-person visit, or could not be completed. We note that
completing each element of the defined service is a different question
than whether a beneficiary receives any benefit at all from the
telehealth-only form of a candidate service. The practical basis for
Step 3 mirrors the practical basis for proposed Step 1 and 2, which is
a consistent application of review criteria. Many submissions that CMS
received during the PHE lacked evidence indicating that some or all
elements of a service could be completed using an interactive
telecommunications system without still requiring an in-person
interaction with a patient to furnish t
[…truncated; see source link]Indexed from Federal Register on August 7, 2023.
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