Proposed Rule2022-14562
Medicare and Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicare and Medicaid Provider Enrollment Policies, Including for Skilled Nursing Facilities; Conditions of Payment for Suppliers of Durable Medicaid Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); and Implementing Requirements for Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs To Provide Refunds With Respect to Discarded Amounts
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 29, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare and Medicaid provider enrollment policies, including for skilled nursing facilities; updates to conditions of payment for DMEPOS suppliers; HCPCS Level II coding and payment for wound care management products; 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 (SUPPORT) for Patients and Communities Act (SUPPORT Act); updates to the Medicare Ground Ambulance Data Collection System; and provisions under the Infrastructure Investment and Jobs Act.
Full Text
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[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Proposed Rules]
[Pages 45860-46843]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14562]
[[Page 45859]]
Vol. 87
Friday,
No. 145
July 29, 2022
Part II
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 2023 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment Policies;
Medicare Shared Savings Program Requirements; Medicare and Medicaid
Provider Enrollment Policies, Including for Skilled Nursing Facilities;
Conditions of Payment for Suppliers of Durable Medicaid Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS); and Implementing
Requirements for Manufacturers of Certain Single-Dose Container or
Single-Use Package Drugs To Provide Refunds With Respect To Discarded
Amounts; Proposed Rule
Federal Register / Vol. 87, No. 145 / Friday, July 29, 2022 /
Proposed Rules
[[Page 45860]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 423, 424, 425, and 455
[CMS-1770-P]
RIN 0938-AU81
Medicare and Medicaid Programs; CY 2023 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment
Policies; Medicare Shared Savings Program Requirements; Medicare and
Medicaid Provider Enrollment Policies, Including for Skilled Nursing
Facilities; Conditions of Payment for Suppliers of Durable Medicaid
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); and
Implementing Requirements for Manufacturers of Certain Single-Dose
Container or Single-Use Package Drugs To Provide Refunds With Respect
to Discarded Amounts
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This major proposed rule addresses: changes to the physician
fee schedule (PFS); other changes to Medicare Part B payment policies
to ensure that payment systems are updated to reflect changes in
medical practice, relative value of services, and changes in the
statute; Medicare Shared Savings Program requirements; updates to the
Quality Payment Program; Medicare coverage of opioid use disorder
services furnished by opioid treatment programs; updates to certain
Medicare and Medicaid provider enrollment policies, including for
skilled nursing facilities; updates to conditions of payment for DMEPOS
suppliers; HCPCS Level II coding and payment for wound care management
products; 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 (SUPPORT) for Patients and Communities Act
(SUPPORT Act); updates to the Medicare Ground Ambulance Data Collection
System; and provisions under the Infrastructure Investment and Jobs
Act.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 6,
2022.
ADDRESSES: In commenting, please refer to file code CMS-1770-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-1770-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-1770-
P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-
1850.
FOR FURTHER INFORMATION CONTACT:
<a href="/cdn-cgi/l/email-protection#9ed3fbfaf7fdffecfbcef6e7edf7fdf7fff0d8fbfbcdfdf6fbfaebf2fbdefdf3edb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="c28fa7a6aba1a3b0a792aabbb1aba1aba3ac84a7a791a1aaa7a6b7aea782a1afb1ecaaaab1eca5adb4">[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, 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.
Sarah Leipnik, (410) 786-3933, and Anne Blackfield, (410) 786-8518,
for issues related to the comment solicitation on strategies for
improving global surgical package valuation.
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 telehealth services
and other services involving communications technology.
Regina Walker-Wren, (410) 786-9160, for issues related to nurse
practitioner and clinical nurse specialist certification by the Nurse
Portfolio Credentialing Center (NPCC).
Lindsey Baldwin, (410) 786-1694, or
<a href="/cdn-cgi/l/email-protection#723f17161b11130017221a0b011b111b131c34171721111a1716071e1732111f015c1a1a015c151d04"><span class="__cf_email__" data-cfemail="733e16171a10120116231b0a001a101a121d35161620101b1617061f1633101e005d1b1b005d141c05">[email protected]</span></a>, for issues related to PFS
payment for behavioral health services.
<a href="/cdn-cgi/l/email-protection#feb39b9a979d9f8c9bae96878d979d979f90b89b9bad9d969b9a8b929bbe9d938dd096968dd0999188"><span class="__cf_email__" data-cfemail="d598b0b1bcb6b4a7b085bdaca6bcb6bcb4bb93b0b086b6bdb0b1a0b9b095b6b8a6fbbdbda6fbb2baa3">[email protected]</span></a>, for issues related to PFS
payment for evaluation and management services.
Geri Mondowney, (410) 786-1172, Morgan Kitzmiller, (410) 786-1623,
Julie Rauch, (410) 786-8932, and Tamika Brock, (312) 886-7904, for
issues related to malpractice RVUs and geographic practice cost indices
(GPCIs).
<a href="/cdn-cgi/l/email-protection#256840414c46445740754d5c564c464c444b63404076464d4041504940654648560b4d4d560b424a53"><span class="__cf_email__" data-cfemail="eda08889848e8c9f88bd85949e848e848c83ab8888be8e858889988188ad8e809ec385859ec38a829b">[email protected]</span></a>, for issues related to
non-face-to-face nonphysician services/remote therapeutic monitoring
services (RTM).
Zehra Hussain, (214) 767-4463, or
<a href="/cdn-cgi/l/email-protection#c38ea6a7aaa0a2b1a693abbab0aaa0aaa2ad85a6a690a0aba6a7b6afa683a0aeb0edababb0eda4acb5"><span class="__cf_email__" data-cfemail="de93bbbab7bdbfacbb8eb6a7adb7bdb7bfb098bbbb8dbdb6bbbaabb2bb9ebdb3adf0b6b6adf0b9b1a8">[email protected]</span></a>, for issues related to payment
of skin substitutes.
Pamela West, (410) 786-2302, for issues related to revisions to
regulations to allow audiologists to furnish diagnostic Tests, as
appropriate without a physician order.
Emily Forrest, (202) 205-1922, Laura Ashbaugh, (410) 786-1113, and
Erick Carrera, (410) 786-8949, for issues related to PFS payment for
dental services.
Heidi Oumarou, (410) 786-7942, for issues related to the rebasing
and revising of the Medicare Economic Index (MEI).
Laura Kennedy, (410) 786-3377, and Rachel Radzyner, (410) 786-8215,
for issues related to requiring manufacturers of certain single-dose
container or single-use package drugs payable under Medicare Part B to
provide refunds with respect to discarded amounts.
Laura Ashbaugh, (410) 786-1113, and Rasheeda Arthur, (410) 786-
3434, for issues related to Clinical Laboratory Fee Schedule.
Lisa Parker, (410) 786-4949, or <a href="/cdn-cgi/l/email-protection#50160118137d00000310333d237e3838237e373f26"><span class="__cf_email__" data-cfemail="d197809992fc81818291b2bca2ffb9b9a2ffb6bea7">[email protected]</span></a>, for issues
related to FQHCs.
Michele Franklin, (410) 786-9226, or <a href="/cdn-cgi/l/email-protection#b0e2f8f3f0d3ddc39ed8d8c39ed7dfc6"><span class="__cf_email__" data-cfemail="b9ebf1faf9dad4ca97d1d1ca97ded6cf">[email protected]</span></a>, for issues
related to RHCs.
Daniel Feller, (410) 786-6913, and Elizabeth Truong (410) 786-6005,
for issues related to coverage of colorectal cancer screening.
Heather Hostetler, (410) 786-4515, for issues related to removal of
selected national coverage determinations.
Lindsey Baldwin, (410) 786-1694, for issues related to Medicare
coverage of opioid use disorder treatment services furnished by opioid
treatment programs.
Kathleen Johnson, (410) 786-3295, and Sabrina Ahmed, (410) 786-
7499, for issues related to the Medicare Shared Savings Program (Shared
Savings Program) Quality performance standard and quality reporting
requirements.
Sabrina Ahmed, (410) 786-7499, for issues related to the Medicare
Shared
[[Page 45861]]
Savings Program burden reduction proposal on OHCAs.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or <a href="/cdn-cgi/l/email-protection#62310a031007063103140b0c051132100d0510030f22010f114c0a0a114c050d14"><span class="__cf_email__" data-cfemail="2b78434a594e4f784a5d42454c587b59444c594a466b48465805434358054c445d">[email protected]</span></a>, for issues related to Shared
Savings Program beneficiary assignment, and financial methodology.
Naseem Tarmohamed, (410) 786-0814, or
<a href="/cdn-cgi/l/email-protection#faa9929b889f9ea99b8c93949d89aa88959d889b97ba999789d4929289d49d958c"><span class="__cf_email__" data-cfemail="64370c051601003705120d0a031734160b03160509240709174a0c0c174a030b12">[email protected]</span></a>, for inquiries related to Shared
Savings Program application, compliance and beneficiary notification
requirements.
Rachel Radzyner, (410) 786-8215, and Michelle Cruse, (443) 478-
6390, for issues related to vaccine administration services.
Katie Parker, (410) 786-0537, for issues related to medical
necessity and documentation requirements for nonemergency, scheduled,
repetitive ambulance services.
Frank Whelan, (410) 786-1302, for issues related to Medicare
provider enrollment regulation updates (including for skilled nursing
facilities), State options for implementing Medicaid provider
enrollment affiliation provisions, and conditions of payment for DMEPOS
suppliers.
Mei Zhang, (410) 786-7837, and Daniel Standridge, (410) 786-2419,
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#2a6b47485f464b44494f6e4b5e4b694546464f495e4345446a49475904424259044d455c"><span class="__cf_email__" data-cfemail="93d2fef1e6fff2fdf0f6d7f2e7f2d0fcfffff6f0e7fafcfdd3f0fee0bdfbfbe0bdf4fce5">[email protected]</span></a>,
for issues related to the Medicare Ground Ambulance Data Collection
System.
Sundus Ashar, <a href="/cdn-cgi/l/email-protection#7023051e1405035e11031811024130131d035e1818035e171f06"><span class="__cf_email__" data-cfemail="fba88e959f8e88d59a88939a89cabb989688d5939388d59c948d">[email protected]</span></a>, for issues related to
HCPCS Level II Coding for skin substitutes.
Renee O'Neill, (410) 786-8821, or Kati Moore, (410) 786-5471, 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 individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
Addenda Available Only Through the internet on the CMS website: The
PFS Addenda along with other supporting documents and tables referenced
in this proposed rule are available on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html</a>. Click on the link on the left side of the
screen titled, ``PFS Federal Regulations Notices'' for a chronological
list of PFS Federal Register and other related documents. For the CY
2023 PFS proposed rule, refer to item CMS-1770-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#5e133b3a373d3f2c3b0e36272d373d373f30183b3b0d3d363b3a2b323b1e3d332d7036362d70393128"><span class="__cf_email__" data-cfemail="f9b49c9d909a988b9ca991808a909a909897bf9c9caa9a919c9d8c959cb99a948ad791918ad79e968f">[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 a
copyright of 2020 American Medical Association (AMA); all rights
reserved; and CPT is a registered trademark of the 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 Protecting Medicare and American
Farmers from Sequester Cuts Act (PMAFSCA) (Pub. L. 117-71, December 10,
2021), Infrastructure Investment and Jobs Act (Pub. L. 117-58, November
15, 2021), Consolidated Appropriations Act, 2021 (CAA, 2021) (Pub. L.
116-260, December 27, 2020), Bipartisan Budget Act of 2018 (BBA of
2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment
(SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub. L.
115-271, October 24, 2018), related to Medicare Part B payment. In
addition, this major proposed rule includes proposals regarding other
Medicare payment policies described in sections III. and IV.
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 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 2023 for the PFS to ensure that our payment systems are updated to
reflect changes in medical practice and the relative value of services,
as well as changes in the statute. This proposed rule also includes
discussions and provisions regarding several other Medicare Part B
payment policies.
Specifically, this proposed rule addresses:
<bullet> 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 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> Determination of Malpractice Relative Value Units (RVUs)
(section II.H.)
<bullet> Non-Face-to-Face/Remote Therapeutic Monitoring (RTM) Services
(section II.I.)
<bullet> Payment for Skin Substitutes (section II.J.)
<bullet> Proposal to Allow Audiologists to Furnish Certain Diagnostic
Tests Without a Physician Order (section II.K.)
<bullet> Proposals and Request for Information on Medicare Parts A and
B Payment for Dental Services (section II.L.)
<bullet> Rebasing and Revising the Medicare Economic Index (MEI)
(section II.M.)
<bullet> Requiring Manufacturers of Certain Single-dose Container or
Single-use Package Drugs to Provide Refunds with Respect to Discarded
Amounts (Sec. Sec. 414.902 and 414.940) (section III.A.)
[[Page 45862]]
<bullet> Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (section III.B.)
<bullet> Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions, and Proposals for Specimen
Collection Fees and Travel Allowance for Clinical Diagnostic Laboratory
Tests (section III.C.)
<bullet> Expansion of Coverage for Colorectal Cancer Screening and
Reducing Barriers (section III.D.)
<bullet> Removal of Selected National Coverage Determinations (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> Medical Necessity and Documentation Requirements for
Nonemergency, Scheduled, Repetitive Ambulance Services (section III.I.)
<bullet> Medicare Provider and Supplier Enrollment and Conditions of
DMEPOS Payment (section III.J.)
<bullet> State Options for Implementing Medicaid Provider Enrollment
Affiliation Provision (section III.K.)
<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.L.)
<bullet> Medicare Ground Ambulance Data Collection System (GADCS)
(section III.M.)
<bullet> Proposal to Revise HCPCS Level II Coding Procedures for Wound
Care Management Products (section III.N.)
<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.
B. Determination of PE RVUs
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding 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 RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the 5-year review of work RVUs under the
PFS and proposed changes to the PE methodology CY 2007 PFS proposed
notice (71 FR 37242) and the CY 2007 PFS final rule with comment period
(71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, 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
[[Page 45863]]
surgery since these specialties currently are not separately recognized
by Medicare, nor do we have a method to blend the PPIS data with
Medicare recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file titled ``CY 2023 PFS proposed rule PE/HR'' on the
CMS website under downloads for the CY 2023 PFS proposed rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level based on the
direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion. The general
approach to developing the indirect portion of the PE RVUs is as
follows:
<bullet> For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
<bullet> Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
<bullet> Then, we incorporate the specialty specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: a
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct readers to the file titled ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2023 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.
[[Page 45864]]
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 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning specialty mix based on the specialties
of the practitioners reporting the services in the claims data, we use
the expected specialty that we identify on a list developed based on
medical review and input from expert interested parties. We display
this list of expected specialty assignments as part of the annual set
of data files we make available as part of notice and comment
rulemaking and consider recommendations from the RUC and other
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
[[Page 45865]]
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.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
<bullet> Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
<bullet> Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
<bullet> Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
<bullet> Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time
[[Page 45867]]
accordingly. Table 2 details the manner in which the modifiers are
applied.
[GRAPHIC] [TIFF OMITTED] TP29JY22.001
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)[caret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage=1); generally, 150,000 minutes.
usage = variable, see discussion below in this 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 final rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
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 45868]]
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] TP29JY22.002
We are not proposing any changes to the equipment interest rates
for CY 2023.
3. Adjusting RVUs To Match PE Share of the Medicare Economic Index
(MEI)
For CY 2023, as explained in detail in section II.M. of this
proposed rule, we are proposing to rebase and revise the Medicare
Economic Index (MEI) to reflect more current market conditions faced by
physicians in furnishing physicians' services. The MEI is an index that
measures changes in the market price of the inputs used to furnish
physician services. This index measure was authorized by statute and is
developed by the CMS Office of the Actuary. We believe that the MEI is
the best measure available of the relative weights of the three
components in payments under the PFS--work, PE and malpractice.
Accordingly, we believe that to assure that the PFS payments reflect
the relative resources in each of these 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 MEI. In the past, we
have proposed (and subsequently, finalized) to accomplish this by
holding the work RVUs constant and adjusting the PE RVUs, the MP RVUs
and the CF to produce the appropriate balance in RVUs among the PFS
components and payment rates for individual services. The most recent
adjustments to reflect changes in the MEI weights were made for the CY
2014 RVUs, when the MEI was last updated. 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 finalized 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 past when we have proposed a rebasing and/or revision of the
MEI, as we do in section II.M. of this proposed rule, we typically have
also proposed 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, as previously described in the CY 2014 PFS final rule (78 FR
74236 and 74237), and to recalibrate the relativity adjustment that we
apply in step 18 as described in the CY 2014 PFS final rule. Instead,
we are proposing to delay the adjustments to the PE pools in steps 3
and 10 and the recalibration of the relativity adjustment in step 18
until the public has an opportunity to comment on the proposed rebased
and revised MEI, as discussed in section II.M. of this proposed rule.
Because there are significant proposed methodological and data source
changes to the MEI for CY 2023 and significant time has elapsed since
the last rebasing and revision of the MEI, we believe it is important
to allow public comment and
[[Page 45869]]
finalization of the proposed MEI changes based on the review of public
comment before we incorporate the updated MEI into PFS ratesetting, and
we believe this is consistent with our efforts to balance payment
stability and predictability with incorporating new data through more
routine updates. We refer readers to the comment solicitation in
section II.B. of this proposed rule, where we discuss our ongoing
efforts to update data inputs for PE to aid stability, transparency,
efficiency, and data adequacy. Similarly, we are delaying the
implementation of the proposed rebased and revised MEI for use in the
PE geographic practice cost index (GPCI) and soliciting comment on
appropriate timing for implementation for potential future rulemaking,
discussed in detail in section II.G. and section VII. of this proposed
rule.
In light of the proposed delay in using the proposed update to the
MEI to make the adjustments to the PE pools in steps 3 and 10 and the
relativity adjustment in step 18, we are soliciting comment on when and
how to best incorporate the proposed rebased and revised MEI discussed
in section II.M. of this proposed rule into PFS ratesetting, and
whether it would be appropriate to consider a transition to full
implementation for potential future rulemaking. In section VII. of this
proposed rule, we present the impacts of implementing the proposed
rebased and revised MEI in PFS ratesetting through a 4-year transition
and through full immediate implementation, that is, with no transition
period. Given the significance of the impacts that result from a full
implementation and the interaction with other CY 2023 proposals, we did
not consider proposing to fully implement a rebased and revised MEI in
PFS ratesetting for CY 2023. We are seeking comment on other
implementation strategies for potential future rulemaking that are not
outlined in section VII. of this proposed rule.
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 2023 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2023 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 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
[[Page 45870]]
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 crosswalked to the
new listing of clinical labor activity codes. These lists are available
on the CMS website under downloads for the CY 2023 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 2023, we are proposing to update the price of eight supplies
and two equipment items in response to the public submission of
invoices following the publication of the CY 2022 PFS final rule. The
eight supply and equipment items with proposed updated prices are
listed in the valuation of specific codes section of the preamble under
Table 15, CY 2023 Invoices Received for Existing Direct PE Inputs.
We are not proposing to update the price of another eight supplies
and two equipment items which were the subject of public submission of
invoices. Our rationale for not updating these prices is detailed
below:
<bullet> Acetic acid 5% (SH001): We received an invoice submission
for an increase in price from 3 cents per ml to 9.5 cents per ml for
the SH001 supply. However, the invoice stated that this price was for
an ``Alcian Blue 1% in 3% Acetic Acid pH 2.5'' supply and it is not
clear that this represents the same supply as the ``Acetic acid 5%''
described by the SH001 supply item. We also do not believe that the
typical price for this supply has increased 200 percent in the 3 years
since StrategyGen researched its pricing, especially given that the
price for the SH001 supply previously increased from 1.2 cents in CY
2019 to its current price of 3 cents for CY 2022.
<bullet> Cytology, lysing soln (CytoLyt) (SL039): We received an
invoice submission for an increase in price from 6 cents per ml to 80
cents per ml for the SL039 supply. We do not believe that the typical
price for this supply has increased 1200% in the 3 years since
StrategyGen researched its pricing, especially given that the price for
the SL039 supply previously increased from 3.4 cents in CY 2019 to its
current price of 6 cents for CY 2022.
<bullet> Fixative (for tissue specimen) (SL068): We received an
invoice submission for an increase in price from 1.3 cents per ml to
$4.87 for the SL068 supply. We believe that this was the result of
confusion on the part of the interested party regarding the unit
quantity for the SL068 supply. This item is paid on a per ml basis and
not a per unit basis; there was not enough information on the submitted
invoice to determine the price for the SL068 supply on a per ml basis.
<bullet> Ethanol, 100% (SL189): We received an invoice submission
for an increase in price from 0.33 cents per ml to 1.2 cents per ml for
the SL189 supply. However, we noted that the invoice was
[[Page 45871]]
based on the price for a single gallon of 100% ethanol which is
typically sold in much larger quantities than a single gallon. We found
that 100% ethanol was readily available for sale online in larger unit
sizes and the current price of 0.33 cents per ml (based on the past
StrategyGen market research) appears to be accurate based on online
bulk pricing. We also found that the submitted invoices for the
ethanol, 70% (SL190), ethanol, 95% (SL248), and stain, PAP OG-6 (SL491)
supplies were also based on pricing for a single gallon. Each of these
supply items was also available for purchase in larger unit quantities
which indicated that the current pricing remained typical for these
supplies. Therefore, we are not proposing to update the prices for the
SL189, SL190, SL248 or SL491 supply, as we do not believe that the
higher prices paid for smaller quantities of these supplies would be
typical.
<bullet> Biohazard specimen transport bag (SM008): We received an
invoice submission for an increase in price from 8 cents to 45 cents
for the SM008 supply. However, it is not clear that the item described
on the invoice is the same item as the SM008 supply. The invoice states
only that the price is for ``Supplied Case Red Bags'' which was not
enough information to determine if this would be typical for the SM008
supply. We also do not believe that the typical price for this supply
has increased 460 percent in the 3 years since StrategyGen researched
its pricing, especially given that the price for the SM008 supply
previously increased from 3.5 cents in CY 2019 to its current price of
8 cents for CY 2022.
<bullet> International Normalized Ratio (INR) analysis and
reporting system w-software (EQ312): We did not receive an invoice for
this equipment item, only a letter stating that the cost of the EQ312
equipment should be increased from the current price of $19,325 to
$1,600,000. We previously finalized a policy in the CY 2011 PFS final
rule (75 FR 73205) to update supply and equipment prices through an
invoice submission process. We require pricing data indicative of the
typical market price of the supply or equipment item in question to
update the price. It is not sufficient to state a different price
without providing information to support this new valuation. Since we
did not receive an invoice to support the higher costs asserted in the
letter, we are not proposing a new price for the EQ312 equipment item.
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#18485d47486a717b7d475176686d6c474d687c796c7d587b756b3670706b367f776e"><span class="__cf_email__" data-cfemail="f4a4b1aba4869d9791abbd9a848180aba18490958091b4979987da9c9c87da939b82">[email protected]</span></a>. We also note that in order
to be considered a direct PE input, an equipment item must be
individually allocable to a particular patient for a particular
service. Costs associated with the implementation, maintenance, and
upgrade of equipment that is not individually allocable to a particular
patient for a particular service, or other costs associated with
running a practice, would typically be classified as forms of indirect
PE under our methodology.
The same interested parties that addressed the pricing of the EQ312
equipment item questioned the assignment of the General Practice
specialty crosswalk for indirect PE for home Prothrombin Time (PT)/INR
monitoring services. These individuals stated that the predominant code
used for PT/INR monitoring (HCPCS code G0249) will be significantly and
negatively impacted by the continuing implementation over a 4-year
period of changes in the clinical labor rates finalized in the CY 2022
PFS final rule (86 FR 65024). The individuals requested that CMS change
the crosswalk for home PT/INR monitoring services to All Physicians or
Pathology which would partially offset the reduction that HCPCS code
G0249 is facing due to changes in the clinical labor rates.
We note for these interested parties that we finalized a crosswalk
to the General Practice specialty for home PT/INR monitoring services
(HCPCS codes G0248, G0249, and G0250) in the CY 2021 PFS final rule (85
FR 84477 and 84478). The data submitted by the commenters at the time
indicated that the direct-to-indirect cost percentages to furnish home
PT/INR monitoring are in the range of 31:69, similar to the ratio
associated with the General Practice specialty. We disagree, as we did
in response to comments in the CY 2021 PFS final rule, that these home
PT/INR monitoring services should be reassigned to a different
specialty that is less reflective of the cost structure for these
services to offset reductions in payment for the services that result
from an unrelated policy proposal (the clinical labor pricing update).
We also note that we have not received any new information about PT/INR
monitoring services since CY 2021 to indicate that All Physicians or
Pathology would be more accurate choices for use in indirect PE
allocation but are open to receiving new relevant information that CMS
could consider in future rulemaking. As such, we are not proposing to
change the assigned specialty for PT/INR services; we direct interested
parties to the previous discussion of this topic in the CY 2021 PFS
final rule (85 FR 84477 and 84478) and again in the CY 2022 PFS final
rule (86 FR 65000). Interested parties are encouraged to submit new
information to support the most accurate specialty choice to use in
indirect PE allocation for PT/INR monitoring services distinct from
what has previously been reviewed during the last two rule cycles.
<bullet> Remote musculoskeletal therapy system (EQ402): We received
an invoice submission for a price of $1,000 for the EQ402 equipment
item. Since this equipment already has a price of $1,000 we are not
proposing to make any changes in the pricing; we thank the interested
party for their invoice submission confirming the current price.
(1) Invoice Submission
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC-recommended values for the codes. 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#18485d47486a717b7d475176686d6c474d687c796c7d587b756b3670706b367f776e"><span class="__cf_email__" data-cfemail="ffafbaa0af8d969c9aa0b6918f8a8ba0aa8f9b9e8b9abf9c928cd197978cd1989089">[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.
[[Page 45872]]
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
crosswalked or extrapolated the wages for several staff types using
supplementary data sources for verification whenever possible. In
situations where the price wages of clinical labor types were not
referenced in the BLS data, we used the national salary data from the
Salary Expert, an online project of the Economic Research Institute
that surveys national and local salary ranges and averages for
thousands of job titles using mainly government sources. (A detailed
explanation of the methodology used by Salary Expert to estimate
specific job salaries can be found at <a href="http://www.salaryexpert.com">www.salaryexpert.com</a>). We
previously used Salary Expert information as the primary backup source
of wage data during the last update of clinical labor pricing in CY
2002. If we did not have direct BLS wage data available for a clinical
labor type, we used the wage data from Salary Expert as a reference for
pricing, then crosswalked these clinical labor types to a proxy BLS
labor category rate that most closely matched the reference wage data,
similar to the crosswalks used in our PE/HR allocation. For example,
there is no direct BLS wage data for the Mammography Technologist
(L043) clinical labor type; we used the wage data from Salary Expert as
a reference and identified the BLS wage data for Respiratory Therapists
as the best proxy category. We calculated rates for the ``blend''
clinical labor categories by combining the rates for each labor type in
the blend and then dividing by the total number of labor types in the
blend.
As in the CY 2002 clinical labor pricing update, the proposed cost
per minute for each clinical staff type was derived by dividing the
average hourly wage rate by 60 to arrive at the per minute cost. In
cases where an hourly wage rate was not available for a clinical staff
type, the proposed cost per minute for the clinical staff type was
derived by dividing the annual salary (converted to 2021 dollars using
the Medicare Economic Index) by 2080 (the number of hours in a typical
work year) to arrive at the hourly wage rate and then again by 60 to
arrive at the per minute cost. 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. 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.
BILLING CODE 4120-01-P
[[Page 45873]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.003
(1) CY 2023 Clinical Labor Pricing Update Proposals
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 are
proposing this $0.64 rate for the L037B clinical labor type for CY
2023; we are also proposing 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 are also proposing 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). The proposed
pricing increase for these three clinical labor types is included in
Table 5; the CY 2023 pricing for all other clinical labor types would
remain unchanged from the pricing finalized in the CY 2022 PFS final
rule.
[[Page 45874]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.004
BILLING CODE 4120-01-C
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
[[Page 45875]]
the 4-year transition period. We updated the pricing of a number of
clinical labor types in the CY 2022 PFS final rule in response to
information provided by commenters. We welcome additional feedback on
clinical labor pricing from commenters in response to this proposed
rule, especially any data that will continue to improve the accuracy of
our final pricing. 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).
5. Soliciting Public Comment on Strategies for Updates to Practice
Expense Data Collection and Methodology
The PE inputs used in setting PFS rates, including both the
development of PE RVUs and, historically, the relative shares among
work, PE, and malpractice RVUs across the PFS, are central in
developing accurate rates and maintaining appropriate relativity among
PFS services and overall payment among the professionals and suppliers
paid under the PFS. Consequently, the underlying PE data inputs are a
consistent point of interest among interested parties. However, unlike
other payment systems with cost reporting systems, PFS data inputs are
primarily based on exogenous proprietary data that become available as
the data are collected. Specifically, we rely on historical survey data
(almost all of which is over a decade old), some publicly available
data collected for other purposes (for example, Bureau of Labor
Statistics (BLS) wage data), recommendations from the American Medical
Association and other provider groups, and annual Medicare claims data.
a. History of Updates to PE Inputs
Each year we continue to improve accuracy, predictability, and
sustainability of updates to the PE valuation methodology to reduce the
risks of possible misvaluation and other unintended outcomes. We have
continued to develop policies geared toward providing more consistent
updates to the direct PE inputs used in PFS ratesetting, including
supply/equipment pricing and clinical labor rates. These efforts to
develop these policies should contribute to improved standardization
and transparency for all PE inputs used to update the PFS. As we
continue our work to improve the information we use in our PE
methodology, we are issuing a general comment solicitation to better
understand how we might improve the collection of PE data inputs and
refine the PE methodology.
In recent years, we have refined specific PE data inputs using a
combination of market research and publicly available data (for
example, market research on medical supply and equipment items and BLS
data to update clinical labor wages) to update the direct PE data
inputs used in the PFS ratesetting process. Last year, we implemented a
final transition year for supply and equipment pricing updates and
started the first year of a 4-year phase-in update to the clinical
labor rates. However, the indirect PE data inputs remain tied to legacy
information that is well over a decade old. To build on much needed
progress, we now believe indirect PE would also benefit from a refresh
that implements similar standard and routine updates. We believe that a
data refresh, and use of data sources that receive routine refreshes,
would reduce the likelihood of unpredictable shifts in payment,
especially when such shifts could be driven by the age of data
available rather than comprehensive information about changes in actual
costs.
b. Data Collection, Analysis and Findings
In light of feedback from interested parties, CMS has prioritized
stability and predictability over ongoing updates, and has taken a
measured approach to updating PE data inputs. We have worked with
interested parties and CMS contractors over a period of 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. Thus, we must
balance the various interests of the public, and any path forward
should allow for ongoing and routine cycles of PE updates.
Of the various PE data inputs, we believe that indirect PE data
inputs, which reflect costs such as office rent, IT costs, and other
non-clinical expenses, present the opportunity to build consistency,
transparency, and predictability into our methodology to update PE data
inputs. The primary source for indirect PE information is the Physician
Practice Information Survey (PPIS), fielded by the AMA. The survey was
most recently conducted in 2007 and 2008 (reflecting 2006 data). The
survey respondents were self-employed physicians and selected
nonphysician practitioners.
In general, interested parties have expressed the following
concerns regarding CMS's approach to indirect PE allocation:
<bullet> CMS seems to rely on increasingly out-of-date data
sources, and there is a dearth of mechanisms to update empirical
inputs.
<bullet> The approach exacerbates payment differentials that
possibly create inappropriate variation of reimbursement across
ambulatory places of service (for example, significantly higher
payments for the same service provided in a hospital outpatient
department versus a physician office).
<bullet> CMS's method of indirect PE allocation may not accurately
reflect variation in PE across different types of services, different
practice characteristics, or evolving business models.
Beyond these issues, we have also explored other concerns with our
indirect PE allocation method in depth in previous rulemaking. For
example, refer to our previous comment solicitation and discussion of
resource costs for services involving the use of innovative
technologies in our CY 2022 PFS proposed rule (86 FR 39125). PE data
inputs, and the methodological and evidence-based principles that shape
use of such information in the context of reimbursement, are discussed
in depth in a RAND Corporation (``RAND'') report prepared for CMS,
entitled Practice Expense Methodology and Data Collection Research and
Analysis, available at <a href="https://www.rand.org/pubs/research_reports/RR2166.html">https://www.rand.org/pubs/research_reports/RR2166.html</a>.\1\
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\1\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. <a href="https://www.rand.org/pubs/research_reports/RR2166.html">https://www.rand.org/pubs/research_reports/RR2166.html</a>.
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Various interested parties have taken issue with the use of certain
costs in our current PE allocation methodology that they do not believe
are associated with increased indirect PE. Some interested parties
argue that the costs of disposable supplies, especially expensive
supplies, and equipment are not relevant to allocating indirect PE; or
that similarly, work in the facility setting (for example, work RVUs
for surgical procedures) is not relevant to allocating indirect PE,
though they agree that work in the office setting may be relevant to
allocating indirect PE. \2\ However, we do not believe that there is
sufficient, if any,
[[Page 45876]]
data or peer-reviewed evidence available to definitively show that
shifting indirect PE allocations based on the setting of care, or based
on specialty, would result in improved allocations of PE that reflect
true costs. Further, varying indirect PE allocations based on setting
of care or based on specialty might create unintended consequences such
as reduced access to care for beneficiaries, or reduced competition and
autonomy of small group practices or individual clinicians whose
revenue is based in part on services furnished under contract in the
facility setting.
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\2\ Kazungu, Jacob S., Edwine W. Barasa, Melvin Obadha, and Jane
Chuma. ``What Characteristics of Provider Payment Mechanisms
Influence Health Care Providers' Behaviour? A Literature Review.''
The International Journal of Health Planning and Management 33, no.
4 (October 2018): e892-905. <a href="https://doi.org/10.1002/hpm.2565">https://doi.org/10.1002/hpm.2565</a>.
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We believe it is necessary to establish a roadmap toward more
routine PE updates, especially because potentially improper or outdated
allocation of PE across services may affect access to certain services,
which could exacerbate disparities in care and outcomes. Establishing
payments that better reflect current practice costs would mitigate
possible unintended consequences, such as labor market distortions due
to indirect cost allocations that do not reflect the current evolution
of health care practice.\3\ Interested parties have reiterated their
desire for CMS to move away from the current PE allocation approach and
continued to raise concerns with CMS's methodology and the underlying
PE data inputs. In response to these and other concerns, we continue to
review the methodology we use to establish the PE RVUs and to identify
refinements. As part of this effort, we have contracted with RAND to
develop and assess potential improvements in the current methodology
used to allocate indirect practice costs in determining PE RVUs for a
service, model alternative methodologies for determining PE RVUs, and
identify and assess alternative data sources that CMS could use to
regularly update indirect practice cost estimates.\4\
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\3\ Laugesen, Miriam J. ``Regarding `Committee Representation
and Medicare Reimbursements: An Examination of the Resource-Based
Relative Value Scale.' '' Health Services Research 53, no. 6
(December 2018): 4123-31. <a href="https://doi.org/10.1111/1475-6773.13084">https://doi.org/10.1111/1475-6773.13084</a>.
\4\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. <a href="https://www.rand.org/pubs/research_reports/RR2166.html">https://www.rand.org/pubs/research_reports/RR2166.html</a>.
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In this proposed rule, we are signaling our intent to move to a
standardized and routine approach to valuation of indirect PE and we
welcome feedback from interested parties on what this might entail,
given our discussion above. We would propose the new approach to
valuation of indirect PE in future rulemaking.
We seek comment on the following topics related to identification
of the appropriate instrument, methods, and timing for updating
specialty-specific PE data:
<bullet> Potential approaches to design, revision, and fielding of
a PE survey that foster transparency (for example, transparency in
terms of the methods of survey design, the content of the survey
instrument, and access to raw results for informing PFS ratesetting);
and
<bullet> Mechanisms to ensure that data collection and response
sampling adequately represent physicians and non-physician
practitioners across various practice ownership types, specialties,
geographies, and affiliations.
We also seek comment on any alternatives to the above that would
result in more predictable results, increased efficiencies, or reduced
burdens. For example:
<bullet> Use of statistical clustering or other methods that would
facilitate a shift away from specialty-specific inputs to inputs that
relate to homogenous groups of specialties without a large change in
valuation relative to the current PE allocations.
<bullet> Avenues by which indirect PE can be moved for facility to
non-facility payments, based on data reflecting site of service cost
differences.
<bullet> Methods to adjust PE to avoid the unintended effects of
undervaluing cognitive services due to low indirect PE.
<bullet> A standardized mechanism and publicly available means to
track and submit structured data and supporting documentation that
informs pricing of supplies or equipment.
<bullet> Sound methodological approaches to offset circularity
distortions, where variable costs are higher than necessary costs for
practices with higher revenue.
We also seek comment on the cadence, frequency, and phase-in of
adjustments for each major area of prices associated with direct PE
inputs (Clinical Labor, Supplies/Equipment). We ask that commenters
address the following:
<bullet> Whether CMS should stagger updates year-to-year for each
update, or establish ``milestone'' years at regular intervals during
which all direct PE inputs would be updated in the same year.
<bullet> The optimal method of phasing in the aggregate effect of
adjustments, such that the impacts of updates gradually ramp up to a
full 100 percent over the course of a few years (for example, 25
percent of the aggregate adjustment in Year 1, then 50 percent of the
aggregate adjustment in Year 2, etc.).
<bullet> How often CMS should repeat the cycle to ensure that
direct PE inputs are based on the most up-to-date information,
considering the burden of data collection on both respondents and
researchers fielding instruments or maintaining datasets that generate
data.
c. Changes to Health Care Delivery and Practice Ownership Structures,
and Business Relationships Among Clinicians and Health Care
Organizations
Market consolidation, and shifts in workforce alignment, as well as
an evolution in the type of business entities predominant in health
care markets, all suggest significant transformation in the composition
and proportions of practice expenses required to furnish care. These
evolving conditions collectively highlight the need for a comprehensive
update to PE data inputs, and possibly the PE methodology as a
whole.\5\ Ideally, more comprehensive PE data inputs and a different PE
calculation methodology would better account for indirect/overhead
costs, current trends in the delivery of health care, the use of
machine learning technology, and EHRs, and the cost differentials in
independent versus facility-based practices.
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\5\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. <a href="https://www.rand.org/pubs/research_reports/RR2166.html">https://www.rand.org/pubs/research_reports/RR2166.html</a>.
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We seek comment on current and evolving trends in health care
business arrangements, use of technology, or similar topics that might
affect or factor into indirect PE calculations. We are interested in
learning whether any PE data inputs may be obsolete, unnecessary, or
misrepresentative of the actual costs involved in operating a medical
practice.
d. Unintended Consequences and Missing Information
We request comment on additional information that we may have not
considered or discussed above about updating and maintaining PE data
inputs, as well as any unintended impacts (or positive outcomes) that
could result from changes to the overall strategy. We are especially
interested in public comment on any concerns about beneficiaries'
access to care, possible consolidation of group practices, or burden on
small group or solo practitioners. We are also interested in public
comments on any collateral
[[Page 45877]]
program integrity or quality issues that could arise from potential
updates. We request that any respondents who provide feedback ensure
that the response includes discussion of any possible health equity
impacts.
6. Soliciting Public Comment on Strategies for Improving Global
Surgical Package Valuation
In preparation for future rulemaking, we are seeking public comment
on strategies to improve the accuracy of payment for the global
surgical packages (herein referred to as ``global packages') under the
PFS. Currently, there are over 4,000 physicians' services paid as
global packages under the PFS. Global packages generally include the
surgical procedure and any services typically provided during the pre-
and postoperative periods (including evaluation and management (E/M)
services and hospital discharge services). There are three types of
global packages:
<bullet> The 0-day global package, which includes the procedure and
the preoperative and postoperative physicians' services on the day of
the procedure.
<bullet> The 10-day global package, which includes services on the
day of, and 10 days after, the procedure.
<bullet> The 90-day global package, which includes services
furnished one day prior to the procedure, and on the day of, and 90
days immediately following the day of the procedure.
More detail about how global packages are billed and what
activities are included may be found in Chapter 12, Section 40, of the
Medicare Claims Processing Manual (Pub. 100-04).
We have applied the concept of global payment for some procedures
since the inception of the PFS on January 1, 1992 (54 FR 59502).
However, in the past decade we have engaged with interested parties
regarding numerous concerns about the accuracy and validity of the
valuation of global packages, with particular attention paid to the E/M
visits included in the services. We have made previous requests for
public feedback on global packages, including solicitations for
information or data that could be used to help support more accurate
valuations. We now wish to expand on our conversations with the public,
considering the current status of a multi-year data collection and
analysis project, as well as ongoing changes we have made to payments
for other types of patient care that may impact the global packages.
a. History of Global Valuation Discussion
In the CY 2013 PFS proposed rule (77 FR 44737 through 44738), we
discussed two reports released by the HHS Office of the Inspector
General in 2005 and 2012 with findings that practitioners were
performing fewer E/M postoperative visits than had been included in the
valuation for these global packages, suggesting that Medicare was
paying for care that was not being delivered. In response to the
concerns raised by the OIG reports, we solicited public feedback on
methods of obtaining accurate and current data on E/M services
furnished as part of a global package. We summarized public comment in
the CY 2013 PFS final rule (77 FR 68911 through 68913).
In the CY 2015 PFS proposed rule (79 FR 40341), we delved into
barriers to accurate valuation of global packages, especially as
compared to other forms of bundled payments made under the inpatient or
outpatient prospective payment systems. In addition to the ongoing
concerns about whether E/M visits presumed to be furnished in
connection with global packages were actually being performed by the
physician receiving the global package payment, we noted issues such
as:
<bullet> E/M services in the global period that occur post-
discharge are valued with practice expense values associated with
follow-up visits in the physician's office. Many of these follow-up
visits may occur in a hospital outpatient department where the
physician may not incur many PE costs.
<bullet> The direct PE inputs often differ slightly between an E/M
service furnished in a global period and a stand-alone E/M service. For
example, follow-up visits for certain surgeries may include specialized
clinical labor such as an RN rather than a general nurse blend.
<bullet> The types of physicians furnishing a specific service
dictate the direct and indirect percentages, as well as the indirect
practice cost index, in the PE methodology. Most surgical specialties
have a lower direct percentage mix, resulting in higher indirect costs
that extend to the E/M visits in the global periods.
<bullet> Because the E/M visits embedded in the global package are
not reported separately and do not appear in claims data, it is
difficult to quantify the number and level of E/M services furnished in
connection with global packages under the fee-for-service system.
<bullet> In some cases we have limited billing of the 10- and 90-
day global packages in conjunction with some of the payment policies
intended to encourage coordination of care through payments for non-
face-to-face services, such as transitional care management and chronic
care management, because of presumed overlap between these services.
To address these concerns, we solicited comment and finalized a
policy in the CY 2015 PFS final rule (79 FR 67586) intended to, over a
period of several years, transition all services with 10-day and 90-day
global periods to 0-day global periods. As stated in the CY 2015 PFS
final rule, we believed it would be more accurate to value the surgical
procedure-day services separately from postop E/M visits, and would
avoid potentially duplicative or unwarranted payments. For our full
discussion and rationale, refer to 79 FR 67586 through 67591.
Implementation of this policy, however, was halted by the Medicare
Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L.110-14).
Section 523(a) of the MACRA amended section 1848(c)(8) of the Act to
prohibit the Secretary from implementing the transition policy
finalized in the CY 2015 PFS final rule. The amendments to section
1848(c)(8) also require CMS to collect additional data on how best to
value global packages and to reassess every 4 years the continued need
for this data collection. Section 1848(c)(8) of the Act directs CMS to
use the information collected to improve the accuracy of valuation of
these services under the PFS starting in CY 2019. (Refer to the CY 2016
PFS final rule at 80 FR 70915 for additional discussion of these
requirements.)
In response to the statutory requirements as added by section
523(a) of the MACRA, we engaged in multiple discussions with interested
parties about methods of data collection and analysis, including
through public comment solicitation in the CY 2016 PFS proposed rule
(80 FR 41707) and CY 2017 PFS proposed rule (81 FR 46191), a national
listening session, and a town hall meeting. (Materials for the January
20, 2016 listening session are available at <a href="https://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2016-01-20-MCRA-Presentation.pdf">https://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2016-01-20-MCRA-Presentation.pdf</a>. The transcript of the town hall meeting held August
25, 2016 is available at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Townhall.pdf">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Townhall.pdf</a>.) In the CY 2017 PFS final rule (81 FR 80209 through
80213), we finalized a claims-based process to collect data from
practitioners on both
[[Page 45878]]
the number and level of postoperative visits furnished as part of the
10- and 90-day global packages. We also contracted with RAND to support
this data collection and analysis.
b. Data Collection, Analysis, and Findings
In 2019, RAND issued two reports based on its analysis of the data
collected through the data collection process we established. The
reports examined, using claims-based and survey-based data, the number
of postoperative visits furnished during the 10- and 90-day global
periods for certain high-volume procedures and the level of visits
furnished for certain procedures. (Complete details about the data
collected are discussed in the CY 2017 PFS final rule starting at 81 FR
80212, the CY 2020 PFS final rule at 84 FR 62857, and in the reports
themselves, available at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-</a>.)
Notably, RAND's analysis found that, according to claims-based data,
the reported number of E/M visits matched the expected number (included
for purposes of PFS valuation) for only 4 percent of reviewed 10-day
global packages and 38 percent of reviewed 90-day global packages.
Based on these analyses, RAND released a third report that analyzed the
current valuation of global packages based on the difference between
the number of postoperative E/M visits observed via the claims-based
data collection process and the expected number of such E/M visits. The
report modeled how valuation for global packages would change by
adjusting the work RVUs, physician time, and direct PE inputs to
reflect the observed number of E/M visits. The report provided
hypothetical valuations for the global packages based on these
adjustments. These three RAND reports were made available to the public
and are available at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-</a>.
The RAND reports were shared with the public, and we received
public comment about these reports in the CY 2020 PFS final rule (84 FR
62866). Public commenters raised concerns about the findings in the
reports, including questions as to whether the E/M visit data were
collected from a true representative sample of practitioners, and
various other challenges to the validity of the RAND methodology. Other
members of the public, however, were supportive of our overall efforts
to collect and analyze the data, and supplied additional data similarly
suggesting that the 10- and 90-day global packages are overvalued. In
2021, RAND responded to the CY 2020 public comments that were critical
of the methodologies used in the three earlier reports in a separate
report entitled, ``Responses to Comments on RAND Global Services
Reports,'' which is available at <a href="https://www.rand.org/content/dam/rand/pubs/research_reports/RR4300/RR4314-1/RAND_RR4314-1.pdf/">https://www.rand.org/content/dam/rand/pubs/research_reports/RR4300/RR4314-1/RAND_RR4314-1.pdf/</a>.
While some interested parties have challenged the methodology or
conclusions of the RAND reports, we have not yet received data
suggesting that postoperative E/M visits are being performed more
frequently than indicated by the data collected and analyzed in the
RAND reports. We continue to be concerned that our current valuations
of the global packages reflect certain E/M visits that are not
typically furnished in the global period, and thus, are not occurring.
We also believe that RAND has adequately responded to critiques of its
methodologies and findings. However, as part of our ongoing assessment
of our data collection process, we continue to welcome any comments
from the public on ideas for other sources of data that would help us
to assess global package valuation (including the typical number and
level of E/M services), as well as our data collection methodology and
the RAND report findings.
c. Changes to Health Care Delivery and Payment for E/M Services
Since the inception of the PFS 30 years ago, there have been
significant changes in health care, including improvements in medical
and information technology, new models of health care delivery and
coordination between multiple clinicians furnishing care to a single
patient, and an expanding beneficiary population. (For information on
Medicare service utilization, beneficiary demographics, provider
characteristics, and payment models, please visit the resources at
<a href="http://data.cms.gov">data.cms.gov</a>.) We are interested in hearing from the public on whether
the postoperative health care landscape has changed in ways that impact
the relevance of the global packages.
We believe that changes to health care delivery may impact proper
valuation of global services. We are soliciting comment on whether
changes to health care delivery, including changes in coordination of
care and use of medical technology over the past 3 decades, as well as
during the recent PHE, have impacted: the number and level of
postoperative E/M visits needed to provide effective follow-up care to
patients; the timing of when postoperative care is being provided; and
who is providing the follow-up care. We have formed hypotheses that
some beneficiaries are not receiving the number of postoperative visits
that were contemplated when valuing the global surgical packages or are
not receiving any follow-up E/M visits at all during global periods
either because the physician who performed the surgical procedure has
determined they are unnecessary (perhaps due to improvements in medical
technology or evolution in standards of care) or as the result of more
comprehensive discharge planning. It has also been suggested by some
interested parties that physicians are, in fact, performing the number
of postoperative visits that were contemplated when valuing the global
surgical packages, but the visits may, for various reasons, be
scheduled outside the global period. Others have suggested that
physicians are, without formally transferring follow-up care to another
clinician, instructing patients to follow up with another physician or
NPP (such as the patient's primary care physician or other
practitioner), and that the other clinician then furnishes and bills
for E/M services furnished for postoperative care (whether the care is
performed during or after the global period). We would appreciate
comments on these ideas, and on other factors not mentioned here that
could affect the ways that postoperative E/M care is provided.
We are also soliciting comment on whether, or how, recent changes
in the coding and valuation of separately billable E/M services may
have impacted global packages. One change is the expansion of payment
for non-face-to-face care management services. Historically, an
advantage of global packages was that they compensated physicians for
non-face-to-face work related to the patient's transition from the
hospital to the community, or management of other health care needs
following a procedure or serious illness. Over the years, we have
implemented payment for many care management services to better reflect
non-face-to-face time spent by physicians and clinical staff on behalf
of patients with complex health care needs, including transitional care
management services in CY 2013 (77 FR 68978); chronic care management
in CY 2015 (78 FR 74414) and CY 2019 (83 FR 58577); complex chronic
care management in CY 2017 (81 FR 80244); and principal care management
in CY 2020 (84 FR 62962).
[[Page 45879]]
We solicit comment on whether global packages, and especially those
with 10- and 90-day global periods, continue to serve a purpose when
physicians could otherwise bill separately not only for the
postoperative E/M visits they furnish, but also for aspects of
postoperative care management they furnish for some patients. We also
would like to hear generally what, if any, components of preoperative
or postoperative care are currently only compensated as part of payment
for global packages.
We have also heard from some interested parties who believe that
recent changes to the coding and valuation of standalone office and
outpatient E/M visits finalized in the CY 2021 PFS final rule have
skewed the relativity between these visits and the E/M visits included
in the current global package valuations (which were not modified in
response to the coding and valuation changes). In the CY 2020 PFS final
rule (84 FR 62851 through 84 FR 62854), we finalized new--and generally
increased, RVUs for the CPT-revised office and outpatient E/M code set.
Some commenters encouraged us to increase the value of the E/M visits
included in the global surgical packages commensurate with the
increased RVUs for the standalone E/M visits. However, we declined to
do so, noting that at the time that it was unclear whether it would be
appropriate to treat the E/M visits reflected in global packages as
discrete components of the package (in other words, to use a building-
block approach to calculating the value of the service, versus valuing
the services using the more holistic magnitude estimation, or possibly
another approach.) Furthermore, we cited the uncertainty as to whether
the E/M services included in valuing the global packages are typically
furnished as part of global surgery services, reasoning that if the
number and level of E/M services for global packages is not
appropriate, adopting increases in the value of E/M services in global
surgery codes would exacerbate rather than ameliorate any potential
relativity issues. (Refer to the CY 2020 PFS final rule at 84 FR 62856
through 62860 for a complete summary of comments and our responses on
the topic of increasing the value of E/M visits included in the global
packages.) We welcome additional comments on the perceived misalignment
between the E/M visits included in global packages and separately
billable E/M services, including thoughts on how this current tension
reflects on global payment valuation and the appropriate methodology
for determining appropriate values for global packages.
d. Strategies To Address Global Package Valuation
Consistent with the discussion above, we continue to believe that:
(1) there is strong evidence suggesting that the current RVUs for
global packages are inaccurate; (2) many interested parties agree that
the current values for global packages should be reconsidered, whether
they believe the values are too low or too high; and (3) it is
necessary to take action to improve the valuation of the services
currently valued and paid under the PFS as global surgical packages.
We would like to re-engage with the public about whether the global
packages are indeed misvalued, and if so, what would be an appropriate
approach to valuation. We have previously sought assistance from the
public on possible methods of revaluation, such as in the CY 2015 PFS
rule (at 79 FR 67586).
As noted in the ``Data Collection, Analysis, and Findings'' section
above (section II.B.6.b.), RAND has provided a comprehensive roadmap
for a possible revaluation strategy. (See specifically the RAND report,
``Using Claims-Based Estimates of Postoperative Visits to Revalue
Procedures with 10- and 90-Day Global Periods,'' available at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-</a>) We are soliciting
additional input on the RAND methodology, including advantages and
drawbacks of applying the RAND methodology to revaluation (in addition
to previous feedback that was provided by the public in the CY 2020
final rule at 84 FR 62867). We also request input on specific
alternatives, including: (1) requesting the RUC to make recommendations
on new values; or (2) another method proposed by the public.
We solicit feedback from the public on possible strategies for a
revaluation process for global services. We believe that the available
information provided in the RAND reports (discussed in section
II.B.6.b. of this proposed rule and available at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-</a>) indicates that there is a mismatch between
the value of the global package and work being performed. In
particular, it appears that for some services, the number of
postoperative visits typically furnished by the billing physician is
much lower than what was reflected in the global package value, and
thus we believe it may be necessary to revalue those services. (As
noted in section II.B.6.b. of this proposed rule, RAND's analysis found
that the reported number of E/M visits matched the expected E/M visits
for only 4 percent of reviewed 10-day global packages and 38 percent of
reviewed 90-day global packages. We refer specifically to the RAND
report, ``Claims-Based Reporting of Postoperative Visits for Procedures
with 10- or 90-Day; Global Periods--Updated Results Using Calendar Year
2019 Data'' available at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-</a>).
Because there are a large number and volume of services paid as global
packages, we must consider the resources needed to revalue even a
subset of the global packages, as well as the impacts across the PFS
and healthcare delivery system in general if we were to change the
values of a significant number of services at one time. We are
considering various approaches we could pursue, such as: (1) revaluing
all 10- and 90-day global packages at one time (perhaps with staggered
implementation dates); (2) revaluing only the 10-day global packages
(because these appear to have the lowest rate of postoperative visit
performance, per RAND's analysis of claims data); (3) revaluing 10-day
global packages and some 90-day global packages (such as those with
demonstrated low postoperative visit performance rates as identified in
RAND's analysis of these services); or (4) relying on the Potentially
Misvalued Code process to identify and revalue misvalued global
packages over the course of many years. (We note that regardless of
whether we review particular global packages as part of a specific
revaluation strategy, the public may always nominate any global
packages to be reviewed through the Potentially Misvalued Code process;
refer to the description of the Potentially Misvalued Code process in
section II.C. of this proposed rule.) We solicit comment on any of the
strategies identified in this paragraph, as well as any additional
ideas members of the public may have that would address the concerns
described above about valuation of global packages. We also welcome
comment on ancillary considerations including timing considerations for
implementation of any future strategy (such as whether to have
staggered effective dates for new valuations and what criteria to use
if assigning staggered effective dates.)
We also solicit comment on additional considerations affecting
valuation of global services that may not have been thoroughly explored
in
[[Page 45880]]
previous public comment opportunities. For instance, we are aware that
some interested parties are concerned that not enough attention has
been paid to the value of preservice work bundled into the global
payment, which could affect accurate valuation of 10- and 90-day global
packages, as well as the value of the service if it is transitioned to
a 0-day global. We solicit additional information about this concern,
as well as any other concerns about valuation not otherwise mentioned
here.
e. Other Payment Structure Changes, Unintended Consequences, and
Missing Information
We solicit public comment on any other aspects of the global
payment structure (aside from the valuation of services) that
commenters believe are noteworthy. Much of the discussion over the
years has focused on whether global surgical packages are properly
valued and whether they are needed at all. We encourage commenters to
point out ways in which global surgical packages may continue to have a
positive impact on health care delivery (such as their potential to
support innovation). We also solicit suggestions on other ways that
global surgical package payments could be modified (aside from changing
their valuation) that could help improve accurate valuation or help
address other concerns about the payments (such as the lack of
transparency about what care is being provided as part of the package).
We also request comment on additional information that we may not
have considered or discussed above about proper valuation of the global
packages, as well as any unintended impacts (or positive outcomes) that
could result from changes to how we value global services. We are
especially interested in public comment on any concerns about
beneficiaries' access to care, continuity of care, cost sharing, or
program integrity.
C. Potentially Misvalued Services Under the PFS
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the relative
value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of
the Act requires the Secretary to periodically identify potentially
misvalued services using certain criteria and to review and make
appropriate adjustments to the relative values for those services.
Section 1848(c)(2)(L) of the Act also requires the Secretary to develop
a process to validate the RVUs of certain potentially misvalued codes
under the PFS, using the same criteria used to identify potentially
misvalued codes, and to make appropriate adjustments.
As discussed in section II.E. of this proposed rule, Valuation of
Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the American
Medical Association (AMA) Resource-Based Relative Value Scale (RVS)
Update Committee (RUC), 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 consider information provided by other interested
parties. We conduct a review to assess the appropriate RVUs in the
context of contemporary medical practice. We note that section
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
other techniques to determine the RVUs for physicians' services for
which specific data are not available and requires us to take into
account the results of consultations with organizations representing
physicians who provide the services. In accordance with section 1848(c)
of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (<a href="http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0">http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0</a>), MedPAC discussed
the importance of appropriately valuing physicians' services, noting
that misvalued services can distort the market for physicians'
services, as well as for other health care services that physicians
order, such as hospital services. In that same report, MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work 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.
[[Page 45881]]
<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
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#59143c3d303a382b3c0931202a303a3038371f3c3c0a3a313c3d2c353c193a342a7731312a773e362f"><span class="__cf_email__" data-cfemail="c588a0a1aca6a4b7a095adbcb6aca6aca4ab83a0a096a6ada0a1b0a9a085a6a8b6ebadadb6eba2aab3">[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''). 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.
3. CY 2023 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
[[Page 45882]]
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 received public nominations for potentially
misvalued codes by February 10th and we displayed these nominations on
our public website, where we include the submitter's name and their
associated organization for full transparency. Some submissions are for
specific, PE-related inputs for codes, and we refer readers to section
II.B. of this rule under Determination of PE RVUs for further
discussions on PE-related submissions. We summarize below this year's
submissions under the potentially misvalued code initiative.
An interested party nominated the home-based physician visit codes:
CPT code 99344 (Home visit for the evaluation and management of a new
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 presenting problem(s) are of high
severity. Typically, 60 minutes are spent face-to-face with the patient
and/or family), CPT code 99345 (Home visit for the evaluation and
management of a new 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 patient is
unstable or has developed a significant new problem requiring immediate
physician attention. Typically, 75 minutes are spent face-to-face with
the patient and/or family), CPT code 99349 (Home visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: A detailed interval history; A
detailed examination; Medical decision making of moderate complexity.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are moderate to high
severity. Typically, 40 minutes are spent face-to-face with the patient
and/or family), and CPT code 99350 (Home visit for the evaluation and
management of an established patient, which requires at least 2 of
these 3 key components: A comprehensive interval history; A
comprehensive examination; Medical decision making of moderate to high
complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the presenting problem(s) are of
moderate to high severity. The patient may be unstable or may have
developed a significant new problem requiring immediate physician
attention. Typically, 60 minutes are spent face-to-face with the
patient and/or family) as potentially misvalued.
In their submission, the nominator expressed concern that there is
no payment for transportation costs incurred when it is medically
necessary for a physician to drive to the home of the patient for a
face-to-face in-home E/M Visit, and that they are not compensated for
opportunity loss they incur by seeing fewer patients because they spend
time commuting to patients' homes, versus seeing more patients that
come to their offices. The nominator also argued that Medicare does not
compensate physicians for the work and time associated with assessing a
patient's home environment, which provides insight into a patient's
overall health and living conditions. The nominator collectively called
these non-medical factors that can affect a patient's overall health
the ``Social Determinants of Health'' (SDoH). The nominator requested
that we increase the overall RVUs for CPT codes 99344, 99345, 99349,
and 99350, by including the resources associated with: (1) the
physician's transportation costs to patients' homes; (2) lost income
opportunity for home versus in-office visits; and (3) in-home SDoH
assessment work. The nominator estimated that the adjustments to RVUs
to reflect transportation costs and opportunity costs would result in
Medicare payment that is 67 percent higher than the current Home-based
E/M Visits payment rates, and that adjustments to account for the
physician's SDoH assessment would add an additional 55 percent increase
to the payment rates for Home-based E/M Visits. In total, the nominator
suggests that if these resources were taken into account, the payment
rates for Home-based E/M CPT codes would increase by what the nominator
estimates as a 222 percent increase from their current amounts.
The nominator included references as evidence to support their
claim that the home-based E/M CPT codes are potentially misvalued, such
as the CMS ``Medicaid Non-Emergency Medical Transportation Booklet for
Providers'' (April 2016) <SUP>6 7</SUP> and a press release from the
Better Medicare Alliance entitled, ``Report Shows Dramatic Increase in
Medicare Advantage Activity to Address Social Determinants of Health,
But Barriers Remain''.\8\
---------------------------------------------------------------------------
\6\ <a href="https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/nemt-booklet.pdf">https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/nemt-booklet.pdf</a>.
\7\ <a href="https://storage.aanp.org/www/documents/NP-Infographic.pdf">https://storage.aanp.org/www/documents/NP-Infographic.pdf</a>.
\8\ https://bettermedicarealliance.org/news/report-shows-
dramatic-increase-in-medicare-advantage-activity-to-address-social-
determinants-of-health-but-barriers-remain/
#:~:text=Social%20determinants%20of%20health%20are,to%20the%20World%2
0Health%20Organization.
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We note that the nominator did not nominate the entire family of
home- based E/M visit codes.
When we establish values for codes or consider whether codes are
potentially misvalued under the PFS, we take into account the resources
involved in furnishing the specific service as described by the CPT
code. As such, historically, we do not take into account: (1) travel
costs incurred by the physician or other practitioner; (2) potential
opportunity costs to a physician or other practitioner when care is
delivered in one setting versus another; or (3) the physician or other
practitioner's work and time expended in performing activities that are
outside the scope of the specific service as described by the CPT code.
These are not considered to be resources involved in furnishing the
service, are not included in establishing payment rates under the PFS
in accordance with
[[Page 45883]]
section 1848 of the Act, and, as such, do not provide justification for
potential misvaluation of those payments. That said, in February 2021,
the AMA CPT Editorial Panel deleted the family of domiciliary codes,
CPT codes 99324 to 99340, and merged the services described by those
codes into the existing family of home-based E/M visits, CPT codes
99341 to 99350 (a range of codes that includes CPT codes 99344, 99345,
99349, and 99350). In addition, the AMA RUC has made recommendations
regarding the values for these home-based E/M codes in section II.E. of
this proposed rule. Since CMS has already received AMA RUC
recommendations for these home-based E/M visit codes for this year's
proposed rule, we refer readers to the discussion found in section
II.E. of this proposed rule, Valuation of Specific Codes, where we seek
additional public comments, recommendations, and independent analysis
as supporting evidence from all interested parties regarding the
valuations for the home-based E/M visits, including CPT codes 99344,
99345, 99349, and 99350. Because we address and are soliciting public
comment on the valuation of these codes in section II.E. of this
proposed rule, there is no need to consider these home-based E/M visits
here as potentially misvalued.
An interested party has nominated the following cataract surgery
codes, CPT codes 65820 (Goniotomy--Incision to improve eye fluid flow),
66174 (Transluminal dilation of aqueous outflow canal; without
retention of device or stent), 66982 (Complex Extracapsular cataract
removal with insertion of intraocular lens prosthesis (one stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification), 66984 (Extracapsular cataract
removal with insertion of intraocular lens prosthesis (one stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification)), 66989 (Complex Extracapsular
cataract removal w/IOL insertion, complex; with insertion of
intraocular (e.g., trabecular meshwork, supraciliary, suprachoroidal)
anterior segment aqueous drainage device, without extraocular
reservoir, internal approach, one or more), and 66991 (Extracapsular
cataract removal w/IOL insertion; with insertion of intraocular (e.g.,
trabecular meshwork, supraciliary, suprachoroidal) anterior segment
aqueous drainage device, without extraocular reservoir, internal
approach, one or more), as well as the following retinal procedure
codes, CPT codes 67015 (Aspiration or release of vitreous, subretinal
or choroidal fluid, pars plana approach (posterior sclerotomy)), 67036
(Vitrectomy, mechanical, pars plana approach), 67039 (Vitrectomy,
mechanical, pars plana approach; with focal endolaser
photocoagulation), 67040 (Vitrectomy, mechanical, pars plana approach;
with endolaser panretinal photocoagulation), 67041 (Vitrectomy,
mechanical, pars plana approach; with removal of preretinal cellular
membrane (e.g., macular pucker)), 67042 (Vitrectomy, mechanical, pars
plana approach; with removal of internal limiting membrane of retina
(e.g., for repair of macular hole, diabetic macular edema), includes,
if performed, intraocular tamponade (i.e., air, gas or silicone oil)),
67043 (Vitrectomy, mechanical, pars plana approach; with removal of
subretinal membrane (e.g., choroidal neovascularization), includes, if
performed, intraocular tamponade (i.e., air, gas or silicone oil) and
laser photocoagulation), 67108 (Repair of retinal detachment; with
vitrectomy, any method, including, when performed, air or gas
tamponade, focal endolaser photocoagulation, cryotherapy, drainage of
subretinal fluid, scleral buckling, and/or removal of lens by same
technique), and 67113 (Repair of complex retinal detachment (e.g.,
proliferative vitreoretinopathy, stage C-1 or greater, diabetic
traction retinal detachment, retinopathy of prematurity, retinal tear
of greater than 90 degrees), with vitrectomy and membrane peeling,
including, when performed, air, gas, or silicone oil tamponade,
cryotherapy, endolaser photocoagulation, drainage of subretinal fluid,
scleral buckling, and/or removal of lens), as potentially misvalued
because there is currently no established non-facility payment rate for
these global 090-day surgical procedures. These codes are complex
surgical eye procedures and they require dedicated spaces, similar to
facility-based spaces that are not typically found in an
ophthalmologist's office, such as a well-lighted and sterile surgical
theater, specific eye surgery equipment and possibly clinical staff and
other medical personnel trained to assist in these surgeries and the
patient's immediate post-surgery recovery, including anesthesia
services. In the past, with concerns for patient safety and given the
intricate and delicate nature of these surgeries, we understood that
these procedures would only be performed in a well-equipped and fully
staffed medical facility. This may still be the case, but this
nominator suggests that these cataract and retinal procedures can be
properly performed in the non-facility office, safely, effectively, and
perhaps more conveniently for patients and physicians; and thus
requests that we should establish non-facility RVUs under the PFS to
recognize the additional resources that would be expended in the non-
facility setting.
The nominator has included a list of practice expense items
involved in furnishing these services in the non-facility setting to
help us to consider establishing non-facility values for these codes.
They include the possible number and types of clinical staff and their
work time in minutes, and a list of various equipment and supplies
typically needed to furnish the services described by the nominated
codes.
The nominator also noted that there is projected backlog for these
cataract and retinal services that may have been building up due to the
COVID-19 restrictions from the past 2 years. We seek comment on the
merits of continuing to value these codes only in the facility setting,
as opposed to also establishing non-facility values for these cataract
and retinal surgery codes. We also seek comment on any appropriate
safety considerations for these codes in the non-facility setting and
whether these codes are potentially misvalued. We note that in last
year's CY 2022 PFS final rule with comment (86 FR 65096 through 65097),
we did review CPT codes 66982, 66984, 66987, 66988, 66989, 66991, and
0671T (Cataract Removal with Drainage Device Insertion) and did not
establish non-facility values for those services, but we did note a
potential rank order anomaly when considering minimally invasive
glaucoma surgeries (MIGS) and cataract surgeries together, and
suggested that the AMA RUC should consider re-surveying all of these.
An interested party has nominated add-on CPT code 20931 (Allograft,
structural, for spine surgery only (List separately in addition to code
for primary procedure)) as a potentially misvalued service with respect
to the physician's labor for spinal surgeries involving the use of
biomechanical synthetic cage devices versus the use of structural
allograft bone as it relates to a set of CPT codes related to anterior
cervical discectomy and fusion (ACDF). Ordinarily, interested parties
nominate a primary service code as potentially misvalued, or a primary
service code and its related add-on codes, but not an add-on code
alone. The valuation of an add-on code is typically developed with
reference to some portion of the work (or other resource inputs)
involved in furnishing the primary service code. For
[[Page 45884]]
example, the AMA CPT 2022 Professional Edition, page 147, states ``Use
code 20931 in conjunction with codes 22319, 22532-22533, 22548-22558,
22590-22612, 22630, 22633, 22634, 22800-22812''). The primary spinal
surgery codes and the add-on CPT code 20931 have not been recently
reconsidered or reviewed by the AMA RUC or CMS, and no new or
additional information has been included with this nomination to
persuade CMS that CPT code 20931 is individually potentially misvalued.
This nomination of an add-on code as potentially misvalued is similar
to the nomination we discussed in the CY 2022 PFS proposed rule (86 FR
65044) of CPT code 22551 (Arthrodesis, anterior interbody, including
disc space preparation, discectomy, osteophytectomy and decompression
of spinal cord and/or nerve roots; cervical below C2) and the
accompanying add-on codes.
The nominator refers to two different methods of vertebral fusion--
one using biomechanical synthetic cage devices, the other using
structural allograft bone; and describes a typical vertebral fusion
case that uses three units of one of these products. Both of these
methods of vertebral fusion are described by CPT code 22551 (includes a
90-day global period), which has a work RVU of 25.00. Both methods of
vertebral fusion also involve two units of CPT code 22552 (Arthrodesis,
anterior interbody, including disc space preparation, discectomy,
osteophytectomy and decompression of spinal cord and/or nerve roots;
cervical below C2, each additional interspace (List separately in
addition to code for primary procedure)), which have a total work RVU
of 13.00 (6.50 x 2), and 1 unit of CPT code 22846 (Anterior
instrumentation; 4 to 7 vertebral segments (List separately in addition
to code for primary procedure)), which has a work RVU of 12.40. The
vertebral fusion method employing three synthetic cage devices with
plate would involve three units of CPT code 22853 (Insertion of
interbody biomechanical device(s) (e.g., synthetic cage, mesh) with
integral anterior instrumentation for device anchoring (e.g., screws,
flanges), when performed, to intervertebral disc space in conjunction
with interbody arthrodesis, each interspace (List separately in
addition to code for primary procedure)) for a total work RVU of 12.75
(4.25 x 3), and one unit of CPT code 20930 (Allograft, morselized, or
placement of osteopromotive material, for spine surgery only (List
separately in addition to code for primary procedure)) with a work RVU
of 0.00 (because Medicare considers this code to be bundled into codes
for other services). The nominator states that the typical vertebral
fusion employing three synthetic cage devices with plate would total to
63.15 work RVUs.
In contrast, the nominator asserts that the vertebral fusion method
employing structural allograft bones with plate involves the same set
of services and codes (that is, one unit of CPT code 22551, two units
of CPT code 22552, and one unit of CPT code 22846), but the structural
allograft bone method includes CPT code 20931 (Allograft, structural,
for spine surgery only (List separately in addition to code for primary
procedure)), with a work RVU of 1.81, instead of CPT codes 22853 and
20930, for a total work RVU of 52.21. The nominator suggests that this
difference in total work RVUs for the two methods of vertebral fusion,
63.15 versus 52.21, is evidence that add-on CPT code 20931 is
potentially misvalued; however, we do not agree with this nominator's
method of aggregating and comparing sums of work RVUs for groups of
services that may be furnished together as being potentially misvalued,
nor consider CPT code 20931 as the source of misvaluation within this
grouping.
We understand that the nominator believes there should be an
equivalent total sum payment for all services involved in vertebral
fusion surgeries using either method, and that there should not be a
potential incentive for physicians to prefer the method that uses
synthetic cage devices because of the higher available payment amount.
The nominator asserts that the total sum payment for this kind of
spinal surgery using the structural allograft bone method is
undervalued as compared to the total sum payment for this kind of
spinal surgery using the synthetic cage method.
We note that CPT code 22853, which the commenter associates with
the synthetic cage device method of vertebral fusion, is a 45-minute
ZZZ-code (indicating an add-on code) with an IWPUT (intra-service work
(RVU) per unit of time) of 0.0944, whereas CPT code 20931, which the
commenter associates with the allograph method of vertebral fusion, is
a 20-minute ZZZ-code with an IWPUT of 0.0905. Given the much longer
intra-service time and greater IWPUT for CPT code 22853 than for CPT
code 20931, the allograph method of vertebral fusion would be expected
to have a lower total sum of work RVUs.
The nominator's description of why and how each vertebral fusion
method is potentially misvalued when compared to the other does not
present a situation that fits within our process for identifying
individual services that are potentially misvalued using certain
criteria, as described in the beginning of this section. Our
determination that one or more codes are potentially misvalued
generally revolves around the specific RVUs assigned to individual
codes, or with the inter-code relativity between the RVUs assigned to
several individual codes found within a family of codes with
hierarchical relationships. CMS generally does not examine the summed
differences in total RVUs (as is the case presented here), based on
billing patterns for a combination of codes representing differing
physician work for different methods of performing a service, and then
comparing the total RVUs of each method as evidence of the potential
misvaluation of codes. We do not believe that the nominator has
provided sufficient evidence to demonstrate that CPT code 20931 itself
is misvalued, and therefore, we are not inclined to propose this code
as potentially misvalued; however, we seek additional comment and any
independent analysis and studies (see the supporting documentation
options listed above under ``CY 2023 Identification and Review of
Potentially Misvalued Services,'' particularly in regard to any changes
in the resources to providing a service) as supporting evidence from
commenters in agreement or disagreement with this nomination.
See Table 6 for the listing of nominated potentially misvalued
codes.
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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 symptom.
<bullet> Reduced recovery time.
[[Page 45886]]
In the CY 2021 PFS final rule (85 FR 84507), we created a third
category of criteria for adding services to the Medicare Telehealth
Services List on a temporary basis following the end of the PHE for the
COVID-19 pandemic: Category 3. 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 criterion described above. We assessed codes that were
temporarily available on the list for the duration of the PHE to
determine their appropriateness for inclusion on the Medicare
Telehealth Services List on a Category 3 basis. We have reassessed the
services that are temporarily available via telehealth for the PHE,
based on both information provided by interested parties and our own
internal review. We have assessed whether or not these services can,
outside of the circumstances of the PHE, be furnished using the full
scope of service elements via two-way, audio-video communication
technology, without jeopardizing patient safety or quality of care, and
we now believe that there are additional services that would be
appropriate for addition to the Medicare Telehealth Services List on a
Category 3 basis that we did not identify in the CY 2021 rulemaking. In
this proposed rule, we are proposing to add these additional services
to the Medicare Telehealth Services List on a Category 3 basis, as
further discussed below.
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 2023, requests to add services to the Medicare
Telehealth Services List must have been submitted and received by
February 10, 2022. 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 submit 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 2023
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
criterion not only streamlines our review process for publicly
requested services that fall into this category, but also expedites our
ability to identify codes for the Medicare Telehealth Services List
that resemble those services already on the Medicare Telehealth
Services List. We add services on a Category 2 basis when the service
does not fall within Category 1, and based upon our assessment of
whether the services are accurately described by the corresponding code
when delivered via telehealth and whether the use of a
telecommunications system to deliver the service produces demonstrated
clinical benefit to the patient. We add services on a temporary
Category 3 basis when the services were temporarily included on the
Medicare Telehealth Services List during the PHE, and we find that
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.
We received several requests to permanently add various services to
the Medicare Telehealth Services List effective for CY 2023. 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. We also assessed the
appropriateness of adding these services to the Medicare Telehealth
Services List on a Category 3 basis instead.
We are not proposing changes to the length of time the services
that we temporarily included on a Category 3 basis will remain on the
Medicare Telehealth Services List; the services we temporarily included
on the Medicare Telehealth Services List on a Category 3 basis will
continue to be included through the end of CY 2023. In the event that
the PHE extends well into CY 2023, we may consider revising this
policy.
We are proposing to add some services to the Medicare Telehealth
Services List on a Category 3 basis through the end of 2023, some of
which we had not previously added to the Medicare Telehealth List
during the PHE, but will be added on a subregulatory basis as provided
in Sec. 410.78(f) of our regulations. For some of these services, we
have received information from interested parties suggesting potential
clinical benefit. For others, we continue to believe there is
sufficient evidence of potential clinical benefit to warrant allowing
additional time for interested parties to gather data to support their
possible inclusion on the Medicare Telehealth Services List on a
Category 1 or 2 basis. The Medicare Telehealth Services List requests
for CY 2023 are listed in Table 7.
Additionally, the Consolidated Appropriations Act, 2022 (CAA, 2022)
(Pub. L. 117-103, March 15, 2022) amended section 1834(m) of the Act to
extend a number of flexibilities that are in place during the PHE for
COVID-19 for 151 days after the end of the PHE. To align the
availability of these services with those flexibilities
[[Page 45887]]
extended under the Act, we are proposing to continue to allow certain
telehealth services that would otherwise not be available via
telehealth after the expiration of the PHE to remain on the Medicare
Telehealth Services List for 151 days after the expiration of the PHE.
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BILLING CODE 4120-01-C
We remind interested parties that the criterion for adding services
to the Medicare Telehealth Services List under Category 1 is that the
requested services are similar to professional consultations, office
visits, and/or 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 7 met the Category 1 or 2 criteria.
We received a request to permanently add CPT code S9443 (Lactation
classes, non-physician provider, per session) to the Medicare
Telehealth Services List. This service has a status code of ``I,''
which means that it is not valid for Medicare billing purposes. We
understand that this is a temporary code established by a private payor
for private payor use, and thus, it is not valid for nor payable by
Medicare. As such, this code is not separately billable under the PFS.
We generally do not add services to the Medicare Telehealth Services
List unless they are separately billable under the PFS. Outside of the
circumstances of the PHE, the Medicare Telehealth Services List only
includes services that are covered if they are furnished without the
use of telecommunication technology in-person. Because CPT code S9443
is not billable under the PFS when furnished in-person, we do not
believe it would be appropriate to allow the service to be billed
separately when furnished as a Medicare telehealth service. As noted in
the CY 2018 PFS final rule (82 FR 53011), if a service does not
describe a service typically furnished in-person, it would not be
considered a telehealth service under the applicable provisions of the
statute. We are not proposing to add CPT code S9443 to the Medicare
Telehealth Services List.
(1) Therapy Services
We received requests to add Therapy Procedures: CPT codes 97110,
97112, 97116, 97150, and 97530; Physical Therapy Evaluations: CPT codes
97161-97164; Therapy Personal Care services: CPT codes 97535, 97537,
and 97542; and Therapy Tests and Measurements services: CPT codes
97750, 97755, and 97763, to the Medicare Telehealth Services List on a
Category 1 basis.
In the CY 2022 PFS final rule (86 FR 65051), we determined that
these services did not meet the Category 1 criteria for addition to the
Medicare Telehealth Services List because they involve direct
observation and/or physical contact between the practitioner and the
patient and, in many instances, are therapeutic in nature, and that
they did not meet Category 2 criteria, because we thought
[[Page 45890]]
that the request did not provide sufficient detail to determine whether
all of the necessary elements of the service could be furnished
remotely. We continue to believe this is the case. We still do not have
sufficient information to determine whether these services meet the
Category 2 criteria. However, we note that some of these codes,
including codes 97110, 97112, 97116, 97150, 97530, 97161-97164, 97535,
97542, 97750, and 97755 have been added to the list on a temporary
basis for the duration of the PHE.
In assessing the evidence that was supplied 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. Information regarding safety,
appropriateness, and that indicates that all elements of a given CPT
code can be furnished via telehealth is still needed to assess whether
these services meet the Category 2 criteria. However, we also believe
that the therapy services that are currently on the Medicare Telehealth
Services List on a temporary basis for the PHE (including CPT codes
97150, 97530, and 97542), but are not currently included on a Category
3 basis, may continue to be furnished safely via two-way, audio-video
communication technology outside of the circumstances of the PHE.
Therefore, we are proposing that CPT codes 97150, 97530, and 97542
(the set of therapy services that are currently on the Medicare
Telehealth Services List on a temporary basis for the PHE), should be
added to the Medicare Telehealth Services List through the end of CY
2023 on a temporary, Category 3 basis, to allow time to gather
additional data that could support their inclusion on the list on a
permanent basis. Therefore, we are proposing to add CPT codes 97150,
97530, and 97542 to the Medicare Telehealth Services List on a Category
3 basis. CPT codes 97110, 97112, 97116, 97161-97164, 97535, 97750, and
97755 will continue to be available on the Medicare Telehealth Services
List on a Category 3 basis. We anticipate that keeping these services
on the Medicare Telehealth Services List on a Category 3 basis, as
proposed, through the end of CY 2023 would preserve access to care and
promote health equity, and based on information provided by interested
parties and internal review, we believe that they may safely be
furnished as telehealth outside of the circumstances of the PHE through
the end of CY 2023. However, we remind readers that the practitioners
who primarily furnish these services, physical therapists, are not,
outside the circumstances of the PHE (and the 151 day period following
the expiration of the PHE), authorized to furnish Medicare telehealth
services. We note that if the PHE and the 151 day period following the
expiration of the PHE both end in CY 2023, the pre-PHE rules will take
effect, and these services could no longer be furnished by therapists
as Medicare telehealth services.
Certain other requested therapy services, namely CPT codes 97537,
97763, 90901, and 98960-98962 are not currently on the Medicare
Telehealth Services List; however, we are adding these services to the
Medicare Telehealth Services List on a temporary basis during the PHE,
in accordance with Sec. 410.78(f). As explained below in section
II.D.1.d. of this proposed rule, services included on the Medicare
Telehealth Services List on a temporary basis during the PHE that have
not been added to the list on a Category 3 basis will remain on the
list for 151 days following the end of the PHE. Furthermore, we are
proposing to add CPT codes 97537, 97763, 90901, and 98960-98962 to the
Medicare Telehealth Services List on a Category 3 basis through the end
of CY 2023. Our clinical analyses of these services indicate that they
can be furnished in full using two-way, audio and video technology
during the circumstances of the PHE, and information provided by
requestors indicates that there may be clinical benefit; however, there
is not yet sufficient evidence available to consider the services for
permanent addition to the Medicare Telehealth Services List under the
Category 1 or Category 2 criteria. Including these services on the
Medicare Telehealth Services List during the PHE and through CY 2023
would allow additional time for the development of evidence for CMS to
consider when evaluating these services for potential permanent
addition to the Medicare Telehealth Services List on a Category 1 or 2
basis. We continue to encourage commenters to supply additional
information in support of adding these services to the Medicare
Telehealth Services List on a permanent basis, including information
regarding the safety and appropriateness of furnishing these services
via telehealth.
(2) Telephone E/M Services
We have also received requests to temporarily add Telephone E/M
visit codes, CPT codes 99441, 99442, and 99443 to the Medicare
Telehealth Services List on a Category 3 basis. In the March 31, 2020
interim final rule with comment period (IFC), we established separate
payment for audio-only telephone E/M services (85 FR 19264 through
19266) for the duration of the PHE for the COVID-19 pandemic. Although
these services were previously considered non-covered under the PFS, in
the context of the PHE for COVID-19 and with the goal of reducing
exposure risks associated with COVID-19 (especially in situations when
two-way, audio and video technology is not available to furnish a
Medicare telehealth service), we believed there were circumstances
where prolonged, audio-only communication between the practitioner and
the patient could be clinically appropriate, yet not fully replace a
face-to-face visit. In the May 8, 2020 COVID-19 IFC, we noted that
interested parties had informed us that use of audio-only services was
more prevalent than we had previously considered, especially because
many beneficiaries were not using video-enabled communication
technology from their homes. In other words, there were many cases
where practitioners who would ordinarily furnish audio-video telehealth
or in-person visits to evaluate and manage patients' medical concerns
were instead using audio-only interactions to manage more complex care
(85 FR 27589 through 27590). While we had previously acknowledged the
likelihood that, under the circumstances of the PHE for COVID- 19, more
time would be spent interacting with the patient via audio-only
technology, we stated that the intensity of furnishing an audio-only
visit to a beneficiary during the unique circumstances of the PHE for
COVID-19 was not accurately captured by the valuation of these services
that we established in the March 31, 2020 IFC (85 FR 27590). This would
be particularly true to the extent that these audio-only services are
serving as a substitute for office/outpatient (O/O) Medicare telehealth
visits for beneficiaries not using video-enabled telecommunications
technology, which is contrary to the situation we anticipated when
establishing separate payment for them in the March 31, 2020 IFC. In
the May 8, 2020 COVID-19 IFC, we stated that, given our understanding
that these audio-only services were being furnished primarily as a
replacement for care that would otherwise be reported as an in-person
or telehealth visit using the O/O E/M codes, we established new RVUs
for the telephone E/M services based on crosswalks to the most
analogous O/O E/M codes, based on the time
[[Page 45891]]
requirements for the telephone codes and the times assumed for
valuation for purposes of the O/O E/M codes. Specifically, we
crosswalked the levels 2-4 O/O E/Ms for established patients, as
described by CPT codes 99212, 99213, and 99214, to CPT codes 99441,
99442, and 99443, respectively. Additionally, we stated that, given our
understanding that these audio-only services were being furnished as
substitutes for O/O E/M services, we recognized that they should be
considered as telehealth services, and added them to the Medicare
Telehealth Services List for the duration of the PHE for COVID-19 (85
FR 27590).
In the CY 2022 PFS final rule (86 FR 65055), in response to
requests that these codes be added to the Medicare Telehealth Services
List on a Category 3 basis, we stated that we were finalizing a change
to the definition of ``telecommunications system'' to allow telehealth
services for the diagnosis, evaluation, and treatment of mental health
conditions to be furnished through audio-only technology in certain
circumstances after the end of the PHE. For example, the O/O E/M codes
are on the Medicare Telehealth Services List permanently and when used
to describe care for mental health conditions, will be reportable when
furnished via audio-only technology to patients in their homes. Since
audio-only telecommunications technology can be used to furnish mental
health telehealth services to patients in their homes, the addition of
these codes to the Medicare Telehealth Services List is unnecessary for
mental health telehealth services. For telehealth services other than
mental health care, we stated that we believe that two-way, audio-video
communications technology is the appropriate standard that will apply
for telehealth services after the PHE ends. Further, we note that
section 1834(m)(2)(A) of the Act requires that payment to a distant
site physician or practitioner that furnishes Medicare telehealth
services to an eligible telehealth individual be equal to the amount
that would have been paid under Medicare if such physician or
practitioner had furnished the service without a telecommunications
system. We believe that the statute requires that telehealth services
be so analogous to in-person care such that the telehealth service is
essentially a substitute for a face-to-face encounter. However, these
audio-only telephone E/M services are inherently non-face-to-face
services, since they are furnished exclusively through remote, audio-
only communications. Outside the circumstances of the PHE, the
telephone E/M services would not be analogous to in-person care; nor
would they be a substitute for a face-to-face encounter. Therefore, we
do not believe it would be appropriate for these codes to remain on the
Medicare Telehealth Services List after the end of the PHE and the 151-
day post-PHE extension period. Accordingly, we are not proposing to
keep these telephone E/M services on the Medicare Telehealth Services
List after that period on a Category 3 basis, because the codes
describe services that can only be furnished using audio-only
telecommunications technology, and outside of the circumstances of the
PHE, they do not describe services that are a substitute for an in-
person visit. While we acknowledge that audio-only technology can be
used to furnish mental health telehealth services to patients in their
homes under certain circumstances after the PHE ends, two-way, audio-
video communications technology continues to be the appropriate
standard that will apply for Medicare telehealth services after the PHE
and the 151-day extension period. As we noted in the CY 2021 PFS final
rule (85 FR 84535), we will assign these Telephone E/M visit codes (CPT
codes 99441, 99442, and 99443) a ``bundled'' status after the end of
the PHE and the 151-day extension period, and we will post the RUC-
recommended RVUs for these codes in accordance with our usual practice.
(3) GI Tract Imaging and Continuous Glucose Monitoring
We received requests to add CPT codes describing GI Tract Imaging,
CPT code 91110 (Gastrointestinal tract imaging, intraluminal (e.g.,
capsule endoscopy), esophagus through ileum, with interpretation and
report) and Ambulatory Continuous Glucose Monitoring, CPT code 95251
(Ambulatory continuous glucose monitoring of interstitial tissue fluid
via a subcutaneous sensor for a minimum of 72 hours; analysis,
interpretation and report), to the Medicare Telehealth Services List on
a Category 3 basis. We believe these codes may describe services that
are inherently non-face-to-face services, (the patient need not be
present in order for the service to be furnished in its entirety), and
therefore, they do not describe services that are a substitute for an
in-person visit. As stated earlier, we believe that the statute
requires that telehealth services be so analogous to in-person care
such that the telehealth service is essentially a substitute for a
face-to-face encounter. For this and other reasons, we are not
proposing to add these services to the Medicare Telehealth Services
List on a Category 3 basis; we do not believe these CPT codes describe
services that are a substitute for an in-person visit, and we believe
that services that are not inherently face-to-face services are not
services that can be furnished as Medicare telehealth services. Even
so, we are interested in information that would help us to understand
whether these services would meet the criteria for inclusion on the
Medicare Telehealth Services List either for the PHE, as Category 3
services, or permanently on a Category 1 or 2 basis, given our
questions as to whether they are inherently non-face-to-face services,
and therefore, may not fit within the scope of services that could be
furnished as Medicare telehealth services. Therefore, we are also
seeking comment on whether these services would involve an in-person
service when furnished without the use of a telecommunications system.
(4) Neurostimulator Pulse Generator/Transmitter
We received requests to add codes describing the electronic
analysis of an implanted neurostimulator pulse generator/transmitter to
the Medicare Telehealth Services List. These included a request to add
CPT codes 95976 (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 simple
cranial nerve neurostimulator pulse generator/transmitter programming
by physician or other qualified health care professional) and 95977
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group[s], interleaving, amplitude, pulse
width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with complex
cranial nerve neurostimulator pulse generator/transmitter programming
by physician or other qualified health care professional) permanently
on a Category 1 basis, as well as a request to add CPT codes 95970
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group[s],
[[Page 45892]]
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), 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 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)) to the Medicare Telehealth Services List on a
temporary Category 3 basis.
The request to add CPT codes 95976 and 95977, which are codes that
describe analysis of cranial nerve neurostimulation, indicated that the
ability to fully furnish this service using two-way, audio-video
communication technology was forthcoming, but is currently unavailable.
Therefore, we are not proposing to add CPT codes 95976 and 95977 to the
Medicare Telehealth Services List, because the full scope of service
elements described by these codes cannot currently be furnished via
two-way, audio-video communication technology. However, we will
consider additional evidence regarding the ability to furnish these
services as telehealth services, such as information indicating that
current technology has evolved, as it becomes available for future
rulemaking. We are also not proposing to add them on a Category 1 basis
because they do not describe services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the Medicare Telehealth Services List.
With regard to CPT codes 95970, 95983, and 95984, which describe
general brain nerve neurostimulation, we have some 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,
and Medicare claims data suggest that these services are being provided
via telehealth. 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 to the Medicare Telehealth
Services List under the Category 1 or Category 2 criteria. With that
said, CPT codes 95970, 95983, and 95984 do meet the criteria for
temporary inclusion on the Medicare Telehealth Services List on a
Category 3 basis. Therefore, we are proposing to add CPT codes 95970,
95983, and 95984 to the Medicare Telehealth Services List on a Category
3 basis, while soliciting comment on our concerns regarding patient
safety and whether these services are appropriate for inclusion on the
Medicare Telehealth Services List outside the circumstances of the PHE.
(5) Emotional/Behavior Assessment, Psychological, or Neuropsychological
Testing and Evaluation Services
We received requests to add a number of emotional/behavior
assessment, psychological, or neuropsychological testing and evaluation
services, described by CPT codes 97151 (Behavior identification
assessment
[…truncated; see source link]Indexed from Federal Register on July 29, 2022.
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