Rule2023-24184
Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program
Primary source
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
November 16, 2023
Effective
January 1, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; payment for dental services inextricably linked to specific covered medical services; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare and Medicaid provider and supplier enrollment policies, electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); updates to the Ambulance Fee Schedule regulations and the Medicare Ground Ambulance Data Collection System; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; expansion of the diabetes screening and diabetes definitions; pulmonary rehabilitation, cardiac rehabilitation and intensive cardiac rehabilitation expansion of supervising practitioners; appropriate use criteria for advanced diagnostic imaging; early release of Medicare Advantage risk adjustment data; a social determinants of health risk assessment in the annual wellness visit and Basic Health Program.
Full Text
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[Federal Register Volume 88, Number 220 (Thursday, November 16, 2023)]
[Rules and Regulations]
[Pages 78818-80047]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24184]
[[Page 78817]]
Vol. 88
Thursday,
No. 220
November 16, 2023
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 2024 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment and Coverage
Policies; Medicare Shared Savings Program Requirements; Medicare
Advantage; Medicare and Medicaid Provider and Supplier Enrollment
Policies; and Basic Health Program; Final Rule
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 /
Rules and Regulations
[[Page 78818]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 418, 422, 423, 424, 425, 455,
489, 491, 495, 498, and 600
[CMS-1784-F]
RIN 0938-AV07
Medicare and Medicaid Programs; CY 2024 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements;
Medicare Advantage; Medicare and Medicaid Provider and Supplier
Enrollment Policies; and Basic Health Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This major final rule addresses: changes to the physician fee
schedule (PFS); other changes to Medicare Part B payment policies to
ensure that payment systems are updated to reflect changes in medical
practice, relative value of services, and changes in the statute;
payment for dental services inextricably linked to specific covered
medical services; Medicare Shared Savings Program requirements; updates
to the Quality Payment Program; Medicare coverage of opioid use
disorder services furnished by opioid treatment programs; updates to
certain Medicare and Medicaid provider and supplier enrollment
policies, electronic prescribing for controlled substances for a
covered Part D drug under a prescription drug plan or an MA-PD plan
under the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act (SUPPORT Act);
updates to the Ambulance Fee Schedule regulations and the Medicare
Ground Ambulance Data Collection System; codification of the Inflation
Reduction Act and Consolidated Appropriations Act, 2023 provisions;
expansion of the diabetes screening and diabetes definitions; pulmonary
rehabilitation, cardiac rehabilitation and intensive cardiac
rehabilitation expansion of supervising practitioners; appropriate use
criteria for advanced diagnostic imaging; early release of Medicare
Advantage risk adjustment data; a social determinants of health risk
assessment in the annual wellness visit and Basic Health Program.
DATES: These regulations are effective on January 1, 2024.
FOR FURTHER INFORMATION CONTACT:
<a href="/cdn-cgi/l/email-protection#1a577f7e73797b687f4a7263697379737b745c7f7f4979727f7e6f767f5a79776934727269347d756c"><span class="__cf_email__" data-cfemail="69240c0d000a081b0c3901101a000a0008072f0c0c3a0a010c0d1c050c290a041a4701011a470e061f">[email protected]</span></a>, for any issues not
identified below. Please indicate the specific issue in the subject
line of the email.
<a href="/cdn-cgi/l/email-protection#0b466e6f62686a796e5b6372786268626a654d6e6e5868636e6f7e676e4b68667825636378256c647d"><span class="__cf_email__" data-cfemail="034e66676a60627166536b7a706a606a626d45666650606b6667766f6643606e702d6b6b702d646c75">[email protected]</span></a>, for the following issues:
practice expense, work RVUs, conversion factor, and PFS specialty-
specific impacts; the comment solicitation on strategies for updates to
practice expense data collection and methodology, caregiver training
services, community health integration services, social determinants of
health risk assessment, and principal illness navigation services;
potentially misvalued services under the PFS, direct supervision using
two-way audio/video communication technology, telehealth, and other
services involving communications technology; teaching physician
services, advancing access to behavioral health services, PFS payment
for evaluation and management services, geographic practice cost
indices (GPCIs), payment for skin substitutes, supervision of
outpatient therapy services, KX modifier thresholds, diabetes self-
management training (DSMT) services, and DSMT telehealth services, and
dental services inextricably linked to specific covered services.
Laura Ashbaugh, (410) 786-1113, and Erick Carrera, (410) 786-8949,
Zehra Hussain, (214) 767-4463, or
<a href="/cdn-cgi/l/email-protection#94d9f1f0fdf7f5e6f1c4fcede7fdf7fdf5fad2f1f1c7f7fcf1f0e1f8f1d4f7f9e7bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="327f57565b51534057625a4b415b515b535c74575761515a5756475e5772515f411c5a5a411c555d44">[email protected]</span></a>, for issues related to dental
services inextricably linked to specific covered medical services.
Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, and
Rachel Radzyner, (410) 786-8215, for issues related to Drugs and
Biological Products Paid Under Medicare Part B.
<a href="/cdn-cgi/l/email-protection#2a674f4e43494b584f7a4253594349434b446c4f4f7949424f4e5f464f6a49475904424259044d455c"><span class="__cf_email__" data-cfemail="155870717c76746770457d6c667c767c747b53707046767d7071607970557678663b7d7d663b727a63">[email protected]</span></a>, for issues related to
complex drug administration.
Laura Ashbaugh, (410) 786-1113, and Ariana Pitcher, (667) 290-8840,
or <a href="/cdn-cgi/l/email-protection#04474842575b4d6a75716d766d6177446769772a6c6c772a636b72"><span class="__cf_email__" data-cfemail="31727d77626e785f4044584358544271525c421f5959421f565e47">[email protected]</span></a> for issues related to Clinical Laboratory
Fee Schedule.
Lisa Parker, (410) 786-4949, or <a href="/cdn-cgi/l/email-protection#cf899e878ce29f9f9c8faca2bce1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="9adccbd2d9b7cacac9daf9f7e9b4f2f2e9b4fdf5ec">[email protected]</span></a>, for issues
related to FQHC payments.
Michele Franklin, (410) 786-9226, or <a href="/cdn-cgi/l/email-protection#2f7d676c6f4c425c0147475c01484059"><span class="__cf_email__" data-cfemail="dc8e949f9cbfb1aff2b4b4aff2bbb3aa">[email protected]</span></a>, for issues
related to RHC payments.
Kianna Banks, (410) 786-3498 and Cara Meyer, (667) 290-9856, for
issues related to RHCs and FQHCs definitions of staff and Conditions
for Certification or Coverage.
Sarah Fulton, (410) 786-2749, for issues related to pulmonary
rehabilitation, cardiac rehabilitation and intensive cardiac
rehabilitation expansion of supervising practitioners.
Lindsey Baldwin, (410) 786-1694, Ariana Pitcher, (667) 290-8840, or
<a href="/cdn-cgi/l/email-protection#afe0fbfff0e2cacbc6ccceddcaefccc2dc81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="2b647f7b74664e4f42484a594e6b48465805434358054c445d">[email protected]</span></a>, for issues related to Medicare coverage of
opioid use disorder treatment services furnished by opioid treatment
programs.
Sabrina Ahmed, (410) 786-7499, or <a href="/cdn-cgi/l/email-protection#a2f1cac3d0c7c6f1c3d4cbccc5d1f2d0cdc5d0c3cfe2c1cfd18ccacad18cc5cdd4"><span class="__cf_email__" data-cfemail="abf8c3cad9cecff8caddc2c5ccd8fbd9c4ccd9cac6ebc8c6d885c3c3d885ccc4dd">[email protected]</span></a>,
for issues related to the Medicare Shared Savings Program (Shared
Savings Program) Quality performance standard and quality reporting
requirements.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or <a href="/cdn-cgi/l/email-protection#61320900130405320017080f061231130e0613000c21020c124f0909124f060e17"><span class="__cf_email__" data-cfemail="2c7f444d5e49487f4d5a45424b5f7c5e434b5e4d416c4f415f0244445f024b435a">[email protected]</span></a>, for issues related to Shared
Savings Program beneficiary assignment and benchmarking methodology.
Lucy Bertocci, (410) 786-3776, or <a href="/cdn-cgi/l/email-protection#e6b58e87948382b587908f888195b694898194878ba6858b95c88e8e95c8818990"><span class="__cf_email__" data-cfemail="ecbf848d9e8988bf8d9a85828b9fbc9e838b9e8d81ac8f819fc284849fc28b839a">[email protected]</span></a>,
for issues related to Shared Savings Program advance investment
payments, and eligibility requirements.
Rachel Radzyner, (410) 786-8215, and Michelle Cruse, (443) 478-
6390, for issues related to preventive vaccine administration services.
Mollie Howerton, (410) 786-5395, for issues related to Medicare
Diabetes Prevention Program.
Sarah Fulton, (410) 786-2749, for issues related to appropriate use
criteria for advanced diagnostic imaging.
Frank Whelan, (410) 786-1302, for issues related to Medicare and
Medicaid provider and supplier enrollment regulation updates.
Daniel Feller, (410) 786-6913 for issues related to expanding
diabetes screening and definitions.
Daniel Feller, (410) 786-6913 for issues related to a social
determinants of health risk assessment in the annual wellness visit.
Mei Zhang, (410) 786-7837, and Kimberly Go, (410) 786-4560, for
issues related to requirement for electronic prescribing for controlled
substances for a covered Part D drug under a prescription drug plan or
an MA-PD plan (section 2003 of the SUPPORT Act).
Amy Gruber, (410) 786-1542, or <a href="/cdn-cgi/l/email-protection#0e4f636c7b626f606d6b4a6f7a6f4d6162626b6d7a6761604e6d637d2066667d20696178"><span class="__cf_email__" data-cfemail="43022e21362f222d202607223722002c2f2f2620372a2c2d03202e306d2b2b306d242c35">[email protected]</span></a>,
for issues related to the Ambulance Fee Schedule (AFS) and the Medicare
Ground Ambulance Data Collection System.
Mary Rossi-Coajou, (410) 786-6051, for issues related to hospice
Conditions of Participation.
[[Page 78819]]
Cameron Ingram, (410) 409-8023 for issues related to
Histopathology, Cytology, and Clinical Cytogenetics Regulations under
CLIA of 1988.
Meg Barry, (410) 786-1536, for issues related to the Basic Health
Program (BHP) provisions.
Renee O'Neill, (410) 786-8821, or Sophia Sugumar, (410) 786-1648,
for inquiries related to Merit-based Incentive Payment System (MIPS)
track of the Quality Payment Program.
Richard Jensen, (410) 786-6126, for inquiries related to
Alternative Payment Models (APMs).
SUPPLEMENTARY INFORMATION:
Addenda Available Only Through the internet on the CMS website: The
PFS Addenda along with other supporting documents and tables referenced
in this final rule are available on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html</a>. Click on the link on the left side of the
screen titled, ``PFS Federal Regulations Notices'' for a chronological
list of PFS Federal Register and other related documents. For the CY
2024 PFS final rule, refer to item CMS-1784-F. Readers with questions
related to accessing any of the Addenda or other supporting documents
referenced in this final rule and posted on the CMS website identified
above should contact <a href="/cdn-cgi/l/email-protection#efa28a8b868c8e9d8abf87969c868c868e81a98a8abc8c878a8b9a838aaf8c829cc187879cc1888099"><span class="__cf_email__" data-cfemail="89c4ecede0eae8fbecd9e1f0fae0eae0e8e7cfececdaeae1ecedfce5ecc9eae4faa7e1e1faa7eee6ff">[email protected]</span></a>.
CPT (Current Procedural Terminology) Copyright Notice: Throughout
this final rule, we use CPT codes and descriptions to refer to a
variety of services. We note that CPT codes and descriptions are
copyright 2020 American Medical Association. All Rights Reserved. CPT
is a registered trademark of the American Medical Association (AMA).
Applicable Federal Acquisition Regulations (FAR) and Defense Federal
Acquisition Regulations (DFAR) apply.
I. Executive Summary
A. Purpose
This major final rule revises payment polices under the Medicare
PFS and makes other policy changes, including to the implementation of
certain provisions of the Consolidated Appropriations Act, 2023 (Pub.
L. 117-328, September 29, 2022), Inflation Reduction Act of 2022 (IRA)
(Pub. L. 117-169, August 16, 2022), Consolidated Appropriations Act,
2022 (Pub. L. 117-103, March 15, 2022), Consolidated Appropriations
Act, 2021 (CAA, 2021) (Pub. L. 116-260, December 27, 2020), Bipartisan
Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018)
and the Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L.
115-271, October 24, 2018), related to Medicare Part B payment. In
addition, this major final rule includes provisions regarding other
Medicare payment policies described in sections III. and IV.
This rulemaking updates the Rural Health Clinic (RHC) and Federally
Qualified Health Clinic (FQHC) Conditions for Certification and
Conditions for Coverage (CfCs), respectively, to implement the
provisions of the Consolidated Appropriations Act (CAA), 2023 (Pub. L.
117-328, December 29, 2022), now allowing payment under Medicare Part B
for services furnished by a Marriage and Family Therapist (MFT) or
Mental Health Counselor (MHC).
This rulemaking also updates the Hospice Conditions of
Participation (CoPs) to implement division FF, section 4121 of the CAA
2023 regarding the addition of marriage and family therapists (MFTs) or
mental health counselors (MHCs) as part of the hospice
interdisciplinary team and make changes to the hospice personnel
requirements.
This rulemaking also seeks to further advance Medicare's overall
value-based care strategy of growth, alignment, and equity through the
Medicare Shared Savings Program (Shared Savings Program) and the
Quality Payment Program (QPP). The structure of the programs enables us
to develop a set of tools for measuring and encouraging improvements in
care, which may support a shift to clinician payment over time into
Advanced Alternative Payment Models (APMs) and accountable care
arrangements which reduce care fragmentation and unnecessary costs for
patients and the health system.
This rulemaking also updates the public reporting requirements of
procedure volume data (Part B non-institutional claims) on clinician
profile pages of the Compare Tool to include Medicare Advantage (MA)
encounter data. This enables us to use and analyze MA encounter data as
part of the aggregated information disclosed through the Care Compare
website, more broadly fulfilling the public reporting requirements of
section 104 of the MACRA and section 10331 of the ACA and providing
beneficiaries with useful and appropriate information when selecting a
provider. This rulemaking also amends Sec. 422.310(f)(3) to permit the
release of the MA encounter data on the timeframe(s) used for
disclosure and release of the data on the Care Compare website.
This rulemaking also updates the Ambulance Fee Schedule regulations
to implement division FF, section 4103 of the CAA 2023 regarding the
ground ambulance extenders provisions and also provides further changes
and clarifications to the Medicare Ground Ambulance Data Collection
System.
This rulemaking also updates Medicare and Medicaid provider and
supplier enrollment regulations.
B. Summary of the Major Provisions
The statute requires us to establish payments under the PFS, based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: work,
practice expense (PE), and malpractice (MP) expense. In addition, the
statute requires that each year we establish, by regulation, the
payment amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
The statute requires us to establish payments under the PFS, based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: work,
practice expense (PE), and malpractice (MP) expense. In addition, the
statute requires that we establish each year by regulation the payment
amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major final rule, we are establishing RVUs for CY 2024 for
the PFS to ensure that our payment systems are updated to reflect
changes in medical practice and the relative value of services, as well
as changes in the statute. This final rule also includes discussions
and provisions regarding several other Medicare Part B payment
policies, Medicare and Medicaid provider and supplier enrollment
policies, and other policies regarding programs administered by CMS.
Specifically, this final rule addresses:
<bullet> Background (section II.A.)
<bullet> Determination of PE RVUs (section II.B.)
<bullet> Potentially Misvalued Services Under the PFS (section II.C.)
<bullet> Payment for Medicare Telehealth Services Under Section 1834(m)
of the
[[Page 78820]]
Social Security Act (the Act) (section II.D.)
<bullet> Valuation of Specific Codes (section II.E.)
<bullet> Evaluation and Management (E/M) Visits (section II.F.)
<bullet> Geographic Practice Cost Indices (GPCI) (section II.G.)
<bullet> Payment for Skin Substitutes (section II.H.)
<bullet> Supervision of Outpatient Therapy Services, KX Modifier
Thresholds, Diabetes Self-Management Training (DSMT) Services by
Registered Dietitians and Nutrition Professional, and DSMT Telehealth
Services (section II.I.)
<bullet> Advancing Access to Behavioral Health Services (section II.J.)
<bullet> Policies on Medicare Parts A and B Payment for Dental Services
Inextricably Linked to Specific Covered Services (section II.K.)
<bullet> Drugs and Biological Products Paid Under Medicare Part B
(section III.A.)
<bullet> Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (section III.B.)
<bullet> Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) Conditions for Certification or Coverage (CfCs)
(section III.C.)
<bullet> Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions (section III.D.)
<bullet> Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive
Cardiac Rehabilitation Expansion of Supervising Practitioners (section
III.E.)
<bullet> Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.F.)
<bullet> Medicare Shared Savings Program (section III.G.)
<bullet> Medicare Part B Payment for Preventive Vaccine Administration
Services (section III.H.)
<bullet> Medicare Diabetes Prevention Program Expanded Model (section
III.I.)
<bullet> Appropriate Use Criteria for Advanced Diagnostic Imaging
(section III.J.)
<bullet> Medicare and Medicaid Provider and Supplier Enrollment
(section III.K.)
<bullet> Expand Diabetes Screening and Diabetes Definitions (section
III.L.)
<bullet> Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D Drug under a Prescription Drug Plan or
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.M.)
<bullet> Changes to the Regulations Associated with the Ambulance Fee
Schedule and the Medicare Ground Ambulance Data Collection System
(GADCS) (section III.N.)
<bullet> Hospice: Changes to the Hospice Conditions of Participation
(section III.O.)
<bullet> RFI: Histopathology, Cytology, and Clinical Cytogenetics
Regulations under the Clinical Laboratory Improvement Amendments (CLIA)
of 1988 (section III.P.)
<bullet> Changes to the Basic Health Program Regulations (section
III.Q.)
<bullet> Updates to the Definitions of Certified Electronic Health
Record Technology (section III.R.)
<bullet> A Social Determinants of Health Risk Assessment in the Annual
Wellness Visit (section III.S.)
<bullet> Updates to the Quality Payment Program (section IV.)
<bullet> Collection of Information Requirements (section V.)
<bullet> Response to Comments (section VI.)
<bullet> Regulatory Impact Analysis (section VII.)
C. Summary of Costs and Benefits
We have determined that this final rule is economically
significant. For a detailed discussion of the economic impacts, see
section VII., Regulatory Impact Analysis, of this final rule.
II. Provisions of the Final Rule for the PFS
A. Background
In accordance with section 1848 of the Act, CMS has paid for
physicians' services under the Medicare physician fee schedule (PFS)
since January 1, 1992. The PFS relies on national relative values that
are established for work, practice expense (PE), and malpractice (MP),
which are adjusted for geographic cost variations. These values are
multiplied by a conversion factor (CF) to convert the relative value
units (RVUs) into payment rates. The concepts and methodology
underlying the PFS were enacted as part of the Omnibus Budget
Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239, December 19,
1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
(Pub. L. 101-508, November 5, 1990). The final rule published in the
November 25, 1991 Federal Register (56 FR 59502) set forth the first
fee schedule used for Medicare payment for physicians' services.
We note that throughout this final rule, unless otherwise noted,
the term ``practitioner'' is used to describe both physicians and
nonphysician practitioners (NPPs) who are permitted to bill Medicare
under the PFS for the services they furnish to Medicare beneficiaries.
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 Relative Value Scale Update Committee (RUC) and those provided
in response to public comment periods. For a detailed explanation of
the direct PE methodology, including examples, we refer readers to the
5-year review of work RVUs under the PFS and proposed changes to the PE
methodology in the CY 2007 PFS proposed rule (71 FR 37242) and the CY
2007 PFS final rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
Socioeconomic Monitoring System (SMS). The AMA administered a new
[[Page 78821]]
survey in CY 2007 and CY 2008, the Physician Practice Information
Survey (PPIS). The PPIS is a multispecialty, nationally representative,
PE survey of both physicians and NPPs paid under the PFS using a survey
instrument and methods highly consistent with those used for the SMS
and the supplemental surveys. The PPIS gathered information from 3,656
respondents across 51 physician specialty and health care professional
groups. We believe the PPIS is the most comprehensive source of PE
survey information available. We used the PPIS data to update the PE/HR
data for the CY 2010 PFS for almost all of the Medicare recognized
specialties that participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by 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 2024 PFS final rule PE/HR'' on the
CMS website under downloads for the CY 2024 PFS final rule at<a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
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
[[Page 78822]]
calculating PE RVUs is the same for both the facility and nonfacility
RVUs but is applied independently to yield two separate PE RVUs. In
calculating the PE RVUs for services furnished in a facility, we do not
include resources that would generally not be provided by physicians
when furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: a
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we
direct readers to the CY 2010 PFS final rule with comment period (74 FR
61745 through 61746). We also direct readers to the file titled
``Calculation of PE RVUs under Methodology for Selected Codes'' which
is available on our website under downloads for the CY 2024 PFS final
rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>. This file
contains a table that illustrates the calculation of PE RVUs as
described in this final rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to 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.
We did not make any proposals associated with the list of expected
specialty assignments for low volume services, however we received
public comments on this topic from interested parties. The following is
a summary of the comments we received and our responses.
Comment: Several commenters stated that they had performed an
analysis to identify all codes that meet the criteria to receive a
specialty override under this CMS policy and drafted updated
recommendations for CY 2024. Commenters stated that the purpose of
assigning a specialty to these codes was to avoid the major adverse
impact on MP RVUs that result from errors in specialty utilization data
magnified in representation (percentage) by small sample size. These
commenters submitted a list of several dozen low volume HCPCS codes
with recommended expected specialty assignments.
Response: After reviewing the information provided by the
commenters to determine that the submitted specialty assignments were
appropriate for the services in question, we are finalizing the
additions to the list of expected specialty assignments for low volume
services identified in Table 1. We agreed with the commenters that CPT
code 33230 should be crosswalked to the Cardiac Electrophysiology
specialty and that CPT code 96446 should be crosswalked to the
Gynecological Oncology specialty. However, we do not have PE/HR data
for these specialties as they were not part of the PPIS when it was
conducted in 2007; therefore, we are crosswalking these CPT codes to
the Cardiology and Obstetrics/Gynecology specialties, respectively, as
listed on Table 1.
We disagreed with the commenters that CPT code 44384 should be
[[Page 78823]]
crosswalked to the Gastroenterology specialty and that CPT code 60505
should be crosswalked to the General Surgery specialty. In each case,
there was another specialty which was reported more than twice as often
in the claims data as the requested specialty. Therefore, we are
crosswalking CPT code 44384 to the Urology specialty and CPT code 60505
to the Otolaryngology specialty as these were the dominant specialties
in the claims data. These crosswalks are included in Table 1.
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Comment: A commenter noted that the CMS expected specialty
assignment list in the public use file that was part of the CY 2024
proposed rule also includes a column specifying if a service that
previously had an anticipated specialty override continues to meet the
criteria for the override to be applied for CY 2024. The commenter
provided a list of approximately a dozen CPT codes and requested
additional information as to why the expected specialty override was
not being applied in these cases.
Response: We reviewed the CPT codes identified by the commenter and
can provide the following information about their expected specialty
override status for CY 2024. CMS did not apply the specialty override
to CPT codes 33238, 33254, 33475, and 33507 as each code exceeded 100
allowed services in the Medicare claims data. CMS did not apply the
specialty override to CPT codes 33602, 33619, 33778, and 43045 because
they were unneeded, with the entirety of their very small number of
allowed services already reported under their expected specialty. CPT
codes 33600, 33710, and 43312 did have their respective specialty
overrides applied; this was correctly detailed in the public use file
for the CY 2024 proposed rule for CPT code 43312 but was missing from
CPT codes 33600 and 33710, due to a technical error in the generation
of the public use file.
We also note for commenters that each HCPCS code that appears on
the list of expected specialty assignments for low volume services
remains on the list from year to year, even if the code in question is
not a low volume service for a certain calendar year because the volume
rises to over 100 services. The HCPCS codes and expected specialty
assignment remain on the list, and will be applied should the code fall
below the low volume threshold (below 100 services) in any calendar
year; as a result, there is no need to ``reactivate'' individual codes
as some commenters have suggested in past submissions.
After consideration of the public comments, we are finalizing the
updates to the list of expected specialty assignments for low volume
services as detailed Table 1.
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.
[[Page 78826]]
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the aggregate work RVUs scaled by the ratio of current
aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in
the PFS account for the fact that certain specialties are excluded from
the calculation of PE RVUs but included in maintaining overall PFS BN.
(See ``Specialties excluded from ratesetting calculation'' later in
this final rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased in
over a 2-year period. In implementing the phase-in, we consider a 19
percent reduction as the maximum 1-year reduction for any service not
described by a new or revised code. This approach limits the year one
reduction for the service to the maximum allowed amount (that is, 19
percent), and then phases in the remainder of the reduction. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
Comment: Several commenters referenced the CY 2018 PFS finalized
policy for the adjustment to allocation of indirect PE for some office-
based services, generally services associated with behavioral health
(82 FR 52999 through 53000). Commenters stated that for each of the
services that qualify for the indirect PE allocation adjustment, CMS
first establishes an indirect PE floor using the work RVU for the
qualifying service and the ratio between the indirect PE RVUs and the
work RVUs for the marker code (currently CPT code 99213). Commenters
stated that CMS then identifies the difference between the indirect PE
RVU for the qualifying service produced under standard methodology and
the indirect PE floor; the modified methodology then increases the
allocation of indirect PE RVUs to one quarter of that difference.
Commenters stated that they supported the current policy, since they
believe that the current PFS reimbursement rate methodology undervalues
behavioral health services and recommended that CMS expand the indirect
PE floor methodology by increasing the minimum value for non-facility
indirect PE RVUs by adding the full difference between the indirect PE
floor RVUs and indirect PE RVUs calculated for the eligible codes under
the standard methodology (instead of one quarter of the distance).
Commenters stated that this expansion of the current indirect PE floor
policy would assure that a more appropriate number of indirect PE RVUs
are allocated to these services and would provide greater resources to
behavioral health practitioners providing services to Medicare
beneficiaries with behavioral and mental health needs.
Response: We appreciate the support from the commenters for our
previously finalized policy for the adjustment to allocation of
indirect PE for some office-based services. While we share the concern
of the commenters in ensuring that behavioral health practitioners have
the proper resources that they need to provide services to Medicare
beneficiaries, we note that we did not propose to make any adjustments
to this indirect PE policy for CY 2024 and we are not finalizing any
adjustments to this indirect PE policy for CY 2024. We will consider
the recommendations from the commenters for potential use in future
rulemaking.
(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 2.
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<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 78828]]
accordingly. Table 3 details the manner in which the modifiers are
applied.
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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
final rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1 (1/((1 +
interest rate)- life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage=1); generally, 150,000 minutes.
usage = variable, see discussion below in this final rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this final rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
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 78829]]
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
referred 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 4.
[GRAPHIC] [TIFF OMITTED] TR16NO23.004
We did not propose any changes to the equipment interest rates for
CY 2024.
3. Adjusting RVUs To Match the PE Share of the Medicare Economic Index
(MEI)
In the past, we have stated that we believe that the MEI is the
best measure available of the relative weights of the three components
in payments under the PFS--work, practice expense (PE), and malpractice
(MP). Accordingly, we believe that to assure that the PFS payments
reflect the relative resources in each of these PFS components as
required by section 1848(c)(3) of the Act, the RVUs used in developing
rates should reflect the same weights in each component as the cost
share weights in the Medicare Economic Index (MEI). In the past, we
have proposed (and subsequently, finalized) to accomplish this by
holding the work RVUs constant and adjusting the PE RVUs, MP RVUs, and
CF to produce the appropriate balance in RVUs among the three PFS
components and payment rates for individual services, that is, that the
total RVUs on the PFS are proportioned to approximately 51 percent work
RVUs, 45 percent PE RVUs, and 4 percent MP RVUs. As the MEI cost shares
are updated, we would typically propose to modify steps 3 and 10 to
adjust the aggregate pools of PE costs (direct PE in step 3 and
indirect PE in step 10) in proportion to the change in the PE share in
the rebased and revised MEI cost share weights, and to recalibrate the
relativity adjustment that we apply in step 18 as described ``3.
Adjusting RVUs To Match PE Share of the Medicare Economic Index (MEI)''
of the CY 2023 PFS final rule (87 FR 69414 and 69415) and CY 2014 PFS
final rule (78 FR 74236 and 74237). The most recent recalibration was
done for the CY 2014 RVUs.
In the CY 2014 PFS proposed rule (78 FR 43287 through 43288) and
final rule (78 FR 74236 through 74237), we detailed the steps necessary
to accomplish this result (see steps 3, 10, and 18). The CY 2014
proposed and final adjustments were consistent with our longstanding
practice to make adjustments to match the RVUs for the PFS components
with the MEI cost share weights for the components, including the
adjustments described in the CY 1999 PFS final rule (63 FR 58829), CY
2004 PFS final rule (68 FR 63246 and 63247), and CY 2011 PFS final rule
(75 FR 73275).
In the CY 2023 PFS final rule (87 FR 69688 through 69711), we
finalized to rebase and revise the Medicare Economic Index (MEI) to
reflect more current market conditions faced by physicians in
furnishing physicians' services. We also finalized a delay of the
adjustments to the PE pools in steps 3 and 10 and the recalibration of
the relativity adjustment in step 18 until the public had an
opportunity to comment on the rebased and revised MEI (87 FR 69414
through 69416). Because we finalized significant methodological and
data source changes to the MEI in the CY 2023 PFS final rule and
significant time has elapsed since the last rebasing and revision of
the MEI in CY 2014, we believed that delaying the
[[Page 78830]]
implementation of the finalized CY 2023 rebased and revised MEI was
consistent with our efforts to balance payment stability and
predictability with incorporating new data through more routine
updates. We refer readers to the discussion of our comment solicitation
in the CY 2023 PFS final rule (87 FR 69429 through 69432), where we
reviewed our ongoing efforts to update data inputs for PE to aid
stability, transparency, efficiency, and data adequacy. We also
solicited comment in the CY 2023 PFS proposed rule on when and how to
best incorporate the CY 2023 rebased and revised MEI into PFS
ratesetting, and whether it would be appropriate to consider a
transition to full implementation for potential future rulemaking. We
presented the impacts of implementing the rebased and revised MEI in
PFS ratesetting through a 4-year transition and through full immediate
implementation, that is, with no transition period in the CY 2023 PFS
proposed rule. We also solicited comment on other implementation
strategies for potential future rulemaking in the CY 2023 PFS proposed
rule. In the CY 2023 PFS final rule, we discussed that many commenters
supported our proposed delayed implementation and many commenters
expressed concerns with the redistributive impacts of the
implementation of the rebased and revised MEI in PFS ratesetting. Many
commenters also noted that the AMA has stated it intends to collect
practice cost data from physician practices in the near future which
could be used to derive cost share weights for the MEI and RVU shares.
In light of the AMA's intended data collection efforts in the near
future and because the methodological and data source changes to the
MEI finalized in the CY 2023 PFS final rule would have significant
impacts on PFS payments, we continue to believe that delaying the
implementation of the finalized 2017-based MEI cost share weights for
the RVUs is consistent with our efforts to balance payment stability
and predictability with incorporating new data through more routine
updates. Therefore, we did not propose to incorporate the 2017-based
MEI in PFS ratesetting for CY 2024.
As discussed above, in the CY 2023 PFS rulemaking, we finalized to
rebase and revise the MEI to reflect more current market conditions
faced by physicians in furnishing physicians' services. The final 2017-
based MEI relies on a methodology that uses publicly available data
sources for input costs that represent all types of physician practice
ownership, not limited to only self-employed physicians. The 2006-based
MEI relied on the 2006 AMA PPIS survey data; as of this CY 2024
rulemaking, this survey had not been updated. Given the changes in the
physician and supplier industry and the time since the last update to
the base year, we finalized a methodology that would allow us to update
the MEI on a consistent basis in the future. The 2017-based MEI cost
share weights are derived predominantly from the annual expense data
from the U.S. Census Bureau's Services Annual Survey (SAS, <a href="https://www.census.gov/programs-surveys/sas.html">https://www.census.gov/programs-surveys/sas.html</a>). We supplement the 2017 SAS
expense data by using several data sources to further disaggregate
compensation costs and all other residual costs (87 FR 69688 through
69708).
We continue to review more recently available data from the Census
Bureau Services Annual Survey, the main data source for the major
components of the 2017-based MEI cost share weights. Data is currently
available through 2021. Given that the impact of the PHE may influence
the 2020 and 2021 data, we continue to evaluate whether the recent
trends are reflective of sustained shifts in cost structures or were
temporary as a result of the COVID-19 PHE. The 2022 data from the
Services Annual Survey will be available later this year. We will
monitor that data and any other data that may become available related
to physician services' input expenses and will propose any changes to
the MEI, if appropriate, in future rulemaking.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters supported our continued delayed
implementation of the rebased and revised MEI in PFS ratesetting. Most
of these commenters urged CMS to pause consideration of other sources
for the MEI until the AMA's efforts to collect practice cost data from
physician practices have concluded. A few commenters urged CMS to
implement the MEI for PFS ratesetting as soon as possible.
Response: We appreciate commenters' feedback, specifically as it
relates to updating PFS ratesetting, and will consider the commenters'
feedback in future rulemaking.
Comment: One commenter stated that the methodology for deriving the
2017-based MEI cost share weights is flawed because the use of the SAS
data as the primary data source for expenses omits facility-based
physicians which, according to BLS Occupational Employment and Wage
Statistics (OEWS) data, accounts for 36 percent of physicians who are
employed in the health sector. The commenter states that correcting for
the omission would result in an increase to the physician work cost
share weight and a much smaller reduction to the professional liability
insurance (PLI) cost share weight in the MEI.
The commenter noted that in response to a similar comment in the CY
2023 PFS final rule, CMS responded that ``for physicians who are
employed in other healthcare settings directly, such as hospitals, we
do not believe that including costs for physicians that do not incur
any operating expenses associated with running a practice would be
technically appropriate.'' However, the commenter stated that this
fails to consider that the MEI cost share weights also cover physician
compensation and professional liability insurance. The commenter stated
that by excluding NAICS 6221 General Medical and Surgical Hospitals in
the CMS MEI cost share weights analysis, CMS inadvertently omitted over
$30 billion in physician compensation and over $7 billion in
professional liability insurance compensation. Also, the commenter
noted that physician practices do still have some indirect PE costs
even for providers who are solely facility-based (coding, billing,
scheduling, etc.). The commenter claimed that the CMS analysis of the
US Census SAS data captured a large majority of PE covered by the PFS
but only a subset of the physician compensation and professional
liability insurance premiums.
The commenter requested that CMS make changes to the methodology
for deriving the MEI cost share weights to correct for the omission of
costs for facility-based physicians.
Response: We appreciate the commenter's concern regarding the
methodology for the 2017-based MEI. As explained in the 2023 PFS final
rule (87 FR 69688 through 69710), the development of the MEI cost share
weights (which would reflect all costs including work, PE and PLI) is
intended to be consistent with costs associated with providing
physician services as paid for by the PFS. Thus, we are using a data
source that reflects the nature of those costs, which we have
determined to be the U.S. Census Bureau's Services Annual Survey. This
data source shows all ownership types of physicians' offices as
determined by the North American Industrial Classification System
(NAICS). Unfortunately, there is currently no data source available
that would provide a comprehensive
[[Page 78831]]
collection of physician expense data for physicians that directly
contract with hospitals or other healthcare settings. While there are
compensation costs for employed physicians working in an alternative
setting such as a hospital or SNF and other associated expenses,
including those for PLI, those costs would be captured in reporting for
those other settings--such as hospitals, home health agencies, or
skilled nursing facilities. For example, if a physician is directly
employed by a hospital, that is, not just a hospital-owned physician
practice, then those costs would be captured in the reported SAS
expenses for NAICS 622 (Hospitals) and on the Medicare cost report
submitted by the hospital. Unfortunately, there is currently no
mechanism for identifying those specific expenses distinct to providing
physician services separately from the provider's other expenses.
Therefore, we have used a data source that we believe reflects the most
up-to-date, comprehensive, and regularly published data on physician
expenses for the majority of physicians (which would be captured in
NAICS 621111--Offices of Physicians). We welcome the public to provide
any other data source that could be considered, in concert with the SAS
data, to address the commenters concerns. Additionally, we understand
that the AMA is currently collecting data on physician expenses and we
will analyze the data if made available to CMS. We note that CMS did
not propose changes to the methodology for deriving the MEI cost share
weights for CY 2024.or.
4. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2024 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2024 PFS final
rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
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 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
[[Page 78832]]
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 through 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 2024, 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 2024 PFS final rule at
<a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
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 1,300 supplies and 750 equipment items currently used as
direct PE inputs. Given the potentially significant changes in payment
that would occur, in the CY 2019 PFS final rule we finalized a policy
to phase in our use of the new direct PE input pricing over a 4-year
period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25
percent (CY 2021), and 100/0 percent (CY 2022) split between new and
old pricing. We believed that implementing the proposed updated prices
with a 4-year phase-in would improve payment accuracy, while
maintaining stability and allowing interested parties the opportunity
to address potential concerns about changes in payment for particular
items. This 4-year transition period to update supply and equipment
pricing concluded in CY 2022; for a more detailed discussion, we refer
readers to the CY 2019 PFS final rule with comment period (83 FR 59473
through 59480).
For CY 2024, we proposed to update the price of 16 supplies and two
equipment items in response to the public submission of invoices
following the publication of the CY 2023 PFS final rule. The 16 supply
and equipment items with proposed updated prices were listed in the
valuation of specific codes section of the preamble under Table 15, CY
2024 Invoices Received for Existing Direct PE Inputs (88 FR 52348).
We did not propose to update the price of another eleven supplies
which were the subject of public submission of invoices. Our rationale
for not updating these prices is detailed below:
<bullet> Extended external ECG patch, medical magnetic tape
recorder (SD339): We received additional invoices for the SD339 supply
from an interested party. Upon review of the invoices, we determined
that they contained the identical price point that we previously
incorporated into last year's rule when we finalized a price of $260.35
for the supply item (87 FR 69514 through 69516). Since these invoices
did not contain any new information, we stated in the proposed rule
that we are maintaining the previously finalized price of $260.35 for
the SD339 supply.
<bullet> Permanent marking pen (SL477), Liquid coverslip (Ventana
650-010) (SL479), EZ Prep (10X) (Ventana 950-102) (SL481), Cell
Conditioning 1 (Ventana 950-124) (SL482), and Hematoxylin II (Ventana
790-2208) (SL483): We received invoices from interested parties for use
in updating the price of these laboratory supplies. In each case,
however, we were able to find the same supply item available for sale
online at the current price or cheaper. Therefore, we do not believe
that the submitted invoices represent typical market pricing for these
supplies and we did not propose to update their prices.
<bullet> Mask, surgical (SB033), scalpel with blade, surgical (#10-
20) (SF033), eye shield, non-fog (SG049), gauze, non-sterile 4in x 4in
(SG051), and towel, paper (Bounty) (per sheet) (SK082): We received
invoices from interested parties for use in updating the price of these
common supply items. In each case, we received a single invoice and
once again we were able to find the same supply items available for
sale online at the current price or cheaper. Generally speaking, we
avoid updating the price for common supply items like the SB033
surgical mask (included in approximately 380 HCPCS codes) based on the
submission of a single invoice, as an invoice unrepresentative of
current market pricing will have far-reaching effects across the PFS.
We did not find that the typical price for a surgical mask had
increased by more than 60 percent since the supply and equipment
pricing update concluded in CY 2022, and as such we stated in the
proposed rule that we are maintaining the current price for these
supply items.
[[Page 78833]]
We received the following comments on our proposed updates to
supply and equipment pricing:
Comment: Several commenters stated that they supported the proposed
pricing updates of the following supplies and equipment items: SC084,
SC085, SM008, SL491, EP034, EP111, SA110, SL077, SL495, SL475, SL488,
SL474, and SL486. The commenters urged CMS to finalize the updates as
proposed.
Response: We appreciate the support for our proposed pricing from
the commenters.
Comment: A commenter stated that they had submitted invoices during
the pre-rulemaking period, in February 2023, to support CMS with
identifying the appropriate direct PE inputs for equipment and supplies
used in physician pathology services. The commenter listed ten supply
and equipment items with updated pricing in the proposed rule (EP034,
EP111, SA110, SL077, SL474, SL475, SL486, SL488, SL491, SL495) and
stated that they supported the proposed pricing changes for these items
and urged CMS to finalize them as proposed in the final rule.
Response: We appreciate the support for our proposed pricing from
the commenter.
Comment: Several commenters stated that they appreciated CMS'
conclusion that the current price of $260.35 should be maintained for
supply item SD339 (extended external ECG patch, medical magnetic tape
recorder) for CY 2024. The commenters stated that the proposed pricing
represented much-needed payment stability for providers of the long
term electrocardiographic (LT-ECG) monitoring service and it was in the
best interest of Medicare beneficiaries for CMS to support continued
patient access to these services through the maintenance of fair and
stable provider reimbursement.
Response: We appreciate the support for our proposed pricing from
the commenters.
Comment: A commenter submitted approximately 50 invoices with the
intention of persuading CMS to update the pricing for the Tubing set,
blood warmer (SC084) and Tubing set, plasma exchange (SC085) supplies.
The commenter stated that these invoices were based on sales to U.S.
customers in June and July 2023 and requested that CMS update their
prices to reflect the data contained on the invoices.
Response: We appreciate the large quantity of pricing data provided
by the commenter for use in updating the pricing of the SC084 and SC085
supplies. After reviewing the invoices, we agree with the commenter
that the Tubing set, blood warmer (SC084) supply is more accurately
priced at $16.27 and the Tubing set, plasma exchange (SC085) supply is
more accurately priced at $277.20. We are finalizing these updated
prices based on the market-based pricing contained in this large sample
of submitted invoices.
The following are additional comments that we received associated
with supply and equipment pricing:
Comment: A commenter stated that the non-facility reimbursement is
significantly undervalued for CPT code 36836 (Percutaneous
arteriovenous fistula creation, upper extremity, single access of both
the peripheral artery and peripheral vein, including fistula maturation
procedures (e.g., transluminal balloon angioplasty, coil embolization)
when performed, including all vascular access, imaging guidance and
radiologic supervision and interpretation). The commenter stated that
an angiography room (EL011) should be included in the equipment item
inputs for CPT code 36836, since it is included in CPT code 36837,
instead of the current vascular ultrasound room (EL016). The commenter
also stated that CMS should update the pricing for the Ellipsys
Vascular Access Catheter (SD351) supply item as the price of $6,000 is
not representative of the current cost of the device. The commenter
submitted approximately 70 invoices with the intention of persuading
CMS to update the pricing for the SD351 supply to $7,378.75.
Response: We disagree with the commenter that the use of an
angiography room would be more typical than the use of a vascular
ultrasound room for CPT code 36837; the vascular ultrasound room was
recommended by the RUC and finalized by CMS in CY 2023 rulemaking (87
FR 69485 through 69489). However, we appreciate the submission of a
large quantity of pricing data provided by the commenter for use in
updating the pricing of the SD351 supply. We previously wrote in CY
2023 rulemaking that we were concerned that the submission of a single
invoice would represent an increase from $6,000 to $8,950 for the SD351
supply, an extraordinary increase in the span of 6 months since the
service was reviewed at the January 2022 RUC meeting, and that we would
consider supply pricing in future updates to this service.
With the much larger batch of invoice data supplied by the
commenter, it is clear that the Ellipsys Vascular Access Catheter
(SD351) supply item has a bimodal pricing structure, with almost
exactly half of the submitted invoices listed at the current price of
$6,000 while the other half were priced at $8,950. Based on this
updated pricing data, we therefore agree that the commenter's suggested
price change to $7,378.75 is an appropriate update to the price of the
SD351 supply as it falls between the two poles of the pricing
distribution. We are finalizing this update to the price of the SD351
supply to more accurately reflect the typical market price.
Comment: A commenter submitted a series of approximately 100
invoices for use in pricing a new supply item known as the WatchPAT One
device. The commenter stated that this was a separate supply from the
WatchPAT pneumo-opt slp probes (SD263) item currently listed in the CMS
supply database priced at $73.32. The commenter detailed the clinical
benefits associated with the WatchPAT One device and provided to CMS
copies of purchase invoices reflecting sales of approximately 3,000
units across all geographic regions of the country to support the
commenter's requested value of $98.20 for the supply item.
Response: We appreciate the submission of this large quantity of
pricing data associated with the WatchPAT One device. Although there
are no HCPCS codes that currently include the WatchPAT One device as a
supply item, we will add the WatchPAT One device to our supply database
with its own supply code (SD362) at the requested price of $98.20 so
that it can be used in future reviews of services that typically make
use of this product.
Comment: A commenter stated that there are numerous discrepancies
between the aggregated cost of some of the supply packs and the
individual item components contained within. The commenter stated that
these mathematical errors should be rectified as soon as possible by
CMS to ensure that the sum correctly matches the totals from the
individual items, and the commenter recommended that CMS resolve these
pricing discrepancies in the supply packs during CY 2024 rulemaking.
The commenter submitted RUC workgroup recommendations to update pricing
for a series of supply packs along with their comment letter.
Response: We appreciate the additional information and RUC
workgroup recommendations provided by the commenter regarding
discrepancies in the aggregated cost of some supply packs. However, due
to the projected significant cost revisions in the pricing of supply
packs, and because we did not propose to address supply pack pricing in
the CY 2024 proposed
[[Page 78834]]
rule, we believe that this issue would be better addressed in future
rulemaking. For example, the cleaning and disinfecting endoscope pack
(SA042) is included as a supply input in more than 300 HCPCS codes
which could have a sizable impact on the overall valuation of these
services, and which was not incorporated into the proposed RVUs
published for the CY 2024 proposed rule. We believe that interested
parties will be better served if CMS addresses this topic in a
comprehensive manner during a potential future rulemaking in which
commenters could provide feedback in response to proposed pricing
updates.
Comment: A commenter reviewed the issue of skin adhesives and
identified several generic alternatives to the use of the skin adhesive
(Dermabond) (SG007) supply. The commenter stated that there are
multiple skin adhesive products, at different price points, available
that work similarly to Dermabond and requested that generic
alternatives should be used overall in place of brand names in the CMS
supply database. The commenter made a series of suggestions for CMS to
create new medical supply item codes to encompass the generic
formulations of cyanoacrylate skin adhesive in multidose form and
single use sterile application.
Response: We note that these revisions to the skin adhesive
supplies were incorporated into the recommendations from the April 2023
RUC meeting where several skin adhesive procedures were reviewed. As we
stated with respect to the pricing of supply packs above, we believe
that this issue would be better addressed in a potential future
rulemaking, for example as part of the RUC review of these skin
adhesive procedures for the upcoming CY 2025 cycle. This would allow
CMS to make any potential revisions to the skin adhesive supplies while
the HCPCS codes in question are also under formal review to minimize
disruption to existing services.
Comment: Several commenters recommended that CMS separately
identify and pay for high-cost disposable supplies. Commenters stated
that this would address the outsized impact that high-cost disposable
supplies have within the current PE RVU methodology; if high cost
supplies were paid separately with appropriate HCPCS codes, their
indirect expense would no longer be associated with that service.
Commenters stated that the result would be that indirect PE RVUs would
be redistributed throughout the specialty PE pool and the PE for all
other services. Commenters recommended that CMS separately identify and
pay for high-cost disposable supplies priced more than $500 using
appropriate HCPCS codes.
Response: We have received a number of prior requests from
interested parties, including the RUC, to implement separately billable
alpha-numeric Level II HCPCS codes to allow practitioners to be paid
the cost of high cost disposable supplies per patient encounter instead
of per CPT code. We stated at the time, and we continue to believe,
that this option presents a series of potential problems that we have
addressed previously in the context of the broader challenges regarding
our ability to price high cost disposable supply items. (For a
discussion of this issue, we direct the reader to our discussion in the
CY 2011 PFS final rule with comment period (75 FR 73251)).
After consideration of the comments, we are finalizing updates to
the pricing of the supply and equipment items as listed in Table 17 and
detailed above. These supply and equipment items with updated prices
are listed in the valuation of specific codes section of the preamble
under Table 17, CY 2024 Invoices Received for Existing Direct PE
Inputs.
(1) Invoice Submission
We remind readers that we routinely accept public submission of
invoices as part of our process for developing payment rates for new,
revised, and potentially misvalued codes. Often these invoices are
submitted in conjunction with the RUC-recommended values for the codes.
To be included in a given year's proposed rule, we generally need to
receive invoices by the same February 10th deadline we noted for
consideration of RUC recommendations. However, we will consider
invoices submitted as public comments during the comment period
following the publication of the PFS proposed rule and would consider
any invoices received after February 10th or outside of the public
comment process as part of our established annual process for requests
to update supply and equipment prices. Interested parties are
encouraged to submit invoices with their public comments or, if outside
the notice and comment rulemaking process, via email at
<a href="/cdn-cgi/l/email-protection#c797829897b5aea4a2988ea9b7b2b39892b7a3a6b3a287a4aab4e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="1343564c43617a70764c5a7d6366674c46637772677653707e603d7b7b603d747c65">[email protected]</span></a>.
c. Clinical Labor Pricing Update
Section 220(a) of the PAMA provides that the Secretary may collect
or obtain information from any eligible professional or any other
source on the resources directly or indirectly related to furnishing
services for which payment is made under the PFS, and that such
information may be used in the determination of relative values for
services under the PFS. Such information may include the time involved
in furnishing services; the amounts, types, and prices of PE inputs;
overhead and accounting information for practices of physicians and
other suppliers, and any other elements that would improve the
valuation of services under the PFS.
Beginning in CY 2019, we updated the supply and equipment prices
used for PE as part of a market-based pricing transition; CY 2022 was
the final year of this 4-year transition. We initiated a market
research contract with StrategyGen to conduct an in-depth and robust
market research study to update the supply and equipment pricing for CY
2019, and we finalized a policy in CY 2019 to phase in the new pricing
over a period of 4 years. However, we did not propose to update the
clinical labor pricing, and the pricing for clinical labor has remained
unchanged during this pricing transition. Clinical labor rates were
last updated for CY 2002 using Bureau of Labor Statistics (BLS) data
and other supplementary sources where BLS data were not available; we
refer readers to the full discussion in the CY 2002 PFS final rule for
additional details (66 FR 55257 through 55262).
Interested parties raised concerns that the long delay since
clinical labor pricing was last updated created a significant disparity
between CMS' clinical wage data and the market average for clinical
labor. In recent years, a number of interested parties suggested that
certain wage rates were inadequate because they did not reflect current
labor rate information. Some interested parties also stated that
updating the supply and equipment pricing without updating the clinical
labor pricing could create distortions in the allocation of direct PE.
They argued that since the pool of aggregated direct PE inputs is
budget neutral, if these rates are not routinely updated, clinical
labor may become undervalued over time relative to equipment and
supplies, especially since the supply and equipment prices are in the
process of being updated. There was considerable interest among
interested parties in updating the clinical labor rates, and when we
solicited comment on this topic in past rules, such as in the CY 2019
PFS final rule (83 FR 59480), interested parties supported the idea.
Therefore, we proposed to update the clinical labor pricing for CY
2022, in conjunction with the final year of the supply and equipment
pricing update (86 FR 39118 through 39123). We
[[Page 78835]]
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. (86 FR 65025) An
example of the transition from the current to the fully-implemented new
pricing that we finalized in the CY 2022 PFS final rule is provided in
Table 5.
[GRAPHIC] [TIFF OMITTED] TR16NO23.005
(1) CY 2023 Clinical Labor Pricing Updates
For CY 2023, we received information from one interested party
regarding the pricing of the Histotechnologist (L037B) clinical labor
type. The interested party provided data from the 2019 Wage Survey of
Medical Laboratories which supported an increase in the per-minute rate
from the $0.55 finalized in the CY 2022 PFS final rule to $0.64. This
rate of $0.64 for the L037B clinical labor type is a close match to the
online salary data that we had for the Histotechnologist and matches
the $0.64
[[Page 78836]]
rate that we initially proposed for L037B in the CY 2022 PFS proposed
rule. Based on the wage data provided by the commenter, we proposed
this $0.64 rate for the L037B clinical labor type for CY 2023; we also
proposed a slight increase in the pricing for the Lab Tech/
Histotechnologist (L035A) clinical labor type from $0.55 to $0.60 as it
is a blend of the wage rate for the Lab Technician (L033A) and
Histotechnologist clinical labor types. We also proposed the same
increase to $0.60 for the Angio Technician (L041A) clinical labor type,
as we previously established a policy in the CY 2022 PFS final rule
that the pricing for the L041A clinical labor type would match the rate
for the L035A clinical labor type (86 FR 65032).
Based on comments received on the CY 2023 proposed rule, we
finalized a change in the descriptive text of the L041A clinical labor
type from ``Angio Technician'' to ``Vascular Interventional
Technologist''. We also finalized an update in the pricing of three
clinical labor types: from $0.60 to $0.84 for the Vascular
Interventional Technologist (L041A), from $0.63 to $0.79 for the
Mammography Technologist (L043A), and from $0.76 to $0.78 for the CT
Technologist (L046A) based on submitted wage data from the 2022
Radiologic Technologist Wage and Salary Survey (87 FR 69422 through
69425).
(2) CY 2024 Clinical Labor Pricing Update Proposals
We did not receive new wage data or other additional information
for use in clinical labor pricing from interested parties prior to the
publication of the CY 2024 PFS proposed rule. Therefore, our proposed
clinical labor pricing for CY 2024 was based on the clinical labor
pricing that we finalized in the CY 2023 PFS final rule, incremented an
additional step for Year 3 of the update:
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[[Page 78837]]
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[[Page 78838]]
[GRAPHIC] [TIFF OMITTED] TR16NO23.007
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 the 4-year transition period. We updated the pricing
of a number of clinical labor types in the CY 2022 and CY 2023 PFS
final rules in response to information provided by commenters. For the
full discussion of the clinical labor pricing update, we direct readers
to the CY 2022 PFS final rule (86 FR 65020 through 65037).
We received the following comments on our clinical labor pricing
update proposals for CY 2024:
Comment: Several commenters stated that CMS created a rank order
anomaly in the pricing of the cytotechnologist (L045A) clinical labor
type when it increased the clinical labor rates for the vascular
interventional technologist (L041A), mammography technologist (L043A),
and CT technologist (L046A) in CY 2023. The commenters stated that the
education requirements for a cytotechnologist were greater than the
requirements for these clinical labor types and that the
cytotechnologist should be valued 10 percent more than the CT
technologist based on Salary Expert data. Commenters stated that
cytotechnologists are responsible for more intensive clinical
responsibilities than MRI technologists, such as preparing and
evaluating human cellular samples from all body sites, to detect and
highlight for the pathologist's attention cells with pre-cancerous
changes, cancer cells, benign tumors, infectious agents, and
inflammatory processes. Commenters requested that CMS crosswalk the
cytotechnologist clinical labor type to the BLS 29-9092 category
(genetic counselors) at a rate of $0.85 to correct this pricing anomaly
and supported their request with data from the 2021 American Society of
Clinical Pathologists (ASCP) Wage Survey of Medical Laboratories, in
which the average cost per minute for cytotechnologists was $0.86.
Response: We appreciate the additional information surrounding the
cytotechnologist (L045A) clinical labor type supplied by the
commenters, especially the 2021 ASCP wage survey containing wage data
on this clinical labor type. After reviewing the information submitted
by the commenters, we concur that a crosswalk to the BLS 29-9092
category at a rate of $0.85 would be more accurate for the L045A
clinical labor type, based on the wage data provided by Salary Expert
and the 2021 ASCP wage survey. We are finalizing this update in the
clinical labor pricing of the L045A clinical labor type from $0.76 to
$0.85 based on this new information.
Comment: Several commenters expressed their disagreement with the
ongoing clinical labor pricing update. Commenters stated that the
pricing update continued to apply a huge and unfair burden on
specialties that require expensive supplies and/or equipment to care
for their patients, and that while the increase in clinical labor
pricing was appropriate, it was not appropriate that some physicians
were negatively impacted by the change. Commenters stated that these
dramatic cuts will also further exacerbate disparities in access to
care and health outcomes, among rural and minority populations, by
constraining and in some cases preventing physicians in community-based
office settings from providing critical patient care to underserved
populations. Commenters asked CMS to hold harmless the specialties that
were most affected by the clinical labor pricing update and not move
forward with the third year of the phase-in. One commenter disagreed
with the finalized BLS 2021 benefit multiplier of 1.296 and stated that
CMS should use the originally proposed 1.366 benefits multiplier
instead.
Response: We finalized the implementation of the clinical labor
pricing update 2 years ago in the CY 2022 PFS final rule (86 FR 65020
through 65037) where we previously addressed these same comments. As we
stated at that time, although we recognize that payment for some
services will be reduced because of the pricing update, due to the
budget neutrality requirements of the PFS, we do not believe that this
is a reason to refrain from updating clinical labor pricing to reflect
changes in resource costs over time. The PFS is a resource-based
relative value payment system that necessarily relies on accuracy in
the pricing of resource inputs; continuing to use clinical labor cost
data that are nearly 2 decades old would maintain distortions in
relativity that undervalue many services which involve a higher
proportion of clinical labor. As noted above, we also finalized the
implementation of the pricing update through a 4-year transition to
help address the concerns of the commenters about stabilizing RVUs and
reducing large fluctuations in year-to-year payments.
For CY 2024, we solicited comments regarding new wage data or other
additional information for use in clinical labor pricing from
interested parties. The clinical labor pricing update itself, including
its pricing methodology, was previously finalized through rulemaking
and the first 2 years of the 4-year transition have already been
implemented; as such, these comments are out of scope for CY 2024
rulemaking.
After consideration of the comments, we are finalizing the clinical
labor prices as shown in Table 7; aside from the Cytotechnologist
(L045A) clinical labor type detailed above, all other clinical labor
pricing remains unchanged from the proposed rule.
BILLING CODE 4120-01-P
[[Page 78839]]
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[[Page 78840]]
[GRAPHIC] [TIFF OMITTED] TR16NO23.009
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 remaining course of the 4-year transition period. We welcome
additional feedback on clinical labor pricing from commenters in next
year's rulemaking cycle, especially any data that will continue to
improve the accuracy of our finalized pricing.
d. Technical Corrections to Direct PE Input Database and Supporting
Files
Following the publication of the CY 2023 PFS proposed rule, an
interested party notified CMS that CPT code 86153 (Cell enumeration
using immunologic selection and identification in fluid specimen (e.g.,
circulating tumor cells in blood); physician interpretation and report,
when required) appeared to be missing its work time in the Physician
Work Time public use file. We reviewed the request from the interested
party and determined that this was indeed an unintended technical
error; we stated in the CY 2013 PFS final rule that we were finalizing
0 minutes pre-service time, 20 minutes intraservice time, and 0 minutes
post-service time to CPT code 86153 (77 FR 69059); however, work time
was inadvertently completely missing for this code. Therefore, we
proposed to add the correct 20 minutes of intraservice work time to CPT
code 86153 for CY 2024.
Comment: A commenter stated that they agreed with the correction of
this error and urged CMS to finalize the update of 20 minutes of intra
service work time for CPT code 86153.
Response: We appreciate the support for our proposal from the
commenter. We received no other comments regarding this proposal, and
we are finalizing the addition of the correct 20 minutes of
intraservice work time to CPT code 86153 for CY 2024, as proposed.
We received the following comments on technical corrections to the
direct PE input database and supporting files:
Comment: A commenter stated that transcatheter valve procedures are
extremely technical in nature and require a highly functional multi-
disciplinary surgical and operating room team, which was not reflected
in the indicators currently assigned to certain Category III codes
associated with this service. The commenter stated that these Category
III codes should have their assistant surgeon, co-surgeon, and team
surgeon indicators match CPT codes 33418 and 33419. Specifically, the
commenter requested that CMS change the assistant surgeon payment
policy indicator from ``0'' to ``2'' for the following transcatheter
valve CPT codes: 0483T, 0544T, 0545T, 0569T, 0570T and 0646T; change
the co-surgeon payment policy indicator from ``0'' to ``1'' for
transcatheter valve CPT codes 0544T, 0545T, 0569T and 0570T, and to
``2'' for CPT code 0646T; and change the team surgeon payment policy
indicator from ``0'' to ``1'' for CPT code 0646T.
Response: We appreciate the feedback from the commenter regarding
the need for greater consistency in the indicators for these Category
III transcatheter valve procedures. After reviewing the request from
the commenter, we concur that these Category III codes should match the
assistant surgeon, co-surgeon, and team surgeon indicators for CPT
codes 33418 and 33419 which had a national coverage determination
released to this effect in 2014 and 2015 (see <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/MM9002.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/MM9002.pdf</a>).
Therefore, we are finalizing the indicator changes requested by the
commenter in the previous paragraph.
Comment: Several commenters raised the topic of indirect PE
allocation for the home PT/INR monitoring services described by HCPCS
codes G0248 and G0249. Commenters stated their appreciation that CMS
acknowledged their concerns about the lack of a specialty designation
that accurately reflects the indirect costs of home PT/INR monitoring
suppliers in the CY 2021 PFS rulemaking cycle and agreed to update the
indirect factors for home PT/INR monitoring by crosswalking to the
General Practice Specialty (85 FR 84477 through 84478). Commenters
stated that proposed policies in the CY 2023 PFS rule completely
negated the limited benefit from this crosswalk to General Practice,
and they again appreciated that CMS changed the crosswalk for PT/INR
suppliers to the All Physician specialty which more closely reflected
indirect-to-direct cost ratios for home PT/INR monitoring services (87
FR 69417 through 69419). Commenters noted that CMS did not propose any
changes in the crosswalk for these services and requested that the
crosswalk remain as previously finalized for CY 2024.
Response: As the commenters noted, we did not propose any changes
to the specialty crosswalk for indirect PE allocation for home PT/INR
monitoring services and we are not finalizing any changes to the
crosswalk for PT/INR monitoring services. Nevertheless, we appreciate
the support from the commenters for our previously finalized policies.
Comment: A commenter questioned the proposed PE RVU for CPT code
97610 (Low frequency, non-contact, non-thermal ultrasound, including
topical application(s), when performed, wound assessment, and
instruction(s) for ongoing care, per day) in the nonfacility setting.
The commenter stated that the proposed reduction was an unfair decrease
that was specific only to CPT code 97610 when other clinically similar
CPT wound care codes were not similarly reduced. The commenter
requested that the nonfacility PE RVU for CPT code 97610 be reviewed
for accuracy and increased
[[Page 78841]]
to match its previous valuation for CY 2024.
Response: We reviewed CPT code 97610 in response to the commenter's
concerns and we can confirm that there are no technical errors
affecting the valuation of this code. We did not make any specific
proposals regarding CPT code 97610 for CY 2024; however, the valuation
for this code is being affected by the ongoing clinical labor pricing
transition. Supply costs make up 94.5 percent of the direct PE inputs
for CPT code 97610 and, as a result, the increased pricing for clinical
labor across all services on the PFS translates into a lower valuation
for CPT code 97610, after budget neutrality is applied to the PE. For
additional information on this topic, we direct readers to the extended
discussion of the clinical labor pricing update in the CY 2022 final
rule (86 FR 65020 through 65037).
Comment: A commenter stated that StrategyGen's market-based supply
and equipment research contained numerous flaws in how it arrived at
the cost of the external counterpulsation (ECP) system (EQ012) used in
HCPCS code G0166 (External counterpulsation, per treatment session) for
CY 2021. The commenter stated that they appreciated CMS' assistance in
recent years to correct some of these errors, but the continued phase-
in of PE RVU decreases associated with equipment costs, as well as the
clinical labor pricing updates adversely impacting services with high
capital expenses, continued to place incredible stress on the
reimbursement for ECP therapy. The commenter stated that the
reimbursement for a full course of therapy has decreased from 2018 to
2023 by nearly the cost of the routinely purchased supplies necessary
for delivering this service, and as a result it is no surprise that
practices that do not specialize in ECP therapy would rather abandon
the service than continue to pay the expensive system maintenance
costs.
Response: We note for the commenter that we did not make any
proposals specifically regarding HCPCS code G0166 or the EQ012
equipment for CY 2024 and the commenter did not supply invoices or
other data to support a change in pricing. If the commenter has reason
to believe that the EQ012 equipment is inaccurately priced, interested
parties are encouraged to submit invoices containing pricing data with
their public comments or, if outside the notice and comment rulemaking
process, via email at <a href="/cdn-cgi/l/email-protection#88d8cdd7d8fae1ebedd7c1e6f8fdfcd7ddf8ece9fcedc8ebe5fba6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="ffafbaa0af8d969c9aa0b6918f8a8ba0aa8f9b9e8b9abf9c928cd197978cd1989089">[email protected]</span></a>. If the
commenter believes that HCPCS code G0166 may be potentially misvalued,
we encourage them to consider nominating the code under our potentially
misvalued process (detailed in section II.C. of this final rule) for
additional review.
5. Soliciting Public Comment on Strategies for Updates to Practice
Expense Data Collection and Methodology
a. Background
The AMA PPIS was first introduced in 2007 as a means to collect
comprehensive and reliable data on the direct and indirect PEs incurred
by physicians (72 FR 66222). In considering the use of PPIS data, the
goal was to improve the accuracy and consistency of PE RVUs used in the
PFS. The data collection process included a stratified random sample of
physicians across various specialties, and the survey was administered
between August 2007 and March 2008. Data points from that period of
time are integrated into PFS calculations today. In the CY 2009 PFS
proposed rule (73 FR 38507 through 3850), we discussed the indirect PE
methodology that used data from the AMA's survey that predated the
PPIS. In CY 2010 PFS rulemaking, we announced our intent to incorporate
the AMA PPIS data into the PFS ratesetting process, which would first
affect the PE RVU. In the CY 2010 PFS proposed rule, we outlined a 4-
year transition period, during which we would phase in the AMA PPIS
data, replacing the existing PE data sources (74 FR 33554). We also
explained that our proposals intended to update survey data only (74 FR
33530 through 33531). In our CY 2010 final rule, we finalized our
proposal, with minor adjustments based on public comments (74 FR 61749
through 61750). We responded to the comments we received about the
transition to using the PPIS to inform indirect PE allocations (74 FR
61750). In the responses, we acknowledged concerns about potential gaps
in the data, which could impact the allocation of indirect PE for
certain physician specialties and suppliers, which are issues that
remain important today. The CY 2010 PFS final rule explains that
section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub.
L. 106-113, November 29, 1999) directed the Secretary to establish a
process under which we accept and use, to the maximum extent
practicable and consistent with sound data practices, data collected or
developed by entities and organizations to supplement the data we
normally collect in determining the PE component. BBRA required us to
establish criteria for accepting supplemental survey data. Since the
supplemental surveys were specific to individual specialties and not
part of a comprehensive multispecialty survey, we had required that
certain precision levels be met in order to ensure that the
supplemental data was sufficiently valid, and acceptable for use in the
development of the PE RVUs. At the time, our rationale included the
assumption that because the PPIS is a contemporaneous, consistently
collected, and comprehensive multispecialty survey, we do not believe
similar precision requirements are necessary, and we did not propose to
establish them for the use of the PPIS data (74 FR 61742). We noted
potential gaps in the data, which could impact the allocation of
indirect PE for certain physician and suppliers. The CY 2010 final rule
adopted the proposal, with minor adjustments based on public comments,
and explained that these minor adjustments were in part due to non-
response bias that results when the characteristics of survey
respondents differ in meaningful ways, such as in the mix of practices
sizes, from the general population (74 FR 61749 through 61750).
Throughout the 4-year transition period, from CY 2010 to CY 2013,
we gradually incorporated the AMA PPIS data into the PFS rates,
replacing the previous data sources. The process involved addressing
concerns and making adjustments as necessary, such as refining the PFS
ratesetting methodology in consideration of interested party feedback.
For background on the refinements that we considered after the
transition began, we refer readers to discussions in the CY 2011
through 2014 final rules (75 FR 73178 through 73179; 76 FR 73033
through 73034; 77 FR 98892; 78 FR 74272 through 74276).
In the CY 2011 PFS proposed rule, we requested comments on the
methodology for calculating indirect PE RVUs, explicitly seeking input
on using survey data, allocation methods, and potential improvements
(75 FR 40050). In our CY 2011 PFS final rule, we addressed comments
regarding the methodology for indirect PE calculations, focusing on
using survey data, allocation methods, and potential improvements (75
FR 73178 through 73179). We recognized some limitations of the current
PFS ratesetting methodology but maintained that the approach was the
most appropriate at the time. In the CY 2012 PFS final rule, we
responded to comments related to indirect PE methodology, including
concerns about allocating indirect PE to specific services and using
the AMA PPIS data for certain specialties (76 FR
[[Page 78842]]
73033 through 73034). We indicated that CMS would continue to review
and refine the methodology and work with interested parties to address
their concerns. In the CY PFS 2014 final rule, we responded to comments
about fully implementing the AMA PPIS data. By 2014, the AMA PPIS data
had been fully integrated into the PFS, serving as the primary source
for determining indirect PE inputs (78 FR 74235). We continued to
review data and the PE methodology annually, considering interested
party feedback and evaluating the need for updates or refinements to
ensure the accuracy and relevance of PE RVUs (79 FR 67548). In the
years following the full implementation of the AMA PPIS data, we
further engaged with interested parties, thought leaders and subject
matter experts to improve our PE inputs' accuracy and reliability. For
further background, we refer readers to our discussions in final rules
for CY 2016 through 2022 (80 FR 70892; 81 FR 80175; 82 FR 52980 through
52981; 83 FR 59455 through 59456; 84 FR 62572; 85 FR 84476 through
84478; 86 FR 62572).
In our CY 2023 PFS final rule, we issued an RFI to solicit public
comment on strategies to update PE data collection and methodology (87
FR 69429 through 69432). We solicited comments on current and evolving
trends in health care business arrangements, the use of technology, or
similar topics that might affect or factor into PE calculations. We
reminded readers that we have worked with interested parties and CMS
contractors for years to study the landscape and identify possible
strategies to reshape the PE portion of physician payments. The
fundamental issues are clear but thought leaders and subject matter
experts have advocated for more than one tenable approach to updating
our PE methodology.
As described in last year's rule, we have continued interest in
developing a roadmap for updates to our PE methodology that account for
changes in the health care landscape. Of various considerations
necessary to form a roadmap for updates, we reiterate that allocations
of indirect PE continue to present a wide range of challenges and
opportunities. As discussed in multiple cycles of previous rulemaking,
our PE methodology relies on AMA PPIS data, which may represent the
best aggregated available source of information at this time. However,
we acknowledge the limitations and challenges interested parties have
raised about using the current data for indirect PE allocations, which
we have also examined in related ongoing research. We noted in last
year's rule that there are several competing concerns that CMS must
take into account when considering updated data sources, which also
should support and enable ongoing refinements to our PE methodology.
Many commenters last year asked that CMS wait for the AMA to
complete a refresh of AMA survey data. We responded to these comments
by explaining the tension that waiting creates in light of concerns
raised by other interested parties. Waiting for refreshed survey data
would result in CMS using data nearly 20 years old to form indirect PE
inputs to set rates for services on the PFS. We reminded readers that
many of the critical issues discussed in the background and history
above are mainly unchanged and possibly would not be addressed by an
updated survey alone but may also require revisions to the PFS
ratesetting methodology.
b. Summary of the Comments and Responses for the Request for
Information
In the CY 2024 PFS proposed rule, we continued to encourage
interested parties to provide feedback and suggestions to CMS that give
an evidentiary basis to shape optimal PE data collection and
methodological adjustments over time. We stated that submissions should
discuss the feasibility and burden of implementing any suggested
adjustments and highlight opportunities to optimize the cadence,
frequency, and phase-in of resulting adjustments. We stated that we
were continuing to consider ways that we may engage in dialogue with
interested parties to better understand how to address possible long-
term policies and methods for PFS ratesetting. We believe some of those
concerns may be alleviated by having ways to refresh data and make
transparent how the information affects valuations for services payable
under the PFS more accurately and precisely.
Considering our ratesetting methodology and prior experiences
implementing new data, we issued a follow-up solicitation for general
information. We solicited comments from interested parties on
strategies to incorporate information that could address known
challenges we experienced in implementing the initial AMA PPIS data.
Our current methodology relies on the AMA PPIS data, legislatively
mandated supplemental data sources (for, example, we use supplemental
survey data collected in 2003, as required by section 1848(c)(2)(H)(i)
of the Act to set rates for oncology and hematology specialties), and
in some cases crosswalks to allocate indirect PE as necessary for
certain specialties and provider types.
We also sought to understand whether, upon completion of the
updated PPIS data collection effort by the AMA, contingencies or
alternatives may be necessary and available to address the lack of data
availability or response rates for a given specialty, set of
specialties, or specific service suppliers who are paid under the PFS.
In light of the considerations discussed above, we requested
feedback on the following:
(1) If CMS should consider aggregating data for certain physician
specialties to generate indirect allocators so that PE/HR calculations
based on PPIS data would be less likely to over-allocate (or under-
allocate) indirect PE to a given set of services, specialties, or
practice types. Further, what thresholds or methodological approaches
could be employed to establish such aggregations?
(2) Whether aggregations of services, for purposes of assigning PE
inputs, represent a fair, stable and accurate means to account for
indirect PEs across various specialties or practice types?
(3) If and how CMS should balance factors that influence indirect
PE inputs when these factors are likely driven by a difference in
geographic location or setting of care, specific to individual
practitioners (or practitioner types) versus other specialty/practice-
specific characteristics (for example, practice size, patient
population served)?
(4) What possible unintended consequences may result if CMS were to
act upon the respondents' recommendations for any of highlighted
considerations above?
(5) Whether specific types of outliers or non-response bias may
require different analytical approaches and methodological adjustments
to integrate refreshed data?
We received public comments on this RFI. The following is a summary
of the comments we received and our responses.
Comment: Most commenters stated that CMS should defer significant
changes until the AMA PPIS results become available. In responding to
our RFI, the AMA RUC provided a set of responses, which many other
commenters repeated in their separate, individual comments. In summary,
the AMA RUC letter responds to all five prompts in the RFI with
rationales that support the assertion that CMS should not consider
further changes until PPIS data collection and analysis is complete.
[[Page 78843]]
Response: We thank the AMA RUC for commenting. In totality, the AMA
comments generally do not support any change to the methodology and
assert that CMS should wait to consider any further changes until PPIS
updates become available. Further, we note that through its contractor,
Mathematica, the AMA secured an endorsement for the PPIS updates from
each State society, national medical specialty society, and others
prior to fielding the survey.\1\ We believe the AMA's approach may
possibly mitigate nonresponse bias, which created challenges using
previous PPIS data. However, we remain uncertain about whether
endorsements prior to fielding the survey may inject other types of
bias in the validity and reliability of the information collected.
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\1\ Refer to the AMA's summary of the PPIS, available at <a href="https://www.ama-assn.org/system/files/physician-practice-information-survey-summary.pdf">https://www.ama-assn.org/system/files/physician-practice-information-survey-summary.pdf</a>.
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Comment: Some commenters did not recommend that CMS defer
significant changes until the AMA PPIS results become available. These
commenters stated that reliance on the PPIS updates may not improve the
accuracy and stability of the PE methodology because of the survey
design, possible implementation challenges, and a possible lack of
transparency or granularity in resulting datasets.
Response: We thank commenters for their feedback. We believe it
remains important to reflect on the challenges with our current
methodology, and to continue to consider alternatives that improve the
stability and accuracy of our overall PE methodology. We reiterate our
discussion summarizing the responses to last year's RFI in the CY 2023
final rule (refer to 87 FR 69429 through 69432). In last year's RFI, we
signaled our intent to move to a standardized and routine approach to
valuation of PE and we solicited feedback. We solicited comment on the
appropriate instrument, methods, and timing for updating PE data, and
requested information on any alternatives that would result in more
predictable results, increased efficiencies, or reduced burdens, for
subsequent updates in later years CMS continues to seek alternatives
that use verifiable, more objective data sets in the future to
supplement or augment survey data used to establish PE RVUs for PFS
services.
Comment: Some commenters stated that regardless of whether one
supports or does not support updating and using updated PPIS data, the
duration between updates and the expense of fielding a survey
instrument may promote further market consolidation. Additionally,
other commenters stated that dependence on the PPIS or survey data in
general, due to timing and frequency constraints, may continue to
jeopardize independent practice and discourage fair competition among
suppliers and providers of services paid under the PFS. These
commenters assert that if current trends continue, it will result in
far fewer independent practices and more consolidation before the
availability of updated survey data, undermining the sampling
methodology of any survey and the general goals of our PE methodology
updates.
Response: We thank commenters for their feedback, and we encourage
interested parties to continue to engage with us regarding the
intersection of PE data and these important issues
Comment: We received a comment co-signed by a broad and varied set
of interested parties (for example, professional membership
organizations, vendors, practitioners, health systems) that requested a
separate RFI. The authors asked that CMS address topics regarding
machine learning, AI, and software and explore a means outside our
annual rulemaking cycle, so that CMS may address changes in healthcare
related to these topics and better account for such changes in payment
moving forward. Commenters asserted that the rapid pace of innovation
may require far more significant changes than would be practical to
address in a given calendar year. The commenters also highlighted the
AMA's efforts to develop Appendix S of the CPT Manual, which
establishes a taxonomy for medical AI.
Response: We remain committed to fostering dialogue with interested
parties on a variety of PE issues, including how to most appropriately
incorporate new and evolving technologies in both collection of PE data
and the PE methodology itself. Further, we acknowledge the efforts of
the AMA to establish a taxonomy for AI, which was informed by
engagement with HHS ONC and others (refer to <a href="https://www.healthit.gov/sites/default/files/page/2020-02/GettingerModeratorSlidesAIPanelsforONCAnnualMeeting12720Final.pdf">https://www.healthit.gov/sites/default/files/page/2020-02/GettingerModeratorSlidesAIPanelsforONCAnnualMeeting12720Final.pdf</a>). We
encourage readers to review general resources that provide overviews of
efforts across HHS that address these topics. Examples include ONC's AI
Showcase, held in late 2022, available at <a href="https://www.healthit.gov/news/events/onc-artificial-intelligence-showcase-seizing-opportunities-and-managing-risks-use-ai">https://www.healthit.gov/news/events/onc-artificial-intelligence-showcase-seizing-opportunities-and-managing-risks-use-ai</a> and this year's issuance of a notice of
proposed rulemaking for Health Data, Technology, and Interoperability:
Certification Program Updates, Algorithm Transparency, and Information
Sharing (HTI-1), (88 FR 23746); as well as the FDA's Artificial
Intelligence/Machine Learning (AI/ML)-Based Software as a Medical
Device (SaMD) Action Plan, available at <a href="https://www.fda.gov/media/145022/download">https://www.fda.gov/media/145022/download</a> and Good Machine Learning Practice for Medical Device
Development: Guiding Principles, available at <a href="https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles">https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles</a>.
C. Potentially Misvalued Services Under the PFS
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the relative
value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of
the Act requires the Secretary to periodically identify potentially
misvalued services using certain criteria and to review and make
appropriate adjustments to the relative values for those services.
Section 1848(c)(2)(L) of the Act also requires the Secretary to develop
a process to validate the RVUs of certain potentially misvalued codes
under the PFS, using the same criteria used to identify potentially
misvalued codes, and to make appropriate adjustments.
As discussed in section II.E. of this final rule, under Valuation
of Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the American
Medical Association (AMA) Resource-Based Relative Value Scale (RVS)
Update Committee (RUC), MedPAC, and other interested parties. For many
years, the RUC has provided us with recommendations on the appropriate
relative values for new, revised, and potentially misvalued PFS
services. We review these recommendations on a code-by-code basis and
consider these recommendations in conjunction with analyses of other
data, such as claims data, to inform the decision-making process as
authorized by statute. We may also consider analyses of work time, work
RVUs, or direct PE inputs using other data sources, such as Department
of Veteran Affairs (VA), National Surgical Quality Improvement Program
(NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based
Incentive Payment System (MIPS) data. In addition to considering the
most recently available data, we assess the results of physician
surveys and
[[Page 78844]]
specialty recommendations submitted to us by the RUC for our review. We
also considered information provided by other interested parties such
as from the general medical-related community and the public. We
conducted a review to assess the appropriate RVUs in the context of
contemporary medical practice. We note that section 1848(c)(2)(A)(ii)
of the Act authorizes the use of extrapolation and other techniques to
determine the RVUs for physicians' services for which specific data are
not available and requires us to take into account the results of
consultations with organizations representing physicians who provide
the services. In accordance with section 1848(c) of the Act, we
determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (<a href="http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0">http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0</a>), MedPAC discussed
the importance of appropriately valuing physicians' services, noting
that misvalued services can distort the market for physicians'
services, as well as for other health care services that physicians
order, such as hospital services. In that same report, MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work required
for certain services would be expected to decline as physicians become
more familiar with the service and more efficient in furnishing it.''
We believe services can also become overvalued when PE costs decline.
This can happen when the costs of equipment and supplies fall, or when
equipment is used more frequently than is estimated in the PE
methodology, reducing its cost per use. Likewise, services can become
undervalued when physician work increases or PE costs rise.
As MedPAC noted in its March 2009 Report to Congress (<a href="http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf">http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf</a>), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
<bullet> Codes that have experienced the fastest growth.
<bullet> Codes that have experienced substantial changes in PE.
<bullet> Codes that describe new technologies or services within an
appropriate time-period (such as 3 years) after the relative values are
initially established for such codes.
<bullet> Codes which are multiple codes that are frequently billed in
conjunction with furnishing a single service.
<bullet> Codes with low relative values, particularly those that are
often billed multiple times for a single treatment.
<bullet> Codes that have not been subject to review since
implementation of the fee schedule.
<bullet> Codes that account for the majority of spending under the PFS.
<bullet> Codes for services that have experienced a substantial change
in the hospital length of stay or procedure time.
<bullet> Codes for which there may be a change in the typical site of
service since the code was last valued.
<bullet> Codes for which there is a significant difference in payment
for the same service between different sites of service.
<bullet> Codes for which there may be anomalies in relative values
within a family of codes.
<bullet> Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
<bullet> Codes with high intraservice work per unit of time.
<bullet> Codes with high PE RVUs.
<bullet> Codes with high cost supplies.
<bullet> Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period (76 FR 73026, 73058 through 73059),
other individuals and groups submit nominations for review of
potentially misvalued codes as well. Individuals and groups may submit
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#8dc0e8e9e4eeecffe8dde5f4fee4eee4ece3cbe8e8deeee5e8e9f8e1e8cdeee0fea3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="6c210908050f0d1e093c04151f050f050d022a09093f0f0409081900092c0f011f4204041f420b031a">[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
[[Page 78845]]
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'' \2\).
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.
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\2\ The research team and panels of experts at the Harvard
School of Public Health developed the original work RVUs for most
CPT codes, in a cooperative agreement with the Department of Health
and Human Services (HHS). Experts from both inside and outside the
Federal Government obtained input from numerous physician specialty
groups. This input was incorporated into the initial PFS, which was
implemented on January 1, 1992.
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3. CY 2024 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67548,
67606 through 67608), we modified this process whereby the public and
interested parties may nominate potentially misvalued codes for review
by submitting the code with supporting documentation by February 10th
of each year. Supporting documentation for codes nominated for the
annual review of potentially misvalued codes may include the following:
<bullet> Documentation in peer reviewed medical literature or other
reliable data that demonstrate changes in physician work due to one or
more of the following: technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
<bullet> An anomalous relationship between the code being proposed
for review and other codes.
<bullet> Evidence that technology has changed physician work.
<bullet> Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
<bullet> Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
<bullet> Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
<bullet> Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
<bullet> National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate for each nominated code whether we
agree with its inclusion as a potentially misvalued code. The public
has the opportunity to comment on these and all other proposed
potentially misvalued codes. In each year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
In each proposed rule, we seek nominations from the public and from
interested parties of codes that they believe we should consider as
potentially misvalued. We receive public nominations for potentially
misvalued codes by February 10th and we display these nominations on
our public website, where we include the submitter's name and their
associated organization for full transparency. We sometimes receive
submissions for specific, PE-related inputs for codes, and discuss
these PE-related submissions, as necessary under the Determination of
PE RVUs section of the rule. We summarize below this year's submissions
under the potentially misvalued code initiative. For CY 2024, we
received 10 nominations concerning various codes. The nominations are
as follows:
(1) CPT Code 59200
In the CY 2022 PFS proposed rule, an interested party nominated CPT
code 59200 (Insertion cervical dilator (e.g., laminaria,
prostaglandin)) (000 zero day global code) as potentially misvalued,
because the direct PE inputs for this code do not include the supply
item, Dilapan-S. Previous parties had initially sought to establish a
Level II HCPCS code for Dilapan-S, but CMS did not find sufficient
evidence to support that request. The same interested party then
submitted Dilapan-S to be considered as a practice expense (PE) supply
input to a Level I CPT code 59200 (86 FR 65045). This year, a different
interested party nominated CPT code 59200 again, and provided the same
reasoning as to why this code is potentially misvalued.
Specifically, the current nominee recommended adding 4 rods of
Dilapan-S at $80.00 per unit, for a total of $320.00 to this one PE
supply inputs, as a replacement for the current PE supply item--
laminaria tent (a small rod of dehydrated seaweed that rehydrates,
absorbing the water from the surrounding tissue). The laminaria tent is
currently listed at $4.0683 per unit, with a total of 3 units, for a
total of $12.20. The current nominee stated that Dilapan-S is more
consistent and reliable, and suggested that it had higher patient
satisfaction than the laminaria tent, and that it was less likely to
cause leukocytosis. CPT code 59200 is a relatively low volume code,
with respect to Medicare claims and, as the nominator stated, this
service is more typically billed for the Medicaid population, as
evidenced by 1.3 million Medicaid claims for this service. Medicaid
programs are able to set their own payment policies, which can be
different from Medicare payment policies. The current Medicare payment
for CPT code 59200 in CY 2023 is about $108.10 in the nonfacility/
office setting, which is much less than the typical cost of the
Dilapan-S supplies requested by the interested party. The requested 4
rods of Dilapan-S would increase the
[[Page 78846]]
supply costs of CPT code 59200 by a factor of five and represent an
enormous increase in the direct costs for the service.
We did not agree that CPT code 59200 was potentially misvalued, and
we did not agree with interested parties that the use of the Dilapan-S
supply would be typical for the service. By including the increased
direct costs of the service ($320.00, the typical cost of four units of
this supply item, Dilapan-S) in the valuation for this code, the cost
of this service would expand both Medicare spending and cost sharing
for any beneficiary who received this service. The cost of Dilapan-S is
over 19 times higher than the cost of the current supply item
(laminaria tent) for CPT code 59200. We agreed with the nominator that
CPT code 59200 was more frequently reported in the Medicaid population,
and therefore, we suggested that interested parties submit a request
for new and separate Medicaid payments to Medicaid.
While we did not propose to consider CPT code 59200 as potentially
misvalued for CY 2024, we solicited comments on this code.
Specifically, we asked commenters whether the absence of supply item
Dilapan-S makes the nonfacility/office Medicare payment for this code
potentially misvalued.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters suggested replacing the laminaria tent
supply item with Dilapan-S, both of which are used to dilate the cervix
in preparation for the induction of labor. Commenters stated that the
code and supply input pricing for CPT code 59200 are both outdated
since the service has evolved and the prices for its PE and supply
items have increased since the code was last reviewed in 2003. One
commenter noted that the use of the laminaria tent instead of Dilapan-S
is not typical of, and does not reflect the standard of care for, term
induction of labor; and that there are now many methods of cervical
dilation, including pharmacological, mechanical, and surgical.
Also, commenters noted that CPT code 59200 only describes the
insertion of the cervical dilator using the laminaria and/or
prostaglandins and it does not describe the insertion of the cervical
dilator with other practice expense supply items. As a result,
commenters suggested CPT code 59200 should be reviewed.
Response: We thank commenters for pointing out that CPT code 59200
is a specific procedure for cervical dilation and that other methods of
cervical dilation (pharmacological, mechanical, and surgical) have come
into practice that are not described by CPT code 59200. We also
appreciate commenters' pointing out that the current market price of
the laminaria tent has increased since the supply item price was
established in 2003. Lastly, we acknowledge commenters' suggestion
regarding the replacement of the supply item laminaria tent with
Dilapan-S.
Comment: A number of commenters stated that CPT code 59200
performed in the office or in the outpatient setting is more efficient
in many ways (including in overall costs) and helps in inducing labor,
which in turn, helps promotes vaginal births rather than concluding as
Cesarean sections when there is not enough dilation. The commenters
noted that in comparison, vaginal births obviously shorten hospital
stays and patient recoveries and improves patient satisfaction in the
birthing method.
Commenters noted that alternate cervical dilation such as
prostaglandins medication must be administered as inpatient, and
mechanical dilation is performed in an outpatient setting, but CPT code
59200 can typically be performed in the office, which is more
desirable. Physicians have noted that patient populations today tend to
have higher incidences of obesity, hypertension, diabetes, and
advancing maternal age complications and to ensure healthy births and
maintain the highest standards of care, the induction of labor is
necessary, which begins with CPT code 59200, cervical dilation. One
commenter adds that the use of laminaria instead of Dilapan-S is not
the standard of care for term induction of labor.
Response: After reviewing the comments concerning CPT code 59200,
we are mainly concerned with whether the code currently represents how
the medical procedure is performed today. We agree with commenters that
CPT code 59200 is a potentially misvalued service since the code has
not been reviewed in 20 years and the current typical practice of this
code has likely evolved since then, warranting a comprehensive review.
As such, we believe that CPT code 59200 could benefit from a review of
its supply, equipment, and clinical labor items, plus physician work
RVUs and physician work times. Therefore, based on the information
provided by commenters regarding the outdated nature of the code and
supply input pricing, we are finalizing CPT code 59200 as potentially
misvalued for CY 2024.
(2) CPT Code 27279
CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or
minimally invasive (indirect visualization), with image guidance,
includes obtaining bone graft when performed, and placement of
transfixing device) (090 day global code) was nominated as potentially
misvalued due to the absence of separate direct PE inputs for this 090
day global code in the nonfacility office setting. Currently, the PFS
only prices CPT code 27279 in the facility setting, at about $826.85
for the physician's professional services, but the nominators were
seeking separate direct PE inputs for this service to better account
for valuation when performed in the nonfacility/office setting.
The nominator claimed that CPT code 27279 could be safely and
effectively furnished in the nonfacility setting and that this
procedure has a low-risk profile, similar to kyphoplasty (CPT codes
22513, 22514, and 22515), which is currently furnished in the
nonfacility setting. The nominator described Kyphoplasty as ``a
percutaneous minimally invasive procedure depositing poly methyl
methacrylate via a cannula into vertebral bodies near neural
structures.'' The nominator stated that permitting payment for direct
PE inputs for CPT code 27279 in the nonfacility/office setting would
increase access to this service for Medicare patients. The nominator
also submitted one sample invoice for $17,985.00 with three units of
the itemized supply item IFuse-3D Implant 7.0 mm x 55mm, US ($5,995.00
per unit) to illustrate the high direct PE costs for CPT code 27279,
should CMS value this code in the nonfacility/office setting.
We expressed concern about whether this 090-day surgical service
could be safely and effectively furnished in the non-facility/office
setting (for example, in an office-based surgical suite). We welcomed
comments on the nomination of CPT code 27279 for consideration as
potentially misvalued.
The following is a summary of the comments we received and our
responses.
Comment: Several commenters supported establishing a nonfacility/
office payment for CPT code 27279. Commenters stated that while the
procedure is currently performed in ASCs, it can be equally effective,
with minimal risk, when done in an office setting. Commenters also
stated that the fact that the service is assigned a 090-day global
period does not imply that the code should only be performed in an
inpatient setting nor that the service
[[Page 78847]]
carries a heightened level of risk, since CPT code 27279 is minimally
invasive. Additionally, to support their recommendation to create a
nonfacility/office payment for CPT code 27279, the commenters cited the
dorsal arthrodesis procedure (Dorsal Sacroiliac Joint Arthrodesis CPT
code 27278 (2X000)) for comparison since it also has a 090 global
period and a nonfacility-office payment.
Response: We appreciate the comments in support of establishing a
nonfacility/office payment for CPT code 27279.
Comment: Several commenters opposed creating a nonfacility/office
payment for CPT code 27279 due to patient safety concerns when
performed in the office setting. Also, some commenters noted that while
the kyphoplasty codes (CPT codes 22513, 22514, 22515) are often cited
as an example of codes supporting nonfacility/office payments similar
to CPT code 27279, those codes have 010 day global periods and do not
have the same level of risk as CPT code 27279. Commenters supported
this point by stating that CPT code 27279 is not necessarily minimally
invasive because it requires the incision and collection of bone as
well as the placement of titanium implants across the sacroiliac joint.
Response: We appreciate the comments opposing the establishment of
a nonfacility/office payment for CPT code 27279.
We thank the commenters for the multiple perspectives regarding
nonfacility/office payment for these services. We note that there does
not appear to be a consensus on whether these services may be safely
and effectively furnished in the nonfacility/office setting, which is a
primary concern in our policy consideration. Therefore, for CY 2024, we
are not finalizing CPT code 27279 as potentially misvalued.
However, after reviewing the public comments, we note a growing
number of potentially misvalued code nominations requesting that we
establish nonfacility payment rates where there currently are none. We
acknowledge that the practice of medicine continues to evolve in ways
that, in clinically appropriate and effective circumstances, there may
be support for a transition of complex procedures into ambulatory
settings. We also acknowledge that PE inputs for such services should
be appropriately determined and established to appropriately reflect
typical clinical practice. We believe services such as those described
by the nominator would benefit from review by other interested parties,
such as the AMA RUC and private payors, even as we consider our
policies for such services.
We look forward to considering valuation recommendations for such
services and additional information that may inform our payment policy
considerations in future rulemaking.
(3) CPT Codes 99221, 99222, and 99223
An interested party nominated the Hospital Inpatient and
Observation Care visit CPT codes 99221 (Initial hospital care, per day,
for the evaluation and management of a patient, which requires these 3
key components: A detailed or comprehensive history; A detailed or
comprehensive examination; and Medical decision making that is
straightforward or of low complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the problem(s)
requiring admission are of low severity. Typically, 30 minutes are
spent at the bedside and on the patient's hospital floor or unit.),
99222 (Initial hospital care, per day, for the evaluation and
management of a patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of moderate complexity. Counseling and/or coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of moderate severity. Typically, 50
minutes are spent at the bedside and on the patient's hospital floor or
unit.), and 99223 (Initial hospital care, per day, for the evaluation
and management of a patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of high complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the problem(s)
requiring admission are of high severity. Typically, 70 minutes are
spent at the bedside and on the patient's hospital floor or unit.) as
potentially misvalued. We note that CMS reviewed these codes in the CY
2023 final rule (87 FR 69588) and established new physician work times
and new work RVU payments for these services. The nominator disagreed
with these values and asserted that these ``facility-based codes are
always inherently (or proportionately) more intense than E/M services
provided in other settings [in particular],'' with patients presenting
with potentially infectious diseases, such as meningitis; pneumonia;
tuberculosis; HIV/AIDS; Ebola virus; Zika virus; and, most recently,
SARS-CoV-2 and mpox, and that the inpatient setting has a predominance
of more seriously ill patients, who are sometimes immunocompromised
and/or have multiple drug interaction issues and/or with comorbidities,
making them extraordinarily more complex than those patients typically
found in the office setting (with many of these infections being
healthcare-associated infections and antibiotic-resistant bacterial
infections). We note that these new requests did not offer appreciably
new information relative to last year's nomination/consideration.
The nominator sought a new work RVU value of 1.92 for CPT code
99221, a new work RVU of 2.79 for CPT code 99222, and a new work RVU
value of 4.25 for CPT code 99223. Currently, CPT code 99221 has a work
RVU of 1.63, a reduction of 15.1 percent from its 1.92 work RVU from CY
2022. CPT code 99222 had a work RVU of 2.61 in CY 2022 and is now at
2.60. CPT code 99223 had a work RVU of 3.86 in CY 2022. It now has a
value of 3.50, which is a reduction of 9.3 percent. The nominator
requested that the work RVU for CPT code 99221 be restored back to
1.92, that the work RVU of CPT code 99222 be increased to 2.79, and
that the work RVU of CPT code 99223 be increased to 4.25 (please see
Table 8 for a comparison of work RVU values for CY 2022, CY 2023, and
of those requested by the nominator).
[[Page 78848]]
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After consideration of these nominations and their requests for
higher work RVUs for CPT codes 99221, 99222, and 99223, we proposed to
maintain the values that we finalized for these codes in the CY 2023
PFS final rule (87 FR 69588). Even so, we welcomed comments on the
nomination of these codes as potentially misvalued.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters stated that CMS should not have accepted
the CY 2023 AMA RUC-recommended RVU values for CPT codes 99221, 99222,
and 99223 because they resulted in payment decreases for all three
services (partially due to a decrease in survey times), due to
significant flaws with the AMA RUC evaluation process. Several
commenters suggested that the work RVUs for CPT codes 99221, 99222, and
99223 be restored to their original values from before CY 2023 or be
increased to mimic the increases that the E/M family of codes has
experienced in recent years.
Response: We thank commenters for their feedback.
After consideration of public comments, we do not believe CPT codes
99221, 99222, and 99223 are potentially misvalued since they were
recently valued in the CY 2023 final rule (87 FR 69588). In that
regulation, we accepted the AMA RUC recommendations. We believe that
the AMA RUC recommendations are still appropriate and best reflect the
work intensity and time involved in furnishing these services.
Therefore, for CY 2024, we are not finalizing CPT codes 99221, 99222,
and 99223 as potentially misvalued.
(4) CPT Codes 36514, 36516, 36522
An interested party nominated CPT codes 36514 (Therapeutic
apheresis; for plasma pheresis), 36516 (Therapeutic apheresis; with
extracorporeal immunoadsorption, selective adsorption or selective
filtration and plasma reinfusion), and 36522 (Photopheresis,
extracorporeal) (all 000 day global codes) as potentially misvalued.
The interested party stated that the direct PE of clinical labor L042A,
``RN/LPN'' (for labor rate of $0.525 per minute), was incorrect and
should be changed to a more specific entry of ``a therapeutic apheresis
nurse specialist (RN)'' (for a labor rate of about $1.06 to $1.14 per
minute), which would approximately double all three of these codes'
clinical labor PE entries. In addition, the nominator disagreed with
the current direct PE of supply item SC085, ``Tubing set, plasma
exchange'' at $186.12 per item, and believed that this would be worth
$248.77 per item with CPT code 36514, using a quantity of one item. The
nominator believed that supply item SC084, ``Tubing set, blood
warmer,'' which we currently have listed at $8.01 per item, should be
worth $14.71 per item with CPT code 36514, also using a quantity of one
item. The nominator submitted sample invoices (not actual invoices) for
illustration and support. We welcomed comments on whether these codes
were potentially misvalued.
The following is a summary of the comments we received and our
responses.
Comment: Several commenters were in favor of establishing a
specific new Therapeutic Apheresis Nurse Specialist labor category for
CPT codes 36514, 36516, and 36522 because they did not believe the
current RN/LPN labor code accurately captured their nurses' specialized
skills, experience, work, and time. Commenters pointed out that
recruiting and retaining nursing personnel has been challenging, and
when competing for an experienced specialized apheresis nurse, salary
demands are higher to attract and keep them. The nominator also
mentioned that a typical apheresis nurse tends to have an extensive
clinical background and specialized therapeutic apheresis experience.
Additionally, commenters noted that these nurses spend significant time
with patients during apheresis procedures, often not leaving the
patient's bedside during the long procedure. Commenters noted that
these nurses are trained to set up specialized equipment, work with
hospital blood banks to acquire blood products, work with pharmacies
for required medications, and consult with medical and nursing staff.
Response: We thank commenters for their detailed description of the
typical duties of an apheresis nurse and how they might differ from a
general RN/LPN nurse.
Comment: Several commenters opposed the nomination of CPT codes
36514, 36516, 36522 as potentially misvalued and advised us to review
the results of the forthcoming AMA PPIS survey before making any
changes. One commenter added that there might be a clinical labor type
gap that CMS could resolve.
Response: We thank commenters for their feedback and for
acknowledging the forthcoming AMA PPIS survey.
After considering the public comments, we believe there may be a
possible disparity with the clinical labor type for this service and
that these codes would benefit from additional review in future
rulemaking. We believe that it is likely that a general RN/LPN labor
category is not adequately equivalent to an Apheresis Nurse Specialist
and while there is currently no Apheresis Nurse category listed in the
PFS, there may be existing nurse categories that can act as a
substitute, such as an oncology nurse. Therefore, for CY 2024, we are
finalizing CPT codes 36514, 36516, and 36522 as potentially misvalued.
(5) CPT Codes 44205 and 44204
An interested party nominated CPT code 44205 (Laparoscopy,
surgical; colectomy, partial, with removal of terminal ileum with
ileocolostomy), as potentially misvalued, requesting that payment for
this code be made equivalent to the higher payment for CPT code 44204
(Laparoscopy, surgical; colectomy, partial, with anastomosis). Both
codes are 090 day global codes, currently valued only in the facility
setting. CPT code 44204 has a total RVU of 45.62 for CY 2023, and CPT
code 44205 has a total RVU of 39.62 for CY 2023, with a difference of
6.00 RVUs. CPT code 44204 is associated with 5 to 6 percent more
physician work time: 455.0 minutes in total, compared to 428.5 minutes
for CPT code 44205. The
[[Page 78849]]
work RVU for CPT code 44204 is also 15 percent higher than the work RVU
for CPT code 44205. The direct PE entries for both codes are the same
regarding supplies, equipment, and clinical labor, except that in the
clinical labor and equipment entries, the number of usage minutes is
higher for CPT code 44204.
Though these two codes appear to be similar, they are still
different in their purpose, physician work times, and direct PE, with
CPT code 44204 involving more time and resources (and having a higher
payment, accordingly). For these reasons, we disagreed with the
assertion that CPT code 44205 is potentially misvalued when compared to
CPT code 44204, and we disagree to modify this payment differential by
paying more for CPT code 44205. We solicited feedback regarding the
nomination of CPT code 44205 as potentially misvalued.
We did not receive public comments on this provision, and
therefore, we are finalizing our proposal not to nominate this service
as potentially misvalued.
(6) CPT Codes 93655 and 93657
An interested party nominated CPT codes 93655 (Intracardiac
catheter ablation of a discrete mechanism of arrhythmia which is
distinct from the primary ablated mechanism, including repeat
diagnostic maneuvers, to treat a spontaneous or induced arrhythmia
(List separately in addition to code for primary procedure)) and 93657
(Additional linear or focal intracardiac catheter ablation of the left
or right atrium for treatment of atrial fibrillation remaining after
completion of pulmonary vein isolation (List separately in addition to
code for primary procedure)), as potentially misvalued. We recently
reviewed these add-on codes in the CY 2022 (86 FR 65108) and CY 2023
(87 FR 69516) final rules.
The nominator reiterated that the primary procedures involve ``high
intensity clinical decision making, complexity in the intraoperative
skills required for treatment, morbidity/mortality risks to the
patient, and work intensity'' and that the work RVUs for both of these
add-on codes should reflect the AMA RUC recommended work RVU of 7.00.
We disagreed with this value in CY 2022 and continued to believe that a
work RVU of 5.50 was appropriate for the 60 minutes of physician
service time for both codes. We saw no reason to reconsider our
valuation of CPT codes 93655 and 93657 for CY 2022 or CY 2023, and we
do not consider these codes to be potentially misvalued now and did not
propose to nominate these codes as potentially misvalued for CY 2024.
Comment: We received very few comments addressing these two cardiac
ablation add-on codes, which were finalized in CY 2023. The commenters
urged CMS to accept the AMA RUC's recommendation for CPT codes 93655
and 93657 of 7.00 work RVUs.
Response: We believe the code valuations we established in CY 2023
are accurate and that these codes are not potentially misvalued;
however, we will continue to monitor this issue and the Medicare claims
data for these codes in the coming years.
We continue to believe that the current code valuations are
accurate and most appropriate for these services. Therefore, for CY
2024, we are not finalizing these codes as potentially misvalued.
(7) CPT Code 94762 and 95800
An interested party nominated CPT code 94762 (Noninvasive ear or
pulse oximetry for oxygen saturation; by continuous overnight
monitoring (separate procedure)), a PE-only code as potentially
misvalued. The nominator noted that the technology behind this code had
changed considerably over the last 14 years, and because the PE inputs
were last reviewed in 2009, the PE items included in the service no
longer reflected current practice. In their submission, the nominator
listed equipment items for CPT code 94762, including EQ212 ``pulse
oxymetry recording software (prolonged monitoring)'' and EQ353 ``Pulse
oximeter 920 M Plus,'' which the nominator asserted are now typically
found in a one-time use supply item: SD263 ``WatchPAT pneumo-opt slp
probes'' (extended external overnight pulse oximeter device probe and
battery with bluetooth, medical magnetic tape recorder) (WatchPAT One
Device) with a cost of $99.00 each (derived from two sample invoices,
not actual invoices, included with the nomination). According to our PE
supply list, item SD263 costs $73.32, which is $25.68 less than the
amounts found in the sample invoices submitted by the nominators. The
nominator retained equipment item EQ212 ``pulse oxymetry recording
software (prolonged monitoring)'', and replaced equipment item EQ353
with ED021, a ``computer, desktop, w-monitor.
The same interested party who nominated CPT code 94762, also
nominated CPT code 95800 (Sleep study, unattended, simultaneous
recording; heart rate, oxygen saturation, respiratory analysis (e.g.,
by airflow or peripheral arterial tone), and sleep time) as potentially
misvalued. The nominator requested that CMS update PE items for this
code, asserting that the PE inputs were last reviewed in 2017. CPT code
95800 currently includes the entry of a one-time use supply item, SD263
``WatchPAT pneumo-opt slp probes'' (extended external overnight pulse
oximeter device probe and battery with bluetooth, medical magnetic tape
recorder) (WatchPAT One Device), which costs $73.32 per item, in
contrast to the pricing in the sample invoice--$99.00 each (case of 12
x $99.00 = $1,188.00).
The nominator excluded the current equipment for this code (EQ335
``WatchPAT 200 Unit with strap, cables, charger, booklet and patient
video'' and EQ336 ``Oximetry and Airflow Device'') and instead included
ED021 (``computer, desktop, w-monitor'') in the PE for this code. We
noted that we did not previously include ED021 as a specialized
equipment item dedicated to this function (and EQ212 ``pulse oxymetry
recording software (prolonged monitoring)'' was also not included in
the PE for CPT code 95800, as it was with CPT code 94762). The
nominator included the PE listings for CPT code 93245 (Heart rhythm
recording, analysis, interpretation and report of continuous external
EKG over more than 1 week up to 1 weeks) as an example of how PE supply
items for CPT code 95800 should be structured, but this code included
supply item, SD339 ``extended external ECG patch, medical magnetic tape
recorder'' and equipment item ED021 ``computer, desktop, w-monitor,''
which is presumed to be used to record the data from the ECG patch and
to be used to analyze the data.
There is no clear evidence whether the WatchPAT One Device needs or
does not need the specific monitoring and recording system (equipment
item EQ212 ``pulse oxymetry recording software (prolonged
monitoring)'') for CPT code 95800, as opposed to any other system/
process. The interested party requested the PE changes discussed above
to support their argument that these CPT codes are potentially
misvalued (see Table 9).
BILLING CODE 4120-01-P
[[Page 78850]]
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BILLING CODE 4120-01-C
We welcomed comments as to whether these codes are potentially
misvalued.
The following is a summary of the comments we received and our
responses.
Comment: One commenter disagreed with the replacement of various PE
items with alternative items. For example, for CPT code 94762, the
existing pulse oximeter 920 M Plus (CMS equipment item EQ353) would be
replaced with the disposable WatchPAT One supply item (SD263). The
commenter expressed concern about removing the pulse oximetry devices
from CPT code 94762 and whether the WatchPAT One supply item properly
assessed and monitored a patient's sleep, as described by the code.
Response: We thank commenters for their feedback. There seems to be
a general misunderstanding from the original nomination regarding which
PE items should be replaced or retained and which items are considered
duplicated, according to the public comments received.
We cannot properly assess if CPT codes 94762 and 95800 are
potentially misvalued based on the evidence submitted with the original
nomination and subsequent public comments we received in response to
the CY 2024 PFS proposed rule. After considering the public comments,
it is still unclear whether CPT codes 94762 and 95800 are potentially
misvalued. We invite the original nominator or other parties to
resubmit their nomination with information providing additional clarity
for further consideration in future rulemaking. Therefore, for CY 2024,
we are not finalizing CPT codes 94762 and 95800 as potentially
misvalued.
(8) CPT Codes 0596T and 0597T
An interested party nominated CPT codes 0596T (Initial insertion of
temporary valve-pump in female urethra) and 0597T (Replacement of
temporary valve-pump in female urethra) as potentially misvalued. This
nominator generally expressed concern about variability in MAC pricing
for the contractor-priced service and requested that CMS establish
national pricing to stabilize payments that more accurately reflected
the work, professional liability costs, and especially the nonfacility
PE for these services, including the costs associated with the Vesiflo
inFlow
[[Page 78851]]
System, the primary supply included in the procedures described by the
two Category III CPT codes. The nominator stated that the MAC-
determined payment amounts had been inappropriately low and did not
account for the time and the work involved in furnishing the services
or all of the PE. In their submission, the nominator discussed their
expected inputs for both codes. For CPT code 0596T, the nominator
asserted that a physician would typically spend 60 minutes of work
inserting the Vesiflo inFlow System. The nominator also discussed the
PE items used to furnish the procedure. These specified PE items
included a power table, a mayo stand, an examination light, clinical
labor time of a RN/LPN/MTA totaling to 73 minutes, and a list of
supplies summing to $1,902.76, primarily from the inFlow Measuring
Device of $140.00, the inflow Device of $495.00, and the inflow
Activator Kit of $1,250.00, with the inflow supply items making up
about 99 percent of the total cost of supplies.
For CPT code 0597T, the nominator asserted that a physician would
typically spend 25 minutes replacing the Vesiflo inFlow System. The
specified PE items for this service included a power table, a mayo
stand, an examination light, clinical labor time of a RN/LPN/MTA
totaling 38 minutes, and a list of supplies summing to $505.30,
primarily from the inflow device of $495.00, with the inflow supply
items making up about 98 percent of the total cost of supplies. A
sample invoice was included in this nomination (as opposed to an actual
invoice).
We welcomed comments on whether these two temporary category III
CPT codes, CPT codes 0596T and 0597T, were potentially misvalued and
whether these codes should remain contractor-priced.
The following is a summary of the comments we received and our
responses.
Comment: We received several comments supporting our proposal to
nominate CPT codes 0596T and 0597T as potentially misvalued. These
commenters recommended that we establish national pricing for these
services, stating that a change to national pricing would address the
misvaluation and pricing variability for the service and allow for the
appropriate inclusion of the Vesiflo system in the code's PE.
Response: We note that CPT codes 0596T and 0597T are category III
codes and describe relatively new and low-volume services. Generally,
category III codes are contractor-priced under the PFS, meaning that
each MAC can establish pricing for the code for areas within its
jurisdiction. We appreciate the nominators' and commenters' concerns
about variability in payment across the different MAC jurisdictions.
After consideration of public comments, we are not finalizing CPT
codes 0596T and 0597T as potentially misvalued. These are contractor-
priced codes and they will remain contractor priced for the present.
However, we encourage interested parties to continue to engage with the
MACs and provide accurate and appropriate cost data to inform the MAC's
consideration and pricing of these services.
(9) CPT Code 93000
An interested party nominated CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report) as
potentially misvalued, arguing that we should increase Medicare payment
for CPT code 93000 to $35.64 when used in conjunction with other
supplies and services, to reflect PE costs equivalent to (1) $6.10 for
EKG leads; (2) $21.19 for a nurse visit of typically 5 minutes (as
illustrated by CPT code 99211 (Office or other outpatient visit for the
evaluation and management of an established patient, that may not
require the presence of a physician or other qualified health care
professional. Usually, the presenting problem(s) are minimal.
Typically, 5 minutes are spent performing or supervising these
services.)); and (3) $7.64 for the interpretation and report for the
EKG service (as illustrated by CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only).
While the interested party did not provide invoices or other evidence
for consideration, they asked that we value the grouping of these
services at $35.64, even though the direct costs for these identified
PE inputs total to $34.93.
After consideration of submitted information, we decided not to
propose to nominate CPT code 93000 as potentially misvalued for CY
2024. We did not believe that the total of a mix of services is a
persuasive indication that one code--in this case, CPT code 93000--was
potentially misvalued.
We did not receive public comments on this nomination. Therefore,
for CY 2024, we are not finalizing CPT codes code 93000 as potentially
misvalued.
(10) 19 Therapy Codes
An interested party nominated 19 therapy codes as potentially
misvalued. We noted in the proposed rule that these 19 therapy codes
were last reviewed by CMS in the CY 2018 PFS final rule (82 FR 53073
through 53074). The nominators asserted that the direct PE clinical
labor minutes, as recommended by the AMA Relative Value Scale Update
Committee (RUC) and Healthcare Professional Advisory Committee (HCPAC)
Review Board, reflected inappropriate multiple procedure payment
reductions (MPPR), which are likely duplicative of the CMS MPPR policy
implemented in CMS' claims processing systems.
As discussed in the proposed rule, we reviewed the clinical labor
time entries for these 19 therapy codes. We noted that we did not
believe a payment reduction should have been applied to the 19
nominated therapy codes' clinical labor time entries (Table 10) since
the payment valuation reduction would be duplicative of the MPPR we
apply during claims processing. We proposed to nominate these 19 codes
as potentially misvalued for CY 2024, as we believed that the valuation
of these services would benefit from additional review through the AMA
RUC HCPAC valuation process. We also sought comment on our proposal.
The following is a summary of the comments we received and our
responses.
Comment: Numerous commenters supported our proposal to nominate
these 19 therapy codes as potentially misvalued. There were no comments
asserting that these codes should not be considered potentially
misvalued.
Response: After consideration of the public comments for this
issue, we are finalizing our proposal to consider the 19 therapy codes
as potentially misvalued for CY 2024.
[[Page 78852]]
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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
[…truncated; see source link]Indexed from Federal Register on November 16, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.